Medtronic, Inc.

Medtronic Vascular, Inc.

Brent L Locsin

Don H Tran

William Berthiaume

H Allan Steingisser

Erik Griswold

Maria Valdovinos

James Calvin Allan

William A Berthiaume

Suruchi Anand

Barry Wohl

Maria Waldovinos

An inner subassembly of a delivery system assembly extends within a lumen of an elongate outer tube of the assembly, and includes a flared distal end, which is preferably configured to conform to a proximal end of an implantable medical device; a distal-most portion of the outer tube is sized to contain both the flared distal end and an entirety of the medical device. The inner subassembly includes a core, an elongate pull-wire, extending along the core, and a sheath surrounding the pull-wire and the core; the sheath includes a slot opening that allows the pull-wire to pass laterally therethrough. The assembly preferably has a pre-formed curvature along a length of the sheath, and the slot opening extends along the pre-formed curvature. The outer tube is longitudinally moveable relative to the inner subassembly, for example, to deploy the medical device.

Delivery system assemblies for implantable medical devices

A delivery system assembly includes an elongate outer tube, an elongate inner member extending within a lumen of the outer tube, and an articulation sheath surrounding the outer tube between a handle of the assembly and a distal-most portion of the outer tube. The outer tube is longitudinally moveable within the sheath; and an inner diameter of the sheath is preferably smaller than that of the handle and the distal-most portion of the outer tube. Navigation of the assembly through a venous system, for deployment of an implantable medical device, is facilitated by deflection of the sheath, to orient a distal-most portion of the outer tube, within which an entirety of the medical device is contained/loaded, and by subsequent advancement of the distal-most portion, with respect to the sheath, to move the distal end of the inner member, along with the contained/loaded device into proximity with a target implant site.

Delivery system assemblies and associated methods for implantable medical devices

A tether subassembly, which may be employed by a tool that deploys an implantable medical device, includes a test segment for verification of adequate fixation of the device at an implant site. When the device is located in proximity to a distal opening of the tube, a tether first length extends through an attachment structure of the device and within an elongate tube of the tool, a tether second length extends alongside the tether first length within the tube, and the test segment is located in proximity to the distal opening. The test segment is configured so that only a tug force, applied to the tether first length, and greater than or equal to a predetermined force, can pull the test segment through an aperture, either of the delivery tool or of the device. The predetermined force corresponds to a minimum adequate fixation force for the device.

Interventional medical systems, tools, and subassemblies

A delivery system assembly includes an outer tube, an inner member, extending within a lumen of the outer tube, and a deflectable shaft, extending within the outer tube lumen and around the inner member; the tube and inner member are longitudinally moveable with respect to the shaft, and a distal end of the inner member is located distal to the shaft within the tube lumen. A medical device can be loaded into the tube lumen, along a distal-most portion of the tube, and contained between the inner member and a distal opening of the tube lumen. Deflecting the shaft orients the distal-most portion for navigation of the assembly, and, when the distal end of the inner member is engaged within the tube lumen, distal movement of the tube, with respect to the shaft, causes similar distal movement of the inner member and the loaded medical device toward an implant site.

A tool of an interventional medical systems system includes a core configured to be temporarily attached to the implantable medical device, as the tool deploys the device to expose a fixation member of the device for engagement with tissue at a target implant site; the core is then employed to verify adequate fixation of the deployed device via a tug test. An operator determines that the device is adequately fixed by the engaged fixation member, if a tug force that is applied to the core modifies the temporary attachment between the core and the device, to allow release of the device from the temporary attachment. A tether, which is fixedly attached to the core, may be employed to create the temporary attachment between the core and the device, or the temporary attachment may be created by a snap fit formed between the core and the attachment structure of the device.

Interventional medical systems, tools, and associated methods

Implantable medical devices and methods use an intravascular implantable medical device having an elongated housing module to contain one or more circuitry components. An opening is defined through the elongated housing module. A lead, including at least one electrode, is coupled towards the distal end of the elongated housing module and at least a portion of the at least one electrode is in a stowed position within the opening defined through the elongated housing module during implant of the implantable medical device. The at least one electrode is advanceable from the stowed position to a location distal of the distal end of the elongated housing module.

Intravascular medical device with advancable electrode

A delivery system assembly includes an elongate inner member that extends distally through a lumen of an elongate outer tube of the assembly; the outer tube is moveable relative to the inner member between first and second positions to deploy an implantable medical device that is held within the outer tube lumen. The inner member may include a flared distal end that abuts, and preferably conforms to, the proximal end of the device, when the device is held within the outer tube lumen. The assembly further includes a stability sheath that surrounds a limited length of the outer tube, in proximity to the handle, to provide an interface for both an operator, who handles the assembly, and for an introducer sheath that provides passage for the assembly into the venous system, so that movement of the outer tube is not hindered by either during device deployment.

A steerable delivery catheter includes an outer sheath with a housing disposed at a distal end thereof to define a chamber for a medical device, the chamber having an open distal end and a proximal inner shelf. An inner shaft is slidably disposed within the sheath and has an abutment attached to the distal end of the shaft, the abutment being slidably contained within the chamber. During navigation of the catheter, when the inner shaft is tensioned the abutment engages the shelf to apply a compressive force to the sheath to selectively deflect a distal region of the catheter. When the catheter has been navigated to the deployment site the sheath is withdrawn while the abutment maintains the medical device in place as it is deployed. A delivery method also is disclosed.

Steerable delivery catheter

A catheter for delivering a medical implant in a patient's vasculature includes an elongate catheter having a distensible and frangible cap mounted across the open distal end thereof. The cap is distendable by pressure within the catheter to provide a bumper tip for guiding the catheter through a patient's vasculature. At the desired site for deploying the medical implant, the cap is ruptured to permit the implant to be advanced through the distal opening. Methods of using the catheter are also disclosed.

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San Francisco, CA, United States of America

Brent L Locsin