Abstract: New methods for implanting a cardiac therapy system include implanting a lead of the system substernally anterior of the heart without attaching to the myocardium or pericardium. An illustration includes placement of an anchor beneath the sternum in the vicinity of one of the sternal angle, a location superior of the ventricles, the area bounded by the 2nd or 3rd ribs, and level with the aortic arch. A tension element or tether is attached to the anchor and a lead is introduced over the tension element or tether and secured in a desired position relative to the anchor. Other examples also include implantation, sub sternally, of a lead without the use of a pre-tunneling tool or sheath over the lead itself, for example by using an advancing tool for pushing the lead into position.

Abstract: New methods for implanting a cardiac therapy system include implanting a lead of the system substernally anterior of the heart without attaching to the myocardium or pericardium. An illustration includes placement of an anchor beneath the sternum in the vicinity of one of the sternal angle, a location superior of the ventricles, the area bounded by the 2nd or 3rd ribs, and level with the aortic arch. A tension element or tether is attached to the anchor and a lead is introduced over the tension element or tether and secured in a desired position relative to the anchor. Other examples also include implantation, substernally, of a lead without the use of a pre-tunneling tool or sheath over the lead itself, for example by using an advancing tool for pushing the lead into position.

Abstract: Methods and tool kits for implanting a lead subcutaneously. Examples include tool kits and methods for establishing first and second subcutaneous tunnels at an angle relative to one another to facilitate introduction of a lead to the subcutaneous space. In an example, a first insertion tool is used to establish a first subcutaneous tunnel, and a second insertion tool, with or without the use of a blunt dissector, sheath, guidewire, or steering mechanism, is used to initiate or form the second subcutaneous tunnel. Such methods and tool kits may reduce the number of incisions needed to implant a subcutaneous lead along a subcutaneous path having a curve therein.

Abstract: Various aspects describe a lead delivery system for percutaneous introduction of a lead to a stimulation site near a neural target, such as the vagus nerve for nerve stimulation. The lead delivery system may include a needle assembly having a needle adapted to cut through tissue and provide initial access into the carotid sheath. The needle may be retracted into the lead delivery system to prevent cutting structures in the carotid sheath. The lead delivery system may also include a dilator assembly having one or more dilators to dilate a path to the stimulation site. The lead delivery system may further comprise a dilator assembly including a retractable needle adapted to cut through tissue. One or more locating elements, alternatively or in addition to one or more imaging elements, may be used on individual components of the lead delivery system for enhanced trackability and locatability within the body.

Abstract: The disclosure relates to a needle assembly for delivering a lead and methods of use. The needle assembly is configured to cut tissue and reduce the potential for cutting vulnerable bodily structures. The needle assembly includes an outer needle with a blunt tip and an inner needle with a sharp tip. The outer needle may be curved, and the inner needle may be curved. When the inner needle is rotated with respect to the outer needle, the inner needle protracts or retracts with respect to the outer needle. A stopping feature on the needle assembly may be included to resist over-rotation or over-extension. The needle assembly provides an initial path that may be further dilated for delivering a lead, such as a vagus nerve stimulation lead to a target site. The target site may be electrically tested with some embodiments.

Abstract: Various embodiments concern implanting a lead to directly stimulate the bundle of His. Various embodiments can include introducing a curve of an outer guide catheter into the right ventricle, extending a curve of an inner guide catheter from a lumen of the outer guide catheter, extending a fixation element on a distal tip of an anchor wire from a lumen the inner guide catheter, and anchoring the anchor wire to target tissue within the right ventricle, the target tissue along the septal wall and proximate the tricuspid valve and the bundle of His. A distal tip of an implantable lead with a lumen can then be advanced over the anchor wire to the target tissue as the anchor wire guides the distal tip of the lead to the target tissue.

Abstract: New methods for implanting a cardiac therapy system include implanting a lead of the system substernally anterior of the heart without attaching to the myocardium or pericardium. An illustration includes placement of an anchor beneath the sternum in the vicinity of one of the sternal angle, a location superior of the ventricles, the area bounded by the 2nd or 3rd ribs, and level with the aortic arch. A tension element or tether is attached to the anchor and a lead is introduced over the tension element or tether and secured in a desired position relative to the anchor. Other examples also include implantation, substernally, of a lead without the use of a pre-tunneling tool or sheath over the lead itself, for example by using an advancing tool for pushing the lead into position.

Abstract: Methods and tool kits for implanting a lead subcutaneously. Examples include tool kits and methods for establishing first and second subcutaneous tunnels at an angle relative to one another to facilitate introduction of a lead to the subcutaneous space. In an example, a first insertion tool is used to establish a first subcutaneous tunnel, and a second insertion tool, with or without the use of a blunt dissector, sheath, guidewire, or steering mechanism, is used to initiate or form the second subcutaneous tunnel. Such methods and tool kits may reduce the number of incisions needed to implant a subcutaneous lead along a subcutaneous path having a curve therein.

Abstract: Various embodiments concern a guide catheter for delivery of an implantable lead within the coronary vein. Such a guide catheter can comprise a tubular body having a main lumen and at least one preformed bend. The tubular body can comprise a liner defining an inner surface, braiding circumferentially surrounding the liner, a jacket covering the braiding and defining an exterior surface of the tubular body, and a plurality of inflation tubes embedded within the jacket. The guide catheter can include a balloon mounted on the tubular body, each of the plurality of inflation tubes in communication with the balloon. The guide catheter can further include a hub providing access to the main lumen, the hub comprising a first port for introduction of contrast media into the main lumen and a second port in communication with the plurality of inflation tubes.

Abstract: Approaches for selecting an electrode combination of multi-electrode pacing devices are described. Electrode combination parameters that support cardiac function consistent with a prescribed therapy are evaluated for each of a plurality of electrode combinations. Electrode combination parameters that do not support cardiac function are evaluated for each of the plurality of electrode combinations. An order is determined for the electrode combinations based on the parameter evaluations. An electrode combination is selected based on the order, and therapy is delivered using the selected electrode combination.

Abstract: The disclosure relates to a needle assembly for delivering a lead and methods of use. The needle assembly is configured to cut tissue and reduce the potential for cutting vulnerable bodily structures. The needle assembly includes an outer needle with a blunt tip and an inner needle with a sharp tip. The outer needle may be curved, and the inner needle may be curved. When the inner needle is rotated with respect to the outer needle, the inner needle protracts or retracts with respect to the outer needle. A stopping feature on the needle assembly may be included to resist over-rotation or over-extension. The needle assembly provides an initial path that may be further dilated for delivering a lead, such as a vagus nerve stimulation lead to a target site. The target site may be electrically tested with some embodiments.

Abstract: Various aspects describe a lead delivery system for percutaneous introduction of a lead to a stimulation site near a neural target, such as the vagus nerve for nerve stimulation. The lead delivery system may include a needle assembly having a needle adapted to cut through tissue and provide initial access into the carotid sheath. The needle may be retracted into the lead delivery system to prevent cutting structures in the carotid sheath. The lead delivery system may also include a dilator assembly having one or more dilators to dilate a path to the stimulation site. The lead delivery system may further comprise a dilator assembly including a retractable needle adapted to cut through tissue. One or more locating elements, alternatively or in addition to one or more imaging elements, may be used on individual components of the lead delivery system for enhanced trackability and locatability within the body.

Abstract: A multipolar lead evaluation device may be configured to easily permit electrical contact to be made between a pacing system analyzer and the terminal pin and each of the terminal contacts of an implantable lead without damaging the implantable lead. Alligator clips may be used to secure electrical conductors from the pacing system analyzer to spring contact clips disposed within the lead evaluation device.

Abstract: Approaches for selecting an electrode combination of multi-electrode pacing devices are described. Electrode combination parameters that support cardiac function consistent with a prescribed therapy are evaluated for each of a plurality of electrode combinations. Electrode combination parameters that do not support cardiac function are evaluated for each of the plurality of electrode combinations. An order is determined for the electrode combinations based on the parameter evaluations. An electrode combination is selected based on the order, and therapy is delivered using the selected electrode combination.

Abstract: Cardiac lead implantation systems, devices, and methods for lead implantation are disclosed. An illustrative cardiac lead implantation system comprises a mapping guidewire including one or more electrodes configured for sensing cardiac electrical activity, a signal analyzer including an analysis module configured for analyzing an electrocardiogram signal sensed by the mapping guidewire, and a user interface configured for monitoring one or more hemodynamic parameters within the body. The sensed electrical activity signal can be used by the analysis module to compute a timing interval associated with ventricular depolarization.

Abstract: Approaches for selecting an electrode combination of multi-electrode pacing devices are described. Electrode combination parameters that support cardiac function consistent with a prescribed therapy are evaluated for each of a plurality of electrode combinations. Electrode combination parameters that do not support cardiac function are evaluated for each of the plurality of electrode combinations. An order is determined for the electrode combinations based on the parameter evaluations. An electrode combination is selected based on the order, and therapy is delivered using the selected electrode combination.

Abstract: A lead assembly for an implantable medical device includes a lead body having a proximal end, a distal end, and a longitudinal axis that extends between the proximal end and distal end. The lead assembly also includes a strain relief tube that surrounds a portion of the lead body. The strain relief tube includes a flexible material configured to include contours such that the portion of the lead body surrounded by the strain relief tube maintains a formed shape that varies from the longitudinal axis of the lead body. The contours vary in response to forces on the lead body to prevent strain at the distal end of the lead body.

Abstract: Approaches for selecting an electrode combination of multi-electrode pacing devices are described. Electrode combination parameters that support cardiac function consistent with a prescribed therapy are evaluated for each of a plurality of electrode combinations. Electrode combination parameters that do not support cardiac function are evaluated for each of the plurality of electrode combinations. An order is determined for the electrode combinations based on the parameter evaluations. An electrode combination is selected based on the order, and therapy is delivered using the selected electrode combination.

Abstract: Various embodiments concern wrapping a stimulation cuff around a nerve. The cuff can comprise a main body and at least one electrode. The main body can comprise an inner tab, an outer tab, and an intermediate portion extending between the inner tab and the outer tab, the at least one electrode disposed on the intermediate portion, the main body biased such that the cuff assumes the coiled arrangement. The cuff can be uncoiled by pulling on a first elongate element attached to a first tubular member, the first tubular member encircled within the cuff. The nerve can be engaged with an inner surface of the main body along the intermediate portion while the inner tab is releaseably attached to the first elongate element. The first elongate element can be released to allow the cuff to wrap around the nerve.

Abstract: Described is a system for stimulating a target region of a vagus nerve from a location within an internal jugular vein. The system comprises a medical lead and an insulating element. The insulating element is formed from a flexible sheet of electrically insulative material, and is to be implanted within the internal jugular vein to insulate nerve structures proximate the vagus nerve from stimulation. The insulating sheath includes at least one window through which the electrical stimuli can be delivered to the target region of the vagus nerve.