Feedback/registration mechanism for ultrasound devices

Among other things, there is disclosed structure and methods for registering images obtained through internal (e.g. intravascular) ultrasound devices. Embodiments of a device with a rotating ultrasound beam is provided, with a wall of the device being anisotropic in ultrasound passage. As examples, a cable opaque to ultrasound is attached along the wall of the device, so that the ultrasound beam at the location of the cable is blocked, reflected or scattered. As another example, a thin film of metallic material is placed on or in the wall to allow a portion of the beam to be blocked or attenuated. The imaging system recognizes the changes to the signals made by the anisotropic wall, and registers successive images according to those changes.

Endovascular prosthesis and a method of connecting a structural component and a woven graft material

An endovascular prosthesis that includes a stent and a woven graft material. The stent is connected to the graft material by direct attachment of the stent to the graft material at thermoplastically fused regions of the graft material.

COATED MEDICAL DEVICE

A coated medical device () including a structure () adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material () having a bioactive material layer () disposed thereon. The medical device is preferably an implantable stent or balloon () of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material () positioned between the base and bioactive material layers of the balloon. 121-. (canceled)22. A medical device comprising a balloon having a surface; wherein the balloon surface comprises paclitaxel and a low molecular weight matrix substance; and wherein the low molecular weight matrix substance comprises a hydrophilic material.23. The medical device of wherein the balloon surface comprising paclitaxel and a low molecular weight matrix substance is a solution of paclitaxel and the low molecular weight hydrophilic material applied to the balloon and dried.24. The medical device of claim 22 , wherein the hydrophilic material is an iodine-containing radiopaque agent.25. The medical device of wherein the hydrophilic material comprises a sugar.26. The medical device of wherein the sugar comprises a polysaccharide.27. The medical device of wherein the sugar comprises dextran.281. The medical device of claim wherein the hydrophilic material comprises an alcohol.29. The medical device of wherein the alcohol comprises alpha-tocopherol.30. The medical device of wherein the hydrophilic material comprises a sugar derivative.31. The medical device of wherein the sugar derivative ...

Catheter systems and methods useful for cell therapy

Described in one aspect is a multi-pressure monitoring system for cell or other therapy includes a first catheter having a first lumen for accepting a treatment device, a second lumen for inflating a balloon, a pressure sensor for monitoring fluid pressure within the first lumen, and a flow restrictor such as a hemostasis valve for limiting the exchange of fluids into and out of the first lumen while treatment devices are present or exchanged in the first lumen. Also disclosed is a method of using the first catheter with a first pressure monitor coupled to the first pressure sensor along with a second catheter attached to a second pressure sensor coupled to a second pressure monitor. The second catheter is positioned within the first lumen of the first catheter during treatment operations and the first and second pressure monitors are used to verify proper pressures throughout the procedure. Described also are novel methods, systems, and catheters for delivering flowable therapeutic substances ...

Coated medical device

A coated medical device ( 10 ) including a structure ( 12 ) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material ( 14 ) having a bioactive material layer ( 18 ) disposed thereon. The medical device is preferably an implantable stent or balloon ( 26 ) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material ( 58 ) positioned between the base and bioactive material layers of the balloon.

COATED MEDICAL DEVICE

A coated medical device () including a structure () adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material () having a bioactive material layer () disposed thereon. The medical device is preferably an implantable stent or balloon () of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material () positioned between the base and bioactive material layers of the balloon. 121.-. (canceled)22. A catheter balloon having a surface and composition applied thereto , wherein the composition comprises: at least one lipophilic anti-hyperplastic agent selected from paclitaxel , heparin , prostacyclins , colchicine , and rapamycin; wherein said balloon surface does not contain a pharmacological polymer , and wherein said composition is of a form suitable for administration into a blood vessel section; wherein the composition contains a solubility promoter that does not form micelles.231. The catheter balloon according to claim , wherein the solubility promoter is ethanol.241. The catheter balloon according to claim , wherein said at least one lipophilic anti-hyperplastic agent is rapamycin.251. The catheter balloon according to claim , wherein said at least one lipophilic anti-hyperplastic agent is paclitaxel.261. The catheter balloon according to claim , wherein said composition further comprises an iodine-containing X-ray contrast agent.271. The catheter balloon according to claim , wherein said composition further comprises a coagulation inhibitor , a platelet aggregation ...

Mechanical scanning ultrasound transducer with micromotor

A system for use with ultrasound procedures including an ultrasound control and/or imaging system which has a microminiature motor, a rotatable reflector and a stationary ultrasound transducer. The transducer may be placed between the motor and the reflector, so as to eliminate the need for placement of wires or other artifact-creating items in the path of ultrasound signals. In particular embodiments, such systems can be incorporated in or retrofitted to commercially standard diagnostic and therapeutic catheters or other housings. Examples can be used in variety of ultrasound procedures, e.g. to perform intravascular ultrasound (IVUS) imaging.

Methods, substrates, and systems useful for cell seeding of medical grafts

Described are methods, cell growth substrates, and devices that are useful in preparing cell-containing graft materials for administration to patients. Tubular passages can be defined in cell growth substrates to promote distribution of cells into the substrates. Also described are methods and devices for preparing cell-seeded graft compositions, methods and devices for preconditioning cell growth substrates prior to application of cells, and cell seeded grafts having novel substrates, and uses thereof.

Internal transducer assembly with slip ring

A device for internal ultrasound imaging including a micro-motor rotates a drive shaft and ultrasound transducer. Conductors attach between the transducer and slip ring assemblies. The slip ring assemblies conductively couple the transducer conductors to a set of conductors extending toward a console.

PRODUCTS COMPRISING AN EXTRACELLULAR MATRIX TISSUE MATERIAL AND OSTEOGENIC PROTEIN

Osteogenic compositions include a decellularized extracellular matrix tissue and bone morphogenic protein, preferably BMP-2. The compositions make beneficial use of the BMP, which can be used at relatively low doses and can bind to native components (e.g., native sulfated glycosaminoglycans such as heparin and/or heparan sulfate) remaining in the decellularized extracellular matrix tissue. Methods for preparation and use of such compositions are also described. The compositions and related methods can be used in the treatment of diseased or damaged bone tissue. 1. An osteogenic composition , comprising:a collagenous extracellular matrix tissue material; andbone morphogenic protein.2. The composition of claim 1 , wherein:the collagenous extracellular matrix tissue material is a solid; andthe bone morphogenic protein is impregnated in the solid.3. The composition of claim 1 , wherein:the collagenous extracellular matrix tissue material retains native heparin from a source tissue for the collagenous extracellular matrix tissue material; andat least a portion of the bone morphogenic protein is bound to the native heparin.4. The composition of claim 1 , wherein:the bone morphogenic protein comprises recombinant human BMP-2.5. The composition of claim 1 , wherein:the collagenous extracellular matrix tissue material retains native components from a source tissue for the collagenous extracellular matrix tissue material; andat least a portion of the bone morphogenic protein is bound to the native components.6. The composition of claim 1 , wherein the bone morphogenic protein is present at a level in the range of about 75 μg to about 300 μg per gram (dry weight) of the collagenous extracellular matrix tissue material.7. The composition of claim 1 , wherein the extracellular matrix tissue material retains native growth factors claim 1 , glycosaminoglycans claim 1 , proteoglycans and glycoproteins from a source tissue for the extracellular matrix tissue material.8. The ...

Vascular occlusion devices and methods

The present invention provides, in certain embodiments, unique products and methods for occluding vascular vessels. Implantable devices useful in some inventive embodiments include at least two expandable occluding members, e.g., self-expandable sponge form devices, with an intermediate segment extending between the members. These devices are preferably compressible for placement in a delivery device lumen for delivery to a vascular vessel site. Upon deployment in the vessel, each of the members expands to occlude the vessel at a separate vessel location with the intermediate segment occupying space in the vessel between the two members. Optionally, the intermediate segment can be constructed to provide a hollow or other interior region for receiving one or more materials, for example, to receive an injectable fill material after one or both of the expandable members have been deployed.

SYSTEMS AND METHODS FOR FILLING AND SEALING VIALS

A filling and sealing system is provided for efficiently filling a series of individual vials with therapeutic liquids. In particular embodiments, the system includes a filling zone or station, a sealing zone or station, an unloading zone or station, and electronic controls. 14.-. (canceled)5. An apparatus for filling vials having a chamber and an inlet tube with therapeutic biological liquids , comprising:a carriage for holding a plurality of the vials through a filling and sealing process, wherein the carriage includes a tray as a base, the tray having side upwardly-extending walls;a liquid nozzle connected to a liquid dispenser that draws from a liquid reservoir, the liquid nozzle lowerable into inlet tubes of individual vials to dispense liquid via the inlet tube into the vial chamber so that some liquid remains in the inlet tube;an air nozzle connected to an air dispenser and dispensing filtered air, the air nozzle lowerable into inlet tubes of individual vials and operable to force air into the inlet tube to force liquid through the inlet tube into the vial chamber and to create suction to remove a portion of air from the inlet tube so as to leave an aliquot of liquid between air pockets in the inlet tube;at least one pair of sealing bars, each having a pair of heating elements separated by at least the distance between the air pockets, adapted to be pressed together against the inlet tube to make seals in the inlet tube on either side of the aliquot in the inlet tube.6. The apparatus of claim 5 , wherein the carriage includes supports extending upward from the tray claim 5 , and an upper mount attached to the supports claim 5 , the upper mount having a horizontal arm with a set of slots for accommodating vials.7. The apparatus of any of claim 6 , further comprising a locking bar pivotally connected to the upper mount at a pivot point and having a series of slots claim 6 , the locking bar being pivotable outward from a closed position in which the locking bar ...

Reciprocating ultrasound device

A device for internal ultrasound procedures includes a motor which rotates a drive shaft and an ultrasound transducer. A gearing assembly provides reciprocating rotational motion from a unidirectional motor. A cam assembly provides reciprocating pivotal motion to the transducer. Conductors can attach to the transducer and extend through the drive shaft.

Internal ultrasound assembly with port for fluid injection

There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms.

OVER-THE-WIRE ULTRASOUND SYSTEM WITH TORQUE-CABLE DRIVEN ROTARY TRANSDUCER

Disclosed are embodiments of devices and methods for imaging the inside of a body part, such as a blood vessel. In particular embodiments, a catheter has a chamber within which is a transducer. A wire guide channel extends throughout the length of the catheter. The transducer is rotatable about the wire guide channel and the transducer is driven by a cable or other device that is connected to a motor which is located outside the catheter. In one form, a torque cable connects the transducer to the motor. In other embodiments, a pusher piece having a plurality of lumens is positioned in the catheter. Each of the lumens is sized to receive a cable, wire, and/or flushing fluid. The lumens maintain the orientation and separation of the cables, wires, and/or to flushing fluid. 1. A medical ultrasound device comprising:a housing having a longitudinal axis;a transducer configured for transmitting and/or receiving ultrasound signals and operatively coupled with a drive shaft extending substantially along the longitudinal axis, the transducer and the drive shaft positioned within the housing, wherein the transducer rotates about the longitudinal axis in response to rotation of the drive shaft;a non-rotating wire guide positioned along the longitudinal axis within the housing; anda torque cable offset a distance from the longitudinal axis, the torque cable operably connected to the drive shaft and a motor so that the drive shaft rotates in response to the torque cable.2. The device of claim 1 , further comprising:a first gear operably connected to the torque cable; anda second gear operably connected to the drive shaft, wherein the second gear is configured to interact with the first gear such that the second gear is configured to rotate when the first gear rotates.3. The device of claim 2 , wherein the first gear has a rotational axis offset from the longitudinal axis and the first gear is configured to rotate about the rotational axis; andthe second gear is configured to ...

Peripheral sealing venous check-valve

Among other things, there are disclosed embodiments of a valve implant that in particular examples are implantable within a blood vessel, which include a first set of elongate members, a second set of elongate members, and a hood affixed to the first set of elongate members. The first set of elongate members is resiliently deformable, and their distal ends are flared radially outward. The distal ends of the second set of elongate members are distal to the ends of the first set of elongate members. The hood is affixed to the first set of elongate members, and seals against the interior wall of the blood vessel in an expanded configuration. When blood flows from the proximal to the distal side of the valve implant, it presses on the hood, compressing the first set of elongate members, breaking the seal.

Percutaneous, ultrasound-guided introduction of medical devices

Described are methods and systems and system components useful for percutaneously delivering or retrieving vascular implant devices, such as filters, utilizing intravenous ultrasound (IVUS) imaging alone or in combination with external (e.g. transabdominal) ultrasound or other imaging technology. Implants deliverable by such systems, such as vena cava or other vascular filters, can have two or more echogenic markers spaced at such a distance that they are separately discernible by IVUS and/or external ultrasound imaging.

Coated medical device

A coated medical device ( 10 ) including a structure ( 12 ) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material ( 14 ) having a bioactive material layer ( 18 ) disposed thereon. The medical device is preferably an implantable stent or balloon ( 26 ) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material ( 58 ) positioned between the base and bioactive material layers of the balloon.

CATHETER SYSTEMS AND METHODS USEFUL FOR CELL THERAPY

Described in one aspect is a multi-pressure monitoring system for cell or other therapy includes a first catheter having a first lumen for accepting a treatment device, a second lumen for inflating a balloon, a pressure sensor for monitoring fluid pressure within the first lumen, and a flow restrictor such as a hemostasis valve for limiting the exchange of fluids into and out of the first lumen while treatment devices are present or exchanged in the first lumen. Also disclosed is a method of using the first catheter with a first pressure monitor coupled to the first pressure sensor along with a second catheter attached to a second pressure sensor coupled to a second pressure monitor. The second catheter is positioned within the first lumen of the first catheter during treatment operations and the first and second pressure monitors are used to verify proper pressures throughout the procedure. Described also are novel methods, systems, and catheters for delivering flowable therapeutic substances, such as viable cellular preparations, to patients. 1. A method of delivering a liquid medium to a patient , comprising:advancing the liquid medium under pressure through a first catheter lumen and into a patient bodily lumen so as to generate a first fluid pressure in the catheter lumen and a second fluid pressure in the bodily lumen;during said advancing, measuring the first fluid pressure with a first fluid pressure sensor operably coupled to the first catheter lumen; andduring said advancing, measuring the second fluid pressure with a second fluid pressure sensor operably coupled to a second catheter lumen in fluid communication with the bodily lumen.2. The method of claim 1 , wherein the liquid medium contains viable cells.3. A method of delivering viable cells to a target bodily passage site of a patient claim 1 , comprising: (i) first advancing an inflatable balloon of a first catheter to the first bodily passage site, the first catheter having a first catheter shaft ...

Apparatus and method for the delivery of an intravascular filter

A delivery apparatus for introducing an intravascular filter into a body vessel of a patient includes a sheath defining a lumen, an intravascular filter positioned in the lumen, an ultrasound transducer positioned to the application side of the intravascular filter, a guide wire cannula and a tip located at an application side end of the delivery apparatus.

Apparatus and method for the retrieval of an intravascular filter

A retrieval apparatus for removing an intravascular filter from a body vessel of a patient includes an outer sheath defining an outer lumen, an inner sheath defining an inner lumen wherein the inner sheath is positioned within the outer lumen, a retrieval member positioned in the inner lumen, an ultrasound transducer positioned on the application side of the retrieval member, a guide wire cannula extending between the outer sheath and the inner sheath, the guide wire cannula including an application side end, and a dilator located at an application side end of the retrieval apparatus, said dilator being coupled to said ultrasound transducer and receiving the application side end of said guide wire cannula.

Modifiable medical grafts and related methods and apparatuses

Described are medical graft materials and devices which can be usefully modified with liquid additives such as cell suspensions, bioactive agents, or combinations of these. The medical graft materials and devices can have a first outer surface and a second outer surface and can define an internal chamber between the first outer surface and the second outer surface. The medical graft materials and devices can also have at least one region of the graft material interrupting the chamber and surrounded by the chamber. Also described are methods for making and using these medical graft materials and devices.

ANEURYSM STOP PRESSURE SYSTEM

Intravascular devices and systems useful for blocking the opening of an aneurysm or a vessel branch are disclosed. In some aspects, the disclosure provides arrangements that align a covering material of a stent graft with an opening in the vessel wall before, during, and/or after expansion of the stent graft within the vasculature of a patient. In some instances, systems and devices include a sheath with a side aperture arranged to align a portion of the sheath and/or a portion of a stent graft contained within the sheath with the mouth of an aneurysm. Similarly, the present disclosure also provides embodiments in which the stent graft comprises an aligning member arranged to align the stent graft and/or a sheath with the mouth of an aneurysm. Other embodiments are disclosed. 1. A system for delivering a stent graft useful for closing an opening in a vessel wall of a patient , comprising:a delivery member, a stent graft, and an aligning member;said stent graft having a supporting structure expandable between a first configuration arranged for delivery of said stent graft with the delivery member and a second configuration arranged for deployment in a vessel;said stent graft having a covering material extending along a portion of said stent graft; andsaid aligning member coupled to said stent graft and extending from an area of said stent graft covered by said covering material.2. The system of claim 1 , wherein:said delivery member comprises a sheath having a distal end region, a proximal end region, and a sidewall extending between said distal and proximal end regions;said sidewall defining a lumen extending along a length of said sheath and a side aperture extending through said sidewall and communicating with said lumen;said side aperture arranged to slidably receive said aligning member; andsaid stent graft slidably positioned within said lumen.3. The system of claim 2 , wherein:said side aperture having a portion positioned proximally of said distal end region ...

Implements for identifying sheath migration

Attachable implements, systems, and methods for identifying the migration of a medical device extending through a percutaneous insertion site of a patient's skin are disclosed. In one embodiment, an attachable implement for identifying migration comprises a attachable implement body having a coupling surface and a skin contacting surface, the coupling surface arranged to couple to a surface of the medical device, and the skin contacting surface arranged to contact the skin of the patient; wherein the attachable implement body is arranged to be side mountable on the medical device and wherein the attachable implement is configured to move from a first position adjacent to the patient's skin to a second position remote from the patient's skin. Systems, methods, and other embodiments are disclosed.

Stent attachment for endovascular aneurysm repair

The technology described herein relates to a stent graft and a method of making the stent wherein the stent comprises interconnected struts and is connected to the graft material by applying at least one band of polymer so as to cover at least a portion of at least some of the struts. A stent supported area is created by the stent's attachment to the graft material and the at least one band of polymer is applied so as to leave the majority of the stent supported area uncovered by the at least one band of polymer.

VASCULAR OCCLUSION DEVICES AND METHODS

The present invention provides, in certain embodiments, unique products and methods for occluding vascular vessels. Implantable devices useful in some inventive embodiments include at least two expandable occluding members, e.g., self-expandable sponge form devices, with an intermediate segment extending between the members. These devices are preferably compressible for placement in a delivery device lumen for delivery to a vascular vessel site. Upon deployment in the vessel, each of the members expands to occlude the vessel at a separate vessel location with the intermediate segment occupying space in the vessel between the two members. Optionally, the intermediate segment can be constructed to provide a hollow or other interior region for receiving one or more materials, for example, to receive an injectable fill material after one or both of the expandable members have been deployed. 1. A medical product for occluding a vascular vessel , the medical product comprising: a first expandable member;', 'a second expandable member spaced from the first expandable member, wherein the first expandable member and the second expandable member are each compressible to permit delivery through the vasculature to the vascular vessel site, and expandable at the site to block flow through the vessel; and', 'an intermediate segment extending between the first expandable member and the second expandable member and including an interior region for receipt of a fill material; and, 'a vascular implant suitable for transluminal vascular delivery to a vascular vessel site, the implant comprisinga fill material for filling at least part of the interior region.2. The medical product of claim 1 , wherein at least one of the first expandable member and the second expandable member is comprised of a naturally derived material.3. The medical product of claim 1 , wherein at least one of the first expandable member and the second expandable member is comprised of a non-naturally derived ...

APPARATUSES AND METHODS FOR COOLING SPECIFIC TISSUE

The present disclosure provides, among other things, a system for providing therapeutic cooling or hypothermia to localized areas of the body such as the brain. A source of compressed gas such as a medical-use oxygen canister is connected via a delivery tube to a mask fitted to a patient. The gas undergoes adiabatic cooling as it enters the delivery tube, and is provide to the patient in such cooled state. The system may be provided as a portable or ambulatory device or kit, with the delivery tube or other part easily disconnected from one compressed gas source and connected to another, for continued therapy even during transportation. 1. A system for therapeutic cooling of a patient , comprising:a mask having a strap and a hole, said mask being adapted to cover at least the patient's nose and to be held to the patient's head by said strap, so that when said mask rests against the patient's face a space between at least a portion of the patient's face and said mask exists;a source of coolant, said coolant consisting essentially of compressed breathable gas, wherein a flow path extends from said source through said hole of said mask;a regulator in said flow path between said coolant source and said hole of said mask; anda delivery tube having a lumen defining at least part of said flow path for said coolant, for conducting said coolant toward said mask;wherein said coolant is cooled adiabatically on or after release from said source.2. The apparatus of claim 1 , wherein said source is a canister of compressed breathable gas.3. The apparatus of claim 1 , further comprising first and second insertion tubes connected to said delivery tubing claim 1 , each extending to a respective free end having an opening claim 1 , said insertion tubes sized and configured to be inserted into respective nares of a patient's nose so that said free ends are positioned in the airway beyond the anterior turbinate area of the patient's nose claim 1 , so that the gas passes the mucosa and ...

PERCUTANEOUS, ULTRASOUND-GUIDED INTRODUCTION OF MEDICAL DEVICES

Described are methods and systems and system components useful for percutaneously delivering or retrieving vascular implant devices, such as filters, utilizing intravenous ultrasound (IVUS) imaging alone or in combination with external (e.g. transabdominal) ultrasound or other imaging technology. Implants deliverable by such systems, such as vena cava or other vascular filters, can have two or more echogenic markers spaced at such a distance that they are separately discernible by IVUS and/or external ultrasound imaging. 1. A retrievable vascular filter , comprising:a filter structure configured to trap embolic matter in a vascular vessel;a retrieval structure connected to the filter structure, for retrieval of the vascular filter from the vessel;a first echogenic marker on the filter; anda second echogenic marker on the filter;wherein the first and second echogenic markers are operable to generate discrete, spaced ultrasound images of the first and second echogenic markers demarking a retrieval structure capture zone between the first and second echogenic markers.2. The filter of claim 1 , which is a vena cava filter.3. The filter of claim 1 , wherein said distance is greater than 3 mm.4. The filter of claim 1 , wherein said distance is in the range of 4 mm to 10 mm.5. The filter of claim 1 , comprising a filter hub claim 1 , and wherein the first echogenic marker is on the hub claim 1 , and the second echogenic marker is on the retrieval structure.6. The filter of claim 1 , also comprising at least a third echogenic marker claim 1 , the third echogenic marker positioned on the filter structure.7. The filter of claim 1 , wherein the filter structure comprises a plurality of struts.8. The filter of claim 1 , wherein the retrieval structure comprises a hook.9. A method for the capture of a vascular filter positioned within avascular vessel of a patient claim 1 , comprising:introducing a snare device through a percutaneous access site spaced from the vascular filter; ...

CATHETER SYSTEMS AND METHODS USEFUL FOR CELL THERAPY

Described in one aspect is a multi-pressure monitoring system for cell or other therapy includes a first catheter having a first lumen for accepting a treatment device, a second lumen for inflating a balloon, a pressure sensor for monitoring fluid pressure within the first lumen, and a flow restrictor such as a hemostasis valve for limiting the exchange of fluids into and out of the first lumen while treatment devices are present or exchanged in the first lumen. Also disclosed is a method of using the first catheter with a first pressure monitor coupled to the first pressure sensor along with a second catheter attached to a second pressure sensor coupled to a second pressure monitor. The second catheter is positioned within the first lumen of the first catheter during treatment operations and the first and second pressure monitors are used to verify proper pressures throughout the procedure. Described also are novel methods, systems, and catheters for delivering flowable therapeutic substances, such as viable cellular preparations, to patients. 1. A catheter apparatus , comprising:a catheter shaft defining a first lumen and a second lumen;a proximal port in fluid communication with the first lumen, the proximal port having associated therewith a resilient valve member operable to seal around an elongate device extended through the proximal port;a sensor operable to measure fluid pressure in the first lumen;a distal port in fluid communication with the first lumen, the distal port positionable within a vascular vessel of a patient and arranged to receive blood under pressure when positioned in the vascular vessel;an inflatable balloon mounted on the catheter shaft, the inflatable balloon having an inner void in fluid communication with the second lumen; anda proximal inflation port in fluid communication with the second lumen.2. The catheter apparatus of claim 1 , wherein the sensor is positioned to sense fluid pressure from a location within the first lumen.3. The ...

COATED MEDICAL DEVICE

A coated medical device () including a structure () adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material () having a bioactive material layer () disposed thereon. The medical device is preferably an implantable stent or balloon () of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material () positioned between the base and bioactive material layers of the balloon. 121-. (canceled)22. A balloon catheter medical device that releases a drug by immediate release for the selective therapy of specific diseased tissue or an organ part to which said drug will bind , comprising such a drug which is lipophilic , water-insoluble and immediately releasable , adhered to a smooth surface of the balloon of said catheter that comes into contact with the diseased tissue or organ part , which adhered drug when pressed against said tissue or organ part at least for a short time , is immediately released into said tissue or organ part , wherein the concentration of said drug on said surface is up to 20 μg/mm.23. The device according to claim 22 , wherein said balloon catheter comprises a stent.24. The device according to claim 23 , wherein the balloon further comprising preformed longitudinal folds is coated with the drug claim 23 , and the inclination of said folds to refold is not lost after inflation.25. The device according to claim 23 , wherein the balloon is coated with said drug and comprises smooth material to which said drug adheres sufficiently well to resist forces ...

WEEPING BALLOON CATHETER WITH ULTRASOUND ELEMENT

Systems and methods for treating a blood clot positioned within a blood vessel are disclosed. In one embodiment, a balloon member is positioned on a distal end region of a catheter and an ultrasound emitting element is positioned within the balloon member and arranged for actively emitting ultrasound. In some exemplary embodiments, the disclosure provides a multi-wall balloon member and a multi-lumen catheter with at least one and/or all cavities of the balloon member arranged for heat transfer with the ultrasound emitting element. The disclosure also provides catheter arrangements with an ultrasound emitting element arranged to heat tissue adjacent to the balloon member. Additionally, in some embodiments, at least one and/or all walls of the balloon member have apertures arranged to release a therapeutic agent such as a thrombolytic drug. 1. A medical device for treating a blood clot in a blood vessel , comprising:a multi-lumen catheter having a multi-wall balloon positioned thereon and an ultrasound emitting element positioned within the multi-wall balloon;wherein the ultrasound emitting element is arranged for actively emitting ultrasound.2. The medical device of claim 1 , wherein:the ultrasound emitting element is positioned on an outer surface of the catheter.3. The medical device of claim 1 , wherein:the ultrasound emitting element is positioned in a wall of the catheter.4. The medical device of claim 1 , wherein:the ultrasound emitting element is movable and positioned within a lumen of the catheter.5. The medical device of claim 1 , wherein:the ultrasound emitting element is arranged to heat tissue or thrombus adjacent to the multi-wall balloon.6. The medical device of claim 1 , wherein:the ultrasound emitting element is arranged to heat a fluid positioned within the multi-wall balloon.7. The medical device of claim 6 , wherein:the multi-wall balloon is configured to transfer heat to the surrounding tissue.8. The medical device of claim 1 , wherein:an outer ...

INTERNAL ULTRASOUND ASSEMBLY WITH PORT FOR FLUID INJECTION

There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms. 1. An apparatus for ultrasound procedures , comprising:a transducer for emitting and/or receiving ultrasound signals, the transducer being within a chamber, the chamber defined at least partially by a wall forming an acoustic window for transmission of ultrasound signals;an injection port communicating with the chamber adapted for passing coupling media through and into the chamber, andan exhaust port communicating with the chamber through which gas within the chamber can be exhausted from the chamber when coupling media is inserted into the chamber.2. The apparatus of claim 1 , wherein the injection port comprises a flexible insert fixed with respect to the wall claim 1 , the insert permitting insertion of a needle through it and thereafter providing a leak-tight seal when a needle is removed from it.3. The apparatus of claim 1 , wherein the insert is placed at a forward-most tip of the chamber.4. The apparatus of claim 1 , wherein the chamber is attached to or part of an elongated tubular housing having an internal surface and an external surface claim 1 , and wherein the injection port comprises a lumen opening into the chamber and extending through at least part of the housing between the internal surface and the external surface.5. The apparatus of claim 4 , wherein at least part of the lumen is within a tube ...

VASCULAR ANCHORING INTRODUCER SHEATH

Among other things, there is disclosed structure and methods for maintaining access to a location in the body while reducing or eliminating the potential for pulling an access device (e.g. a catheter) back through an opening. An introducer sheath includes a distal indented portion and a balloon, so that once placed in a desired location through tissue, the balloon can be inflated to anchor the sheath against retraction. In particular embodiments, structure and methods for accessing the pericardial cavity via the right atrial appendage are shown. 18-. (canceled)9. A method of accessing a pericardial cavity of a patient via a right atrial appendage of the patient with an introducer sheath , comprising:inserting the introducer sheath into the inferior vena cava of the patient, the introducer sheath having a curved medial portion and a linear distal portion, the linear distal portion including an indented portion around the entire circumference and a balloon in a deflated condition within the indented portion so that no part of the balloon extends beyond a maximum outer diameter of the linear distal portion or outside of the indented portion;moving the introducer sheath to the right atrium of the heart of the patient to a position adjacent the right atrial appendage;passing the sheath through the right atrial appendage to the pericardial cavity so that the indented portion is within the pericardial cavity;inflating the balloon within the pericardial cavity, wherein the inflating does not enlarge a hole through the right atrial appendage through which the sheath passes; andengaging the balloon with tissue of the right atrial appendage that faces the pericardial cavity.101. The method of claim 9 , wherein the introducer sheath is the introducer sheath of claim .11. The method of claim 9 , further comprising imaging the sheath when the sheath extends through the right atrial appendage claim 9 , and confirming that a marker abutting a proximal edge of the indented section ...

MEDICAL DEVICE DESIGN, MANUFACTURE AND TESTING SYSTEMS

Described are methods and systems for testing lumens of cannulated delivery components or assemblies thereof that may be used to deliver cells to a patient. Test cells are contacted with walls of the lumens and/or liquids that contact walls of the lumens, potentially over an incubation period. The test cells are then assessed for an effect of the wall contact, or the liquid contact, on at least one and preferably multiple characteristics of the test cells such as innate immune response, metabolic activity, viability, cytotoxic response, and/or motility. Methods and systems as described can be used in the development and/or manufacture of cannulated delivery devices, for example providing specifications for design or process inputs or outputs, design or process validations, and/or device lot approvals. Also described are devices or products produced in accordance with such methods and systems. 1. A method for testing a region of a medical device , comprising:incubating a liquid medium in contact with a wall of the region;contacting at least one cell with the liquid medium; andassessing the affect of said contacting on the expression of at least one toll-like receptor by the cell.2. The method of claim 1 , wherein the medical device is a medical delivery device claim 1 , and the region is a lumen.3. The method of claim 1 , wherein the at least one cell includes exogenous DNA encoding the at least one toll-like receptor.4. The method of claim 1 , wherein the cell is a mammalian cell.5. The method of claim 1 , wherein the cell is a human cell.69-. (canceled)10. The method of claim 1 , wherein the at least one toll-like receptor includes toll-like receptor 2 claim 1 , toll-like receptor 4 claim 1 , or both.1113-. (canceled)14. A method for testing a region of a medical device claim 1 , comprising:first assessing the region for an effect on innate immune response of a cell; andsecond assessing the region for an effect on at least one other characteristic of a cell, said ...

Internal transducer assembly with slip ring

A device for internal ultrasound imaging including a micro-motor rotates a drive shaft and ultrasound transducer. Conductors attach between the transducer and slip ring assemblies. The slip ring assemblies conductively couple the transducer conductors to a set of conductors extending toward a console.

RECIPROCATING INTERNAL ULTRASOUND TRANSDUCER ASSEMBLY

A device for endoluminal therapeutic and diagnostic ultrasound procedures includes a motor which rotates a drive shaft and ultrasound transducer. In one example, conductors attach to the transducer and extend through a hollow drive shaft. In another example, a bias member conducts electric signals and stores energy. The device includes an operational state in which the motor rotates the drive shaft alternatingly between a first direction and an opposite second direction. 1. A medical ultrasound device , comprising:a stationary motor having a rotary drive shaft, wherein the drive shaft is positioned radially inward of the motor, wherein the drive shaft extends substantially along a rotation axis, wherein operation of the stationary motor rotates the drive shaft about the rotation axis;a transducer configured for transmitting and/or receiving ultrasound signals and operatively coupled with the drive shaft so that it rotates in response to rotation of the drive shaft, wherein the transducer is rotatable about the rotation axis through a range which defines a viewing window extending from the transducer, wherein the entire viewing window has acoustic attenuation that allows passage of imagable ultrasound signals;a first conduction path extending from the transducer through the drive shaft, wherein a portion of the first conduction path includes at least a first conductor extending through the drive shaft; andwherein the stationary motor has an operational state in which the stationary motor rotates the drive shaft about the rotation axis alternatingly between a first rotational direction and an opposite second rotational direction.2. The device of claim 1 , wherein the first conductor is integral to the drive shaft.3. The device of claim 2 , further comprising a second conduction path extending from the transducer through the drive shaft claim 2 , wherein a portion of the second conduction path includes at least a second conductor integral to the drive shaft and ...

FEEDBACK/REGISTRATION MECHANISM FOR ULTRASOUND DEVICES

Among other things, there is disclosed structure and methods for registering images obtained through internal (e.g. intravascular) ultrasound devices. Embodiments of a device with a rotating ultrasound beam is provided, with a wall of the device being anisotropic in ultrasound passage. As examples, a cable opaque to ultrasound is attached along the wall of the device, so that the ultrasound beam at the location of the cable is blocked, reflected or scattered. As another example, a thin film of metallic material is placed on or in the wall to allow a portion of the beam to be blocked or attenuated. The imaging system recognizes the changes to the signals made by the anisotropic wall, and registers successive images according to those changes. 1. An internal ultrasound device with a feedback system , comprising:a transducer for emitting and/or receiving an ultrasound beam, the beam adapted to rotate around at least a portion of the device;a wall through which at least part of the ultrasound beam passes, the wall having a first portion affecting the ultrasound beam in a first fashion and a second portion affecting the ultrasound beam in a second fashion, wherein the ultrasound beam as it rotates at least periodically travels along a path that intersects the first portion and the transducer, and wherein the ultrasound beam as it rotates at least periodically travels along a path that intersects the second portion and the transducer; andan ultrasound control system electronically connected to the transducer for receiving and assessing electronic signals from the transducer representing one or more qualities of ultrasound energy that has traveled along a path of the beam,wherein a first electronic signal sent by the transducer representing one or more qualities of ultrasound along a path that intersects the first portion of the wall have at least one characteristic different from a second electronic signal sent by the transducer representing one or more qualities of ...

DEVICES AND METHODS FOR THREE-DIMENSIONAL INTERNAL ULTRASOUND USAGE

There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms. 1. An apparatus for ultrasound procedures , comprising:a transducer for emitting and/or receiving ultrasound signals;a rotary motor including a rotatable shaft extending substantially along a rotating axis, wherein operation of the rotary motor rotates the rotatable shaft around the rotating axis;a pivoting mechanism operationally connected to the rotatable shaft of the rotary motor so that the pivoting mechanism rotates in response to rotation of the rotatable shaft, the pivoting mechanism having a base and pivoting member that is pivotable with respect to the base around a pivoting axis, the pivoting axis being substantially perpendicular to the rotating axis,a forcing member operationally connected to the pivoting member, wherein a force applied via the forcing member controls pivoting of the pivoting member around the pivoting axis.2. The apparatus of claim 1 , wherein the forcing member is movable with respect to the rotatable shaft.3. The apparatus of claim 1 , wherein the rotatable shaft has a longitudinal lumen claim 1 , and wherein the forcing member extends at least partially through the lumen.4. The apparatus of claim 1 , wherein the forcing member comprises a filament such that pulling the filament results in pivoting the pivoting member around the pivoting axis.5. The apparatus of claim 1 , wherein the ...

MECHANICAL SCANNING ULTRASOUND TRANSDUCER WITH MICROMOTOR

A system for use with ultrasound procedures including an ultrasound control and/or imaging system which has a microminiature motor, a rotatable reflector and a stationary ultrasound transducer. The transducer may be placed between the motor and the reflector, so as to eliminate the need for placement of wires or other artifact-creating items in the path of ultrasound signals. In particular embodiments, such systems can be incorporated in or retrofitted to commercially standard diagnostic and therapeutic catheters or other housings. Examples can be used in variety of ultrasound procedures, e.g. to perform intravascular ultrasound (IVUS) imaging. 1. A system for use with ultrasound procedures comprising:an transducer connected to a support for maintaining the transducer in position, the transducer adapted to emit and/or receive ultrasound signals substantially along an axis;a reflector connected to a shaft, the reflector positioned with respect to the ultrasound element to reflect in a direction non-parallel to the axis ultrasound waves emitted from the transducer; andwherein the shaft and support are positioned concentrically and at least a part of the support is positioned concentrically inward relative to the microminiature motor, so that the shaft is rotatable relative to the support about the axis.2. The system of claim 1 , further including a housing around the transducer and the reflector claim 1 , wherein the support is fixed in a stationary position relative to the housing.3. The system of claim 1 , further comprising at least one electrical wire connected to the transducer claim 1 , wherein the reflector is angled with respect to the axis of the transducer so that a reflection direction from the reflector is non-parallel to the axis claim 1 , and wherein the wire does not cross the reflection direction.4. The system of claim 3 , wherein the reflector forms an angle of between about 10 and 84 degrees with respect to the axis.5. The system of claim 1 , further ...

IMPLEMENTS FOR IDENTIFYING SHEATH MIGRATION

Attachable implements, systems, and methods for identifying the migration of a medical device extending through a percutaneous insertion site of a patient's skin are disclosed. In one embodiment, an attachable implement for identifying migration comprises a attachable implement body having a coupling surface and a skin contacting surface, the coupling surface arranged to couple to a surface of the medical device, and the skin contacting surface arranged to contact the skin of the patient; wherein the attachable implement body is arranged to be side mountable on the medical device and wherein the attachable implement is configured to move from a first position adjacent to the patient's skin to a second position remote from the patient's skin. Systems, methods, and other embodiments are disclosed. 1. An attachable implement for identifying migration of a medical device that extends through the skin of a patient , comprising:a attachable implement body comprising a coupling surface and a skin contacting surface;said coupling surface arranged to couple to a surface of the medical device; andsaid skin contacting surface arranged to contact the skin of the patient;wherein said attachable implement body is arranged to be side mountable onto the medical device;wherein when said attachable implement body is mounted onto the medical device the medical device extends in a direction transverse to said skin contacting surface; andwherein said attachable implement body is configured to move with the medical device from a first position where the skin contacting surface is adjacent to the patient's skin to a second position where the skin contacting surface is remote from the patient's skin, such that an operator may identify that the medical device has migrated.2. The attachable implement of claim 1 , wherein:said attachable implement body comprises cooperating first and second portions.3. The attachable implement of claim 2 , wherein:said first and second portions are pivotably ...

CLOSING DEVICE FOR TISSUE OPENINGS

There are shown and described embodiments of closure devices and systems for closing holes in tissue such as those caused unintentionally (e.g. hernia) or intentionally (e.g. openings in the right atrial appendage to access cardiac tissue). Such devices and systems include one or more mesh elements or anchors. In particular embodiments, a closure device includes first and second mesh closure members and a tether or stem connecting them. Embodiments of a delivery device for such closure devices are also described. 1. A closure for an opening in tissue , comprising:a first closure element, the first closure element having a first mesh enclosure, the first mesh enclosure having a first distal narrowed end and a second proximal narrowed end and a central volume, each of the first and second ends being inverted so as to be within the central volume of the first mesh enclosure, each of the first and second ends being surrounded by respective external surfaces of the first mesh enclosure;a second closure element, the second closure element having a second mesh enclosure physically separate from the first mesh enclosure, the second mesh enclosure having a third distal narrowed end and a fourth proximal narrowed end and a central volume, the third end being inverted so as to be within the central volume of the second mesh enclosure, each of the third and fourth ends being surrounded by respective external surfaces of the second mesh enclosure;a tether joining the first and second closure elements in an initial configuration prior to delivery of the closure elements to the opening, the tether having first and second enlarged ends, wherein the tether extends through at least the first narrowed end, parallel to and alongside the second narrowed end and into the second closure element, so that the first enlarged end of the tether is outside the first closure element adjacent or engaging the first end and the second enlarged end of the tether is within the central volume of the ...

MULTI-CELL SEALED CONTAINER

Described in one aspect is a multi-cell or multi-chambered container for sealing various materials such as therapeutic or diagnostic agents, animal or human tissue, tissue samples, specimens, blood, genetic material, or any other material. The container includes seals formed by folding the wall of the elongate body transverse to the interior of the elongate body and maintaining the folded wall portions adjacent one another or joining them together. In another aspect, the container disclosed may be made according to a method involving creating multiple seals at various locations along the elongate body thus creating sealed voids or cells between the seals within the elongate body. 1. A container , comprising:an elongate body with a first, second, and third seal at three separate locations respectively along the elongate body defining a first hermetically sealed void within the elongate body between the first and second seals, and a second hermetically sealed void within the elongate body between the second and third seals;wherein at least one of the first or second hermetically sealed voids contains a therapeutic or diagnostic agent;wherein the elongate body has a wall defining an interior lumen that has an inner surface;wherein the first seal includes a plurality of folds in the wall defining corresponding sealing portions of the wall;wherein the sealing portions extend transverse to the interior lumen; andwherein the sealing portions are joined to one another to form the first seal.2. The container of claim 1 , wherein the first seal claim 1 , the second seal claim 1 , and/or the third seal each includes at least three folds defining at least three sealing portions per seal claim 1 , the sealing portions extending transverse to the interior lumen in different directions claim 1 , and wherein the sealing portions are on the inner surface of the interior lumen.3. (canceled)4. The container of claim 1 , wherein the sealing portions are fused together to form a unitary ...

PRODUCTS COMPRISING AN EXTRACELLULAR MATRIX MATERIAL AND OSTEOGENIC PROTEIN

Osteogenic compositions include a decellularized extracellular matrix tissue and bone morphogenic protein, preferably BMP-2. The compositions make beneficial use of the BMP, which can be used at relatively low doses and can bind to native components (e.g., native sulfated glycosaminoglycans such as heparin and/or heparan sulfate) remaining in the decellularized extracellular matrix tissue. Methods for preparation and use of such compositions are also described. The compositions and related methods can be used in the treatment of diseased or damaged bone tissue. 1. An osteogenic composition , comprising:a collagenous extracellular matrix tissue material; andbone morphogenic protein.2. The composition of claim 1 , wherein:the collagenous extracellular matrix tissue material is a solid; andthe bone morphogenic protein is impregnated in the solid.3. The composition of claim 1 , wherein:the collagenous extracellular matrix tissue material retains native heparin from a source tissue for the collagenous extracellular matrix tissue material; andat least a portion of the bone morphogenic protein is bound to the native heparin.4. The composition of claim 1 , wherein:the bone morphogenic protein comprises recombinant human BMP-2.5. The composition of claim 1 , wherein:the collagenous extracellular matrix tissue material retains native components, preferably native sulfated glycosaminoglycans, from a source tissue for the collagenous extracellular matrix tissue material; andat least a portion of the bone morphogenic protein is bound to the native components.6. The composition of claim 1 , wherein the bone morphogenic protein is present at a level in the range of about 75 μg to about 300 μg per gram (dry weight) of the collagenous extracellular matrix tissue material.7. The composition of claim 1 , wherein the extracellular matrix tissue material retains native growth factors claim 1 , glycosaminoglycans claim 1 , proteoglycans and glycoproteins from a source tissue for the ...

CELL-SEEDED COMPOSITIONS AND METHODS USEFUL FOR TREATING BONE REGIONS

Compositions and methods for treating diseased or damaged bone, preferably ischemic and/or necrotic bone, include the use of a combination of endothelial progenitor cells and mesenchymal stem cells, desirably also in conjunction with a collagenous extracellular matrix tissue. Methods for preparation of such compositions are also described. 1. A method for treating damaged or diseased bone in a patient , comprising:administering to the damaged or diseased bone a composition including endothelial progenitor cells (EPCs) and mesenchymal stem cells (MSCs).2. A composition useful for treating damaged or diseased bone in a patient , comprising endothelial progenitor cells (EPCs) and mesenchymal stem cells (MSCs).3. A method or composition of claim 1 , wherein the composition includes the EPCs and MSCs in a respective cell number ratio: (i) of at least about 1.5:1 claim 1 , more preferably at least about 2:1 claim 1 , even more preferably at least about 3:1; or (ii) in the range of about 2:1 to about 10:1.4. A method of claim 1 , wherein the EPCs are endothelial colony forming cells (ECFCs).5. A method of claim 1 , wherein at least one of the EPCs and the MSCs is allogenic to the patient.6. A method of claim 1 , wherein at least one of the EPCs and the MSCs is autologous to the patient.7. A method of claim 1 , wherein the MSCs are allogenic to the patient and the EPCs are allogenic to the patient.8. A method of claim 1 , wherein the MSCs are cord blood derived MSCs.9. A method of claim 1 , wherein the EPCs are cord blood derived EPCs.10. A method of claim 9 , wherein the MSCs are bone marrow-derived MSCs.11. A method of claim 1 , wherein the composition also comprises a solid carrier material claim 1 , and preferably wherein at least about 50% of the total number of EPCs and MSCs are attached to the solid carrier material.12. A method of claim 11 , wherein the solid carrier material comprises a collagenous extracellular matrix (ECM) tissue material.13. A method according ...

Coated medical device

A coated medical device ( 10 ) including a structure ( 12 ) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material ( 14 ) having a bioactive material layer ( 18 ) disposed thereon. The medical device is preferably an implantable stent or balloon ( 26 ) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material ( 58 ) positioned between the base and bioactive material layers of the balloon.

METHODS, SUBSTRATES, AND SYSTEMS USEFUL FOR CELL SEEDING OF MEDICAL GRAFTS

Described are methods, cell growth substrates, and devices that are useful in preparing cell-containing graft materials for administration to patients. Tubular passages can be defined in cell growth substrates to promote distribution of cells into the substrates. Also described are methods and devices for preparing cell-seeded graft compositions, methods and devices for preconditioning cell growth substrates prior to application of cells, and cell seeded grafts having novel substrates, and uses thereof. 1. A cell growth substrate , comprising:a cell growth substrate for supporting the growth of cells, the cell growth substrate including at least one elongate tubular passage, the elongate tubular passage having passage walls defining a lumen extending from a first lumen opening at a surface of the cell growth substrate body into an interior region of the cell growth substrate, with said lumen configured to receive flow of a cell-containing liquid medium to distribute cells into the interior region of the cell growth substrate.2. The cell growth substrate of claim 1 , wherein the substrate comprises collagen claim 1 , and also comprising a synthetic polymeric tubular element exterior of the substrate and fluidly coupled to the lumen opening.3. The cell growth substrate of claim 1 , comprising a plurality of said tubular passages.4. The cell growth substrate of claim 1 , wherein the at least one elongate tubular passage includes at least one primary tubular passage with at least one secondary tubular passage branching from the primary tubular passage.5. The cell growth substrate of claim 1 , wherein the tubular passage extends from the first lumen opening to a second lumen opening spaced on said substrate from the first lumen opening.6. The cell growth substrate of claim 1 , wherein the tubular passage terminates within the substrate.7. The cell growth substrate of claim 1 , wherein the substrate comprises a remodelable collagenous extracellular matrix sheet material.8 ...

COMPARTMENTED CRYOPRESERVATION CONTAINER AND USES THEREOF

Described are medical products, methods, and cryogenic bags or other containers suitable for storing and/or transporting and/or processing cellular compositions and other related materials. In certain aspects, the contents of such cryogenic bags may be warmed, mixed, and applied to a patient. Medical products described herein find particular use in treating diseased and/or damaged tissue such as in wound repair and/or bone repair. Related methods of manufacture are also described. 114-. (canceled)15. A method for making a cryogenic product , comprising:introducing a flowable cellular composition into a first compartment within an internal volume of a cryogenic bag through a first opening defined by the first compartment, said first opening in fluid communication with a third compartment of said cryogenic bag;introducing a porous matrix composition into a second compartment within said internal volume of said cryogenic bag through a second opening defined by the second compartment, said second opening in fluid communication with said third compartment;sealing said internal volume of said cryogenic bag to provide a sealed cryogenic bag containing the cellular composition in the first compartment and the porous matrix composition in the second compartment; andsubjecting the sealed cryogenic bag to cryopreservation conditions.16. The method of claim 15 , said sealing step is conducted with said first opening and said second opening in fluid communication with said third compartment.17. A cryogenic product useful for the storage or preparation of a composition claim 15 , comprising:a cryogenic storage container defining a sealed internal volume;a cellular composition received within said internal volume;a cryodamage sensitizing material said internal volume; andwherein said cryodamage sensitizing material and cellular composition are discrete from one another in said sealed internal volume.18. The cryogenic product of claim 17 , wherein said cellular composition includes ...

OVER-THE-WIRE ULTRASOUND SYSTEM

Disclosed are embodiments of devices and methods for imaging the inside of a body part, such as a blood vessel. In particular embodiments, a catheter has a chamber within which is a transducer. A wire guide channel extends throughout the length of the catheter. The transducer is rotatable around the wire guide channel. 2. The device of claim 1 , wherein the transducer includes a first element and a second element claim 1 , wherein the first element is positioned opposite to the second element with respect to the rotation axis claim 1 , and wherein the channel extends between the first element and the second element.3. The device according to claim 1 , further comprising:a pivot mechanism rotatable about the rotation axis;a pivot member mounted to the pivot mechanism and pivotable about a pivot axis that is substantially perpendicular to the rotation axis, wherein the transducer is included in the pivot member.4. The device according to claim 3 , wherein the second element is connected to the first element so that the second element pivots about the pivot axis in response to pivoting motion of the first element.5. The device according to claim 3 , wherein the pivot member includes a magnetic layer claim 3 , and further comprising a coil positioned concentric to the rotation axis claim 3 , wherein the coil includes a plurality of electrically conductive windings claim 3 , and wherein application of electric current to the coil creates a torque on the pivot member about the pivot axis.6. The device according to claim 1 , further comprising a rotatable shaft extending substantially parallel to the rotation axis and rotatable about the rotation axis claim 1 , wherein the shaft includes a conduit extending therethrough claim 1 , wherein the wire guide channel extends through the shaft claim 1 , and wherein the transducer is operatively coupled with the rotatable shaft so that it rotates in response to rotation of the shaft.710-. (canceled)11. The device according to claim ...

APPARATUS AND METHOD FOR THE DELIVERY OF AN INTRAVASCULAR FILTER

A delivery apparatus for introducing an intravascular filter into a body vessel of a patient includes a sheath defining a lumen, an intravascular filter positioned in the lumen, an ultrasound transducer positioned to the application side of the intravascular filter, a guide wire cannula and a tip located at an application side end of the delivery apparatus. 1. A delivery apparatus for introducing an intravascular filter into a body vessel of a patient , said delivery apparatus comprising:a sheath having an annular wall defining a lumen;an intravascular filter positioned in said lumen; andan ultrasound transducer positioned to the application side of said intravascular filter.2. The delivery apparatus of which includes a guide wire cannula extending through said lumen and including an application side end.3. The delivery apparatus of which includes a dilator located at an application side end of said delivery apparatus.4. The delivery apparatus of wherein said ultrasound transducer is constructed and arranged for providing a 3D scan capability.5. A delivery apparatus for introducing an intravascular filter into a body vessel of a patient claim 1 , said delivery apparatus comprising:a sheath having an annular wall defining a lumen;an intravascular filter positioned in said lumen;an ultrasound transducer positioned to the application side of said intravascular filter;a guide wire cannula extending through said lumen and including an application side end; anda dilator located at an application side end of said delivery apparatus, said dilator receiving the application side end of said guide wire cannula.6. The delivery apparatus of wherein said intravascular filter includes a plurality of primary struts and a plurality of secondary struts.7. The delivery apparatus of wherein said intravascular filter further includes a hub and a removal hook.8. The delivery apparatus of wherein said removal hook is constructed and arranged to extend beyond an application side face of ...

APPARATUS AND METHOD FOR THE RETRIEVAL OF AN INTRAVASCULAR FILTER

A retrieval apparatus for removing an intravascular filter from a body vessel of a patient includes an outer sheath defining an outer lumen, an inner sheath defining an inner lumen wherein the inner sheath is positioned within the outer lumen, a retrieval member positioned in the inner lumen, an ultrasound transducer positioned on the application side of the retrieval member, a guide wire cannula extending between the outer sheath and the inner sheath, the guide wire cannula including an application side end, and a dilator located at an application side end of the retrieval apparatus, said dilator being coupled to said ultrasound transducer and receiving the application side end of said guide wire cannula. 1. A retrieval apparatus for removing an intravascular filter from a body vessel of a patient , said retrieval apparatus comprising:an outer sheath having an annular wall defining an outer lumen;an inner sheath having an annular wall defining an inner lumen, said inner sheath being positioned in said outer lumen;a retrieval member positioned in said inner lumen;an ultrasound transducer positioned on the application side of said retrieval member;a guide wire cannula extending between said outer sheath and said inner sheath; anda dilator located on the application side of said retrieval member, said dilator being coupled to said ultrasound transducer and receiving said guide wire cannula.2. The retrieval apparatus of wherein said retrieval member includes a plurality of loops.3. The retrieval apparatus of wherein an upper portion of each loop of said plurality of loops is bent over into a coplanar arrangement.4. The retrieval apparatus of wherein the plurality of loops includes four loops which are interconnected.5. The retrieval apparatus of any of wherein each loop of said plurality of loops is formed by a wire section which is received within a cannula.6. The retrieval apparatus of wherein an upper portion of each loop of said plurality of loops is adjacent said ...

SYSTEMS AND METHODS FOR APPLYING PRESSURE TO A BODILY ORGAN

Among other things, there are disclosed embodiments of belts or bands that can be used in treatments for tricuspid valve regurgitation. In some embodiments, such belts may be heat-set in a particular configuration to effectively decrease tricuspid annulus when deployed around the atrioventricular groove. Embodiments include one or more tensioning sutures for applying cinching or tightening to belts when deployed, and structure for effectively distributing force during such tightening. Embodiments of tensioning members, protective members, and devices and methods for open-surgical placement (e.g. around a heart for annuloplasty) are also disclosed. 1. A belt for placement along the atrioventricular groove of the heart , comprising:a mesh tube having a first open end and a second open end and a lumen passing through the tube from the first open end to the second open end along a longitudinal axis of the tube, the tube configured longitudinally in a loop so as to be placed around the heart and along the atrioventricular groove;a first suture portion within the tube, the first suture portion fixed to the tube adjacent the first open end and extending through the lumen toward the second open end, the first suture portion connected to the tube within the lumen by a plurality of holding elements so that the first suture portion is longitudinally movable through the holding elements with respect to the tube;a second suture portion within the tube and parallel to and spaced from the first suture portion, the second suture portion fixed to the tube adjacent the first open end and extending through the lumen toward the second open end, the second suture portion connected to the tube within the lumen by a plurality of holding elements so that the second suture portion is longitudinally movable through the holding elements with respect to the tube;wherein pulling the first and second suture portions cinches the tube to reduce an area of the loop so that the tube compress ...

COATED MEDICAL DEVICE

A coated medical device () including a structure () adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material () having a bioactive material layer () disposed thereon. The medical device is preferably an implantable stent or balloon () of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material () positioned between the base and bioactive material layers of the balloon. 121.-. (canceled)22. A method for making a drug-coated angioplasty catheter , comprising: applying a solution of a lipophilic drug directly to a surface of a balloon wall of a balloon of an angioplasty catheter , and drying the solution to form a coating of the lipophilic drug directly on the balloon wall to provide an outermost surface over the balloon , wherein said solution comprises a solvent , said lipophilic drug , and a contrast agent , and said lipophilic drug is selected from prostacyclin and prostacyclin analogues , rapamycine , colchicine , and paclitaxel.23. The method of claim 22 , wherein the lipophilic drug is paclitaxel.24. The method of claim 23 , wherein the solution consists of said solvent claim 23 , paclitaxel claim 23 , and said contrast agent.25. The method of claim 22 , wherein the solution consists of said solvent claim 22 , said lipophilic drug claim 22 , and said contrast agent.26. The method of claim 22 , also comprising processing said angioplasty catheter to be suitable for insertion into a patient with said coating providing said outermost surface.27. The method of ...

MODIFIABLE MEDICAL GRAFTS AND RELATED METHODS AND APPARATUSES

Described are medical graft materials and devices which can be usefully modified with liquid additives such as cell suspensions, bioactive agents, or combinations of these. Also described are methods for making and using these medical graft materials and devices. 1. A medical graft , comprising:a graft material having a first outer surface and a second outer surface, the graft material defining an internal chamber between the first outer surface and the second outer surface of the graft material; andat least one region of the graft material interrupting the chamber and surrounded by the chamber.2. The medical graft of claim 1 , also comprising a thru-hole defined in said at least one region of the graft material claim 1 , the thru-hole extending between the first outer surface and the second outer surface of the graft material.3. The medical graft of claim 1 , wherein the graft material comprises a matrix for supporting cell growth.4. The medical graft of claim 1 , comprising:a first wall of the graft material defining a first boundary of the chamber;a second wall of the graft material defining a second boundary of the chamber; andthe first and second walls laminated to one another to provide said at least one region of the graft material.5. The medical graft of claim 4 , wherein the first wall and second wall comprise an extracellular matrix material.6. The medical graft of claim 1 , comprising a plurality of said regions.7. The medical graft of claim 6 , wherein each of said regions defines a thru-hole.8. The medical graft of claim 1 , also comprising a peripheral flange defined by the graft material claim 1 , the peripheral flange extending around said internal chamber.10. The medical graft of claim 8 , also comprising at least one open passage defined by the graft material of the peripheral flange claim 8 , the open passage extending through the flange and opening into the internal chamber.11. A medical graft device claim 8 , comprising:a graft material defining ...

INTRAVASCULAR DEVICE ATTACHMENT SYSTEM HAVING BIOLOGICAL MATERIAL

A method of attaching an intravascular device to a vessel wall of a body vessel is disclosed. The attachment system includes an intravascular device and biological attachment material connected to the intravascular device. The biological attachment material is configured to attach the intravascular device to the vessel wall. 1. A method for attaching an intravascular device to a vessel wall of a body vessel , comprising:introducing the intravascular device into the body vessel, the intravascular device comprising a cardiac assist device for assisting with blood circulation, a biological attachment material connected to the cardiac assist device;allowing the biological attachment material to adhere to the vessel wall such that host cells of the vessel wall grow into the biological attachment material.2. The method of claim 1 , wherein the biological attachment material comprises an extracellular matrix material.3. The method of claim 2 , wherein the extracellular matrix material comprises small intestinal submucosa (SIS).4. The method of claim 1 , wherein the intravascular device further comprises a plurality of barbs connected to the cardiac assist device to anchor the cardiac assist device to the vessel wall.5. The method of claim 4 , wherein each barb is connected to the cardiac assist device with a biodegradable connection.6. The method of claim 5 , wherein the biodegradable connection is a biodegradable weld.7. The method of claim 1 , wherein the cardiac assist device comprises a pump and a pump housing.8. The method of claim 7 , wherein the cardiac assist device comprises a through channel to allow fluid to flow therethrough in a substantially unimpeded manner.9. The method of claim 1 , wherein the intravascular device further comprises a retrieval member to facilitate the removal of the intravascular device.10. The method of claim 9 , wherein the retrieval member is selected from the group consisting of a tether claim 9 , an electrical conduit claim 9 , and a ...

RECIPROCATING ULTRASOUND DEVICE

A device for internal ultrasound procedures includes a motor which rotates a drive shaft and an ultrasound transducer. A gearing assembly provides reciprocating rotational motion from a unidirectional motor. A cam assembly provides reciprocating pivotal motion to the transducer. Conductors can attach to the transducer and extend through the drive shaft. 1. A medical device , comprising:a unidirectional rotary motor;a bidirectional ultrasound transducer; anda unidirectional-to-bidirectional gearing assembly operatively disposed between the motor and the transducer.2. The device of claim 1 , wherein the transducer is configured for transmitting and/or receiving ultrasound signals;wherein the rotary motor is operatively coupled with a first drive shaft, wherein the first drive shaft extends substantially along a rotation axis, and wherein operation of the motor rotates the drive shaft about the rotation axis;wherein the gearing assembly comprises an internal gear and first and second external gears, wherein the first external gear is interengaged with the second external gear, wherein the internal gear is positioned to rotate about the rotation axis, wherein the gearing assembly is operatively coupled with the first drive shaft and the transducer; andwherein the internal gear has a first toothed portion and a first untoothed portion and is disposed so that during rotation of the internal gear the first toothed portion alternately engages the first and second external gears.3. The device of claim 2 , further comprising a diametric first external gear and a diametric second external gear claim 2 , wherein the diametric first external gear is positioned diametrically opposite to the first external gear and the diametric second external gear is positioned diametrically opposite to the second external gear claim 2 , wherein the diametric first external gear engages both the second external gear and the diametric second external gear claim 2 , and wherein the diametric ...

BELT FOR APPLYING PRESSURE TO A BODILY ORGAN

Among other things, there are disclosed embodiments of belts or bands that can be used in treatments for tricuspid valve regurgitation. In some embodiments, such belts may be heat-set in a particular configuration to effectively decrease tricuspid annulus when deployed around the atrioventricular groove. Embodiments include one or more tensioning sutures for applying cinching or tightening to belts when deployed, and structure for effectively distributing force during such tightening. 1. A belt for placement along the atrioventricular groove of the heart , comprising:a mesh tube having a first open end and a second open end and a lumen passing through the tube from the first open end to the second open end along a longitudinal axis of the tube, the tube configured longitudinally in a loop so as to be placed around the heart and along the atrioventricular groove;a first suture portion within the tube, the first suture portion fixed to the tube adjacent the first open end and extending through the lumen toward the second open end, the first suture portion connected to the tube within the lumen by a plurality of holding elements so that the first suture portion is longitudinally movable through the holding elements with respect to the tube;a second suture portion within the tube and parallel to and spaced from the first suture portion, the second suture portion fixed to the tube adjacent the first open end and extending through the lumen toward the second open end, the second suture portion connected to the tube within the lumen by a plurality of holding elements so that the second suture portion is longitudinally movable through the holding elements with respect to the tube;wherein pulling the first and second suture portions cinches the tube to reduce an area of the loop so that the tube compress longitudinally in at least selected locations along the tube.2. The belt of claim 1 , wherein the first suture portion and second suture portion each extend through the ...

METHODS, SUBSTRATES, AND SYSTEMS USEFUL FOR CELL SEEDING OF MEDICAL GRAFTS

Described are methods, cell growth substrates, and devices that are useful in preparing cell-containing graft materials for administration to patients. Tubular passages can be defined in cell growth substrates to promote distribution of cells into the substrates. Also described are methods and devices for preparing cell-seeded graft compositions, methods and devices for preconditioning cell growth substrates prior to application of cells, and cell seeded grafts having novel substrates, and uses thereof. 119-. (canceled)20. A device for seeding a matrix with cells , the device comprising:a first chamber for receiving a liquid suspension of cells;a second chamber for receiving a cell growth matrix material to be seeded with the cells;a passageway for transfer of amounts of the liquid suspension of cells from the first chamber to the second chamber;a device for detecting at least one condition of the liquid suspension of cells; andan application device for applying said amounts of the liquid suspension of cells to a matrix material received in the second chamber.21. The device of claim 20 , wherein the application device includes at least one spray nozzle.22. The device of claim 20 , wherein the application device includes at least one cannula having a lumen.23. The device of claim 21 , also comprising a mechanism for moving the spray nozzle.24. The device of claim 22 , also comprising a mechanism for moving the cannula.25. The device of claim 24 , wherein said mechanism is operable to withdraw the cannula proximally while dispensing a liquid suspension of cells from the distal opening.26. The device of claim 21 , also comprising a registration structure for holding the matrix material in a predetermined position relative to said application device.2764-. (canceled)65. An extracellular matrix composition claim 21 , comprising:a particulate extracellular matrix material comprising sheet-form extracellular matrix particles having a compact shape.66. The composition of ...

METHODS, SUBSTRATES, AND SYSTEMS USEFUL FOR CELL SEEDING OF MEDICAL GRAFTS

Described are methods, cell growth substrates, and devices that are useful in preparing cell-containing graft materials for administration to patients. Tubular passages can be defined in cell growth substrates to promote distribution of cells into the substrates. Also described are methods and devices for preparing cell-seeded graft compositions, methods and devices for preconditioning cell growth substrates prior to application of cells, and cell seeded grafts having novel substrates, and uses thereof. 110-. (canceled)11. A method for preparing a cell-seeded composition for delivery to a patient , comprising:providing a fluid extracellular matrix particulate composition comprising particles of extracellular matrix and a liquid medium;combining the fluid extracellular matrix composition with a liquid cell suspension to form a cellular fluid composition; andmixing the cellular fluid composition.12. The method of claim 11 , also comprising causing said cellular fluid composition to gel.13. The method of claim 12 , wherein said causing comprises altering the pH of the cellular fluid composition.14. The method of claim 12 , wherein said causing comprises altering the temperature of the cellular fluid composition.1551-. (canceled)52. A method for treating a patient claim 12 , comprising:introducing a cellular graft into the patient, wherein the cellular graft includes cellularized particulate bodies comprised of cells attached to extracellular matrix particles.5355-. (canceled)56. A cellular graft material claim 12 , comprising:a particulate cell growth substrate material, and cells attached to particles of said cell growth substrate material, wherein the cells comprise endothelial progenitor cells, muscle derived cells, or a combination thereof.5787-. (canceled) This application is a continuation of U.S. patent application Ser. No. 16/127,872, filed Sep. 11, 2018 which is a continuation of U.S. patent application Ser. No. 14/835,005, filed Aug. 25, 2015, which is a ...

TEMPORAL ECHOGENIC MARKERS

Devices and methods for enhancing observability under ultrasound imaging of medical devices include temporal markers which are dynamic, producing a variable ultrasound image over time. Included are rotating markers which produce a Doppler shift visible through ultrasound imaging in a Doppler mode and which enhance visibility of the marker. Other devices and methods include alternating streams of fluid contrast agents and saline as well as destroying a fluid contrast agent stream with a high intensity ultrasound pulse. 1. A device for use with ultrasound imaging procedures comprising:a medical device having a marker rotatable about an axis;wherein the marker is adapted to rotate at a first rotation rate; andwherein when positioned within a body and when rotating at the first rotation rate the marker produces a Doppler shift which is observable through ultrasound imaging procedures when the marker is subjected to ultrasound waves.2. The medical device of claim 1 , wherein the medical device is configured to be implanted within a body.3. The medical device of claim 1 , further comprising a converter which includes a piezoelectric element excitable by ultrasound waves claim 1 , wherein the converter converts ultrasound wave energy into rotational energy claim 1 , whereby when the medical device is placed within a body and viewed on an ultrasound image during ultrasound imaging procedures claim 1 , application of ultrasound waves to the medical device causes the marker to rotate about the axis.4. The medical device of claim 1 , wherein the marker further comprises echogenic enhancements located on surfaces of the marker claim 1 , whereby when an ultrasound signal is applied to the marker the echogenic enhancements cause a scattering of the ultrasound waves.5. The medical device of claim 1 , further comprising a battery and an ultrasound sensor claim 1 , wherein rotation of the marker is powered by the battery claim 1 , wherein the medical device is switchable between an ...

NON-LINEAR ECHOGENIC MARKERS

Medical devices include echogenic subregions and echolucent subregions arranged in an alternating pattern and having exogenous features. Examples include metal printing and cast metal being applied to a plastic structure. Other examples include a fluid contrast agent including microbubbles housed in compartments within a structure. Additional examples include small resonators built into a structure for resonating at a specific frequency and imageable with a harmonic imaging mode of an ultrasound imaging system. 1. A medical device detectable with ultrasound imaging equipment comprising:an echogenic region, wherein the echogenic region includes a plurality of first subregions being defined by borderlines and a plurality of second subregions, wherein the first subregions include an echogenic enhancement, and wherein the first subregions and second subregions are arranged in an alternating pattern wherein at least one second subregion lies between each pair of first subregions with no borderlines shared between any pair of the first subregions.2. The medical device of claim 1 , wherein the medical device includes a planar structure which supports the echogenic region.3. The medical device of claim 1 , wherein the medical device includes a support structure having a cylindrically shaped surface claim 1 , and wherein the echogenic region is positioned within the support structure.4. The medical device of claim 1 , wherein the first subregions and the second subregions are arranged in a checkerboard pattern.5. The medical device of claim 1 , wherein the first subregions include a metal film printed on a plastic surface.6. The medical device of claim 1 , further comprising a plastic structure claim 1 , and wherein the echogenic enhancement includes a plurality of gaseous pits positioned within the plastic structure.7. The medical device of claim 6 , wherein the gaseous pits are formed by laser pitting.8. The medical device of claim 1 , wherein the echogenic enhancement ...

COATED IMPLANTABLE MEDICAL DEVICE

Bioactive-coated medical devices are provided, including coated vascular stents. The medical device coating can include a coating layer posited over at least a portion of the medical device surface, and can include a butyl methacrylate polymer or an ethylene-vinyl acetate copolymer in combination with a bioactive material that can function as both an immunosuppressive agent and an antiproliferative agent. Optionally, multilayer coatings can further include an adhesion promoting layer comprising parylene positioned between the coating layer and the medical device surface, a porous layer comprising butyl methacrylate positioned over at least a portion of the coating layer, or both. The coating layer preferably comprises between about 0.5 and 2.0 μg/mmof the bioactive material on the outer surface of the medical device. The bioactive material can be absorbed into the coating layer, which can have a thickness of between about 0.5 μm to about 5 μm.

PERIPHERAL SEALING VENOUS CHECK-VALVE

Among other things, there are disclosed embodiments of a valve implant that in particular examples are implantable within a blood vessel, which include a first set of elongate members, a second set of elongate members, and a hood affixed to the first set of elongate members. The first set of elongate members is resiliently deformable, and their distal ends are flared radially outward. The distal ends of the second set of elongate members are distal to the ends of the first set of elongate members. The hood is affixed to the first set of elongate members, and seals against the interior wall of the blood vessel in an expanded configuration. When blood flows from the proximal to the distal side of the valve implant, it presses on the hood, compressing the first set of elongate members, breaking the seal. 1. A valve implant for implantation in a bodily lumen , the implant having a central axis , a proximal end , and a distal end , the implant comprising:a first set of resiliently deformable, elongate members, each having respective proximal and distal ends, the proximal ends adjacent to one another, and respective distal ends flared radially outward;a second set of elongate members, each having respective proximal and distal ends, the proximal ends adjacent to the proximal ends of the first set of elongate members, and the distal ends both flared radially outward and distal to the distal ends of the first set of elongate members;a substantially fluid-tight hood affixed to the first set of elongate members, the hood and first set of elongate members forming a concavity;wherein at least part of the hood is collapsible toward the central axis when blood flows in a direction generally from the proximal end to the distal end, thereby allowing blood to flow past the vascular implant.2. The valve implant of claim 1 , further comprising a collar that affixes the distal ends of at least one of the sets of the elongate members to one another.3. The valve implant of claim 1 , ...

QUILTED IMPLANTABLE GRAFT

Described are embodiments of a multilaminate or multiple layer implantable surgical graft with an illustrative graft comprising a remodelable collagenous sheet material, the graft including one or more interweaving members to stitch together the graft to help prevent the layers from delaminating or separating during handling and the initial stages of remodeling. The interweaving members may comprise lines of suture, thread, individual stitches, strips of material, etc. that are woven through the layers of biomaterial in a desired pattern. In one embodiment, the interweaving members comprise a pharmacologically active substance, such as a drug, growth factors, etc. to elicit a desired biological response in the host tissue. In another embodiment, the graft further comprises a reinforcing material, such as a synthetic mesh, within the layers of remodelable biomaterial and stitched together by one or more interweaving members. 1. A multilayer surgical graft , comprising:a first remodelable extracellular matrix sheet;a second remodelable extracellular matrix sheet;a synthetic mesh material disposed between said first remodelable extracellular matrix sheet and said second remodelable extracellular matrix sheet; andat least one interweaving member interwoven through said first remodelable extracellular matrix sheet and said second remodelable extracellular matrix sheet such that said first remodelable extracellular matrix sheet and said second remodelable extracellular matrix sheet are affixed together.2. The multilayer surgical graft of claim 1 , wherein said first remodelable extracellular matrix sheet includes two or more laminated remodelable extracellular matrix layers.3. The multilayer surgical graft of claim 2 , wherein said second remodelable extracellular matrix sheet includes two or more laminated remodelable extracellular matrix layers.4. The multilayer surgical graft of claim 3 , wherein said at least one interweaving member comprises a bioresorbable material. ...

BELT FOR APPLYING PRESSURE TO A BODILY ORGAN

Among other things, there are disclosed embodiments of belts or bands that can be used in treatments for tricuspid valve regurgitation. In some embodiments, such belts may be heat-set in a particular configuration to effectively decrease tricuspid annulus when deployed around the atrioventricular groove. Embodiments include one or more tensioning sutures for applying cinching or tightening to belts when deployed, and structure for effectively distributing force during such tightening. 1. A belt for placement along the atrioventricular groove of the heart , comprising:a mesh tube having a first open end and a second open end and a lumen passing through the tube from the first open end to the second open end along a longitudinal axis of the tube, the tube configured longitudinally in a loop so as to be placed around the heart and along the atrioventricular groove;a first suture portion within the tube, the first suture portion fixed to the tube adjacent the first open end and extending through the lumen toward the second open end, the first suture portion connected to the tube within the lumen by a plurality of holding elements so that the first suture portion is longitudinally movable through the holding elements with respect to the tube;a second suture portion within the tube and parallel to and spaced from the first suture portion, the second suture portion fixed to the tube adjacent the first open end and extending through the lumen toward the second open end, the second suture portion connected to the tube within the lumen by a plurality of holding elements so that the second suture portion is longitudinally movable through the holding elements with respect to the tube;wherein pulling the first and second suture portions cinches the tube to reduce an area of the loop so that the tube compress longitudinally in at least selected locations along the tube.2. The belt of claim 1 , wherein the first suture portion and second suture portion each extend through the ...

CATHETER SYSTEMS AND METHODS USEFUL FOR CELL THERAPY

Described in one aspect is a multi-pressure monitoring system for cell or other therapy includes a first catheter having a first lumen for accepting a treatment device, a second lumen for inflating a balloon, a pressure sensor for monitoring fluid pressure within the first lumen, and a flow restrictor such as a hemostasis valve for limiting the exchange of fluids into and out of the first lumen while treatment devices are present or exchanged in the first lumen. Also disclosed is a method of using the first catheter with a first pressure monitor coupled to the first pressure sensor along with a second catheter attached to a second pressure sensor coupled to a second pressure monitor. The second catheter is positioned within the first lumen of the first catheter during treatment operations and the first and second pressure monitors are used to verify proper pressures throughout the procedure. Described also are novel methods, systems, and catheters for delivering flowable therapeutic substances, such as viable cellular preparations, to patients. 1. A method of delivering a liquid medium to a patient , comprising:advancing the liquid medium under pressure through a first catheter lumen and into a patient bodily lumen so as to generate a first fluid pressure in the catheter lumen and a second fluid pressure in the bodily lumen;during said advancing, measuring the first fluid pressure with a first fluid pressure sensor operably coupled to the first catheter lumen; andduring said advancing, measuring the second fluid pressure with a second fluid pressure sensor operably coupled to a second catheter lumen in fluid communication with the bodily lumen.2. The method of claim 1 , wherein the liquid medium contains viable cells.3. A method of delivering viable cells to a target bodily passage site of a patient claim 1 , comprising: (i) first advancing an inflatable balloon of a first catheter to the first bodily passage site, the first catheter having a first catheter shaft ...

ECHOLUCENT GUIDEWIRE TIP

A medical device includes a guidewire with a lumen, a plastic tip, and a removable mandrel. The medical device has echogenic properties which can be altered between an echogenic state and an echolucent state by evacuating the lumen and applying a liquid or gas within the lumen.

INTERNAL ULTRASOUND ASSEMBLY FLUID SEAL

There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms. 1. An apparatus , comprising:a housing, the housing having a uniform-diameter chamber defined at least partially by an acoustic window for transmission of ultrasound signals;a transducer for emitting and/or receiving ultrasound signals, the transducer being within the chamber;a shaft operatively connected to the transducer, the shaft adapted to rotate with respect to the housing so that the transducer rotates in response to rotation of the shaft; anda seal partially bounding the chamber, a part of the seal engaged with the housing across the chamber's diameter, the seal having an opening through which the shaft extends, with a portion of the seal around the opening engaging the outside of the shaft to create a fluid-tight connection between the seal and the shaft.2. The apparatus of claim 1 , wherein the seal includes a body having a lip portion that is elastically bent with respect to the rest of the body.3. The apparatus of claim 2 , wherein the lip portion includes a rounded convex surface facing the opening claim 2 , and wherein a portion of the rounded convex surface engages the outside of the shaft to create a fluid-tight connection between the seal and the shaft.4. The apparatus of claim 2 , wherein at least a portion of the body is fixed substantially perpendicular to the housing.5. The apparatus of claim 2 , ...

INTERNAL ULTRASOUND ASSEMBLY WITH PORT FOR FLUID INJECTION

There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms. 1. An apparatus for ultrasound procedures , comprising:a transducer for emitting and/or receiving ultrasound signals, the transducer being within a chamber, the chamber defined at least partially by a wall forming an acoustic window for transmission of ultrasound signals;an injection port communicating with the chamber adapted for passing coupling media through and into the chamber, andan exhaust port communicating with the chamber through which gas within the chamber can be exhausted from the chamber when coupling media is inserted into the chamber.2. The apparatus of claim 1 , wherein the injection port comprises a flexible insert fixed with respect to the wall claim 1 , the insert permitting insertion of a needle through it and thereafter providing a leak-tight seal when a needle is removed from it.3. The apparatus of claim 2 , wherein the insert is placed at a forward-most tip of the chamber.4. The apparatus of claim 1 , wherein the chamber is attached to or part of an elongated tubular housing having an internal surface and an external surface claim 1 , and wherein the injection port comprises a lumen opening into the chamber and extending through at least part of the housing between the internal surface and the external surface.5. The apparatus of claim 4 , wherein at least part of the lumen is within a tube ...

CLOSING DEVICE FOR TISSUE OPENINGS

There are shown and described embodiments of a closure device for closing holes in tissue, for example in the right atrial appendage. The closure device in particular embodiments includes first and second mesh closure members and a tether or stem connecting them. Embodiments of a delivery device for the closure device are also described. 1. A closure for an opening in tissue , comprising:a first closure element, the first closure element having a first mesh enclosure, the first mesh enclosure having a first distal narrowed end and a second proximal narrowed end and a central volume, each of the first and second ends being inverted so as to be within the central volume of the first mesh enclosure, each of the first and second ends being surrounded by respective external surfaces of the first mesh enclosure;a second closure element, the second closure element having a second mesh enclosure, the second mesh enclosure having a third distal narrowed end and a fourth proximal narrowed end and a central volume, the third end being inverted so as to be within the central volume of the second mesh enclosure, each of the third and fourth ends being surrounded by respective external surfaces of the second mesh enclosure;a tether joining the first and second closure elements in an initial configuration prior to delivery of the closure elements to the opening, the tether having first and second enlarged ends, wherein the tether extends through the first, second and third narrowed ends so that the first enlarged end of the tether is outside the first closure element adjacent or engaging the first end and the second enlarged end of the tether is within the central volume of the second closure element,wherein the first closure element is adapted to engage a distal side of the tissue having the opening, and the second closure element is adapted to engage a proximal side of the tissue, and the tether is adapted to pass through the opening.2. The closure of claim 1 , further ...

QUILTED IMPLANTABLE GRAFT

Described are embodiments of a multilaminate or multiple layer implantable surgical graft with an illustrative graft comprising a remodelable collagenous sheet material, the graft including one or more interweaving members to stitch together the graft to help prevent the layers from delaminating or separating during handling and the initial stages of remodeling. The interweaving members may comprise lines of suture, thread, individual stitches, strips of material, etc. that are woven through the layers of biomaterial in a desired pattern. In one embodiment, the interweaving members comprise a pharmacologically active substance, such as a drug, growth factors, etc. to elicit a desired biological response in the host tissue. In another embodiment, the graft further comprises a reinforcing material, such as a synthetic mesh, within the layers of remodelable biomaterial and stitched together by one or more interweaving members. 17-. (canceled)8. A multilayer surgical graft , comprising:a first remodelable extracellular matrix sheet;a second remodelable extracellular matrix sheet; anda synthetic mesh material with a plurality of mesh openings disposed between said first remodelable extracellular matrix sheet and said second remodelable extracellular matrix sheet,said first remodelable extracellular matrix sheet and said second remodelable extracellular matrix sheet contacting and bonded to one another through said plurality of mesh openings to provide bonded regions between said first remodelable extracellular matrix sheet and said second remodelable extracellular matrix sheet.9. The multilayer surgical graft of further including at least one interweaving member interwoven through said first remodelable extracellular matrix sheet and said second remodelable extracellular matrix sheet such that said first remodelable extracellular matrix sheet and said second remodelable extracellular matrix sheet are affixed together.10. (canceled)11. The multilayer surgical graft of ...

Compartmented cryopreservation container and uses thereof

Described are medical products, methods, and cryogenic bags or other containers suitable for storing and/or transporting and/or processing cellular compositions and other related materials. In certain aspects, the contents of such cryogenic bags may be warmed, mixed, and applied to a patient. Medical products described herein find particular use in treating diseased and/or damaged tissue such as in wound repair and/or bone repair. Related methods of manufacture are also described.

DEVICES AND METHODS FOR THREE-DIMENSIONAL INTERNAL ULTRASOUND USAGE

There are disclosed embodiments of devices and methods for ultrasound imaging, for example of the inside of a body part such as a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a second motor operating a shaft or a filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms. 1. An apparatus for ultrasound procedures , comprising:a transducer for emitting and/or receiving ultrasound signals;first and second motors, wherein the first motor is operatively connected to the transducer so that operation of the first motor turns the transducer around a rotation axis of the apparatus, andwherein the second motor is operatively connected to the transducer so that pivoting motion of the transducer around a pivoting axis transverse to the rotation axis of the apparatus is a function of the operation of the second motor.2. The apparatus of claim 1 , wherein the first motor is a rotary motor and the second motor is one of a linear motor and a rotary motor.3. The apparatus of claim 1 , wherein the first motor turns a first shaft having a lumen and operatively connected to the transducer claim 1 , and wherein the second motor operates a second shaft that extends through the lumen of the first shaft and is operatively connected to the transducer.4. The apparatus of claim 3 , further comprising:a pivoting mechanism operationally connected to the first motor so that the pivoting mechanism rotates in response to operation of the first motor, the pivoting mechanism having a base and pivoting member that is pivotable with respect to the base around the pivoting axis, the ...

VASCULAR ANCHORING INTRODUCER SHEATH

Among other things, there is disclosed structure and methods for maintaining access to a location in the body while reducing or eliminating the potential for pulling an access device (e.g. a catheter) back through an opening. An introducer sheath includes a distal indented portion and a balloon, so that once placed in a desired location through tissue, the balloon can be inflated to anchor the sheath against retraction. In particular embodiments, structure and methods for accessing the pericardial cavity via the right atrial appendage are shown. 1. An introducer sheath for insertion through the right atrial appendage into the pericardial cavity , comprising:an inner lubricious layer defining an internal lumen extending along a longitudinal axis of the sheath from a proximal end to a distal end of the sheath;an outer heat-settable layer surrounding the inner layer and extending from the proximal end to the distal end;a coil core fixed between the inner layer and the outer layer, the coil core extending through at least part of a proximal portion of the sheath and at least part of a medial curved portion of the sheath but not into a linear distal portion of the sheath which includes the distal end;wherein the linear distal portion has a circumference around the longitudinal axis, and includes an indented portion around the entire circumference, the indented portion having proximal and distal edges an outer diameter less than a maximum outer diameter of the linear distal portion, and further comprising a balloon in the indented portion, the balloon having a deflated condition in which the balloon does not extend past either of the edges or the maximum outer diameter of the linear distal portion and an inflated condition in which the balloon extends coaxially past the maximum outer diameter of the linear distal portion around the circumference of the linear distal portion, and wherein the balloon in the inflated condition has a surface facing proximally that is angled ...

Suture lock device

Among other things, there are shown embodiments of locking mechanisms for holding sutures in tension. Such devices may be used with implants that use or require sutures, and are easily locked remotely. In particular embodiments, a lock includes a housing member, a pin member at least partially within the housing member, and a spring biasing the pin member into the housing member. The pin member includes a gripping portion, and has a retracted condition and a locked condition. When retracted, a suture can move through the housing member and around the gripping portion of the pin member. When locked, the gripping portion of the pin member engages the suture and presses it against the interior of the housing member.

PERCUTANEOUS, ULTRASOUND-GUIDED INTRODUCTION OF MEDICAL DEVICES

Described are methods and systems and system components useful for percutaneously delivering or retrieving vascular implant devices, such as filters, utilizing intravenous ultrasound (IVUS) imaging alone or in combination with external (e.g. transabdominal) ultrasound or other imaging technology. Implants deliverable by such systems, such as vena cava or other vascular filters, can have two or more echogenic markers spaced at such a distance that they are separately discernible by IVUS and/or external ultrasound imaging. 133-. (canceled)34. A method for the capture of a vascular filter positioned within a vascular vessel of a patient , comprising:introducing a retrieval device through a percutaneous access site spaced from the vascular filter;advancing the retrieval device through the vascular system toward the vascular filter;visually observing an ultrasound-generated image of a first echogenic marker on the vascular filter;visually observing an ultrasound-generated image of a second echogenic marker on the vascular filter, the second echogenic marker longitudinally spaced a distance from the first echogenic marker;visually observing an ultrasound-generated image of a third echogenic marker within a capture zone between the first and second echogenic markers, the third echogenic marker on the retrieval device; andactuating the retrieval device within the capture zone so as to capture the vascular filter.3562-. (canceled)63. A system for ultrasound guidance , comprising:a computer processor for receiving signal data from an intravascular ultrasound probe and generating ultrasound images using the signal data;a visual display device; andsaid computer processor and display device operable to display two-dimensional, real time images generated using the signal data simultaneously with a three-dimensional image generated from prior-acquired intravascular ultrasound image signal data.64. The system of claim 63 , wherein the three-dimensional image is generated by ...

INTERNAL ULTRASOUND ASSEMBLY FLUID SEAL

There are disclosed embodiments of devices and methods for imaging the inside of a body part, particularly a blood vessel. In particular embodiments, a catheter has a tip chamber, within which is an ultrasound transducer mounted on a pivot mechanism, a motor for turning the transducer, and an implement for pivoting the transducer. Examples of such an implement are a linear motor, a shaft or filament, and the pivot mechanism may be biased to return to a base position when the implement is not pivoting the transducer. In other embodiments, a mirror reflecting ultrasound signals from the transducer may be rotated and/or pivoted, using similar mechanisms.

GUIDE MEMBERS AND ASSOCIATED APPARATUSES USEFUL FOR INTRAVASCULAR ULTRASOUND PROCEDURES

Described are guidewires having at least one echolucent segment, and associated apparatuses and methods. The guidewires can be combined with devices equipped with intravascular ultrasound probes and used to effectively image regions during procedures underway in the vascular environment. The echolucent segment can have one or more echogenic markers to enable detection of the segment and/or relative movement of the segment using intravascular ultrasound. 1. An intravascularly-introducible apparatus , comprising:an elongate carrier body for intravascular passage, the carrier body defining at least one lumen and carrying at least one intravascular ultrasound probe for generating image data representing an imageable region external of the carrier body; anda guide member having an elongate guide body receivable through said lumen, the elongate guide body having at least a first guide body portion capable of passage into said imageable region;wherein said first guide body portion includes an echolucent material and has associated therewith at least one echogenic marker.2. The apparatus of claim 1 , wherein elongate guide body comprises at least two longitudinally-extending guide body portions joined to one another.3. The apparatus of claim 2 , further comprising:a second guide body portion formed of an echogenic material;wherein said elongate guide body includes at least said first guide body portion joined to said second guide body portion.4. The apparatus of claim 2 , wherein the first guide body portion includes a polymeric material claim 2 , and the second guide body portion includes a metal.5. The apparatus of claim 1 , wherein the at least one echogenic marker includes a plurality of longitudinally spaced echogenic marker regions.6. The apparatus of claim 1 , wherein the at least one echogenic marker includes a plurality of discrete echogenic markers or a continuous longitudinally-extending echogenic marker.7. The apparatus of claim 6 , wherein the at least one ...

PERIPHERAL SEALING VENOUS CHECK-VALVE

Among other things, there are disclosed embodiments of a valve implant that in particular examples are implantable within a blood vessel, which include a first set of elongate members, a second set of elongate members, and a hood affixed to the first set of elongate members. The first set of elongate members is resiliently deformable, and their distal ends are flared radially outward. The distal ends of the second set of elongate members are distal to the ends of the first set of elongate members. The hood is affixed to the first set of elongate members, and seals against the interior wall of the blood vessel in an expanded configuration. When blood flows from the proximal to the distal side of the valve implant, it presses on the hood, compressing the first set of elongate members, breaking the seal. 1. A valve implant for implantation in a bodily lumen , the implant having a central axis , a proximal end , and a distal end , the implant comprising:a first set of resiliently deformable, elongate members, each having respective proximal and distal ends, the proximal ends adjacent to one another and immobile with respect to each other, and respective distal ends flared radially outward and mobile with respect to each other, the first set of elongate members defining a plurality of spaces between them;a second set of elongate members, each having respective proximal and distal ends, the proximal ends of the second set adjacent to and immobile with respect to the proximal ends of the first set of elongate members, and the distal ends of the second set flared radially outward;wherein at least one of the elongate members of the first set or at least one of the elongate members of the second set includes at least a portion pivotable toward and away from the central axis; anda substantially fluid-tight hood which, during operation of the implant, is fixed to the portion or portions of the pivotable member or members;wherein at least part of the hood is movable between a ...

CLOSING DEVICE FOR TISSUE OPENINGS

There are shown and described embodiments of a closure device for closing holes in tissue, for example in the right atrial appendage. The closure device in particular embodiments includes first and second mesh closure members and a tether or stem connecting them. Embodiments of a delivery device for the closure device are also described. 1. A closure for an opening in tissue , comprising:a first closure element, the first closure element having a first mesh enclosure, the first mesh enclosure having a first distal narrowed end and a second proximal narrowed end and a central volume, each of the first and second ends being inverted so as to be within the central volume of the first mesh enclosure, each of the first and second ends being surrounded by respective external surfaces of the first mesh enclosure;a second closure element, the second closure element having a second mesh enclosure, the second mesh enclosure having a third distal narrowed end and a fourth proximal narrowed end and a central volume, the third end being inverted so as to be within the central volume of the second mesh enclosure, each of the third and fourth ends being surrounded by respective external surfaces of the second mesh enclosure;a tether joining the first and second closure elements in an initial configuration prior to delivery of the closure elements to the opening, the tether having first and second enlarged ends, wherein the tether extends through the first, second and third narrowed ends so that the first enlarged end of the tether is outside the first closure element adjacent or engaging the first end and the second enlarged end of the tether is within the central volume of the second closure element,wherein the first closure element is adapted to engage a distal side of the tissue having the opening, and the second closure element is adapted to engage a proximal side of the tissue, and the tether is adapted to pass through the opening.2. The closure of claim 1 , further ...

METHODS, SUBSTRATES, AND SYSTEMS USEFUL FOR CELL SEEDING OF MEDICAL GRAFTS

Described are methods, cell growth substrates, and devices that are useful in preparing cell-containing graft materials for administration to patients. Tubular passages can be defined in cell growth substrates to promote distribution of cells into the substrates. Also described are methods and devices for preparing cell-seeded graft compositions, methods and devices for preconditioning cell growth substrates prior to application of cells, and cell seeded grafts having novel substrates, and uses thereof. 110-. (canceled)11. A method for preparing a cell-seeded composition for delivery to a patient , comprising:providing a fluid extracellular matrix particulate composition comprising particles of extracellular matrix and a liquid medium;combining the fluid extracellular matrix composition with a liquid cell suspension to form a cellular fluid composition; andmixing the cellular fluid composition.12. The method of claim 11 , also comprising causing said cellular fluid composition to gel.13. The method of claim 12 , wherein said causing comprises altering the pH of the cellular fluid composition.14. The method of claim 12 , wherein said causing comprises altering the temperature of the cellular fluid composition.1549-. (canceled)50. A method for treating a patient claim 12 , comprising:combining a suspension of cells with a particulate cell growth substrate;incubating the suspension of cells in contact with the particulate cell growth substrate to form cellularized particulate bodies having cells attached to particles of the particulate cell growth substrate, wherein said incubating is for a duration and under conditions such that significant expansion of the number of cells does not occur; andadministering said cellularized particulate bodies to the patient.51. The method of claim 50 , wherein said incubating is for a duration and under conditions effective to achieve attachment of at least 20% of the cells in said suspension to said particles but without expansion of ...

VIAL FILLING SYSTEM WITH LOCALIZED CLEAN ZONE

Among other things, there is shown a system for filling vials with fluid that maintains a localized sterile zone around the filling location. In particular embodiments, the sterile zone is provided by a manifold having an internal space to which clean air is supplied. One or more filling assemblies are attached to the manifold. Vials enter the sterile zone and are filled within it. Additional structure, such as coverings for vials, are disclosed to assist in maintaining sterility. 1. A vial-filling apparatus , comprising:a disposable clean-air zone including a manifold having an upper surface and a lower surface bounding an internal space, a clean-air inlet communicating with the internal space, and at least one slot in the lower surface adapted to accept at least a portion of a vial, so that such portion of the vial may enter the space through the slot,wherein the manifold also includes at least one opening in the upper surface and over the slot, whereby fluid can be passed through the opening and into a vial at least partially in the clean-air zone.2. The apparatus of claim 1 , further comprising a fluid transfer assembly at least partially within the opening claim 1 , the fluid transfer assembly including a nozzle extending into the space in the manifold and sized and configured to enter a fill tube of a vial claim 1 , a fluid port in fluid communication with the nozzle claim 1 , and an air flush port in fluid communication with the nozzle.3. The apparatus of claim 2 , wherein each fluid transfer assembly is fixed with respect to the manifold.4. The apparatus of claim 1 , including multiple said fluid inlets above one or more said slots.5. The apparatus of claim 1 , wherein the manifold includes a shroud around three sides of the slot claim 1 , the shroud extending down from the lower surface.6. The apparatus of claim 5 , wherein the manifold includes a guide extending down from the lower surface and curving toward the slot claim 5 , whereby clean air exiting the ...

COATED MEDICAL DEVICE

A coated medical device () including a structure () adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material () having a bioactive material layer () disposed thereon. The medical device is preferably an implantable stent or balloon () of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material () positioned between the base and bioactive material layers of the balloon. 1. A medical device suitable for introduction in a patient , comprising:a vascular stent comprising a biocompatible metal or metal alloy base material;a coating comprising a bioactive material for preventing restenosis of a blood vessel posited directly on a surface of the metal or metal alloy base material, the surface having a texture sufficient for adhesion of the bioactive material to the surface; andwherein the bioactive material for preventing restenosis is not contained within or covered by a containment layer.2. The medical device of claim 1 , wherein the bioactive material is an antiproliferative agent.3. The medical device of claim 1 , wherein the coating consists essentially of the bioactive material.4. The medical device of claim 1 , wherein the base material comprises at least one of stainless steel claim 1 , tantalum claim 1 , titanium claim 1 , nitinol claim 1 , gold claim 1 , platinum claim 1 , inconel claim 1 , iridium claim 1 , silver claim 1 , tungsten claim 1 , or an alloy of any of these.5. The medical device of claim 1 , wherein the base material comprises nitinol.6. The ...

Temperature-based, rate-modulated cardiac therapy apparatus and method

A temperature-based, rate-modulated cardiac pacemaker having means for variably controlling the stimulation rate of the heart according to multiple temperature characteristics of the blood referenced to multiple moving baseline temperatures. A target rate is periodically calculated by obtaining a weighted sum of the following rate components: (1) the magnitude of a decrease in temperature below resting temperature, a first moving baseline, (2) the magnitude of an increase in temperature above a local minimum temperature, a second moving baseline, (3) the magnitude of an increase in the resting baseline above a daily minimum temperature, a third moving baseline, and (4) the absolute value of the rate of change of temperature. The resting temperature is preferably calculated over a longer interval than the local minimum temperature but a much shorter interval than the daily minimum temperature. A positive rate of change of temperature is distinguished from a negative rate of change of temperature and is used differently in the calculation of target rate. The target rate is not directly applied as the new pacing rate but is instead averaged with the previous rate in order to provide smoother transitions between pacing rates. An intermediate rate limit is included in addition to lower and upper rate limits, and rank filtering is employed in the determination of rate components.

Multiple monopolar system and method of measuring stroke volume of the heart

A multiple monopolar system and method for measuring stroke volume of a patient's heart. An intracardiac impedance catheter is provided with a plurality of monopolar electrodes axially spaced along the surface of its distal end, and is used in conjunction with a distant reference electrode which may, for example, be incorporated into the conductive case of a pacemaker. The proximal end of the catheter is attached to the pacemaker, which, in addition to pulse generator circuitry and circuitry for sensing electrical activity of the heart and for controlling pacing rate, includes a constant-current source for current injection into the volume of blood in the patient's ventricle and an impedance processor for measuring the resultant voltage between one of the monopolar electrodes in the ventricle and the pacemaker case and for calculating stroke volume therefrom. A system and method are also disclosed for generating a three-phase relationship between cardiac output and heart rate for an individual patient at a particular workload, for purposes of determining optimal heart rate, as is a method of using the monopolar electrode configuration to detect ventricular fibrillation.

Method and apparatus for volumetric interstitial conductive hyperthermia

A system and method for producing volumetric conductive hyperthermia for the treatment of a cancerous tumor in a patient. The location and volume of the tumor are determined with the aid of a CT scanning system, and an array of probes each containing a heat-emitting element is formed by interstitial implantation in the tumor in a predetermined pattern for volumetric heating using a template for guiding the probes into parallel alignment in the tumor. The template is affixed with respect to the patient's body and with respect to the imaging plane of the CT scanning system. After implantation, the probes are connected to a manifold connector which is in turn connected to an external control system capable of independently controlling the probes while monitoring various analog and digital values representative of system performance.

Silver implantable medical device

A silver implantable medical device 29 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material posited on one surface of structure 12; and at least one porous layer 20 posited over the bioactive material layer 18 posited on one surface of structure (12) and the bioactive-material-free surface. Also included is a layer or impregnation of silver 45. Preferably, the structure 12 is a coronary stent. The porous layer 20 is comprised of a polymer applied preferably by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor. Silver is included as a base material, coating or included in a carrier, drug, medicant material utilized with the implantable stent.

Implantable medical device

Coated implantable medical device

Coated implantable medical device

A medical device (10) includes a structure (12) adapted for introduction into a patient, the structure (12) being formed of a preferably non-porous base material (14) having a roughened or textured surface (16). The structure (12) is conveniently configured as a vascular stent with a base material (14) of stainless steel, nitinol or another suitable material. The medical device (10) also includes a layer (18) of a bioactive material posited directly upon the roughened or textured surface (16) of the base material (14) of the structure (12). The surface (16) of the base material (14) is roughened or textured by etching or by abrasion with sodium bicarbonate or another suitable grit. A preferred roughened or textured surface (16) is thought to have a mean surface roughness of about 10 νin. (about 250 nm) and a surface roughness range between about 1/νin. and about 100 νin. (about 25 nm and about 2.5 νm). The particularly preferred use of sodium bicarbonate as the abrasive to provide roughness or texture to the surface (16) of the base material (14) of the structure (12) is additionally advantageous in the low toxicity of the sodium bicarbonate to production workers, the ease of product and waste cleanup, and the biocompatibility of any residual sodium bicarbonate.

Coated implantable medical device

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Coated implantable medical device

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material positioned over the structure 12; and at least one porous layer 20 positioned over the bioactive material layer 18. Preferably, the structure 12 is a coronary stent, and the bioactive material is at least one of heparin, dexamethasone or a dexamethasone derivative. The device 10 includes layers 18 and 22 of heparin and dexamethasone, the layer 22 of dexamethasone being positioned above the layer 18 of heparin. The layers of bioactive material also can be individual materials or a combination of different materials. Unexpectedly, the more soluble heparin markedly promotes the release of the less soluble dexamethasone above it. The porous layer 20 is composed of a polymer applied by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyimide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor.

Coated implantable medical device

A medical device includes a structure adapted for introduction into a patient, the structure being formed of a non-porous bio compatible metal material having a textured surface. The medical device also includes a layer of a bioactive material posited directly upon the textured surface of the base material of the structure. The surface of the base material is textured with a mean surface roughness of about 10 µin. and a surface roughness range between about 1 µin. and about 100 µin. The surface roughness of the surface of the base material is sufficient for adhesion of the bioactive material to the surface.

Transurethral ablation catheter

Method and apparatus for treating tissue with first and second modalities

Method and apparatus is disclosed for treating tissue interstitially with multiple modalities of treatment. The apparatus comprises a semi-rigid elongated member that is implanted interstitially in the malignant tumor. A hollow passageway is longitudinally positioned in the member for positioning one or more modalities inserted or positioned therein. The elongated member is coated with another modality such as a carrier substance that is responsive at a temperature above normal tissue temperature for releasing a carried substance such as a therapeutic anti-cancer drug. Within the elongated member, an electrical heater element for one modality produces heat when energized for heating the probe, the carrier substance, the anti-cancer drug, and the surrounding tissue. A second modality such as a source of radiation is inserted in the passageway after the probe is interstitially implanted. A trocar stylet is initially inserted in the passageway to implant the probe. When the probe is implanted, the trocar stylet is removed, and the heater element and/or source of radiation is inserted into the passageway. The several modalities combine in a synergistic manner to provide an overall treatment that has an effectiveness level greater than the sum of the individual modalities.

Ablation catheter

An ablation catheter is provided with an elongated member or shaft (110) and a plurality of helically-shaped cutting wires (104) atached to the shaft to form a cutting basket (150). Each of the cutting wires has a section formed as a circumferentially subscribing arc (105) and together the wires present a circumferential cutting area of an essentially cylindrical configuration. Each of the wires (104) comprises a first curved or straight section (123) extending from the distal end of shaft (110) to a discontinuity such as a corner or kink (125). Obstructing matter on the inner surface of a vessel cavity, such as a blood vessel or the like, is separated from the surface as the catheter is moved through the vessel. The catheter may be inserted in a vessel in a standard fashion using a wire guide (102) which extends through a longitudinal passageway in the shaft and a hub (103) interconnecting the basket wire. The shaft and basket together may be contained in an outer sheath to facilitate insertion. The outer sheath with the basket in a collapsed state in the outer sheath may be readily moved past an obstruction, and the sheath withdrawn to allow the basket to expand and come in contact with the interior surface of the vessel cavity. The proximal ends of the cutting wires extend from the shaft through a vibratory transducer, and the distal ends are connected together by a hub. Electrical current is applied to electrical terminals connected to the cutting wires at the proximal end of the shaft to heat the wires to facilitate separating obstructing matter from a vessel surface. Futhermore, the vibration transducer vibrates the cutting wires to further aid in separating plaque and obstructions from soft tissue such as the intima layer of the wall of a blood vessel.

Coated implantable medical device

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract, and at least one layer 18 of an immunosuppressive agent posited over at least one surface of the structure 12. Optionally, the device 10 can include at least one porous, preferably polymeric layer 20 posited over the layer 18 of immunosuppressive agent, and can alternatively or additionally include at least one coating layer 16 posited on one surface of the structure 12, the at least one layer 18 of immunosuppessive agent being posited in turn on at least a portion of the coating layer 16. The porous layer 20 and the coating layer 16 each provide for the controlled release of the bioactive material from the device 10. The structure 12 is preferably configured as a coronary stent. The polymer of the porous layer 20 is preferably applied by vapor or plasma deposition. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative which is deposited without solvents, heat or catalysts, but rather by condensation of a monomer vapor.

Endoluminal device with extracellular matrix material and methods

An endoluminal device comprises a stent and a tubular graft supported by the stent. The graft has a proximal and a distal opening and comprises a synthetic material and a bioremodelable material. The bioremodelable material is disposed on an exterior surface in at least one band adjacent at least one of the proximal and distal openings.

Barb and expandable transluminal graft prosthesis for repair of aneurysm

An improved prosthesis assembly for placement at an aneurysm in the bifurcated lumen of the aorta and the common iliac arteries extending therefrom. The prosthesis assembly includes a single lumen graft or a bifurcated lumen graft having a main body and ipsilateral and contralateral limbs extending therefrom. The main body and ipsilateral and contralateral limbs each have a spring assembly about their orifices for conforming that portion of the graft to the wall of the vessel lumen. The main body spring assembly has an improved barb with first and second attachment arms for securely anchoring the spring assembly to the vessel wall. The improved barb includes two forms of mechanical attachment such as, for example, a helical coil body positioned around a spring assembly arm and, secondly, a bonding material such as, for example, solder for fixedly attaching the coil and spring assembly arm. The attachment arms of the barb are positioned longitudinally along the spring assembly arm for engagement with the vessel wall without engaging each other when the spring assembly is in a collapsed condition. The ipsilateral and contralateral spring assemblies also include the improved barb with only a single attachment arm for anchoring the spring assembly to the vessel wall.

Modular prosthesis and method for branch vessels

A modular endoluminal prosthesis for deployment in a body lumen that has a first prosthetic module and a second prosthetic module. The first prosthetic module has a first prosthetic trunk integral with a first prosthetic side branch and the second prosthetic module has a second prosthetic trunk with a first notch. A telescoping interconnection is established when the first and the second prosthetic modules are interconnected

Endoluminal device with extracellular matrix material and methods

An endoluminal device (170) comprises a stent and a tubular graft supported by the stent. The graft has a proximal (174) and a distal opening (176) and comprises a synthetic material and a bioremodelable material. The bioremodelable material is disposed on an exterior surface in at least one band (171) adjacent at least one of the proximal and distal openings.

Endoluminal device with extracellular matrix material and methods

An endoluminal device comprises a stent and a tubular graft supported by the stent. The graft has a proximal and a distal opening and comprises a synthetic material and a bioremodelable material. The bioremodelable material is disposed on an exterior surface in at least one band adjacent at least one of the proximal and distal openings.

Endoluminal device with extracellular matrix material and methods

An endoluminal device comprises a stent and a tubular graft supported by the stent. The graft has a proximal and a distal opening and comprises a synthetic material and a bioremodelable material. The bioremodelable material is disposed on an exterior surface in at least one band adjacent at least one of the proximal and distal openings.

Exercise responsive cardiac pacemaker

An exercise-responsive cardiac pacemaker is provided which physiologically controls the stimulation rate of a heart by sensing the venous blood temperature in the right ventricle of the heart. A temperature sensing means which includes a thermistor produces an output signal which is sent to an algorithm implementing means for implementing the output signal by an algorithm which represents the mathematical function between venous blood temperature in the right ventricle and heart rate in a normally functioning heart. The algorithm implementing means produces an output signal which is variable between a maximum and minimum level corresponding to the desired maximum and minimum levels of heart rate in a normally functioning heart. The algorithm implementing means is also programmable by telemetry after implantation. A cardiac pacemaker is connected to the algorithm implementing means and is responsive thereto in order to variably control the stimulation rate of the heart.

Personal electrocardiogram monitor

A pocket-sized, self-contained electrocardiogram monitor with a dot-matrix, liquid-crystal display. The monitor uses dry electrodes and is suitable for direct placement against the patient's chest without the use of paste or gel to insure electrical contact. An A/D converter converts an ECG signal to a digital signal which is then processed by a microprocessor and then displayed on the liquid-crystal display in real time. The microprocessor is programmed to select the maximum and minimum digital values from four consecutive samples from the A/D converter and to supply data representative of the maximum and minimum values to the display at one-fourth the conversion sampling rate.

Implantable cardiovascular treatment device container for sensing a physiological parameter

An implantable container for housing a cardiovascular treatment device is disclosed with a window positioned in an external wall thereof for sensing a physiological parameter for the treatment device. The window is formed of an insulating material such as glass, a semiconductor material, or a membrane for sensing any one of a plurality of various physiological parameters. In one embodiment, the window material is glass on which a pair of electroptic devices are positioned on the interior surface thereof for emitting and receiving optical signals for sensing the physiological parameter. In another embodiment, the window comprises glass with a plurality of electrodes externally positioned thereon for measuring, for example, the electrical properties of the physiological parameter. In yet another embodiment of the window, the window material comprises a semiconductor material having a plurality of layers formed therein to form an ion selective field effect transistor for measuring concentrations of various fluids coming in contact therewith. In another embodiment, the semiconductor material forms a thermistor for sensing thermal properties of the physiological parameter. In yet another embodiment, the window comprises a membrane through which mechanical vibrations or pressures of surrounding tissue or fluids are sensed.

Coated implantable medical device

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16, wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18, wherein the porous layer is includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Thrombolytic treated intravascular medical device

An intravascular medical device having a structure shaped and sized for introduction into the vascular system of a patient including a base material and a coating of a thrombolytic agent on the base material. The thrombolytic agent advantageously dissolves or breaks up the formation of thrombus on the surface of the structure when placed in the vascular system of a patient. The intravascular medical device also includes a antithrombogenic agent for inhibiting the formation of thrombus on the surface of the medical device. The method of treating a medical device with a thrombolytic agent includes providing a base material for the medical device along with a thrombolytic agent. The base material is dipped into the thrombolytic agent and then removed to allow the thrombolytic agent to dry on the surface thereof. The dipping and drying steps are repeated to increase the concentration or quantity of the thrombolytic agent on the device.

Coated implantable medical device

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16 , wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18 , wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Silver implantable medical device

A silver implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one layer 18 of a bioactive material posited on one surface of structure 12 ; and at least one porous layer 20 posited over the bioactive material layer 18 posited on one surface of structure 12 and the bioactive-material-free surface. Also included is a layer or impregnation of silver 45 . Preferably, the structure 12 is a coronary stent. The porous layer 20 is comprised of a polymer applied preferably by vapor or plasma deposition and provides a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, merely by condensation of a monomer vapor. Silver is included as a base material, coating or included in a carrier, drug, medicament material utilized with the implantable stent.

Coated implantable medical device

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16 , wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18 , wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Coated implantable medical device method

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16 , wherein the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 can be posited over the bioactive material layer 18 , wherein the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Coated implantable medical device

A coated implantable medical device 10 includes a structure 12 adapted for introduction into the vascular system, esophagus, trachea, colon, biliary tract, or urinary tract; at least one coating layer 16 posited on one surface of the structure; and at least one layer 18 of a bioactive material posited on at least a portion of the coating layer 16 , where the coating layer 16 provides for the controlled release of the bioactive material from the coating layer. In addition, at least one porous layer 20 may be posited over the bioactive material layer 18 , where the porous layer includes a polymer and provides for the controlled release of the bioactive material therethrough. Preferably, the structure 12 is a coronary stent. The porous layer 20 includes a polymer applied preferably by vapor or plasma deposition and provides for a controlled release of the bioactive material. It is particularly preferred that the polymer is a polyamide, parylene or a parylene derivative, which is deposited without solvents, heat or catalysts, and merely by condensation of a monomer vapor.

Coated medical device

A coated medical device ( 10 ) including a structure ( 12 ) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material ( 14 ) having a bioactive material layer ( 18 ) disposed thereon. The medical device is preferably an implantable stent or balloon ( 26 ) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material ( 58 ) positioned between the base and bioactive material layers of the balloon.

Coated medical device

A coated medical device ( 10 ) including a structure ( 12 ) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material ( 14 ) having a bioactive material layer ( 18 ) disposed thereon. The medical device is preferably an implantable stent or balloon ( 26 ) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material ( 58 ) positioned between the base and bioactive material layers of the balloon.

Coated medical device

A coated medical device ( 10 ) including a structure ( 12 ) adapted for introduction into a passage or vessel of a patient. The structure is formed of preferably a non-porous base material ( 14 ) having a bioactive material layer ( 18 ) disposed thereon. The medical device is preferably an implantable stent or balloon ( 26 ) of which the bioactive material layer is deposited thereon. The stent can be positioned around the balloon and another layer of the bioactive material posited over the entire structure and extending beyond the ends of the positioned stent. The ends of the balloon extend beyond the ends of the stent and include the bioactive material thereon for delivering the bioactive material to the cells of a vessel wall coming in contact therewith. The balloon further includes a layer of hydrophilic material ( 58 ) positioned between the base and bioactive material layers of the balloon.

Coated implantable medical device