# US 12,213,881 B2 · Systems and methods for applying pressure to a bodily organ

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- Number: US 12,213,881 B2
- Document ID: US12213881B2
- Status: Granted
- Kind: B2
- Application number: 17/032,283
- Filed: 2020-09-25
- Published: 2021-04-01
- Granted: 2025-02-04
- Earliest claimed: 2019-09-26
- Assignees: Muffin Incorporated
- Applicants: Muffin Incorporated
- Inventors: William J. Havel; Neal E. Fearnot; Jeremy T. Newkirk; Shaun Davis Gittard; John C. Sigmon, Jr.; Gregory James Hardy; Rita Hadley; Yun Zhou; Mitch Turley; David Reuter
- Web page: https://patentgrep.com/patent/US12213881B2

## CPC

- A61F 2/2445: {Annuloplasty rings in direct contact with the valve annulus}
- A61F 2/2481: {Devices outside the heart wall, e.g. bags, strips or bands}
- A61F 2/482: {Electrical means}
- A61F 2210/0014: using shape memory or superelastic materials, e.g. nitinol
- A61F 2210/0019: operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
- A61F 2220/0075: sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
- A61F 2230/0008: elliptical or oval
- A61F 2230/0095: Saddle-shaped
- A61F 2250/0096: Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- 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

Among other things, there are disclosed embodiments of belts or bands that can be used in treatments for tricuspid valve regurgitation. In some embodiments, such belts may be heat-set in a particular configuration to effectively decrease tricuspid annulus when deployed around the atrioventricular groove. Embodiments include one or more tensioning sutures for applying cinching or tightening to belts when deployed, and structure for effectively distributing force during such tightening. Embodiments of tensioning members, protective members, and devices and methods for open-surgical placement (e.g. around a heart for annuloplasty) are also disclosed.

## Claims

### Claim 1

An annuloplasty system for use in open-surgical procedures, comprising:
a tensioning member adapted to be implanted by wrapping around the heart, wherein said tensioning member comprises an elongate member forming a continuous loop configured to be positioned around the heart;
a protective member through which the tensioning member passes, the protective member being of a shape-memory material that resists twisting such that a widened dimension of the protective member contacts with the heart, the protective member comprising a material visible with one or more of the following: fluoroscopy, CT scanning, ultrasound imaging, and/or magnetic resonance imaging, and wherein the protective member comprises a continuous ring structure;
locking means for holding the tensioning member in tension around the heart and for permitting adjustment of tension in the tensioning member.

### Claim 2 (depends on 1)

The annuloplasty system of claim 1, the protective member having guides for the tensioning member.

### Claim 3 (depends on 2)

The annuloplasty system of claim 2, wherein the locking means includes a stabilizing plate having a well and a valley section, and a spool seated in the well, wherein the tensioning member may be wrapped around the spool to increase tension on the tensioning member and unwrapped from the spool to reduce tension on the tensioning member.

### Claim 4 (depends on 2)

The annuloplasty system of claim 2, further comprising at least one of a miniature motor and transmission operatively connected to the tensioning member, wherein operation of the at least one of a miniature motor and transmission is adapted to perform at least one of tightening and loosening the tensioning member when the tensioning member is placed around the heart.

### Claim 5 (depends on 1)

The annuloplasty system of claim 1, further comprising a device operatively connected to the tensioning member for directly or indirectly measuring tension or length of the tensioning member that has been displaced in tightening the tension member, the device from the group consisting of an encoder to measure displacement of the tensioning member; a sensor measuring current draw on a motor operatively connected to the tensioning member; a torque sensor operatively connected to the tensioning member; a load cell placed in series with the tensioning member; a tensioning tool including a scale or gauge for measuring displacement of the tensioning member.

### Claim 6 (depends on 1)

The annuloplasty system of claim 1, wherein said locking means comprises a first buckle configured to engage the tensioning member at a first location.

### Claim 7 (depends on 6)

The annuloplasty system of claim 6, wherein said locking means comprises a second buckle configured to engage the tensioning member at a second location.

### Claim 8

The annuloplasty system for use in open-surgical procedures, comprising:
a tensioning member adapted to be implanted by wrapping around the heart, wherein said tensioning member comprises an elongate member forming a loop configured to be positioned around the heart;
locking means for holding the tensioning member in tension around the heart and for permitting adjustment of tension in the tensioning member, wherein said locking means comprises a first buckle configured to engage the tensioning member at a first location, wherein said locking means comprises a second buckle configured to engage the tensioning member at a second location, and wherein said tensioning member comprises an elongate member forming a loop having a first end attached to said first buckle and a second end attached to said second buckle;
a first portion of said tensioning member slideably received in said second buckle, the first portion being towards the first end of the tensioning member; and
a second portion of said tensioning member slideably received in said first buckle, the second portion being towards the second end of the tensioning member, such that as the first buckle and the second buckle are pushed apart the tensioning member is tightened.

### Claim 9 (depends on 8)

The annuloplasty system of claim 8, further comprising a protective member through which the tensioning member passes, the protective member having guides for the tensioning member and being of a shape-memory material that resists twisting.

### Claim 10

An annuloplasty system for use in open-surgical procedures, comprising:
a tensioning member adapted to be implanted by wrapping around the heart, wherein said tensioning member comprises an elongate member forming a continuous loop configured to be positioned around the heart;
a protective member through which the tensioning member passes, the protective member being of a shape-memory material that resists twisting such that a widened dimension of the protective member contacts with the heart, the protective member comprising a material visible with one or more of the following: fluoroscopy, CT scanning, ultrasound imaging, and/or magnetic resonance imaging;
locking means for holding the tensioning member in tension around the heart and for permitting adjustment of tension in the tensioning member, wherein said locking means comprises a first buckle configured to engage the tensioning member at a first location.

### Claim 11 (depends on 10)

The annuloplasty system of claim 10, wherein said locking means comprises a second buckle configured to engage the tensioning member at a second location.
