Endopelvic fascia treatment for incontinence

• US 6,292,700 B1
• Filed: 10/06/1999
• Issued: 09/18/2001
• Est. Priority Date: 09/10/1999
• Status: Expired due to Term

• Current Assignee: ASTORA Women's Health, LLC (Endo International PLC)
• Original Assignee: SURX, Inc. (Endo International PLC)
• Inventors: Dietz, Timothy G., Carter, Garry L., Morrison, George A.
• Primary Examiner(s): GIBSON, ROY DEAN
• Application Number:
  US09/413,100
• Time in Patent Office: 713 Days
• Field of Search: 607/96, 607/98-102, 607/113, 606/27-33
• US Class Current: 607/98
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 2018/00011 with fluids
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00517 Urinary bladder or urethra
• CPC Class Codes: A61B 2018/00523 Treatment of incontinence
• CPC Class Codes: A61B 2018/00714 Temperature
• CPC Class Codes: A61B 2018/00791 Temperature
• CPC Class Codes: A61B 5/202 Assessing bladder functions, e.g. incontinence assessment
• CPC Class Codes: A61B 5/205 Determining bladder or urethral pressure

Abstract

Methods, devices, and systems for treating the support structures of the body, particularly for incontinence, take advantage of two mechanisms to enhance the support provided by the fascia, ligaments and tendons: first, the invention increases a modulus of elasticity of these tissues, and particularly of the fascial tissues. The increase in modulus can be effected by directing sufficient energy to the fascial tissue so as to promote the formation of scar tissue. The second mechanism attaches tissue planes together, often by directing energy to an interface between adjacent fascial tissues.

Claims

1. A method for treating incontinence, the method comprising reducing an elasticity of a pelvic support tissue system along a length of the tissue sufficiently so that the tissue inhibits incontinence, wherein the tissue is loaded along the length under an incontinence-event stress pulse, and wherein the elasticity of the tissue is reduced without significantly reducing the length.

2. The method of claim 1 wherein the elasticity is reduced as a result of delivering energy or an active agent to the pelvic support tissue.

3. The method of claim 1, wherein the elasticity reducing step comprises promoting scarring of a fascial tissue supporting the urethra or bladder, and wherein the scarring increases a modulus of elasticity of the fascial tissue so that the fascial tissue inhibits incontinence.

4. The method of claim 3, wherein the promoting scarring step comprises directing the energy into the fascial tissue so as to injure the fascial tissue without ablating the fascial tissue.

5. The method of claim 4, wherein the directing energy step heats the fascial tissue without significantly shrinking the fascial tissue.

6. The method of claim 4, wherein the directing energy step comprises transmitting RF current from at least one electrode to the fascial tissue.

7. The method of claim 6, further comprising irrigating the fascial tissue with sufficient fluid to avoid fouling of the electrode when the transmitting electrode moves over the fascial tissue.

8. The method of claim 1, wherein the elasticity reducing step comprises applying at least one element selected from the set containing laser energy, focused ultrasound energy, microwave energy, a caustic composition, a pleurodesis agent, a sclerosing agent, and a growth factor.

9. The method of claim 1, wherein the tissue comprises a member selected from the group consisting of:

anterior sacro-coccygeal ligament;

arcus tendineus fasciae pelvis;

fasciae of the obturator internus muscle;

the arcs tendineus levator ani;

bulbocavernosus muscle;

ischiocavernosus muscle;

urethrovaginal sphincter;

m. compressor urethrae muscle;

m. sphincter urethrovaginal muscle;

structures of the bladder and urethra;

urethrovesical fascia;

detrusor muscle;

pubo-coccygeus muscle;

structures of the vagina;

vagino-uterine fascia;

lamina propria;

pubo-urethral or puboprostatic ligaments;

pubo-vesicle ligament and posterior pubo-urethral or pubo-prostatic ligament;

pubovesicle muscle;

pubocervical fascia;

structures of the uterus;

round ligament;

sacrouterine ligament; and

broad ligament;

structures cf the bowel;

rectal fascia and Mackenrodt'"'"'s ligament.

15. The method of claim 9, wherein the directing energy step comprises transmitting RF current from at least one electrode to the fascial tissue.

18. The method of claim 9, wherein the injured fascial tissue surface is acutely fused with the second tissue by heat.

20. The method of claim 9, wherein the attachment promoting step results in formation of adhesions between the first and second tissues.

10. A method for treating incontinence, the method comprising:

reducing an elasticity of a pelvic support tissue system, the tissue system comprising a fascial tissue supporting the urethra or bladder, by promoting scarring of the fascial tissue, the scarring increasing a modulus of elasticity of the fascial tissue without significantly shrinking the fascial tissue and the tissue system so that the fascial tissue and the tissue system inhibit incontinence, wherein the elasticity is reduced as a result of delivering energy to the fascial tissue so as the heat the fascial tissue to a temperature in a range from 45 to below 60°

C.

11. A method for treating incontinence, the method comprising:

reducing an elasticity of a pelvic support tissue system sufficiently so that the tissue system inhibits incontinence, wherein the elasticity is reduced, without significantly shrinking the tissue system, by directing energy into a fascial tissue of the tissue system so as to injure the fascial tissue without ablating the fascial tissue, and so as to promote scarring of the fascial tissue, the fascial tissue supporting a urethra or bladder, the scarring increasing a modulus of elasticity of the fascial tissue so that the fascial tissue inhibits incontinence, the directing energy step comprising transmitting RF current from at least one electrode to the fascial tissue; and

maintaining an intermediate tissue disposed between the electrode and the fascial tissue at a temperature lower than a treatment temperature of the fascial tissue by cooling the intermediate tissue with the electrode, wherein the electrode transmits the RF current via the cooled tissue to the fascial tissue.

14. The method of claim 11, wherein the attachment promoting step comprises directing sufficient energy to an interface between the first tissue and the second tissue to injure a surface of a fascial tissue without ablating the fascial tissue.

23. The method of claim 11, wherein the attachment promoting step comprises applying at least one element selected from the set containing laser energy, focused ultrasound energy, microwave energy, a caustic composition, a pleurodesis agent, a sclerosing agent, a growth factor, a biomaterial mesh, and a surgical sealant.

12. A method for treating incontinence, the method comprising:

reducing an elasticity of a pelvic support tissue system along a length of the tissue sufficiently so that the tissue inhibits incontinence, wherein the tissue is loaded along the length under an incontinence-event stress pulse, and

comparing a change in urethral pressure relative to a change in vesicle pressure, and tailoring an incontinence therapy in response to the comparing step to maintain the urethral pressure above the vesicle pressure throughout the incontinence-event stress pulse.

13. A method for treating incontinence, the method comprising promoting attachment between a first tissue and a second tissue with energy or an active agent, the second tissue slidingly engaging the first tissue prior to attachment so that the attachment limits motion between the first and second tissues and the limited motion inhibits incontinence.

16. The method of claim 13, further comprising irrigating the fascial tissue surface with sufficient fluid to avoid fouling of the electrode when the transmitting electrode moves over the fascial tissue surface.

17. The method of claim 13, further comprising cooling the electrode sufficiently to maintain a tissue disposed between the electrode and the fascial tissue surface at a temperature lower than a treatment temperature of the fascial tissue surface.

19. The method of claim 16, wherein collagen of the fused first and second tissues is cross-linked during healing.

21. The method of claim 13, wherein the first tissue is selected from a group consisting of:

anterior sacro-coccygeal ligament;

arcus tendineus fasciae pelvis;

fasciae of the obturator internus muscle;

the arcs tendineus levator ani;

bulbocavernosus muscle;

ischiocavernosus muscle;

urethrovaginal sphincter;

m, compressor urethrae muscle;

m, sphincter urethrovaginal muscle;

structures of the bladder and urethra;

urethrovesical fascia;

detrusor muscle;

pubo-coccygeus muscle;

structures of the vagina;

vagino-uterine fascia;

lamina propria;

pubo-urethral or puboprostatic ligaments;

pubo-vesicle ligament and posterior pubo-urethral or pubo-prostatic ligament;

pubovescile muscle;

pubocervical fascia;

structures of the uterus;

round ligament;

sacrouterine ligament;

structures of the bowel;

rectal fascia and Mackenrodt'"'"'s ligament.

22. The method of claim 16, wherein the second tissue is also selected from the group.

24. A method for treating incontinence, the method comprising:

measuring a urethral pressure and a vesicle pressure during a stress;

comparing a change in the measured urethral pressure relative to a change in the measured vesicle pressure; and

reducing an elasticity of a pelvic support system in response to the comparing step sufficiently that the urethral pressure will remain greater than the vesicle pressure during stress.

25. A system to treat incontinence, the system comprising:

a probe for delivering energy or an active agent to a pelvic support tissue so as to reduce an elasticity of the pelvic support tissue;

a control system coupled to the probe, the control system limiting the delivery from the probe to avoid collateral damage;

a urethral pressure sensor;

a vescile pressure sensor; and

a processor coupled to the urethral pressure sensor and the vescile pressure sensor, the processor generating an output indicating a change in urethral pressure relative to a change in vesicle pressure.