Transvaginal anchor implantation device and method of use

• US 6,319,272 B1
• Filed: 03/29/2000
• Issued: 11/20/2001
• Est. Priority Date: 11/08/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Corporation
• Original Assignee: Boston Scientific Corporation
• Inventors: Gellman, Barry N., Brenneman, Rodney, Morin, Armand A., Sauvageau, David
• Primary Examiner(s): Reca, Henry J.
• Assistant Examiner(s): Woo, Julian W.
• Application Number:
  US09/537,320
• Time in Patent Office: 601 Days
• Field of Search: 606/104, 606/72, 606/73, 606/75, 606/148, 606/139, 606/232, 606/219, 128/898
• US Class Current: 606/232
• 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 17/0642 for bones, e.g. for osteosynthesis or connecting tendon to bone
• 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 2017/2904 curved, but rigid

Abstract

Bone anchor implantation devices and methods for their use are disclosed. The bone anchor implantation devices and methods find particular application in maintaining or improving urinary continence by suspending or stabilizing the bladder neck. The devices and methods simplify procedures for suspending or stabilizing the bladder neck and further reduce their invasiveness.

Claims

1. A method for inserting a bone anchor coupled to a suture releasably engaged to a hook-shaped bone anchor implantation device into a bone comprising the steps of:

providing a bone anchor inserter, comprising;

a handle including a proximal end, a distal end, and a longitudinal axis;

a hook shaped shaft including a first end and a second end, the first end being connected to the handle;

a tapered bone anchor mount for releasably engaging the bone anchor coupled to a suture connected to the second end of the shaft, the bone anchor mount comprising an outer cylinder, and a tapered bone anchor receptacle, wherein the tapered bone anchor mount includes a longitudinal axis and the longitudinal axis of the tapered bone anchor mount is aligned with the longitudinal axis of the handle; and

a protective sheath connected to the bone anchor mount for isolating the bone anchor prior to implantation of the bone anchor into bone,

locating a bone anchor implantation site; and

implanting the bone anchor into the bone by applying a retrograde force to the bone anchor insertor substantially along the longitudinal axis of the handle.

2. The method of claim 1, wherein the providing a bone anchor inserter step further comprises providing a bone anchor inserter in which the outer cylinder comprises a cavity therein and an inner cylinder is connected to the outer cylinder within the cavity.

3. The method of claim 1, wherein the providing a bone anchor inserter step further comprises providing a bone anchor inserter in which the outer cylinder comprises a distal end and a proximal end, the outer cylinder also comprising an annular shoulder at the proximal end.

4. The method of claim 1, wherein the providing a bone anchor inserter step further comprises providing a bone anchor inserter in which the bone anchor receptacle comprises at least one groove adapted to accommodate the suture.

5. The method of claim 2, wherein the providing a bone anchor inserter step further comprises providing a bone anchor inserter in which the inner cylinder includes at least one groove adapted to accommodate the suture.

6. The method of claim 1, wherein the providing a bone anchor inserter step further comprises providing a bone anchor inserter in which the shaft includes a lumen, adapted to accommodate the suture.

7. The method of claim 1, wherein the implanting step comprises the step of applying retrograde force to the bone anchor insertor to translate the retrograde force to the bone anchor.

8. The method of claim 1, wherein the locating and implanting steps are accomplished transvaginally.

9. The method of claim 1, wherein at least one bone anchor couple to a suture is implanted transvaginally into a pubic bone of a patient.

10. The method of claim 9, wherein said at least one bone anchor couple to a suture is implanted into the interior surface of the pubic bone.

11. The method of claim 9, wherein said at least one bone anchor couple to a suture is implanted in the pubic bone on either side of the urethra.

12. The method of claim 10, at said least one bone anchor couple to a suture is implanted lateral to the symphysis pubis and cephalad to the inferior edge of the pubic bone.

13. The method of claims 12, further comprising stabilizing the bladder neck with the suture attached to the bone anchor.

14. The method of claim 12, further comprising:

creating an opening in the tissue between the vaginal wall and the urethra;

positioning a sling in the opening; and

stabilizing the bladder neck with the sling using sutures connected between the sling and the bone anchors.