Abstract: A nerve cover for covering a nerve within a living body tissue to protect the nerve includes a base of a flat plate shape, and a pair of covers protruding upward the base to form a hole for receiving a nerve, with one end attached to the base and the other end spaced apart from the one end, wherein when the base is bent in an arch shape when viewed from a side, a spacing between the pair of covers is expanded. In addition, an apparatus for insertion of an electrode structure includes a nerve cover fixing part which fixes the nerve cover with the base being bent, and an electrode structure fixing part in which the electrode structure is mounted, and which linearly moves the mounted electrode structure in an insertion direction to insert the electrode structure into the nerve surrounded by the nerve cover.

Abstract: A leafless biostimulator, such as a leadless pacemaker, includes a housing sized and configured to be implanted within a heart of a patient and includes both primary and secondary fixation features. The primary fixation feature is adapted to rotate to fix the leadless biostimulator to a wall of the heart during initial implantation. Once the leadless biostimulator is implanted, the secondary fixation feature is adapted to resist counter-rotation of the leadless biostimulator. The primary fixation feature may include a fixation helix configured to affix the housing to the heart by rotating in a screwing direction. The secondary fixation feature may include an apex to engage the heart to resist unscrewing of the primary fixation feature.

Abstract: Systems and methods for epicardial pacing are provided. For example, this document provides epicardial pacing using a percutaneously delivered bifurcated pacing lead that has multiple electrodes that are directionally insulated to prevent extracardiac stimulation, including prevention of phrenic stimulation. In addition, the devices, systems, and methods provided can be used for ablation, defibrillation, and/or defibrillation in combination with pacing.

Abstract: An implantable medical device assembly includes a mounting structure, an electrode, and fixation tines. The electrode protrudes from a surface of the structure, offset proximally from a distal end of the structure, and approximately centered between first and second sides of the structure. Each tine extends away from the surface—a first adjacent the first side, and a second adjacent the second side. Each tine is elastically deformable from a relaxed condition, in which the tine extends toward a proximal end of the structure, to an extended condition, in which the tine extends away from the distal end of the structure. A delivery tool has first and second longitudinally extending sidewalls to receive passage of the structure therebetween. When the structure distal end is located between proximal ends of the sidewalls, a rail-like edge of each sidewall receives, and elastically deforms to the extended condition, a corresponding tine.

Abstract: A cardiac pacing system that includes a pulse generator to generate therapeutic electrical pulses and at least one lead inserted through an intercostal space in the region of a cardiac notch of the left lung of a patient, the lead having a distal end configured to transmit the therapeutic electrical pulses generated by the pulse generator to pace the heart of the patient.

Abstract: Systems and methods for epicardial pacing are provided. For example, this document provides epicardial pacing using a percutaneously delivered bifurcated pacing lead that has multiple electrodes that are directionally insulated to prevent extracardiac stimulation, including prevention of phrenic stimulation. In addition, the devices, systems, and methods provided can be used for ablation, defibrillation, and/or defibrillation in combination with pacing.

Abstract: A cannula assembly, further comprising a cannula body for directing blood from the heart of a patient, having distal and proximal ends and a lumen therebetween. A tip coupled to the distal end of the body, the tip having an opening. A pump for drawing blood into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system. The lumen of the cannula body further comprises a first inner diameter at the proximal end and a second inner diameter at the distal end, the first inner diameter being larger than the second inner diameter. A tapered portion defined as a decrease in inner diameter from the first inner diameter to the second inner diameter between the proximal and distal ends, the tapered portion configured to prevent cavitation of the blood within the cannula.

Abstract: An epicardial lead is passively fixed in a pericardial space by a passive fixation member. The passive fixation member extends from a distal portion of an epicardial lead and acts against a pericardial layer and an epicardial layer to hold the lead in place. The epicardial lead may include an electrode that is connected to a conductor that extends from a distal portion of the lead. In some embodiments the epicardial lead includes a material that promotes fibrosis to fix the lead to heart tissue. The passive fixation member may include a shocking coil.

Abstract: The invention relates to an electrode assembly for temporary cardioversion/defibrillation and/or for temporary stimulation of the heart after open heart surgery consisting of two defibrillation electrodes with at least one indifferent pole each and an elastic section, where each defibrillation electrode in the operating position is positioned on the right and left atrium, which means the defibrillation electrodes together include the right and left atrium. The defibrillation electrodes each distally comprise a fixation member and each proximally end into a protective tube to protect the epicardium. The fixation members are elastic and enable reversible fastening of the defibrillation electrodes in the pericardium on the right and left side. The protective tubes are preferably fed together into a guide tube, where the guide tube is slidable along the longitudinal axis.

Abstract: A device comprising: a lead extending between a proximal end and a distal end, the lead comprising, at its distal end portion, an electrode element configured for fixing in a first body tissue, the lead further comprising: an anchoring element disposed between the proximal and the distal end for anchoring the device to a second tissue; and an elastic element disposed between the anchoring element and the distal end and configured so as to permit the pulling of the distal end away from the anchoring element against the biasing force of the elastic element.

Abstract: An apparatus including a pledget; and an anchor disposed through the pledget in a manner to form a loop over a surface of the pledget, wherein the anchor comprises electrically conductive material. A kit including a pledget; an anchor of an electrically conductive material including at least one end having a structure capable of puncturing myocardial tissue; and a heart wire. A method including placing an electrically conductive portion of a heart wire between a pledget and an anchor coupling the pledget to a heart of a patient; and establishing conductive contact between the anchor and the heart wire. An advantage of the apparatus and method is that an anchor may be placed in healthy myocardial tissue and a heart wire electrically connected to the anchor may be removed with minimal risk of bleeding.

Abstract: A cannula assembly, further comprising a cannula body for directing blood from the heart of a patient, having distal and proximal ends and a lumen therebetween. A tip coupled to the distal end of the body, the tip having an opening. A pump for drawing blood into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system. The lumen of the cannula body further comprises a first inner diameter at the proximal end and a second inner diameter at the distal end, the first inner diameter being larger than the second inner diameter. A tapered portion defined as a decrease in inner diameter from the first inner diameter to the second inner diameter between the proximal and distal ends, the tapered portion configured to prevent cavitation of the blood within the cannula.

Abstract: The invention provides an implantable multi-electrode device (300) and related methods and apparatuses. In one embodiment, the invention includes an implantable device (300) comprising: an assembly block (320); and a plurality of leads (340 . . . 348) radiating from the assembly block (320), each of the plurality of leads (340 . . . 348) containing at least one electrode (342A), such that the electrodes are distributed within a three-dimensional space, wherein the assembly block (320) includes a barb (350) for anchoring the assembly block (320) within implanted tissue.

Abstract: A leadless intra-cardiac medical device (LIMD) includes a housing configured to be implanted entirely within a single local chamber of the heart.

Abstract: A cannula assembly, further comprising a cannula body for directing blood from the heart of a patient, having distal and proximal ends and a lumen therebetween. A tip coupled to the distal end of the body, the tip having an opening. A pump for drawing blood into the cannula assembly and dispensing the blood from the cannula assembly and into the patient circulatory system. The lumen of the cannula body further comprises a first inner diameter at the proximal end and a second inner diameter at the distal end, the first inner diameter being larger than the second inner diameter. A tapered portion defined as a decrease in inner diameter from the first inner diameter to the second inner diameter between the proximal and distal ends, the tapered portion configured to prevent cavitation of the blood within the cannula.

Abstract: An implantable epicardial electrode assembly comprises electrode poles fixed on the heart having a large surface area and being multipolar and can at the same time be used as sensing and stimulating electrodes, wherein the electrode assembly has the shape of a tennis racket or is circular, elliptical, hexagonal, rectangular, oakleaf-shaped, star-shaped or cloverleaf-shaped and comprises at least two electrode poles which are arranged over a large surface area, and a further electrode arrangement which comprises at least one electrode pole and which is arranged between the large surface area electrode poles and further comprises a fixing element, wherein the defibrillation can take place between the mutually insulated poles of the electrodes, and wherein the stimulation of the heart can take place between one of the electrode poles and a pole of the electrode arrangement.

Abstract: An implantable lead having at least one electrode contact at or near its distal end prevents undesirable movement of the electrode contact from its initial implant location. One embodiment relates to a spinal cord stimulation (SCS) lead. A first injectable material is injected into the dura space to mechanically position the electrode array with respect to the spinal cord. Conjunctively for use with adhesives, or alternatively for use instead of the adhesives, a balloon may be positioned on the electrode lead array. The balloon is filled with air, liquid or a compliant material. When inflated, the balloon stabilizes the lead with respect to the spinal cord and holds the lead in place. An elastic aspect of the balloon serves as an internal contained relief valve to limit the pressure the balloon may place on the surrounding tissues when the epidural space is constrained.

Abstract: A medical device that includes a lead having a lead body extending from a proximal end to a distal end, and a housing having a connector block for receiving the proximal end of the lead body. A fixation mechanism is positioned proximal to an electrode coil located at the distal end of the lead body, and includes a locking sleeve and a mating portion positioned along the lead body proximal to the electrode. The fixation mechanism is capable of being advance from a first state corresponding to a first inner diameter of the locking sleeve and a second state corresponding to a second inner diameter of the locking sleeve greater than the first inner diameter to fixed position the electrode at a target site.

Abstract: This disclosure is directed to extra, intra, and transvascular medical lead placement techniques for arranging medical leads and electrical stimulation and/or sensing electrodes proximate nerve tissue within a patient.

Abstract: A medical fixation system for temporary fixation of an implantable medical device such as a short lead pacemaker outside of the heart in a larger blood vessel such as the superior or inferior vena cava. The fixation mechanism or element is temporary in nature in that the fixation holds the implantable medical device in place until the implantable medical device is grown in to the wall of the vessel and the short lead attached to the implantable medical device and implanted in the heart is grown in. The cell tissue surrounding the implantable medical device and the short lead then keeps the implantable medical device in place without the temporary fixation element.

Abstract: An anchor for an implantable medical device, anchor delivery tools, kits, and methods, all directed to securing a therapy delivery element at a target location in a patient. An anchor for a therapy delivery element having an outer surface about which the anchor is disposable. The anchor includes a body portion having elastomeric properties, a first opening, a second opening, and a non-linear lumen extending though the body portion from the first opening to the second opening in a relaxed state. The non-linear lumen becomes a linear lumen in a stretched state. The linear lumen of the body portion is adapted to receive the therapy delivery element and the non-linear lumen frictionally engages the outer surface of the therapy delivery element in the relaxed state.

Abstract: A lead anchor includes a body defining at least one first portion of a lead lumen, the body having a first opening and a second opening. An obstructing member is disposed within the body. The obstructing member defines a second portion of the lead lumen. A spring is disposed in the body and configured and arranged to operate on the obstructing member so that the second portion of the lead lumen is coterminous with the at least one first portion of the lead lumen and forms a continuous lead path when the spring is compressed and the second portion of the lead lumen is offset from the at least one first portion of the lead lumen when the spring is not compressed.

Abstract: A device comprising: a lead extending between a proximal end and a distal end, the lead comprising, at its distal end portion, an electrode element configured for fixing in a first body tissue, the lead further comprising: an anchoring element disposed between the proximal and the distal end for anchoring the device to a second tissue; and an elastic element disposed between the anchoring element and the distal end and configured so as to permit the pulling of the distal end away from the anchoring element against the biasing force of the elastic element.

Abstract: An implantable anchor for anchoring a lead or catheter relative to biological tissue, implantable system including such an anchor and a lead or catheter, and a method of use of such anchor. The anchor comprises a body having a channel adapted to receive a catheter or lead, and a cover mounted on the body for pivoting motion along a lateral axis, that is an axis that extends generally in the lateral direction perpendicular to the catheter or lead, between an open position in which the anchor is adapted to allow a lead or catheter to be placed in or moved along the channel, and a locked position in which the anchor is adapted to retain a lead or catheter within the channel.

Abstract: The intrapericardial lead includes a lead body having a proximal portion and a flexible, pre-curved distal end portion. The distal end portion carries at least one electrode assembly containing an electrode adapted to engage pericardial tissue. The distal end portion further carries a pre-curved flexible wire member having ends attached to spaced apart points along the distal end portion of the lead body, the flexible wire member having a normally expanded state wherein an intermediate portion of the wire member is spaced apart from the distal end portion, and a generally straightened state wherein the wire member and the distal end portion are disposed in a more parallel, adjacent relationship so as to present a small frontal area to facilitate delivery into the pericardial space. The wire member re-expands to its normal state after delivery into the pericardial space to anchor the distal end portion of the lead body relative to the pericardial tissue.

Abstract: A device comprises a medical implant and an actively deployable clip attached to the medical implant that operates to restrict movement of the medical implant once the actively deployable clip is deployed within a body of a patient. In some embodiments, the medical implant is an electrical lead for electrical stimulation. The actively deployable clip is operable to fixate the medical implant to a body tissue once deployed, such that the actively deployable clip performs a similar function to a suture. In this manner, embodiments of the invention may provide a medical implant that requires few or even no sutures to properly fixate the implant within the patient.

Abstract: A transseptal cannula assembly for directing blood from the heart of a patient and a minimally invasive method of implanting the same. The transseptal cannula assembly includes a flexible cannula body having proximal and distal portions with a lumen therebetween, a tip coupled to the distal portion of the flexible cannula body, and first and second anchors coupled to the tip. The anchors can be configured to be deployed from a contracted state to an expanded state and are configured to engage opposite sides of the heart tissue when in the expanded state. The anchors resist movement of the cannula assembly along a lengthwise central axis of the flexible cannula body.

Abstract: A medical pacing wire comprising a clamp that is adapted to be moved between an open position and a closed position and further adapted to allow a user to attach an electrode to a living tissue. In particular embodiments, the medical pacing wire may include a memory shape alloy having a memory state, which is adapted to cause the clamp to move from the closed position toward the open position when the memory shape alloy is caused to move from a non-memory state to the memory state. Also, in some embodiments, the clamp may comprise a superelastic material, and the medical pacing wire may be adapted to allow a user to remotely cause the clamp to substantially release the living tissue that has been closed within the clamp without substantially damaging the living tissue.

Abstract: A transseptal cannula assembly for directing blood from the heart of a patient and a minimally invasive method of implanting the same. The transseptal cannula assembly includes a flexible cannula body having proximal and distal portions with a lumen therebetween, a tip coupled to the distal portion of the flexible cannula body, and first and second anchors coupled to the tip. The anchors can be configured to be deployed from a contracted state to an expanded state and are configured to engage opposite sides of the heart tissue when in the expanded state. The anchors resist movement of the cannula assembly along a lengthwise central axis of the flexible cannula body.

Abstract: A lead system has an elongate body, an active fixation assembly movable relative to the elongate lead body, including a non-stationary electrode. The lead system further includes a non-stationary electrode member and an electrical interconnect electrically connected between the non-stationary electrode member and the stationary electrode member. The electrical interconnect provides a reliable electrical interconnection between the stationary electrode and the non-stationary electrode, while allowing the non-stationary electrode to move relative to the stationary electrode.

Abstract: Methods and devices for implanting pacing electrodes or other apparatus, or for delivering substances, to the heart of other tissues within the body. A guided tissue penetrating catheter is inserted into a body lumen (e.g., blood vessel) or into a body cavity or space (e.g., the pericardial space) and a penetrator is advanced from the catheter to a target location. In some embodiments, a substance or an apparatus (such as an electrode) may be delivered through a lumen in the penetrator. In other embodiments, a guidewire may be advanced through the penetrator, the penetrating catheter may then be removed and an apparatus (e.g., electrode) may then be advanced over that guidewire. Also disclosed are various implantable electrodes and electrode anchoring apparatus.

Abstract: Certain aspects of the disclosure pertain to methods and apparatus for providing positive fixation of medical components to a portion of incised pericardial tissue. Accordingly, a resilient member protrudes through an incision in the pericardium and produces a positive biasing force to adjacent pericardial tissue against a side surface of an attached body structure. The resilient member can optionally be compressed during implantation and then relaxed to thereafter provide the positive biasing force. Diverse medical components can thus be safely and reliably chronically deployed into the pericardial space, including without limitation, cardiac sensing/pacing, defibrillation and/or cardioversion electrodes, mechanical and/or metabolic sensors and the like. More than one body structure can be linked to a single medical electrical lead and the medical components can couple within and/or upon a portion of the body structure, the resilient member, and the lead in myriad configurations.

Abstract: A lead anchor includes a body defining at least one first portion of a lead lumen, the body having a first opening and a second opening. An obstructing member is disposed within the body. The obstructing member defines a second portion of the lead lumen. A spring is disposed in the body and configured and arranged to operate on the obstructing member so that the second portion of the lead lumen is coterminous with the at least one first portion of the lead lumen and forms a continuous lead path when the spring is compressed and the second portion of the lead lumen is offset from the at least one first portion of the lead lumen when the spring is not compressed.

Abstract: Gastric stimulation devices, systems and methods are provided, particularly for stimulating a gastric organ having an internal cavity. Such devices and systems are typically implanted outside of the gastric organ while the environment of the internal cavity is probed and monitored by one or more sensors. The sensor information may be used to affect the stimulation signals provided to the gastric organ by the devices and systems. Such feedback integration assists in providing treatments and stimulation programs that are tailored to the needs of the individual patient.

Abstract: The disclosure describes an implantable medical lead for delivering stimulation to a patient. Electrodes may be located on two or more surfaces of the lead to, for example, selectively deliver stimulation to one or more tissue layers within the patient. The lead may be implanted within or between intra-dermal, deep dermal, or subcutaneous tissue layers, and may be used to, for example, deliver peripheral nerve field stimulation to treat pain experienced by the patient at the site at which the lead is implanted. The lead may comprise a paddle lead or a multiple level lead, e.g., a lead having a plurality of flat or paddle shaped lead bodies arranged in substantially parallel planes. Further, the lead may include fixation structures on the distal end, proximal end, or both ends to prevent migration.

Abstract: An implantable medical lead is disclosed herein wherein the lead employs a helical distal tip anchor having improved fixation capabilities. The implantable medical lead may include a body and a helical anchor. The body may include a distal end and a proximal end. The helical anchor may be at least one of extending and extendable from the distal end. The helical anchor may include at least one loop including first and second straight sides that intersect at a first corner.

Abstract: A medical device that includes a lead having a lead body extending from a proximal end to a distal end, and a housing having a connector block for receiving the proximal end of the lead body. A fixation mechanism is positioned proximal to an electrode coil located at the distal end of the lead body, and a fixation member or a plurality of fixation members extend from the fixation mechanism from a fixation member proximal end to a fixation member distal end. The fixation members are advanceable from a first position corresponding to the fixation member distal end being positioned along the lead during subcutaneous placement of the lead, to a second position corresponding to the fixation member distal end being positioned away from the lead to fixedly engage the lead at a target site.

Abstract: Surgical systems, devices and methods including one or more tissue stimulation elements that, in some instances, may also be used for sensing purposes. Some of the surgical devices also include a tissue coagulation element.

Abstract: A medical stimulation lead is provided. The medical stimulation lead includes an elongated lead body including a substantially rounded cross-section and including a first biased portion forming a first section of the substantially rounded cross-section and a second biased portion forming a second section of the substantially rounded cross-section. A plurality of electrodes are provided connected to the elongated lead body. A restraining body is removably connected to the elongated lead body releasably exerting a force substantially counter to the biases of the first biased portion and the second biased portion. The retraining body releasably maintains the substantially rounded cross-section of the elongated lead body, wherein removal of the restraining body permits the first biased portion and the second biased portion to expand, dividing the substantially rounded cross-section.

Abstract: A medical electrical lead includes a glue segment to adhere the lead to a treatment site. The glue segment, which may be disposed within a tip electrode of the lead, includes tissue adhesive which may encapsulated within a capsule.

Abstract: A medical electrical lead adapted to stimulate a patient's cardiac plexus includes a flexible distal portion having a surface adapted to conform to an outer surface of an aortic region generally associated with the cardiac plexus. The distal portion can have one or more elongate members. Alternatively, the distal portion can have a generally planar portion. The distal portion is flexible such that it can be furled or otherwise compacted such that it can be delivered to a target stimulation site using a guide catheter or other delivery tool, such as a cannula.

Abstract: A coiled member of a medical device extends along a length of an elongate body of the device. A surface of the coiled member extends at an angle, with respect to a longitudinal axis of the body, from a first edge to a second edge, toward the proximal end of the body, such that the first edge of the surface is disposed in close proximity to the body and the second edge of the surface is spaced apart from the body.

Abstract: Minimally invasive introducers and methods that can be used for rotationally securing devices within the human body. Introducers can include a distal element for releasably engaging a lead head controllable from a proximal control located outside of the body. An inner stem can extend between a proximal portion and a distal portion, and be pivotally and rotatably coupled to the distal lead engagement mechanism. An outer tube can be rotatably disposed over the inner stem and be flexibly coupled over the pivot to rotationally drive the distal element. A helical epicardial-myocardial lead electrode can be secured and oriented straight ahead and introduced through a port or small incision with the introducer in a straight configuration. The introducer can then be bent and rotated to screw the helical electrode into the heart.

Abstract: An implantable anchor for anchoring a lead or catheter relative to biological tissue, implantable system including such an anchor and a lead or catheter, and a method of use of such anchor. The anchor comprises a body having a channel adapted to receive a catheter or lead, and a cover mounted on the body for pivoting motion along a lateral axis, that is an axis that extends generally in the lateral direction perpendicular to the catheter or lead, between an open position in which the anchor is adapted to allow a lead or catheter to be placed in or moved along the channel, and a locked position in which the anchor is adapted to retain a lead or catheter within the channel.

Abstract: An epicardial lead is passively fixed in a pericardial space by a passive fixation member. The passive fixation member extends from a distal portion of an epicardial lead and acts against a pericardial layer and an epicardial layer to hold the lead in place. The epicardial lead may include an electrode that is connected to a conductor that extends from a distal portion of the lead. In some embodiments the epicardial lead includes a material that promotes fibrosis to fix the lead to heart tissue. The passive fixation member may include a shocking coil.

Abstract: The intrapericardial lead includes a lead body having a proximal portion and a flexible, pre-curved distal end portion. The distal end portion carries at least one electrode assembly containing an electrode adapted to engage pericardial tissue. The distal end portion further carries a pre-curved flexible wire member having ends attached to spaced apart points along the distal end portion of the lead body, the flexible wire member having a normally expanded state wherein an intermediate portion of the wire member is spaced apart from the distal end portion, and a generally straightened state wherein the wire member and the distal end portion are disposed in a more parallel, adjacent relationship so as to present a small frontal area to facilitate delivery into the pericardial space. The wire member re-expands to its normal state after delivery into the percaridal space to anchor the distal end portion of the lead body relative to the pericardial tissue.

Abstract: Disclosed is a lead anchor comprising a body made of an elastomeric material and defining a first opening and a second opening through which a lead can pass, one or more fasteners disposed within the body, with the ends of the fasteners protruding from the body, wherein the ends are configured and arranged to be clamped down to secure a lead passing through the body.

Abstract: A method for detecting the myocardial state of a heart with a measuring apparatus which includes inserting a bipolar cardiological measuring electrode (4) into a heart division (8) at an acute attachment angle (9) on the myocardium (6) of less than 90°, measuring a cardiological stimulation signal such as an IEGM in sequential cardiac cycles, and in addition, determining the positive and negative maximum amplitudes Vp and Vn of the IEGM, ascertaining an asymmetry factor ? of the stimulation signal (IEGM) of sequential cardiac cycles according to the equation ?=(Vp?|Vn|)/(Vp+|Vn|) and storing the asymmetry factor ? of sequential cardiac cycles for analysis.

Abstract: A method for inserting a lead electrode into body tissue using a rotatable lead introducer is described. The introducer can include a distal element for releasably engaging a lead head controllable from a proximal control located outside of the body. An inner stem can extend between a proximal portion and a distal portion, and be pivotally and rotatably coupled to the distal lead engagement mechanism. An outer tube can be rotatably disposed over the inner stem and be flexibly coupled over the pivot to rotationally drive the distal element. A helical epicardial-myocardial lead electrode can be secured and oriented straight ahead and introduced through a port or small incision with the introducer in a straight configuration. The introducer can then be bent and rotated to screw the helical electrode into the heart.

Abstract: An implantable cardiac patch is configured to be joined to a surface of a heart and includes a body portion having an inner surface configured to be joined to the surface of the heart. The body portion also has a plurality of pores extending into the body portion from the inner surface. A plurality of electrodes are attached to the body portion such that the electrodes are positioned proximate the surface of the heart, and a lead is electrically connected to the electrodes at a connecting portion of the lead. The lead has a proximal end configured for joining to an implantable device.