Tuck and fold fascia shortening for incontinence

• US 6,478,791 B1
• Filed: 12/23/1999
• Issued: 11/12/2002
• Est. Priority Date: 06/23/1998
• Status: Expired due to Fees

• Current Assignee: Ams Research Corporation (Endo International PLC)
• Original Assignee: SURX, Inc. (Endo International PLC)
• Inventors: Do, Paul L., Densow, David C., Claude, John P., Carter, Garry L., Morrison, George A.
• Primary Examiner(s): PEFFLEY, MICHAEL F
• Application Number:
  US09/470,906
• Time in Patent Office: 1,055 Days
• Field of Search: 606/1, 606/139, 606/151, 606/142, 606/143, 606/148, 606/152, 606/153, 606/45-50, 606/51, 606/52, 607/138
• US Class Current: 606/1
• 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 reasborbable suture, staple, or the like). The plicating probe draws the tissue inward to provide a uniform plication within a predetermined size range.

Claims

1. An endopelvic fascia plication tool comprising:

a probe having a proximal end and a distal end;

means for grasping a region of the endopelvic fascia and for forming a fold in the endopelvic fascia that extends away from the plication tool, the grasping means disposed near the distal end; and

an actuation mechanism coupled to the grasping means so that actuation of the mechanism draws the grasped region inward from an initial configuration having an initial area to a smaller configuration having a smaller area.

2. A plication tool as claimed in claim 1, further comprising means for affixing the inward drawn region in the smaller configuration, the affixing means disposed near the grasping means.

3. A placation tool as claimed in claim 2, wherein the affixing means comprises a member selected from the group consisting of an electrode, adhesive, suture, a staple, a helical coil, and a barbed tack.

4. A plication tool as claimed in claim 2, wherein the affixing means is reabsorbable, and further comprising means for promoting adhesion formation, the adhesion promoting means oriented for engaging a surface of the endopelvic fascia disposed within the fold of the endopelvic fascia formed as the grasped region is drawn inward from the initial configuration to the smaller configuration.

5. An endopelvic fascia plication system comprising:

a probe having a proximal end and a distal end;

a grasper adjacent the distal end for engaging a surface region of the endopelvic fascia tissue and for forming a fold in the endopelvic fascia that extends away from the probe; and

a first actuation mechanism coupled to the grasper so that actuation of the first mechanism draws the engaged tissue inward from an initial configuration to a smaller area configuration.

6. A plication system as claimed in claim 5, further comprising a fastener disposable near the grasper and a second mechanism coupled to the fastener such that actuation of the second mechanism advances the fastener at least partially through the tissue so as to affix the tissue in the smaller configuration.

7. A plication system as claimed in claim 5, further comprising an electrode disposed near the grasper and an electrical conductor extending proximally from the advanced fastener to a current source for application of sufficient current to affix the tissue in the smaller configuration.

8. A plication system as claimed in claim 5, wherein the grasper comprises a pair of elements having tissue engaging surfaces configured to unslidingly engage the endopelvic fascia, wherein actuation of the first mechanism moves the tissue engaging surfaces inward.

9. A plication system as claimed in claim 8, further comprising a fold element extendable distally between the graspers to shape a fold of the tissue as the first mechanism removes the tissue engaging surfaces inward.

10. A plication system as claimed in claim 9, wherein at least one of the tissue engaging surfaces comprises a circumferentially oriented surfaces of a ripper wheel.

11. A plication system as claimed in claim 9, wherein at least one of the tissue engaging surfaces is disposed on an arm pivotally coupled to a shaft of the probe.

12. A plication system as claimed in claim 9, wherein the fold element is configured to injure tissue engaged thereby so as to promote formation of adhesions.

13. A plication system as claimed in claim 12, wherein the fold element has a roughened outer surface.

14. An endopelvic fascia plication system comprising:

a probe having a proximal end and a distal end;

a grasper comprising actuatable jaws adjacent the distal end for engaging a surface region of the endopelvic fascia tissue; and

a first actuation mechanism coupled to the grasper so that actuation of the first mechanism draws the engaged tissue inward from an initial configuration to a smaller area configuration into a fixed channel between a pair of slide surfaces.

15. An endopelvic fascia plication system comprising:

a probe having a proximal end and a distal end;

a grasper comprising a cavity having a rim oriented for engaging the tissue surface while the probe is positioned perpendicularly to the tissue surface; and

a first actuation mechanism coupled to the grasper and extending along the probe between the proximal and distal ends so that actuation of the first mechanism evacuates the cavity to draw the tissue therein.