Abstract: A cardiac pacemaker or other implantable electrostimulation device has one or more durable fine wire leads to the heart or other electrostimulation site. The lead is formed of a core of silica or glass fiber or similar material, with a protective coating preferably including a metal buffer for conduction. The lead can be unipolar or bipolar (or even with three or more conductors), of small diameter and preferably with an anchoring configuration at the distal end of the lead. The anchor feature can take any of several nonlinear forms such that once implanted in a constrained configuration, the anchor can be released to the expanded, nonlinear configuration. The electrostimulation leads of the invention are extremely durable, can be bent through small radii and can exhibit long life without fatigue failure.

Abstract: Durable fine wire electrical conductors are robust, durable, small in profile, and light weight, yet capable of operating under extreme environmental conditions. Formed of a glass, silica, sapphire or crystalline quartz fiber core with a metal coating and one or more polymer layers, a unipolar electrical conductor can have an outer diameter as small as about 300 microns or even smaller. The metal buffer coating may be deposited directly on the glass/silica fiber, or upon an intermediate layer between the glass/silica fiber and metal, consisting of carbon and/or polymer. The resulting metallized glass/silica fibers are extremely durable, can be bent through small radii and will not fatigue even from millions of iterations of flexing. Bipolar electrical conductors can include several insulated metallized glass/silica fibers residing side by side, or can be coaxial with two or more insulated metal conductive paths. An outer protective sheath of a flexible polymer material can be included.

Abstract: A cardiac pacemaker or other CRT device has one or more fine wire leads to the heart. Formed of a glass, silica, sapphire or crystalline quartz fiber with a thin metal coating, a unipolar lead can have an outer diameter as small as about 300 microns or even smaller. The thin metal conductor poses unique challenges for attachment to standardized connectors as well as to stimulation electrodes. This invention describes structures and materials for creating robust and durable electrically conductive connections between the fine wire lead body and a proximal standardized connector and distal ring and tip electrodes by utilization of fine metal coils or mesh and electrically conductive adapters to aid in stabilizing the connections.

Abstract: A heart size measuring tool includes a tubular body, a flexible measuring cord having length indicia, a measuring cord support mechanism movable between retracted and extended states with respect to the body, and an actuating mechanism to move the measuring cord support mechanism. When in the retracted state the measuring cord support mechanism is positioned within the tubular body with the measuring cord in a collapsed position. When the measuring cord support mechanism is in the extended state the measuring cord extends around a portion of a heart to be measured. A scale on the body can be used in connection with the indicia on the measurement cord to provide a reading of the heart size.

Abstract: A method for managing the pericardium during intra-pericardial procedures such as the delivery of cardiac support devices. One embodiment of the method includes making an incision through the pericardium to provide access to the pericardial space, and inserting a plurality of strips of lubricious material into and through the incision. The strips of material are spaced around the edges of the incision to form a tubular barrier against the pericardium. End portions of the strips of material in the pericardial space are expanded away from the body to form a lip that lines the inside of the pericardium around the incision.

Abstract: A delivery device for efficiently delivering a cardiac support device of the type having a jacket. The device includes a body, a deployment mechanism and an actuating mechanism. The deployment mechanism is for releasable connection to a cardiac support device and movable within the jacket between retracted and extended states to drive the jacket between collapsed and open configurations. At least portions of the deployment mechanism within the jacket have a lubricious surface to substantially reduce friction between the jacket and a heart onto which the jacket is being positioned. The actuating mechanism moves the deployment mechanism between the retracted and extended states.

Abstract: A cardiac pacemaker or other CRT device has one or more fine wire leads to the heart. Formed of a glass, silica, sapphire or crystalline quartz fiber with a thin metal coating, a unipolar lead can have an outer diameter as small as about 300 microns or even smaller. The thin metal conductor poses unique challenges for attachment to standardized connectors as well as to stimulation electrodes. This invention describes structures and materials for creating robust and durable electrically conductive connections between the fine wire lead body and a proximal standardized connector and distal ring and tip electrodes by utilization of fine metal coils or mesh and electrically conductive adapters to aid in stabilizing the connections.

Abstract: Implantable medical devices intended for electrostimulation and sensing devices typically incorporate one or more electrical conductors as leads for electrical stimulation to, or retrieval of localized sensing data from, discrete points in the body, such as the heart. Certain applications require delivery of high intensity electrical pulses, i.e. CRTs, or defibrillators. As described herein a CRT delivers high energy pulses via a durable fine wire lead formed of a glass, silica, sapphire or crystalline quartz fiber core with a metal coating. A unipolar electrical conductor can have an outer diameter of about 150 microns or even smaller. The buffered fibers support conduction of high intensity electrical pulses as required for internal or external defibrillators, or other biomedical applications, as well as non-medical applications.

Abstract: Durable fine wire electrical conductors are robust, durable, small in profile, and light weight, yet capable of operating under extreme environmental conditions. Formed of a glass, silica, sapphire or crystalline quartz fiber core with a metal coating and one or more polymer layers, a unipolar electrical conductor can have an outer diameter as small as about 300 microns or even smaller. The metal buffer coating may be deposited directly on the glass/silica fiber, or upon an intermediate layer between the glass/silica fiber and metal, consisting of carbon and/or polymer. The resulting metallized glass/silica fibers are extremely durable, can be bent through small radii and will not fatigue even from millions of iterations of flexing. Bipolar electrical conductors can include several insulated metallized glass/silica fibers residing side by side, or can be coaxial with two or more insulated metal conductive paths. An outer protective sheath of a flexible polymer material can be included.

Abstract: A cardiac pacemaker or other CRT device has one or more fine wire leads to the heart. Formed of a glass, silica, sapphire or crystalline quartz fiber with a metal coating, a unipolar lead can have an outer diameter as small as about 300 microns or even smaller. The metal buffer coating may be deposited directly on the glass/silica fiber, or upon an intermediate layer between the glass/silica fiber and metal, consisting of carbon and/or polymer. The resulting metallized glass/silica fibers are extremely durable, can be bent through small radii and will not fatigue even from millions of iterations of flexing. Bipolar fine wire leads can include several insulated metallized glass/silica fibers residing side by side, or can be coaxial with two or more insulated metal conductive paths. An outer protective sheath of a flexible polymer material can be included.

Abstract: A cardiac constraint device comprising a jacket of biological compatible material and an adjustment member. The jacket is adapted to be secured to the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole. The adjustment mechanism is configured to alter the internal volume defined by the jacket after the jacket is secured to the heart. The invention also provides a method for treating cardiac disease.

Abstract: A cardiac support device including a jacket and elastic attachment structure for self-securing the jacket to a heart. The attachment structures can include undulating metal and polymer elements, a silicone band and elastomeric filaments on a base end of the jacket.

Abstract: A cardiac constraint device comprising a jacket of biological compatible material and an adjustment member. The jacket is adapted to be secured to the heart to snugly conform to an external geometry of the heart and assume a maximum adjusted volume to constrain circumferential expansion of the heart beyond the maximum adjusted volume during diastole and to permit unimpeded contraction of the heart during systole. The adjustment mechanism is configured to alter the internal volume defined by the jacket after the jacket is secured to the heart. The invention also provides a method for treating cardiac disease.

Abstract: A cardiac pacemaker or other implantable electrostimulation device has one or more durable fine wire leads to the heart or other electrostimulation site. The lead is formed of a core of silica or glass fiber or similar material, with a protective coating preferably including a metal buffer for conduction. The lead can be unipolar or bipolar (or even with three or more conductors), of small diameter and preferably with an anchoring configuration at the distal end of the lead. The anchor feature can take any of several nonlinear forms such that once implanted in a constrained configuration, the anchor can be released to the expanded, nonlinear configuration. The electrostimulation leads of the invention are extremely durable, can be bent through small radii and can exhibit long life without fatigue failure.

Abstract: A device for delivery of a cardiac support device for treating cardiac disease of a heart includes a multistage deployment mechanism and an actuating mechanism for controlling the positions of the deployment mechanism. The deployment mechanism is operable to change between a retracted state and an extended state, and includes a plurality of independent stages, including, in one embodiment, a first stage including a guide structure for location adjacent a portion of the patient's heart when in the extended state. A second stage is movably coupled to the first stage, and is guided by the guide structure between the retracted and extended states. The second stage further releasably engages and supports the cardiac support device and positions the cardiac support device at the desired implantation location, guided by the guide structure of the stage. In some embodiments, the deployment mechanism may include additional stages.

Abstract: Methods and apparatus are disclosed for treating congestive heart failure. The method includes relieving wall stress on a diseased heart by an amount to decrease a rate of myocardial cell loss. Further, the method includes pharmacologically encouraging a myocardial cell gain. Cell gain may be encouraged by cell replication, cell recruitment or inhibition of cell death. Further embodiments of the method include a passive cardiac constraint selected to reduce wall stress on the heart. An apparatus of the present invention includes a passive cardiac constraint and a pharmacological agent to encourage cell gain.

Abstract: A method for managing the pericardium during intra-pericardial procedures such as the delivery of cardiac support devices. One embodiment of the method includes making an incision through the pericardium to provide access to the pericardial space, and inserting a plurality of strips of lubricious material into and through the incision. The strips of material are spaced around the edges of the incision to form a tubular barrier against the pericardium. End portions of the strips of material in the pericardial space are expanded away from the body to form a lip that lines the inside of the pericardium around the incision.

Abstract: A cardiac support device including a jacket and elastic attachment structure for self-securing the jacket to a heart. The attachment structures can include undulating metal and polymer elements, a silicone band and elastomeric filaments on a base end of the jacket.

Abstract: A device for delivery of a cardiac support device for treating cardiac disease of a heart includes a multistage deployment mechanism and an actuating mechanism for controlling the positions of the deployment mechanism. The deployment mechanism is operable to change between a retracted state and an extended state, and includes a plurality of independent stages, including, in one embodiment, a first stage including a guide structure for location adjacent a portion of the patient's heart when in the extended state. A second stage is movably coupled to the first stage, and is guided by the guide structure between the retracted and extended states. The second stage further releasably engages and supports the cardiac support device and positions the cardiac support device at the desired implantation location, guided by the guide structure of the stage. In some embodiments, the deployment mechanism may include additional stages.

Abstract: A system for delivering an antimicrobial agent into the lumen of a trans-dermal catheter. In an embodiment, the system comprises an elongate member configured for insertion into a lumen of a catheter; an expandable portion of the elongate member, said expandable portion configured to increase in diameter upon exposure to an aqueous fluid; and an antimicrobial composition positioned to be delivered into the catheter. In another embodiment, the system comprises an elongate member configured for insertion into a lumen of a trans-dermal catheter, said elongate member comprising a hydrogel; and an antimicrobial composition positioned to be delivered into the catheter; wherein the elongate member defines a volume of liquid that is at least substantially contained within the lumen of the trans-dermal catheter.