Abstract: An implantable cardioverter defibrillator (ICD) including a set of leads having electrodes disposed therein. The electrodes may include a weld electrode connected to an internal wire of the lead and the ICD and a tip electrode. The tip electrode may have a set of grooves or cut out regions in its outer surface to provide edge effects for currents applied through the tip electrode. The grooves or cut out regions may form gaps in the surface of the tip electrode exposing a medical compound that is housed within the tip electrode. The medical compound may elute through the gaps.

Abstract: A complementary drug delivery sheath for implantable medical devices. The complementary drug delivery sheath is covered, impregnated or otherwise carries one or more drugs. The complementary drug-delivery sheaths are manufactured separately from to the implantable device and are operationally combined with the device subsequent to the device's manufacture and/or sterilization. For example, embodiments of the complementary drug-delivery sheaths may be configured, for example, to attain an implanted position adjacent to one or more surfaces of an implantable medical device. In certain embodiments, the sheath is configured in the form of a glove, pocket, pouch, or the like to receive and to partially or completely wrap around or envelop an implantable medical device. Embodiments of the complementary drug delivery sheath may be implanted into the recipient prior to, concurrently with, or subsequent to the implantation of the implantable medical device.

Abstract: In an implantable cardiac stimulation electrode, an implantable cardiac stimulation lead, and a stimulation delivery method, the electrode body is provided with a matrix metalloproteinase inhibitor or a precursor thereof, in a release structure that allows release of the metalloproteinase inhibitor or precursor thereof from the electrode body into surrounding tissue, after implantation.

Abstract: The present disclosure describes intravascular systems that may be used for a variety of functions. The elements of the disclosed systems include at least one device body implanted within the vasculature. Electrodes on a lead and/or on the device body itself are used to direct electrical energy to neurological targets. These systems may additionally include one or more fluid reservoirs housing drugs or other agents to be delivered to tissue.

Abstract: A cardiac lead includes a half-domed or semi-spherical shaped distal assembly and an active fixation mechanism. The half-domed or semi-spherical shape provides directionality as to whether a flat side of the lead is facing the myocardial tissue and therefore the active fixation mechanism can be deployed safely into the myocardial tissue.

Abstract: An implantable shock electrode line having a proximal terminal for connection to an implantable defibrillator, an elongated flexible line body, and a shock electrode and a drug delivery device arranged at or near the distal end of the line body. A drug depot connected to the drug delivery device is provided in the shock electrode line, and the terminal is designed as a purely electric standard terminal. The drug delivery device is designed for control by an electric pulse transmitted over the electric terminal to the shock electrode line.

Abstract: Guide catheters for facilitating implantation of cardiac leads for applying electrical stimulation to and/or sensing electrical activity of the heart through one or more electrodes positioned at an implantation site within a heart chamber or cardiac vessel adjacent a heart chamber. Such a cardiac lead has low torqueability and pushability through a pathway to enable attachment of the cardiac lead at the implantation site. The catheter body comprises a delivery lumen to introduce a small diameter cardiac lead and a guide lumen to receive a guide tool to locate the catheter body distal end at the implantation site. The small diameter lumen within a small diameter guide tube extends distally from the delivery exit port of the delivery lumen. The catheter body is shaped to bias the delivery lumen exit port toward the heart.

Abstract: A medical electrical lead includes a tapered distal tip having a tapered drug-eluting component incorporated therein. The drug-eluting component can be an overmolded drug-eluting collar or a pre-molded drug eluting collar. The drug-eluting collar is disposed in a recess formed in the tapered distal tip and maintains the overall tapered profile of the distal tip.

Abstract: Tissue ablation probes and methods for treating tissue are provided. The tissue ablation probe comprises an elongated probe shaft, at least one electrode carried by the distal end of the probe shaft, and a pharmaceutical agent carried by the probe shaft. The pharmaceutical agent may be disposed on the electrode(s), the probe shaft, or a releasable portion associated with the electrode or the probe shaft. A method for treating tissue comprises introducing a tissue ablation probe to a tissue site, operating the tissue ablation probe to ablate tissue at the tissue site, and releasing a pharmaceutical agent from the tissue ablation probe at the tissue site.

Abstract: An apparatus includes an electrical lead comprising a lead body and an electrical conductor, and an electrode coupled to the electrical conductor, wherein the electrode includes a coating on at least a portion of a surface of the electrode, the coating including two or more layers, with a first layer adjacent the surface of the electrode comprising an insulative material and a second layer adjacent the first layer comprising at least one pharmacological agent.

Abstract: A lead may include a lead body including a proximal end and a distal end, an electrode proximate to the distal end of the lead body, and a monolithic controlled release device located proximate to the electrode. According to this aspect of the disclosure, the monolithic controlled release device includes a polymer, a steroid mixed in the polymer, and an antimicrobial mixed in the polymer.

Abstract: An insulative housing formed about a distal end of a medical electrical lead body includes a cavity and a port; an ionically conductive medium fills the cavity and is in intimate contact with an electrode surface contained within the cavity. When a current is delivered to the electrode surface contained within the cavity, a first current density generated at the electrode surface is smaller than a second current density generated out from the port of the insulative housing; thus, the port forms a high impedance and low polarization tissue-stimulating electrode.

Abstract: The present invention relates to materials having therapeutic compositions releasably contained within the materials. The materials are configured to release therapeutic compositions at a desired rate. The present invention also relates to devices incorporating the materials.

Abstract: The present invention relates to materials having therapeutic compositions releasably contained within the materials. The materials are configured to release therapeutic compositions at a desired rate. The present invention also relates to devices incorporating the materials.

Abstract: A cardiac lead comprising a lead body extending from a proximal end portion to a distal end portion; a cardiac electrode disposed along the lead body; and a coating associated with at least a portion of the electrode, wherein the coating comprises a conductive polymer.

Abstract: Medical device and methods are provided for controlled drug delivery in a cardiac patient. The device includes an implantable drug delivery module comprising reservoirs containing a drug and a control means for selectively releasing an effective amount of drug from each reservoir; one or more electrodes or sensors for cardiac monitoring, stimulation, or both; and a microcontroller for controlling operational interaction of the drug delivery module and the cardiac electrode. The electrodes may comprise ECG monitoring, cardioversion, or cardiac pacing electrodes.

Abstract: An implantable system control unit (SCU) includes means for measuring tissue impedance or other condition to determine allograft health, in order to predict or detect allograft rejection. The SCU also includes at least two electrodes coupled to means for delivering electrical stimulation to a patient within whom the device is implanted, and may also include a reservoir for holding one or more drugs and a driver means for delivering the drug(s) to the patient. In certain embodiments, the system is capable of open- and closed-loop operation. In closed-loop operation, at least one SCU includes a sensor, and the sensed condition is used to adjust stimulation parameters. Alternatively, this sensory “SCU” sounds an alarm, communicates an alarm to an external device, and/or is responsive to queries regarding sensed information, such as tissue impedance.

Abstract: An electrode assembly for use in an iontophoresis device for the transcutaneous administration of an active therapeutic species has a base layer of including a linking conductive base material which is consumed (oxidizes or reduces) preferentially to water, a first upper layer of sacrificial material coated on a first portion of the base layer wherein the sacrificial material is consumed preferentially to the linking conductive base material of the base layer. A second upper layer of non-conducting material is coated on a second portion of the base layer, the second upper layer being spaced from the first upper layer, connected by a narrow exposed linking area of the base layer material remaining exposed therebetween.

Abstract: A system delivers cardiac pacing therapy and chemical and/or biological therapy to modulate myocardial tissue growth in a heart after myocardial infarction (MI). The system includes an agent delivery device to release one or more agents to an MI region to modulate myocardial tissue growth in that region, and a cardiac rhythm management (CRM) device to deliver pacing pulses to enhance the effects of the one or more agents by altering myocardial wall stress and cardiac workload. In one embodiment, the system is an implantable system including an implantable agent delivery device and an implantable CRM device.

Abstract: A highly flexible implantable lead that offers improved flexibility, fatigue life and fatigue and abrasion resistance improved reliability, effective electrode tissue contact with a small diameter and low risk of tissue damage during extraction. In one embodiment the lead is provided with both defibrillation electrodes and pacing/sensing electrodes. For defibrillation/pacing leads, the lead diameter may be as small as six French or smaller. The construction utilizes helically wound conductors. For leads incorporating multiple separate conductors, many of the helically wound conductors are arranged in a multi-filar relationship. Preferably, each conductor is a length of wire that is uninsulated at about the middle of its length to create an electrode, wherein the conductor is folded in half at about the middle of the length to create first and second length segments that constitute parallel conductors.

Abstract: The various embodiments disclosed herein relate to medical electrical leads. More specifically, certain embodiments relate to leads having one or more drug-eluting components that are overmolded or otherwise positioned on the lead. Other embodiments relate to leads having one or more patterned surfaces, including some leads with one or more patterned surfaces over which one or more drug-eluting components are positioned. Further implementations relate to leads having one or more overmolded patterned surfaces, including some embodiments in which the overmolded surfaces contain at least one drug-eluting component.

Abstract: An implantable line for implantation in the left ventricle or left atrium of the heart with perforation of the atrial or ventricular septum, having an elongated flexible line body and an electrode and/or a sensor and/or a medication-dispensing device in a distal segment of the line body, i.e., in the left atrium or the left ventricle in the use state of the, such that the part of the line body situated in the blood vessel in or on the heart in the use state is at least partially provided with a surface coating or a surface structure that promotes ingrowth with endogenous tissue.

Abstract: An implantable subcutaneous device includes a lead and electrode for cardiac monitoring and intervention. The device has an implantable lead including a lead body, a subcutaneous electrode supported by the lead body and a pharmacological agent impelled from the device using phoresis. The pharmacological agent provides a therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent and using phoresis to impel the pharmacological agent into subcutaneous non-intrathoracic tissue surrounding the lead.

Abstract: A medical electrical lead comprises a flexible, elongate lead body extending along a longitudinal axis and having a proximal end and a distal end. A protective distal tip structure is disposed on the distal end of the lead body. The tip structure includes a plurality of compliant projections each extending distally from the distal end of the body in the direction of the longitudinal axis. The projections are configured to contact and bear against cardiac tissue when the lead is implanted, and are deformable under the action of an axially or radially directed force. The projections optionally include a coating over a substrate. The coating can include a hydrogel material and/or a pharmaceutical agent such as a steroid for reducing inflammation at the implantation site.

Abstract: Apparatus and methods are disclosed for inserting electrical leads within a heart. A method is provided for positioning a medical electrical lead in a cardiac vein. The method comprises inserting a lead within a coronary sinus, dispersing at least one vasodilating agent to dilate at least one cardiac vein, and inserting the lead into a dilated cardiac vein.

Abstract: An intravenous pacemaker electrode has an electrode tip designed to release a drug, where the drug contains at least one of the active substances sirolimus, paclitaxel, everolimus, fibrin, rapamycin, and tacrolimus.

Abstract: An implantable medical device can be configured to directly or indirectly release nitric oxide during its insertion in a patient. Such a device can reduce the amount of time required for implantation as well as reduce or prevent damage to the region surrounding the implanted device.

Abstract: A biologic agent delivery system provides for delivery of a biologic agent to a stimulation site to which electrical stimulation pulses are to be delivered from an electrical stimulation device. Examples of the electrical stimulation device include cardiac pacemakers and neural stimulators. The biologic agent modifies tissue property to lower the stimulation threshold of the stimulation site. The genetic modification of the tissue property improves efficacy and/or energy efficiency of an electrical stimulation therapy.

Abstract: A drug delivery system uses an electrically sensitive polymer to store a drug and applies an electric field onto the electrically sensitive polymer for quantitatively and temporally controlled drug delivery. In one embodiment, the drug delivery system is part of a cardiac rhythm management (CRM) system that includes an implantable CRM device and an implantable drug delivery device. The implantable CRM device delivers electrical therapies to a heart and controls the implantable drug delivery device by producing the electrical field with controllable amplitude, frequency, and timing.

Abstract: An implantable cardioverter defibrillator (ICD) including a set of leads having electrodes disposed therein. The electrodes may include a weld electrode connected to an internal wire of the lead and the ICD and a tip electrode. The tip electrode may have a set of grooves or cut out regions in its outer surface to provide edge effects for currents applied through the tip electrode. The grooves or cut out regions may form gaps in the surface of the tip electrode exposing a medical compound that is housed within the tip electrode. The medical compound may elute through the gaps.

Abstract: The present invention relates generally to medical devices; in particular and without limitation, to unique electrodes and/or electrical lead assemblies for stimulating cardiac tissue, muscle tissue, neurological tissue, brain tissue and/or organ tissue; to electrophysiology mapping and ablation catheters for monitoring and selectively altering physiologic conduction pathways; and, wherein said electrodes, lead assemblies and catheters optionally include fluid irrigation conduit(s) for providing therapeutic and/or performance enhancing materials to adjacent biological tissue, and wherein each said device is coupled to or incorporates nanostructure or materials therein. The present invention also provides methods for fabricating, deploying, and operating such medical devices.

Abstract: An implantable cardioverter defibrillator (ICD) including a set of leads having electrodes disposed therein. The electrodes may include a weld electrode connected to an internal wire of the lead and the ICD and a tip electrode. The tip electrode may have a set of grooves or cut out regions in its outer surface to provide edge effects for currents applied through the tip electrode. The grooves or cut out regions may form gaps in the surface of the tip electrode exposing a medical compound that is housed within the tip electrode. The medical compound may elute through the gaps.

Abstract: Implantable cardiac drug delivery systems. The systems are installed endocardially into a chamber in the heart, and are variously capable of delivering anti-arrhythmia agents into the heart wall, and into the epicardial space outside the heart, and into other chambers in the heart through the septa of the heart.

Abstract: The disclosure provides for devices and coatings that are substantially free of organic solvent sand suitable for insertion into a patient, and that comprise a metal layer and a coating with a thickness of about 20 nm to about 2000 nm wherein the coating comprises a biocompatible polymer comprising at least one residue covalently bonded to a nitric oxide generating compound.

Abstract: An implantable subcutaneous device and method employ a lead and an electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode coupled to the lead body, and a pharmacological agent provided on the implantable lead and/or electrode. The pharmacological agent provides a temporary therapeutic treatment to subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads involves providing a lead including a lead body, a subcutaneous electrode, and a pharmacological agent, and delivering the pharmacological agent to subcutaneous non-intrathoracic tissue surrounding the lead.

Abstract: An instrument for deploying a cardiac valve prosthesis, including a plurality of radially expandable portions, at an implantation site, includes a plurality of deployment elements each independently operable to obtain the radial expansion of a radially expandable portion of the valve prosthesis. The instrument includes a microprocessor configured to processes signals from one or more sensors and to optimize deployment of the valve prosthesis.

Abstract: A myocardial lead attachment system for securing a distal end of a lead within a myocardium of a patient's heart. The system includes a lead body, an anchor mechanism formed of a bioabsorbable or biodegradable polymer for engaging a surface of the patient's heart and a surface feature formed on a portion of the lead body for promoting formation of scar tissue around said portion of the lead body.

Abstract: A cardiac lead that is adapted and configured to elute a therapeutic agent to treat the surrounding tissue at a target location within a patient's heart is described. The cardiac lead includes a drug eluting member having a predetermined number of macroscopic surface features formed on its exterior surface. The macroscopic surface features allow the elution rate to be controlled and/or increased without the need for modifying the amount of therapeutic agent in the drug eluting member.

Abstract: A method for stimulating angiogenesis is provided that includes the use of an electrical output channel adapted to deliver a sub-threshold voltage, a lead that includes a proximal end adapted to be electrically connected to the electrical output channel and a distal end adapted to be placed in the blood conduit where the distal end of the lead is adapted to deliver a treatment agent that stimulates therapeutic angiogenesis, and at least one electrode on the distal end of the first lead.

Abstract: A cardiac stimulation assembly includes an energy source coupled to an energy emitter that extends form a delivery member into a region of tissue in the heart. An array of the emitters are adapted to extend from a delivery assembly and into unique locations along the region of tissue, such as by use of extendable, pre-shaped needles. A volume of conductive agent is delivered into the region and enhances stimulation of the region with the energy emitter. The agent may be an injectable preparation of living cells that express production of connexin, e.g. connexin 43, and may be genetically modified to over-express such production. The agent may include a non-living material, such as conductive polymer or metal or combination thereof. The combination of energy emitters and conductive agent enhances stimulation of the region. Delivering the stimulation assembly and conductive agent into the interventricular septum allows for improved biventricular septal pacing.

Abstract: Some embodiments relate to a method of implanting a cardiac lead. An expansion module is implanted in a target region within vasculature, the target region being defined by a portion of a brachiocephalic vein and a portion of a corresponding subclavian vein. The expansion module is transitioned from a collapsed state to an expanded state within the target region to contact the vasculature. A cardiac lead is implanted through the expansion module, the cardiac lead defining an intermediate section corresponding to the target region. The intermediate section of the cardiac lead includes a surface treatment adapted to reduce at least one of cell proliferation, thrombosis, fibrosis, and inflammation at the target region.

Abstract: An implantable cardiac lead includes an elongated lead body having opposed proximal and distal end portions, and a fluid delivery lumen extending therethrough. A connector assembly is operatively associated with the proximal end portion of the lead body. The connector assembly has a threaded engagement stem depending therefrom, and the lead includes a ported connector fitting having a body with a threaded engagement bore for threadably engaging the engagement stem. The body of the fitting has at least one passageway extending therethrough for communicating with the fluid delivery lumen of the lead body.

Abstract: In an elastomeric tube and a method for making such a tube, two medical-grade silicone rubber compositions are coaxially coextruded to form a tube. The compositions respectively differ in at least one physical property and respectively have similar curing conditions. The two compositions are blended at an interface formed between the two compositions during the coextruding, so that between 1-99% of the tube forms a blended gradient. The coextruded tube is then cured.

Abstract: A device that includes an electrical output channel adapted to deliver a sub-threshold voltage, a lead that includes a proximal end adapted to be electrically connected to the electrical output channel and a distal end adapted to be placed in the blood conduit where the distal end of the lead is adapted to deliver a treatment agent that stimulates therapeutic angiogenesis, and at least one electrode on the distal end of the first lead.

Abstract: In an electrically conductive lead adapted for implantation in a human or animal body, and a method for making such a lead, a drug-dispensing member is disposed at a distal end portion of the lead, at which an electrode member is disposed that is adapted to emit and/or sense electrical signals associated with medical therapy. The drug-dispensing member has a configuration so that, after implantation, the amount of drug released into the body per time unit is automatically controlled to smoothly vary with time from al larger amount to a smaller amount in accordance with a predetermined relationship of the amount of drug released as a function of time.

Abstract: A combined electrical and chemical stimulation lead is especially adapted for providing treatment to intervertebral discs. The combination lead may be placed proximate to intervertebral disc cellular matrix and nucleus pulposus tissue to promote tissue regeneration and repair, as well as nociceptor and neural tissue modulation. The stimulation lead includes electrodes that may be selectively positioned along various portions of the stimulation lead in order to precisely direct electrical energy to stimulate the target tissue. The lead also includes a central infusion passageway or lumen that communicates with various infusion ports spaced at selected locations along the lead to thereby direct the infusion of nutrients/chemicals to the target tissue.

Abstract: This document discusses, among other things, a lead assembly including a lead body, at least one conductor extending through the lead body, and a covering having varied material properties. In an example, the covering is made by forming pieces of material having varied material properties. In another example, the covering is made by varying parameters such as heat or tension during wrapping of a piece of material onto a lead assembly.

Abstract: A drug-eluting endocardial lead and method of manufacture. The silicone elastomer of the present invention is ideally suited to a manufacturing environment due to its extended pot life and decreased curing time. A preferred silicone elastomer is comprised of a multi-part mixture having at least a base portion and a curing portion. Additionally, since curing does not begin until the base and curing portions are combined, the mixing can be physically undertaken closer to the location of the endocardial lead and the curing “clock” does not start until the mixing occurs and external heat is applied. Since the silicone elastomer formed by base and curing components have improved the pot life and curing characteristics, the mixture is suitable for mixing with a steroid and then dispensing into an endocardial lead tip thus eliminating current design limitations imposed by current art while concomitantly minimizing manufacturing costs.

Abstract: The present invention provides delivery systems for and methods of delivering ion channel protein genetic material to cardiac cells in areas adjacent to where an electrode is to be positioned in a patient's heart to improve or correct the signal to noise ratio of cardiac signals, such as the P-wave. More specifically, there is provided a system and method for delivering sodium ion channel proteins or nucleic acid molecules encoding sodium ion channel proteins to a site in the heart adjacent to an electrode to increase the expression of the same, thereby enhancing the cardiac signal amplitude and enabling improved sensing of cardiac signals by an implanted pacemaker.

Abstract: One or more multi-electrode lead couplable with a medical device, such as an implantable medical device. Each lead includes a lead body extending from a lead proximal end portion to a lead distal end portion. The proximal end portion includes a connector assembly for connection to the medical device. An intermediate or distal end portion includes two or more electrodes and a drug region shared by at least two of the electrodes. In one example, the drug region is positioned between two or more electrodes such each of the electrodes may benefit from a drug in the region. In another example, the medical device comprises circuitry adapted to sense a heart in a first instance and stimulate the heart in a second instance using a selected electrode configuration. A method of forming a lead having a drug region shared by more than one electrode is also discussed.

Abstract: A low brightness pigment and method is provided from a heretofore rejected waste kaolin stream. Kaolin processing rejects are high in iron-stained TiO.sub.2. After separating the stained TiO.sub.2 from the high brightness kaolin and concentrating the resulting fraction, the material can be processed to produce a low brightness pigment suitable of many applications where lower brightness is desirable, such as coating paper board without mottling.