# US 12,004,730 B2 · Systems, devices, and methods for closing an abdominal wall defect

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- Number: US 12,004,730 B2
- Document ID: US12004730B2
- Status: Granted
- Kind: B2
- Application number: 17/412,942
- Filed: 2021-08-26
- Published: 2021-12-16
- Granted: 2024-06-11
- Earliest claimed: 2017-01-13
- Assignees: TAS Medical Inc.
- Applicants: TAS Medical Inc.
- Inventors: Albert K. Chin; Thomas A. Kramer
- Web page: https://patentgrep.com/patent/US12004730B2

## CPC

- A61B 17/0057: {Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect (sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009)}
- A61B 17/0467: {Instruments for cutting sutures (surgical cutting instruments A61B17/32)}
- A61B 17/0469: {Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery}
- A61B 17/0482: {Needle or suture guides (guides for drills, pins or wire A61B17/17; guides for puncturing needles A61B17/3403)}
- A61B 17/0487: {Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks (suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122)}
- A61B 17/06109: {Big needles, either gripped by hand or connectable to a handle}
- A61B 34/30: Surgical robots
- A61B 2017/00349: {Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue (A61B17/06066 takes precedence)}
- A61B 2017/00663: {the implement being a suture}
- A61B 2017/0488: {Instruments for applying suture clamps, clips or locks}
- A61B 2017/0496: {for tensioning sutures}
- A61B 2017/06057: {Double-armed sutures, i.e. sutures having a needle attached to each end}
- A61B 2017/06176: {with protrusions, e.g. barbs}
- A61B 2090/064: {for measuring force, pressure or mechanical tension}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Systems and methods for closing a tissue defect are disclosed. The systems may include a subcutaneous guide that is placed transcutaneously between two skin access sites and a self-locking strap that may be advanced into the body through a first access site via a first needle and then passed to a second needle. The strap may be withdrawn with the second needle through a second access site to the outside of the body. The strap may be withdrawn from the first needle, leaving the strap placed through both access sites and across the defect. As the subcutaneous guide is withdrawn from the body it pulls the captured strap such that both ends of the strap protrude from the first access site, allowing the strap to be tightened around the defect. Devices for closure of a tissue defect are also disclosed.

## Claims

### Claim 1

A system for closing a tissue defect, the system comprising:
a self-locking strap;
a lock-head;
a first needle having a lumen for delivering the self-locking strap through a first incision site;
a second needle having a hook at its distal end for engaging the self-locking strap and pulling the strap from the body through a second incision site;
a guide having an aperture near its distal end for passing the second needle therethrough, the guide being capable of retaining the strap after the second needle is removed from the aperture;
and a linear cutter having an inner tube defining a lumen, an outer tube and a radially flexible blade that is configured to depress into the lumen of the inner tube when engaged by the outer tube.

### Claim 2 (depends on 1)

The system of claim 1, further comprising a support tube for pushing on the lock-head while the strap is being tensioned.

### Claim 3 (depends on 1)

The system of claim 1, further comprising a support tube with at least one blade at the distal end for severing the self-locking strap adjacent to the lock-head.

### Claim 4 (depends on 1)

The system of claim 1, further comprising a tensioner having at least one lock-head to hold tension on the self-locking strap.

### Claim 5 (depends on 4)

The system of claim 4, wherein the tensioner includes a tension gauge to measure the tension in the strap.

### Claim 6 (depends on 5)

The system of claim 5, further comprising an indicator to display the tension in the strap.

### Claim 7 (depends on 5)

The system of claim 5, wherein the tension gauge is a mechanical spring gauge.

### Claim 8 (depends on 5)

The system of claim 5, wherein the tension gauge is a force transducer.

### Claim 9 (depends on 5)

The system of claim 5, wherein the tension gauge is configured to convert the measured tension into an electrical signal and transit the electrical signal to a display or receiving computer.

### Claim 10 (depends on 1)

The system of claim 1, further comprising a laparoscopic grasper for placing the self-locking strap into engagement with the second needle.

### Claim 11 (depends on 10)

The system of claim 10, wherein the laparoscopic grasper includes a robotic arm interface enabling it to be robotically controlled.

### Claim 12 (depends on 1)

The system of claim 1, wherein the lock-head is separate from the strap and capable of receiving both ends of the strap.

### Claim 13 (depends on 1)

The system of claim 1, wherein the self-locking strap has a loop at its distal end for engaging with the second needle.

### Claim 14 (depends on 1)

The system of claim 1, wherein the first needle includes a slot along its length for removing the self-locking strap.

### Claim 15 (depends on 1)

The system of claim 1, further comprising a robotic interface fixed to the proximal end of the guide.

### Claim 16 (depends on 1)

The system of claim 1, wherein the strap further comprises a plurality of apertures through the strap to facilitate ingrowth of tissue.

### Claim 17

A self-locking strap comprising:
an elongate body having a distal end, a proximal end, a top side and a bottom side;
a first set of ramped teeth on the top side;
a second set of ramped teeth on the top side having a ramp direction in the opposite direction to the first set of teeth;
a third set of ramped teeth on the bottom side having a ramp direction in the same direction as the first set of teeth;
a fourth set of ramped teeth on the bottom side having a ramp direction in the same direction as the second set of teeth; and
a detached lock-head having an aperture capable of passing the distal end and proximal end simultaneously,
wherein the lock-head has a set of opposing pawls protruding into the aperture for engaging with the distal end and the proximal end,
wherein the third set of ramped teeth is spaced longitudinally from the first set of ramped teeth and the fourth set of ramped teeth is spaced longitudinally from the second set of ramped teeth.

### Claim 18 (depends on 17)

The self-locking strap of claim 17, further comprising a plurality of apertures through the strap to facilitate tissue ingrowth.

### Claim 19 (depends on 17)

The self-locking strap of claim 17, wherein the distal and proximal ends of the strap are tapered and having an aperture therethrough configured to engage with a surgical instrument.

### Claim 20

A method for closing a tissue defect, the method comprising:
pushing the distal end of a first self-locking strap through a first incision in skin and through a first puncture site in the rectus abdominus and into a body cavity on a first side of a defect, while leaving the proximal end of the first strap outside of the body;
pulling the distal end of the first strap, from within the body cavity, through a second puncture site in the rectus abdominus on the opposite side of the defect, and out of the body through a second incision;
pulling the distal end of the first strap subcutaneously, until the distal end of the first strap exits through the first incision such that the first strap encircles the defect;
placing the distal end of the first strap through a lock-head on the proximal end of the first strap;
pulling the distal end of the first strap until the lock-head passes under the skin;
placing a support tube over the first self-locking strap; and
pulling the proximal end of the first self-locking strap while pushing the support tube against the lock-head to tighten the first self-locking strap.

### Claim 21 (depends on 20)

The method of claim 20, further comprising the steps of:
pushing the distal end of a second self-locking strap through a third incision in skin and through a third puncture site in the rectus abdominus and into the body cavity on a first side of a defect, while leaving the proximal end of the second strap outside of the body;
pulling the distal end of the second strap, from within the body cavity, through a fourth puncture site in the rectus abdominus on the opposite side of the defect, and out of the body through a second incision;
pulling the distal end of the second strap subcutaneously until the distal end of the second strap exits through the third incision such that the second strap encircles the defect;
placing the distal end of the second strap through a lock-head on the proximal end of the second strap;
pulling the distal end of the second strap until the lock-head passes under the skin; and
tightening the second strap.

### Claim 22 (depends on 21)

The method of claim 21, wherein the third and fourth puncture sites are spaced apart, along the defect, from the first and second puncture sites respectively.

### Claim 23 (depends on 22)

The method of claim 22, further comprising the steps of:
sequentially tightening the first strap and the second strap to incrementally close the defect; and
cutting excess strap material from the first strap and the second strap.