System and method for treating urinary incontinence

• US 8,911,347 B2
• Filed: 06/01/2011
• Issued: 12/16/2014
• Est. Priority Date: 10/12/2000
• Status: Expired due to Fees

• Current Assignee: Coloplast A/S
• Original Assignee: Coloplast A/S
• Inventors: Browning, James
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US13/150,026
• Publication Number:
  US 20110237876A1
• Time in Patent Office: 1,294 Days
• Field of Search: 600 29- 31, 600/37, 128897-898, 128/DIG.25, 606139-144, 606151-158, 606232-233
• US Class Current: 600/37
• CPC Class Codes: 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
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0427 having anchoring barbs or pins extending outwardly from the anchor body
• CPC Class Codes: A61B 2017/0435 the barbs being separate elements mechanically linked to the anchor, e.g. by pivots
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

A method for supporting the urethra of a patient to treat urinary incontinence includes introducing a surgical implant through an incision in an upper wall of the patient'"'"'s vagina. The surgical implant includes a suburethral support, first and second soft tissue anchors connected to the suburethral support, and a flexible filamentary member extending between a proximal end of the first soft tissue anchor and a first end of the suburethral support. The first and second soft tissue anchors are inserted into soft tissue without penetrating the abdominal wall. The method also includes adjusting a position of the suburethral support below the patient'"'"'s urethra and manipulating the filamentary member to connect the proximal end of the first anchor to the first end of the suburethral support with the support at the adjusted position.

Claims

1. A method for supporting the urethra of a patient to treat urinary incontinence, comprising:

introducing a surgical implant through an incision in an upper wall of the patient'"'"'s vagina, the surgical implant including a suburethral support, first and second soft tissue anchors connected to first and second opposite ends of the suburethral support, wherein each anchor has a central portion extending between a proximal end and a distal end with a tip on the distal end, and a plurality of projections extending from the central portion at longitudinally spaced locations along a length of the central portion between the proximal and distal ends, and a flexible filamentary member;

inserting the first soft tissue anchor into soft tissue on a first side of the urethra without penetrating the abdominal wall, including causing projections on the first anchor to engage the tissue at a plurality of spaced locations;

inserting the second soft tissue anchor into soft tissue on a second side of the urethra without penetrating the abdominal wall, including causing projections on the second anchor to engage the tissue at a plurality of spaced locations;

adjusting the position of the suburethral support below the patient'"'"'s urethra; and

coupling the filamentary member to the proximal end of the first anchor and extending the filamentary member from the proximal end of the first anchor to the first end of the suburethral support with the support at an adjusted position.

2. The method of claim 1 wherein coupling the filamentary member includes:

adjusting a length of the filamentary member; and

securing the filamentary member to the first end of the suburethral support.

3. The method of claim 2 wherein securing the filamentary member to the suburethral support includes tying a knot in the filamentary member.

4. The method of claim 1 wherein coupling the filamentary member includes tying a knot in the filamentary member.

5. The method of claim 1, further comprising adjusting a length of the filamentary member.

6. The method of claim 1 wherein:

introducing the surgical implant further includes introducing an implant having tips on the first and second anchors comprising;

a conical shape;

a truncated distal end;

a proximal shoulder; and

an introducing tool tip-receiving bore extending from the proximal shoulder through the truncated distal end; and

inserting the first and second tissue anchors further includes mounting each anchor to an introducer tool comprising;

a handle; and

an elongate and curved body extending from the handle, including;

a narrowed portion on a distal end of the body, the narrowed portion sized to extend through the bore in the tip of at least one of the first and second anchors;

an abutment on a proximal end of the narrowed portion for engaging the proximal shoulder on the anchor; and

a tip on a distal end of the narrowed section that extends beyond the truncated distal end of the tip of the anchor when the narrowed portion of the body extends through the bore in the tip of the anchor; and

mounting each anchor to the introducer tool includes extending the narrowed portion of the tool through the bore in the tip of the anchor to engage the shoulder of the anchor on the abutment of the body with the tip of the narrowed portion extending beyond the distal end of the tip of the anchor.

7. The method of claim 6 wherein inserting the first and second tissue anchors further includes:

operating the introducer tool with the mounted soft tissue anchor to insert the anchor, including pushing the tool along a curved path; and

removing the introducer tool from the patient after inserting the anchor, including withdrawing the narrowed portion of the body from the tip of the anchor.

8. A method for supporting the urethra of a female patient to treat urinary incontinence, comprising:

providing a surgical implant including;

an elongate polymer suburethral support having first and second opposite ends; and

first and second elongate polymer soft tissue anchors connected to the first and second opposite ends of the suburethral support, each anchor having;

a central portion with a proximal end;

a conical tip on a distal end of the central portion, the tip having a truncated distal end, a proximal shoulder, and an introducing tool tip-receiving bore extending from the proximal shoulder through the truncated distal end; and

a plurality of projections extending from the central portion at longitudinally spaced locations along the length of the central portion between the proximal and distal ends; and

an elongated flexible member coupled to the proximal end of the first soft tissue anchor and the first end of the suburethral support;

providing an introducer tool including;

a handle; and

an elongate and curved body extending from the handle, the body including;

a narrowed portion on a distal end of the body, the narrowed portion sized to extend through the bore in the tip of at least one of the first and second anchors;

an abutment on a proximal end of the narrowed portion for engaging the proximal shoulder on the anchor; and

a tip on a distal end of the narrowed section that extends beyond the truncated distal end of the tip of the anchor when the narrowed portion of the body extends through the bore in the tip of the anchor;

introducing the surgical implant into an incision made on an upper wall of the patient'"'"'s vagina;

mounting the first soft tissue anchor on the introducer tool, including extending the narrowed portion of the tool through the bore in the tip of the anchor to engage the shoulder of the anchor on the abutment of the body with the tip of the narrowed portion extending beyond the distal end of the tip of the anchor;

operating the introducer tool with the mounted first soft tissue anchor to insert the first soft tissue anchor through the incision into soft tissue on a first side of the urethra, including pushing the tool along a curved path and causing a plurality of spaced projections on the first anchor to engage the tissue at a plurality of longitudinally spaced locations without penetrating the abdominal wall;

removing the introducer tool from the patient after inserting the first soft tissue anchor, including withdrawing the narrowed portion of the body from the tip of the soft tissue anchor;

mounting the second soft tissue anchor on the introducer tool, including extending the narrowed portion of the tool through the bore in the tip of the anchor to engage the shoulder of the anchor on the abutment of the body with the tip of the narrowed portion extending beyond the distal end of the tip of the anchor;

operating the introducer tool with the mounted second soft tissue anchor to insert the second soft tissue anchor through the incision into soft tissue on a second side of the urethra, including pushing the tool along a curved path and causing a plurality of spaced projections on the second anchor to engage the tissue at a plurality of longitudinally spaced locations without penetrating the abdominal wall;

removing the introducer tool from the patient after inserting the second soft tissue anchor, including withdrawing the narrowed portion of the body from the tip of the soft tissue anchor;

adjusting the position of the suburethral support below the patient'"'"'s urethra with the elongated flexible member; and

securing the elongated flexible member to the first end of the suburethral support.

9. The method of claim 8 wherein securing the elongated flexible member to the suburethral support includes tying a knot in the flexible member.

10. The method of claim 9 wherein providing a surgical implant further includes providing a surgical implant having a suburethral support with tapered ends.

11. The method of claim 10 wherein providing a surgical implant further includes providing a surgical implant having a suburethral support with smooth edges.