# US 12,544,072 B2 · Tissue anchor for securing tissue layers

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- Number: US 12,544,072 B2
- Document ID: US12544072B2
- Status: Granted
- Kind: B2
- Application number: 17/412,360
- Filed: 2021-08-26
- Published: 2021-12-09
- Granted: 2026-02-10
- Earliest claimed: 2008-05-12
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: Fiona M. Sander; Michael P. Allen; Mattew Yurek; Kenneth F. Binmoeller
- Web page: https://patentgrep.com/patent/US12544072B2

## CPC

- A61B 17/1114: {of the digestive tract, e.g. bowels or oesophagus}
- A61B 17/11: for performing anastomosis; Buttons for anastomosis
- A61B 17/12009: {Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 2017/00004: {(bio)absorbable, (bio)resorbable or resorptive}
- A61B 2017/00278: {Transorgan operations, e.g. transgastric}
- A61B 2017/0034: {adapted to be inserted through a working channel of an endoscope}
- A61B 2017/00867: {shape memory effect}
- A61B 2017/1103: {Approximator}
- A61B 2017/1139: {Side-to-side connections, e.g. shunt or X-connections}
- A61B 2017/3486: {Balloon}
- A61F 2/82: Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents (stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07)
- A61M 2025/0096: {being laterally outward extensions or tools, e.g. hooks or fibres}
- A61M 2025/09125: {Device for locking a guide wire in a fixed position with respect to the catheter or the human body}
- A61M 2025/1059: {having different inflatable sections mainly depending on the response to the inflation pressure, e.g. due to different material properties}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- 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

Tissue anchors comprise a woven filament braid body having an elongated tubular configuration and a foreshortened configuration where proximal and distal ends of the body expand radially into double-walled flange structures while leaving a cylindrical saddle region therebetween. The tissue anchors are deployed through penetrations between adjacent tissue layers, where the flanges engage the outer surfaces of the tissue layers and the saddle region resides within the tissue penetrations.

## Claims

### Claim 1

A medical device, comprising:
a body formed of a filament braid, the body having an unconstrained configuration and a constrained configuration, the body having a first end, a second end, and a central region extending therebetween, wherein, in the unconstrained configuration, the first end radially expands into a flange structure and the central region expands into a saddle region, establishing a fluid flow path therethrough, wherein a length of the body in the unconstrained configuration is at least 70% less than a length of the body in the constrained configuration, wherein the flange structure includes an atraumatic tissue apposing surface adjacent to the saddle region, and wherein the atraumatic tissue apposing surface comprises a double-ringed flange structure having a pair of adjacent annular rings that face each other,
wherein the saddle region is extensible to reduce trauma from the flange tissue apposing surface, and
wherein the flange structure has an open end at least as great as a diameter of the saddle region.

### Claim 2 (depends on 1)

The medical device of claim 1, wherein the flange structure has a diameter that is at least substantially 1.5 times the diameter of the saddle region.

### Claim 3 (depends on 1)

The medical device of claim 1, wherein the flange structure includes a wall that is aligned substantially perpendicular to a longitudinal axis of the saddle region when in the unconstrained configuration.

### Claim 4 (depends on 1)

The medical device of claim 1, wherein at least the saddle region comprises a covering.

### Claim 5 (depends on 1)

The medical device of claim 1, wherein a diameter of the flange structure ranges from 5 mm to 40 mm in the unconstrained configuration.

### Claim 6 (depends on 1)

The medical device of claim 1, wherein the flange structure is formed from a singular tubular structure of the filament braid.

### Claim 7

A drainage stent, comprising:
a body formed of a filament braid, the body having an unconstrained configuration and a constrained configuration, the body having a first end, a second end, and a central region configured therebetween, and the body in the unconstrained configuration configured to form a fluid drainage path;
wherein, in the unconstrained configuration, the first end radially expands into a flange structure and the central region expands into a saddle region;
wherein the flange structure has a diameter that is at least substantially 1.5 times the diameter of the saddle region;
wherein the flange structure includes an atraumatic tissue apposing surface adjacent to the saddle region, and wherein the atraumatic tissue apposing surface comprises a double-ringed flange structure having a pair of adjacent annular rings that face each other,
wherein the saddle region is extensible to reduce trauma from the flange tissue apposing surface, wherein the flange structure has an open end at least as great as the diameter of the saddle region, and
wherein a length of the body in the unconstrained configuration is at least 70% less than a length of the body in the constrained configuration.

### Claim 8 (depends on 7)

The drainage stent of claim 7, wherein the flange structure includes a wall that is aligned substantially perpendicular to a longitudinal axis of the saddle region when in the unconstrained configuration.

### Claim 9 (depends on 7)

The drainage stent of claim 7, wherein at least the saddle region comprises a covering.

### Claim 10 (depends on 7)

The drainage stent of claim 7, wherein a diameter of the flange structure ranges from 5 mm to 40 mm in the unconstrained configuration.

### Claim 11

A drainage stent, comprising:
a body formed of a filament braid, the body having an unconstrained configuration and a constrained configuration, the body having a first end, a second end, and a central region configured therebetween, and the body in the unconstrained configuration configured to form a drainage path therethrough;
wherein, in the unconstrained configuration, the first end radially expands into a flanged retention structure, the second end radially expands into a retention region, and the central region expands into a saddle region extending therebetween;
wherein the flanged retention structure has a diameter that is at least substantially 1.5 times the diameter of the saddle region;
wherein the flanged retention structure includes an atraumatic tissue apposing surface adjacent to the saddle region, and wherein the atraumatic tissue apposing surface comprises a double-ringed flange structure having a pair of adjacent annular rings that face each other,
wherein the saddle region is extensible to reduce trauma from the flange tissue apposing surface, wherein the flanged retention structure has an open end at least as great as the diameter of the saddle region, and
wherein a length of the body in the unconstrained configuration is at least 70% less than a length of the body in the constrained configuration.

### Claim 12 (depends on 11)

The drainage stent of claim 11, wherein each of the flanged retention structure and the retention region are formed from a singular tubular structure.

### Claim 13 (depends on 11)

The drainage stent of claim 11, wherein the retention region has an open end at least as great as the diameter of the saddle region.

### Claim 14 (depends on 11)

The drainage stent of claim 11, wherein the diameter of the flanged retention structure is greater than twice a diameter of the saddle region in the unconstrained configuration.

### Claim 15 (depends on 11)

The drainage stent of claim 11, wherein at least the saddle region comprises a covering.
