Surgical instrument and method for treating organ prolapse conditions

• US 20030176762A1
• Filed: 02/06/2003
• Published: 09/18/2003
• Est. Priority Date: 03/09/2000
• Status: Active Grant

• Current Assignee: Ethicon Incorporated (Johnson & Johnson)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Kammerer, Gene W.
• Granted Patent: US 7,131,943 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• 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 2017/00805 Treatment of female stress urinary incontinence
• 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 2017/06076 helically or spirally coiled for sutures A61B2017/06171
• 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 2090/306 using optical fibres
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61F 2/0045 Support slings

Abstract

A mesh, a surgical kit including a mesh, and a method for using the same to restore a prolapsed organ within a patient'"'"'s pelvic cavity are provided. The surgical kit includes a mesh for supporting the organ including a support sheet portion to be positioned beneath the organ, and first and second front attachment strips extending from a proximal region of the mesh and first and second rear attachment strips extending form a distal region of the mesh. The kit also includes a first guide needle for penetrating tissue to create a passageway through which the attachment strips can be pulled, and coupling means for coupling the ends of the mesh to the attachment strips.

Claims

1. A surgical kit for performing a surgical procedure on a patient to restore a prolapsed organ within a patient'"'"'s pelvic region comprising:

a mesh for supporting the organ, the mesh including a support sheet portion to be positioned substantially beneath the organ having a distal end region and a proximal end region, first and second front attachment strips extending from the proximal end region, and first and second rear attachment strips extending from the distal end region;

a first guide needle for penetrating tissue within the patient'"'"'s body to create a passageway through the patient'"'"'s pelvic region through which the first or second front or rear attachment strips can be pulled, the guide needle having a proximal end and a tissue penetrating blunt tip at a distal end, and defining in part a curved shaft having a first curvature; and

coupling means for coupling a distal end of each of the first and second front and rear attachment strips to the distal end of the guide needle.

2. The surgical kit according to claim 1, wherein, for each of the first and second front and rear attachment strips, the coupling means is a coupling element fixedly secured at a first end to a distal end of the attachment strips, and having an opening at a second end dimensioned to receive therein and securely engage the distal end of the guide needle.

3. The surgical kit according to claim 1, wherein the coupling element can be detachably coupled to the distal end of the guide needle.

4. The surgical kit according to claim 1, wherein, for each of the first and second front and rear attachment strips, the coupling means comprises a needle element fixedly coupled at a proximal end to a distal end of the attachment strip, and a coupling device for coupling a distal end of the needle element to the distal end of the guide needle.

5. The surgical kit according to claim 4, wherein the coupling device has a first opening at a first end dimensioned to receive therein and securely engage the distal end of the needle element and a second opening at a second end dimensioned to receive therein and securely engage the distal end of the guide needle.

6. The surgical kit according to claim 1, wherein the distal end region of the support sheet portion has a recess therein between the first and second rear attachment strips.

7. The surgical kit according to claim 6, wherein the proximal end region of the support sheet portion has a recess therein between the first and second front attachment strips.

8. The surgical kit according to claim 1, wherein the first and second front and rear attachment strips extend outwardly from the proximal and distal end regions respectively at an angle of approximately 30-60 degrees relative to a midline of the mesh.

9. The surgical kit according to claim 8, wherein the first and second rear attachment strips extend outwardly from the distal end region at an angle of approximately 40 degrees relative to the midline of the mesh.

10. The surgical kit according to claim 9, wherein the first and second front attachment strips extend outwardly from the proximal end region at an angle of approximately 60 degrees relative to the midline of the mesh.

11. The surgical kit according to claim 1, further comprising a second guide needle for penetrating tissue within the patient'"'"'s body to create a passageway through the patient'"'"'s pelvic region through which the first or second front or rear attachment strips can be pulled, the guide needle having a proximal end and a tissue penetrating blunt tip at a distal end and defining in part a curved shaft.

12. The surgical kit according to claim 11, wherein the curved shaft of the second guide needle has a curvature different than that of the first guide needle, and wherein the passageway created by the first guide needle is different than that of the second guide needle.

13. The surgical kit according to claim 12, wherein the organ is the patient'"'"'s bladder, and wherein the curvature of the first guide needle is such it can extend from an exterior of the abdomen, around the pubic bone, and into the vagina.

14. The surgical kit according to claim 13, wherein the curvature of the second guide needle is such that it can extend from an exterior of the abdomen at a location caudal and lateral to that of the first guide needle, around the side of the bladder, and out into the vagina.

15. The surgical kit according to claim 14, wherein the curvature of the second guide needle forms a compound curve.

16. The surgical kit according to claim 1, further comprising, for each of the first and second front and rear attachment strips, a removable sheath substantially covering the attachment strip.

17. A mesh for supporting a prolapsed bladder comprising:

a support sheet portion to be positioned substantially beneath the bladder having a distal end region and a proximal end region, the proximal end region having a first recess therein and the distal end region having a second recess therein so that, when the mesh is positioned within a patient'"'"'s body, the proximal end region is positioned substantially under the bladder with the bladder neck positioned substantially within the first recess, and the distal end region is positioned under a posterior end of the bladder with the second recess positioned above the apex of the vagina and/or proximal of the cervix;

first and second front attachment strips extending from the proximal end region at an angle of between approximately 30 and 60 degrees relative to a midline of the mesh; and

first and second rear attachment strips extending from the distal end region at an angle of between approximately 30 and 60 degrees relative to the midline.

18. The mesh according to claim 17, further comprising, for each of the first and second front and rear attachment strips, a removable sheath substantially covering the attachment strip.

19. The mesh according to claim 17, wherein the first and second front attachment strips extend from the proximal end region at an angle of approximately 60 degrees relative to the midline.

20. The mesh according to claim 19, wherein the first and second rear attachment strips extend from the proximal end region at an angle of approximately 40 degrees relative to the midline.

21. The mesh according to claim 17, further comprising coupling elements coupled to a distal end of each of the first and second front and rear attachment strips, the coupling elements each further having a means for attaching to the distal end of a guide needle to couple it thereto, and each being dimensioned to pass through a passageway through the patient'"'"'s body created by the guide needle.

22. A method for restoring a prolapsed organ within a patient'"'"'s pelvic cavity comprising the steps of:

providing a mesh for supporting the prolapsed organ, the mesh including a support sheet portion to be positioned substantially beneath the organ having a distal end region and a proximal end region, first and second front attachment strips extending from the proximal end region, and first and second rear attachment strips extending from the distal end region;

for each of the first and second front and rear attachment strips, using the guide needle to create a passageway through the patient'"'"'s body from an exterior of the body and into the patient'"'"'s vagina, coupling the guide needle to a distal end of the attachment strip using a coupling means, and retracting the guide needle and attached attachment strip through the body through the passageway;

adjusting the mesh using ends of the attachment strips so that the mesh supports the prolapsed organ;

removing a portion of the attachments strips that are outside of the body; and

leaving the mesh and remaining attachment strips within the body.

23. The method according to claim 22, wherein, for the first and second front attachment strips, the passageway through the patient'"'"'s body extends from an exterior of the abdomen, around the pubic bone and out of the vagina, on first and second sides of the bladder respectively.

24. The method according to claim 23, wherein, for the first and second rear attachment strips, the passageway through the patient'"'"'s body extends from an exterior of the abdomen at a location caudal and lateral to the location of the first and second front attachment strips, around the bladder and out through the vagina, on first and second sides of the bladder respectively.

25. The method according to claim 23, wherein, for the first and second front attachment strips, the passageway through the patient'"'"'s body extends from an exterior of the medial side of the hip, through the obturator fossa, around the obturator bone, and out thought the vagina, on first and second sides of the bladder respectively.

26. The method according to claim 22, wherein a first guide needle is used to create the passageway for the first and second front attachment strips, and as second guide needle is used to create the passageway for the first and second rear attachment strips, and wherein the first guide needle has a curvature different than the second guide needle.

27. The method according to claim 22, wherein, for each of the first and second front and rear attachment strips, the coupling means is a coupling member fixedly secured at one end to a distal end of the attachment strip, and having an opening at a second end for receiving therein and securely engaging a distal end of the guide needle.

28. The method according to claim 22, wherein, for each of the first and second front and rear attachment strips, the coupling means comprises a needle element fixedly attached at a proximal end to a distal end of the attachment strip, and a coupling device for coupling the distal end of the needle element with the distal end of the guide needle.

29. The method according to claim 28, wherein the coupling device has an opening at a first end for receiving therein and securely engaging the distal end of the needle element, and an opening at a second end for receiving therein and securely engaging the distal end of the guide needle.