Abstract: An apparatus and method for delivering a drug selectively and locally to internal body tissue with a catheter using electric current/voltage controlled in conjunction with active pacing of cardiac activity.

Abstract: A body-implantable transvenous endocardial lead for an implantable medical device system. The lead includes inner and outer coiled conductors each surrounded by a flexible elongate sheath such that the inner conductor is rotatable within the outer sheath. An electrode assembly disposed at the distal end of the lead includes a distally-projecting fixation helix. A sliding member in the electrode assembly includes a helix-engaging collar for engaging the coils of the fixation helix, such that when the helix is rotated in a first direction with respect to the sliding member, it is advanced in a screw-like fashion distally forward with respect to the sliding member, and when the helix is rotated in a second direction with respect to the sliding member, it is retracted proximally backward with respect to the sliding member. A tip electrode is disposed on the distal end of the sliding member.

Abstract: A medical lead which has a reinforced tine assembly. In particular, the medical electrical lead of the present invention features an elongated lead body covered by an insulative sheath. Positioned upon the proximal end of the lead body is a terminal assembly. Terminal assembly permits the lead to be connected to a pulse generator. Positioned at the distal end of the lead body is an electrode. Also positioned proximate the electrode is a tine assembly. The tine assembly is preferably made from a insulative bio-compatible material, preferably silicone. The tine assembly further features a reinforcement to prevent the tine assembly from elongating. In the preferred embodiment, a polyester is used to provide reinforcement member.

Abstract: An implantable devices for the effective elimination of an arrhythmogenic site from the myocardium is presented. By inserting small biocompatible conductors and/or insulators into the heart tissue at the arrhythmogenic site, it is possible to effectively eliminate a portion of the tissue from the electric field and current paths within the heart. The device would act as an alternative to the standard techniques for the removal of tissue from the effective contribution to the hearts electrical action which require the destruction of tissue via energy transfer (RF, microwave, cryogenic, etc.). This device is a significant improvement in the state of the art in that it does not require tissue necrosis.In one preferred embodiment the device is a non conductive helix that is permanently implanted into the heart wall around the arrhythmogenic site.

Abstract: A pacing lead having a stylet introduced anti-inflammatory drug delivery element advanceable from the distal tip electrode. The element is preferably formed as a moldable biocompatible composite material. The element has a biocompatible matrix material which may be combined with drugs and therapeutic agents to deliver the drugs and agents by co-dissolution or diffusion to the point of either passive or active fixation. The drug delivery element may be rigid and serve to center the means, preferably a helix, for active fixation of the lead in the myocardium.

Abstract: A joint for cardiac stimulation lead has a sleeve that joins a conductor to an electrode. The conductor and electrode are inserted into passages formed through the sleeve and are bonded at least to the sleeve surface by laser welding, crimping, or resistance welding. The distal end of the conductor is attached to the sleeve and either the proximal end or the distal end of the electrode may be attached to the sleeve. The number, size, shape and positioning of passages in the sleeve are varied according to the desired lead configuration to allow passage of additional conductors through the joint.

Abstract: A stylet-actuated, steroid-eluting, screw-in, endocardial, transvenous bipolar pacing lead. In an embodiment, the lead is provided, with a sharpened helix. Advancing and retraction of the helix is accomplished with a stylet having a flattened, screw-driver tip. Rotation of the stylet imparts rotation to the helix assembly, causing the helix to advance or retract. A segmented tip electrode having a porous coating thereon allows steroid from a monolithic controlled released device housed within the electrode assembly to be eluted at the location of the implant site.

Abstract: A medical electrical lead system having a torque transfer stylet. In a preferred embodiment, the torque transfer stylet comprises an elongated, stylet wire having proximal, intermediate and distal sections. The proximal and distal section of the stylet wire have a first diameter. The intermediate section spans between the proximal and distal sections. The stylet wire in this region, however, has a second diameter, the second diameter smaller than the first diameter of the proximal and distal sections. In addition, the intermediate section further has a length of torque coil wrapped thereabout. The torque coil preferably is wound in a coiled diameter which is the same as the first diameter of the proximal and distal sections of the stylet wire. Through such a configuration the stylet has an overall nearly uniformed diameter through its length.

Abstract: A body implantable electrode with rate controlled drug delivery is disclosed. A body implantable lead is provided for the delivery of stimulation energy to a desired body site includes a drug dispenser carried by the lead which retains a drug to be dispensed at least adjacent the desired body stimulation site. The drug may be one which is intended to counter thrombus formation, fibrosis, inflammation or arrhythmias, for example. The drug may be in liquid or powder form retained in a reservoir carried by the lead. The reservoir is formed as a pump which controls dispensing of the drug using a fluid drawing agent such as a salt.

Abstract: A chronic myocardial pacing lead for the delivery of stimulation energy to and the sensing of electrical signals from the myocardium of a human heart. In one embodiment the lead is bipolar, having a sleeve electrode implanted into the myocardium and a pad electrode positioned on the epicardium. The lead includes a drug for delivery through the sleeve electrode to the myocardium. The disclosed lead is highly flexible to minimize tissue reaction, this permits the lead to offer relatively low pacing thresholds, high impedance, and excellent sensing in a configuration which is relatively easy to implant.

Abstract: The invention relates to implantable devices and materials, in which at least one part of the surface is provided with a tissue-plasminogen activator (t-PA). In this way, inflammatory reactions of the body and the formation of fibrous capsules, which ordinarily occur after implantation, are avoided or reduced.

Abstract: Heart function is monitored by monitoring the momentum or velocity of the heart masses, preferably by means of a sensor implanted in the heart mass.

Abstract: A pacing lead having a stylet introduced anti-inflammatory drug delivery element advanceable from the distal tip electrode. The element is preferably formed as a moldable biocompatible composite material. The element has a biocompatible matrix material which may be combined with drugs and therapeutic agents to deliver the drugs and agents by co-dissolution or diffusion to the point of either passive or active fixation. The drug delivery element may be rigid and serve to center the active fixation element, preferably a helix, for active fixation of the lead in the myocardium.

Abstract: An ablation catheter and a method of performing cardiac ablation. The catheter is provided with a hollow, helical electrode, which is screwed into cardiac tissue at a desired ablation site and connected to a source of R-F electrical energy to ablate the tissue adjacent the electrode. Prior to ablation, a conductive fluid may be injected through the hollow needle, both to provide for cooling of the tissue adjacent the needle and to increase the conductivity of the tissue in the area of the electrode.

Abstract: An electrical lead has a cardioverting/defibrillating electrode composed of a multiplicity of tiny flexible elongate metallic fibers, for implantation in a patient. One embodiment of the lead is implanted by puncturing the chest/abdominal wall of the patient and inserting the lead, fiber electrode first, into the body through the puncture site followed by maneuvering the lead by endoscopy to position the electrode adjacent the epicardium of the heart for electrical interaction with the ventricles. The fibers may be interwoven to form a thin tube prestressed to assume a flat spiral shape to permit it to be straightened with a stiffening wire for maneuvering to return to its flat spiral shape after proper positioning and removal of the wire. In other embodiments, the lead has multiple conductors electrically connected to respective electrodes arranged on the lead for positioning transvenously relative to selected regions of the heart.

Abstract: An ablation catheter and a method of performing cardiac ablation using alcohol or other ablating agents. The catheter is provided with a helical hollow needle, which is screwed into heart tissue, after which the ablating agent is delivered through the needle. Prior to ablation, the catheter may be employed to locate an appropriate ablation site or to assess the suitability of an identified ablation site by injection of a exitability reducing agent such as lidocaine, through the hollow needle, followed by a determination of whether the arrhythmia intended to be treated as temporarily terminated.

Abstract: An epicardial lead having an stab-in electrode extending from the bottom thereof in combination with an anchoring system adapted to secure the lead to the heart without the use of complex procedures or tools. In particular the lead achieves stable fixation through the provision of a flexible member moveable between a first position and a second position and a pair of fixation members connected to said flexible member, each fixation member having a distal end and a root, said distal end and root defining a plane said through which said stab-in electrode crosses.

Abstract: A system for controlled release, site-specific delivery of therapeutic agents, particularly myocardial agents such as antiarrhythmic agents, comprises a biocompatible polymeric matrix with an incorporated therapeutic agent for direct placement at the epicardium. Advantageously, the dosage form can be fabricated in such a manner as to tailor the release characteristics as required by the nature of the physical condition desired to be treated. In a specific illustrative embodiment, lidocaine, an antiarrhythmic depressant, is incorporated in polyurethane by a unique method which permits drug-loading of the polymeric matrix from about 5% up to 40% by weight, with about 25% to 30% in a preferred embodiment. A novel FeCl.sub.3 catalyst causes the polyurethane to polymerize despite the presence of drug in the polymeric matrix mixture.

Abstract: A catheter with a retractable anchor mechanism for providing drugs and/or electrical stimulation to the human body. The catheter has a flexible tubular casing consisting of a outer member and an inner member which enclose at least one lumen. The retractable anchor mechanism is located near the distal end of the catheter and is moveable from a first extended position to a second retracted position. A capture member is connected to the anchor mechanism. The capture member has a socket portion and a necked down portion for guiding the enlarged tip of a stylet into the socket portion for releasable engagement therewith. The anchor mechanism is moved from the first extended position to the second retracted position by inserting a stylet and applying pressure in the distal direction and is moved from the second retracted position to the first extended position by partially withdrawing the stylet thereby applying pressure in the proximal direction.

Abstract: A lead for delivering electrical stimulation pulses to pace the cardiac muscle and for sensing electrical signals occurring in the cardiac muscle is disclosed which as a rigid helix disposed at the extreme distal end thereof which rigid helix may be operated by the implanting physical to extend the tip of the rigid helix from a stored position within the distal end of the lead to a deployed position projecting from the distal end of the lead. The rigid helix pierces and engages the heart tissue to anchor the lead in place within the heart. The tip of the rigid helix has an axial bore therein which is filled with a therapeutic medication such as a steroid or steroid-based drug for inhibiting inflammation and promoting tissue growth. After the tip of the helical screw is disposed in the heart tissue, the therapeutic medication will be slowly eluted into the surrounding tissue, thereby minimizing the trauma of implantation and assisting in the anchoring of the lead.

Abstract: An implantable stimulation lead having an anti-inflammatory coating on the exposed surface area of the distal tip electrode. The coating is a semi-viscous or gelatinous material having the ability to absorb physiological fluids to provide electrical conductivity through the coating. The coating preferably has a matrix having an innate hypo-inflammatory property which can be combined with drugs and therapeutic agents to deliver the drugs and agents by co-dissolution or diffusion, or alternatively the matrix material can be used as a coating to keep the electrode surface electrochemically clean prior to and during implant.

Abstract: A system and method for cardiac diagnosis and treatment inserts the distal end of a catheter into a heart chamber. The distal end of the catheter supports at least one electrode. The catheter has a fluid flow conduit extending through it. The conduit has a valve that prevents fluid flow from the heart chamber into the conduit in response to in vivo pressure generated during heart systole and diastole. The valve permits fluid flow from the conduit into the heart at a pressure above the in vivo pressure. In use, the catheter locates the electrode in contact with a portion of the endocardium, and fluid is conducted from an external source through the conduit at a pressure above the in vivo pressure to flush the area surrounding the electrode.

Abstract: A small diameter, unipolar or bipolar, atrial or ventricular transvenous or epimyocardial pacing lead with a porous, platinized, steroid eluting cathode electrode exhibiting an effective surface area in the range of 0.1 to 4.0 mm.sup.2, preferably 0.6 to 3.0 mm.sup.2, provides low stimulation thresholds in the range of 0.5 volts, 0.5 milliseconds, very high pacing impedance (800 to 2,000 .OMEGA.), relatively low polarization, good to excellent sensing, and adequately low source impedance. The high pacing impedance prolongs the longevity of pacing pulse generators and allows for the miniaturization of their components. The low thresholds allow large safety factors at low applied voltages, which also contribute to increased battery longevity.

Abstract: A method for placing various types of catheters into the pericardial space takes advantage of the fact that the right auricle is a thin-walled, low-pressure structure which can be readily penetrated without damaging the pericardium or the epicardium. The method avoids surgical trauma and the risks of general anesthesia and infection. A catheter is guided downstream through one of the venae cavae to the right atrium. Once inside the right atrium, the catheter is passed into the right auricle. The wall at the apex of the right auricle is then pierced to gain access to the pericardial space. The method can be used, for example, to provide electrical stimuli to the heart (e.g., for pacing, cardioversion, and defibrillation), to pick-up an ECG signal, to deliver pharmacologic agents to the heart, to improve vascularization, to remove pericardial fluid for analysis or pericardiocentesis, or to inject a radio-labelled or echo-sensitive dye into the pericardial space for precision fluid imaging.

Abstract: A cardiac pacemaker lead wherein a tubular catheter has a proximal end connected to a pacemaker and a distal end provided with an electrode which can be anchored in or otherwise connected with a wall in the heart of a patient. The lead can be extracted from the body of the patient by resorting to an elongated flexible wire-like stylet having a front end receivable in an internal chamber of the distal end of the catheter. The front end of the stylet constitutes or includes a first coupling element and the chamber confines or is defined by a second coupling element which can be engaged by the first coupling element, e.g., in response to rotation of the fully inserted stylet relative to the catheter or in response to heating of the first coupling element. The coupling prevents tearing of the flexible portion of the catheter and/or separation of the flexible portion from the distal end during extraction of the stylet.

Abstract: A cardiac lead for transmitting electric current to the heart and/or sensing and monitoring electrical activity of the heart has an elongated electrical conductor connected to a head. An electrode mounted on the head comprises a helical wire adapted to be turned into heart tissue. The helical wire is coated with platinum black particles which decrease electrical losses at the electrode-tissue interface. A plug impregnated with a drug located within the head is in contact with the helical wire and platinum black particles thereon. The drug migrates from the plug to the active outer end section of the electrode.

Abstract: The pacemaker includes a casing housing a pulse generator having at least one electrode tip preferably projecting out of said casing and being insulated therefrom, whereby no plug-receptacle nor electrode catheter is required. The pacemaker is to be surgically located below the heart in the virtual cavity formed between the epicardium and the pericardium with its electrode tip in close contact with the epicardium of the heart.