Abstract: Elongated medical devices are disclosed adapted to be inserted through an access pathway into a body vessel, organ or cavity to locate a therapeutic or diagnostic distal segment of the elongated medical device into alignment with an anatomic feature of interest. Multi-lumen steerable catheters having a deflection lumen liner and a delivery lumen liner are adapted to be deflected by a deflection mechanism within or advanced through the deflection lumen liner to enable advancement of the catheter distal end through a tortuous pathway. At least one lumen liner is formed of a no yield elastomer.

Abstract: The present invention relates generally to medical devices; in particular and without limitation, to unique electrodes and/or electrical lead assemblies for stimulating cardiac tissue, muscle tissue, neurological tissue, brain tissue and/or organ tissue; to electrophysiology mapping and ablation catheters for monitoring and selectively altering physiologic conduction pathways; and, wherein said electrodes, lead assemblies and catheters optionally include fluid irrigation conduit(s) for providing therapeutic and/or performance enhancing materials to adjacent biological tissue, and wherein each said device is coupled to or incorporates nanotube structures or materials therein. The present invention also provides methods for fabricating, deploying, and operating such medical devices.

Abstract: A splined multilumen body for use in elongated medical devices is provided for carrying multiple conductors, wires or cables to multiple device components along the device body. Open lumens may be provided through which medical devices or therapies may be delivered. The multilumen body is constructed from a generally tubular outer member having inward-radiating splines that mate with outward-radiating splines on a generally tubular inner member. Lumens formed between sets of mated splines isolate conductors carried therein. Interaction of mated splines provides good torque transfer between outer and inner members. Materials for fabricating outer and inner members may be selected to achieve desired torque transfer properties, flexibility, and surface friction.

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: A method involves selecting a type of cell for implantation into a mammal and identifying the specific gravity or density of the cell type. Then, a carrier liquid is selected which has a specific gravity or density within a range of specific gravities or densities which approximately matches the specific gravity or density of the selected cell type. A liquid for delivery of growth cells into tissue of a mammal is also provided in which the density of a carrier fluid component is matched to the density of the cells being consistently delivered by the carrier fluid.

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: 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 slitting tool for severing a tubular body includes a body portion, extending along a first axis, joined to a nose portion extending along a second axis, the second axis extending at an angle between approximately 5 degrees and approximately 90 degrees with respect to the first axis.

Abstract: A slitting tool is provided for severing a tubular body such as the body of an introducer or a guide catheter that is positioned around an implantable medical device (IMD) such as a lead or another catheter. The slitting tool includes a body member that has a surface adapted to be gripped by a user. The surface includes a channel that is provided to align the IMD with respect to the body of the slitting tool. The gripping action of the user maintains the IMD within the channel such that the channel need not attach to the IMD. The slitting tool includes a cutting member coupled to the body member and positioned to sever the tubular body without severing the IMD.

Abstract: A steerable guidewire or stylet that has increased torsional strength is disclosed. A braided structure located in the vicinity of at least the distal end of the guidewire or stylet provides for a more efficient transfer of rotational force over the length of the guidewire or stylet. The braided structure may be comprised of a flat metal ribbon wire that may optionally be reinforced with a polyimide. According to one aspect of the invention, the stylet includes an outer member, and a pull-wire located within the outer member. The pull-wire is coupled to the distal tip of the outer member such that when tension is applied to the pull-wire, the distal tip of the outer member is deflected. The distal tip of the outer member may be formed of a material having superelastic properties such as a nickel titanium alloy, whereas the proximal portion of the stylet may be formed of a material having more torsional strength.

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: An introducer system for introducing a lead or catheter and a method of use. The introducer system includes an elongated introducer sheath which has a luer hub mounted to its proximal end through which a lead or catheter is introduced and a slitter for slitting the luer hub and the introducer sheath. The slittable luer hub takes the form of a conical or cylindrical member carrying a laterally extending tab adapted to engage internal threading on a female luer lock fitting and has a slittable portion angularly displaced from the tab. The slitter includes a blade, a handle carrying the blade, a mechanism for engaging the lead or catheter in the vicinity of the blade and a mechanism for engaging the lead or catheter proximal to the blade, configured such that the lead or catheter body when engaged by the slitter is angled proximal to the blade of the slitter.

Abstract: A deflectable stylet or guidewire formed of an elongated tube having a coil mounted to its distal end and a movable tension or push wire mounted within the coil and the tube, mechanically coupled to the distal end of the coil. A backbone is located within the coil, mechanically coupled to the proximal and distal ends of the coil and extending along one side of the coil. The backbone may be provided with projections extending laterally between adjacent turns of the coil and may have a generally arcuate cross section having a width greater than its arc height. In some embodiments the backbone may be formed from a tube having a slot extending longitudinally along one side thereof. In some embodiments the backbone may be attached to the coil at points between the proximal and distal ends of the coil.

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 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: 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: 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 deflectable tip introducer or guide catheter optimized for placement of leads or catheters within the vasculature of the human body is disclosed. The introducer includes inner and outer concentrically located tubular sheaths. The inner and outer sheaths are preferably provided with different curved configurations, allowing the over-all displayed curvature of the introducer over its distal portion to be adjusted by longitudinal movement of the inner and outer sheaths relative to one another. The outer sheath may be fabricated of a thin tube of polyetheretherketone (PEEK) or other material having a relatively large stiffness as compared to the inner sheath. The outer sheath is sized to fit closely around the inner sheath. The inner sheath may be formed of a reinforced polyurethane, and preferably has a thin wall that is of about 0.005 inches in thickness or less.

Abstract: An introducer is structured with an elongated tube having first and second lumens. A molded handle is coupled to the proximal end of the tube with an opening aligned with the first lumen. Further, a wall adjacent the opening of the handle defines a slot and is located diametrically opposite the second lumen. A tubular reinforcement member is located within the second lumen and the handle is provided with a second opening, thereby having a communication with the second lumen. In another embodiment a lead/catheter introducer includes an implantable lead or catheter having an elongated first lumen through which the lead or catheter passes and a second lumen extends parallel to the first lumen along at least a distal portion thereof. A tubular reinforcement member is disposed within the second lumen. The tubular reinforcement member further includes an internal lumen and a curvable stylet disposed in the lumen.