Sling delivery system and method of use

• US 20030045774A1
• Filed: 10/25/2002
• Published: 03/06/2003
• Est. Priority Date: 01/23/2001
• Status: Active Grant

• Current Assignee: David Staskin
• Original Assignee: American Medical Systems Incorporated (Endo International PLC)
• Inventors: Snitkin, Eva S., Neisz, Johann J., Staskin, David R., Anderson, Kimberly A., Westrum, John W. Jr., Rocheleau, Gary A.
• Granted Patent: US 6,971,986 B2
• Time in Patent Office: Days
• US Class Current: 600/29
• CPC Class Codes: A61B 17/04 for suturing wounds; Holders or packages for needles or suture materials suture materials A61L17/00
• 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 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• 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 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• 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 2017/320044 Blunt dissectors blunt suture needles A61B2017/06085
• 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

An apparatus and method of use are disclosed to treat urological disorders. The biocompatible device includes a handle, needle, dilator and sling assembly configured to be minimally invasive and provide sufficient support to the target site. In addition, the configuration of the sling assembly also allows the sling to be adjusted during and/or after implantation. The device and treatment procedure are highly effective and produce little to no side effects or complications. Further, operative risks, pain, infections and post operative stays are reduced, thereby improving patient quality of life.

Claims

1. A surgical device for treating a patient comprising:

at least one needle;

at least one atraumatic dilator having a connection means for conveniently and securely connecting the dilator to the at least one needle during a surgical procedure, and

a sling material having a length sufficient for the sling material to extend from an abdominal wall of the patient to the urethra of a patient and back to the abdominal wall of a patient, and means for associating the sling with the dilator.

2. A surgical device according to claim 1 wherein the dilator is sized and shaped to afford atraumatic passage through body tissue.

3. A surgical device according to claim 1 wherein the dilator includes a tapered surface.

4. A surgical device according to claim 1 wherein the dilator is shaped to deflect tissue out of the path of the dilator.

5. A surgical device according to claim 1 wherein the dilator includes means for receiving at least a portion of the end of the sling assembly without substantially increasing the profile of the dilator.

6. A sling assembly for use in treating a patient comprising:

a surgical mesh having a length sufficient to extend from a pubic space of the patient beneath the urethra to an abdomen of the patient on either side of a bladder of the patient;

a dilator for passage through tissue of the patient, the dilator being associated with an end of the surgical mesh; and

including surfaces that are sized and shaped to atraumatically deflect tissue during passage of the dilator through tissue, the dilator including an association means that is sized and shaped for association between the dilator and a surgical needle during a surgical procedure so that the needle can pull the dilator and surgical mesh through tissue of a patient.

7. A sling assembly according to claim 6 further including a protective sheath.

8. A sling assembly according to claim 7 wherein the protective sheath is attached to the dilator.

9. A sling assembly according to claim 7 wherein the protective sheath and sling are attached to the dilator.

10. A surgical kit assembly for treating a patient comprising:

at least two needles, each of the needles sized and shaped to extend substantially between an abdominal wall and a pubic region of a patient;

at least two dilators permanently attachable to the needles;

a length of implantable material with a pair of ends, means for associating the ends of the implantable material with the dilators; and

at least two handles corresponding to the needles, the handles being releasably attachable to either end of the needles.

11. A surgical kit according to claim 10 further comprising a cystoscopic aid having an inner lumen that is sized and shaped to allow the cystoscopic aid to be pushed along the outer surface of a needle after the needle is inserted in the tissue of the patient.

12. A method of treating urinary incontinence in a patient comprising the steps of:

creating a pathway in tissue that extends between an abdominal wall of the patient to a pubic space of the patient;

dilating the pathways;

pulling an implantable support material into the pathways while the pathways are being dilated; and

positioning the implantable support material in a therapeutically effective anatomical position relative to tissue of the patient that is intended to be supported.

13. A sling system for use in treating a patient comprising:

at least one curved needle having opposing ends;

a sling material adapted to be associated with one end of the at least one needle, the sling material being sized and shaped to extend beneath a patient'"'"'s urethra up to a patient'"'"'s abdomen;

the needle being adapted to pull the sling through tissue of a patient, and

an atraumatic dilator for deflecting tissue as the needle pulls the sling through tissue.

14. A method of treating urinary incontinence in a patient comprising the steps of:

creating at least one incision in vaginal tissue,

creating at least one suprapubic incision,

providing an assembly comprising a synthetic implantable material, and a protective sheath situated about the implantable material, the sheath constructed of a material that affords visual examination of the implantable material and that affords passage of the assembly through tissue of the patient, at least one needle that is sized, shaped and designed to either i) initially pass the needle from the vaginal incision to the supra pubic

incision, or ii) initially pass the needle from the supra pubic incision to the vaginal incision; and

means for associating the needle with the assembly,

selecting to either initially pass the needle from the vaginal incision to the supra pubic incision, or to initially pass the needle from the supra-pubic incision to the vaginal incision;

passing the assembly through tissue of the patient using the needle according to the selection to locate the implantable material in a therapeutically effective position relative to the urethra of the patient; and

removing the protective sheath.

15. A surgical needle for implanting a sling of a sling assembly that includes a dilator, the needle comprising:

an elongate arcuate portion that is sized and shaped to withstand forces encountered during a sling implantation procedure;

a first end having attachment means for associating the first end with either a releasably attachable handle or a dilator of the sling assembly, and

a second end having attachment means for associating the second end with either a releasably attachable handle or a dilator of the sling assembly.

16. A surgical needle according to claim 15 wherein the attachment means of the first end includes surfaces adapted to engage with complementary surfaces on either i) a handle assembly with a releasable, locking feature or ii) a quick, secure connect dilator of the sling assembly.

17. A method of implanting a sling to treat urinary incontinence in a female patient comprising the steps of:

creating at least one incision in vaginal tissue,

creating at least one suprapubic incision,

initially passing an end of a curved needle guide through the suprapubic incision,

identifying the posterior portion of the patient'"'"'s pubic bone with the end of the needle to controllably move the end of the needle toward the vaginal incision and to avoid damaging structures such as the urethra and bladder of the patient,

passing the end of the needle through the vaginal incision,

associating a sling with the needle, and

implanting the sling in a therapeutically effective position.

18. A method according to claim 17 wherein the step of passing the end of the needle through the vaginal incision includes the step of placing the surgeon'"'"'s finger adjacent the patient'"'"'s endopelvic fascia to locate the end of the needle.

19. A method according to claim 17 wherein the step of associating a sling with the needle includes the step of securely associating the needle with the sling, and

the step of implanting the sling includes the step of pulling the needle in a direction away from the vaginal incision toward the suprapubic incision while the sling is securely associated with the needle.

20. A method according to claim 17 wherein the step of associating the sling with the needle includes the step of pushing a dilator along the exterior of the needle from the vaginal incision toward the suprapubic incision, and the step of implanting the sling includes the step of having a sling associated with the dilator so that passage of the dilator along the needle from the vaginal incision toward the suprapubic incision implants the sling.

21. A method according to claim 17 wherein the step of associating a sling with the needle occurs after the step of passing the end of the needle through the vaginal incision.

22. A method according to claim 17 wherein the step of initially passing an end of a curved needle through the suprapubic incision includes the step of associating a removable handle with an end of the needle that is opposite the end of the needle this is passed through the suprapubic incision.

23. A method according to claim 22 wherein the step of associating the sling with the needle includes the step of pushing a dilator along the exterior of the needle from the vaginal incision toward the suprapubic incision, and the step of implanting the sling includes the steps of removing the handle from the needle and having a sling associated with the dilator so that passage of the dilator along the needle from the vaginal incision toward the suprapubic incision implants the sling.

24. A method according to claim 17 wherein the step of associating the sling with the needle includes the step of associating the needle with a sling assembly that includes a protective sheath, and the method includes the step of removing the sheath after the sling is implanted.

25. A method according to claim 17 wherein the step of associating a sling with the needle includes the step of associating a synthetic sling with the needle.

26. A method according to claim 17 wherein the step of associating a sling with the needle includes the step of associating a cadaveric sling with the needle.

27. A method of implanting a sling to treat urinary incontinence in a patient comprising the steps of:

creating at least one incision in vaginal tissue,

creating at least one suprapubic incision,

placing a curved needle with a removable handle between the vaginal incision and the suprapubic incision,

then removing the handle,

then associating a sling with the needle, and

implanting the sling in a therapeutically effective position.

28. A method according to claim 27 wherein the step of associating the sling with the needle includes the step of pushing a dilator along the exterior of the needle.

29. A method according to claim 27 wherein the step of placing a curved needle with a removable handle between the vaginal incision and the suprapubic incision, includes the step of initially placing the needle in the vaginal incision and moving the needle toward the suprapubic incision.

30. A method according to claim 27 wherein the step of placing a curved needle with a removable handle between the vaginal incision and the suprapubic incision includes the step of initially placing the needle in the suprapubic incision and moving the needle toward the vaginal incision.

31. A method of implanting a sling to treat urinary incontinence in a male patient comprising the steps of:

creating at least one perineal incision,

creating at least one suprapubic incision,

initially passing an end of a curved needle guide through the suprapubic incision,

identifying the posterior portion of the patient'"'"'s pubic bone with the end of the needle to controllably move the end of the needle toward the perineal incision and to avoid damaging sensitive tissues,

passing the end of the needle through the perineal incision,

associating a sling with the needle, and

implanting the sling in a therapeutically effective position.