Method and device for anchor implantation and support of bodily structures

• US 6,595,911 B2
• Filed: 04/03/2001
• Issued: 07/22/2003
• Est. Priority Date: 04/03/2001
• Status: Expired due to Fees

• Current Assignee: Michael Lovuolo
• Original Assignee: Michael Lovuolo
• Inventors: LoVuolo, Michael
• Primary Examiner(s): HOOK, JAMES F
• Application Number:
  US09/825,032
• Publication Number:
  US 20020143234A1
• Time in Patent Office: 840 Days
• Field of Search: 600/29, 600/30, 600/31, 600/32, 600/37, 128/DIG.25
• US Class Current: 600/30
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61F 2/0045 Support slings
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: Y10S 128/25 Artificial sphincters and devices for controlling urinary incontinence

Abstract

A method and device for suspending, stabilizing, and/or slightly compressing a bodily structure, such as a urethrovesical junction. The device comprising a delivery needle with a trocar, a stylet for being matingly received into the delivery needle, and a support formed by an anchor toggle and elongate first and second sutures. A longitudinal slot can be disposed at the distal end of the delivery needle for allowing the sutures to protrude therefrom. The delivery needle can have a curve with the slot and a base of the trocar disposed on an inside of the curve. An aligning handle, visual and tactile orientation indicators, and depth indicators can be disposed on the delivery needle for allowing a determination of the orientation, depth, and location of the distal end of the delivery needle. A sling can be used to spread a supporting force of the sutures over a greater area.

Claims

1. A device for suspending, stabilizing, and/or slightly compressing a bodily structure, the device comprising:

a delivery needle comprising an elongate cannula with a proximal end, a distal end, and a body portion;

a stylet comprising an elongate rod for being matingly received into the cannula of the delivery needle; and

a support comprising an anchor toggle and elongate first and second sutures wherein each of the first and second sutures has a first end secured to the anchor toggle and a free second end wherein each of the first and second sutures extend from a central portion of the anchor toggle;

whereby the delivery needle and the stylet can be used to deploy the anchor toggle remotely in a desired location in a body to provide support for the first and second sutures and thereby to support, stabilize, and/or compress a bodily structure.

2. The device of claim 1 further comprising a trocar disposed at the distal end of the delivery needle.

3. The device of claim 1 further comprising a longitudinal slot formed in the delivery needle wherein the longitudinal slot begins at the distal end of the cannula, communicates longitudinally along the cannula, and terminates a given distance away from the distal end of the cannula whereby the support can be retained within the distal end of the delivery needle with the anchor toggle at least partially disposed in the distal end of the delivery needle and the first and second sutures protruding from the slot.

4. The device of claim 3 wherein the body portion of the delivery needle has a curve therein and wherein the slot is disposed on an inside of the curve whereby the first and second sutures protrude through the slot on the inside of the curve.

5. The device of claim 4 further comprising a trocar disposed at the distal end of the delivery needle wherein the trocar is angled such that the trocar has a distal tip and a proximal base and wherein the slot is disposed adjacent to the base of the trocar.

6. The device of claim 5 wherein the distal tip of the trocar is disposed on an outside of the curve in the delivery needle.

7. The device of claim 1 wherein the body portion of the delivery needle has a curve therein and further comprising an aligning handle fixed adjacent to the proximal end of the delivery needle.

8. The device of claim 7 further comprising a visual orientation marker on the aligning handle for indicating an orientation of the delivery needle wherein the visual orientation marker comprises a color marking disposed to a first side of the curve in the delivery needle but not to a second side of the curve in the delivery needle.

9. The device of claim 7 further comprising a tactile orientation indicator disposed on the aligning handle for indicating an orientation of the delivery needle.

10. The device of claim 9 wherein the tactile orientation indicator comprises a plurality of ridges disposed on the aligning handle wherein the plurality of ridges are disposed to a first side of the curve in the delivery needle but not to a second side of the curve in the delivery needle.

11. The device of claim 1 further comprising a means for indicating a depth to which the delivery needle has been inserted into a patient'"'"'s body.

12. The device of claim 11 wherein the means for indicating the depth to which the delivery needle has been inserted comprises a series of depth calibration markings disposed along the body portion of the delivery needle.

13. The device of claim 12 wherein the series of depth calibration markings comprise a plurality of coded stripes wherein different numbers of stripes indicate different depths.

14. The device of claim 1 wherein the elongate rod of the stylet is formed from a nickel titanium alloy.

15. The device of claim 1 wherein the anchor toggle comprises a cylinder with an aperture in a central portion thereof and wherein the first and second sutures extend from the aperture in the central portion of the anchor toggle.

16. The device of claim 15 wherein the first and second sutures travel through the anchor toggle and out opposite ends thereof and wherein the first ends of the first and second sutures are secured to the anchor toggle by a knot in each suture tied beyond the opposite ends of the anchor toggle.

17. The device of claim 1 further comprising a sling for coupling with the first and second sutures to spread a supporting force of the first and second sutures over a greater area.

18. A device for suspending, stabilizing, and/or slightly compressing a bodily structure, the device comprising:

a delivery needle comprising an elongate cannula with a proximal end, a distal end, and a body portion;

a trocar disposed at the distal end of the delivery needle;

a stylet comprising an elongate rod for being matingly received into the cannula of the delivery needle; and

a support comprising an anchor toggle and elongate first and second sutures wherein each of the first and second sutures has a first end secured to the anchor toggle and a free second end wherein each of the first and second sutures extend from a central portion of the anchor toggle;

a longitudinal slot formed in the delivery needle wherein the longitudinal slot begins at the distal end of the cannula, communicates longitudinally along the cannula, and terminates a given distance away from the distal end of the cannula whereby the support can be retained within the distal end of the delivery needle with the anchor toggle at least partially disposed in the distal end of the delivery needle and the first and second sutures protruding from the slot;

wherein the body portion of the delivery needle has a curve therein, wherein the trocar is angled such that the trocar has a distal tip and a proximal base with the distal tip of the trocar disposed on an outside of the curve in the delivery needle, and wherein the slot is disposed in the base of the trocar and on an inside of the curve whereby the first and second sutures protrude through the slot on the inside of the curve;

whereby the delivery needle and the stylet can be used to deploy the anchor toggle remotely in a desired location in a body to provide support for the first and second sutures and thereby to support, stabilize, and/or compress a bodily structure.

19. The device of claim 18 further comprising a means for indicating a depth to which the delivery needle has been inserted into a patient'"'"'s body.

20. The device of claim 19 wherein the means for indicating the depth to which the delivery needle has been inserted comprises a series of depth calibration markings disposed along the body portion of the delivery needle wherein the series of depth calibration markings comprise a plurality of coded stripes wherein different numbers of stripes indicate different depths.

21. A method for the correction of urinary incontinence without percutaneous incision, the method comprising the steps of:

providing a delivery needle comprising an elongate cannula with a proximal end, a distal end, and a body portion;

providing a stylet comprising an elongate rod for being matingly received into the cannula of the delivery needle;

providing a urethrovesical support comprising an anchor toggle with at least an elongate first suture with a proximal end fixed to the anchor toggle and a free distal end;

inserting the distal end of the elongate cannula of the delivery needle partially into a perineum of a patient'"'"'s body that has a bladder structure with a bladder, a urethrovesical junction, and a urethra;

passing the distal end of the cannula through the perineum wall, across the space of the Retzius behind the symphysis pubis, and then to a desired supporting location but not so far that the distal end of the cannula or the anchor toggle creates a percutaneous incision;

inserting the anchor toggle of the urethrovesical support at least partially into the cannula of the delivery needle;

inserting the elongate rod of the stylet into the proximal end of the cannula of the delivery needle;

deploying the anchor toggle of the urethrovesical support by sliding the elongate rod of the stylet increasingly deeper into the cannula of the delivery needle at least until the distal end of the elongate rod drives the anchor toggle out of the distal end of the cannula and into the desired supporting location;

removing the elongate cannula of the delivery needle from the patient'"'"'s body thereby leaving the anchor toggle in position and leaving the at least one elongate first suture in place; and

coupling the at least one suture to the bladder structure of the patient'"'"'s body thereby providing support, compression, and/or stabilization to the bladder structure with the anchor toggle acting as a supporting anchor and the at least one suture acting as a supporting line;

whereby urinary stress incontinence in the patient can be corrected.

22. The method of claim 21 wherein the step of providing the urethrovesical support comprises providing an anchor toggle and elongate first and second sutures wherein each of the first and second sutures has a first end secured to the anchor toggle and a free second end wherein each of the first and second sutures extend from a central portion of the anchor toggle.

23. The method of claim 22 wherein the step of coupling the at least one suture to the bladder structure of the patient'"'"'s body comprises the steps of disposing the first suture to a first side of the bladder structure, disposing the second suture to a second side of the bladder structure, and securing the second end of the first suture relative to the second end of the second suture thereby to provide support, compression, and/or stabilization to the bladder structure.

24. The method of claim 23 wherein the step of securing the second end of the first suture relative to the second end of the second suture comprises tying the second ends of the first and second sutures directly together.

25. The method of claim 23 further comprising the step of providing a sling for coupling with the first and second sutures to spread a supporting force of the first and second sutures over a greater area.

26. The method of claim 21 wherein the step of passing the distal end of the cannula through the perineum wall, across the space of the Retzius behind the symphysis pubis, and then to a desired supporting location comprises passing the distal end of the cannula through the perineum wall, across the space of the Retzius behind the symphysis pubis, and then until the distal end of the cannula has pierced a rectus abdominus of the patient thereby carrying the anchor toggle through the rectus abdominus but not so far that the distal end of the cannula or the anchor toggle creates a percutaneous incision.

27. The method of claim 21 wherein the step of providing the delivery needle comprises the step of providing a delivery needle with a longitudinal slot formed therein wherein the longitudinal slot begins at the distal end of the cannula, communicates longitudinally along the cannula, and terminates a given distance away from the distal end of the cannula, wherein the step of inserting the anchor toggle at least partially into the cannula of the delivery needle is performed prior to the step of inserting the distal end of the elongate cannula of the delivery needle partially into the perineum of the patient'"'"'s body, and wherein the step of inserting the anchor toggle at least partially into the cannula of the delivery needle comprises disposing the anchor toggle at least partially in the distal end of the delivery needle with the first and second sutures protruding from the longitudinal slot.

28. The method of claim 27 wherein the step of providing the delivery needle comprises the step of providing a delivery needle with a curve therein, with the slot disposed on an inside of the curve whereby the first and second sutures protrude through the slot on the inside of the curve, and a trocar disposed at the distal end of the delivery needle with the trocar angled such that the trocar has a distal tip on an outside curve of the delivery needle and a proximal base and with the slot disposed adjacent to the base of the trocar.