Articles, devices, and methods for pelvic surgery

• US 7,740,576 B2
• Filed: 04/05/2006
• Issued: 06/22/2010
• Est. Priority Date: 04/05/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Bouchier, Mark S., Anderson, Kimberly A., Cox, James E., Hodroff, Marc A.
• Primary Examiner(s): Marmor, II; Charles A
• Assistant Examiner(s): Burk; Catherine E
• Application Number:
  US11/398,368
• Publication Number:
  US 20060260618A1
• Time in Patent Office: 1,539 Days
• Field of Search: 600 29- 30, 600/37, 128/898
• US Class Current: 600/29
• CPC Class Codes: A61B 17/06066 Needles, e.g. needle tip configurations making needles B21G1/00
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/06009 having additional means for releasably clamping the suture to the needle, e.g. actuating rod slideable within the needle
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06076 helically or spirally coiled
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

Described are implants, tools, and related methods, for use in pelvic surgery to treat conditions such as prolapse and incontinence, including one embodiment of a method that uses a transcoccyx tissue path; other embodiments that use particular implants with various features relating to, e.g., end portions; and other embodiments relating to particular tools.

Claims

1. A method for supporting vaginal tissue, the method comprising:

providing an implant comprising a tissue support portion and an end portion extending from the tissue support portion,

creating a vaginal incision,

placing the tissue support portion in contact with vaginal tissue in a position to support the vaginal tissue,

producing a tissue path between the position of the tissue support portion and an exterior incision, the tissue path passing through tissue of a coccyx region bounded by an upper edge of a sacrospinous ligament, a tip of a coccyx bone, a point approximately 2.5 centimeters lateral to the tip of the coccyx bone, and an ischial spine,

associating a tip of a needle with the end portion of the implant, and

inserting the needle tip and associated end portion into the vagina and transvaginally through the vaginal incision, and

pushing the needle tip and end portion of the implant through the tissue path and through the external incision thereby extending the end portion through the tissue path to the external incision.

2. The method of claim 1, wherein the method is for treatment of a condition selected from vaginal vault prolapse, enterocele, rectocele, cystocele, and combinations thereof.

3. The method of claim 1, wherein the tissue path passes through a coccyx region bounded by a lower edge of a sacrospinous ligament, a tip of a coccyx bone, a point approximately 2.5 centimeters lateral to the tip of the coccyx bone, and an ischial spine.

4. The method of claim 1, wherein the tissue path passes through a coccyx region bounded by an edge of the coccyx bone between a tip of the coccyx bone and a lower edge of a sacrum, and a line 2.5 centimeters from the edge of the coccyx bone lateral and parallel to the edge.

5. The method of claim 1, wherein the tissue path passes from a region of the vaginal apex, through coccygeous or iliococcygeous muscle, to the external incision.

6. The method of claim 1, wherein the tissue path does not traverse gluteus maximus muscle.

7. The method of claim 1, wherein the implant comprises supportive portions consisting of a tissue support portion and only one end portion, and the method includes making only one tissue path between the vaginal apex region and the external incision, for passing the one end portion between the vaginal apex region and the external incision.

8. A method of claim 1, further comprising using a surgical tool comprising

a handle comprising a longitudinal axis,

a two-dimensional elongate needle extending from the handle, the elongate needle comprising

a first curved portion proximal to the handle, the first curved portion having a first radius of curvature and a first arclength,

a second curved portion extending from a distal end of the first curved portion, the second curved portion having a second radius of curvature and a second arclength that are different from the first radius of curvature and first arclength, and

and a straight portion extending from a distal end of the second curved portion to a needle tip.

9. The method of claim 1, wherein the implant comprises a dilator at an end of the end portion distal from the tissue support portion, the dilator capable of cooperating with the insertion tool to push or pull the dilator through tissue.

10. The method of claim 1, wherein the implant comprises an elongate sheath surrounding at least a portion of an end portion, and a dilator attached at a distal end of the sheath.

11. A method of treating a pelvic condition, the method comprising

providing an implant comprising supportive portions consisting of

a central support portion having two opposing sides and two opposing ends and

a shorter end portion extending from one end of the central support portion and a longer end portion extending from the opposing end of the central support portion

wherein the central support portion has a width greater than a width of the end portions, and

the shorter end portion has a length that is shorter than a length of the longer end portion

providing a tool comprising a curved needle, a tip of the needle adapted to engage a distal end of an end portion,

contacting the tissue support portion with a pelvic tissue,

engaging the tool with a distal end of the shorter end portion and implanting the shorter end portion in a patient, and

after implanting the shorter end portion, engaging the tool with a distal end of the longer end portion and implanting the longer end portion in the patient.

12. The method of claim 11, for treating vaginal vault prolapse.

13. A method of implanting a pelvic implant, the method comprising

providing an implant comprising:

a tissue support portion and first and second elongate end portions extending from the tissue support portion,

a first and second dilator attached to a distal end of each end portion,

first and second elongate sheaths surrounding at least a portion of each end portion, the sheaths comprising a distal end attached to the dilator,

wherein

the end portions include a passage inside of the sheaths, to an internal surface of each dilator,

providing a tool comprising an elongate needle having a needle tip adapted to engage the internal surface of the dilators through the passages,

placing the tool inside at least a portion of the first sheath surrounding a length of the first end portion, and engaging the first dilator,

inserting the first dilator through a first tissue path by pushing the first dilator using the tool.

14. The method of claim 13, further comprising:

disengaging the first dilator from the needle tip,

withdrawing the needle from the first tissue path,

after withdrawing the needle from the first tissue path, inserting the needle into the sheath of the second end portion surrounding a length of the second end portion and engaging a second dilator with the needle tip, and

inserting the second dilator through a second tissue path by pushing the second dilator using the tool.

15. A method for supporting vaginal tissue, the method comprising

providing an implant comprising a tissue support portion and an end portion extending from the tissue support portion,

creating a vaginal incision,

placing the tissue support portion in contact with vaginal tissue in a position to support the vaginal tissue,

producing a tissue path between the position of the tissue support portion and an exterior incision, the tissue path passing through tissue of a coccyx region bounded by an upper edge of a sacrospinous ligament, a tip of a coccyx bone, a point approximately 2.5 centimeters lateral to the tip of the coccyx bone, and an ischial spine,

extending the end portion through the tissue path to the external incision,

wherein the implant comprises supportive portions consisting of a tissue support portion and only one end portion, and the method includes making only one tissue path between the vaginal apex region and the external incision, for passing the one end portion between the vaginal apex region and the external incision.