Abstract: A method for selecting a cardiac pacing site includes steps of: securing first and second electromagnetic receiver coils at first and second positions, respectively, along a heart wall; collecting a set of non-paced heart wall motion data from each of the coils secured at the corresponding positions; applying cardiac pacing stimulation at at least one first pacing site; collecting a first set of paced heart wall motion data from each of the secured coils; comparing the non-paced heart wall motion data to the first set of paced heart wall motion data; and determining, based on the comparing, whether to maintain pacing at the at least one first cardiac pacing site or to apply pacing stimulation at a second pacing site for collection of a second set of paced heart wall motion data. The at least one first pacing site may include a right ventricular site and a left ventricular site.

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: An elongated sheath of a guide catheter includes a fully radiopaque and echogenic distal tip having a length greater than approximately 0.08 inch.

Abstract: An implantable medical device (IMD) includes a connector header for making electrical and mechanical connections with a proximal connector assembly of an electrical medical lead and includes a retainer for retaining a penetrable grommet within a header grommet aperture. A connector block disposed within a header body of the connector header has a threaded bore aligned with a header grommet aperture and a connector block bore aligned with a header connector bore. The penetrable grommet is disposed within the header grommet aperture, and a setscrew is threaded into the threaded bore having a setscrew socket disposed to be engaged by a tool inserted through the penetrable grommet within the header grommet aperture to enable rotation of the setscrew within the threaded bore to tighten the setscrew against or to loosen the setscrew from a lead connector element received in the header connector bore.

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: A manipulator joined to a distal end of a delivery system shaft includes a plurality of arms and a collar. A proximal portion of each of the arms is joined to the shaft and a distal portion of each of the arms is joined to the collar such that the collar is substantially aligned with a lumen of the shaft. The lumen and the collar slideably and rotatably engage a medical electrical lead while a plurality of control wires, adapted to manipulate the manipulator, join to each of the plurality of manipulator arms in proximity to the distal end of the shaft.

Abstract: A non-sheath based medical device delivery system is provided including an elongated tubular guide body having a distal end fixedly attached to a resilient collet with a longitudinal opening to receive a medical lead or other device. The collet may be opened by actuating a retraction member to cause the closing member to slide proximally along the collet shaft, allowing the collet to maintain a normally open position. With the collet closed, the device may be advanced to a desired internal body location by advancing the guide body. The majority of the device body will be exposed, running alongside the guide body, allowing any sensors or electrodes located on the device body to be fully operational during the implantation procedure. The delivery system may be removed by opening the collet, to slidably disengage from the device body.

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: 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 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 electrically insulative layer of a shape memory alloy (SMA) actuator includes an inorganic material formed upon a portion of an SMA substrate. A conductive material formed upon a portion of the electrically insulative layer in a trace pattern includes a first end, a second end, and a heating element disposed between the first and second ends. The SMA substrate is trained to deform at a transition temperature achieved when electricity is conducted through the conductive material via first and second interconnect pads terminating the first and second ends of the trace pattern.

Abstract: An electrically insulative layer of a shape memory alloy (SMA) actuator includes an inorganic material formed upon a portion of an SMA substrate. A conductive material formed upon a portion of the electrically insulative layer in a trace pattern includes a first end, a second end, and a heating element disposed between the first and second ends. The SMA substrate is trained to deform at a transition temperature achieved when electricity is conducted through the conductive material via first and second interconnect pads terminating the first and second ends of the trace pattern.

Abstract: A shape memory alloy (SMA) actuator includes a groove formed in a surface of a shape memory alloy (SMA) substrate establishing a trace pattern for a layer of conductive material formed over an electrically insulative layer. The trace pattern includes a first end, a second end, and a heating element disposed between the first and second ends. The SMA substrate is trained to deform at a transition temperature achieved when electricity is conducted through the conductive material via first and second interconnect pads terminating the first and second ends of the trace pattern.

Abstract: A manipulator joined to a distal end of a delivery system shaft includes a plurality of arms and a collar. A proximal portion of each of the arms is joined to the shaft and a distal portion of each of the arms is joined to the collar such that the collar is substantially aligned with a lumen of the shaft. The lumen and the collar slideably and rotatably engage a medical electrical lead while a plurality of control wires, adapted to manipulate the manipulator, join to each of the plurality of manipulator arms in proximity to the distal end of the shaft.

Abstract: Improvements in connector headers of implantable medical devices (IMDs) for making electrical and mechanical connections with a connector element of a proximal connector assembly of an electrical medical lead and components thereof are disclosed. A connector block disposed within a header body of the connector header has a threaded bore aligned with a header grommet aperture and a connector block bore aligned with a header connector bore. A penetrable grommet is disposed within the header grommet aperture, and a setscrew is threaded into the threaded bore having a setscrew socket disposed to be engaged by the tool inserted through the penetrable grommet within the header grommet aperture to enable rotation of the setscrew within the threaded bore to tighten the setscrew against or to loosen the setscrew from a lead connector element received in the header connector bore.

Abstract: Bilumen catheters and methods of using same for facilitating implantation of cardiac leads for applying electrical stimulation to and/or sensing electrical activity of the heart through one or more electrode positioned at an implantation site within a heart chamber or cardiac vessel adjacent a heart chamber, and more particularly to a method and apparatus for introducing such a cardiac lead having low torqueability and pushability through a tortuous pathway to enable attachment of the cardiac lead at the implantation site employing a bilumen guide catheter are disclosed. The bilumen catheter body includes a relatively large diameter delivery lumen to introduce a small diameter cardiac lead and a small diameter guide lumen to receive a stylet or guidewire to locate the guide catheter body distal end at the implantation site. The small diameter lumen within a small diameter guide tube extends distally from the delivery exit port of the delivery lumen.

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: 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: An elongated sheath of a guide catheter includes a fully radiopaque and echogenic distal tip having a length greater than approximately 0.08 inch.

Abstract: A non-sheath based medical device delivery system is provided including an elongated tubular guide body having a distal end fixedly attached to a resilient collet with a longitudinal opening to receive a medical lead or other device. The collet may be opened by actuating a retraction member to cause the closing member to slide proximally along the collet shaft, allowing the collet to maintain a normally open position. With the collet closed, the device may be advanced to a desired internal body location by advancing the guide body. The majority of the device body will be exposed, running alongside the guide body, allowing any sensors or electrodes located on the device body to be fully operational during the implantation procedure. The delivery system may be removed by opening the collet, to slidably disengage from the device body.