Abstract: A delivery system for placing a gastrointestinal device in a mammalian gastrointestinal tract comprises a container assembly; a gastrointestinal implant device that includes proximal and distal ends stored within the container assembly, the proximal end including an anchor and the distal end including a sleeve, coupled to the anchor and folded into the container assembly; and an inner extension to draw a portion of the sleeve from the anchor and from the container assembly as the anchor is retained therein. The inner extension comprises an atraumatic tip, such as a ball, that includes a guidewire rail. Further, a handle is provided that retains or captures an inner catheter within the handle. Within the handle is an elongated element that surrounds a portion of the catheter. A button on a side of the handle is configured to cause engagement of the catheter via the element when the button is depressed.

Abstract: Devices and methods are disclosed that detect and/or prevent intraoperative full thickness penetration of anatomic walls and provide delineation of anatomic structures during surgery.

Abstract: An electrode catheter device with indifferent electrode for direct current tissue therapies is disclosed. An example of the catheter device has a flexible tubing with at least one ablation electrode. The catheter device also may also be used with a sheath for introducing the flexible tubing inside a patient's body. An indifferent electrode on the sheath can provide a ground for a direct current (DC) pulse to deliver electrical energy and create an electrical field adjacent a tissue. Various other embodiments are also disclosed.

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 system is provided to determine whether an insulating layer of an implanted lead is damaged.

Abstract: A reinforced suture sleeve designed to cover and protect a medical lead from physical damage resulting from an over tightened suture is described. The reinforced suture sleeve comprises a metallic tubular insert with at least one slot that cut through the surface of the insert in a spiraled pattern. A biocompatible and pliable polymeric body is molded over the insert. The spiraled cut slot in the metallic tubular insert provides flexibility without degrading structural integrity. An alternate embodiment comprises a polymeric body provided with an embedded fiber mesh made of polymeric fibers, metallic fibers or combinations thereof. The fiber mesh prevents an over tightened suture from cutting through the suture sleeve and damaging the medical lead.

Abstract: A pre-sutured anchor including a deformable anchor sleeve with a lumen sized to receive the therapy delivery element. An outer surface of the anchor sleeve including one or more annular compression grooves oriented generally co-axial to the lumen. At least one compression member is located in a compression groove in an open configuration. The compression member includes at least one stop. A suture material pre-tied in a self-locking compression knot extends around each compression member. The suture material includes distal ends adapted to receive a tension force that is transmitted as a radial compression force to deform the compression members and substantially engage the stop in a compressed configuration. The anchor sleeve compressively engages the therapy delivery element in the compressed configuration.

Abstract: Bioelectric implants are provided in three distinct embodiments, namely a bone/tissue anchor, a suture construction, and a plate. The bioelectric implants function in dual capacities as both fixation devices, and as galvanic cells for the production of electrical energy used for therapeutic purposes in tissue regeneration and healing. The bioelectric anchor may take the general form of a screw or pin having a hollow interior or cavity that extends through the body of the anchor. A coating can be applied to the cavity to form the anode portion of the galvanic cell. The outer surface of the anchor serves as a cathode. Bodily fluids and tissue act as an electrolyte to facilitate the chemical reactions necessary for the galvanic cell. For the suture construction, one or more strands of material are the cathode, and one or more strands of peripheral surrounding material act as the anode. Bodily fluids/tissue in contact with the suture act as an electrolyte.

Abstract: An embodiment includes a sensor coupled to a sternal closure wire. The sternal closure wire holds two sternum portions of a patient adjacent to one another and the first sensor senses a biological signal of the patient. An embodiment includes a current source coupled to a sternal closure wire. The sternal closure wire holds two sternum portions of a patient adjacent to one another, and the current source delivers an electrical current to the patient via the sternal closure wire. Other embodiments are described herein.

Abstract: Medical devices and therapeutic methods for use in the field of cardiology, cardiac rhythm management and interventional cardiology, and more specifically to catheter-based systems for implantation of pacing leads and electrodes, or intramural myocardial reinforcement devices, within the myocardial wall of the heart, such as the ventricles, to provide improved cardiac function.

Abstract: The invention is directed toward stimulation of a selected tissue layer. A device is attached to a target tissue by applying vacuum pressure to a vacuum cavity of the device and advancing a needle into tissue within the vacuum cavity. The depth on the vacuum cavity is selected to permit deployment at the selected tissue layer. In one embodiment, the invention is directed toward an implantable medical device comprising a device housing defining a vacuum cavity, and a vacuum port for application of vacuum pressure to draw tissue into the vacuum cavity, an electrode that is movable into the vacuum cavity of the device housing to contact at least a portion of the tissue drawn into the vacuum cavity, and a lead comprising at least one conductor coupled to the electrode.

Abstract: A lead anchor includes a plurality of parallel tubular members and at least one suture element configured and arranged for receiving a suture to suture the lead anchor to patient tissue. Each tubular member defines a lead lumen having a first opening and a second opening through which a lead can pass.

Abstract: An implantable port with an integral attachment mechanism. The implantable port includes one or more suture needles enclosed within a port body, the suture needle(s) coupled to a movable member such that movement of the movable member results in movement of the suture needle(s) out of the port body and into the tissue of a body into which it is implanted. The movable member can be a cam or tensioning member that rotates about a central port axis. The movable member can be coupled to a gear to permit movement of the movable member following implantation of the port within a subcutaneous pocket.

Abstract: An anchor for securing a therapy delivery element in a desired location within a living body is disclosed. The anchor includes an anchor body having a space, which may be a main channel, to receive the therapy delivery element. A fill port is provided in the anchor body to introduce an adhesive into the space when the therapy delivery element is positioned within the space. In one embodiment, the fill port is coupled to a fill port extension that transfers the adhesive from a dispenser located a distance from the fill port into the space. Multiple fill ports, any of which may be coupled to a respective fill port extension, may be provided to introduce the adhesive at various locations of the space. One or more of the fill ports may extend into multiple side channels to introduce the adhesive at various locations of the space.

Abstract: There is disclosed various embodiments of an implantable anchor for permanently anchoring a medical lead. The implantable anchor may include a body having a longitudinal lumen, an access opening defined within a side of the body and in communication with the longitudinal lumen, a locking opening defined on an interior surface of the body, an arm having an interior face, the arm rotatably coupled to the body such that the arm is movable from a first position in which the arm covers the access opening to a second position in which the arm does not cover the access opening, and a locking feature protruding from the interior face of the arm and sized to extend into the locking opening.

Abstract: New and/or alternative designs for implantable leads that have fixation structures to keep leads at a desired location after implant. Fixation structure may take several forms that create distally located fixation for use primarily in subcutaneous implantation. Some examples include new and/or alternative methods of implanting such leads. Some examples also include fixation structures, such as a suture sleeve, that can be attached to a lead for fixation thereof. Some further examples show methods of implanting a subcutaneous lead, and others include methods of extracting implanted subcutaneous leads.

Abstract: A suture sleeve for securing an implantable lead to body tissue has a lumen that receives the lead and that includes a locking arrangement that secures the sleeve at a selected position along the lead. The locking arrangement provides the suture sleeve with three modes of operation. In the first mode, the size of the lumen exceeds the diameter of the lead, such that the suture sleeve is easily movable along the lead. In the second mode, the size of at least a portion of the lumen is reduced, causing the sleeve to apply pressure to the lead so that relative movement between the sleeve and the lead is prevented. In the third mode, the pressure is temporarily released, allowing the sleeve to again be movable along the lead.

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: An implantable port with an integral attachment mechanism. The implantable port includes one or more suture needles enclosed within a port body, the suture needle(s) coupled to a movable member such that movement of the movable member results in movement of the suture needle(s) out of the port body and into the tissue of a body into which it is implanted. The movable member can be a cam or tensioning member that rotates about a central port axis. The movable member can be coupled to a gear to permit movement of the movable member following implantation of the port within a subcutaneous pocket.

Abstract: An implantable lead for a medical device with a coplanar coupling for connecting a conductor to a contact reduces conductor bending moments to improve lead reliability. The implantable lead comprises a lead body having a proximal end and a distal end, at least one conductor, at least one contact carried on the proximal end, at least one contact carried on the distal end, and at least one coupling. The lead body has an exterior surface. The conductor is contained in the lead body and extends from the lead proximal end to the distal end. The conductor is also electrically insulated. The contact carried on the proximal end is electrically connected to the conductor. The coupling has a conductor coupling and a contact coupling. The conductor coupling is placed over the conductor and attached to the conductor. The contact coupling exits the lead body and has a weld to connect the contact coupling to the contact.

Abstract: Implantable lead assembly including a lead body, an elongated conductor, a coiled electrode, and a tether line. The lead body maintains the conductor. The electrode is coupled to the conductor, defining proximal and distal ends. The tether line defines a trailing segment and a leading segment terminating in a leading end. The tether line is coupled to the coiled electrode at a point proximal the distal end, and the leading end extends distal the distal end. With this configuration, a pulling force applied to the leading segment is transferred to the electrode at a point proximal the distal end as a pushing force, thereby minimizing an opportunity for overt stretching of the coiled electrode during implantation. The lead assembly can further include a needle connected to the tether line.

Abstract: A tubular, suture sleeve to efficiently position and secure an implantable lead thereto without the use of a suture is disclosed. The sleeve comprises first and second ends with first and second inner lumens respectively. The first end is relatively rigid in comparison to the more flexible second end. The circumference of the inner lumen of the first end is larger than a circumference of a lead body to allow the suture sleeve to slide easily along the longitudinal axis of the lead body. The second end is movable between furled and unfurled positions. When unfurled, the inner lumen of the second end is smaller than a circumference of the lead body, thereby allowing the second end to snugly grip the lead body and secure the sleeve at the desired location along the longitudinal axis of the lead body without the use of a suture.

Abstract: A connector for connecting to an energy source such as a pulse generator for a cardiac stimulator system. The connector assembly includes a pin, at least one ring and a sleeve composed of an insulative hard polymer molded between the pin and ring such that the sleeve provides electrical insulation between the pin and ring and mechanically couples the pin and ring.

Abstract: A lead assembly for use with an implantable cardiac function management system. The lead assembly includes an elongated flexible pacing lead having a proximal end and a distal end. A terminal connector is connected to the proximal end of the pacing lead and has a distal end formed with a first coupling feature. A pacing lead stabilizer having a central bore is mounted on the pacing lead and is slidable along the pacing lead. The pacing lead stabilizer has a stabilizer proximal end formed with a mating feature complementary to the first coupling feature, such that the pacing lead stabilizer is releasably coupleable to the terminal connector.

Abstract: An improved suture sleeve for a lead body includes an elongated tubular sleeve body formed of a compressible elastomeric material wherein a surface of the lumen has a relatively rough texture formed by a particulate or fibrous media embedded therein.

Abstract: An implantable electrode lead excelling in workablity during the introduction and in fastness of fixing by ligation is provided. This implantable electrode lead comprises a lubricating coat layer provided on an insulating coat over a length of at least not less than 100 mm and to a position at a distance of not more than 300 mm from the distal end of the implantable electrode lead. When this lead further comprises on the more proximal end side of the lubricating coat layer a section having regions containing a lubricating coat layer and regions containing no lubricating coat layer formed alternately therein, the workablity during the introduction can be attained and the fastness of fixing by ligation can be also secured.

Abstract: A surgical electrode has an anchor which is constrained by a coating made from a bioabsorbable material. The anchor may have a barbed harpoon-like shape designed to enhance the retention strength of the anchor.

Abstract: A connector assembly of an electrophysiologial device. The connector assembly includes a substrate forming a tube extending from a proximal end to a distal end an electrical circuit formed on the substrate, such as etching or printing, where the substrate is optionally non-conductive. In another option, the connector assembly includes clad wires and/or flexible circuits within an insulated terminal structure.

Abstract: A connector for connecting to an energy source such as a pulse generator for a cardiac stimulator system. The connector assembly includes a pin, at least one ring and a sleeve composed of an insulative hard polymer molded between the pin and ring such that the sleeve provides electrical insulation between the pin and ring and mechanically couples the pin and ring.

Abstract: A connector for connecting to an energy source such as a pulse generator for a cardiac stimulator system. The connector assembly includes a pin, at least one ring and a sleeve composed of an insulative hard polymer molded between the pin and ring such that the sleeve provides electrical insulation between the pin and ring and mechanically couples the pin and ring.

Abstract: A surgical electrode has an anchor which is constrained by a coating made from a bioabsorbable material. The anchor may have a barbed harpoon-like shape designed to enhance the retention strength of the anchor.

Abstract: The present invention relates to an intramuscular medical electrical lead, a system for providing electrical stimulation or sensing using such a lead, and methods of implanting, making and using same. The lead includes at least a first fixation member disposed distally or proximally from a sensing or stimulating electrode, and may further include a second fixation member disposed at the opposite end of the electrode form the first fixation member. The fixation members permit the electrode to be reliably and fixedly secured within a patient's muscle tissue at a desired site, and to remain so secured for a predetermined suitable period of time.

Abstract: A temporary cardiac electrical stimulating lead comprises a stimulating electrode mounted in or on a biodegradable electrode mounting pad disposed at a distal end of the lead. The electrode mounting pad is capable of biodegradably dissolving over time in human body fluids and is loaded with a drug for therapeutically treating a medical condition of a patient's heart. The electrode mounting pad may be loaded with any of a variety of different drugs, such anti-arrhythmia or anti-inflammatory drugs. When the lead body is pulled away from the electrode mounting pad and removed from the patient, any portion of the electrode mounting pad remaining within the patient dissolves over time and disappears.

Abstract: A low-cost temporary lead for pacing, sensing, monitoring, or defibrillating at least a portion of a human or animal organ, and methods for implanting and making same. The lead has at least two electrodes and distal and proximal ends, and a novel weakened zone disposed between the blunt end of a needle and at least two electrical connectors attached to the proximal end of the lead body. The novel weakened zone permits the needle to be separated from the connectors by application of a sufficiently large bending moment or pulling force thereto. Following separation of the connectors from the needle, the connectors may be attached directly and quickly to an external electrical apparatus.

Abstract: An implantable epicardial lead (13) is provided which is comprised of two spherical ICs (25) and (26) disposed at opposite ends of a supporting structure and separated by a predetermined distance. These spherical ICs comprise an anode and a cathode, each having connections thereto. The epicardial lead (13) includes circuitry for allowing inductive coupling of power into the epicardial lead (13) for storage in a capacitor (926). A switch (928) allows for selective discharge of the capacitor (926) to the surrounding myocardium into which it is implanted. The epicardial lead (13) also includes a receive/transmit device (942) for receiving command information for storage in a memory (939) to provide operation information therefor and also for receiving sensed information therefrom. The sensed information is sent via a switch (930).

Abstract: A temporary cardiac pacing wire (TPW) includes an electrically conductive flexible wire having a bioabsorbable anchor near its distal end. The anchor includes a tubular section that surrounds the wire and a leg that extends from the tubular section at an acute angle to the wire. The bioabsorbable anchor causes minimal trauma to the heart when it is inserted with the TPW, but securely anchors the TPW in the heart. After the TPW is no longer needed, it can be removed, again with minimal trauma to the heart, leaving behind only the bioabsorbable anchor. The bioabsorbable anchor is suitable for use with both monopolar and bipolar TPWs.

Abstract: The present invention provides an a storage device for an epicardiac pacing lead having a flexible cable. In particular, the storage device of the present invention accommodates the flexible cable in the stored condition and provides a spool and freely rotatable spindle that allows the stored cable to be unwound as it is progressively withdrawn from the storage device.

Abstract: A surgical electrode of the type used as a temporary cardiac pacing wire provides electrical contact between a patient's heart and a source of electrical pulses (i.e., a pacemaker). One end of the wire attaches to the heart. The other end is attached to a surgical needle that has a weakened zone in its shaft, to permit the sharp end of the needle to be broken off and discarded. The remaining shaft connects to the pacemaker. By providing an insulating coating over part of the shaft, the electrode of the invention protects against harm to the patient that would otherwise be caused by mis-connecting the electrode or by shorting the two electrodes that comprise a setup.

Abstract: An anchoring sleeve for retaining an electrical lead including a sleeve base and a locking member latchable to the sleeve base to lock the locking member to the sleeve base encircling the lead and engaging it around its full circumference. The locking member may be an arcuate member joined to said sleeve base by a hinge and pivotable to latch said locking member to the sleeve base. Alternatively the locking member may be a member formed separately from the sleeve base. The base may be provided with one or more C-shaped members to temporarily retain the lead prior to latching.

Abstract: The present invention includes within its scope a low-cost temporary lead for pacing, sensing, monitoring, or defibrillating at least a portion of a human or animal organ, and methods for implanting and making same. The lead has at least two electrodes and distal and proximal ends, and a novel weakened zone disposed between the blunt end of a needle and at least two electrical connectors attached to the proximal end of the lead body. The novel weakened zone permits the needle to be separated from the connectors by application of a sufficiently large bending moment or pulling force thereto. Following separation of the connectors from the needle, the connectors may be attached directly and quickly to an external electrical apparatus.

Abstract: The present invention includes within its scope a temporary lead for pacing, sensing, monitoring, or defibrillating at least a portion of a human or animal organ, and methods for implanting and making same. The lead has at least two electrodes and distal and proximal ends, and a novel weakened zone disposed between the blunt end of a needle and at least two electrical connectors attached to the proximal end of the lead body. The novel weakened zone permits the needle to be separated from the connectors by application of a sufficiently large bending moment or pulling force thereto. Following separation of the connectors from the needle, the connectors may be attached directly and quickly to an external electrical apparatus.

Abstract: A post-surgical atrial cardioverting, atrial pacing, and ventricular pacing system and lead system provides for cardioverting the atria, pacing the atria, and/or pacing the ventricles of the heart of a post-surgical heart patient. The system includes a first lead and a second lead providing a pair of atrial cardioverting electrodes, an atrial pacing electrode, and a ventricular pacing electrode. The electrodes are electrically isolated from each other. The system further includes at least one anchor releasably disposing the electrodes beneath the skin of the patient with each atrial cardioverting electrode electrically contacting a respective given one of the atria, the atrial pacing electrode electrically contacting one of the atria, and the ventricular pacing electrode electrically contacting a ventricle.

Abstract: A medical electrical lead which may be introduced using a thorascope and is used to electrically stimulate tissue, such as a heart. The lead of the present invention has a "ski-shaped" needle, a strand of between 1-5 cm. attached to the needle, an electrode attached to the strand, and an insulated lead body attached to the electrode. In addition, a test wire is also attached to the needle to permit the electrical characteristics of tissue to be ascertained before the lead is fully inserted. In an alternate embodiment the strand may feature a fixation helix. Due to the shape of the needle and the relatively short strand, the lead is particularly suitable for implantation to a heart using minimally invasive techniques, such as through a trocar.

Abstract: A cardiac simulator including a patient warning apparatus, having an electrically conductive suture point in electrical communication with the patient warning apparatus. An electrically conductive suture passed through the suture point connects said stimulator mechanically and electrically to excitable tissue such as skeletal tissue. Inside the suture point is a connection for assuring a reliable electrical contact between the suture point and the suture. The cardiac stimulator automatically alters the peak voltage of its output stimulus whenever a condition exists requiring patient notification or warning. A specialized shunt circuit mounted within the stimulator or in the header of the stimulator re-directs electrical current from the standard stimulation electrode to the electrically conductive suture point. A controlled switch may be mounted within a hermetically sealed can of the stimulator to re-direct a stimulation pulse to the suture point. The controlled switch could also be mounted in the header.

Abstract: A medical electrical lead which features an improved anchoring sleeve. Specifically the anchoring sleeve has a first end and a second end and further has a series of circumferential suture grooves thereabout. A longitudinally extending slot is provided across each circumferential suture groove. Each slot extends across each groove but is separate from every other slot. In such a manner the area of the anchoring sleeve may be compressed in the area of the groove due to the relevant slot. Because each slot, however, only extends across one groove, the lead body is not otherwise easily compressed in the area away from each groove. Thus the sleeve does not unintentionally engage with and frictionally interfere with the lead body therethrough unless so intended. In the preferred embodiment the anchoring sleeve has three circumferential grooves, each groove having a slot through the anchor sleeve which extends across.

Abstract: A chronic myocardial pacing lead for the delivery of stimulation energy to and the sensing of electrical signals from the myocardium of a human heart. In one embodiment the lead is bipolar, having a sleeve electrode implanted into the myocardium and a pad electrode positioned on the epicardium. The lead includes a drug for delivery through the sleeve electrode to the myocardium. The disclosed lead is highly flexible to minimize tissue reaction, this permits the lead to offer relatively low pacing thresholds, high impedance, and excellent sensing in a configuration which is relatively easy to implant.

Abstract: A method and apparatus for determining the optimum location for implanting a muscle stimulating electrode. A test probe is provided for producing an electric current at various muscle tissue locations to determine comparative threshold measurements of the selected muscle tissue locations and determine the optimum location for implanting the muscle stimulating electrode.

Abstract: An intramuscular lead for the electrical stimulation of muscle tissue. The improved lead has a needle connected to a strand of suture, a coiled conductor coupled to the strand by a tapered section of the coiled conductor, an insulative cover covers part of the coiled conductor, and a terminal connector coupled to the coiled conductor provides a connection to a pulse generator. Through such a construction the lead may be more readily introduced through muscle tissue.

Abstract: A body implantable cardioversion/defibrillation device includes an electrically conductive lead, three lead extensions coupled to the lead through a junction body, and an electrode array consisting of three electrodes, one electrode being coupled to each of the lead extensions. Each electrode has several separate electrically conductive paths, including a primary conductor in the form of a helically wound coil, and a linear shunt conductor in the form of a cable surrounded by the primary coil. The shunt cable is a composite, including a DBS core surrounded by an insulative coating. A dielectric sheath surrounds the shunt cable, preventing the cable from contacting the primary coil and isolating the shunt cable from contact with body tissue or body fluids. At each end of each electrode is a connector structure including a shunt connector attached to an end of the shunt cable, and an outer coil connector surrounding an end of the primary coil and the shunt connector.

Abstract: A novel cardiac pacing lead. The pacing lead has a conductive wire comprising a single filament of a low modulus metal. A surgical needle is mounted to a distal end of the wire and an electrode needle is mounted to the proximal end of the wire. An integral anchor is formed in a distal, uninsulated section of the wire for anchoring the pacing lead in heart muscle. The wire has a "hand" similar to multifilament wires.