Surgical instrument

• US 6,494,887 B1
• Filed: 10/19/2000
• Issued: 12/17/2002
• Est. Priority Date: 10/22/1999
• Status: Expired due to Term

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Kaladelfos, George
• Primary Examiner(s): Lindsey, Rodney M.
• Application Number:
  US09/692,332
• Time in Patent Office: 789 Days
• Field of Search: 606/119, 606/148, 606/185, 606/139, 600/30, 604/272, 128/898, 128/DIG.25
• US Class Current: 606/148
• 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 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• 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

Abstract

The invention provides a surgical instrument for inserting an elongate element into a human patient. In the preferred form of the invention the instrument has a curved hollow shaft defining an arc corresponding to the general curvature of a passage between the anterior vaginal wall and the abdomen of a female patient and having a cutting tip at one end and a handle at the other end. An elongate threading element is used draw a filamentary element through the shaft. Once the filamentary element is in position the shaft is removed from the patient, leaving the element in position. The instrument is preferably used to insert a U-shaped loop of filamentary material into the patient which passes around the patient'"'"'s urethra and helps the patient improve her urinary control.

Claims

1. A surgical instrument for use in placing an elongate filamentary element into a patient to treat female incontinence said instrument comprising:

an elongate shaft defining an internal passage, said shaft having a cutting tip formed on one end thereof and a handle formed on the other end thereof;

the shaft including the handle being sized and shaped such that the shaft may be passed into and through a patient, the internal passage being provided to introduce a said elongate element into the patient whilst the instrument is located in a patient in use;

wherein the shaft has one of a longitudinally extending slot, a groove and a channel formed therein which extends at least part way along the length thereof and defines at least in part said internal passage.

2. A surgical instrument according to claim 1 wherein the handle comprises a shaft portion integrally formed on said shaft and a handle portion, which is non-rotatably connectable to said other end of the shaft.

3. A surgical instrument according to claim 1 wherein the shaft is generally arcuately curved.

4. A surgical instrument according to claim 1 wherein the shaft is tubular.

5. A surgical element according to claim 1 wherein said tube has a substantially uniform cross section along its entire length.

6. A surgical instrument according to claim 1 wherein said shaft is of generally tubular construction and has a longitudinally extending slot formed through the wall thereof.

7. A surgical instrument according to claim 1 wherein the cutting tip lies in a plane which is transverse and angled to the longitudinal axis of the shaft.

8. A surgical instrument according to claim 1 wherein the cutting tip lies in two intersecting planar bevel faces, said bevel faces intersecting along a line which is perpendicular to the longitudinal axis of the shaft.

9. A surgical instrument according to claim 8 wherein the line along which the two bevel faces intersect is laterally offset to one side of the longitudinal centreline of the shaft.

10. A surgical instrument according to claim 1 wherein the internal passage terminates rearward of the cutting tip.

11. A surgical instrument for use in placing an elongate filamentary element into a patient to treat female incontinence said instrument comprising:

an elongate shaft defining an internal passage, said shaft having a cutting tip formed on one end thereof and a handle formed on the other end thereof, the shaft including the handle being sized and shaped such that the shaft may be passed into and through a patient, the internal passage being provided to introduce a said elongate element into the patient whilst the instrument is located in a patient in use;

wherein the shaft has a series of apertures spaced apart along the length of at least part of the shaft, said apertures passing through a wall of the shaft into said internal passage.

12. A surgical instrument for use in placing a filamentary element into a female patient so as to form a sling or loop around the urethra extending over the back of the pubic bone to the abdominal wall, said instrument comprising:

a generally arcuately curved tubular shaft defining an internal passage, said shaft having a cutting tip formed on one end thereof and a handle attachment formed on the other end thereof;

a handle, non-rotatably and removably connected to the handle attachment of the shaft and being selectively disconnectable from the shaft during surgical procedures; and

a flexible threading element a adapted to be inserted into and through said internal passage and adapted to be used to draw one end of a said filamentary element through said internal passage;

wherein the shaft has a series of apertures spaced apart along the length of at least part of the shaft, said apertures passing through a wall of the shaft into said internal passage.

13. A surgical instrument for use in placing a filamentary element into a female patient so as to form a sling or loop around the urethra over the back of the pubic bone, to the abdominal wall, said instrument comprising:

a generally arcuately curved shaft defining a longitudinally extending internal passage, said shaft having a cutting tip formed on one end thereof and a handle attachment formed on the other end thereof;

a handle, non-rotatably connectable to the handle attachment of the shaft; and

a flexible threading element insertable into and through said internal passage from either end of said shaft and adapted to be used to draw one end of a said filamentary element through said internal passage;

said tubular shaft being curved so that the shaft lies substantially in a single plane;

wherein the shaft has one of a longitudinally extending slot, a groove and a channel formed therein which extends at least part way along the length thereof and defines at least in part said internal passage;

the cutting tip at least in part being of planar bevel shape so as to lie in a plane perpendicular to said single plane and at an acute angle to the shaft axis.

14. A surgical instrument according to claim 13 wherein the acute angle is between 20°

and 70°

.

15. A surgical instrument according to claim 14 wherein the acute angle is approximately 45°

.

16. A surgical instrument according to claim 13 wherein the cutting tip lies in two intersecting planar bevel faces, said bevel faces intersecting along a line which is generally perpendicular to the longitudinal axis of the shaft.

17. A surgical instrument according to claim 13 wherein the handle attachment comprises screw threads formed on the radially outer surface of the shaft.

18. A surgical instrument according to claim 17 wherein the shaft tapers divergently towards the handle attachment so as to form a smooth transition between a cylindrical central portion of said shaft and said handle attachment.

19. A surgical instrument according to claim 13 wherein the interior surface of said internal passage at or towards said other end of the shaft includes one of a notch and a detent formation with which said handle engages to provide said non-rotatable connection.

20. A surgical instrument according to claim 13 wherein said handle comprises a hand engagable portion which is significantly wider than said shaft, and an elongate connection portion, adapted to be axially aligned with said other end of the shaft when the handle and the shaft are operatively connected.

21. A surgical instrument according to claim 20 wherein said elongate connection portion has a distal end of reduced diameter adapted to be inserted into the internal passage of the shaft.

22. A surgical instrument according to claim 20 wherein said shaft is formed with screw threads and the handle includes an annular flange on said elongate connection portion which is adapted to engage against said other end of the shaft, and a union nut captively held on said elongate connection portion between the annular flange and the handle portion, and slidable on said shaft portion, said union nut adapted to engage with said screw threads in order to hold the shaft and handle together.

23. A surgical instrument according to claim 13 wherein the shaft has a generally arcuate portion towards said one end thereof, and a generally straight portion towards said other end thereof.

24. A surgical instrument according to claim 13 having at least one aperture passing through the wall thereof between the internal passage and the exterior of the shaft.

25. A surgical instrument according to claim 24 wherein there are a series of apertures spaced apart along the length of the shaft which are located on the radially outer side of said curve shaft.

26. A surgical element according to claim 13 wherein said tube has a substantially uniform cross section along its entire length.

27. A surgical instrument comprising:

a. a hollow curved tubular shaft defining an interior passage and having an acutely cut first end forming a sharp point and a handle that is non-rotatable and is further detachably connectable to the other end;

b. a flexible threading element which is at least as long as the shaft, the threading element and the shaft being adapted to be used, when the handle is detached, to draw a filamentary element through the internal passage through the shaft; and

c. the shaft is shaped and configured to be used to pass a filamentary element through a female patient through an anterior wall of the vagina to an anterior wall of the abdomen through the wall thereof into the interior passage wherein the filamentary element forms a sub urethral sling, in part extending over the back of the pubic bone to the abdominal wall.

28. A surgical instrument for use in placing a filamentary element into a female patient so as to form a sling or loop around the urethra extending over the back of the pubic bone to the abdominal wall, said instrument comprising:

a generally arcuately curved tubular shaft defining an internal passage, said shaft having a cutting tip formed on one end thereof and a handle attachment formed on the other end thereof;

a handle, non-rotatably and removably connected to the handle attachment of the shaft and being selectively disconnectable from the shaft during surgical procedures; and

a flexible threading element a adapted to be inserted into and through said internal passage and adapted to be used to draw one end of a said filamentary element through said internal passage;

wherein the shaft has one of a longitudinally extending slot, a groove and a channel formed therein which extends at least part way along the length thereof and defines at least in part said internal passage.

29. A surgical instrument for use in placing a filamentary element into a female patient so as to form a sling or loop around the urethra over the back of the pubic bone, to the abdominal wall, said instrument comprising:

a generally arcuately curved shaft defining a longitudinally extending internal passage, said shaft having a cutting tip formed on one end thereof and a handle attachment formed on the other end thereof;

a handle, non-rotatably connectable to the handle attachment means of the shaft; and

a flexible threading element insertable into and through said internal passage from either end of said shaft and adapted to be used to draw one end of a said filamentary element through said internal passage;

said tubular shaft being curved so that the shaft lies substantially in a single plane;

wherein the shaft has a series of apertures spaced apart along the length of at least part of the shaft, said apertures passing through a wall of the shaft into said internal passage; and

the cutting tip at least in part being of planar bevel shape so as to lie in a plane perpendicular to said single plane and at an acute angle to the shaft axis.

30. A method of introducing a filamentary element into a female patient so as to form a sling or loop extending around the urethra to the abdominal wall, said method including the steps of:

a) inserting a generally arcuately curved shaft having a longitudinally extending internal passage into the patient through a first incision in the anterior surface of the vaginal wall, so as to pass on one side of the urethra between the pubis and the bladder and out of the patient through the abdominal wall;

b) passing a threading element through the internal passage from one or other end thereof so that the distal end of the threading element passes out of the remote end of the internal passage;

c) attaching a filamentary element to the distal end of the threading element and drawing the filamentary element through the internal passage with the threading element;

d) withdrawing the hollow shaft from the patient whilst leaving the filamentary element in position in the patient;

e) inserting the shaft into the patient through the anterior surface of the vaginal wall, so as to pass on the other side of the urethra between the pubis and the bladder;

f) drawing the filamentary element into position through the internal passage using the threading element; and

g) withdrawing the shaft from the patient whilst leaving the filamentary element in position thereby forming a loop which extends around the urethra to the abdominal wall.

31. A method according to claim 30 in which the filament is drawn in steps c) and f) through the patient by pulling the filamentary element through the patient from the abdominal side of the patient.

32. A method according to claim 30 or 31 prior to conducting step e) a second incision is made through the anterior surface of the vaginal wall and a tunnel is created between the first and second incisions, and the end of the filamentary element adjacent the vagina is passed through said tunnel and out of said second incision.

33. A method according to claim 30 wherein the shaft is withdrawn from the patient from the abdominal side of the patient.