Trans-septal anchoring system and method

A pressure sensor, in one embodiment, is passed through the atrial septal wall. A plurality of anchors is disposed on each side of the septal wall and secures the position of the pressure sensor. An inflatable deployment balloon is used to actuate the anchors.

Trans-septal anchoring system and method

A pressure sensor, in one embodiment, is passed through the atrial septal wall. A plurality of anchors is disposed on each side of the septal wall and secure the position of the pressure sensor.

Guide catheters for accessing cardiac sites

A method and apparatus for introducing a cardiac lead to an implantation site that includes a catheter body having an outer wall and a distal leader and having a proximal portion extending from the first proximal end to a second distal end. An inner member is positioned within an outer lumen of the catheter body and is spaced from the outer wall to form a first inner lumen for receiving a guide tool inserted therein and a second lumen for receiving the cardiac lead while the guide tool is positioned within the first inner lumen. A distal end of the inner member forms a first opening at a distal end of the first inner lumen and a second opening at a distal end of the second inner lumen, the first opening and the second opening positioned proximal the distal leader.

Arrangement for implanting a miniaturized cardiac lead having a fixation helix

An introducer system and method for positioning and fixedly engaging a lead at an implantation site that includes a torque transfer sheath, extending from a proximal end to a distal end, receiving the lead, an outer sheath, having a distal end, receiving the lead positioned within the torque transfer sheath, and a handle operable between a first position enabling advancement and retraction of the lead through the handle and a second position fixedly engaging a proximal end of the lead within the handle. The lead is advanced through the outer sheath to extend outward a predetermined distance from the distal end of the outer sheath and the fixation helix is rotated through the predetermined distance to be fixedly engaged at the implantation site in response to simultaneous rotation and advancement of the lead and the torque transfer sheath through rotation and advancement of the handle in the second position.

DRIVELINE/CONNECTOR FOR USE WITH IMPLANTABLE HVAD PUMP OR LVAS SYSTEMS

A connector for a medical device. The connector including an elongate body having a proximal end and a distal end. The connector further including a strut, a plurality of conductors, and a plurality of electrical contacts. The strut being disposed within the elongate body and defining a plurality of channels. Each of the plurality of channels having a proximal end and a distal end opposite the proximal end. The plurality of conductors being disposed within the elongate body and are sized and configured to be received within the plurality of channels and extend between the proximal end and the distal end. The plurality of electrical contacts being coupled to an outer surface of the elongate body and in communication with the plurality of conductors.

Medical electrical lead anchoring

A lead body of a medical electrical lead includes a distal end, a first elongated insulated conductor extending toward the distal end and a first electrode coupled to the conductor. A second elongated insulated conductor includes a first portion extending within the lead body to the distal end and a second portion extending distally from the distal end of the lead body where it is terminated by a tissue anchor on which a second electrode is mounted; the tissue anchor includes a surface for receiving a push force from an insertion tool, which is adapted to insert the anchor within a segment of tissue such that the first electrode of the lead body is in close proximity to the segment of tissue.

Medical electrical lead anchoring

A non-rigid tether extends distally from an electrode of a medical electrical lead body coupling a tissue anchor to the lead body. The tissue anchor includes a surface to receive a push force from an insertion tool adapted to insert the anchor within a segment of tissue so that the electrode is held in close proximity to the tissue.

Guide catheters for accessing cardiac sites

Guide catheters and methods of using same for facilitating implantation of cardiac leads for applying electrical stimulation to and/or sensing electrical activity of the heart through one or more electrode positioned at an implantation site within a heart chamber or cardiac vessel adjacent a heart chamber and more particularly to a method and apparatus for introducing such a cardiac lead having low torqueability and pushability through a pathway to enable attachment of the cardiac lead at the implantation site are disclosed. The catheter body comprises delivery lumen to introduce a small diameter cardiac lead and a guide lumen to receive a guide tool to locate the catheter body distal end at the implantation site. The small diameter lumen within a small diameter guide tube extends distally from the delivery exit port of the delivery lumen. The catheter body is shaped to bias the delivery lumen exit port toward the heart.

IMPLANTABLE LVAD PUMP CONTROLLER HEADER

A connector block for an implantable controller. The connector block includes a first pair of side-by-side bores extending distally from a proximal end of the connector block and defining a major longitudinal axis. A second pair of side-by-side bores extends distally from a distal end of the first pair of side-by-side bores, each of the first pair of side-by-side bores defining a first diameter and each of the second pair of side-by-side bores defining a second diameter less than the first diameter, each pair of the second pair of side-by-side lead bores include a setscrew bore sized to receive a setscrew and being transverse to the major longitudinal axis.

Medical electrical lead having improved inductance

A conductor for connecting an electrode near a distal end of a medical electrical lead with an implantable medical device connected with a proximal end of the medical electrical lead includes a multi-filar coil wrapped around a central core. The multi-filar coil has an inductance of approximately 0.5 μH or greater, and the central core is non-conducting and provides reinforcement for the multi-filar coil.

Novel implantable lead including sensor

An implantable lead includes a defibrillation electrode and a sensor coupled thereto. The electrode and sensor are positioned along a body of the lead such that, when a fixation element couples the lead to an endocardial surface of a right ventricle, the sensor is located in a high flow region and a portion of the defibrillation electrode is located in proximity to a right ventricular apex.

IMPLANTABLE MEDICAL DEVICES FOR MULTI-CHAMBER PACING

Systems, devices, and methods may be used to deliver and provide cardiac pacing therapy to a patient. Leads or leadlets carrying one or more left ventricular electrodes may be positioned in or near the interventricular septum to sense and pace left ventricular signals of the patient's heart. In one example, a leadlet including one or more left ventricular electrodes may extend in the coronary sinus from a leadless implantable medical device located in the right atrium. 1. An implantable medical device comprising: ["a right atrial electrode positionable within the right atrium to deliver cardiac therapy to or sense electrical activity of the right atrium of the patient's heart; and", "at least one left ventricular electrode positionable proximate the left ventricle of the patient's heart to deliver cardiac therapy to or sense electrical activity of the left ventricle of the patient's heart;"], 'a plurality of electrodes comprisinga housing extending from a proximal end region to a distal end region, wherein the right atrial electrode is leadlessly coupled to the proximal end region;a leadlet extending from a proximal region to a distal region, wherein the proximal region is coupled to the distal end region of the housing and the at least one ventricular electrode is coupled to the distal region of the leadlet, wherein the leadlet is configured to extend through the coronary sinus ostium and into the coronary sinus or a coronary vein of the patient's heart to position the least one left ventricular electrode proximate the left ventricle of the patient's heart;a therapy delivery circuit within the housing and operably coupled to the plurality of electrodes to deliver cardiac therapy to the patient's heart;a sensing circuit within the housing and operably coupled to the plurality of electrodes to sense electrical activity of the patient's heart; and monitor electrical activity using the processing circuitry and one or more of the plurality of electrodes; and', ' ...

SEPARATE POSITIONABLE HEMOSTASIS VALVE FOR IMPLANTABLE MEDICAL LEAD INTRODUCER HUB

A medical system including an implantable medical, the lead comprising a lead body and a helical electrode at least one of extending or extendable from a distal end of the lead body. The medical system including a hemostasis valve coupled to the lead body proximal the distal end of the lead body, the hemostasis valve configured to slide along the lead body. The distal end of the lead body is configured for insertion into an introducer hub positioned in an opening into a vasculature of a patient and the lead body configured for subsequent advancement through the introducer hub to facilitate securing the hemostasis value to the introducer hub. The hemostasis valve is configured for slidable advancement of the lead body therethrough for continued advancement of the lead body through the introducer hub.

IMPLANTABLE MEDICAL DEVICE INCLUDING CABLE FASTENER

Various embodiments of an implantable medical device and a method of implanting such device are disclosed. The device includes a housing having a first major surface, a second major surface, a sidewall that extends between the first major surface and the second major surface, and a port disposed in the sidewall. The sidewall defines a perimeter of the housing. The device further includes an electronic component disposed within the housing, and a cable electrically connected to the electronic component disposed within the housing, where the cable extends through the port. A portion of the cable is adapted to be removably connected to the housing adjacent an outer surface of the sidewall by a fastener such that the portion of the cable extends along at least a portion of the perimeter of the housing when the portion of the cable is removably connected to the housing. 1. An implantable medical device comprising:a housing comprising a first major surface, a second major surface, a sidewall that extends between the first major surface and the second major surface, and a port disposed in the sidewall, wherein the sidewall defines a perimeter of the housing;an electronic component disposed within the housing; anda cable electrically connected to the electronic component disposed within the housing, wherein the cable extends through the port, and further wherein a portion of the cable is adapted to be removably connected to the housing adjacent an outer surface of the sidewall by a fastener such that the portion of the cable extends along at least a portion of the perimeter of the housing when the portion of the cable is removably connected to the housing.2. The device of claim 1 , wherein the fastener comprises a suture connected to the housing through an opening disposed in at least one of the first major surface or second major surface of the housing adjacent the perimeter of the housing.3. The device of claim 1 , wherein the fastener comprises a slot disposed adjacent ...

Parenteral fluid transfer apparatus

A novel self-blunting needle apparatus (10d) employs a blunting member (70) and a needle (12). The blunting member (70) may be disposed within the needle (12) and may be adapted for fluid flow therethrough. The needle (12) may then be inserted into a patient's tissue and the blunting member (70) may be extended to blunt the apparatus. In other embodiments, e.g., apparatus (10), a driver (76) may be employed to move the blunting member (70) without obstructing fluid flow. There may be a locking spline (58) and cam channel (30) configuration to prevent backward motion of the blunting member (70) in various embodiments. A hollow body (22) is configured to facilitate assembly.

ASSESSING A LEAD BASED ON HIGH-FREQUENCY RESPONSE

In general, this disclosure is directed to techniques and circuitry to determine characteristics of an implantable lead associated with an implantable medical device (IMD). The implantable lead may be designed to be MRI-safe by having one or more components that attenuate frequencies associated with an MRI that, if left unreduced, may interfere with the performance of the lead and/or cause harm to the tissue in which the lead is implanted. The circuitry may transmit a signal through the lead and receive a response signal. The device may determine the lead characteristics by comparing the transmitted signal with the received signal. In addition to determining whether the lead is MRI-safe, the techniques of this disclosure may be also utilized to determine whether the lead is faulty. 1. A method comprising:transmitting, by a device, a signal through at least one medical lead implanted within at least one anatomical region of a patient,wherein the at least one medical lead is coupled to an electrical component configured to attenuate a frequency of energy;receiving, by the device, a response signal;analyzing the response signal; anddetermining characteristics of the at least one medical lead based on the analysis,wherein the characteristics include at least one of an indication whether the electrical component attenuates the frequency or a detected fault in the at least one medical lead.2. The method of claim 1 , wherein the transmitted signal comprises a high frequency signal.3. The method of claim 1 , wherein the transmitted signal comprises a signal with a frequency based on the frequency of the energy.4. The method of claim 1 , wherein analyzing comprises:comparing the response signal to the transmitted signal; anddetermining an impedance mismatch associated with the at least one medical lead based on the comparison.5. The method of claim 1 , wherein analyzing comprises:determining a length associated with the at least one medical lead based on a time differential ...

MAGNETIC RESONANCE IMAGING COMPATIBLE MEDICAL ELECTRICAL LEAD AND METHOD OF MAKING THE SAME

This disclosure describes an implantable medical lead, and method of making such a lead or components of the lead, that reduces the undesirable effects the fields generated by an MRI device may have on the implantable medical lead and the implantable medical device. The implantable medical lead includes an RF filter placed in series with an electrical path to an electrode of the lead. In one example, the RF filter may comprise a conductor wound in such a manner that it provides an inductance and capacitance that provides the RF filter with a resonant frequency, and in some instances, multiple resonant frequencies. At frequencies around the resonant frequency of the RF filter, the RF filter presents a high impedance, thereby blocking the signal from or at least attenuating the signal propagating to the electrode. At frequencies far from the resonant frequency, the RF filter presents a low impedance. 1. A method comprising:obtaining an electrical conductor having a conductive core, a first insulation layer surrounding the conductive core, and a second insulation layer surrounding the first insulation layer, wherein the second insulation layer has a thermal property that occurs at a lower temperature than the same thermal property of the first insulation layer;winding the electrical conductor to form an RF filter; andheating at least a portion of the RF filter to a temperature at or above the thermal property of the second insulation layer and below the thermal property of the first insulation layer such that the second insulation layers of adjacent windings of the electrical conductor bond throughout at least the portion of the RF filter.2. The method of claim 1 , wherein heating at least the portion of the RF filter comprises heating substantially all of the RF filter to the temperature at or above the thermal property of the second insulation layer and below the thermal property of the first insulation layer such that the second insulation layer of adjacent windings ...

COUPLING MECHANISMS FOR USE WITH A MEDICAL ELECTRICAL LEAD

An implantable medical lead may include components or mechanisms that can reduce the amount of induced current that is conducted to electrodes of the lead. A medical lead may, for example, have an energy dissipating structure that is connected to an electrode of the lead. This disclosure provides for coupling mechanisms to couple current induced on the lead to the energy dissipating structure. The coupling mechanisms described herein provide continuous contact with both electrode shaft and the energy dissipating structure while producing forces on the electrode shaft that is small enough to permit extension and retraction of the electrode from the lead. 1. A medical electrical lead comprising:a lead body having a proximal end configured to couple to an implantable medical device and a distal end;a conductive electrode shaft located near the distal end of the lead body;a conductor that extends from the proximal end of the lead body and couples to the conductive electrode shaft,an electrode located near the distal end of the lead body and electrically coupled to an opposite end of the conductive electrode shaft as the conductor;an energy dissipating structure located adjacent the electrode, the energy dissipating structure including a conductive element; and an inner contour of the conductive material that receives the conductive electrode shaft and exerts a inward force on the conductive electrode shaft;', 'an outer contour of the conductive material that exerts an outward force on the energy dissipating structure; and', 'a gap between open ends of segments of the coupling mechanism somewhere along the coupling mechanism, wherein the open ends of the segments can move relative to one another., 'a coupling mechanism formed of a conductive material that couples the conductive electrode shaft and the energy dissipating structure, wherein the conductive material is shaped to form2. The medical electrical lead of claim 1 , wherein the gap reduces forces on the conductive ...

COUPLING MECHANISMS FOR USE WITH A MEDICAL ELECTRICAL LEAD

An implantable medical lead may include components or mechanisms that can reduce the amount of induced current that is conducted to electrodes of the lead. A medical lead may, for example, have an energy dissipating structure that is connected to an electrode of the lead. This disclosure provides for coupling mechanisms to couple current induced on the lead to the energy dissipating structure. The coupling mechanisms described herein provide continuous contact with both electrode shaft and the energy dissipating structure while producing forces on the electrode shaft that is small enough to permit extension and retraction of the electrode from the lead. 1. A medical electrical lead comprising:a lead body having a proximal end configured to couple to an implantable medical device and a distal end;a conductive electrode shaft located near the distal end of the lead body;a conductor that extends from the proximal end of the lead body and couples to the conductive electrode shaft,an electrode located near the distal end of the lead body and electrically coupled to an opposite end of the conductive electrode shaft as the conductor;an energy dissipating structure located adjacent the electrode, the energy dissipating structure including a conductive element; and an inner contour of the conductive material that receives the conductive electrode shaft and exerts a inward force on the conductive electrode shaft;', 'an outer contour of the conductive material that exerts an outward force on the energy dissipating structure; and', 'a relief segment somewhere along the coupling mechanism that is designed to be more susceptible to deformation due to forces than the rest of the coupling mechanism., 'a coupling mechanism formed of a conductive material that contacts the conductive electrode shaft and the energy dissipating structure, wherein the conductive material is shaped to form2. The medical electrical lead of claim 1 , wherein the relief segment reduces forces on the ...

LEAD RECOGNITION FOR AN IMPLANTABLE MEDICAL SYSTEM

The disclosure describes implantable medical systems that respond to occurrence of a lead-related condition by utilizing an elongated coil electrode in defining an alternative pacing therapy vector to maintain optimal drain of an IMD power supply. An exemplary system includes a medical electrical lead having an elongated electrode and an improved sensing and therapy delivery circuitry to provide the alternative pacing therapy vector responsive to the lead-related conditions. The system includes circuitry for recognition of the lead type in order to respond to the occurrence of the lead-related condition. 1. A method for assessing a medical electrical lead , comprising:delivering a first sub-threshold pulse having a first polarity;obtaining a first electrical parameter in response to the delivery of the first sub-threshold pulse;delivering a second sub-threshold pulse having a second polarity;obtaining a second electrical parameter in response to the delivery of the second sub-threshold pulse;computing a difference between the first electrical parameter and the second electrical parameter; anddetermining a lead type of the medical electrical lead based on the computed difference.2. The method of claim 1 , wherein the first electrical parameter and the second electrical parameter comprises an electrical current through the lead.3. The method of claim 1 , wherein the first electrical parameter and the second electrical parameter comprises an electrical voltage through the lead.4. The method of claim 1 , wherein obtaining the first electrical parameter and the second electrical parameter comprises:performing a measurement of a current value across the lead in response to the delivered first and second sub-threshold pulse; andderiving a measure of the impedance based on the measured current value.5. The method of claim 1 , wherein obtaining the first electrical parameter and the second electrical parameter comprises:performing a measurement of a voltage value across the ...

FAULT TOLERANT IMPLANTABLE MEDICAL SYSTEM

The disclosure describes implantable medical systems that respond to occurrence of a lead-related condition by utilizing an elongated coil electrode in defining an alternative pacing therapy vector to maintain optimal drain of an IMD power supply. An exemplary system includes a medical electrical lead having an elongated electrode and an improved sensing and therapy delivery circuitry to provide the alternative pacing therapy vector responsive to the lead-related conditions. The system reconfigures the operation of the sensing and therapy delivery circuitry triggered by the switch to the alternative pacing therapy vector. 1. A method for operating an implantable medical system having a medical electrical lead , comprising:providing a therapy through a first vector including a first electrode of the medical electrical lead;detecting a lead-related condition associated with the first vector;reconfiguring the therapy for delivery through a second vector including an alternate electrode of the medical electrical lead, the alternate electrode having a first section and a second section; anddelivering the reconfigured therapy through the second vector, wherein the reconfigured therapy is directed through the second section of the alternate electrode but not the first section.2. The method of claim 1 , wherein the first section is a proximal portion and the second section is a distal portion.3. The method of claim 1 , wherein the second section comprises a first plurality of segments interspersed between the first section.4. The method of claim 1 , further comprising switching a sensing operation of the implantable medical system in response to detecting the lead-related condition.5. The method of claim 4 , wherein switching the sensing operation comprises adjusting the filter characteristics of a sensing circuit of the implantable medical system to deconstruct a composite signal sensed via the second vector.6. The method of claim 4 , wherein switching the sensing ...

MR-COMPATIBLE IMPLANTABLE MEDICAL LEAD

A medical electrical lead may include a conductive electrode shaft located near the distal end within the lead body, a coiled conductor extending within the lead body from the proximal end and coupled to a first end of the conductive electrode shaft, and an electrode located near the distal end of the lead body and coupled to an opposite end of the conductive electrode shaft as the coiled conductor. The lead may also include an energy dissipating structure located near the distal end of the lead body and defining a lumen through which a portion of the coiled conductor extends. The energy dissipating structure may include a region having one or more protrusions extending toward a central axis of the lumen to push the coiled conductor off center relative to the central axis of the lumen. 1. A medical electrical lead comprising:a lead body having a proximal end configured to couple to an implantable medical device and a distal end;a conductive electrode shaft located near the distal end within the lead body;a coiled conductor extending within the lead body from the proximal end and coupled to a first end of the conductive electrode shaft;an electrode located near the distal end of the lead body and coupled to an opposite end of the conductive electrode shaft as the coiled conductor; andan energy dissipating structure located near the distal end of the lead body and formed from a conductive material that defines a lumen through which a portion of the coiled conductor extends, wherein the energy dissipating structure includes a region having one or more protrusions extending toward a central axis of the lumen defined by the energy dissipating structure to push the coiled conductor off center relative to the central axis of the lumen formed by the energy dissipating structure.2. The medical electrical lead of claim 1 , wherein the coiled conductor and the energy dissipating structure are electrically connected within the region.3. The medical electrical lead of claim 1 , ...

MR-COMPATIBLE IMPLANTABLE MEDICAL LEAD

A medical electrical lead may include a lead body having a proximal end and a distal end, a conductive electrode shaft located near the distal end within the lead body, a coiled conductor extending within the lead body from the proximal end and coupled to a first end of the conductive electrode shaft, and an electrode located near the distal end of the lead body and coupled to an opposite end of the conductive electrode shaft as the coiled conductor. The lead may also include an energy dissipating structure located near the distal end of the lead body and formed from a conductive material that defines a lumen through which a portion of the coiled conductor extends. The portion of the coiled conductor extending through the lumen defined by the energy dissipating structure is formed to provide an interference contact with the energy dissipating structure. 1. A medical electrical lead comprising:a lead body having a proximal end configured to couple to an implantable medical device and a distal end;a conductive electrode shaft located near the distal end within the lead body;a coiled conductor extending within the lead body from the proximal end and coupled to a first end of the conductive electrode shaft;an electrode located near the distal end of the lead body and coupled to an opposite end of the conductive electrode shaft as the coiled conductor;an energy dissipating structure located near the distal end of the lead body and formed from a conductive material that defines a lumen through which a portion of the coiled conductor extends, wherein the portion of the coiled conductor extending through the lumen defined by the energy dissipating structure is formed to provide an interference contact with the energy dissipating structure; anda layer of insulating material covering at least an outer surface of the conductive material of the energy dissipating structure such that the outer surface of the conductive material of the energy dissipating structure does not ...

MR-COMPATIBLE IMPLANTABLE MEDICAL LEAD

A medical electrical lead may include a lead body formed to define a first lumen extending from the proximal end to a location near the distal end and having a first central axis. The lead includes an electrode located near the distal end of the lead body and an energy dissipating structure located near the distal end of the lead body, the energy dissipating structure including a conductive main portion that defines a second lumen having a second central axis that is offset relative to the first central axis of the first lumen defined by the lead body and a conductive transition portion that extends towards the first lumen defined by the lead body. A conductor contacts the energy dissipating structure within the transition portion of the energy dissipating structure to provide a substantially continuous interference contact with the energy dissipating structure. 1. A medical electrical lead comprising:a lead body having a proximal end configured to couple to an implantable medical device and a distal end, wherein the lead body is formed to define a first lumen extending from the proximal end to a location near the distal end and having a first central axis;an electrode located near the distal end of the lead body; a conductive main portion that defines a second lumen having a second central axis that is offset relative to the first central axis of the first lumen defined by the lead body; and', 'a conductive transition portion that extends from the conductive main portion of the energy dissipating structure towards the first lumen defined by the lead body; and, 'an energy dissipating structure located near the distal end of the lead body, the energy dissipating structure includinga conductor that provides at least a portion of a conductive path from the proximal end of the lead body to the electrode, the conductor extending through the first lumen defined by the lead body, through the transition portion of the energy dissipating structure, and at least partially ...

IMPLANTABLE MEDICAL ELECTRICAL LEAD CONDUCTORS AND CONSTRUCTION METHODS

A coiled continuous conductor wire of an implantable medical electrical lead includes a first, electrode length and a second, insulated length, wherein the insulated length of the wire has a radial cross-section defined by a round profile, while the electrode length of the wire has a radial cross-section defined by a flattened profile, a long axis edge of which defines an outer diameter surface of the electrode length. The radial cross-section profile, along the electrode length of wire, is preferably flattened after an entire length of the wire has been coiled. 1. An implantable medical electrical lead comprising a continuous conductor wire wound in a coil , the conductor wire comprising an insulated length , extending distally from a connector terminal of the lead , and an electrode length , extending distally from the insulated length , and wherein the improvement comprises: the insulated length of the wire having a radial cross-section defined by a round profile , while the electrode length of the wire having a radial cross-section defined by a flattened profile , the flattened profile having a long axis and a short axis , and an outer diameter surface of the electrode length being defined by a long axis edge of the flattened profile.2. The lead of claim 1 , wherein the conductor wire is formed of Ta claim 1 , and the electrode length of the wire includes a native pentoxide coating extending over a portion of the outer diameter surface thereof.3. The lead of claim 1 , wherein the electrode length of the conductor wire includes a coating extending over all or a portion of the outer diameter surface thereof claim 1 , the coating being one of: a TiN coating and a Pt coating.4. The lead of claim 1 , wherein the conductor wire is formed of Pt/IR cladded Ta.5. The lead of claim 1 , wherein the electrode length of the conductor wire includes a shunt portion located in proximity to the insulated length.6. The lead of claim 1 , wherein the coil includes a distal end ...

EXTRAVASCULAR IMPLANT TOOLS UTILIZING A BORE-IN MECHANISM AND IMPLANT TECHNIQUES USING SUCH TOOLS

Extravascular implant tools that utilize a bore-in mechanism to safely access extravascular locations and implant techniques utilizing these tools are described. The bore-in mechanism may include a handle and a helix extending from the handle. The bore-in mechanism is used, for example, in conjunction with a tunneling tool to traverse the diaphragmatic attachments to access a substernal location. The tunneling tool may be an open channel tunneling tool or a conventional tunneling tool (e.g., metal rod).

SECURING AN IMPLANTABLE MEDICAL DEVICE IN POSITION WHILE REDUCING PERFORATIONS

Methods and systems of making a medical electrical lead type having a set of tines. A system for implantation of a lead medical electrical lead in contact with heart tissue, comprises an elongated lead body; a set of curved tines mounted to and extending from a distal end of the lead body, the tines having a length (dD) and an effective cross sectional area, and a delivery catheter. The delivery catheter encloses the lead body and has a distal capsule portion enclosing the tines. The tines exerting a spring force against the capsule and provide a stored potential energy. The delivery catheter has an elastic, not stiff and low column strength ejection means for advancing the lead and tines distally from the capsule and fixating the tines within the heart tissue, the controllable and the stored potential energy of the tines together provide a deployment energy. The tines when so fixated in the tissue provide a fixation energy. The deployment energy and the fixation energy of the tines are equivalent. 14-. (canceled)5. A system for implantation of a medical device in contact with heart tissue , comprising:a medical device;a set of curved tines mounted to and extending from a distal end of the device, the tines having a length (dD) and an effective cross-sectional area;a delivery catheter, enclosing the device and having a distal capsule portion enclosing the tines, the tines exerting a spring force against the capsule and providing a stored potential energy, the delivery catheter having an ejection means for advancing the tines distally from the capsule and fixating the tines within the heart tissue, the ejection means and the stored potential energy of the tines together providing a deployment energy, the tines when so fixated in the tissue providing a fixation energy; andwherein the deployment energy and the fixation energy are equivalent.6. A system according to claim 5 , wherein the deployment energy provides a provides a maximum peak force of deployment (dDFmax) ...

COMPACT IMPLANTABLE MEDICAL DEVICE AND DELIVERY DEVICE

Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue. 1. A method for using a delivery device to position a leadlet pacing device (LPD) in cardiac tissue , the delivery device comprising a proximal end , a distal end and a lumen extending therebetween sized to receive the LPD , the LPD having a leadlet with a fixation device extending therefrom , the method comprising:advancing the LPD out of the delivery device using a LPD mover;fixating the LPD with cardiac tissue in a ventricular location;advancing the leadlet out of the delivery device using a leadlet mover;after advancing the leadlet out of the delivery device, torquing the leadlet around the leadlet mover to a torqued state; andreleasing the leadlet from the torqued state to cause the fixation device of the leadlet to fixate with cardiac tissue in an atrial location.2. The method of claim 1 , wherein the ventricular location is in a right ventricle.3. The method of claim 1 , wherein the atrial location is in a right atrium.4. The method of claim 1 , further comprising moving the leadlet mover after advancing the leadlet out of the delivery device claim 1 , wherein the leadlet mover results in torquing the leadlet around the leadlet mover to a torqued state.5. The ...

OPEN CHANNEL IMPLANT TOOLS AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

Implant tools and techniques for implantation of a medical lead, catheter or other component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An implant tool for implanting a medical lead may include a handle and a shaft adjacent the handle. The shaft has a proximal end, a distal end, and an open channel that extends from near the proximal end to the distal end, the open channel having a width that is greater than or equal to an outer diameter of the implantable medical lead. 1. An implant tool for implanting an implantable medical lead within a patient , the implant tool comprising:a shaft including a proximal end, a distal end, and an attachment feature configured to couple to the implantable medical lead; anda handle including a lumen, the lumen configured to receive the proximal end of the shaft to removably couple the shaft to the handle, and wherein the implant tool is configured such that the attachment feature of the shaft is positioned within the lumen of the handle when the handle receives the proximal end of the shaft.2. The implant tool of claim 1 , wherein the shaft includes an open channel configured to receive at least a portion of the implantable medical lead.3. The implant tool of claim 2 , wherein the open channel extends from the proximal end towards the distal end of the shaft.4. The implant tool of claim 2 , wherein the open channel extends from the distal end to the proximal end of the shaft.5. The implant tool of claim 2 , wherein the open channel includes at least one guide along an inner surface of the shaft forming the open channel claim 2 , the guide being recessed into the inner surface of the shaft and configured to receive a protrusion portion of the implantable medical lead within the recess of the guide to guide the lead within the open channel.6. The implant tool of claim 2 , wherein the open channel is sized to ...

IMPEDANCE-BASED VERIFICATION FOR DELIVERY OF IMPLANTABLE MEDICAL DEVICES

A device for delivering an implantable medical device (IMD) includes an elongated member and a deployment bay configured to house the IMD, the deployment bay defining a distal opening for deploying the IMD out of the deployment bay. The device includes a first electrode located inside the deployment bay during intravascular navigation, a second electrode, and impedance detection circuitry configured to deliver an electrical signal to a path between the first electrode and the second electrode through at least one of a fluid or tissue of the patient. The device also includes processing circuitry configured to determine an impedance of the path based on the signal and control a user interface to indicate when an impedance of the path indicates that at least one of the IMD or the distal opening is in a fixation configuration relative to the target site of the patient. 1. An implantable medical device delivery system comprising:an elongated member configured to navigate an intravascular system of a patient;a deployment bay connected to a distal portion of the elongated member and configured to house at least a portion of an implantable medical device (IMD), the deployment bay defining a distal opening configured for deployment of the IMD out of the deployment bay at a target site in a patient;signal generation circuitry configured to deliver an electrical signal to a path between a first electrode located inside of the deployment bay and a second electrode through at least one of a fluid or tissue of the patient; and determine an impedance of the path based on the signal; and', 'generate an output that indicates when an impedance of the path indicates that at least one of the IMD or the distal opening is in a fixation configuration relative to the target site of the patient via a user interface., 'processing circuitry configured to2. The medical delivery system of claim 1 , wherein the fixation configuration includes a first fixation configuration wherein the distal ...

Extravascular lead designs for optimized pacing and sensing having segmented, partially electrically insulated defibrillation coils

A lead body having a defibrillation electrode positioned along a distal portion of the lead body is described. The defibrillation electrode includes a plurality of electrode segments spaced a distance apart from each other. At least one of the plurality of defibrillation electrode segments includes at least one coated portion and at least one uncoated portion. The at least one coated portion is coated with an electrically insulating material configured to prevent transmission of a low voltage signal (e.g., a pacing pulse) while allowing transmission of a high voltage signal (e.g., a cardioversion defibrillation shock). The at least one uncoated portion is configured to transmit both low voltage and high voltage signals. The lead may also include one or more discrete electrodes proximal, distal or between the defibrillation electrode segments.

OPEN CHANNEL IMPLANT TOOLS HAVING AN ATTACHMENT FEATURE AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

Implant tools and techniques for implantation of a medical lead, catheter or other component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An implant tool for implanting a medical lead may include a shaft having a proximal end, a distal end, an open channel that extends from near the proximal end to the distal end, and an attachment feature configured to couple to the medical lead. Such an implant tool provides a user with the versatility to use the same implant tool to either pull the lead through a tunnel formed via the implant tool or push the lead through the tunnel via the open channel in the implant tool. 1. An implant tool for implanting a medical lead , the implant tool comprising: an open channel that extends from near the proximal end to the distal end; and', 'an attachment feature configured to couple to the medical lead., 'a shaft having a proximal end and a distal end, wherein the shaft includes2. The implant tool of claim 1 , further comprising a handle adjacent to the shaft.3. The implant tool of claim 2 , wherein the handle is removable.4. The implant tool of claim 3 , wherein the handle is configured to couple to at least one of the proximal end of the shaft and the distal end of the shaft.5. The implant tool of claim 2 , wherein the handle includes a lumen configured to receive a portion of the shaft claim 2 , the lumen and shaft creating an interference fit that couples the shaft to the handle.6. The implant tool of claim 1 , wherein the attachment feature comprises a hook feature located along a surface of the shaft that is opposite an opening of the channel claim 1 , the hook feature being configured to couple to a feature of the medical lead.7. The implant tool of claim 6 , wherein the shaft has a thickness and the hook feature extends through the thickness shaft such that there is an opening through the surface of the ...

OPEN CHANNEL IMPLANT TOOLS AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

Implant tools and techniques for implantation of a medical lead, catheter or other component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An implant tool for implanting a medical lead may include a handle and a shaft adjacent the handle. The shaft has a proximal end, a distal end, and an open channel that extends from near the proximal end to the distal end, the open channel having a width that is greater than or equal to an outer diameter of the implantable medical lead. 1. An implant tool for implanting an implantable medical lead within a patient , the implant tool comprising:a handle; anda shaft adjacent the handle, the shaft having a proximal end, a distal end, and an open channel that extends from near the proximal end to the distal end, the open channel having a width that is greater than or equal to an outer diameter of the implantable medical lead.2. The implant tool of claim 1 , wherein the open channel further includes a depth that is greater than or equal to the outer diameter of the implantable medical lead.3. The implant tool of claim 1 , wherein the handle is removable.4. The implant tool of claim 3 , wherein the handle includes a lumen configured to receive a portion of the shaft claim 3 , the lumen and shaft creating an interference fit that couples the shaft to the handle.5. The implant tool of claim 3 , wherein the lumen is configured to receive at least one of the proximal end of the shaft and the distal end of the shaft.6. The implant tool of claim 1 , wherein the open channel includes at least one guide along an inner surface of the shaft forming the open channel claim 1 , the guide being configured to receive a portion of an implantable medical lead.7. The implant tool of claim 1 , wherein the implant tool is formed of at least one of a molded polymer and a metal.8. The implant tool of claim 1 , wherein a thickness of ...

EXTRAVASCULAR IMPLANT TOOLS WITH OPEN SHEATH AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

Implant tools and techniques for implantation of a medical lead, catheter or other implantable component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An example implant tool for implanting a medical lead includes a rod having a handle and a shaft, and a sheath configured to be placed on the shaft of the rod. The sheath includes a body having proximal end and a distal, a channel formed by the body, the channel extending from the proximal end to the distal end of the body, and an opening that extends along the body of the sheath from the proximal end to the distal end, wherein the channel is accessible via the opening. 1. An implant tool for implanting a medical lead , the implant tool comprising: a handle; and', 'a shaft having a proximal end adjacent to the handle and a distal end; and, 'a rod that includes a body having proximal end and a distal;', 'a channel formed by the body, the channel extending from the proximal end to the distal end of the body; and', 'an opening that extends along the body of the sheath from the proximal end to the distal end, wherein the channel is accessible via the opening., 'a sheath configured to be placed on the rod, wherein the sheath includes2. The implant tool of claim 1 , wherein the opening of the sheath is less than a diameter of the medical lead.3. The implant tool of claim 2 , wherein the opening of the sheath is at least ten percent (10%) less than the diameter of lead.4. The implant tool of claim 1 , wherein a cross-section of the body includes a first end and a second end that form the opening claim 1 , wherein the first and second ends of the body forming the opening are in contact with one another but are not mechanically coupled and are moveable relative to one another.5. The implant tool of claim 1 , wherein the opening follows at least one of a substantially straight path claim 1 , a spiral ...

IMPLANT TOOLS WITH ATTACHMENT FEATURE AND MULTI-POSITIONAL SHEATH AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

Implant tools and techniques for implantation of a medical lead, catheter or other implantable component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An example implant tool for implanting a medical lead includes a rod and a sheath configured to be placed on the rod. The rod includes a handle, a shaft having a proximal end adjacent to the handle and a distal end, and an attachment feature toward the distal end of the shaft, the attachment feature configured to couple to the medical lead. The sheath is configured to be placed in multiple positions along the rod including a first position in which the sheath does not interact with the attachment feature and second position in which the sheath does interact with the attachment feature. 1. An implant tool for implanting a medical lead , the implant tool comprising: a handle;', 'a shaft having a proximal end adjacent to the handle and a distal end; and', 'an attachment feature toward the distal end of the shaft, the attachment feature configured to couple to the medical lead; and, 'a rod that includesa sheath configured to be placed on the rod, wherein the sheath includes a body having proximal end and a distal end, and further wherein the sheath is configured to be placed in multiple positions along the rod including a first position in which the sheath does not interact with the attachment feature and second position in which the sheath does interact with the attachment feature.2. The implant tool of claim 1 , wherein the attachment feature comprises a hook feature configured to receive an attachment feature of the medical lead claim 1 , wherein in the first position the sheath does not cover the hook feature and in the second position the sheath does cover the hook feature.3. The implant tool of claim 1 , wherein the attachment feature comprises a recess that extends into the distal end of the ...

COMPACT IMPLANTABLE MEDICAL DEVICE AND DELIVERY DEVICE

Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue. 1. A method for using a delivery device to position a leadlet pacing device (LPD) in cardiac tissue , the delivery device comprising a proximal end , a distal end and a lumen extending therebetween sized to receive the LPD , the LPD having a leadlet with a fixation device extending therefrom , the method comprising:(a) introducing the LPD into the distal end of the delivery device and the leadlet extending proximally from the LPD while the fixation device extends distally toward the LPD;(b) advancing the LPD out of the delivery device using a LPD mover;(c) advancing the leadlet out of the delivery device using a leadlet mover;(d) moving the leadlet mover after advancing the leadlet out of the delivery device, wherein the leadlet mover results in torquing of the leadlet around the leadlet mover to a torqued state; and(e) releasing the leadlet from the torqued state to cause the fixation device of the leadlet to engage the fixation device of the leadlet with cardiac tissue.2. The method of wherein the fixation device is a set of tines.3. The method of wherein the fixation device is a helix.4. A delivery device to position a leadlet pacing device (LPD) in cardiac tissue ...

EXTRAVASCULAR IMPLANT TOOLS UTILIZING A BORE-IN MECHANISM AND IMPLANT TECHNIQUES USING SUCH TOOLS

Extravascular implant tools that utilize a bore-in mechanism to safely access extravascular locations and implant techniques utilizing these tools are described. The bore-in mechanism may include a handle and a helix extending from the handle. The bore-in mechanism is used, for example, in conjunction with a tunneling tool to traverse the diaphragmatic attachments to access a substernal location. The tunneling tool may be an open channel tunneling tool or a conventional tunneling tool (e.g., metal rod). 1. An implant tool for implanting an implantable medical lead , implantable catheter or other implantable component within a patient , the implant tool comprising: a handle, and', 'a shaft adjacent the handle, the shaft having a proximal end, a distal end, and an open channel that extends from near the proximal end to the distal end; and, 'an open channel delivery tool that includesa bore-in mechanism configured to interact with the open channel delivery tool.2. The implant tool of claim 1 , wherein the bore-in mechanism includes:a handle; anda helix extending from the handle, the handle and the helix forming a lumen that extends through the handle and the helix and is configured to receive the shaft of the open channel delivery tool.3. The implant tool of claim 2 , wherein a distal end of the helix of bore-in mechanism is sharp.4. The implant tool of claim 1 , wherein the bore-in mechanism comprises:a handle; anda screw extending from the handle, wherein the open channel of the delivery tool is sized to receive the screw of the bore-in mechanism.5. The implant tool of claim 4 , wherein the screw of the bore-in mechanism comprises:a shaft; anda helical thread that extends along at least a portion of the shaft.6. The implant tool of claim 5 , wherein the shaft is constructed of a polymer and the helical thread is constructed of a metal or a metal alloy.7. The implant tool of claim 5 , wherein the helical thread extends along only a distal portion of the shaft of the ...

EXTRAVASCULAR IMPLANT TOOLS AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

This disclosure provides various embodiments of implant tools and implant techniques utilizing those tools to implant components within extravascular locations. In one example, an implant tool for implanting a component within an extravascular location of a patient comprise a handle and a shaft adjacent the handle. The shaft has a proximal end, a distal end, and a body formed to define an open channel that extends from near the proximal end to the distal end. The open channel has a first width. The body has at least one flexible portion that defines an opening via which the open channel is accessed. The opening has a second width that is less than the first width. In another example, a sheath with an opening having the second width may be placed on the shaft of the implant tool instead of the implant tool having the at least one flexible portion. 1. A system for implanting an implantable component within an extravascular location of a patient , the delivery system comprising: a handle, and', 'a shaft adjacent the handle, the shaft having a first length from a proximal end to a distal end, and an open channel that extends from near the proximal end to the distal end, the open channel having a width; and, 'an implant tool that includes a body having a second length from a proximal end and a distal,', 'a channel formed by the body, the channel extending from the proximal end to the distal end of the body, the channel receiving the shaft of the implant tool when the sheath is placed on the implant tool, and', 'an opening that extends along the body of the sheath from the proximal end to the distal end, wherein the channel is accessible via the opening and the opening is less than or equal to the width of the open channel of the shaft of the implant tool., 'a sheath configured to be placed on the implant tool, the sheath including2. The system of claim 1 , wherein claim 1 , when the sheath is placed on the implant tool claim 1 , the open channel of the shaft of the ...

EXTRAVASCULAR IMPLANTABLE ELECTRICAL LEAD HAVING UNDULATING CONFIGURATION

This disclosure describes an implantable medical electrical lead and an ICD system utilizing the lead. The lead includes a lead body defining a proximal end and a distal portion, wherein at least a part of the distal portion of the lead body defines an undulating configuration. The lead includes a defibrillation electrode that includes a plurality of defibrillation electrode segments disposed along the undulating configuration spaced apart from one another by a distance. The lead also includes at least one electrode disposed between adjacent sections of the plurality of defibrillation sections. The at least one electrode is configured to deliver a pacing pulse to the heart and/or sense cardiac electrical activity of the heart. 1. An implantable medical electrical lead , comprisinga lead body defining a proximal end and a distal portion, wherein at least a part of the distal portion of the lead body defines an undulating configuration;a defibrillation electrode that includes a plurality of defibrillation electrode segments disposed along the undulating configuration spaced apart from one another by a distance; andat least one electrode disposed between adjacent segments of the plurality of defibrillation segments, the at least one electrode configured to, at least one of, deliver a pacing pulse to the heart and sense cardiac electrical activity of the heart.2. The lead of claim 1 , wherein the plurality of defibrillation electrode segments are disposed along at least 80% of undulating configuration.3. The lead of claim 1 , wherein the plurality of defibrillation electrode segments are disposed along at least 90% of undulating configuration.4. The lead of claim 1 , wherein the undulating configuration includes a plurality of peaks claim 1 , a first portion of the plurality of peaks extending in a first direction away from a major longitudinal axis of the lead and a second portion of the plurality of peaks extending in a second claim 1 , opposite direction away from ...

OPEN CHANNEL IMPLANT TOOL WITH ADDITIONAL LUMEN AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

This disclosure provides various embodiments of implant tools and implant techniques utilizing those tools. In one embodiment, an implant tool comprises a handle and a shaft. The shaft includes a proximal end adjacent the handle, a distal end, an open channel that extends from near the proximal end to the distal end, and at least one lumen that extends from a proximal end of the shaft to a location near the distal end of the shaft. The implant tool may also include a coupler configured to connect to a fluid delivery device. In one example, the fluid delivery device may be a syringe. In some instances, the handle of the implant tool may include a compartment or a recess configured to receive the fluid delivery device. 1. A implant tool comprising:a handle; and a proximal end adjacent the handle,', 'a distal end,', 'an open channel that extends from near the proximal end to the distal end, and', 'at least one lumen that extends from a proximal end of the shaft to a location near the distal end of the shaft., 'a shaft adjacent the handle, the shaft including2. The implant tool of claim 1 , wherein the at least one lumen comprises two or more lumens.3. The implant tool of claim 1 , wherein the at least one lumen includes an opening at the distal end of the shaft.4. The implant tool of claim 1 , wherein the at least one lumen includes an opening that opens into the open channel of the shaft near the distal end of the shaft.5. The implant tool of claim 1 , further comprising a coupler configured to connect to a fluid delivery device.6. The implant tool of claim 5 , further comprising a syringe that connects to the coupler.7. The implant tool of claim 5 , wherein the handle includes one of a compartment and a recess configured to receive the fluid delivery device.8. A implant tool comprising:a handle; and a proximal end adjacent the handle,', 'a distal end,', 'a first open channel that extends from near the proximal end to the distal end; and', 'a second open channel that ...

RADIOPAQUE MARKERS FOR IMPLANTABLE MEDICAL LEADS

A radiopaque marker may include a body formed of a polymer and being adapted to be disposed around a portion of an implantable medical lead and a symbol formed of at least a radiologically dense powder or liquid added to the body and designed to identify the implantable medical lead as being safe application of a medical procedure. In some instances, the symbol may be formed of a polymer mixed with the radiologically dense powder or liquid. The body may also be formed of a polymer mixed with a radiologically dense powder or liquid wherein the mixed polymer forming the symbol is radiologically denser than the mixed polymer forming the body.

RADIOPAQUE MARKERS FOR IMPLANTABLE MEDICAL LEADS

A radiopaque marker that includes a body being adapted to be disposed around a portion of an implantable medical lead and formed from a polymer mixed with a radiopacifier. The polymer is designed to form a symbol that identifies the implantable medical lead as being designed for safe application of a medical procedure. In some instances, the body of the radiopaque marker includes portions of varying thicknesses, the thick portions of the body being designed to form the symbol that identifies the implantable medical lead as being designed for safe application of a medical procedure such that the thick portions of the body appear more radiologically dense during an imaging procedure. In other instances, the body of the radiopaque marker may have a relatively uniform thickness and is shaped into the symbol that identifies the implantable medical lead as being designed for safe application of a medical procedure.

IMPLANTABLE MEDICAL ELECTRICAL LEADS AND CONNECTOR ASSEMBLIES THEREOF

A connector assembly of an implantable medical electrical lead includes insulation and conductor segments, which may be formed together in a molded subassembly. The insulation segment includes at least one sealing surface, and the conductor segment includes at least one contact surface and a shank electrically common therewith. The shank has a smaller diameter than a uniform outer diameter of the assembly, which is defined by the sealing and contact surfaces, and the smaller diameter is sized to receive a coiled proximal end of a lead conductor mounted thereabout. The connector assembly may include another conductor segment that has a third contact surface, active or inactive, extending between third and fourth sealing surfaces of another insulation segment of the assembly; if active, a distal shank of the segment is electrically common with the third contact surface, and sized to receive a coiled proximal end of another lead conductor mounted thereabout. 1. A connector assembly for an implantable medical electrical lead , the assembly having a uniform outer diameter conforming to a requirement for mating with a connector receptacle of an implantable medical device , the assembly extending along a longitudinal axis , from a proximal end thereof to a distal end thereof , and the assembly comprising:an insulation segment including a first sealing surface extending distally from the proximal end of the assembly, and a second sealing surface spaced apart from the first sealing surface; anda conductor segment including a first contact surface extending between the first and second sealing surfaces of the insulation segment, a second contact surface extending distally from the second sealing surface of the insulation segment, and a shank extending distally from the second contact surface toward the distal end of the assembly, the first and second contact surfaces and the shank being electrically common with one another, and the shank having an outer diameter sized to ...

IMPLANT TOOLS WITH ATTACHMENT FEATURE AND MULTI-POSITIONAL SHEATH AND IMPLANT TECHNIQUES UTILIZING SUCH TOOLS

Implant tools and techniques for implantation of a medical lead, catheter or other implantable component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An example implant tool for implanting a medical lead includes a rod and a sheath configured to be placed on the rod. The rod includes a handle, a shaft having a proximal end adjacent to the handle and a distal end, and an attachment feature toward the distal end of the shaft, the attachment feature configured to couple to the medical lead. The sheath is configured to be placed in multiple positions along the rod including a first position in which the sheath does not interact with the attachment feature and second position in which the sheath does interact with the attachment feature. 1. A method for implanting a medical electrical lead using a rod having a handle , a shaft having a proximal end adjacent to the handle and a distal end , and an attachment feature toward the distal end of the shaft , the attachment feature configured to couple to the medical lead , and a sheath configured to be placed on the shaft of the rod , the sheath having body defining a channel , the medical electrical lead having a proximal end including a connector mechanism configured to connect to an implantable medical device and a distal end including one or more electrodes , the method comprising:creating a first incision at a first location on a torso of a patient;creating a second incision at a second location on the torso of the patient;introducing the rod, with the sheath placed on the rod, into the patient via the first incision;advancing the rod from the first incision to the second incision to create a first path between the first incision and the second incision;attaching an attachment feature of the medical electrical lead to the attachment feature of the rod;advancing the sheath from a first position in ...

INTERVENTIONAL MEDICAL SYSTEMS

An implantable medical device includes ventricular and atrial portions, and a flexible leadlet that extends therebetween. An open channel of the atrial portion, formed along a core thereof, is sized to receive the leadlet therein, when the leadlet is folded over on itself. An interventional medical system includes the device and a delivery tool; a tubular sidewall of the tool defines a lumen and has a tether extending therein. A slot formed in the sidewall extends proximally from an open end thereof, coincident with a distal opening of the lumen. When the atrial portion is contained within the lumen, a segment of the leadlet extends alongside the atrial portion; another segment of the leadlet, being folded over on itself, proximal to the atrial portion, has the tether engaged therewith. The slot may allow passage of the leadlet therethrough, when the atrial portion is positioned for deployment through the distal opening. 1. An implantable medical device comprising:a ventricular portion comprising an hermetically sealed housing extending from a proximal end thereof to a distal end thereof, a ventricular electrode mounted in proximity the housing distal end, and a fixation mechanism mounted in proximity to the housing distal end;an atrial portion comprising a core extending from a first end thereof to a second end thereof, along a longitudinal axis of the atrial portion, an atrial electrode mounted in proximity to the second end of the core, a fixation mechanism mounted in proximity to the second end of the core, and an open channel formed along the core, the channel extending between the first and second ends of the core; anda flexible leadlet extending from the proximal end of the ventricular portion housing to the first end of the atrial portion core, the leadlet comprising a conductor and an insulative tubular member in which the conductor extends, the conductor being coupled to the atrial electrode of the atrial portion, and the open channel of the atrial portion ...

INTERVENTIONAL MEDICAL DEVICES, DEVICE SYSTEMS, AND FIXATION COMPONENTS THEREOF

A fixation mechanism of an implantable medical device is formed by a plurality of tines fixedly mounted around a perimeter of a distal end of the device. Each tine may be said to include a first segment fixedly attached to the device, a second segment extending from the first segment, and a third segment, to which the second segment extends. When the device is loaded in a lumen of a delivery tool and a rounded free distal end of each tine engages a sidewall that defines the lumen, to hold the tines in a spring-loaded condition, the first segment of each tine, which has a spring-biased pre-formed curvature, becomes relatively straightened, and the third segment of each tine, which is terminated by the free distal end, extends away from the axis of the device at an acute angle in a range from about 45 degrees to about 75 degrees. 1. A tissue penetrating fixation component for an implantable medical device , the component comprising a base and a plurality of tines , the base defining a longitudinal axis of the component and being configured to be fixedly attached to the device so that a perimeter of the component extends around an electrode of the device , and so that the longitudinal axis of the component is generally aligned along a longitudinal axis of the device , the plurality of tines extending from the base and being spaced apart from one another around a perimeter thereof , and each tine comprising:a proximal, spring portion being fixedly attached to the base and having a spring-biased pre-formed curvature, the pre-formed curvature, in proximity to the base, extending in a first direction, generally parallel to the axis of the component, and then sweeping laterally, outward from the axis; anda distal portion including a proximal section, a hook section, and tip section terminated by a rounded free distal end, the proximal section extending from the proximal, spring portion and being pre-formed to extend in a second direction and along a relatively straight line ...

COMPACT IMPLANTABLE MEDICAL DEVICE AND DELIVERY DEVICE

Methods and systems for positioning a leadless pacing device (LPD) in cardiac tissue are disclosed. A delivery device is employed that comprises a proximal end, a distal end and a lumen therebetween sized to receive the LPD. The LPD has a leadlet extending therefrom that includes a means to fixate the leadlet to tissue. The delivery device comprises an introducer to introduce the LPD into the lumen of the delivery device. The LPD is loaded in the distal end of the lumen of the delivery device. The leadlet extends proximally from the LPD while the fixation means extends distally toward the LPD. A LPD mover is configured to advance the LPD out of the delivery device. A leadlet mover is configured to advance the leadlet out of the lumen delivery device and cause the leadlet to engage with cardiac tissue. 1. A method for using a delivery device to position a leadlet pacing device (LPD) in cardiac tissue , the delivery device comprising a proximal end , a distal end and a lumen extending therebetween sized to receive the LPD , the LPD having a leadlet with a fixation device extending therefrom , the method comprising:(a) introducing the LPD into the distal end of the delivery device and the leadlet extending proximally from the LPD while the fixation device extends distally toward the LPD;(b) advancing the LPD out of the delivery device using a LPD mover;(c) advancing the leadlet out of the delivery device using a leadlet mover;(d) rotating the leadlet mover after advancing the leadlet out of the delivery device, wherein rotation of the leadlet mover results in counter-rotating of the leadlet around the leadlet mover to a counter rotated state; and(e) releasing the leadlet from the counter-rotated state to cause the fixation device of the leadlet to rotate and engage the fixation device of the leadlet with cardiac tissue.2. The method of wherein the leadlet comprises a proximal end and a distal end claim 1 , the proximal end comprising a leadlet body and a distal end ...

LANCET NEEDLE WITH ALIGNMENT AND RETENTION NOTCH

A lancet needle with an alignment and engagement notch, with material of the lancet body extending into the notch to more securely retain the needle to the lancet body, whereby a shorter needle can be utilized than with typical lancets. The notch optionally also provides a registration point for rotational and/or axial alignment of the needle during overmolding to form the lancet body, for example to maintain consistent positioning of the needle's beveled point. 1. A lancet comprising:{'sub': 'B', 'a lancet body having a length Land comprising a head portion and a body portion;'}{'sub': N', 'B', 'M', 'B, 'a lancing needle having a length Lno more than 75% the lancing body length Land comprising an elongate needle body, an embedded portion having length Lno more than 50% the lancet body length L, a sharp tip exposed from the head portion of the lancet body opposite the body portion, and a notch, wherein the embedded portion is embedded within the lancet body;'}wherein the notch is formed at least partially on the embedded portion; andwherein the sharp tip is formed on an end of the elongate needle body opposite the embedded portion.2. The lancet of claim 1 , wherein the head portion is positioned at a first end of the lancet body and the body portion extends perpendicularly from the center of the head portion towards a second end of the lancet body.3. The lancet of claim 2 , wherein the lancet head portion comprises a circular disk-like member and the lancet body portion comprises a generally oblong member having a first substantially flat side and a second substantially flat side opposite the first side.4. The lancet of claim 1 , wherein the needle body defines a thickness and the notch defines a notch depth of less than one-half the needle body thickness.5. The lancet of claim 1 , wherein the elongate needle body extends along a longitudinal axis.6. The lancet of claim 1 , wherein the notch defines a notch axis generally transverse to the longitudinal axis of the ...

LEAD IMPLANT FIXATION MECHANISM

A fixation mechanism of an implantable lead includes a plurality of depressions of an outermost surface of the lead and a relatively flexible sleeve mounted around the outermost surface. The depressions are spaced apart from one another along a length, and each extends circumferentially, wherein a longitudinal center-to-center spacing between each adjacent depression is uniform along the length, and each depression is of substantially the same size. The sleeve has an internal surface in sliding engagement with the outermost surface of the lead, and an external surface, in which suture grooves are formed. A longitudinal center-to-center spacing between adjacent suture grooves may be substantially the same as, or a multiple of, the longitudinal center-to-center spacing between adjacent depressions of the outermost surface of the lead. The sleeve may also include a ridge protruding from the internal surface, aligned with, or offset (by center-to-center spacing of depressions) from, the grooves. 1. An implantable medical electrical lead comprising:a connector;an electrode;an elongate insulation body extending between the connector and the electrode;an elongate conductor extending within the insulation body and coupling the electrode to the connector; and an outermost surface of the lead overlaying the insulation body, the outermost surface including a plurality of depressions spaced apart from one another along a length of the body, each depression extending circumferentially around the body; and', 'a relatively flexible sleeve mounted around the outermost surface of the lead, the sleeve comprising an internal surface, an external surface, and at least two suture grooves formed in the external surface and extending around a circumference thereof, the internal surface being in sliding engagement with the outermost surface of the lead, and a longitudinal center-to-center spacing between adjacent suture grooves being substantially the same as, or a multiple of, a ...

IMPLANTABLE MEDICAL DEVICES, SYSTEMS AND COMPONENTS THEREOF

An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation. 1. An implantable medical system comprising:an implantable stimulation device; and an elongate insulative body including a proximal segment, a distal segment, and a pre-formed bend extending therebetween,', 'a stimulation electrode circuit,', 'at least one sense electrode circuit, the stimulation and sense electrode circuits being supported by the insulative body, the distal segment of the insulative body having electrodes of the stimulation electrode circuit and the at least one sense electrode circuit mounted thereabout, and', 'a non-conductive filament including a plurality of fixation projections and extending along a length of an outer surface of the pre-formed bend and distal segment of the insulative body, the filament being wound about all or a portion of the length with an open pitch and being secured to the outer surface such that the projections thereof protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface., 'an implantable stimulation lead, the device and lead being adapted for coupling to one ...

IMPLANTABLE MEDICAL ELECTRICAL LEAD CONDUCTORS AND CONSTRUCTION METHODS

A coiled continuous conductor wire of an implantable medical electrical lead includes a first, electrode length and a second, insulated length, wherein the insulated length of the wire has a radial cross-section defined by a round profile, while the electrode length of the wire has a radial cross-section defined by a flattened profile, a long axis edge of which defines an outer diameter surface of the electrode length. The radial cross-section profile, along the electrode length of wire, is preferably flattened after an entire length of the wire has been coiled. 1. An implantable medical electrical lead comprising a continuous conductor wire wound in a coil , the conductor wire comprising an insulated length , extending distally from a connector terminal of the lead , and an electrode length , extending distally from the insulated length , and wherein the improvement comprises: the insulated length of the wire having a radial cross-section defined by a round profile , while the electrode length of the wire having a radial cross-section defined by a flattened profile , the flattened profile having a long axis and a short axis , and an outer diameter surface of the electrode length being defined by a long axis edge of the flattened profile.2. The lead of claim 1 , wherein the conductor wire is formed of Ta claim 1 , and the electrode length of the wire includes a native pentoxide coating extending over a portion of the outer diameter surface thereof.3. The lead of claim 1 , wherein the electrode length of the conductor wire includes a coating extending over all or a portion of the outer diameter surface thereof claim 1 , the coating being one of: a TiN coating and a Pt coating.4. The lead of claim 1 , wherein the conductor wire is formed of Pt/IR cladded Ta.5. The lead of claim 1 , wherein the coil includes a distal end located in proximity to the electrode length of the conductor wire; and further comprising a conductive ring coupled to the distal end.6. The lead of ...

IMPLANTABLE MEDICAL DEVICES, SYSTEMS AND COMPONENTS THEREOF

An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation. 1. A device comprising:an elongate body configured to be inserted in a patient, the elongate body defining an outer surface, and the elongate body comprising an open-work member that defines at least a first portion of a length of the outer surface of the elongate body; anda filament, including a plurality of fixation projections protruding from the filament and configured to engage tissue of the patient, the filament extending along a second portion of the length of the outer surface of the elongate body and being interlaced with the open-work member, wherein the fixation projections are spaced apart from one another along the second portion of the length of the outer surface.2. The device of claim 1 , wherein the fixation projections protrude outward from the outer surface.3. The device of claim 1 , wherein the first portion of the length and the second portion of the length are coextensive.4. The device of claim 1 , wherein:the filament comprises a first filament, the plurality of fixation projections comprises a first plurality of fixation projections, and the ...

LANCET NEEDLE WITH ALIGNMENT AND RETENTION NOTCH

A lancet needle with an alignment and engagement notch, with material of the lancet body extending into the notch to more securely retain the needle to the lancet body, whereby a shorter needle can be utilized than with typical lancets. The notch optionally also provides a registration point for rotational and/or axial alignment of the needle during overmolding to form the lancet body, for example to maintain consistent positioning of the needle's beveled point. 1. A lancing needle for a lancet comprising:a generally elongate body extending along a longitudinal axis from a first end to a second end;a sharp tip formed on at least one end of the body; anda notch formed on at least a portion of the body between the first end and the second end.2. The lancing needle of claim 1 , wherein the needle body defines a thickness and the notch defines a notch depth of less than one-half the needle body thickness.3. The lancing needle of claim 1 , wherein the notch defines a notch axis generally transverse to a longitudinal axis of the elongate needle body.4. The lancing needle of claim 1 , wherein the sharp tip comprises a bevel.5. The lancing needle of claim 4 , wherein a specified registration is maintained between the notch and the bevel.6. A lancet comprising:a lancet body comprising a first end and a second end;a lancet needle comprising a needle body having a sharp lancing tip and a notch, the sharp lancing tip projecting from the first end of the lancet body, and the notch formed on the needle body and engaged with a portion of the lancet body between the first and second end thereof.7. The lancet of claim 6 , wherein the lancet needle has an overall needle length L claim 6 , of which an embedded length Lportion is embedded within the lancet body claim 6 , and an extended length portion Lof the lancet needle extends beyond the first end of the lancet body claim 6 , and wherein the overall needle length Lis no more than about 75% the length Lof the lancet body.8. The ...

Intra-mold sterilization of plastic-embedded needle

Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds.

INTERVENTIONAL MEDICAL SYSTEMS AND ASSOCIATED ASSEMBLIES

A tethering assembly for securing a medical device includes a shaft and a wire that extends in sliding engagement within a proximal lumen, a channel, and a distal receptacle of the shaft. A retainer zone of the shaft, through which the channel extends, stops a transition segment of the wire, which extends between a proximal and a distal segment of the wire, from moving into the shaft receptacle, thereby restraining a distal-most tip of the wire from moving through a distal-most opening of the receptacle. When a projecting member of the device has entered a secure zone of the receptacle, via movement through the distal-most opening and a tapering passageway thereof, the distal-most tip of the wire, which may be spring-biased, can move distally into the passageway so that the tip blocks the projecting member from moving distally, back through the passageway. 1. A tethering assembly for an implantable medical device , the tethering assembly comprising:a shaft that extends longitudinally between a distal end and a proximal end;an attachment component coupled to the distal end of the shaft, the attachment component defining a receptacle for receiving an attachment member of the implantable medical device, the attachment component having a passageway that provides access to the receptacle and that is narrower than the receptacle; anda wire extending in sliding engagement within the shaft between a first position in which a distal most tip of the wire extends into the passageway of the receptacle thereby narrowing the passageway and a second position in which the distal most tip retracts into the receptacle, the wire being moveable from the first position to the second position and from the second position to the first position.2. The tethering assembly of claim 1 , wherein shaft is composed of a flexible material that transfers torque applied at the proximal end of the shaft to the attachment component coupled to the distal end of the shaft.3. The tethering assembly of ...

MEDICAL DEVICE RETRIEVAL WITH MULTIPLE SNARES

An improved assembly for securing an implantable medical device for retrieval from an implant site includes a plurality of snares, wherein distal openings of a first snare carrier lumen and a second snare carrier lumen have a pre-set offset established therebetween. First and second snare shafts, to which first and second snare loops are coupled, respectively, extend within the corresponding snare carrier lumens such that each loop is located in proximity to the corresponding distal opening of the lumen. The pre-set offset allows an operator to simultaneously position the snare loops around the device; and, when the operator retracts the snare shafts to collapse the snare loops until the loops fit snuggly around the device, the pre-set offset can help to align the device for retrieval. 1. An assembly for retrieving an implantable medical device from an implant site , the assembly comprising:a first snare comprising a first carrier, a first loop that is collapsible from a maximum size to a minimum size, and a first shaft, wherein the first loop is connected to a distal end of the first shaft and extends out of a distal end of the first carrier;a second snare comprising a second carrier, a second loop that is collapsible from a maximum size to a minimum size, and a second shaft, wherein the second loop is connected to a distal end of the second shaft and extends out of a distal end of the second carrier;a support tube that surrounds at least a portion of the first carrier and the second carrier, wherein at least one of the first carrier and the second carrier are in sliding engagement with the support tube, and wherein the support tube provides a friction fit between the first carrier and the second carrier.2. The assembly of claim 1 , wherein the support tube comprises a single lumen that surrounds the first carrier and the second carrier.3. The assembly of claim 1 , wherein the support tube comprises a first lumen that surrounds the first carrier and a second lumen ...

IMPLANTABLE MEDICAL DEVICES, SYSTEMS AND COMPONENTS THEREOF

An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation. 1. An implantable medical therapy delivery device comprising:an elongate insulative body having an outer surface; anda non-conductive filament extending along a length of the outer surface of the insulative body, the filament including a plurality of fixation projections, the filament being secured to the outer surface of the body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface.2. The device of claim 1 , wherein the insulative body comprises an open-work member forming at least a portion of the length of the outer surface along which the filament extends claim 1 , the non-conductive filament being interlaced with the open-work member.3. The device of claim 2 , wherein the non-conductive filament comprises a bioabsorbable material.4. The device of claim 2 , wherein the insulative body includes a pre-formed bend claim 2 , the bend coinciding with the open-work member.5. The device of claim 2 , wherein the open-work member forms an entirety of the length of the outer surface of ...

FAULT TOLERANT IMPLANTABLE MEDICAL SYSTEM

The disclosure describes implantable medical systems that respond to occurrence of a lead-related condition by utilizing an elongated coil electrode in defining an alternative pacing therapy vector to maintain optimal drain of an IMD power supply. An exemplary system includes a medical electrical lead having an elongated electrode and an improved sensing and therapy delivery circuitry to provide the alternative pacing therapy vector responsive to the lead-related conditions. The system reconfigures the operation of the sensing and therapy delivery circuitry triggered by the switch to the alternative pacing therapy vector. 1. An implantable medical system , comprising:an implantable medical device; and a first electrode; and', 'wherein the implantable medical device delivers therapy through the first electrode and reconfigures the therapy for delivery through the second section of the alternate electrode in response to detecting a lead-related condition.', 'an alternate electrode having a first section and a second section,'}], 'a medical electrical lead system coupled to the implantable medical device, including2. The implantable medical system of claim 1 , wherein the first section is a proximal portion and the second section is a distal portion.3. The implantable medical system of claim 1 , wherein the second section comprises a first plurality of segments interspersed between the first section.4. The implantable medical system of claim 1 , further comprising:a sensing circuit; andan oversense reduction circuit coupled to the sensing circuit, wherein the oversense reduction circuit analyzes a composite signal detected through the second vector.5. The implantable medical system of claim 1 , wherein reconfiguring the therapy to be delivered by the implantable medical device comprises configuring the alternate electrode as a cathode.6. The implantable medical system of claim 1 , wherein reconfiguring the therapy to be delivered by the implantable medical device ...

EXTRAVASCULAR IMPLANTABLE ELECTRICAL LEAD HAVING UNDULATING CONFIGURATION

This disclosure describes an implantable medical electrical lead and an ICD system utilizing the lead. The lead includes a lead body defining a proximal end and a distal portion, wherein at least a part of the distal portion of the lead body defines an undulating configuration. The lead includes a defibrillation electrode that includes a plurality of defibrillation electrode segments disposed along the undulating configuration spaced apart from one another by a distance. The lead also includes at least one electrode disposed between adjacent sections of the plurality of defibrillation sections. The at least one electrode is configured to deliver a pacing pulse to the heart and/or sense cardiac electrical activity of the heart. 1. An implantable medical electrical lead , comprisinga lead body defining a proximal end and a distal portion, wherein at least a part of the distal portion of the lead body defines an undulating configuration;a defibrillation electrode that includes a plurality of defibrillation electrode segments disposed along the undulating configuration spaced apart from one another by a distance; andat least one electrode disposed between adjacent segments of the plurality of defibrillation segments, the at least one electrode configured to, at least one of, deliver a pacing pulse to the heart and sense cardiac electrical activity of the heart.2. The lead of claim 1 , wherein the plurality of defibrillation electrode segments are disposed along at least 80% of undulating configuration.3. The lead of claim 1 , wherein the plurality of defibrillation electrode segments are disposed along at least 90% of undulating configuration.4. The lead of claim 1 , wherein the undulating configuration includes a plurality of peaks claim 1 , a first portion of the plurality of peaks extending in a first direction away from a major longitudinal axis of the lead and a second portion of the plurality of peaks extending in a second claim 1 , opposite direction away from ...

LEAD IMPLANT FIXATION MECHANISM

A fixation mechanism of an implantable lead includes a plurality of depressions of an outermost surface of the lead and a relatively flexible sleeve mounted around the outermost surface. The depressions are spaced apart from one another along a length, and each extends circumferentially, wherein a longitudinal center-to-center spacing between each adjacent depression is uniform along the length, and each depression is of substantially the same size. The sleeve has an internal surface in sliding engagement with the outermost surface of the lead, and an external surface, in which suture grooves are formed. A longitudinal center-to-center spacing between adjacent suture grooves may be substantially the same as, or a multiple of, the longitudinal center-to-center spacing between adjacent depressions of the outermost surface of the lead. The sleeve may also include a ridge protruding from the internal surface, aligned with, or offset (by center-to-center spacing of depressions) from, the grooves. 1. An implantable medical electrical lead comprising:a connector;an electrode;an elongate insulation body extending between the connector and the electrode;an elongate conductor extending within the insulation body and coupling the electrode to the connector; and an outermost surface of the lead overlaying the insulation body, the outermost surface including a plurality of depressions spaced apart from one another along a length of the body, each depression extending circumferentially around the body; and', 'a relatively flexible sleeve mounted around the outermost surface of the lead, the sleeve comprising an internal surface, an external surface, and at least two suture grooves formed in the external surface and extending around a circumference thereof, the internal surface being in sliding engagement with the outermost surface of the lead, and a longitudinal center-to-center spacing between adjacent suture grooves being substantially the same as, or a multiple of, a ...

MEDICAL ELECTRICAL LEAD JOINTS AND METHODS OF MANUFACTURE

A joint between an insulative sidewall of a medical electrical lead subassembly and an underlying fluoropolymer layer includes an interfacial layer. A first section of the interfacial layer is bonded to the fluoropolymer layer and is formed by a thermoplastic fluoropolymer; a second section of the interfacial layer extends adjacent the first section and is bonded to the insulative sidewall. The insulative sidewall, of the subassembly, and the second section, of the interfacial layer, are each formed from a material that is not a fluoropolymer. A recess is formed in the first section of the interfacial layer and the second section of the interfacial layer extends within the recess. 1. A method for manufacturing a joint in a medical electrical lead , the joint being between an inner surface of an insulative sidewall of the lead and an outer surface of a tubular fluoropolymer layer , the method comprising:thermally bonding a thermoplastic fluoropolymer layer to the outer surface of the fluoropolymer layer, and providing the thermoplastic fluoropolymer layer an outer surface of the thermoplastic fluoropolymer layer with a recess formed therein;assembling a layer of another material into the recess formed in the outer surface of the thermoplastic fluoropolymer layer;thereafter adhesively bonding the other material layer in the recess formed in the outer surface of the thermoplastic fluoropolymer layer to the inner surface of the insulative sidewall of the subassembly;wherein the other material layer and the insulative sidewall of the subassembly are each formed from a material that does not comprise a fluoropolymer.2. The method of claim 1 , wherein the recess formed within the thermoplastic fluoropolymer layer extends circumferentially around the thermoplastic layer.3. The method of wherein the recess formed within the thermoplastic fluoropolymer layer comprises a groove.4. The method of wherein the recess formed within the thermoplastic fluoropolymer layer comprises a ...

SECURING AN IMPLANTABLE MEDICAL DEVICE IN POSITION WHILE REDUCING PERFORATIONS

Methods and systems of making a medical electrical lead type having a set of tines. A system for implantation of a lead medical electrical lead in contact with heart tissue, comprises an elongated lead body; a set of curved tines mounted to and extending from a distal end of the lead body, the tines having a length (dD) and an effective cross sectional area, and a delivery catheter. The delivery catheter encloses the lead body and has a distal capsule portion enclosing the tines. The tines exerting a spring force against the capsule and provide a stored potential energy. The delivery catheter has an elastic, not stiff and low column strength ejection means for advancing the lead and tines distally from the capsule and fixating the tines within the heart tissue, the controllable and the stored potential energy of the tines together provide a deployment energy. The tines when so fixated in the tissue provide a fixation energy. The deployment energy and the fixation energy of the tines are equivalent. 1. A system for implantation of a lead medical electrical lead in contact with heart tissue , comprising:an elongated lead body;a set of curved tines mounted to and extending from a distal end of the lead body, the tines having a length (dD) and an effective cross sectional area;a delivery catheter, enclosing the lead body and having a distal capsule portion enclosing the tines, the tines exerting a spring force against the capsule and providing a stored potential energy, the delivery catheter having an ejection means for advancing the lead and tines distally from the capsule and fixating the tines within the heart tissue, the ejection means and the stored potential energy of the tines together providing a deployment energy, the tines when so fixated in the tissue providing a fixation energy; andwherein the deployment energy and the fixation energy are equivalent.2. A system as in claim 1 , wherein the deployment energy provides a provides a maximum peak force of ...

EXTRAVASCULAR LEAD DESIGNS FOR OPTIMIZED PACING AND SENSING HAVING SEGMENTED, PARTIALLY ELECTRICALLY INSULATED DEFIBRILLATION COILS

A lead body having a defibrillation electrode positioned along a distal portion of the lead body is described. The defibrillation electrode includes a plurality of electrode segments spaced a distance apart from each other. At least one of the plurality of defibrillation electrode segments includes at least one coated portion and at least one uncoated portion. The at least one coated portion is coated with an electrically insulating material configured to prevent transmission of a low voltage signal (e.g., a pacing pulse) while allowing transmission of a high voltage signal (e.g., a cardioversion defibrillation shock). The at least one uncoated portion is configured to transmit both low voltage and high voltage signals. The lead may also include one or more discrete electrodes proximal, distal or between the defibrillation electrode segments. 1. An implantable medical electrical lead comprising:an elongate lead body having a proximal end and a distal portion; [ attenuate transmission of a pacing pulse to a heart of a patient; and', 'allow transmission of a defibrillation shock to the heart of the patient; and, 'a first segment comprising at least one coated portion which is coated with an electrically insulating material configured to, at least one coated portion which is coated with the electrically insulating material; and', transmit a pacing pulse to the heart of the patient; or', 'sense electrical activity of the heart; and, 'at least one uncoated portion configured to perform any one or more of], 'a second segment which is separated from the first segment by a distance, wherein the second segment comprises], 'a first electrode on the distal portion of the elongate lead body, wherein the first electrode comprises deliver one or more pacing pulses the heart; or', 'sense the electrical activity of the heart., 'a second electrode on the distal portion of the lead body, wherein the second electrode is configured to perform one or both of2. The lead of claim 1 , ...

INTRA-MOLD STERILIZATION OF PLASTIC-EMBEDDED NEEDLE

Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds. 1. A method for manufacturing a sterile lancet comprising:retaining a lancet needle within a mold cavity of a mold;injecting plastic to form a lancet body substantially encapsulating the needle therein; andmaintaining a specified minimum mold temperature for a specified minimum cycle time effective to sterilize the lancet needle.2. The method of claim 1 , wherein the lancet further comprises a removable endcap detachably secured to the plastic lancet body and covering a sharp tip of the needle.3. The method of claim 1 , wherein the specified minimum temperature is at least about 370° Fahrenheit.4. The method of claim 1 , wherein the specified minimum time is at least about 10 seconds.5. The method of claim 1 , wherein the specified minimum mold temperature is maintained by a heating element at least partially embedded in the mold and adjacent the mold cavity.6. The method of claim 5 , wherein the heating element is embedded completely within the mold and does not interfere with the mold cavity.7. A lancet comprising a needle having a sharp tip and a plastic lancet body claim 5 , wherein the needle is at least partially embedded in the plastic lancet body claim 5 , and wherein at least the sharp tip of the needle is sterilized during manufacture by molding the plastic lancet body around the needle in a mold and maintaining a specified minimum mold temperature for a specified minimum cycle time effective to sterilize the sharp tip of the needle.8. A ...

MEDICAL LEAD SYSTEM

A medical lead system including an elongated lead body configured to extend through vasculature of a patient. The lead body mechanically supports a fixation member extending distal to a distal end of the lead body. A balloon is affixed to a distal portion of the lead body. The balloon is configured to inflate to extend distal to the distal end of the lead body. The fixation member is configured to extend within a distal cavity defined by the inflated balloon. The medical lead system is configured such that an electrode mechanically supported by the fixation member may electrically communicate with tissue of the patient when the balloon is in the inflated configuration. 1. A medical lead system comprising:an elongated lead body including a distal end, wherein the lead body is configured to extend through vasculature of a patient;a fixation member configured to extend distal to the distal end; anda balloon affixed to an exterior surface of the lead body and defining a deflated configuration and an inflated configuration,wherein the balloon is configured to expand radially outward from the exterior surface and extend distally beyond the distal end of the lead body when the balloon inflates from the deflated configuration to the inflated configuration,wherein a portion of an outer surface of the balloon is configured to define a distal cavity surrounding at least some portion of the fixation member when the balloon expands radially outward, andwherein the portion of the outer surface is configured to flare radially away from the fixation member as the portion of the outer surface extends distally beyond the distal end of the lead body.2. The medical lead system of claim 1 , wherein the fixation member is configured to extend distal to the balloon when the balloon is in the inflated configuration.3. The medical lead system of claim 1 , wherein the balloon is configured to extend distal to the fixation member when the balloon is in the inflated configuration.4. The ...

Method for manufacturing fiber optic sensors

A method is provided-for manufacturing a fiber optic sensor for detecting or measuring a parameter of interest in a sample fluid, including pH, concentration of dissolved gases such as O 2 or CO 2 , and the like. The sensing chemistry is affixed to the distal end of an elongated optical fiber by way of an adhesive layer typically comprised of an acrylic adhesive composition. Novel optical sensors, fabricated using the aforementioned method, are provided as well.

Magnetic resonance imaging compatible medical electrical lead and method of making the same

This disclosure describes an implantable medical lead, and method of making such a lead or components of the lead, that reduces the undesirable effects the fields generated by an MRI device may have on the implantable medical lead and the implantable medical device. The implantable medical lead includes an RF filter placed in series with an electrical path to an electrode of the lead. In one example, the RF filter may comprise a conductor wound in such a manner that it provides an inductance and capacitance that provides the RF filter with a resonant frequency, and in some instances, multiple resonant frequencies. At frequencies around the resonant frequency of the RF filter, the RF filter presents a high impedance, thereby blocking the signal from or at least attenuating the signal propagating to the electrode. At frequencies far from the resonant frequency, the RF filter presents a low impedance.

Interventional medical systems

An implantable medical device includes ventricular and atrial portions, and a flexible leadlet that extends therebetween. An open channel of the atrial portion, formed along a core thereof, is sized to receive the leadlet therein, when the leadlet is folded over on itself. An interventional medical system includes the device and a delivery tool; a tubular sidewall of the tool defines a lumen and has a tether extending therein. A slot formed in the sidewall extends proximally from an open end thereof, coincident with a distal opening of the lumen. When the atrial portion is contained within the lumen, a segment of the leadlet extends alongside the atrial portion; another segment of the leadlet, being folded over on itself, proximal to the atrial portion, has the tether engaged therewith. The slot may allow passage of the leadlet therethrough, when the atrial portion is positioned for deployment through the distal opening.

Impedance-based verification for delivery of implantable medical devices

A device for delivering an implantable medical device (IMD) includes an elongated member and a deployment bay configured to house the IMD, the deployment bay defining a distal opening for deploying the IMD out of the deployment bay. The device includes a first electrode located inside the deployment bay during intravascular navigation, a second electrode, and impedance detection circuitry configured to deliver an electrical signal to a path between the first electrode and the second electrode through at least one of a fluid or tissue of the patient. The device also includes processing circuitry configured to determine an impedance of the path based on the signal and control a user interface to indicate when an impedance of the path indicates that at least one of the IMD or the distal opening is in a fixation configuration relative to the target site of the patient.

Arrangement for implanting a miniaturized cardiac lead having a fixation helix

An introducer system and method for positioning and fixedly engaging a lead at an implantation site that includes a torque transfer sheath, extending from a proximal end to a distal end, receiving the lead, an outer sheath, having a distal end, receiving the lead positioned within the torque transfer sheath, and a handle operable between a first position enabling advancement and retraction of the lead through the handle and a second position fixedly engaging a proximal end of the lead within the handle. The lead is advanced through the outer sheath to extend outward a predetermined distance from the distal end of the outer sheath and the fixation helix is rotated through the predetermined distance to be fixedly engaged at the implantation site in response to simultaneous rotation and advancement of the lead and the torque transfer sheath through rotation and advancement of the handle in the second position.

Implantable medical devices, systems and components thereof

An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation.

Implantable medical devices, systems and components thereof

An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation.

Implantable medical devices, systems and components thereof

An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation.

Forming conductive couplings in medical electrical leads

An inner surface of a coupling component sidewall forms first and second portions of a cavity of the coupling component. A conductive coupling between an electrode and a conductor of a medical electrical lead may be formed by inserting a segment of the conductor into the first portion of the cavity, crimping the sidewall of the coupling component around the inserted segment, inserting a segment of the electrode into the second portion of the cavity, and welding an edge of the sidewall to the inserted electrode segment. The edge of the sidewall may define a slot, extending between first and second portions of the cavity, or a hole extending through the sidewall. The electrode may be part of an electrode assembly, mounted around an inner insulation layer of the lead, and the conductor may be part of a conductor assembly extending between inner and outer insulation layers of the lead.

Extravascular implantable electrical lead having undulating configuration

This disclosure describes an implantable medical electrical lead and an ICD system utilizing the lead. The lead includes a lead body defining a proximal end and a distal portion, wherein at least a part of the distal portion of the lead body defines an undulating configuration. The lead includes a defibrillation electrode that includes a plurality of defibrillation electrode segments disposed along the undulating configuration spaced apart from one another by a distance. The lead also includes at least one electrode disposed between adjacent sections of the plurality of defibrillation sections. The at least one electrode is configured to deliver a pacing pulse to the heart and/or sense cardiac electrical activity of the heart.

Medical electrical leads and conductor assemblies thereof

A conductor assembly for a medical electrical lead includes a web and plurality of conductors. The web includes a plurality of longitudinally extending elements, or sidewalls, each of which define a longitudinally extending lumen, and a plurality of longitudinally extending connectors, each of which join a pair of adjacent sidewalls. Each of the plurality of conductors extends within a corresponding lumen, and each may include an insulative jacket. If each conductor includes an insulative jacket, the jacket is preferably formed from one or more of the following materials: PEEK, PVDF and polysulfone. One or more of the connectors of the web may be flexible to allow for a connected separation, or a gap between adjacent sidewalls; and one or more of these connectors may further include a discrete wall section adapted to facilitate widening of the corresponding gap. Preferably the conductor assembly is coiled for incorporation into the lead.

Lancet needle with alignment and retention notch

A lancet needle (10) with an alignment and engagement notch (30), with material of the lancet body extending into the notch to more securely retain the needle to the lancet body, whereby a shorter needle can be utilized than with typical lancets. The notch optionally also provides a registration point for rotational and/or axial alignment of the needle during overmolding to form the lancet body, for example to maintain consistent positioning of the needle's beveled point.

Interventional medical systems

An implantable medical device includes ventricular and atrial portions, and a flexible leadlet that extends therebetween. An open channel of the atrial portion, formed along a core thereof, is sized to receive the leadlet therein, when the leadlet is folded over on itself. An interventional medical system includes the device and a delivery tool; a tubular sidewall of the tool defines a lumen and has a tether extending therein. A slot formed in the sidewall extends proximally from an open end thereof, coincident with a distal opening of the lumen. When the atrial portion is contained within the lumen, a segment of the leadlet extends alongside the atrial portion; another segment of the leadlet, being folded over on itself, proximal to the atrial portion, has the tether engaged therewith. The slot may allow passage of the leadlet therethrough, when the atrial portion is positioned for deployment through the distal opening.

Implantable medical devices, systems and components thereof

An implantable medical therapy delivery device includes a non-conductive filament extending along a length of an outer surface of an insulative body of the device, wherein the filament includes a plurality of fixation projections and is secured to the outer surface of the insulative body such that the projections protrude outward from the outer surface and are spaced apart from one another along the length of the outer surface. The filament may be wound about the length with an open pitch. In some cases, the insulative body includes an open-work member forming at least a portion of the outer surface thereof, and the filament may be interlaced with the open-work member. In these cases, the filament may be bioabsorbable, for example, to provide only acute fixation via the projections thereof, while the open-work member provides a structure for tissue ingrowth and, thus, more permanent or chronic fixation.

Method for manufacturing fiber optic sensors and novel sensors provided thereby

A method is provided for manufacturing a fiber optic sensor for detecting or measuring a parameter of interest in a sample fluid, including pH, concentration of dissolved gases such as O2 or CO2, and the like. The sensing chemistry (20) is affixed to the distal end of an elongated optical fiber device (10) by way of an adhesive layer (16) typically comprised of an acrylic adhesive composition. Novel optical sensors, fabricated using the aforementioned method, are provided as well.

Lancet needle with alignment and retention notch

A lancet needle (10) with an alignment and engagement notch (30), with material of the lancet body extending into the notch to more securely retain the needle to the lancet body, whereby a shorter needle can be utilized than with typical lancets. The notch optionally also provides a registration point for rotational and/or axial alignment of the needle during overmolding to form the lancet body, for example to maintain consistent positioning of the needle's beveled point.

Intra-mold sterilization of plastic-embedded needle

Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds.

Guide catheters for accessing cardiac sites

A method and apparatus for introducing a cardiac lead to an implantation site that includes a catheter body having an outer wall and a distal leader and having a proximal portion extending from the first proximal end to a second distal end. An inner member is positioned within an outer lumen of the catheter body and is spaced from the outer wall to form a first inner lumen for receiving a guide tool inserted therein and a second lumen for receiving the cardiac lead while the guide tool is positioned within the first inner lumen. A distal end of the inner member forms a first opening at a distal end of the first inner lumen and a second opening at a distal end of the second inner lumen, the first opening and the second opening positioned proximal the distal leader.

Implantable medical electrical lead conductors and construction methods

A coiled continuous conductor wire of an implantable medical electrical lead includes a first, electrode length and a second, insulated length, wherein the insulated length of the wire has a radial cross-section defined by a round profile, while the electrode length of the wire has a radial cross-section defined by a flattened profile, a long axis edge of which defines an outer diameter surface of the electrode length. The radial cross-section profile, along the electrode length of wire, is preferably flattened after an entire length of the wire has been coiled.

Medical device retrieval with multiple snares

DEVICE FOR IMPLANTING A MINIATURE HEADLINE WITH A SCREWING END

Method for manufacturing fiber optic sensors and novel sensors provided thereby

A method is provided for manufacturing a fiber optic sensor for detecting or measuring a parameter of interest in a sample fluid, including pH, concentration of dissolved gases such as O2 or CO2, and the like. The sensing chemistry (20) is affixed to the distal end of an elongated optical fiber device (10) by way of an adhesive layer (16) typically comprised of an acrylic adhesive composition. Novel optical sensors, fabricated using the aforementioned method, are provided as well.

Extravascular implant tools utilizing a bore-in mechanism and implant techniques using such tools

Extravascular implant tools that utilize a bore-in mechanism to safely access extravascular locations and implant techniques utilizing these tools are described. The bore-in mechanism may include a handle and a helix extending from the handle. The bore-in mechanism is used, for example, in conjunction with a tunneling tool to traverse the diaphragmatic attachments to access a substernal location. The tunneling tool may be an open channel tunneling tool or a conventional tunneling tool (e.g., metal rod).

Implantable medical devices, systems and components thereof

An implantable medical system comprising an implantable stimulation device; and an implantable stimulation lead (300, 400, 500), the device and lead being adapted for coupling to one another, the lead (300, 400, 500) comprising, an elongate insulative body (350, 450) including a proximal segment (353), a distal segment (351), and a pre-formed bend (352) extending therebetween, a stimulation electrode circuit, at least one sense electrode circuit, the stimulation and sense electrode circuits being supported by the insulative body (350), the distal segment (351) of the insulative body (350) having electrodes of the stimulation electrode circuit and the at least one sense electrode circuit mounted thereabout, and a non-conductive filament (200) including a plurality of fixation projections (205), wherein the filament, including the fixation projections (205), extends along a length of an outer surface of the pre-formed bend (352) and distal segment (351) of the insulative body, the filament (200) being wound about all or a portion of the length with an open pitch and being secured to the outer surface (355, 455) such that the projections (205) thereof protrude outward from the outer surface (355, 455) and are spaced apart from one another along the length of the outer surface (355, 455).

Assessing a lead based on high-frequency response

In general, this disclosure is directed to techniques and circuitry to determine characteristics of an implantable lead associated with an implantable medical device (IMD). The implantable lead may be designed to be MRI-safe by having one or more components that attenuate frequencies associated with an MRI that, if left unreduced, may interfere with the performance of the lead and/or cause harm to the tissue in which the lead is implanted. The circuitry may transmit a signal through the lead and receive a response signal. The device may determine the lead characteristics by comparing the transmitted signal with the received signal. In addition to determining whether the lead is MRI-safe, the techniques of this disclosure may be also utilized to determine whether the lead is faulty.

Implantable medical lead shield

An example medical device system includes an implantable medical lead including a first defibrillation electrode and a second defibrillation electrode, the first and second defibrillation electrodes configured to deliver antitachyarrhythmia shocks, and a pace electrode disposed between the first defibrillation electrode and the second defibrillation electrode, the pace electrode configured to deliver a pacing pulse that generates an electric field proximate to the pace electrode. The medical device system includes a shield configured to be implanted in a patient separately from the implantable medical lead and disposed anterior at least one of the electrodes, wherein the shield is configured to impede an electric field of the electrical therapy in a direction from at least one of the first defibrillation electrode, the second defibrillation electrode, or the pace electrode away from a heart of the patient.

Implantable medical electrical leads including coil electrodes

A medical electrical lead employing a conductive wire as an electrode and a method of its manufacture. The electrode includes a first length extending along a first, helical path, between a first end of the wire and a second length of the wire; the second length of the wire extends along a second path between the first length and a second end of the wire. A conductor of the lead may be mounted within the second length of the conductive wire, for coupling thereto, and a junction, preferably including a crimp and a weld, may be formed between the wire and the mounted conductor. Prior to coupling the conductor, the second length of the wire may extend at least 270 degrees and less than 360 degrees about an axis, which is offset from an axis of the first, helical path.

Intra-mold sterilization of plastic-embedded needle

Methods for intra-mold sterilization of a plastic-embedded metal component of a product, such as a medical lancet having a metal needle embedded within a plastic lancet body. For example, a lancet needle is retained within a mold, plastic is injected to encapsulate the needle, and a specified minimum temperature is maintained for a specified minimum cycle time. In example forms, the specified minimum mold temperature is at least about 370 degrees Fahrenheit and the specified minimum cycle time is at least about 10 seconds.

Parenteral fluid transfer apparatus

Interventional medical systems

Interventional medical systems

An implantable medical device includes ventricular and atrial portions, and a flexible leadlet that extends therebetween. An open channel of the atrial portion, formed along a core thereof, is sized to receive the leadlet therein, when the leadlet is folded over on itself. An interventional medical system includes the device and a delivery tool; a tubular sidewall of the tool defines a lumen and has a tether extending therein. A slot formed in the sidewall extends proximally from an open end thereof, coincident with a distal opening of the lumen. When the atrial portion is contained within the lumen, a segment of the leadlet extends alongside the atrial portion; another segment of the leadlet, being folded over on itself, proximal to the atrial portion, has the tether engaged therewith. The slot may allow passage of the leadlet therethrough, when the atrial portion is positioned for deployment through the distal opening.

Connector conditioning/bore plug

A bore plug for an implantable medical device. The bore plug includes an elongate body having a proximal portion, a distal portion, and defining a major longitudinal axis therethrough, the distal portion being sized and configured to be received within a bore of the implantable medical device. The distal portion includes a lubricating element configured to lubricate the bore when the distal portion is at least one from the group consisting of inserted within and withdrawn from the bore.

Open channel implant tools having an attachment feature and implant techniques utilizing such tools

Implant tools and techniques for implantation of a medical lead, catheter or other component are provided. The implant tools and techniques are particularly useful in implanting medical electrical leads in extravascular locations, including subcutaneous locations. An implant tool for implanting a medical lead may include a shaft having a proximal end, a distal end, an open channel that extends from near the proximal end to the distal end, and an attachment feature configured to couple to the medical lead. Such an implant tool provides a user with the versatility to use the same implant tool to either pull the lead through a tunnel formed via the implant tool or push the lead through the tunnel via the open channel in the implant tool.

Medical electrical lead with insert-molded electrode sub-assembly

A medical electrical lead that includes a lead body and at least one tubular electrode sub-assembly positioned over and attached to the external surface of the lead body. The lead body includes at least one elongated conductive element, such as a cable, that is electrically connected to a coiled electrode of the tubular electrode sub-assembly. The tubular electrode sub-assembly includes a tubular liner and an electrode embedded in the outer surface of the liner. In some embodiments, only a portion of the inner surface of the tubular liner is attached to the lead body which may potentially improve flexibility of the medical electrode lead in the area occupied by the tubular electrode sub-assembly.

Mr-compatible implantable medical lead

A medical electrical lead may include a lead body formed to define a first lumen extending from the proximal end to a location near the distal end and having a first central axis. The lead includes an electrode located near the distal end of the lead body and an energy dissipating structure located near the distal end of the lead body, the energy dissipating structure including a conductive main portion that defines a second lumen having a second central axis that is offset relative to the first central axis of the first lumen defined by the lead body and a conductive transition portion that extends towards the first lumen defined by the lead body. A conductor contacts the energy dissipating structure within the transition portion of the energy dissipating structure to provide a substantially continuous interference contact with the energy dissipating structure.

Medical lead system

A medical lead system including an elongated lead body configured to extend through vasculature of a patient. The lead body mechanically supports a fixation member extending distal to a distal end of the lead body. A balloon is affixed to a distal portion of the lead body. The balloon is configured to inflate to extend distal to the distal end of the lead body. The fixation member is configured to extend within a distal cavity defined by the inflated balloon. The medical lead system is configured such that an electrode mechanically supported by the fixation member may electrically communicate with tissue of the patient when the balloon is in the inflated configuration.

Trans-septal anchoring system and method

A pressure sensor, in one embodiment, is passed through the atrial septal wall. A plurality of anchors is disposed on each side of the septal wall and secure the position of the pressure sensor.

Medical electrical lead

A medical device lead is presented. One embodiment of the claimed invention includes a lead body, a conductor, and a flexible component. The lead body includes a proximal end and a distal end. The conductor is coupled to the lead body. A sleeve is coupled to the distal end of the lead body. The flexible component is coupled to the distal end of the sleeve. The distal end of the flexible component includes an outer diameter that is greater than the outer diameter of the proximal end.

Medical device retrieval with multiple snares

An improved assembly for securing an implantable medical device for retrieval from an implant site includes a plurality of snares, wherein distal openings of a first snare carrier lumen and a second snare carrier lumen have a pre-set offset established therebetween. First and second snare shafts, to which first and second snare loops are coupled, respectively, extend within the corresponding snare carrier lumens such that each loop is located in proximity to the corresponding distal opening of the lumen. The pre-set offset allows an operator to simultaneously position the snare loops around the device; and, when the operator retracts the snare shafts to collapse the snare loops until the loops fit snuggly around the device, the pre-set offset can help to align the device for retrieval.

Medical electrical leads and conductor assemblies thereof

A conductor assembly for a medical electrical lead includes a web and plurality of conductors. The web includes a plurality of longitudinally extending elements, or sidewalls, each of which define a longitudinally extending lumen, and a plurality of longitudinally extending connectors, each of which join a pair of adjacent sidewalls. Each of the plurality of conductors extends within a corresponding lumen, and each may include an insulative jacket. If each conductor includes an insulative jacket, the jacket is preferably formed from one or more of the following materials: PEEK, PVDF and polysulfone. One or more of the connectors of the web may be flexible to allow for a connected separation, or a gap between adjacent sidewalls; and one or more of these connectors may further include a discrete wall section adapted to facilitate widening of the corresponding gap. Preferably the conductor assembly is coiled for incorporation into the lead.

Medical electrical lead anchoring

A lead body of a medical electrical lead includes a distal end, a first elongated insulated conductor extending toward the distal end and a first electrode coupled to the conductor. A second elongated insulated conductor includes a first portion extending within the lead body to the distal end and a second portion extending distally from the distal end of the lead body where it is terminated by a tissue anchor on which a second electrode is mounted; the tissue anchor includes a surface for receiving a push force from an insertion tool, which is adapted to insert the anchor within a segment of tissue such that the first electrode of the lead body is in close proximity to the segment of tissue.

Integrated conductor coil electrode

An implantable medical lead includes a lead body extending from a proximal end to a distal end. The lead body includes an inner insulation layer and an outer insulation layer. The lead further includes a sleeve mechanically supported by the lead body at the distal end of the lead body. The lead further includes an uninsulated conductor coil. The uninsulated conductor coil includes a first portion having a first inner diameter, and a second portion having a second inner diameter and extending distally from the outer insulation layer. The first portion is positioned between the inner insulation layer and the outer insulation layer. The second inner diameter is greater than the first inner diameter. An outer surface of the second portion is exposed.

Integrated conductor coil electrode

An implantable medical lead includes a lead body extending from a proximal end to a distal end. The lead body includes an inner insulation layer and an outer insulation layer. The lead further includes a sleeve mechanically supported by the lead body at the distal end of the lead body. The lead further includes an uninsulated conductor coil. The uninsulated conductor coil includes a first portion having a first inner diameter, and a second portion having a second inner diameter and extending distally from the outer insulation layer. The first portion is positioned between the inner insulation layer and the outer insulation layer. The second inner diameter is greater than the first inner diameter. An outer surface of the second portion is exposed.

Interventional medical systems and associated assemblies

A tethering assembly for securing a medical device includes a shaft and a wire that extends in sliding engagement within a proximal lumen, a channel, and a distal receptacle of the shaft. A retainer zone of the shaft, through which the channel extends, stops a transition segment of the wire, which extends between a proximal and a distal segment of the wire, from moving into the shaft receptacle, thereby restraining a distal-most tip of the wire from moving through a distal-most opening of the receptacle. When a projecting member of the device has entered a secure zone of the receptacle, via movement through the distal-most opening and a tapering passageway thereof, the distal-most tip of the wire, which may be spring-biased, can move distally into the passageway so that the tip blocks the projecting member from moving distally, back through the passageway.

Temporary pacing lead management system with expandable member

This disclosure describes a system comprising an electrical lead, an implantable medical device, wherein the electrical lead is configured to be electrically connected to the implantable medical device, and wherein the implantable medical device is configured to deliver an electrical therapy to tissue of a patient via the electrical lead, and an expandable member configured to be disposed over the implantable medical device and an excess portion of the electrical lead. The expandable member comprises a first portion defining an inner volume configured to retain the implantable medical device and the excess portion of the electrical lead, and a second portion connected to a proximal end of the first portion, the second portion configured to be disposed over at least a part of the first portion of the expandable member, wherein the expandable member is configured to control a length of the electrical lead within vasculature of the patient..