Sling assembly with secure and convenient attachment

• US 20020151762A1
• Filed: 11/21/2001
• Published: 10/17/2002
• Est. Priority Date: 01/23/2001
• Status: Active Grant

• Current Assignee: David Staskin
• Original Assignee: Ams Research Corporation (Endo International PLC)
• Inventors: Neisz, Johann J., Rocheleau, Gary A., Nachreiner, Gary J.
• Granted Patent: US 6,641,525 B2
• Time in Patent Office: Days
• US Class Current: 600/30
• 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 17/0469 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• 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 17/30 Surgical pincettes without pivotal connectionsfor holding suture needles or materials A61B17/0483; wound clamps A61B17/08 ; hand-held gripping tools without pivotal connections in general B25B9/02
• CPC Class Codes: A61B 17/3211 Surgical scalpels, knives; Accessories therefor
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• 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 2017/00464 for use with different instruments with hole for different instruments A61B2017/22072
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• 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 2017/06014 spring-loaded
• CPC Class Codes: A61B 2017/06042 located close to needle tip
• CPC Class Codes: A61B 2017/06085 having a blunt tip blunt dissectors A61B2017/320044
• CPC Class Codes: A61B 50/30 Containers specially adapted for packaging, protecting, dispensing, collecting or disposing of surgical or diagnostic appliances or instruments for wound clamps A61B17/10; for ligaturing clips A61B17/122; packages or dispensers for surgical gloves or finger-stalls A61B42/40
• CPC Class Codes: A61B 90/02 Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61F 2/0045 : Support slings

Abstract

Surgical articles that are conveniently and securely coupled are disclosed. Improved surgical procedures are also disclosed.

Claims

1. An assembly for treating incontinence comprising:

an elongate needle that is sized and shaped to be initially inserted through an abdominal incision and to then emerge from a vaginal incision, the needle having an insertion end and an end opposite the insertion end,

a sling for implantation in the body during an incontinence procedure, and

a coupler having an axis, the coupler having a first end and a second end with surfaces for conveniently and securely connecting the coupler to the insertion end of the needle by moving the coupler and insertion end of the needle together.

2. An assembly according to claim 1 wherein the coupler is connected to needle by being moved together in a substantially axial fashion.

3. An assembly according to claim 2 wherein after the needle is connected to the coupler, the assembly has a Separation Force of at least about fifteen pounds.

4. An assembly according to claim 3 wherein after the needle is connected to the coupler, the assembly has a Separation Force of at least about thirty pounds.

5. An assembly according to claim 2 wherein, the assembly has an Insertion Force of no more than about fifteen pounds.

6. An assembly according to claim 5 wherein, the assembly has an Insertion Force of no more than about ten pounds.

7. An assembly according to claim 6 wherein, the assembly has an Insertion Force of no more than about eight pounds.

8. An assembly according to claim 1 wherein the coupler is sized and shaped to be connected to the needle after the insertion end of the needle emerges from the vaginal incision.

9. An assembly according to claim 1 wherein the sling includes an insertion sheath and the first end of the coupler is attached to the sheath.

10. An assembly according to claim 1 wherein the tip of the insertion end of the needle is sub stantially blunt.

11. A coupler for use in an incontinence procedure that utilizes a sling and an elongate needle that is sized and shaped to be initially inserted through an abdominal incision and to then emerge from a vaginal incision, the needle having an insertion end, the coupler comprising

an elongate body having an axis,

a first end and a second end, and

surfaces for conveniently and securely connecting the coupler to the insertion end of the needle by moving the second end of the coupler and the insertion end of the needle together in a substantially axial fashion.

12. A coupler according to claim 11 wherein after the needle is connected to the coupler, the connected coupler and needle have a Separation Force of at least about fifteen pounds.

13. A coupler according to claim 11 wherein the Insertion Force to connect the needle to the coupler is no more than about fifteen pounds.

14. A coupler according to claim 11 wherein the coupler includes an internal passageway for receiving the insertion end of the needle,

the internal passageway having a shoulder portion that is sized and shaped to at least abut a complementary structure in a recessed portion of the needle to resist separation of the needle and coupler.

15. A coupler according to claim 11 wherein the second end of the coupler includes surfaces for associating with a second needle.

16. A coupler according to claim 11 wherein the first end of the coupler is adapted to be associated with a sling.

18. A method according to claim 17 wherein the step of connecting the coupler to the needle by moving the coupler and insertion end of the needle includes the step of:

pushing the coupler onto the insertion end of the needle together in a substantially axial fashion with an Insertion Force of less than about fifteen pounds.

19. A method according to claim 17 further including the step of connecting the first end of the coupler to a second needle that is attached to the surgical mesh and insertion sheath.

17. A method of treating incontinence in a female patient comprising the steps of:

providing a synthetic surgical mesh having first and second ends and a plurality of holes that are sized and shaped to afford tissue ingrowth, and a removable synthetic insertion sheath associated with the surgical mesh,

providing a needle that is sized and shaped to be initially inserted through a suprapubic incision and to then emerge from a vaginal incision, the needle having an insertion end and an end opposite the insertion end,

providing a coupler having an axis, the coupler having a first end and a second end with surfaces for conveniently and securely connecting the coupler to the insertion end of the needle,

creating at least one vaginal incision,

creating at least one suprapubic incision,

passing the leading end of the needle initially through the suprapubic incision and then through the vaginal incision,

then connecting the coupler to the needle by moving the coupler and insertion end of the needle together while the insertion end of the needle protrudes from the vaginal incision,

implanting the sling by moving the leading end of the needle from the vaginal incision toward the suprapubic incision, and

then removing the synthetic insertion sheath.

20. A method of treating incontinence in a female patient comprising the steps of:

providing a first needle that is sized and shaped to be initially inserted through an abdominal incision and to then emerge from a vaginal incision, the needle having an insertion end and an end opposite the insertion end,

providing a coupler having an axis, the coupler having a first end and a second end with surfaces for conveniently and securely connecting the coupler to the insertion end of the needle,

providing a second needle that is sized and shaped to be initially inserted through a vaginal incision and to then emerge from an abdominal incision;

the second needle being attached to a synthetic surgical mesh having first and second ends and a plurality of holes that are sized and shaped to afford tissue ingrowth, and a removable synthetic insertion sheath associated with the surgical mesh,

creating at least one vaginal incision,

creating at least one abdominal incision,

initially passing the first needle through the abdominal incision and then through the vaginal incision,

connecting the second end of the coupler to the insertion end of the first needle,

connecting the first end of the coupler to the second needle; and

guiding the second needle from the vaginal incision to the abdominal incision with the first needle to implant the sling.