# US 10,945,837 B2 · Apparatus and methods for implanting a replacement heart valve

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- Number: US 10,945,837 B2
- Document ID: US10945837B2
- Status: Granted
- Kind: B2
- Application number: 15/992,535
- Filed: 2018-05-30
- Published: 2018-09-27
- Granted: 2021-03-16
- Earliest claimed: 2013-08-12
- Assignees: Mitral Valve Technologies Sarl
- Applicants: Mitral Valve Technologies Sarl
- Inventors: Paul A. Spence; Landon H. Tompkins
- Web page: https://patentgrep.com/patent/US10945837B2

## CPC

- A61F 2/2409: {Support rings therefor, e.g. for connecting valves to tissue (annuloplasty rings A61F2/2442)}
- A61F 2/243: {Deployment by mechanical expansion}
- A61F 2/2412: {with soft flexible valve members, e.g. tissue valves shaped like natural valves}
- A61F 2/2418: {Scaffolds therefor, e.g. support stents}
- A61F 2/2433: {using balloon catheter}
- A61F 2/88: the wire-like elements formed as helical or spiral coils
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2220/0016: with sharp anchoring protrusions, e.g. barbs, pins, spikes
- A61F 2230/0008: elliptical or oval
- A61F 2230/0091: helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
- A61F 2250/001: for adjusting a diameter
- A61F 2250/0036: differing in thickness
- A61F 2250/0039: differing in diameter
- A61F 2250/0048: differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
- A61F 2250/006: modular
- A61F 2250/0069: Sealing means
- 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 and methods for docking a heart valve prosthesis. A system can include an anchor formed as multiple coils adapted to support a heart valve prosthesis with coil portions positioned above and below the heart valve annulus. At least one of the coil portions can normally be at a first diameter and be expandable to a second, larger diameter upon application of radial outward force from within the helical anchor. Methods can include delivering an anchor, positioning and implanting a heart valve prosthesis, and expanding the heart valve prosthesis inside the anchor.

## Claims

### Claim 1

A method of implanting a helical anchor and a heart valve prosthesis in the heart of a patient, comprising:
delivering the helical anchor in the form of at least three coils such that a portion of the helical anchor is above a native heart valve annulus and a portion is below the native heart valve annulus,
radially expanding the heart valve prosthesis from an unexpanded state to an expanded state within the at least three coils of the helical anchor such that the heart valve prosthesis is supported by the helical anchor, and
positioning a seal between at least two adjacent coils of the helical anchor and the heart valve prosthesis for preventing leakage of blood flow during operation of the heart valve prosthesis, wherein the seal circumscribes at least a portion of the at least two adjacent coils such that opposite ends of the seal are spaced away from corresponding opposite ends of the helical anchor.

### Claim 2 (depends on 1)

The method of claim 1, wherein a distal end of the opposite ends of the seal is tapered.

### Claim 3 (depends on 1)

The method of claim 1, wherein a proximal end of the opposite ends of the seal is tapered.

### Claim 4 (depends on 1)

The method of claim 1, wherein each end of the opposite ends of the seal is tapered.

### Claim 5

A method of implanting an expansible helical anchor and an expansible heart valve prosthesis in the heart of a patient, comprising:
delivering the expansible helical anchor in the form of multiple coils such that a portion of the expansible helical anchor is above a native heart valve annulus and a portion is below the native heart valve annulus;
positioning the expansible heart valve prosthesis within the multiple coils of the expansible helical anchor with the expansible heart valve prosthesis and the expansible helical anchor in unexpanded states;
expanding the expansible heart valve prosthesis against the expansible helical anchor thereby expanding the expansible heart valve prosthesis while securing the expansible heart valve prosthesis to the expansible helical anchor; and
moving a coil of the expansible helical anchor from a larger diameter to a smaller diameter as the expansible heart valve prosthesis is expanded inside the multiple coils.

### Claim 6 (depends on 5)

The method of claim 5, wherein at least two adjacent coils of the expansible helical anchor are spaced apart, and the method further comprises moving the at least two adjacent coils toward each other as the expansible heart valve prosthesis is expanded inside the multiple coils.

### Claim 7

A method of implanting an expansible helical anchor and an expansible heart valve prosthesis in the heart of a patient, comprising:
delivering the expansible helical anchor in the form of multiple coils such that a portion of the expansible helical anchor is above a native heart valve annulus and a portion is below the native heart valve annulus,
positioning the expansible heart valve prosthesis within the multiple coils of the expansible helical anchor with the expansible heart valve prosthesis and the expansible helical anchor in unexpanded states, and
expanding the expansible heart valve prosthesis against the expansible helical anchor thereby expanding the expansible heart valve prosthesis and expanding a coil of the multiple coils radially outward from the unexpanded state to an expanded state while securing the expansible heart valve prosthesis to the expansible helical anchor.

### Claim 8 (depends on 7)

The method of claim 7, wherein at least two adjacent coils of the expansible helical anchor are spaced apart, and the method further comprises moving the at least two adjacent coils toward each other as the expansible heart valve prosthesis is expanded inside the multiple coils.

### Claim 9 (depends on 7)

The method of claim 7, wherein the expansible helical anchor further comprises a plurality of fasteners, and the method further comprises moving the fasteners from an undeployed state to a deployed state as the expansible heart valve prosthesis is expanded against the expansible helical anchor.

### Claim 10 (depends on 9)

The method of claim 9, further comprising positioning a seal between adjacent coils for preventing blood leakage through the expansible helical anchor and past the expansible heart valve prosthesis, wherein the fasteners engage the seal in the deployed state.

### Claim 11 (depends on 7)

The system of claim 7, wherein at least one compressible element is arranged on and circumscribes the expansible helical anchor, the at least one compressible element being engaged by the expansible heart valve prosthesis as the expansible heart valve prosthesis is expanded inside the multiple coils to assist with affixing the expansible heart valve prosthesis to the expansible helical anchor, and wherein opposite ends of each of the at least one compressible elements are spaced away from corresponding opposite ends of the expansible helical anchor.

### Claim 12 (depends on 11)

The method of claim 11, wherein the at least one compressible element further comprises multiple compressible elements spaced along the multiple coils.

### Claim 13 (depends on 11)

The method of claim 11, wherein the at least one compressible element further comprises a resilient element.

### Claim 14 (depends on 11)

The system of claim 11, wherein the expansible heart valve prosthesis further comprises openings and the openings are engaged by the at least one compressible element as the expansible heart valve prosthesis is expanded inside the multiple coils.

### Claim 15 (depends on 7)

The method of claim 7, wherein the multiple coils of the expansible helical anchor include at least two coils that cross over each other.
