Surgical instrument and method for treating female urinary incontinence

• US 6,932,759 B2
• Filed: 10/31/2002
• Issued: 08/23/2005
• Est. Priority Date: 06/09/1999
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Kammerer, Gene W., Ulmsten, Ulf, Luscombe, Brian, Landgrebe, Susanne, Hoepffner, Hans-Jochen, Angelini, Laura, Lehe, Jorn
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): Veniaminov, Nikita R.
• Application Number:
  US10/285,281
• Publication Number:
  US 20030149440A1
• Time in Patent Office: 1,027 Days
• Field of Search: 600/30, 600/29, 600/37, 128/898, 606/144, 606/148, 606/145, 606/146, 606/167, 606/151, 606/139, 606/232, 606/72, 572/43, 602/44
• US Class Current: 600/30
• CPC Class Codes: A61B 1/00087 Tools A61B17/00234 takes precedence
• CPC Class Codes: A61B 1/042 characterised by a proximal camera, e.g. a CCD camera
• CPC Class Codes: A61B 1/307 for the urinary organs, e.g. urethroscopes, cystoscopes
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06004 Means for attaching suture to needle tipping A61B17/06195; connecting wire to other metallic objects B21F15/00
• 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 for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• 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 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06047 located at the middle of the needle
• CPC Class Codes: A61B 2017/06057 Double-armed sutures, i.e. sutures having a needle attached to each end
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61B 2017/06104 interconnected at their distal ends, e.g. two hollow needles forming a loop for passing a suture
• CPC Class Codes: A61B 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61F 2/0045 : Support slings

Abstract

Described is a surgical instrument and method for treating female urinary stress incontinence. The instrument includes a first curved needle-like element defining in part a curved shaft having a distal end and a proximal, a tape, or mesh, for implanting into the lower abdomen of a female to provide support to the urethra; a second curved needle element having a proximal end and a distal end, and a coupler for simultaneous attachment to the distal end of the first needle and the distal end of the second needle. In an alternate embodiment, the second curved needle is an anesthesia needle and the method includes anesthetizing the needle pathway through a patient'"'"'s body to facilitate the passage of the first needle and mesh therethrough.

Claims

1. A surgical instrument for treating a patient suffering from female urinary stress incontinence, comprising:

a) a tape for implanting into the lower abdomen of a female to provide support to the urethra, said tape having a pair of ends;

b) a curved anesthesia needle having a curvature and length permitting said curved anesthesia needle to extend along a pathway through the patient'"'"'s abdominal wall, over the pubic bone, past the urethra and through the vaginal wall, such that anesthesia can be applied by the curved anesthesia needle along the pathway, said curved anesthesia needle also adapted to function as a guide element and having a distal end;

c) a curved needle element attached to proximate to one end of said tape, said needle element including a curved shaft having a distal; and

d) connecting means for removably connecting said distal end of said curved anesthesia needle to said distal end of said needle element.

2. The surgical instrument of claim 1, wherein said distal end of said anesthesia needle has a diameter of approximately 2 millimeters.

3. A surgical instrument for treating a patient suffering from female urinary stress incontinence, comprising:

(a) a tape for implanting into the lower abdomen of a female to provide support to the urethra, said tape having a pair of opposed ends;

(b) a guide element in the form of an anesthesia needle including means for delivering anesthesia to the patient'"'"'s body and having a distal end;

(c) a curved needle element attached proximate to one end of said tape, said needle element including a curved shaft having a distal end; and

(d) connecting means for removably connecting said distal end of said guide element to said distal end of said needle element, said connecting means having a bore in said distal end of said needle element, said bore being sized and shaped to securely and removably receive said distal end of said anesthesia needle therein.

4. The surgical instrument of claim 3, further comprising another curved needle element attached proximate to an opposite end of said tape, said another needle element including a curved shaft having a distal end;

and second connecting means for removably connecting said distal end of said anesthesia needle to said distal end of said another needle element.

5. The surgical instrument of claim 4, wherein said second connecting means includes a bore in said distal end of said another needle element, said bore being sized and shaped to securely and removably receive said distal end of said anesthesia needle therein.

6. The surgical instrument of claim 5, wherein said tape is substantially flat and flexible.

7. An improved surgical instrument for treating a patient suffering from female urinary stress incontinence, including a tape for implanting into the lower abdomen of a female to provide support to the urethra, said tape having a pair of ends;

a first curved needle element having a distal end;

a second needle element attached proximate to one end of said tape, said second needle element including a curved shaft having a distal end; and

connecting means for removably connecting said distal end of said first needle element to said distal end of said second needle element, the improvement wherein said first curved needle element is an anesthesia needle which includes means for delivering anesthesia to the patient'"'"'s body.

8. A method for treating a patient suffering from female urinary incontinence, comprising the steps of:

anesthetizing a pathway within the patient'"'"'s body proximate to the patient'"'"'s urethra, said pathway extending through the patient'"'"'s abdominal wall, over the pubic bone, past the urethra, and through the vaginal wall by passing an anesthesia needle with a distal end into the patient'"'"'s body along said pathway with periodic pauses along said pathway and injecting a clinically effective amount of anesthesia into the patient'"'"'s body during said periodic pauses such that said pathway is anesthetized;

passing a tape into the patient'"'"'s body along said pathway by attaching a first needle having a distal end to one end of the tape;

attaching a second needle having a distal end to an opposite end of the tape;

removably connecting the distal end of the anesthesia needle to the distal end of the first needle;

withdrawing the anesthesia needle back along said pathway such that the first needle and the one end of the tape are passed through the patient'"'"'s body along said anesthetized pathway and such that the one end of the tape extends through the abdominal wall and out of the patient'"'"'s body;

disconnecting the distal end of the anesthesia needle from the distal end of the first needle;

passing the anesthesia needle into the patient'"'"'s body along a second pathway;

removably connecting the distal end of the anesthesia needle to the distal end of the second needle;

withdrawing the anesthesia needle back along said second pathway such that the second needle and the opposite end of the tap are passed through the patient'"'"'s body along said second anesthesized pathway and such that the opposite end of the tape extends through the abdominal wall and out of the patient'"'"'s body; and

disconnecting the distal end of the anesthesia needle from the distal end of the second needle; and

positioning at least a portion of the tape between the vaginal wall and the urethra such that the tape forms a supportive loop beneath the urethra.

9. The method of claim 8, further comprising the step of adjusting the position and tension of the supportive loop to achieve a clinically acceptable degree of urinary continence.

10. A method for treating a patient suffering from female urinary incontinence, comprising the steps of:

anesthetizing a pathway extending through the patient'"'"'s abdominal wall, over the pubic bone, past the urethra, and through the vaginal wall by inserting a curved anesthesia needle into the patient'"'"'s body periodically pausing and injecting anesthetic during said pauses, said curved anesthesia needle extending along said pathway and injecting a clinically effective amount of anesthesia into the patient'"'"'s body as curved anesthesia needle traverses the pathway;

removably attaching a needle having a distal end to one end of a tape

passing the tape into the patient'"'"'s body along said pathway using the curved anesthesia needle as a guide element, such that when the curved anesthesia needle traverses the pathway, the tape follows the needle and the curved aneshthesia needle along the pathway; and

positioning at least a portion of the tape between the vaginal wall and the urethra such that the tape forms a supportive loop beneath the urethra.

11. A method for treating a patient suffering from female urinary incontinence, comprising the steps of:

anesthetizing a pathway within the patient'"'"'s body proximate to the patient'"'"'s urethra said pathway extending through the patient'"'"'s abdominal wall, over the pubic bone, past the urethra, and through the vaginal wall by passing an anesthesia needle with a distal end into the patient'"'"'s body along said pathway with periodic pauses alone said pathway and injecting a clinically effective amount of anesthesia into the patient'"'"'s body during said periodic pauses such that said pathway is anesthetized;

passing a tape having a pair of opposed ends into the patient'"'"'s body along said pathway by removably attaching a needle having a distal end to one end of the tape;

removably connecting the distal end of the anesthesia needle to the distal end of the needle;

withdrawing the anesthesia needle back along said pathway such that the needle and the one end of the tape are passed through the patient'"'"'s body along said anesthetized pathway and such that the one end of the tape extends through the abdominal wall and out of the patient'"'"'s body;

disconnecting the distal end of the anesthesia needle from the distal end of the needle and disconnecting the needle from the one end of the tape;

removably connecting the needle to an opposite end of the tape;

passing the anesthesia needle into the patient'"'"'s body along a second pathway;

removably connecting the distal end of the anesthesia needle to the distal end of the needle;

withdrawing the anesthesia needle back along said second pathway such that the needle and the opposite end of the tape are passed through the patient'"'"'s body along said second anesthetized pathway and such that the opposite end of the tape extends through the abdominal wall and of the patient'"'"'s body;

disconnecting the distal end of the anesthesia needle from the distal end of the needle; and

positioning at least a portion of the tape between the vaginal wall and the urethra such that the tape forms a supportive loop beneath the urethra.

12. The method of claim 11, further comprising the step of adjusting the position and tension of the supportive loop to achieve a clinically acceptable degree of urinary continence.

13. A surgical instrument for treating a patient suffering from female urinary stress incontinence, comprising:

(a) a tape including a natural material for implanting into the lower abdomen of a female to provide support to the urethra, said tape having a pair of opposed ends made of a synthetic material;

(b) a guide element including means for delivering anesthesia to the patient'"'"'s body

(c) a curved needle element attahed proximate to one end of said tape, said needle element including a curved shaft having a distal end; and

(d) connecting means for removably connecting a distal end of said guide element to said distal end of said needle element.

14. The surgical instrument of claim 13, wherein said natural material is selected from the group consisting of autologous, allograft, xenograft and a tissue engineered matrix.

15. A method for treating a patient suffering from female urinary incontinence, comprising the steps of:

anesthetizing a pathway within the patient'"'"'s body proximate to the patient'"'"'s urethra said pathway extending through the patient'"'"'s abdominal wall, over the pubic bone, past the urethra, and through the vaginal wall by passing an anesthesia needle with a distal end into the patient'"'"'s body along said pathway with periodic pauses along said pathway and injecting a clincally effective amount of anesthesia into the patient'"'"'s body during said periodic pauses such that said pathway is anesthetized;

passing a tape having a pair of opposed ends into the patient'"'"'s body along said pathway by removably connecting the distal end of the anesthesia needle to one end of the tape, the pair of opposed ends being made of a synthetic material and the tape including a natural material between the pair of opposed ends;

withdrawing the anesthesia needle back along said pathway such that the one end of the tape is passed through the patient'"'"'s body along said anesthetized pathway and extends through the abdominal wall and out of the patient'"'"'s body;

disconnecting the distal end of the anesthesia needle from the one end of the tape;

passing the anesthesia needle again into the patient'"'"'s body along said pathway;

removably connecting the distal end of the anesthesia needle to an opposite end of the tape;

withdrawing the anesthesia needle back along said pathway such that the opposite end of the tape is passed through the patient'"'"'s body along said anesthetized pathway and extends through the abdominal wall and out of the patient'"'"'s body;

positioning at least a portion of the tape between the vaginal wall and the urethra such that the tape forms a supportive loop beneath the urethra said positioning step being performed so that the natural material is positioned beneath the urethra; and

disconnecting the distal end of the anesthesia needle from the opposite end of the tape.

16. The method of claim 15, further comprising the step of adjusting the position and tension of the supportive loop to achieve a clinically acceptable degree of urinary continence. issue engineered matrix.