# US 11,439,385 B2 · Systems and method for deploying surgical suture

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- Number: US 11,439,385 B2
- Document ID: US11439385B2
- Status: Granted
- Kind: B2
- Application number: 16/907,151
- Filed: 2020-06-19
- Published: 2020-10-08
- Granted: 2022-09-13
- Earliest claimed: 2016-03-02
- Assignees: Edwards Lifesciences Corporation
- Applicants: Edwards Lifesciences Corporation
- Inventors: Manouchehr A. Miraki
- Web page: https://patentgrep.com/patent/US11439385B2

## CPC

- A61B 17/06: Needles {; Sutures; Needle-suture combinations}; Holders or packages for needles or suture materials
- A61B 17/0483: {Hand-held instruments for holding sutures (A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30)}
- A61B 17/06109: {Big needles, either gripped by hand or connectable to a handle}
- A61B 17/06123: {Flat cylinders, e.g. including an inner reel}
- A61B 2017/0042: {with special provisions for gripping}
- A61B 2017/00424: {ergonomic, e.g. fitting in fist}
- A61B 2017/00438: {connectable to a finger}
- A61B 2017/00663: {the implement being a suture}
- A61B 2017/06052: {Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle}
- A61B 2017/06076: {helically or spirally coiled}
- A61B 2017/0608: {J-shaped}
- A61B 2017/061: {hollow or tubular}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

A device for suturing an incision in an artery has a handle, a supply of suture stored on spindle housed in the handle, a tube extending from the handle having a lumen through which suture extends, and a curved needle at a distal end of the handle, the curved needle having an opening through which a free end of the suture extends. A method for suturing an incision in an artery includes creating sequential openings in first and second flaps of the incision, with loops of suture extending through openings in one flap, with a free end of suture extending through the second flap being pulled through the loops and secured to another free end of suture extending through the first flap, to close the incision.

## Claims

### Claim 1

A method of closing an incision in an artery, the method comprising:
rotating a handle having a curved needle at a distal end of the handle to cause rotation of the curved needle in a first rotational direction to drive the curved needle through a first puncture of a first flap of an artery and through a first puncture of a second flap of the artery, the curved needle carrying a suture, forming a helical loop, and having an opening at a distal end of the curved needle;
drawing a first free end of the suture from the opening of the curved needle;
with the first free end of the suture extended through the first puncture of the second flap, rotating the handle to cause rotation of the curved needle in a second rotational direction opposite to the first rotational direction to draw the curved needle back through the first puncture of the second flap and the first puncture of the first flap;
rotating the handle to cause rotation of the curved needle in the first rotational direction to drive the curved needle through a second puncture of the first flap and through a second puncture of the second flap;
creating a first loop of suture extending through the second puncture of the second flap;
with the first loop extended through the second puncture of the second flap, rotating the handle to cause rotation of the curved needle in the second rotational direction to draw the curved needle back through the second puncture of the second flap and the second puncture of the first flap;
inserting the first free end of suture through the first loop of suture;
pulling the first free end to close the incision; and
securing the first free end to secure the suture.

### Claim 2 (depends on 1)

The method of claim 1, further comprising:
rotating the handle to cause rotation of the curved needle in the first rotational direction to drive the curved needle through a third puncture of the first flap and through a third puncture of the second flap;
creating a second loop of suture extending through the third puncture of the second flap;
with the second loop extending through the third puncture of the second flap, rotating the handle to cause rotation of the curved needle in the second rotational direction to draw the curved needle back through the third puncture of the second flap and the third puncture of the first flap; and
inserting the first free end of suture through the second loop.

### Claim 3 (depends on 1)

The method of claim 1, further comprising cutting the suture to create a second free end.

### Claim 4 (depends on 3)

The method of claim 3, wherein the suture is cut to create the second free end after drawing the curved needle back through the second puncture of the first flap.

### Claim 5 (depends on 3)

The method of claim 3, further comprising:
pulling the second free end to close the incision; and
securing the second free end.

### Claim 6 (depends on 5)

The method of claim 5, wherein securing the first free end and the second free end involves knotting the first free end and the second free end together.

### Claim 7 (depends on 5)

The method of claim 5, wherein securing the first free end and the second free end involves clipping the first free end and the second free end.

### Claim 8 (depends on 1)

The method of claim 1, further comprising supplying the suture from a spool of suture.

### Claim 9 (depends on 8)

The method of claim 8, wherein the spool is housed within a housing of a device comprising a removable cover on the housing.

### Claim 10 (depends on 1)

The method of claim 1, wherein driving the curved needle through the second puncture of the first flap creates a suture bridge from the first puncture of the first flap to the second puncture of the first flap.

### Claim 11 (depends on 1)

The method of claim 1, wherein the first free end and the first loop are configured to be extended through the second flap and outside of the artery.

### Claim 12

A method of closing an incision in an artery, the method comprising:
rotating a handle having a curved needle at a distal end of the handle to cause rotation of the curved needle in a first rotational direction to drive the curved needle through a first entry point of a first flap of an artery and through a first entry point of a second flap of the artery, the curved needle carrying a suture and having an opening at a distal end of the curved needle;
drawing a first free end of the suture from the opening of the curved needle;
with the first free end of the suture extended through the first entry point of the second flap, rotating the handle to cause rotation of the curved needle in a second rotational direction opposite to the first rotational direction to draw the curved needle back through the first entry point of the second flap and the first entry point of the first flap;
rotating the handle to cause rotation of the curved needle in the first rotational direction to drive the curved needle through a second entry point of the first flap and through a second entry point of the second flap;
creating a first loop of suture extending through the second entry point of the second flap;
with the first loop extended through the second entry point of the second flap, rotating the handle to cause rotation of the curved needle in the second rotational direction to draw the curved needle back through the second entry point of the second flap and the second entry point of the first flap;
inserting the first free end of suture through the first loop of suture;
pulling the first free end and a second free end of the suture to close the incision; and
securing the first free end and the second free end to secure the suture;
wherein the curved needle is configured to pass through a lumen of a tube extending from the handle, and wherein the curved needle is configured to form a semi-circular or helical shape that is orthogonal to the tube and extends axially about an axis of the tube.

### Claim 13 (depends on 12)

The method of claim 12, wherein the suture is configured to extend from a spool rotatably mounted within the handle.

### Claim 14 (depends on 13)

The method of claim 13, wherein the handle further comprises a removable cover to provide access to the spool.

### Claim 15 (depends on 12)

The method of claim 12, further comprising:
rotating the handle to cause rotation of the curved needle in the first rotational direction to drive the curved needle through a third entry point of the first flap and through a third entry point of the second flap;
creating a second loop of suture extending through the third entry point of the second flap;
with the second loop extended through the third entry point of the second flap, rotating the handle to cause rotation of the curved needle in the second rotational direction to draw the curved needle back through the third entry point of the second flap and the third entry point of the first flap; and
inserting the first free end of suture through the second loop of suture.

### Claim 16 (depends on 12)

The method of claim 12, wherein the curved needle forms a helical loop.
