# US 11,432,927 B2 · Implantable device and delivery system for reshaping a heart valve annulus

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- Number: US 11,432,927 B2
- Document ID: US11432927B2
- Status: Granted
- Kind: B2
- Application number: 16/718,745
- Filed: 2019-12-18
- Published: 2020-05-14
- Granted: 2022-09-06
- Earliest claimed: 2017-02-10
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Randall Lashinski; Kristian Kristoffersen; Matthew Rust; Richard Glenn; Michael J. Lee; Patrick E. Macaulay; Kenny D. Bruner; Padraig J. Savage; Nathan D. Brown
- Web page: https://patentgrep.com/patent/US11432927B2

## CPC

- A61F 2/2442: {Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve}
- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/243: {Deployment by mechanical expansion}
- A61F 2/2466: {Delivery devices therefor}
- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2230/0056: W-shaped, e.g. M-shaped, sigma-shaped
- A61F 2230/0065: toroidal, e.g. ring-shaped, doughnut-shaped
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61F 2250/0006: for adjusting angular orientation
- A61F 2250/001: for adjusting a diameter
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

Systems, devices and methods related to various heart valve implants and for delivery of those implants are described. The implants may be used to re-size a native valve annulus or to replace a native heart valve. The implants include a re-sizable frame having angled struts. The implant is secured to tissue with anchors that can rotate without axial advancement to engage tissue while drawing the implant closer to the tissue. Collars are used to decrease the angle between struts of a frame to contract the implant. The implants can include a rotatable shaft, such as a threaded shaft, located internally to an axially translatable collar. Rotation of the shaft transmits force to the collar to cause the collar to translate axially, closing the angle of adjacent struts and decreasing the width of the implant and thus of the annulus. The implants can be delivered, secured and contracted via a catheter. The implants are repositionable and retrievable via catheter.

## Claims

### Claim 1

An implant comprising:
a tubular frame having a proximal end, a distal end and a central lumen extending therethrough, the tubular frame comprising a plurality of pairs of struts joined to form a plurality of proximal apices and a plurality of distal apices;
an adjustment mechanism coupled to a first pair of struts that form a proximal apex, the adjustment mechanism configured to control a spacing between distal ends of the first pair of struts;
an anchor housing carried by a distal apex formed by a second pair of struts; and
an anchor translationally disposed within an opening of the anchor housing and axially moveable within the anchor housing between a first position and a second position, wherein in the first position the anchor advances axially relative to the tubular frame in response to rotation of the anchor in a first direction within the anchor housing, and in the second position the anchor is freely rotatable in the first direction within the anchor housing without axially advancing relative to the anchor housing.

### Claim 2 (depends on 1)

The implant of claim 1, wherein the anchor housing includes an opening extending axially therethrough, and the anchor is configured to engage tissue of the mitral valve annulus in the second position by rotating within the anchor housing without advancing axially relative to the anchor housing.

### Claim 3 (depends on 1)

The implant of claim 1, wherein the anchor comprises a proximal coupling portion and a helical coil portion.

### Claim 4 (depends on 1)

The implant of claim 1, wherein the second position is a position wherein the helical coil portion of the anchor is fully within the distal portion of the anchor housing.

### Claim 5 (depends on 1)

A method of anchoring an implant as described in claim 1 to patient tissue proximate to a valve annulus, the method comprising:
transluminally advancing the implant towards the valve annulus;
expanding the implant to an annulus engagement diameter;
rotating an anchor carried by the implant in a first direction to engage a helical coil portion of the anchor into tissue around the valve annulus; and
continuing to rotate the anchor in the first direction relative to the implant without further axially advancing the anchor relative to the implant when the anchor is in an axially extended position on the implant to pull tissue around the valve annulus toward the implant.