Abstract: Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

Abstract: The present disclosure provides systems and methods for retrieving an implantable device. An implantable device includes a casing, and a marker coupled to the casing, wherein the marker includes a detectable material encased in a biocompatible material, and wherein the marker facilitates accurately locating and retrieving the implantable device after implantation in a patient.

Abstract: Disclosed herein is a screw-in lead implantable in the pericardium of a patient heart and a system for delivering such leads to an implantation location. The leads include a helical tip electrode and a curate body including a defibrillator coil with improved contact between the defibrillator coil and the patient heart. The delivery system includes a delivery catheter and lead receiving sheath disposed within the catheter. A fixation tine is disposed on one of the delivery catheter and the lead receiving sheath such that the delivery system may be anchored into the pericardium during fixation of the screw-in lead. In certain implementations, an implantable sleeve receives the leads to bias the defibrillator coil against the patient heart.

Abstract: The present disclosure provides systems and methods for implanting an implantable cardiac monitor. An injection system includes an implantable cardiac monitor (ICM), a plunger, a plunger handle coupled the plunger, and an injector housing. The injector housing includes a tube extending from a first end of the injector housing to a second end of the injector housing, the tube configured to receive the ICM and the plunger, and at least one leaflet formed at the second end of the injector housing, the at least one leaflet configured to rotate outward when a user operates the plunger handle to push the ICM through the injector housing second end via the plunger.

Abstract: The present disclosure provides systems and methods for retrieving an implantable device. An implantable device includes a casing, and a marker coupled to the casing, wherein the marker includes a detectable material encased in a biocompatible material, and wherein the marker facilitates accurately locating and retrieving the implantable device after implantation in a patient.

Abstract: The present disclosure provides systems and methods for retrieving an implantable device. An implantable device includes a casing, and a marker coupled to the casing, wherein the marker includes a detectable material encased in a biocompatible material, and wherein the marker facilitates accurately locating and retrieving the implantable device after implantation in a patient.

Abstract: Systems and methods are provided for implanting an implantable cardiac monitor. An insertion system includes an implantable cardiac monitor (ICM). An insertion housing comprises a passage extending from a first end of the insertion housing to a second end of the insertion housing. The passage configured to receive the obturator and a receptacle in communication with the passage and an external environment. The receptacle configured to receive the ICM. An obturator is configured to move within the passage when the obturator is moved relative to the insertion housing. The obturator has a channel forming section at a distal end thereof and a motion limiter is provided on at least one of the shaft and the insertion housing.

Abstract: Disclosed herein is an implantable lead configured to administer electrotherapy to a patient heart from an implantable pulse generator. The lead may include a lead body and an attachment structure. The lead body includes a bifurcated distal region including first and second lead body branches each terminating in a distal end. At least one of the first lead body branch or second lead body branch includes an electrode. The attachment structure couples together the distal ends of the first and second lead body branches. The attachment structure is configured to release such that the distal ends of the first and second lead body branches can decouple from each other.

Abstract: A protective patch or bandage is provided for use with an implantable trial neurostimulation lead for implant within a patient. In one example, the lead is routed through the patch to a trial neurostimulation generator. In another example, the patch includes an internal electrical connector for connecting the trial neurostimulation lead to a connection line from the trial neurostimulation generator. In either case, the patch is sealed over an implant site to protect and hygienically isolate the site. A central chamber of the patch is provided to hold medical gauze and to further hold a coiled portion of the neurostimulation lead. In some examples, the patient can shower while wearing the protective patch.

Abstract: A leadless intra-cardiac medical device (LIMD) includes an electrode assembly configured to be anchored within a first wall portion of a first chamber of a heart. The electrode assembly includes an electrode main body having a first securing helix, an electrode wire segment extending from the body, and a first segment-terminating contact positioned on the electrode wire segment. The device further includes a housing assembly configured to be anchored within a second wall portion of a second chamber of the heart. The housing assembly includes a body having a second securing helix, a housing wire segment extending from the body, and a second segment-terminating contact positioned on the housing wire segment. The device also includes a connector block that electrically connects the electrode wire segment to the housing wire segment by retaining the first and second segment-terminating contacts.

Abstract: Disclosed herein is an implantable lead configured to administer electrotherapy to a patient heart from an implantable pulse generator. The lead may include a lead body and an attachment structure. The lead body includes a bifurcated distal region including first and second lead body branches each terminating in a distal end. At least one of the first lead body branch or second lead body branch includes an electrode. The attachment structure couples together the distal ends of the first and second lead body branches. The attachment structure is configured to release such that the distal ends of the first and second lead body branches can decouple from each other.

Abstract: Disclosed herein is a disposable enclosure for use with a trial neurostimulation device configured to electrically couple with a neurostimulation lead for implant within a patient. The trial neurostimulation device includes a pulse generator portion. The disposable enclosure includes a first wall structure, a second wall structure opposite the first wall structure, a volume between the first and second wall structures, and a header. The volume is configured to receive therein the pulse generator portion. The header is configured to electrically couple with the neurostimulation lead. The header is supported in the disposable enclosure adjacent the volume and configured to electrically couple with the pulse generator portion when the pulse generator portion is located in the volume.

Abstract: The present disclosure provides systems and methods for implanting an implantable cardiac monitor. An injection system includes an implantable cardiac monitor (CM), a plunger, a plunger handle coupled the plunger, and an injector housing. The injector housing includes a tube extending from a first end of the injector housing to a second end of the injector housing, the tube configured to receive the ICM and the plunger, and at least one leaflet formed at the second end of the injector housing, the at least one leaflet configured to rotate outward when a user operates the plunger handle to push the ICM through the injector housing second end via the plunger.

Abstract: Disclosed herein is a left ventricular lead for tracking over a guide wire into a coronary sinus and providing active fixation in, or adjacent to, the coronary sinus. The guide wire is configured for coronary sinus lead implantation and has an outer diameter. In one embodiment, the lead includes a tubular body including a proximal end, a distal end and a central lumen through which the guide wire is extendable. The lead also includes a lead connector end proximally projecting from the proximal end and comprising at least one electrical contact. The lead also includes a fixed helical anchor comprising a wire member having a diameter of between approximately 0.22 mm and approximately 0.27 mm. The wire member distally extends away from the distal end in a helical arrangement including an inner helical coil diameter that is sufficient to allow the guide wire to extend through the fixed helical anchor.

Abstract: Disclosed herein is a left ventricular lead for tracking over a guide wire into a coronary sinus and providing active fixation in, or adjacent to, the coronary sinus. The guide wire is configured for coronary sinus lead implantation and has an outer diameter. In one embodiment, the lead includes a tubular body including a proximal end, a distal end and a central lumen through which the guide wire is extendable. The lead also includes a lead connector end proximally projecting from the proximal end and comprising at least one electrical contact. The lead also includes a fixed helical anchor comprising a wire member having a diameter of between approximately 0.22 mm and approximately 0.27 mm. The wire member distally extends away from the distal end in a helical arrangement including an inner helical coil diameter that is sufficient to allow the guide wire to extend through the fixed helical anchor.

Abstract: The present disclosure provides systems and methods for retrieving an implantable device. An implantable device includes a casing, and a marker coupled to the casing, wherein the marker includes a detectable material encased in a biocompatible material, and wherein the marker facilitates accurately locating and retrieving the implantable device after implantation in a patient.

Abstract: A method of implanting a leadless intra-cardiac medical device. An introducer assembly is introduced into one of an inferior vena cava or a superior vena cava of a heart and maneuvered into a first chamber of the heart. A housing is pushed out of a sheath of the introducer toward a first implant location within the first chamber, and the housing is anchored to the first implant location. The sheath is moved away from the anchored housing, and an electrode is urged to a distal end of the sheath due to the pushing, anchoring, and moving. The sheath is maneuvered to a second chamber of the heart, and the electrode is forced into a second implant location with the second chamber. The electrode is anchored to the second implant location. The sheath is moved away from the electrode after the anchoring, and the sheath is removed from the heart.

Abstract: Medical device including a lift tool having a distal end configured to removably engage an anatomic layer. The lift tool includes a shaft lumen that extends longitudinally through the lift tool and through the distal end. The shaft lumen is configured to receive an elongated insert device that is movable through the shaft lumen and through the distal end. The medical device also includes a locking mechanism that is coupled to the lift tool. The locking mechanism includes a locking member that is selectively movable with respect to the insert device between a released position and an engaged position. The locking member engages the insert device when in the engaged position to hold the insert device at a fixed position with respect to the lift tool and permits the insert device to move through the shaft lumen when in the released position.

Abstract: The present disclosure provides systems and methods for implanting an implantable cardiac monitor. An injection system includes an implantable cardiac monitor (ICM), a plunger, a plunger handle coupled the plunger, and an injector housing. The injector housing includes a tube extending from a first end of the injector housing to a second end of the injector housing, the tube configured to receive the ICM and the plunger, and at least one leaflet formed at the second end of the injector housing, the at least one leaflet configured to rotate outward when a user operates the plunger handle to push the ICM through the injector housing second end via the plunger.

Abstract: Systems and methods are provided for neurostimulation (NS) of peripheral nerves and/or associated ganglion. The systems and methods create a magnetic field from an elongated transmission coil of an external stimulator and expose an elongated receiver coil of a magnetic driver to the magnetic field. The systems and methods generate at the magnetic driver a pulse forming a stimulation waveform in response to the magnetic field. The systems and methods deliver the stimulation waveform to a target peripheral nerve through an electrode from the magnetic driver.