Medtronic, Inc.

Medtronic Vascular, Inc.

William Berthiaume

Don H Tran

Erik Griswold

H Allan Steingisser

Brent L Locsin

Maria Valdovinos

James Calvin Allan

William W Chang

Suruchi Anand

Steven Lawrence Waldhauser

James Mitchell

Mike Krivoruchko

Karan Punga

Martha Barajas-Torres

Brian Castelli

Victoria Ung

Fatemeh Fatemi Far

Caitlin Dorff

Vance E Swanson

Rudolph A Beasley

Matthew S Poole

Arvind K Srinivas

Ashley Spink

Sean Miller

Fertac Bilge

Somboune Singkeo

Matthew David Bonner

Thomas A Anderson

Michael Gloss

Gianfranco Pellegrini

Joseph Berglund

Olivia P Metcalf

Matthew Genovese

Conor Flannery

Scott Doig

Noelle Christine Hurtig

Emily Grimm

Kris Kristofferson

Chris Collins

Matthew E Genovese

Emily A Grimm

Brent Locsin

Aspects of the disclosure include bodily lumen reshaping and reduction systems, devices and methods. Such implants can include a plurality of anchors serially interconnected with a cinching member. Delivery devices of the disclosure are configured to deploy a first anchor into tissue. The delivery device can then deploy a second anchor and wind the cinching member around the second anchor to reduce a distance between the first and second anchors, placating the tissue between the anchors. Additional anchors can be similarly deployed and the cinching member can be similarly adjusted to reshape the lumen. Methods of deploying and reshaping a bodily lumen are also disclosed. In various examples, the bodily lumen is a heart valve, atrial appendage, portion of a gastrointestinal tract or urethra. Various embodiments include one or more anchors having a ratchet assembly or the like to substantially prevent the cinching member from unwinding.

Systems, devices and methods for reshaping a bodily lumen

A catheter includes a handle with torqueing and steering mechanisms. The torqueing mechanism includes a rotatable nosecone and a bearing coupled to the nosecone to be rotatable therewith. The bearing is concentrically disposed over a shaft of the catheter. The steering mechanism includes a rack coupled to the bearing to be slideable therewith and a pull wire having a proximal end attached to the bearing and a distal end attached to a distal portion of the shaft. Rotation of the nosecone causes an entire length of the shaft to rotate and axial movement of the rack tensions the pull wire to bend the distal portion of the shaft. A valve relief component is slidingly disposed over the shaft and is configured to dock onto the handle when not in use.

Catheter handle with torque mechanism and valve relief component

The disclosure describes an annuloplasty device that includes a wire configured to extend around at least part of an annulus of a cardiac or vascular valve, such as at least partially around a circumference of the annulus, and a plurality of anchors. The anchors of the plurality of anchors are configured to engage the wire and anchor the wire to the annulus. The wire is configured to urge at least some anchors of the plurality of anchors toward each other in a radially inward direction to decrease a distance between valve leaflets that extend from the annulus.

Wire annuloplasty ring

A guide catheter assembly includes a dilator and a guide catheter. The dilator includes a dilator lumen extending from a distal opening at a distal end to a proximal opening at a proximal end, and a side exit port proximal of the distal opening and in communication with the dilator lumen. The guide catheter includes a proximal end, a distal end, and a guide lumen extending therebetween. The dilator and the guide lumen are sized such that the dilator can pass through the guide lumen. The dilator and the guide catheter are sized such that with the proximal end of the dilator generally aligned along an axis with the proximal end of the guide catheter, the distal end of the dilator extends distally past the distal end of the guide catheter and the side exit port is disposed distal of the distal end of the guide catheter.

Sheathless guide catheter assembly

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.

In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with an enlarged distal portion, wherein the enlarged distal portion is configured to substantially fill the inner lumen and close-off the distal opening of the outer sheath. The enlarged distal portion is slidable relative to the outer sheath. The inner sheath further includes a tether with a helical element that is remotely controllable from a proximal end of the inner sheath to release the implantable medical device from a distal portion of the outer sheath.

Implantable medical device delivery catheter with tether

A catheter includes a proximal portion and a distal portion, the distal portion including an arcuate portion. The catheter further includes a rotating portion, the rotating portion connecting the proximal portion and distal portion, the rotating portion including a first piece and a second piece, wherein the first piece and second piece create a snap fit. Methods of using the catheter include threading the inserted catheter through the vasculature and allowing the distal portion to freely rotate about an axis defined by the rotating portion responsive to any tortuosity in the vasculature.

Method of using catheter with rotating portion

In one example, this disclosure is directed to a kit for intravascular implantation of an implantable medical device within a patient, the kit comprising an elongated outer sheath forming an inner lumen with a distal opening, the outer sheath sized to traverse a vasculature of the patient, and an elongated inner sheath with an inflatable member at its distal portion. The inflatable member is inflatable from a proximal end of the inner sheath to close-off the distal opening of the outer sheath when inflated. The inner sheath further includes a stopper proximally located relative to the inflatable member. The inflatable member is remotely controllable from a proximal end of the inner sheath to retract in a proximal direction towards the stopper. The inflatable member can be retracted in a proximal direction towards the stopper and past an implantable medical device positioned within a distal portion of the outer sheath.

Intravascular implantable medical device introduction

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

Growing community of inventors

Santa Rosa, CA, United States of America

William Berthiaume