Abstract: An improved system and method for deploying medical electrical leads is disclosed. The system includes a guiding device such as a guidewire used to navigate the vascular system of a body. The guiding device includes a fixation member that can be deployed to maintain the guiding device at a desired location within the vascular system. The fixation member may be an inflatable device such as a balloon, or alternatively, may be an expandable device constructed of flexible fibers that has both an expanded and a contracted state. The system may further include a coupling member located adjacent to the guiding device. The coupling member may be a rail extending distally from a proximal end of the guiding device to a point proximal the fixation member. In an alternative embodiment of the invention, the coupling member is a channel included in the body of the guiding device adapted to slidably engage an electrode assembly.

Abstract: An improved system and method that is capable of delivering multiple electrode assemblies to predetermined implant sites within a body is disclosed. The system includes an elongated member such as an introducer sheath. The introducer includes an elongated channel along at least a distal end portion of the introducer. The elongated channel opens to the exterior surface of the introducer through an elongated slot. One or more electrode assemblies may be retained within the elongated channel such that the leads exit the introducer via the elongated slot. The elongated introducer further includes a lumen that is in fluid communication with channel through openings, or gaps. The electrode assemblies are loaded within the channel at predetermined positions with respect to the openings. A distal end of a stiffening member such as a stylet may then be advanced within the lumen and through a selected one of the openings to engage an electrode assembly.

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: An electrical lead includes a coil disposed at a distal end of the electrical lead, the coil having an undulated shape in its free state and a fixation electrode disposed on and electrically coupled with the coil. The electrical lead further includes a pace/sense electrode disposed on the coil distally from the fixation electrode and electrically isolated from the coil and a conductor extending to the pace/sense electrode and disposed external to the coil. A method for implanting an electrical lead includes positioning the electrical lead within a vessel, positioning a fixation electrode of the electrical lead into contact with the vessel, and emitting an electrical energy from the fixation electrode to the vessel to anchor the electrical lead to the vessel.

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: An improved system and method for deploying medical electrical leads is disclosed. The system includes a guiding device such as a guidewire used to navigate the vascular system of a body. The guiding device includes a fixation member that can be deployed to maintain the guiding device at a desired location within the vascular system. The fixation member may be an inflatable device such as a balloon, or alternatively, may be an expandable device constructed of flexible fibers that has both an expanded and a contracted state. The system may further include a coupling member located adjacent to the guiding device. The coupling member may be a rail extending distally from a proximal end of the guiding device to a point proximal the fixation member. In an alternative embodiment of the invention, the coupling member is a channel included in the body of the guiding device adapted to slidably engage an electrode assembly.

Abstract: An improved system and method that is capable of delivering multiple electrode assemblies to predetermined implant sites within a body is disclosed. The system includes an elongated member such as an introducer sheath. The introducer includes an elongated channel along at least a distal end portion of the introducer. The elongated channel opens to the exterior surface of the introducer through an elongated slot. One or more electrode assemblies may be retained within the elongated channel such that the leads exit the introducer via the elongated slot. The elongated introducer further includes a lumen that is in fluid communication with channel through openings, or gaps. The electrode assemblies are loaded within the channel at predetermined positions with respect to the openings. A distal end of a stiffening member such as a stylet may then be advanced within the lumen and through a selected one of the openings to engage an electrode assembly.

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: A multi-conductor fluted channel construction catheter lead is comprised of an elongated flexible tubular inner body member having a peripheral surface on which a plurality of longitudinally-oriented fluted channels are defined. A plurality of elongated conductors are provided with at least one conductor being disposed within one of the fluted channels and operably connected at a distal portion to an electrode and at a proximal portion to a connector. An outer insulative sheath member surrounds the inner body member and the conductors. A method of constructing a fluted channel catheter lead is also disclosed.

Abstract: A system for passively anchoring mid-lead electrodes on an endocardial catheter lead includes at least one fibrosis-anchoring opening positioned along the exterior surface of the catheter lead body proximal or distal to the mid-lead electrodes for passively securing the catheter lead against the interior wall of the heart. Within the fibrosis-anchoring openings a suitable material is provided for anchoring the catheter lead body to the heart wall by fibrosis. Preferably, the fibrosis-anchoring openings comprise at least a pair of openings positioned only partially around the exterior of the catheter lead body at locations both proximal and distal to the mid-lead electrodes, with the catheter lead body between the fibrosis-anchoring openings being pre-formed to bias the mid-lead electrodes against the heart wall.

Abstract: An inflation system for pressurization and depressurization of a balloon catheter. The inflation system includes a syringe, including a syringe barrel, a plunger with expandable thread, a handle with cam, a syringe end cap, pressure gauge, flexible tubing, and connectors. The syringe is structured such that part of the syringe barrel has an internal thread which engages the expandable threads of the plunger. In the disengaged mode, the plunger slides freely within the syringe barrel allowing for rapid motion to purge, pressurize, or depressurize the inflation system. Once pressure reaches a predetermined level in the system, the cam on the handle causes the threads to automatically lock against the syringe barrel, and continued pressurization or depressurization is accomplished by the rotation of the plunger handle with respect to the syringe barrel. One advantage of the inflation system is that only one step is necessary for locking the syringe for controlled pressurization and depressurization.

Abstract: A pressure gauge including a bourdon tube where a substantial portion of the pressure gauge is filled with a silicone gel, gelatinous material, or any other suitable materials.