Abstract: Curves and dynamic shapes are imparted in distal segments of medical instruments e.g., catheters, through use of a temperature-activated actuator coupled to distal segment of the instrument body. The actuator comprises includes members extending side-by-side in substantially a common plane and configured to move in opposite directions when independently activated. A first heating device is coupled to a first actuator member and configured to deliver thermal energy to the first actuator member to activate the first actuator member and cause the first actuator member to move the distal segment in a first direction. A second heating device is coupled to a second actuator member and configured to deliver thermal energy to the second actuator member to activate the second actuator member and cause the second actuator member to move the distal segment in a second direction opposed to the first direction.

Abstract: A guide catheter has properties that promote enhanced visibility of the guide catheter using fluoroscopic or ultrasonic imaging techniques. The tip of the guide catheter may incorporate a material that is both fluoro and echo visible. The first material also may be provided in various amounts along the length of the guide catheter. In addition, the guide catheter may incorporate a reinforcing braid that includes one or more strands of a second material that is radio-opaque. As a result, the result guide catheter achieves improved radio-opacity and echogenicity.

Abstract: The present invention generally relates to an improved implantable medical device (IMD) and more particularly to an ultrasonically weld perforated lid for an IMD to form a hermetic seal between the IMD and the perforated lid. Appropriately configured perforated lids retain one or more components within a cavity or port formed in a part of an IMD. Such lids preferably secure a pierceable resilient grommet, septum or other resilient member in a cavity or port. When an adjustment instrument, a pull tool or a syringe is temporarily inserted therethrough and later extracted, the resilient member heals (i.e., seals and/or reseals). Preferably, the resilient member abuts a mechanical stop and is compressed slightly during assembly and ultrasonic welding of the lid. The resilient member preferably has a lateral dimension like the cavity or port so that when the lid compresses the resilient member it expands slightly and contacts the interior cavity surfaces thus improving the seal.

Abstract: An improved system and method for placing implantable medical devices (IMDs) such as leads within the coronary sinus and branch veins is disclosed. In one embodiment, a slittable delivery sheath and a method of using the sheath are provided. The sheath includes a slittable hub, and a substantially straight body defining an inner lumen. The body comprises a shaft section and a distal section that is distal to, and softer than, the shaft section. A slittable braid extends adjacent to at least a portion of one of the shaft section and the distal section. In one embodiment of the invention, the sheath further includes a transition section that is distal to the shaft section, and proximal to the distal section. The transition section is softer than the shaft section, but stiffer than the distal section.

Abstract: A system for delivering a medical electrical lead within a coronary venous system that includes an introducer kit for establishing venous access to the coronary venous system and a plurality of delivery sheaths, each corresponding to a desired approach to a coronary sinus of the coronary venous system and insertable within the coronary venous system through the navigation pathway. A hemostasis valve is coupled to a delivery sheath of the plurality of delivery sheaths, and a guide wire is inserted within the lead lumen, guiding delivery of the distal tip of the medical electrical lead to a target site within the coronary venous system through the hemostasis valve and the delivery sheath. Subsequent to the distal tip being delivered to the target sight, the hemostasis valve is advanced over the connector of the medical electrical lead to remove the hemostasis valve from the medical electrical lead.

Abstract: A loading device for loading a guide wire within a medical electrical lead that includes a navigation portion, having an outer portion, and extending from a front end to a back end, and having an opening formed at the back end. An engagement cavity receives and properly orientates the lead distal tip to align the lumen of the lead with the opening of the navigation portion during the loading of the guide wire within the lead. A first side wall is spaced from a second side wall to form a slot extending along the outer portion from the front end to the back end of the navigation portion, and the guide wire is advanced through the slot as the lead having the guide wire loaded therein is removed from the loading device.

Abstract: This is a combination method and system for intravascularly accessing and visualizing a body structure. A system is disclosed comprising a sheath, a balloon catheter, and a catheter deflection mechanism. A micro-deflection mechanism, which may be placed into the lumen of devices such as cardiac leads or electrophysiology catheters, is also provided for accurate guidance and placement of such devices to their target location. In one embodiment, a procedure for a lead or catheter placement is described in which a combination deflection mechanism, balloon catheter, and sheath assembly access the coronary sinus ostium via a superior approach. A distal balloon on the catheter is inflated and an occlusive venogram is obtained under fluoroscopic guidance to visualize the coronary veins. The sheath is advanced into the coronary sinus ostium and the balloon is deflated. The catheter and deflection mechanism are then removed.

Abstract: The present invention generally relates to implantable medical devices and more particularly to various means for ultrasonically welding, swaging or staking various components in an implantable medical device, most preferably by employing appropriately configured covers or lids. Covers or lids are attached to header or connector modules mounted on an hermetically enclosed and sealed enclosure, where the connector or header module and enclosure comprise an implantable medical device. The covers or lids preferably trap or otherwise secure any of a number of various connector or header module components within the header or connector modules. Examples of such trapped or secured components include grommets, set screw connector blocks, seals, feedthrough wires, multi-beam contacts, electrical contacts, antennas, radio-opaque markers, connector ribbons and the like.

Abstract: The present invention generally relates to implantable medical devices and more particularly to various means for ultrasonically welding, swaging or staking various components in an implantable medical device, most preferably by employing appropriately configured covers or lids. Covers or lids are attached to header or connector modules mounted on an hermetically enclosed and sealed enclosure, where the connector or header module and enclosure comprise an implantable medical device. The covers or lids preferably trap or otherwise secure any of a number of various connector or header module components within the header or connector modules. Examples of such trapped or secured components include grommets, set screw connector blocks, seals, feedthrough wires, multi-beam contacts, electrical contacts, antennas, radio-opaque markers, connector ribbons and the like.

Abstract: The present invention is directed to a thermoplastic resin composition comprising one or more polyetherimide resins; one or more polyester resins; at least one epoxy compound having one or more epoxy functional groups per molecule in an amount effective to improve at least one of impact resistance, hydrolytic resistance, and tab-bending performance of a molded specimen of the composition; and optionally, at least one catalyst in an amount effective to improve at least one of impact resistance, hydrolytic resistance, and tab-bending performance of a molded specimen of the composition as compared to the same composition not containing the catalyst. It was unexpectedly found that the compositions exhibited enhanced heat, impact, hydrolytic resistance, and/or enhanced tab-bending performance over other compositions known in the art. In a preferred embodiment, the epoxy compound contains 3,4-epoxycyclohexylmethyl-3,4-epoxycyclohexanecarboxylate and the catalyst contains sodium stearate.

Abstract: A method and apparatus for attaching a pre-formed header module, e.g. a connector header module or an electrode bearing header module, etc., to a hermetically sealed enclosure of the implantable medical device, typically including electronic integrated circuits, batteries, electromechanical pumps, or the like, are disclosed. A plurality of upstanding tabs that are fixed to the hermetically sealed enclosure, e.g. to the enclosure attachment surface, extend into a like plurality of tab channels formed in the header module housing. The upstanding tab(s) are inserted into the respective tab channel(s) during seating of the module and enclosure attachment surfaces and effects an initial alignment of the header module with the hermetically sealed enclosure.

Abstract: A method and apparatus for attaching a pre-formed header module, e.g. a connector header module or an electrode bearing header module, etc., to a hermetically sealed enclosure of the implantable medical device, typically including electronic integrated circuits, batteries, electromechanical pumps, or the like, are disclosed. A plurality of upstanding tabs that are fixed to the hermetically sealed enclosure, e.g. to the enclosure attachment surface, extend into a like plurality of tab channels formed in the header module housing. The upstanding tab(s) are inserted into the respective tab channel(s) during seating of the module and enclosure attachment surfaces and effects an initial alignment of the header module with the hermetically sealed enclosure.

Abstract: A method and apparatus for attaching a pre-formed header module, e.g. a connector header module or an electrode bearing header module, etc., to a hermetically sealed enclosure of the implantable medical device, typically including electronic integrated circuits, batteries, electromechanical pumps, or the like, are disclosed. A plurality of upstanding tabs that are fixed to the hermetically sealed enclosure, e.g. to the enclosure attachment surface, extend into a like plurality of tab channels formed in the header module housing. The upstanding tab(s) are inserted into the respective tab channel(s) during seating of the module and enclosure attachment surfaces and effects an initial alignment of the header module with the hermetically sealed enclosure.

Abstract: A method and apparatus for attaching a pre-formed header module to a hermetically sealed enclosure of an implantable medical device are described. A plurality of upstanding tabs attached to the hermetically sealed enclosure extend into a plurality of corresponding tab channels formed in the header module. The upstanding tabs are inserted into the respective tab channels during seating of the module and enclosure attachment surfaces and effect an initial alignment of the header module with the hermetically sealed enclosure. Each attachment tab has a retention feature such as a recess formed on or in the tab that is designed to receive molten thermoplastic material when ultrasonic energy is applied in the region of the tab channel.

Abstract: A system for disabling an oximetric device when radiation-carrying channels are exposed to excess ambient radiation is disclosed. It includes a transmitter channel adjacent the sample to be measured, means for isolating the channel from the sample so that it does not carry radiation reflected from or transmitted through the sample, a detector for receiving the transmitted signal, if any, and means for disabling the output in response to the transmitted signal. Preferably, the transmitter channel runs parallel to other transmitter channels in the device, and is isolated from undue ambient light. The system preferably includes means for determining when the second transmitted signal exceeds background noise and the output is disabled when the second transmitted signal exceeds background noise.

Abstract: There are provided melt extruded blends of diene based rubber and preextruded polyphenylene ether, or blends thereof with an effective amount of a stabilizer such as a hindered phenol or metal deactivator/hindered phenol. The resulting polyphenylene ether composition can be further extruded with a polymeric organic matrix material, such as a polyamide or polyetherimide. When molded, the polyphenylene ether compositions have been found to resist loss of impact strength upon thermal aging and recycling.

Abstract: A system for disabling an oximetric device when radiation-carrying channels are exposed to excess ambient radiation is disclosed. It includes a transmitter channel adjacent the sample to be measured, means for isolating the channel from the sample so that it does not carry radiation reflected from or transmitted through the sample, a detector for receiving the transmitted signal, if any, and means for disabling the output in response to the transmitted signal. Preferably, the transmitter channel runs parallel to other transmitter channels in the device, and is isolated from undue ambient light. The system preferably includes means for determining when the second transmitted signal exceeds background noise and the output is disabled when the second transmitted signal exceeds background noise.