Device and method for transvaginally suspending the bladder neck

• US 6,056,688 A
• Filed: 09/29/1997
• Issued: 05/02/2000
• Est. Priority Date: 12/03/1991
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Technology Incorporated (Boston Scientific Corporation)
• Inventors: Benderev, Theodore V., Legome, Mark J., Naves, Neil H.
• Primary Examiner(s): GILBERT, SAMUEL G
• Application Number:
  US08/939,151
• Time in Patent Office: 946 Days
• Field of Search: 600/29, 600/30, 606/151-156, 128/898
• US Class Current: 600/30
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0482 Needle or suture guides guides for drills, pins or wire A61B17/17; for puncturing needles A61B17/3403
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/10 for applying or removing wound clamps, e.g. containing only one clamp or staple A61B17/076 takes precedence; containing multiple wound clamps A61B17/068; Wound clamp magazines containers, packaging elements or packages specially adapted for particular articles or with special means for dispensing contents B65D83/00, B65D85/00
• CPC Class Codes: A61B 17/1739 specially adapted for particular parts of the body
• CPC Class Codes: A61B 17/1796 for holes for sutures or flexible wires
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00349 Needle-like instruments having hook or barb-like gripping means, e.g. for grasping suture or tissue A61B17/06066 takes precedence
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening lateral eyelet for attaching suture to needle A61B2017/06019
• CPC Class Codes: A61B 2017/0461 with features cooperating with special features on the suture, e.g. protrusions on the suture
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0496 for tensioning sutures
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 46/30 : for surgery through the lower body openings, e.g. urology, gynaecology

Abstract

The present invention relates to a tissue staple and staple applier for use in suspending tissue from an internal support structure. The present invention also relates to a transvaginal method of suspending a bladder neck from an internal support structure, such as the pubic bone, using the tissue staple and staple applier.

Claims

1. A tissue suspender for elevating and suspending tissue from an internal support structure, comprising:

a support body having a first tissue contacting side;

at least first and second projections extending from the support body, the projections being adapted for displacement between a first position in which the projections extend generally away from the first tissue contacting side of the support body for penetration of tissue, and a second position in which the first and second projections are inclined towards each other in the distal direction to grasp and retain an internal support structure, wherein the support body has an enlarged central portion relative to the projections, the enlarged central portion having a plurality of openings therein to allow for tissue inprowth and being enlarged in a plane which is generally parallel to the first tissue contacting side of the support body in order to distribute forces on the tissue about a larger area of the tissue.

2. A method of elevating the bladder neck and suspending the elevated bladder neck from an internal support structure in a female human patient having stress urinary incontinence, comprising the steps of:

providing a tissue suspender comprising a support body having a first tissue contacting side, the tissue suspender also comprising at least a first and second projections extending from the support body, and adapted for displacement between a first position in which the projections extend generally away from the first tissue contacting side of the support body for penetration of tissue, and a second position in which the first and second projections are inclined towards each other in the distal direction to grasp and retain an internal suport structure;

transvaginally introducing the tissue suspender into the patient'"'"'s body;

advancing the first and second projections through the vaginal mucosa and towards an internal support structure to elevate the bladder neck;

thereafter deflecting the distal ends of the first and second projections medially to engage the support structure, thereby retaining the tissue suspender.

3. A method as in claim 2, wherein the support structure comprises ligamentous tissue.

4. A method as in claim 3, wherein the support structure comprises an iliopectineal ligament.

5. A method as in claim 2, wherein the support structure comprises a bone.

6. A method as in claim 5, wherein the support structure comprises a pubic bone.

7. A method of suspending a bladder neck from an internal support structure in a patient, comprising the steps of:

providing a tissue staple with an enlarged central portion having a plurality of openings therethrough for allowing tissue ingrowth;

transvaginally introducing the tissue staple into the patient'"'"'s body;

locating a site on a vaginal mucosa generally adjacent the internal support structure;

positioning the staple against the site on the vaginal mucosa; and

advancing the staple through the site on the vaginal mucosa and into the internal support structure to suspend the bladder neck from the internal support structure.

8. The method of claim 7, wherein the advancing step comprises advancing the staple through the site on the vaginal mucosa and into a posterior surface of a pubic bone to suspend the bladder neck from the pubic bone.

9. The method of claim 7, wherein the tissue staple comprises a support body having a first tissue contacting side and at least a first and second projections extending from the support body, and wherein the advancing step comprises advancing the first and second projections through the site on the vaginal mucosa and into the internal support structure to suspend the bladder neck from the internal support structure.

10. The method of claim 7, further comprising:

providing a suture support;

positioning the suture support against the site on the vaginal mucosa; and

advancing the staple through the suture support and into the internal support structure to suspend the bladder from the internal support structure.

11. The method of claims 7, wherein at least two staples are advanced into the support structure, the two staples being advanced into the support structure on opposite sides of the bladder neck to form a bladder neck suspension sling.

12. A tissue support for use in treating urinary incontinence, comprising:

a support body having a first tissue contacting side for contacting a tissue to be supported, said support body having a plurality of openings therethrough for allowing tissue ingrowth;

a first securing section extending from a first end of said support body, said first securing section being adapted for securing said support body relative to the tissue to be supported when said first securing section is placed in a first securing tissue; and

a second securing section located on a second end of said support body, said second securing section being adapted for securing said support body relative to the tissue to be supported when said second securing section is placed in a second securing tissue.

13. The tissue support of claim 12, wherein said first tissue contacting side is adapted to have a concave configuration upon introduction into a patient.

14. The tissue support of claim 13, wherein said concave configuration comprises a partial ellipse.

15. The tissue support of claim 12, wherein said first and second securing sections are adapted for displacement between a first introduction configuration and a second tissue securing configuration.

16. The tissue support of claim 12, wherein said support body has an enlarged central portion relative to said first and second securing sections, the enlarged central portion being enlarged in a plane which is generally parallel to the first tissue contacting side of the support body in order to distribute forces on the tissue about a larger area of the tissue.

17. A method of treating urinary incontinence, comprising the steps of:

providing a tissue support comprising a support body having a first tissue contacting side for contacting a tissue to be supported, said support body having a plurality of openings therethrough for allowing tissue ingrowth, a first securing section extending from a first end of said support body, said first securing section being adapted for securing said support body relative to the tissue to be supported when said first securing section is placed in a first securing tissue, and a second securing section located on a second end of said support body, said second securing section being adapted for securing said support body relative to the tissue to be supported when said second securing section is placed in a second securing tissue;

transvaginally introducing said tissue support into the patient; and

positioning said first and second securing sections in the first and second securing tissues to secure the first tissue contacting side against the tissue to be supported, wherein said tissue to be supported is generally adjacent to a urethra in order to treat the urinary incontinence.

18. The method of claim 17, wherein said providing step further comprises providing a tissue support wherein said first tissue contacting side is adapted to have a concave configuration upon introduction into a patient.

19. The method of claim 18, wherein the step of transvaginally introducing said tissue support comprises transvaginally introducing a tissue support wherein said concave configuration comprises a partial ellipse.

20. The method of claim 17, wherein the step of positioning said first and second securing sections in the first and second securing tissues comprises positioning said first and second securing sections in a pubic bone.

21. The method of claim 17, wherein the step of positioning said first and second securing sections in the first and second securing tissues comprises positioning said first and second securing sections in a ligamentous tissue.

22. The method of claim 21, wherein said ligamentous tissue comprises the iliopectineal ligament.

23. The method of claim 17, further comprising the step of positioning at least two of the tissue supports in the tissue generally adjacent to the urethra on opposite sides of a bladder neck to form a bladder neck suspension sling.

24. The method of claim 17, wherein the step of transvaginally introducing the tissue support further comprises:

transvaginally introducing the tissue support using an apparatus comprising an elongate central section having a proximal end, a distal end, and a longitudinal axis, a handle section for gripping the apparatus, said handle section located at said proximal end of said elongate central section, and an engagement section located at said distal end of said elongate central section, said engagement section being adapted to releasably engage a tissue support, wherein at least a portion of said engagement section is generally curved with respect to the longitudinal axis of said elongate central section such that when said elongate central section is inserted into a vaginal canal said tissue support can pass through a vaginal mucosa generally adjacent to a urethra;

advancing said central section and said engagement section through a vaginal canal; and

advancing said tissue support through a vaginal mucosa.

25. The method of claim 24, further comprising pressing at least a portion of said engagement section into the tissue adjacent to the urethra.