Tuck and fold fascia shortening for incontinence

• US 6,044,847 A
• Filed: 06/23/1998
• Issued: 04/04/2000
• Est. Priority Date: 06/23/1998
• Status: Expired due to Term

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: SURX, Inc. (Endo International PLC)
• Inventors: Claude, John P., Carter, Garry L., Morrison, George A., Do, Paul L., Densow, David C.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/103,352
• Time in Patent Office: 651 Days
• Field of Search: 128/898, 128/DIG. 25, 606/1, 606/139, 606/142, 606/144, 606/148, 607/115, 607/116, 607/138
• US Class Current: 128/898
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/282 Jaws
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0647 having one single leg, e.g. tacks
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2018/00523 Treatment of incontinence

Abstract

Improved devices, methods, and systems for the surgical treatment of urinary incontinence generally enhance the support provided by the natural tissues of the pelvic floor without directly applying compressive pressure against the urethra. The invention provides probes for forming plications in the endopelvic fascia that are displaced laterally on either side of the midline. These probes can impose a predetermined level of trauma to the plicated tissues so as to promote the formation of adhesions. Adhesions can maintain the enhanced support provided by the plication after reabsorption of a temporary fastener (such as a reabsorbable suture, staple, or the like). The plicating probe draws the tissue inward to provide a uniform plication within a predetermined size range.

Claims

1. A therapy for incontinence comprising:

engaging an endopelvic support tissue with a probe;

manipulating the engaged tissue with the probe to form a fold having a first portion of the tissue adjacent to a second portion of the tissue along a fold depth, the fold depth being within a predetermined range;

affixing the adjacent first and second tissue portions together with the probe to decrease a dimension of the tissue such that incontinence is inhibited.

2. The incontinence therapy of claim 1, wherein the tissue portions comprise or support endopelvic fascia.

3. The incontinence therapy of claim 1, wherein the affixing step comprises advancing a fastener from the probe at least partially through each of the first tissue portion and the second tissue portion.

4. The incontinence therapy of claim 3, wherein the fastener comprises at least one member of the group consisting of suture, a staple, a barbed tack, and a helical coil.

5. The incontinence therapy of claim 3, wherein the fastener is at least partially bioabsorbable, and further comprising promoting adhesion formation between the first and second tissue portions.

6. The incontinence therapy of claim 5, wherein the adhesion promoting step comprises abrading adjacent tissue surface regions.

7. The incontinence therapy of claim 1, wherein the affixing step comprises applying an electrical current through the first and second tissue portions.

8. The incontinence therapy of claim 1, wherein the manipulating step comprises evacuating a cavity while a rim of the cavity engages the tissue surface so that the tissue is pulled inward the fold depth.

9. The incontinence therapy of claim 1, wherein the engaging and manipulating steps comprise engaging grasping tissue surfaces of the probe against the tissue surface and moving the grasping surfaces towards each other by at least the fold depth.

10. The incontinence therapy of claim 1, wherein the engaging and manipulating steps comprise grasping a tissue surface with jaws and sliding the grasped tissue into a fixed channel by pulling the jaws into the channel.

11. The incontinence therapy of claim 1, wherein the affixed first and second portions form the fold with a fold depth from about 2 mm to about 2 cm from the tissue surface, the fold extending a fold length of between 1 and 3 cm.

12. A therapy for incontinence of a patient, the patient having endopelvic fascia extending laterally on first and second sides of a urethra, the therapy comprising:

affixing a first surface region of the endopelvic fascia on the first side of the urethra to a second surface region of the endopelvic fascia on the first side of the urethra with a first fastener so as to decrease an effective length of the first side wherein the shortened effective length of the endopelvic fascia enhances the support of the urethra such that incontinence is inhibited.

13. The incontinence therapy of claim 12, further comprising:

affixing a third surface region of the endopelvic fascia on the second side of the urethra to a forth surface region of the endopelvic fascia on the second side of the urethra with a second fastener so as to decrease an effective length of the second side.

14. The incontinence therapy of claim 13, wherein the affixing steps comprise promoting formation of adhesions between the first and second surface regions and between the third and fourth surface regions, and further comprising reabsorbing the fasteners.

15. A therapy for incontinence comprising:

decreasing a first effective length of an endopelvic fascia between a urethra and a first arcus tendinous fascia pelvis;

decreasing a second effective length of the endopelvic fascia between the urethra and a second arcus tendinous fascia pelvis; and

wherein the first and second lengths are separated from the urethra so as to avoid directly compressing the urethra, thereby inhibiting incontinence without obstructing voluntary voiding.