Minimally invasive implant and method

• US 9,918,816 B2
• Filed: 02/20/2015
• Issued: 03/20/2018
• Est. Priority Date: 08/25/2008
• Status: Expired due to Fees

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Roll, Jessica L., Dahdah, Mona N., Otte, John F.
• Primary Examiner(s): LACYK, JOHN P
• Application Number:
  US14/627,537
• Publication Number:
  US 20150164626A1
• Time in Patent Office: 1,124 Days
• Field of Search: 600 29- 32, 600 37, 128DIG 25
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 17/3205 Excision instruments
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• 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 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes

Abstract

Apparatus and methods are provided for treating urinary incontinence, fecal incontinence, and other pelvic defects or dysfunctions, in both males and females, using one or more lateral implants to reinforce the supportive tissue of the urethra. The implants are configured to engage and pull (e.g., pull up) pelvic tissue to cause the lateral sub-urethral tissue, such as the endopelvic fascia, to tighten and provide slack reduction for improved support. As such, certain embodiments of the implants can be utilized to eliminate the need for mesh or other supportive structures under the urethra that is common with other incontinence slings.

Claims

1. A method of tensioning urethral support tissue, the method comprising:

producing a skin incision at an external location inferior to a location of an adductor longus inserting into a pubic ramus, on a side of a patient,

providing an implant comprising a leading end having an anchor, a trailing end having a member, and an extension portion extending between the leading end and the trailing end;

introducing the leading end through the skin incision,

passing the leading end around the pubic ramus, through an obturator foramen and internus muscle, and advancing the leading end and the anchor of the leading end into urethral support tissue lateral to a urethra, on the side of the patient,

after advancing the anchor of the leading end into the urethral support tissue, pulling on the trailing end to place tension along the extension portion, and

positioning the member of the trailing end into or proximate to bodily tissue to maintain the tension.

2. A method of claim 1 comprising:

producing a second skin incision at an external location inferior to a location of an adductor longus inserting into a pubic ramus, on a second side of a patient,

providing a second implant comprising a leading end having an anchor, a trailing end having a member, and an extension portion extending between the leading end and the trailing end;

introducing the leading end of the second implant through the second skin incision,

passing the leading end of the second implant around the pubic ramus, through an obturator foramen and internus muscle, and advancing the leading end and the anchor of the leading end of the second implant into urethral support tissue lateral to the urethra, on the second side of the patient,

after advancing the anchor of the leading end of the second implant into the urethral support tissue on the second side, pulling on the trailing end of the second implant to place tension along the extension portion of the second implant, and

positioning the member of the trailing end of the second implant into or proximate to bodily tissue to maintain the tension.

3. The method of claim 1, wherein the urethral support tissue is endopelvic fascia on the side of the patient.

4. The method of claim 2, wherein the urethral support tissue on the second side of the patient is endopelvic fascia on the second side of the patient.

5. The method of claim 1, wherein the leading end of the implant does not extend to a location below the urethra of the patient.

6. The method of claim 2, wherein the leading end of the second implant does not extend to a location below the urethra of the patient.

7. The method of claim 1, wherein the anchor of the leading end includes comprises a fixating anchor having one or more extending barbs.

8. The method of claim 2, wherein the anchor of the leading end of the second implant comprises a fixating anchor having one or more extending barbs.

9. The method of claim 1 wherein the method does not include dissection of the patient under the urethra.

10. The method of claim 1 wherein the extension portions of the implant and the second implant are porous mesh.

11. The method of claim 1 wherein placing tension along the extension portion returns the urethral support tissue to a correct anatomical position.

12. The method of claim 2 wherein placing tension along the extension portion of the second implant returns the urethral support tissue on the second side to a correct anatomical position.

13. The method of claim 1, wherein the member of the trailing end includes an anchor or a base member.

14. The method of claim 2, wherein the member of the trailing end of the second implant includes an anchor or a base member.