摘要:
An implantable electrical medical lead for a pulse generator includes a distal electrode, a connector for electrical connection with the pulse generator, an electrical conductor within the lead extending between the connector and the distal electrode, and an insulating sheath of flexible resilient material normally covering the electrical conductor having self sealing properties to re-insulate the electrical conductor in the event a rupture of the sheath should occur which exposes the electrical conductor. The insulating sheath includes an outer insulative layer, an inner insulative layer, and an intermediate plasticized layer to seal any occurring rupture in the insulating sheath and re-insulate the electrical conductor which has been exposed.
摘要:
An implantable lead assembly for a body implantable medical system adapted to transmit electrical signals between a proximal end portion of the lead assembly and a distal end portion of the lead assembly to thereby stimulate selected body tissue includes an elongated insulative sheath of flexible resilient material having at least one longitudinally extending lumen, an electrical conductor received within the lumen of the insulative sheath and extending between a proximal end and a distal end, and at least one elongated super plastic element slidably received within the lumen of the insulative sheath, the super plastic element being bendable to configure the lead assembly to negotiate tortuous turns in the vasculature of the body. An electrical connector is coupled to the proximal end of the conductor for releasable attachment to a stimulating pulse generator and an electrode is coupled to the distal end of the conductor.
摘要:
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.
摘要:
To implant a lead system for an implantable cardiac stimulation device, a guide wire is slidably introduced into a longitudinally extending internal passage of an elongated stylet. In turn, the combined stylet and guide wire are slidably introduced into the longitudinally extending lumen of an elongated tubular lead body of flexible resilient insulative material having a thrusting region near its distal end. With the distal end of the stylet in engagement with the thrusting region of the lead, the stylet together with the lead and guide wire are advanced until the lead should encounter a tortuous turn in the vasculature of the body. At this point, the guide wire is advanced through the stylet and into the vasculature until the distal end of the guide wire arrives at a chosen location. The stylet then re-continues its advance together with the lead until the lead reaches the desired implant location.
摘要:
An implantable cardiac stimulation lead system for use with an implantable stimulation device includes at least a pair of conductors, braided together and extending between proximal and distal ends and co-extruded with flexible resilient insulation material. Each conductor may be a multi-strand cable composed of MP35N or DFT and have its outer peripheral surfaces coated with insulative material. An electrical connector is coupled to the proximal end of the lead system for connection with a stimulation device and includes terminals electrically connected to the conductors. The proximal connector is thereby electrically coupled to a distal tip electrode and to at least one electrode proximally spaced from the distal tip electrode. The lead system may include an elongated tubular lead body of flexible resilient insulative material having a longitudinally extending lumen for receiving a stylet for aid in implanting the lead system. Alternatively, an introducer sheath may be employed for implantation.
摘要:
A lead assembly for a body implantable medical system adapted to transmit electrical signals between proximal and distal end portions of the lead assembly to thereby stimulate selected body tissue includes an electrical conductor, an insulative sheath composed of silicone or polyurethane covering the conductor, an electrical connector coupled to the proximal end of the conductor for releasable attachment to a stimulating pulse generator and a distal electrode coupled to the distal end of the conductor. The distal electrode has an outer surface generally coaxial with the lead assembly and facing transversely of the longitudinal axis of the lead assembly and generally parallel to the selected body tissue intended for stimulation. The outer surface of the distal electrode is composed of a biocompatible metallic alloy and includes a layer of a material that exhibits low polarization and thereby enhances the electrical efficacy of the electrode.
摘要:
An implantable cardiac stimulation lead system for use with an implantable stimulation device includes an elongated lead with a conductor extending between distal and proximal ends. A tubular insulating sheath overlies the conductor and has an outer peripheral surface of revolution defined by a radius originating at the longitudinal axis. A tip electrode at the distal end of the lead is attached to the conductor. A proximal connector is in electrical continuity with the stimulation device and coupled to the tip electrode. The insulating sheath is formed with a passive fixation feature formed into the outer peripheral surface for encouraging tissue ingrowth to facilitate stability of the tip electrode when the lead system is implanted. No portion of the passive fixation feature extends radially from the longitudinal axis by a distance greater than the radius of the tubular insulating sheath.
摘要:
An implantable stimulating electrode for directly contacting the endocardium of a human heart exhibits low polarization values of less than about 0.3 mV and is intended for use with an implantable lead having an electrical connector coupled to the proximal end of a conductor for releasable attachment to a stimulating pulse generator. The electrode is comprised of a metallic substrate having an initially exposed outer surface substantially covered with a first inner layer of titanium nitride and a second outer layer of platinum black. The first inner layer of titanium nitride has a thickness of less than about 15 microns and the second outer layer of platinum black overlying the layer of titanium nitride, similarly, has a thickness of less than about 15 microns. The invention includes a method of making the implantable stimulating electrode.
摘要:
An electrode assembly for a body implantable lead comprises a longitudinally extending dispenser housing having an internal cavity with opposed longitudinally extending openings for storing a drug to be dispensed. A tip electrode integral and axially aligned with the dispenser housing has a face adapted for positioning adjacent the desired body site, a transverse channel formed into and transversely across its face, and an orifice extending between the channel and the internal cavity for elution of the drug to the desired body site. A weld sleeve integral and axially aligned with the dispenser housing distant from the tip electrode has an outer peripheral surface for engageably receiving one end of an elongated electrical conductor, and a collar spaced from the dispenser housing. The electrical conductor is welded to the collar to obtain a welded connection for electrical continuity between the tip electrode and the electrical conductor. An insulative sheath of resilient material is fittingly received on the outer peripheral surface of the dispenser housing overlying the longitudinally extending openings and the welded connection between the electrical conductor and the weld sleeve. Insulative tubing is received on the coiled conductor includes a skirt member distant from the tip electrode and coaxial with the insulative tubing and biased radially into engagement with the outer peripheral surface of the insulative tubing. A plurality of fixation tines are integral with, and extend radially outwardly from, the insulative sheath at a plurality of circumferentially spaced locations.
摘要:
Selective high-frequency spinal chord modulation for inhibiting pain with reduced side affects and associated systems and methods are disclosed. In particular embodiments, high-frequency modulation in the range of from about 1.5 KHz to about 50 KHz may be applied to the patient's spinal chord region to address low back pain without creating unwanted sensory and/or motor side affects. In other embodiments, modulation in accordance with similar parameters can be applied to other spinal or peripheral locations to address other indications.