Endoprosthesis having improved strain distribution

An endoprosthesis for delivery in a body lumen can be configured to inhibit structural fatigue, crack formation, and elastic recoil while providing improved crimping and expansion uniformity and radial strength. As such, the endoprosthesis can include at least one multi-stage crest element connecting adjacent bar arms. The multi-stage crest element and, optionally, the connection or transition between the multi-stage crest element and the bar arms can form a plurality of undulations or curves to improve the distribution of the strains experienced by the endoprosthesis. The improved strain distribution can improve the structural integrity and prevent failure of the endoprosthesis.

OFFSET PEAK-TO-PEAK STENT PATTERN

The invention is directed to an expandable stent for implanting in a body lumen, such as a coronary artery, peripheral artery, or other body lumen. The invention provides for an intravascular stent having a plurality of cylindrical rings connected by links. The links between adjacent rings provide axial strength when subjected to longitudinal compressive forces. 1. A stent , comprising:a tubular member having a plurality of rings connected by links, the rings having short peaks and long peaks;adjacent rings being out of phase wherein the long peaks of one ring point toward the long peaks of an adjacent ring; andthe short peaks on one ring being located between long peaks on the same ring in order to promote ring-to-ring contact when longitudinally compressive loads are imparted on the stent.2. The stent of claim 1 , wherein the long peaks have offset bends at the peaks.3. The stent of claim 2 , wherein a first long peak has a first offset bend and a second long peak has a second offset bend.4. The stent of claim 3 , wherein the first offset bend points in first direction and the second offset bend points in a second direction opposite to the first direction.5. The stent of claim 4 , wherein the first offset bend points toward the second offset bend.6. The stent of claim 5 , wherein a short peak is positioned between the first offset bend and the second offset bend.7. The stent of claim 1 , wherein adjacent rings are connected by two links.8. The stent of claim 7 , wherein the links connect a long peak on one ring with a long peak on an adjacent ring.9. The stent of claim 8 , wherein the links have an angular orientation relative to a longitudinal axis of the stent.10. The stent of claim 1 , wherein the stent is balloon expandable or self-expanding.11. A stent claim 1 , comprising:a tubular member having a plurality of rings connected by links, the rings having short peaks and long peaks;a plurality of stent cells having multiple short peaks on adjacent rings; ...

Offset peak-to-peak stent pattern

The invention is directed to an expandable stent for implanting in a body lumen, such as a coronary artery, peripheral artery, or other body lumen. The invention provides for an intravascular stent having a plurality of cylindrical rings connected by links. The links between adjacent rings provide axial strength when subjected to longitudinal compressive forces.

ENDOPROSTHESIS HAVING IMPROVED STRAIN DISTRIBUTION

An endoprosthesis for delivery in a body lumen can be configured to inhibit structural fatigue, crack formation, and elastic recoil while providing improved crimping and expansion uniformity and radial strength. As such, the endoprosthesis can include at least one multi-stage crest element connecting adjacent bar arms. The multi-stage crest element and, optionally, the connection or transition between the multi-stage crest element and the bar arms can form a plurality of undulations or curves to improve the distribution of the strains experienced by the endoprosthesis. The improved strain distribution can improve the structural integrity and prevent failure of the endoprosthesis. 1. An endoprosthesis for delivery in a body lumen , the endoprosthesis comprising:a plurality of longitudinally spaced apart annular rings configured to provide scaffolding support to a lumen, each annular ring comprising:a first multistage crest element including a first link arm, a first curved elbow, and a first curved transition elbow, a first end of the first link arm being connected to a first end of the first curved transition elbow, a second end of the first link arm connected to a first end of the first curved elbow;a second multistage crest element including a second link arm, a second curved elbow, and a second curved transition elbow, a first end of the second link arm being connected to a first end of the second curved transition elbow, a second end of the second link arm connected to a first end of the second curved elbow; anda bar arm having a first end and a second end, the first end of the bar arm being connected to a second end of the first curved transition elbow of the first multistage element and the second end of the bar arm being connected to a second end of the second curved transition elbow of the second multistage element.2. The endoprosthesis of claim 1 , wherein the first curved transition elbow of the first multistage crest element and the second curved ...

INTEGRATED IMAGING AND DEVICE DEPLOYMENT PLATFORM

An integrated imaging and device deployment platform and method may include a catheter, at least one imaging unit, at least one deployment unit, and at least one device configured to be deployed by the at least one deployment unit. The integrated imaging and device deployment platform facilitates improved navigation and deployment of a therapeutic or medical device by providing the at least one imaging unit proximate the deployment unit. Information generated from the at least one imaging unit may be utilized with additional imaging modalities to provide improved imaging and delivery of devices while reducing use of X-ray radiation and contrast injection. 1. An integrated imaging and device deployment platform comprising:at least one catheter;at least one delivery unit connected to the at least one catheter, the at least one delivery unit having a longitudinal axis and being configured to deploy a device; andat least one imaging unit connected to the at least one catheter, the imaging unit having a steerable distal end portion that is selectively moveable between a first position in which the imaging unit is generally aligned with the axis of the at least one delivery unit and a second position in which the imaging unit extends radially outward at an angle relative to the axis of the at least one delivery unit.2. The integrated imaging and device deployment platform of claim 1 , wherein the at least one imaging unit comprises at least one embedded sensor configured to provide location information.3. The integrated imaging and device deployment platform of claim 1 , wherein the at least one imaging unit is a mapping catheter.4. The integrated imaging and device deployment platform of claim 3 , wherein the mapping catheter is an intra-cardiac echocardiography imaging device.5. The integrated imaging and device deployment platform of claim 1 , wherein the device is a therapeutic device suitable for a medical procedure including surgery or a minimally invasive procedure ...

ADJUSTABLE ARM DEVICE FOR GRASPING TISSUES

The present disclosure relates to repair devices configured for use in fixing or approximating tissues, such as cardiac valve tissues and particularly the leaflets of a regurgitant mitral valve. The repair device includes a shaft, a pair of proximal elements pivotally coupled to the shaft and extending from the shaft, and a pair of distal elements pivotally coupled to the shaft and extending from the shaft. The proximal and distal elements are configured so that targeted tissue can be grasped therebetween. The distal elements and/or the proximal elements include adjustable arms that can be extended and retracted to adjust the length of the gripping elements to provide more effective grasping of targeted tissues. 1. A repair device configured for repairing tissues at a targeted anatomical site , the repair device comprising:a shaft;a first distal gripping element having a medial end pivotally coupled to the shaft and extending to a free lateral end;a first proximal gripping element having a medial end pivotally coupled to the shaft and extending to a free lateral end, wherein the proximal gripping element is configured to cooperate with the distal gripping element to grasp targeted tissue therebetween; andat least one adjustable arm coupled to an associated distal gripping element or proximal gripping element so that, upon actuation, the adjustable arm extends to lengthen a lateral reach of the associated gripping element.2. The repair device of claim 1 , wherein the adjustable arm extends by translating laterally relative to the associated gripping element.3. The repair device of claim 2 , wherein the associated gripping element is configured as a track at least partially encompassing the adjustable arm.4. The repair device of claim 2 , further comprising a gear assembly claim 2 , wherein the adjustable arm extends and retracts according to forces transmitted through the gear assembly.5. The repair device of claim 1 , wherein the adjustable arm is biased toward an ...

THERMAL PROCESSING OF POLYMER SCAFFOLDS

Methods are disclosed including thermally processing a scaffold to increase the radial strength of the scaffold when the scaffold is deployed from a crimped state to a deployed state such as a nominal deployment diameter. The thermal processing may further maintain or increase the expansion capability of the scaffold when expanded beyond the nominal diameter. 119.-. (canceled)21. The method of claim 20 , further comprising crimping the scaffold from the processed state to a crimped state over a delivery balloon having a nominal diameter.22. The method of claim 20 , wherein the thermal processing increases the crest angles of the rings.23. The method of claim 20 , wherein a diameter of the scaffold is fixed during the thermal processing which causes the crest angles to increase as the arc length decreases.24. The method of claim 20 , wherein the scaffold is made of a PLA polymer and the temperature is 70 to 90° C. and the time is 5 to 15 min.25. The method of claim 20 , further comprising disposing the scaffold over a tubular mandrel prior to the thermal processing claim 20 , wherein the scaffold diameter decreases to the outer diameter of the mandrel during the thermal processing.26. The method of claim 20 , wherein the thermal processing decreases an arc length of each ring.27. The method of claim 20 , wherein crest angles are less than 100° in the fabricated state and the temperature claim 20 , time claim 20 , scaffold diameter decrease claim 20 , or any combination thereof are selected such that the crest angles are 100° to 150° in the processed state.28. The method of claim 20 , wherein a thickness of the scaffold is 75 to 100 microns in the fabricated state and increases 10 to 30% during the thermal processing.29. The method of claim 20 , wherein the thermal processing is performed during a coating process.30. The method of claim 20 , wherein the fabricated state is an as-cut scaffold.31. The method of claim 20 , wherein a width of the scaffold decreases during ...

METHODS FOR VASCULAR RESTORATION THERAPY

A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold has a structure that produces a low late lumen loss when implanted within a peripheral vessel and also exhibits a high axial fatigue life. In a preferred embodiment the scaffold forms ring structures interconnected by links, where a ring has 12 crowns and at most two links connecting adjacent rings. 2. The medical device of claim 1 , wherein the quantity d(S(t)/S)/dt over the interval of 7 days to 28 days following implantation is about −0.5×10to −1.0×10or about −0.5×10 claim 1 , about −0.8×10or about −1.0×10.3. The medical device of claim 1 , wherein the quantity S(t=7 days)/Sis about 1.0-1.5 claim 1 , or about 1.1-1.3.4. The medical device of claim 1 , wherein the quantity S(t=28 days)/Sis less than S(t=7 days)/Sand about 0.9-1.3.5. The medical device of claim 1 , wherein the quantity S(t=60 days)/Sis less than S(t=28 days)/Sand about 0.7-1.1.6. The medical device of claim 1 , wherein the quantity S(t=90 days)/Sis less than S(t=60 days)/Sand about 0.7-0.9.7. The medical device of claim 1 , wherein S(t) and So are post and pre implant pinching stiffness for the scaffold claim 1 , respectively.8. A method for making the medical device having the properties of claim 1 , comprising making a scaffold from a radially-expanded tube.9. A method of assembling a medical device having the properties of claim 1 , comprising crimping a scaffold to a balloon claim 1 , including the steps of radially reducing the scaffold diameter by at least 200% while the scaffold has a temperature of between 5-15 degrees below Tg-LOW.10. A method for vascular restorative therapy of a peripheral vessel claim 1 , comprising:making a scaffold comprising forming a polymer tube and forming the scaffold form the polymer tube; andcrimping the scaffold to a balloon;whereupon implantation of the scaffold in the peripheral vessel by inflation of the balloon the scaffold has the following ...

ANNULAR AUGMENTATION DEVICE FOR CARDIAC VALVE REPAIR

The present disclosure relates to repair devices for repair of regurgitant mitral valves. A repair device includes a body having a perimeter defining an upper side and a lower side. An annular groove is disposed along a posterior section of the perimeter of the device and is configured to receive posterior rim tissue of a mitral valve annulus. First and second anchors extend from the body in an anterior direction. The first and second anchors are configured to engage with respective commissures of the mitral valve to assist in securing the repair device in position. The repair device is structured to minimize or eliminate imparting or transmitting radially outward forces along an anterior section so as to avoid imparting forces to the septum to avoid hindering the function of the aortic valve and the left ventricular outflow tract. 1. A repair device configured for repairing tissues at a targeted anatomical location , the repair device comprising:a body having a perimeter that defines an upper side and a lower side, the perimeter having a posterior section and an anterior section, the body being shaped so as to define an annular groove disposed along at least a portion of the posterior section, the annular groove being configured to receive tissue of the targeted anatomical location when the repair device is deployed at the targeted anatomical location;a first anchor extending from the body in an anterior direction; anda second anchor extending from the body in the anterior direction,wherein the first and second anchors are configured to engage with tissue to prevent movement of the repair device from the targeted anatomical location when the repair device is deployed at the targeted anatomical location.2. The repair device of claim 1 , wherein the first and second anchors are substantially coplanar with the annular groove.3. The repair device of claim 1 , wherein the body has a crescent shape with a convex side and a concave side claim 1 , the convex side defining ...

METHODS FOR VASCULAR RESTORATION THERAPY

A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold has a structure that produces a low late lumen loss when implanted within a peripheral vessel and also exhibits a high axial fatigue life. In a preferred embodiment the scaffold forms ring structures interconnected by links, where a ring has 12 crowns and at most two links connecting adjacent rings. 2. The medical device of claim 1 , wherein the quantity d(S(t)/S)/dt over the interval of 7 days to 28 days following implantation is about −0.5×10to −1.0×10or about −0.5×10 claim 1 , about −0.8×10or about −1.0×10.3. The medical device of claim 1 , wherein the quantity S(t=7 days)/Sis about 1.0-1.5 claim 1 , or about 1.1-1.3.4. The medical device of claim 1 , wherein the quantity S(t=28 days)/Sis less than S(t=7 days)/Sand about 0.9-1.3.5. The medical device of claim 1 , wherein the quantity S(t=60 days)/Sis less than S(t=28 days)/Sand about 0.7-1.1.6. The medical device of claim 1 , wherein the quantity S(t=90 days)/Sis less than S(t=60 days)/Sand about 0.7-0.9.7. The medical device of claim 1 , wherein S(t) and So are post and pre implant pinching stiffness for the scaffold claim 1 , respectively.8. A method for making the medical device having the properties of claim 1 , comprising making a scaffold from a radially-expanded tube.9. A method of assembling a medical device having the properties of claim 1 , comprising crimping a scaffold to a balloon claim 1 , including the steps of radially reducing the scaffold diameter by at least 200% while the scaffold has a temperature of between 5-15 degrees below Tg-LOW.10. A method for vascular restorative therapy of a peripheral vessel claim 1 , comprising:making a scaffold comprising forming a polymer tube and forming the scaffold form the polymer tube; andcrimping the scaffold to a balloon;whereupon implantation of the scaffold in the peripheral vessel by inflation of the balloon the scaffold has the following ...

SCAFFOLDS HAVING VARIABLE WALL THICKNESS

A scaffold strut is shaped to improve hemocompatibility. The scaffold is made from a tube having variable wall thickness. Methods are disclosed for modifying the thickness of the tube in such a way as to achieve a reduced hemodynamic profile, but without significantly affecting strength properties in areas where stress concentrations exist when the scaffold is loaded. 1. A medical device , comprising:a tubular body made from a polymer material, the tubular body having one of an undulating inner wall surface and an undulating outer wall surface such that a ratio of a maximum wall thickness (t-max) to a minimum wall thickness (t-min) for the tubular body is between 2 and 1.2;wherein the one of an undulating inner wall surface and an undulating outer wall surface comprises a curved surface that repeats every 20, 30, 45, or 180 degrees about a circumference of the tubular body.2. The medical device of claim 1 , wherein the tubular body is a scaffold having interconnected elements comprising a first ring connected to a second ring by a link claim 1 ,wherein the first and second rings have crowns interconnected by struts, andwherein for the curved surface that repeats every 20 degrees the first and second rings have 18 crowns,wherein for the curved surface that repeats every 30 degrees the first and second rings have 12 crowns,wherein for the curved surface that repeats every 45 degrees the first and second rings have 8 crowns.3. The medical device of claim 2 , wherein the curved surface is described by one period of a sinusoid claim 2 , a portion of the curved surface is parabolic claim 2 , or a portion of the curved surface is hyperbolic.4. The medical device of claim 2 , wherein the curved surface is concave between rings.5. The medical device of claim 2 , wherein the curved surface is convex between struts.6. The medical device of claim 2 , wherein the curved surface comprises a first curvature centered over a crown and a second curvature centered over a midpoint ...

Treatment of coronary artery lesions with a scaffold having vessel scaffold interactions that reduce or prevent angina

Methods of treating coronary artery disease (CAD) with bioresorbable stents resulting in reduced angina or non-ischemic chest pain are described. Methods of treatment and devices for treatment of angina and post-procedural chest pain that include anti-angina agents incorporated into the device are disclosed. 1. A method of treating coronary artery disease (CAD) in a patient in need thereof comprising:selecting a patient in need of treatment of CAD having a lesion in a blood vessel that is an indicator of high risk or a susceptibility of the patient to angina or non-ischemic thoracic chest pain; andimplanting a bioresorbable stent at the lesion in a blood vessel of the patient, wherein the implanted scaffold treats the CAD.2. The method of claim 1 , wherein the lesion is a long diffuse lesion having a length of at least 20 mm.3. The method of claim 1 , wherein the stent is a bioresorbable polymer stent.4. The method of claim 1 , wherein the lesion is an ostial lesion.5. The method of claim 4 , wherein the ostial lesion begins within Ito 5 mm of an origin of a major epicardial artery.6. The method of claim 1 , wherein the lesion is a vulnerable plaque suspect lesion.7. The method of claim 6 , wherein the lesion has less than 50% occlusion as shown by angiography.8. The method of claim 1 , wherein the lesion is a bifurcated lesion9. The method of claim 1 , wherein the patient experiences no angina or non-ischemic thoracic chest pain for at least 1 year after implantation.10. The method of claim 1 , wherein the susceptibility comprises a history of angina of the patient within one year prior to implantation.11. The method of claim 1 , wherein the susceptibility comprises a % diameter stenosis of greater than 70% at a site of implantation of the stent.12. A method of treating coronary artery disease (CAD) in a patient or population of patients comprising:recommending treatment or describing advantages relating to reduced angina of bioresorbable polymer stents or a type ...

THERMAL PROCESSING OF POLYMER SCAFFOLDS

Methods are disclosed including thermally processing a scaffold to increase the radial strength of the scaffold when the scaffold is deployed from a crimped state to a deployed state such as a nominal deployment diameter. The thermal processing may further maintain or increase the expansion capability of the scaffold when expanded beyond the nominal diameter. 1. A method of fabricating a polymer stent comprising:providing a biodegradable polymer scaffold comprising a polymer, the scaffold having an expanded configuration and a crimped configuration for delivery in a vascular lumen;thermally treating the scaffold to reverse physical aging of the scaffold; andcrimping the scaffold to the crimped configuration having reversed physical aging or shortly after thermally treating.2. The method of claim 1 , wherein the provided scaffold comprises induced biaxial orientation of the polymer chains and the thermally treated scaffold includes at least some of the induced biaxial orientation.3. The method of claim 1 , wherein the thermal treatment reduces damage due to crimping at the crest regions of the scaffold.4. The method of claim 1 , wherein reversed physical aging comprises a modification selected from the group consisting of decreased density of the scaffold polymer claim 1 , increased elongation at break of the scaffold polymer claim 1 , decreased modulus of the scaffold polymer claim 1 , increased radial strength of the scaffold claim 1 , increase expansion capability of the scaffold claim 1 , reduced damage to the scaffold at crimping claim 1 , and any combination thereof.5. The method of claim 1 , wherein the thermal treatment is above a glass transition temperature (Tg) and below a melting temperature (Tm) of the polymer in the expanded configuration.6. The method of claim 1 , wherein the provided scaffold comprises a crystallinity of at least 20%.7. The method of claim 1 , wherein the thermal treatment is performed after forming the scaffold from a tube and before ...

STENT WITH ENHANCED PROFILE

A stent for implantation in a body lumen, comprising a plurality of rings, each ring being connected to an adjacent ring by at least one link, each ring including a plurality of peaks and valleys, wherein each peak is connected to an adjacent valley by a strut to provide an undulating pattern within each ring. Further, wherein each of a plurality of the struts comprise a first portion and a second portion; each portion has a thickness that is substantially constant throughout both first and second portions; and each portion has a width that is substantially constant throughout both first and second portions. The first portion is connected to the second portion through a reduced zone positioned at a mid-point of the strut, wherein the reduced zone has a minimum thickness between 30% and 80% of the thickness of the first and second portions. 1. A system for treating a vascular condition , comprising:a catheter configured for insertion into a vessel; a plurality of rings, each ring being connected to an adjacent ring by at least one link, each ring including a plurality of peaks and valleys, wherein each peak is connected to an adjacent valley by a strut to provide an undulating pattern within each ring; and further wherein', 'each of a plurality of the struts comprises, in series, a first portion which is directly connected to a second portion, the second portion being directly connected to a third portion;', 'each of the first portion and the third portion has a thickness that is substantially constant throughout both the first portion and the third portion; and', 'the second portion has a minimum thickness between 30% and 80% of the thickness of the first and third portions, and further wherein the second portion is not coated with any therapeutic material., 'a stent mounted on the catheter and configured for delivery into the vessel, the stent comprising2. The system of claim 1 , wherein the stent is a balloon expandable stent.3. The system of claim 1 , wherein the ...

Adjustable arm device for grasping tissues

The present disclosure relates to repair devices configured for use in fixing or approximating tissues, such as cardiac valve tissues and particularly the leaflets of a regurgitant mitral valve. The repair device includes a shaft, a pair of proximal elements pivotally coupled to the shaft and extending from the shaft, and a pair of distal elements pivotally coupled to the shaft and extending from the shaft. The proximal and distal elements are configured so that targeted tissue can be grasped therebetween. The distal elements and/or the proximal elements include adjustable arms that can be extended and retracted to adjust the length of the gripping elements to provide more effective grasping of targeted tissues.

Annular augmentation device for cardiac valve repair

The present disclosure relates to repair devices for repair of regurgitant mitral valves. A repair device includes a body having a perimeter defining an upper side and a lower side. An annular groove is disposed along a posterior section of the perimeter of the device and is configured to receive posterior rim tissue of a mitral valve annulus. First and second anchors extend from the body in an anterior direction. The first and second anchors are configured to engage with respective commissures of the mitral valve to assist in securing the repair device in position. The repair device is structured to minimize or eliminate imparting or transmitting radially outward forces along an anterior section so as to avoid imparting forces to the septum to avoid hindering the function of the aortic valve and the left ventricular outflow tract.

SYSTEMS AND METHODS FOR INTRA-PROCEDURAL CARDIAC PRESSURE MONITORING

The present disclosure relates to delivery devices and interventional devices configured to enable monitoring of pressure and other hemodynamic properties before, during, and/or after a cardiac procedure. A guide catheter includes a routing lumen or a routing groove for routing a sensor wire to a desired location during a cardiac procedure. A guide catheter includes one or more pressure sensors positioned to provide desired pressure measurements when the guide catheter is deploying an interventional device. An interventional device may also include one or more associated sensors for providing hemodynamic information before, during, and/or after deployment. 1. A delivery device configured for delivering an interventional device to a targeted treatment area within a body , the delivery device comprising:an outer guide catheter having a proximal end and a distal end;an inner sleeve positioned radially within the outer guide catheter and configured to be translatable within the outer guide catheter;a delivery catheter positioned radially within the inner sleeve and configured to be translatable within the inner sleeve, the delivery catheter being configured to enable delivery of an interventional device through the inner sleeve and outer guide catheter to a targeted treatment area within a body; andat least one sensor coupled to one or more of the outer guide catheter, inner sleeve, or delivery catheter, the at least one sensor being configured to enable monitoring of one or more hemodynamic properties of the targeted treatment area during deployment of an interventional device using the delivery device.2. The delivery device of claim 1 , wherein the at least one sensor is configured to measure blood pressure.3. The delivery device of claim 1 , wherein the at least one sensor is configured to measure blood flow.4. The delivery device of claim 1 , wherein the at least one sensor includes one or more sensor wires routed through one or more wall lumens claim 1 , each wall ...

BIORESORBABLE SCAFFOLD DELIVERY SYSTEM WITH IMPROVED DISTAL INTEGRITY

Delivery systems are disclosed for bioresorbable scaffolds that decrease in length when expanded to a deployment diameter that allow accurate positioning of the scaffold at a lesion. The scaffolds are mounted on a catheter that includes marker bands that are positioned interior to the proximal and distal edges of the crimped scaffold to anticipate the shortening of the scaffold upon deployment. Delivery systems are further disclosed for bioresorbable scaffolds that increase in length when expanded to a deployment diameter that allow accurate positioning of the scaffold at a lesion. The scaffolds are mounted on a catheter that includes marker bands that are positioned exterior to the proximal and distal edges of the crimped scaffold to anticipate the lengthening of the scaffold upon deployment. 1. A delivery system for a bioresorbable scaffold comprising:a catheter;a balloon disposed over the catheter;a bioresorbable scaffold in a crimped configuration over the catheter comprising a plurality of connected undulating cylindrical rings including crests, wherein two or more of the crests on adjacent rings are connected from a peak of one to a peak of the other and the connected crests point toward each other, wherein when the scaffold is expanded a length of the scaffold decreases; anda proximal marker band and distal marker band disposed over the catheter, wherein the proximal marker band and the distal marker band are interior to a proximal scaffold edge and distal scaffold edge,wherein when the scaffold is expanded to a selected deployment diameter, the proximal marker band is at or overlaps the proximal scaffold edge and the distal marker band is at or overlaps the distal scaffold edge.2. The delivery system of claim 1 , wherein the selected deployment diameter is a nominal deployment diameter.3. The delivery system of claim 1 , wherein the connected crests are connected at the crests.4. The delivery system of claim 1 , wherein the connected crests are connected by ...

Drug-eluting coatings on poly(dl-lactide)-based scaffolds

Stents including a poly(D,L-lactide)(PDLLA)-based scaffold and PDLLA based therapeutic layer are disclosed. The PDLLA based scaffold may be amorphous and may include a primer layer. Methods of applying the PDLLA-based coating to the scaffold are disclosed with solvent processing methods using a solvent blend are also disclosed. Methods of removing residual solvent from a PDLLA-base coating that also condition the scaffold are disclosed. Methods of treating restenosis that release drugs to prevent restenosis without interfering with the natural positive remodeling of a vessel are disclosed.

Augmented Imaging For Valve Repair

Systems and methods for augmenting image data during heart valve repair procedures, such as transcatheter mitral valve repair (TMVr) or transcatheter tricuspid valve repair (TTVr). Image data may be obtained from an imaging device, and may be output to a display with one or more reference markers overlaid on the image data to simplify the visual data. Image data may be augmented or replaced with the reference markers. In some cases, reference markers may provide information about objects that are difficult to see in the image data. In other cases, the reference markers may provide clinical recommendations or feedback.

Thermal processing of polymer scaffolds

Methods are disclosed including thermally processing a scaffold to increase the radial strength of the scaffold when the scaffold is deployed from a crimped state to a deployed state such as a nominal deployment diameter. The thermal processing may further maintain or increase the expansion capability of the scaffold when expanded beyond the nominal diameter.

Leaflet grasping and cutting device

A system configured to cut leaflet tissue at a cardiac valve may comprise a guide catheter and a cutting mechanism routable through the guide catheter. The cutting mechanism includes a cutting arm and a plurality of grasping arms rotatably coupled to the cutting arm. The grasping arms are connected to the cutting arm via a central hinge and are actuatable between a closed position against the cutting arm and an open position where the grasping arms extend laterally away from the cutting arm by rotating about the hinge. Targeted cardiac leaflet tissue may be grasped between the cutting arm and the grasping arms and cut by a cutting element that is attached to or extends through the cutting arm.

Adjustable arm device for grasping tissues

The present disclosure relates to repair devices configured for use in fixing or approximating tissues, such as cardiac valve tissues and particularly the leaflets of a regurgitant mitral valve. The repair device includes a shaft (140), a pair of proximal elements (116) pivotally coupled to the shaft and extending from the shaft, and a pair of distal elements (118) pivotally coupled to the shaft and extending from the shaft. The proximal and distal elements are configured so that targeted tissue can be grasped therebetween. The distal elements and/or the proximal elements include adjustable arms (117, 119) that can be extended and retracted to adjust the length of the gripping elements to provide more effective grasping of targeted tissues.

Systems and methods for intra-procedural cardiac pressure monitoring

The present disclosure relates to delivery devices and interventional devices configured to enable monitoring of pressure and other hemodynamic properties before, during, and/or after a cardiac procedure. A guide catheter includes a routing lumen or a routing groove for routing a sensor wire to a desired location during a cardiac procedure. A guide catheter includes one or more pressure sensors positioned to provide desired pressure measurements when the guide catheter is deploying an interventional device. An interventional device may also include one or more associated sensors for providing hemodynamic information before, during, and/or after deployment.

Augmented imaging for valve repair

Systems and methods for augmenting image data during heart valve repair procedures, such as transcatheter mitral valve repair (TMVr) or transcatheter tricuspid valve repair (TTVr). Image data may be obtained from an imaging device, and may be output to a display with one or more reference markers overlaid on the image data to simplify the visual data. Image data may be augmented or replaced with the reference markers. In some cases, reference markers may provide information about objects that are difficult to see in the image data. In other cases, the reference markers may provide clinical recommendations or feedback.

Adjustable arm device for grasping tissues

The present disclosure relates to repair devices configured for use in fixing or approximating tissues, such as cardiac valve tissues and particularly the leaflets of a regurgitant mitral valve. The repair device includes a shaft, a pair of proximal elements pivotally coupled to the shaft and extending from the shaft, and a pair of distal elements pivotally coupled to the shaft and extending from the shaft. The proximal and distal elements are configured so that targeted tissue can be grasped therebetween. The distal elements and/or the proximal elements include adjustable arms that can be extended and retracted to adjust the length of the gripping elements to provide more effective grasping of targeted tissues.

Integrated imaging and device deployment platform

An integrated imaging and device deployment platform and method may include a catheter, at least one imaging unit, at least one deployment unit, and at least one device configured to be deployed by the at least one deployment unit. The integrated imaging and device deployment platform facilitates improved navigation and deployment of a therapeutic or medical device by providing the at least one imaging unit proximate the deployment unit. Information generated from the at least one imaging unit may be utilized with additional imaging modalities to provide improved imaging and delivery of devices while reducing use of X-ray radiation and contrast injection.

Adjustable arm device for grasping tissues

Valve Repair Clip With Leaflet Capture Confirmation

A heart valve repair clip includes a stud, two arms operatively coupled to the stud and capable of transitioning between an open condition and a closed condition, and includes an indicator coupled to each of the two arms and moveable relative thereto.

Augmented imaging for valve repair

Systems and methods for augmenting image data during heart valve repair procedures, such as transcatheter mitral valve repair (TMVr) or transcatheter tricuspid valve repair (TTVr). Image data may be obtained from an imaging device, and may be output to a display with one or more reference markers overlaid on the image data to simplify the visual data. Image data may be augmented or replaced with the reference markers. In some cases, reference markers may provide information about objects that are difficult to see in the image data. In other cases, the reference markers may provide clinical recommendations or feedback.

Fixation device with symmetrical extension elements

A fixation device for fixation of heart valve leaflets includes a central assembly and first and second arms each pivotally coupled to the central assembly. Each of the first and second arms include a trunk portion having a first end, a second end, and a longitudinal axis extending therebetween. The trunk portion has opposing lateral sides each extending between the first and second ends. Each of the first and second arms further include a coupling portion extending from the first end of the trunk portion. The coupling portion includes a pair of extension elements symmetrical about the longitudinal axis, and configured to be coupled to the central assembly for pivotal movement of the trunk portion relative the central assembly. The fixation device further includes first and second gripping elements each moveable relative to the first and second arms, respectively, to capture native leaflet tissue therebetween.

Size adapter attachments

A fixation device for fixation of heart valve leaflets includes a central assembly and an arm moveably coupled to the central assembly. The arm includes a body portion having a first end and a second end and a longitudinal axis defined therebetween. The body portion has opposing body lateral sides, each body lateral side extending between the first end and the second end. Further, the body portion has a body portion width defined between the opposing body lateral sides. The fixation device further includes a size adapter attached to the arm, the size adapter having a maximum undeformed arm lateral cross-dimension defined between outer lateral edges of the size adapter. The ratio between the body portion width and the maximum undeformed arm lateral cross-dimension is at least about 1:1.8 to about 1:2.2. The fixation device further includes at least one gripping element.

Tunable Fixation Device

A tunable fixation device for fixation of heart valve leaflets includes a central assembly, an arm moveably coupled to the central assembly, and a gripping element moveable relative to the arm to capture a native leaflet therebetween. The arm has a body portion and a wire frame coupled to the body portion. The wire frame has a first and second wire segment, and an interconnection portion interconnecting the first and second wire segments. The interconnection portion is slidingly engaged with the body portion. The first wire segment is configured to deform upon force applied to the second wire segment by sliding movement of the interconnection portion relative to the body portion, and the second wire segment is configured to deform upon force applied to the first wire segment by sliding movement of the interconnection portion relative to the body portion.

Integrated imaging and device deployment platform

An integrated imaging and device deployment platform and method may include a catheter, at least one imaging unit, at least one deployment unit, and at least one device configured to be deployed by the at least one deployment unit. The integrated imaging and device deployment platform facilitates improved navigation and deployment of a therapeutic or medical device by providing the at least one imaging unit proximate the deployment unit. Information generated from the at least one imaging unit may be utilized with additional imaging modalities to provide improved imaging and delivery of devices while reducing use of X-ray radiation and contrast injection.

Tunable fixation device

A tunable fixation device for fixation of heart valve leaflets includes a central assembly, an arm moveably coupled to the central assembly, and a gripping element moveable relative to the arm to capture a native leaflet therebetween. The arm has a body portion and a wire frame coupled to the body portion. The wire frame has a first and second wire segment, and an interconnection portion interconnecting the first and second wire segments. The interconnection portion is slidingly engaged with the body portion. The first wire segment is configured to deform upon force applied to the second wire segment by sliding movement of the interconnection portion relative to the body portion, and the second wire segment is configured to deform upon force applied to the first wire segment by sliding movement of the interconnection portion relative to the body portion.

Valve repair clip with leaflet capture confirmation

A heart valve repair clip includes a stud, two arms operatively coupled to the stud and capable of transitioning between an open condition and a closed condition, and includes an indicator coupled to each of the two arms and moveable relative thereto.

Annular augmentation device for cardiac valve repair

The present disclosure relates to repair devices for repair of regurgitant mitral valves. A repair device includes a body having a perimeter defining an upper side and a lower side. An annular groove is disposed along a posterior section of the perimeter of the device and is configured to receive posterior rim tissue of a mitral valve annulus. First and second anchors extend from the body in an anterior direction. The first and second anchors are configured to engage with respective commissures of the mitral valve to assist in securing the repair device in position. The repair device is structured to minimize or eliminate imparting or transmitting radially outward forces along an anterior section so as to avoid imparting forces to the septum to avoid hindering the function of the aortic valve and the left ventricular outflow tract.

Annular augmentation device for cardiac valve repair

The present disclosure relates to repair devices for repair of regurgitant mitral valves. A repair device includes a body having a perimeter defining an upper side and a lower side. An annular groove is disposed along a posterior section of the perimeter of the device and is configured to receive posterior rim tissue of a mitral valve annulus. First and second anchors extend from the body in an anterior direction. The first and second anchors are configured to engage with respective commissures of the mitral valve to assist in securing the repair device in position. The repair device is structured to minimize or eliminate imparting or transmitting radially outward forces along an anterior section so as to avoid imparting forces to the septum to avoid hindering the function of the aortic valve and the left ventricular outflow tract.

Adjustable Arm Device For Grasping Tissues

The present disclosure relates to repair devices configured for use in fixing or approximating tissues, such as cardiac valve tissues and particularly the leaflets of a regurgitant mitral valve. The repair device includes a shaft, a pair of proximal elements pivotally coupled to the shaft and extending from the shaft, and a pair of distal elements pivotally coupled to the shaft and extending from the shaft. The proximal and distal elements are configured so that targeted tissue can be grasped therebetween. The distal elements and/or the proximal elements include adjustable arms that can be extended and retracted to adjust the length of the gripping elements to provide more effective grasping of targeted tissues.

Leaflet grasping and cutting device

A system configured to cut leaflet tissue at a cardiac valve may comprise a guide catheter and a cutting mechanism routable through the guide catheter. The cutting mechanism includes a cutting arm and a plurality of grasping arms rotatably coupled to the cutting arm. The grasping arms are connected to the cutting arm via a central hinge and are actuatable between a closed position against the cutting arm and an open position where the grasping arms extend laterally away from the cutting arm by rotating about the hinge. Targeted cardiac leaflet tissue may be grasped between the cutting arm and the grasping arms and cut by a cutting element that is attached to or extends through the cutting arm.

Offset peak-to-peak stent pattern

Anterior Mitral Leaflet Laceration Device and Methods of Making and Using Same

In some embodiments, a leaflet laceration device, includes an elongated shaft, a moveable arm coupled to the elongated shaft and pivotable relative thereto between an open condition and a closed condition, and a cutting element coupled to at least one of the elongated shaft and the moveable arm, the cutting element being configured and arranged to contact a first surface of an anterior mitral leaflet.

Clip Delivery Catheter with Helical Multi-Lumen Extrusion for Improved Gripper Actuation and Methods of Making and Using Same

An interventional tool includes a delivery catheter defining a central lumen and a plurality of peripheral lumens, at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter, and at least one line disposed within the at least one of the plurality of peripheral lumens, the at least one line being configured to actuate a medical device.

Anterior mitral leaflet laceration device and methods of making same

In some embodiments, a leaflet laceration device, includes an elongated shaft, a moveable arm coupled to the elongated shaft and pivotable relative thereto between an open condition and a closed condition, and a cutting element coupled to at least one of the elongated shaft and the moveable arm, the cutting element being configured and arranged to contact a first surface of an anterior mitral leaflet.

Clip delivery catheter with helical multi-lumen extrusion for improved gripper actuation and methods of making and using same

An interventional tool includes a delivery catheter defining a central lumen and a plurality of peripheral lumens, at least one of the plurality of peripheral lumens defining a helical path along a portion of the delivery catheter, and at least one line disposed within the at least one of the plurality of peripheral lumens, the at least one line being configured to actuate a medical device.

Repair Clip For Variable Tissue Thickness

Fixation device for fixation of heart valve leaflets includes an elongate central member defining a longitudinal axis of the fixation device and first and second arms rotatable about at least one arm hinge point between an open position and a closed position. The fixation device further includes a first gripping element rotatable about a first gripping element axis of rotation to capture a first leaflet of a heart valve between the first gripping element and the first arm, and a second gripping element rotatable about a second gripping element axis of rotation to capture a second leaflet of a heart valve between the second gripping element and the second arm. At least one of the first gripping element axis of rotation and the second gripping element axis of rotation is variably offset from the arm hinge point by an axis offset distance defined along the longitudinal axis.

Method of Use for Valve Repair Clip with Automatic Locking Mechanism

According to one aspect, a mitral valve clip is introduced using a delivery system. The clip includes two arms at an angle relative to one another and a lock that prevents widening of the angle when the angle is below a locking threshold value, wherein the lock is in a passively disengaged state when the angle is above the locking threshold value. The lock is manually disengaged and the angle is expanded to a leaflet capture starting angle. The lock is returned to the passively disengaged state after the angle is expanded to the leaflet capture starting angle. The leaflets of a mitral valve are captured while the lock remains in the passively disengaged state. The clip is closed to a final closure angle by narrowing the angle while the leaflets are trapped. The lock transitions to an engaged state when the angle falls below the locking threshold value.

Methods for vascular restoration therapy

A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. The scaffold has a structure that produces a low late lumen loss when implanted within a peripheral vessel and also exhibits a high axial fatigue life. In a preferred embodiment the scaffold forms ring structures interconnected by links, where a ring has 12 crowns and at most two links connecting adjacent rings.

Scaffolds having variable wall thickness

A scaffold strut is shaped to improve hemocompatibility. The scaffold is made from a tube having variable wall thickness. Methods are disclosed for modifying the thickness of the tube in such a way as to achieve a reduced hemodynamic profile, but without significantly affecting strength properties in areas where stress concentrations exist when the scaffold is loaded.

Thermal processing of polymer scaffolds

Methods are disclosed including thermally processing a scaffold to increase the radial strength of the scaffold when the scaffold is deployed from a crimped state to a deployed state such as a nominal deployment diameter. The thermal processing may further maintain or increase the expansion capability of the scaffold when expanded beyond the nominal diameter.

Endoprosthesis having improved strain distribution

An endoprosthesis for delivery in a body lumen can be configured to inhibit structural fatigue, crack formation, and elastic recoil while providing improved crimping and expansion uniformity and radial strength. As such, the endoprosthesis can include at least one multi-stage crest element connecting adjacent bar arms. The multi-stage crest element and, optionally, the connection or transition between the multi-stage crest element and the bar arms can form a plurality of undulations or curves to improve the distribution of the strains experienced by the endoprosthesis. The improved strain distribution can improve the structural integrity and prevent failure of the endoprosthesis.