Abstract:
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.
Abstract:
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.
Abstract:
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.
Abstract:
Delivery catheters for delivery of prosthetic heart valves are provided. The delivery catheters include brim recapture funnels configured for recapture of prosthetic heart valves. The brim recapture funnels are configured to recapture valve brims of partially deployed prosthetic heart valves to reduce or minimize damage to patient anatomy during a valve withdrawal procedure. Brim recapture funnels as described herein may be activated via suture control.
Abstract:
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.
Abstract:
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.
Abstract:
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.
Abstract:
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.
Abstract:
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.