# US 9,433,487 B2 · Transobturator surgical articles and methods

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 9,433,487 B2
- Document ID: US9433487B2
- Status: Granted
- Kind: B2
- Application number: 14/518,159
- Filed: 2014-10-20
- Published: 2015-02-05
- Granted: 2016-09-06
- Earliest claimed: 2002-03-07
- Assignees: Astora Women's Health, LLC
- Applicants: AMS Research Corporation
- Inventors: Kimberly A. Anderson; Brian P. Watschke; Georges Mellier; Johann J. Neisz
- Web page: https://patentgrep.com/patent/US9433487B2

## CPC

- A61F 2/0045: {Support slings}
- A61B 17/0401: {Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors (A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811)}
- 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 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 17/06066: {Needles, e.g. needle tip configurations}
- A61B 17/30: Surgical pincettes, i.e. surgical tweezers {without pivotal connections (for holding suture needles or materials A61B17/0483)}
- A61B 17/3211: Surgical scalpels, knives; Accessories therefor
- A61B 50/30: Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments (for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40)
- A61B 90/02: {Devices for expanding tissue, e.g. skin tissue (implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00)}
- A61B 2017/00805: {Treatment of female stress urinary incontinence}
- A61B 2017/00946: {malleable}
- A61B 2017/0417: {T-fasteners}
- A61B 2017/06009: {having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle}
- A61B 2017/06076: {helically or spirally coiled}
- A61B 2017/320056: {Tunnelers}
- A61F 2002/30708: {Means for distinguishing between left-sided and right-sided devices, Sets comprising both left-sided and right-sided prosthetic parts}
- A61F 2250/0084: Means for distinguishing between left-sided and right-sided devices; Sets comprising both left-sided and right-sided prosthetic parts
- Y10S 128/25: Artificial sphincters and devices for controlling urinary incontinence
- 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)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- Y10S: TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS

## Abstract

A surgical instrument for treating incontinence includes a handle portion elongate along a handle axis and a needle portion connected to the handle portion. The needle portion has a spacer portion along the handle axis, and has a distal end. The needle portion includes a substantially helical portion that is a variable spiral portion, extending from the straight spacer portion. The variable spiral portion is sized and shaped to extend from an incision substantially adjacent the patient's obturator foramen through the obturator foramen along a path in a region between the superior pubic ramus and the inferior pubic ramus. The needle portion has a structure near the distal end that associates the instrument with an implantable material configured to treat incontinence.

## Claims

### Claim 1

A method for treating urinary incontinence, the method comprising:
creating a vaginal incision in a patient adjacent to a urethra,
creating an external incision substantially aligned with an obturator foramen of the patient,
providing a surgical instrument comprising a needle comprising a proximal end, a distal end, and a shaft extending therebetween,
connecting an implant for treating urinary incontinence to the surgical instrument,
after connecting the surgical instrument to the implant, inserting the distal end initially into a vaginal introitus of the patient and advancing the distal end through the vaginal incision,
using the surgical instrument to pass a first end of the implant through the vaginal introitus and into the vaginal incision,
advancing at least a portion of the surgical instrument and the implant through the vaginal incision in a direction toward and through an obturator foramen of the patient to advance a first end of the implant from the vaginal incision through the obturator foramen and to the external incision.

### Claim 2 (depends on 1)

The method of claim 1 comprising
creating a second external incision substantially aligned with a second obturator foramen of the patient,
removing the surgical instrument from the patient and re-inserting the distal end initially into the vaginal introitus and advancing the distal end through the vaginal incision,
connecting a second end of the implant to the surgical instrument,
after connecting the surgical instrument to the implant, inserting the distal end initially into a vaginal introitus of the patient and advancing the distal end through the vaginal incision,
using the surgical instrument to pass the second end of the implant through the vaginal introitus and into the vaginal incision,
advancing at least a portion of the surgical instrument and the second end of the implant through the vaginal incision in a direction toward and through the second obturator foramen, to advance the second end of the implant from the vaginal incision through the second obturator foramen and to the second external incision.

### Claim 3 (depends on 2)

The method of claim 2, further comprising adjusting tension of the implant for treating urinary incontinence after positioning adjacent to the patient's urethra and extending through each obturator foramen.

### Claim 4 (depends on 2)

The method of claim 2, further comprising the step of tightening the tension of the implant for treating urinary incontinence after positioning adjacent to the patient's urethra and extending through each obturator foramen.

### Claim 5 (depends on 2)

The method of claim 2 wherein the implant comprises a tensioning member.

### Claim 6 (depends on 2)

The method of claim 2, wherein the implant comprises a sheath.

### Claim 7 (depends on 2)

The method of claim 2, wherein the surgical instrument exhibits a two-dimensional curve.

### Claim 8 (depends on 1)

The method of claim 1 comprising
creating a second external incision substantially aligned with a second obturator foramen of the patient,
providing a second surgical instrument comprising a second needle comprising a second proximal end, a second distal end, and a second shaft extending therebetween,
inserting the second distal end initially into the vaginal introitus and advancing the second distal end through the vaginal incision,
connecting a second end of the implant to the second surgical instrument,
after connecting the second surgical instrument to the second end of the implant, inserting the second distal end initially into a vaginal introitus of the patient and advancing the second distal end through the vaginal incision,
using the second surgical instrument to pass the second end of the implant through the vaginal introitus and into the vaginal incision,
advancing at least a portion of the second surgical instrument and the second end of the implant through the vaginal incision in a direction toward and through the second obturator foramen, to advance the second end of the implant from the vaginal incision through the second obturator foramen and to the second external incision.

### Claim 9 (depends on 8)

The method of claim 8, wherein
the surgical instrument exhibits a two-dimensional curve, and
the second surgical instrument exhibits a two-dimensional curve that is the same as the two-dimensional curve of the surgical instrument.

### Claim 10 (depends on 8)

The method of claim 8, wherein
the surgical instrument exhibits a two-dimensional curve, and
the second surgical instrument exhibits a two-dimensional curve that is the same as the two-dimensional curve of the surgical instrument.

### Claim 11

A method for treating urinary incontinence, comprising:
providing a surgical instrument comprising a distal end, a proximal end, and a curved shaft therebetween,
providing an elongate implant for treating urinary incontinence comprising a first end, a second end, a mesh strip therebetween, and a connector at the first end, wherein the connector is adapted to engage an end of the surgical instrument,
creating a vaginal incision adjacent a patient's urethra,
creating an external incision substantially aligned with an obturator foramen of the patient,
connecting one of the ends of the surgical instrument to the connector,
after connecting the surgical instrument to the connector, inserting at least a portion of the surgical instrument into the vaginal incision and then through a tissue path between the vaginal incision and the external incision, through the obturator foramen, to pass the first end of the implant from the the vaginal incision to the external incision and through the obturator foramen.

### Claim 12 (depends on 11)

A method of claim 11 wherein the elongate implant comprises a second connector at the second end, wherein the second connector is adapted to engage an end of the surgical instrument, the method further comprising
creating a second external incision substantially aligned with a second obturator foramen of the patient,
removing the surgical instrument from the patient,
connecting one of the ends of the surgical instrument to the second connector,
passing at least a portion of the surgical instrument through a tissue path between the vaginal incision and the second external incision, through the second obturator, to pass the second end of the implant between the vaginal incision and the second external incision and through the second obturator foramen.

### Claim 13 (depends on 11)

A method of claim 11 comprising:
providing a second surgical instrument comprising a second distal end, a second proximal end, and a second curved shaft therebetween,
wherein the elongate implant comprises a second connector at the second end, wherein the second connector is adapted to engage an end of the second surgical instrument, the method further comprising
creating a second external incision substantially aligned with a second obturator foramen of the patient,
connecting one of the ends of the second surgical instrument to the second connector,
passing at least a portion of the second surgical instrument through a tissue path between the vaginal incision and the second external incision, through the second obturator, to pass the second end of the implant between the vaginal incision and the second external incision through the second obturator foramen.

### Claim 14 (depends on 13)

The method of claim 13 wherein:
the surgical instrument exhibits a two-dimensional curve, and
the second surgical instrument exhibits a two-dimensional curve that is the same as the two-dimensional curve of the surgical instrument.

### Claim 15 (depends on 13)

The method of claim 13 comprising adjusting tension of the implant after positioning adjacent to the patient's urethra and extending through each obturator foramen.

### Claim 16 (depends on 13)

The method of claim 13 further comprising tightening the tension of the implant after positioning adjacent to the patient's urethra and extending through each obturator foramen.

### Claim 17 (depends on 11)

The method of claim 11 wherein the surgical instrument exhibits a two-dimensional curve.

### Claim 18 (depends on 11)

The method of claim 11 wherein the implant comprises a tensioning member.

### Claim 19 (depends on 11)

The method of claim 11 wherein the implant comprises a sheath.

### Claim 20 (depends on 11)

The method of claim 11 wherein the surgical instrument exhibits a two-dimensional curve.