Abstract: A tachy lead includes a lead body extending from a lead proximal end portion to a lead distal end portion and having an intermediate portion therebetween, one or more tissue sensing/stimulation electrodes disposed along the lead body, one or more terminal connections disposed along the lead proximal end portion. The lead further includes one or more conductors contained within the lead body extending between the tissue sensing/stimulation electrodes and the terminal connections, a porous drug-eluting coating disposed onto at least a portion of the lead body and/or sensing/stimulation electrodes, wherein the drug-eluting coating comprises porous polytetrafluoroethylene (PTFE), a biodegradable polymer and one or more drugs.

Abstract: A medical electrical lead containing a pyroelectric material is provided. The pyroelectric material is capable of dissipating heat generated in the lead due to radio frequency energy. The pyroelectric material may be a polymeric material, such as polyvinylidene fluoride (PVDF).

Abstract: A method for coating a medical device with a drug is provided. Energy, preferably thermal energy, is applied to a crystalline deposit of a drug on the surface of a medical device to increase the molecular mobility and form a conformable drug coating with a low density of micro-cracks and other mechanical defects that can degrade the coating toughness and effective adhesion to the device surface. In a preferred embodiment, solution evaporation methods are used to deposit a crystalline coating of an anti-inflammatory steroid on a medical electrode. Heat applied at a controlled temperature, for a predetermined amount of time, induces a solid-state phase change of the drug coating providing a smooth, uniform, well-attached, conformable coating to form a layer that will elute from the electrode over time when implanted in a patient's body.

Abstract: A medical fluid delivery system includes an implantable medical lead including a fixation element adapted to secure the lead to a tissue site and a fluid delivery device including a tissue piercing distal tip; the device is adapted to pass through a proximal port, a lumen and a distal port of the lead. The system further includes means for adjusting a position of the device distal tip with respect to the lead distal port.

Abstract: A cardiac rhythm management system includes a lead assembly for intracardiac mapping, pacing, and drug delivery. The lead assembly includes an implantable endocardial lead having a proximal end for connection to an implantable cardiac rhythm management device and a distal end for disposal in an intracardiac region. The lead includes a pacing-sensing electrode and a drug delivery device, both located at or near the distal end. A lumen is within and extends throughout the lead, with an opening at or near the proximal end and another opening at or near the distal end. The lumen provides for access to the intracardiac region by a steerable stylet and a hollow needle, one at a time. The steerable stylet allows for electrophysiological mapping of the intracardiac region. The hollow needle allows for delivery of chemical, biochemical, and/or biological substance to the intracardiac region.

Abstract: An assembly is provided for an implantable medical lead. The assembly includes a first lead body comprising one or more electrical leads, and a hermetic encasement. The encasement comprises a housing having first and second openings and interior walls, an interior space defined by the interior walls, an electronic network housed within the interior space, and a circuit board extending through the first and second openings. The circuit board comprises a plurality of layers into which the electronic network is at least partially integrated, a first set of one or more terminals electrically coupling the electronic network to the first lead body, and a second set of one or more terminals electrically coupled to the electronic network for external electrical engagement.

Abstract: The present invention is an apparatus for treating a selected patient tissue or organ region, at the surface of such region. The apparatus has an accessing tool for accessing the patient region, the tool having a distal end, and a proximal end at which the tool can be manipulated to place the distal end adjacent to the patient region. The apparatus also has a probe carried on the distal end and defining a contact surface that may be urged against the patient region thereby creating contact pressure. A pressure transducer is operatively coupled to the probe and is capable of producing a measurable response to the contact pressure. A monitoring device is operatively connected to the pressure transducer, for determining the contact pressure. An effector is operatively disposed on the probe for producing a given effect on the patient region when the effector is activated, and an activator operatively connected to the effector, by which the effector can be activated.

Abstract: An RF-energy modulation system dynamically adjusts tuned receiving circuits within a plurality of slave devices, thereby regulating the level of power reception in each slave device. The slave devices receive power from a single master device, through coupling of a primary antenna in the master device with a secondary antenna in each slave device. The amount of the power received by each slave device is a function of the antenna separation distance, and is thus different at each slave device location. The RF-energy modulation system monitors the power requirements of the slave device within which the modulation system is included, and modulates the tuning of the secondary antenna to maintain the proper power reception level. Advantageously, such modulation controls the power reception by the slave device, versus dissipating energy already received by the slave device.

Abstract: In a cardiac stimulating device, an infection control current is generated and applied to a subject in whom a medical device is implanted by completing a circuit including an entirely electrically conductive exterior of a housing of the device, an electrode carried by an electrode lead of the device, and an electrically conductive surface of a proximal portion of the electrode lead, extending from the housing to a location, after implantation, situated beyond entry of the electrode lead into the venous system and before entry of the electrode lead into the superior vena cava. The infection control current can be a current with a square waveform, and the circuit can be completed at selected times, such as only during the refractory period of the subject's heart.

Abstract: The present invention relates to a system and method for the delivery of therapeutic agents, such as therapeutic drugs or genetic material, into the muscle or tissue that minimizes the loss of therapeutic agents due to contraction of the muscle. In one embodiment, an implant for delivering therapeutic agents into a muscle is provided, wherein the implant has at least one rod for insertion and delivery of therapeutic agents into the muscle and a patch that can be attached to the exterior surface of the muscle for preventing or minimizing therapeutic agent being expelled due to the contraction of the muscle, such as the beating of a heart muscle.

Abstract: A cardiac lead is disclosed which includes an elongated lead body having opposed proximal and distal ends, a tip electrode operatively associated with the distal end of the elongated lead body, a connector operatively associated with the proximal end of the elongated lead body and electrically connected to the tip electrode, and a cylindrical eluting ring disposed proximate the tip electrode and formed from a compound including an elastomer and about 15% to 25% by weight medicament.

Abstract: A medical fluid delivery system includes an implantable medical lead and a fluid delivery device; the device is adapted to pass through a proximal port, a lumen and a distal port of the lead. The fluid delivery device includes a tissue piercing distal tip and a pre-formed curve in proximity to the distal tip such that the tip is directed away from a lead fixation element after passing beyond the distal port of the lead.

Abstract: A lead for delivering electrical signals to and/or receive electrical signals from a human heart that includes a solid inner conductor, and a fixation device having a titanium nitride coated surface and electrically coupled to the inner conductor. A steroid is applied to the titanium nitride surface of the fixation device, and at least one layer of insulation is positioned around the inner conductor. A conductive coil is positioned around and is insulated from the inner conductor, an electrode ring electrically coupled to the conductive coil is positioned around and is electrically isolated from the inner conductor, and an insulating spacer is positioned between and electrically isolates the ring electrode and the fixation device.

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: An implantable device such as a lead is adapted for implantation on or about the heart and for connection to a system for monitoring or stimulating cardiac activity. The implantable device includes an active fixation assembly for securing the device to tissue. The active fixation assembly includes one or more recessed portions therein.

Abstract: An intracardial electrode lead comprises a distal end, a proximal end and an elongate electrode lead body which includes a helical coil having a lumen and a sheath enclosing the helical coil. The distal end of the electrode lead carries a an electrode. The electrode is electrically connected to a connection at the proximal end of the electrode lead for communication with a medical device. The distal end has a sleeve with a proximal end and a distal end, which is enclosed by the distal end of the helical coil at the sleeve proximal end and contacts a lip seal at its distal end. The lip seal elastically closes a distal opening of the lumen. The sleeve is also electrically connected to the electrode, which has an external surface and projects distally beyond the lip seal.

Abstract: A system is disclosed, for administering a therapeutic agent locally and to a depth within cardiac tissue. An elongate, flexible catheter contains a flexible electric conductor and supports at its distal end an implantable electrode incorporating a penetrating element, typically a fixation helix or a linear needle that penetrates cardiac tissue as the electrode is implanted. A therapeutic agent is delivered through the electrode, to the cardiac tissue surrounding the penetrating element. The electrode can act as a sensor, to monitor an electrical condition of the surrounding cardiac tissue, and to control delivery of the agent responsive to the sensed electrical condition. Several embodiments feature a distal reservoir adjacent the electrode for effecting transient deliveries of the therapeutic agent in minute quantities. Other embodiments are disclosed for providing sustained deliveries of the agents.

Abstract: A medical system incorporating fluid delivery and lead delivery lumens dispense fluid into a volume of tissue. The fluid comprises or contains a pharmacologic, genetic, or biologic agent. The fluid may be dispensed initially during implantation or later using a minimally invasive medical procedure.

Abstract: Apparatus (800) for targeted release of a molecule carried in a circulating reservoir, comprising: at least one electrode (804); and a controller (810) adapted to electrify said electrode (804) with at least one electric field, said electric field operative to have at least one desired effect related to said circulating reservoir with said molecule, wherein said electrode and said electrification are adapted such that at least one of said effects is selectively applied to a particular blood vessel that carries blood through tissue and wherein said at least one effect that is selectively applied comprises a release effect, which releases said molecule from said circulating reservoir that circulates in said blood vessel.

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: An electrode assembly for use in an iontophoresis device for the transcutaneous administration of an active therapeutic species includes a base layer of conductive 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 conductive 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, a narrow exposed linking area of the base layer material remaining therebetween. The exposed linking area of the base layer extends across the base layer. During operation of an associated iontophoresis device, the sacrificial material will be sequentially consumed; the first upper layer will be followed by the exposed linking area of the base layer which severs the base layer thereby breaking circuit continuity in the device.

Abstract: A lead assembly includes insulative tubing with at least one tine coupled thereto, and a lumen extends through the tubing. The tine has a first position that extends away from the exterior of the tubing, and a second compressed position. In the second compressed position, the tine at least partially compresses the lumen.

Abstract: A therapeutic device and therapeutic method for delivering electrical energy or a medicament to a body tissue or organ utilizing ultrasonic vibration to cause a device implanted in the body tissue or organ to be treated to discharge an electrical current or medicament to the target area.

Abstract: The patterns of contraction and relaxation of the heart before and during left ventricular or biventricular pacing are analyzed and displayed in real time mode to assist physicians to screen patients for cardiac resynchronization therapy, to set the optimal A-V or right ventricle to left ventricle interval delay, and to select the site(s) of pacing that result in optimal cardiac performance. The system includes an accelerometer sensor; a programmable pace maker, a computer data analysis module, and may also include a 2D and 3D visual graphic display of analytic results, i.e. a Ventricular Contraction Map. A feedback network provides direction for optimal pacing leads placement.

Abstract: A device for treating atrial fibrillation includes a pad which houses the distal end of an electrode which is adapted to deliver a substantially uniform shock gradient to an atrial surface of a postoperative cardiac patient, if atrial fibrillation is detected. The device also includes a catheter for delivering anti-arrhythmic and/or anesthetic drugs to the pad. After a treatment period, the device may be removed by pulling the electrode and the pad, if the pad is not bioabsorbable, into the catheter and then pulling the catheter through the patient's chest wall.

Abstract: An implantable lead system includes an elongated device slideably engaged within a lumen of a lead body. A distal portion of the elongated device is slidable through a helix tip coupled to a distal end of the lead body by passing through a pierceable fluid-tight seal disposed in proximity to the distal end of the lead body; the seal prevents ingress of bodily fluid into the lumen of the lead body.

Abstract: A lead having an electrode assembly has a high impedance electrode. The high impedance electrode includes a partially insulated sleeve electrode or a wire filament. The high impedance electrode includes an exposed surface of less than 1.2 mm2. One or more eluting drugs are disposed adjacent to the high impedance electrode.

Abstract: An ionically conductive polymeric composition is disclosed. The composition is especially useful for coating an implantable hot can defibrillator electrode. The polymeric composition, for example, polyethylene oxide containing NaCl or a similar ionic medium, can be used to coat and fill the pores of a high surface area electrode to provide a continuous ionic network from the can to the adjacent body tissue. The conductive polymeric composition is biocompatible, chemically and mechanically stable and does not dissolve or leach out over the useful lifetime of the defibrillator. A hot can defibrillator employing the polymeric coating avoids development of high polarization at the can/tissue interface and maintains a more uniform defibrillation threshold than conventional implantable defibrillators, thus increasing the feasibility of pectoral implantation, particularly in a “dry pocket” environment.

Abstract: According to one embodiment, a combined electrical and chemical stimulation lead adapted for implantation proximate target nerve tissue in a person for combined electrical and chemical stimulation of the target nerve tissue, includes a lead body. One or more electrodes located along the lead body and adapted to be positioned proximate the target nerve tissue and to deliver electrical stimulation pulses transmitted through the lead to the target nerve tissue. One or more infusion ports located along the lead body and adapted to be positioned proximate the target nerve tissue and to deliver chemical stimulation pulses transmitted through the lead to the target nerve tissue. The lead is adapted to provide combined electrical and chemical stimulation of the target nerve tissue using the one or more electrodes and the one or more infusion ports.

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: 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 implantable subcutaneous device and method employ a lead and/or electrode for cardiac monitoring and intervention. The device includes an implantable lead having a lead body, a subcutaneous electrode supported by the lead body, and a pharmacological agent provided on the implantable lead body and/or an inactive can portion. 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: A catheter is comprised of a flexible cylindrical tube defining a proximal portion and a distal portion terminating in a distal tip. The tube has a plurality of openings formed therethrough to form a diffusion area. The catheter includes a conductive end cap enclosing a distal tip. A flexible conductive member is attached to the conductive end cap and extends to the proximal portion where it is attached to the inside diameter of the flexible tube. The member is movable within the tube. Because of the rules governing abstracts, this abstract should not be relied upon in construing the claims.

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: 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 low cost, accurate, single use, disposable, iontophoretic fluid delivery device having cationic and anionic chambers separated by container structure and arranged to promote a flow of treatment ions into a body. The device desirably uses rugged mini batteries safely to provide increased electromotive force to the ion transfer process compared to galvanic cells having electrolyte matched to a human body's electrolyte. Mini batteries may be located in one or both cationic and anionic chambers, and/or attached to structure of a container outside the chambers. One or more electric circuit components may be arranged in a parallel circuit to the body to provide enhanced efficacy of the device. For example, a shunt resistance may be provided to control delivery of a beneficial agent in an amount over a time interval corresponding to any portion of a battery capacity, typically between 1 mAmp-min to 500 mAmp-min, or more.

Abstract: An irrigation probe useful for ablation during open heart surgery is provided. The irrigation probe comprises a generally rigid probe body and a handle mounted to the proximal end of the probe body. The generally rigid probe body has an electrode at its distal end having at least one irrigation opening through which fluid can pass. An infusion tube extends through the probe body for introducing fluid to the electrode.

Abstract: A medical fluid delivery system includes an implantable medical lead and a fluid delivery device; the device is adapted to pass through a proximal port, a lumen and a distal port of the lead. The fluid delivery device includes a tissue piercing distal tip and a pre-formed curve in proximity to the distal tip such that the tip is directed away from a lead fixation element after passing beyond the distal port of the lead.

Abstract: A method of making a temporary medical electrical lead for pacing or defibrillating a heart of a patient.

Abstract: A small implantable stimulator(s) includes at least two electrodes for delivering electrical stimulation to surrounding tissue and/or a pump and at least one outlet for delivering a drug or drugs to surrounding tissue. One electrochemotherapy method disclosed includes delivery of electrical stimulation in the form of a direct electric current and/or a periodic waveform that locally potentiates the cytotoxic effects of a systemically and/or locally administered chemotherapy agent(s). Open- and closed-loop systems are disclosed.

Abstract: A catheter system for injecting therapeutic agents including large molecules into the body. The catheter includes a distensible penetrating element with a distally locating expansion coil and a distally located chamber for holding a therapeutic agent which is to be injected into the body.

Abstract: An implantable lead system includes an elongated device slideably engaged within a lumen of a lead body. A distal portion of the elongated device is slidable through a helix tip coupled to a distal end of the lead body by passing through a pierceable fluid-tight seal disposed in proximity to the distal end of the lead body; the seal prevents ingress of bodily fluid into the lumen of the lead body.

Abstract: A physiological pacing system including a physiological pacing lead having an electrode array and a means for fixation, including a collar for securing the fixation means to a lead body of the pacing lead, is inserted into a bore within a heart wall at a physiological pacing site. The system further includes a means to create the bore, the means being a piercing tip, which is either coupled to a piercing tool or the pacing lead. The piercing tool may be an elongated hollow shaft into which the pacing lead is slideably insertable or a stylet wire, which is slideably insertable within a lumen of the pacing lead. Once the electrode array is implanted within the bore, a first pair of electrodes is selected for sensing and a second pair of electrodes is selected for pacing.

Abstract: An implantable cardiac lead is disclosed that 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: Apparatus for intracardiac drug administration, including a catheter which is inserted into a chamber of the heart and brought into engagement with a site in the heart wall. The catheter includes at least one position sensor, which generates signals responsive to the position of the catheter within the heart, and a drug delivery device, which administers a desired dose of a therapeutic drug at the site determined responsive to the signals from the position sensor.

Abstract: The present invention is an apparatus for treating a selected patient tissue or organ region, at the surface of such region. The apparatus has an accessing tool for accessing the patient region, the tool having a distal end, and a proximal end at which the tool can be manipulated to place the distal end adjacent to the patient region. The apparatus also has a probe carried on the distal end and defining a contact surface that may be urged against the patient region thereby creating contact pressure. A pressure transducer is operatively coupled to the probe and is capable of producing a measurable response to the contact pressure. A monitoring device is operatively connected to the pressure transducer, for determining the contact pressure. An effector is operatively disposed on the probe for producing a given effect on the patient region when the effector is activated, and an activator operatively connected to the effector, by which the effector can be activated.

Abstract: A catheter having an improved electrode that minimizes irritation to the heart tissue and counters the occurrence of foreign body reactions is provided. The catheter comprises an elongated, flexible catheter body having proximal and distal ends and at least one lumen extending therethrough. At least one electrode, such as a tip electrode or ring electrode, is mounted on the distal end of the catheter body, wherein the electrode comprises a base material having an outer surface and a hydrogel layer applied over at least a portion of the outer surface of the base material. Preferably a drug or other therapeutic agent is incorporated into the hydrogel layer.

Abstract: A high impedance bipolar cardiac lead is disclosed that includes a lead body with a distal electrode assembly that includes an anodic ring electrode and a coaxially disposed cathodic tip electrode, wherein the anodic ring electrode and the cathodic tip electrode are separated from one another by a drug eluting insulating member.

Abstract: A system for accessing targeted tissue within the living being and introduction of particles at select locations into the myocardium and other select tissues. The system includes an instrument and a plurality of flowable particles to be delivered by the instrument via an externally applied force. The particles to the tissue may include one or more of pharmaceuticals, biologically active agents, radiopaque materials, etc.

Abstract: A method and apparatus for accessing the pericardial space which provides for stable short term or long term placement of a delivery catheter or cannula having its distal most end located in the pericardial space. The catheter or cannula may be introduced into the pericardial space either transvenously through the wall of a heart chamber or transthoracically by penetrating the chest wall and the pericardium. Some embodiments are provided with a mechanism for stabilizing the distal end of the catheter or cannula, which mechanism may employ an extensible elastic, generally tubular member located at the distal end of the catheter or cannula. The device may be provided with a mechanism for extending the tubular member longitudinally, causing its diameter to diminish substantially.