Abstract: The invention includes an assembly having a handle for articulating an articulator in an ergonomically improved manner. The handle can be adapted to articulate a distal portion of the articulator when squeezed. The handle can have at least one accessible attachment mechanism useful for reattachably attaching the articulator and the handle during a medical procedure. The invention also includes methods of making and using such a handle.

Abstract: Testing connectors for use with implantable leads are disclosed. The testing connectors are suitable for attachment to an implantable medical lead connector to facilitate electrical testing of the implantable lead. In some cases, a distal end of the lead can be repositioned within a body while the lead is electrically connected to a test device. A testing connector comprising the housing having a first side (106) and a second side (108) is disclosed. The first side of the housing defines a first channel and the second side of the housing defines a second channel. The first channel and the second channel are dimensioned to receive at least a portion of an implantable lead.

Abstract: A system including an implantable defibrillation electrode includes a first layer of porous Polytetrafluoroethylene (PTFE) adjacent to at least one surface of the defibrillation electrode, the first layer of porous PTFE having a fibril length adapted to bleed gas away from the at least one surface of the defibrillation electrode, and a second layer of porous PTFE formed over the first layer, the second layer of porous PTFE having a fibril length adapted to prevent substantially all tissue in-growth.

Abstract: A medical electrical lead is disclosed that is adapted for placement in the coronary sinus, or a branch vein thereof. The lead includes a first and second pace/sense electrode. A selection mechanism is provided to select either the first or the second electrode for use as a cathode, with the other electrode being selected as the anode. According to another aspect of the invention, a high-voltage coil electrode may be provided between the first and second electrodes. The coil electrode may be electrically coupled to the anode to increase the shadow area of the coil electrode.

Abstract: A steerable stylet for use within a lumen of an intravascular device includes a stylet assembly and a handle. The stylet assembly has a distal end portion and a proximal end portion and includes a stylet wire having a lumen and a core wire positioned within the lumen with the distal end portion secured to the stylet wire proximate the distal end portion of the stylet wire. The handle includes a hand-held housing structure connected to one of the proximal end portion of the stylet wire or the core wire. In one embodiment, an adjustable tensioner is connected to the other of the proximal end portion of the stylet wire or the core wire to adjust a relative tension force applied between the stylet wire and the core wire. A tension limiter is arranged to limit the tension force to a limit force that is less than a breaking stress force of the stylet wire when the stylet wire is positioned within the lumen of the intravascular device.

Abstract: A steerable stylet for use within a lumen of an intravascular device includes a stylet assembly and a handle. The stylet assembly has a distal end portion and a proximal end portion and includes a stylet wire having a lumen and a core wire positioned within the lumen with the distal end portion secured to the stylet wire proximate the distal end portion of the stylet wire. The handle includes a hand-held housing structure connected to one of the proximal end portion of the stylet wire or the core wire. In one embodiment, an adjustable tensioner is connected to the other of the proximal end portion of the stylet wire or the core wire to adjust a relative tension force applied between the stylet wire and the core wire. A tension limiter is arranged to limit the tension force to a limit force that is less than a breaking stress force of the stylet wire when the stylet wire is positioned within the lumen of the intravascular device.

Abstract: Disclosed is an improved system and method to selectively promote tissue ingrowth on, or adjacent to, an implantable medical device. In one embodiment, at least one surface of the housing of a medical device is in contact with a first portion of a porous PTFE having a pore size adapted to prevent substantially all tissue in-growth. This first portion, or layer, of porous PTFE material is further in contact at predetermined locations with an additional porous PTFE layer having a pore size adapted to selectively promote tissue in-growth only at the predetermined locations. Each of the PTFE layers may be formed of porous PTFE tubing or tape. Alternatively, the two layers may comprise a single composite structure that has a more porous material exposed on a first surface, and a less porous, more dense, material on a second surface. Another embodiment of the invention involves forming the layers of PTFE into a removable member that is adjacent to at least one surface of the implantable medical device.

Abstract: Disclosed is an improved system and method to selectively promote tissue in-growth on, or adjacent to, an implantable medical device. In one embodiment, at least one surface of the housing of a medical device is in contact with a first portion of a porous PTFE having a pore size adapted to prevent substantially all tissue in-growth. This first portion, or layer, of porous PTFE material is further in contact at predetermined locations with an additional porous PTFE layer having a pore size adapted to selectively promote tissue in-growth only at the predetermined locations. Each of the PTFE layers may be formed of porous PTFE tubing or tape. Alternatively, the two layers may comprise a single composite structure that has a more porous material exposed on a first surface, and a less porous, more dense, material on a second surface. Another embodiment of the invention involves forming the layers of PTFE into a removable member that is adjacent to at least one surface of the implantable medical device.

Abstract: An implantable device including an elastically compressible member coupled to a distal end of a lead and further coupled to at least one electrode. The compressible member is in a contracted state when the electrode is being delivered to an implant site. At the implant site, the compressible member is expanded to urge the electrode into contact with tissue. Compressible member further includes a keyed structure to engage a stiffening member such as a stylet. The stiffening member is used both to deliver the electrode to the implant site, and to rotate the compressible member, if necessary, so that the electrode contacts predetermined body tissue. According to one aspect of the invention, an introducer having an inner lumen with a diameter that is smaller than that of the compressible member may be used to disengage the stiffening member from the compressible member.

Abstract: A steerable stylet for use within a lumen of an intravascular device includes a stylet assembly and a handle. The stylet assembly has a distal end portion and a proximal end portion and includes a stylet wire having a lumen and a core wire positioned within the lumen with the distal end portion secured to the stylet wire proximate the distal end portion of the stylet wire. The handle includes a hand-held housing structure connected to one of the proximal end portion of the stylet wire or the core wire. In one embodiment, an adjustable tensioner is connected to the other of the proximal end portion of the stylet wire or the core wire to adjust a relative tension force applied between the stylet wire and the core wire. A tension limiter is arranged to limit the tension force to a limit force that is less than a breaking stress force of the stylet wire when the stylet wire is positioned within the lumen of the intravascular device.

Abstract: An implantable device including an elastically compressible member coupled to a distal end of a lead and further coupled to at least one electrode. The compressible member is in a contracted state when the electrode is being delivered to an implant site. At the implant site, the compressible member is expanded to urge the electrode into contact with tissue. Compressible member further includes a keyed structure to engage a stiffening member such as a stylet. The stiffening member is used both to deliver the electrode to the implant site, and to rotate the compressible member, if necessary, so that the electrode contacts predetermined body tissue. According to one aspect of the invention, an introducer having an inner lumen with a diameter that is smaller than that of the compressible member may be used to disengage the stiffening member from the compressible member.

Abstract: Disclosed is an improved system and method to selectively promote tissue in-growth on, or adjacent to, an implantable medical device. In one embodiment, at least one surface of the housing of a medical device is in contact with a first portion of a porous PTFE having a pore size adapted to prevent substantially all tissue in-growth. This first portion, or layer, of porous PTFE material is further in contact at predetermined locations with an additional porous PTFE layer having a pore size adapted to selectively promote tissue in-growth only at the predetermined locations. Each of the PTFE layers may be formed of porous PTFE tubing or tape. Alternatively, the two layers may comprise a single composite structure that has a more porous material exposed on a first surface, and a less porous, more dense, material on a second surface. Another embodiment of the invention involves forming the layers of PTFE into a removable member that is adjacent to at least one surface of the implantable medical device.

Abstract: A medical electrical lead is disclosed that is adapted for placement in the coronary sinus, or a branch vein thereof. The lead includes a first and second pace/sense electrode. A selection mechanism is provided to select either the first or the second electrode for use as a cathode, with the other electrode being selected as the anode. According to another aspect of the invention, a high-voltage coil electrode may be provided between the first and second electrodes. The coil electrode may be electrically coupled to the anode to increase the shadow area of the coil electrode.

Abstract: A system and method for deploying a lead in a cardiac chamber, a cardiac vein, or a coronary artery of a patient is disclosed. The system includes a delivery device such as a guidewire having an electrode retention member at the guidewire distal end to engage an electrode assembly. The guidewire is adapted to be inserted into the inner lumen of an introducer sheath so that the electrode retention member extends beyond the distal tip of the introducer. The electrode assembly is then coupled to the electrode retention member of the guidewire. The introducer includes means at the distal end adapted to engage the proximal end of the electrode assembly that is mounted on the guidewire. This allows the introducer to push the electrode assembly and the guidewire through the vasculature to a predetermined point of implant. The introducer may then be utilized to dislodge the electrode assembly from the guidewire at the predetermined implant site before the guidewire and introducer are withdrawn.

Abstract: An implantable electrode in the form a helically wound conductor having an electrically conductive polymeric layer coaxially surrounding and contacting the helically wound conductor, wherein the electrically conductive polymeric layer is electrically conductive in a dry state prior to implantation. Preferably, the electrode has two conductive portions, the additional second conductive portion being preferably located at the distal tip. The implantable electrode preferably incorporates an insulating portion wherein an additional length of the helically wound conductor is continuous with the remaining length of helically wound conductor coaxially covered by the electrically conductive polymeric layer. The insulating portion has a coaxial covering of impermeable polymeric electrically insulating material which is preferably silicone tubing.

Abstract: An implantable lead for use with cardiac pacemakers, defibrillators and other long term implantable electrical devices intended for sensing or tissue stimulation, having a helically wound conductor with a surrounding tubular insulating layer of elastomeric material such as silicone or polyurethane and an additional coaxial tubular exterior biocompatible layer of porous PTFE having a microstructure of nodes interconnected by fibrils. The exterior tubular layer of porous PTFE may be fitted coaxially over the elastomeric tubular layer whereby the porous PTFE tubular layer is in longitudinal compression and the fibrils within the microstructure have a bent and wavy appearance. Any portion of the length of the porous PTFE tubing in longitudinal compression allows that portion of the length of the lead wire to be extensible to a controlled extent limited by the straightening of the bent fibrils within the porous PTFE microstructure.

Abstract: A porous electrode for pacemakers is comprised of a plurality of platinum globules sintered together to form a porous mass of semi-hemispherical shape at the end of a platinum electrode stem. The globules, which are themselves made by sintering together spherically-shaped particles of approximately one micron diameter, provide the globules with an irregular outer surface of high total surface area. The globules have diameters within a critical range of 40-200 microns. The large total surface area of the globules improves the sensing function of an electrode configuration of given size and surface area, while the globule diameters of 40-200 microns have been found to beneficially accommodate tissue ingrowth within the electrode. In a preferred method of making the electrode, the platinum globules, which are formed by sintering together platinum particles of much smaller size, are mixed with organic solvent and organic binder to form a paste.

Abstract: A subcutaneous data port which may be surgically implanted beneath the skin of a subject and electrically connected to implanted leads, sensors or an implanted medica device. The data port provides electrical connections through conductive rubber access ports. The access ports can be penetrated by a coated needle, establishing an electrical connection. An indifferent plate electrode provides a replicable ground or body reference electrode.

Abstract: An implantable endocardial lead with retractable sharpened helix. The piston has a central bore for receiving a specialized stylet. The stylet comprises a flexible wire having an enlarged distal end or tip. An elastomeric sliding sleeve fits over the wire. When the proximal end of the stylet is inserted into the bore in the piston, the wire can be withdrawn slightly, pulling the enlarged tip into the tube, and wedging the tube against the walls of the bore. By manipulating the stylet, the helix can be exposed outside of the lead, or retractable into the lead, as desired.

Abstract: A porous electrode for pacemakers is comprised of a plurality of platinum globules sintered together to form a porous mass of semi-hemispherical shape at the end of a platinum electrode stem. The globules, which are themselves made by sintering together spherically-shaped particles of approximately one micron diameter, provide the globules with an irregular outer surface of high total surface area. The globules have diameters within a critical range of 40-200 microns. The large total surface area of the globules improves the sensing function of an electrode configuration of given size and surface area, while the globule diameters of 40-200 microns have been found to beneficially accommodate tissue ingrowth within the electrode. In a preferred method of making the electrode, the platinum globules, which are formed by sintering together platinum particles of much smaller size, are mixed with organic solvent and organic binder to form a paste.