Devices and methods for treating e.g. urinary stress incontinence

• US 6,517,566 B1
• Filed: 07/14/2000
• Issued: 02/11/2003
• Est. Priority Date: 05/11/1998
• Status: Expired due to Fees

• Current Assignee: Surgical Connections, Inc.
• Original Assignee: Surgical Connections, Inc.
• Inventors: Robinson, Paul J., Hovland, Claire T., Abrams, Jerome H.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US09/616,411
• Time in Patent Office: 942 Days
• Field of Search: 606/219, 600/29
• US Class Current: 606/219
• CPC Class Codes: A61B 17/062 Needle manipulators
• CPC Class Codes: A61B 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/0643 with separate closing member, e.g. for interlocking with staple
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61F 2/0022 placed deep in the body opening occluding blood vessels by internal devices A61B17/12022

Abstract

Embodiments of the invention provide a permanent implanted support for e.g. the urethral neck of the bladder, generally preventing urinary leakage caused by transmission of intra-abdominal pressure pulse waves. The support is implanted in a straightforward manner without the significant complexity and invasiveness associated with known surgical techniques. Pelvic trauma is dramatically reduced. Embodiments of the invention can be used in treatment of stress incontinence, and other types of incontinence, in both males and females.

Claims

1. An implantable surgical staple, comprising:

a main body generally in the form of a coil, the main body having a sharp, tissue-penetrating tip at one end thereof and an engagement portion at an opposite end thereof;

wherein the engagement portion is constructed to engage a staple advancing device for longitudinal and rotational advancement of the staple into an implanted configuration;

further wherein the staple has a generally circular shape defining a circumferential path when viewed from an end of the staple, the engagement portion being generally disposed along the circumferential path;

further wherein the staple is composed of a generally stiff biocompatible material to maintain the same shape of the staple in the implanted configuration and during advancement into the implanted configuration.

2. The staple of claim 1, wherein the engagement portion is disposed entirely within the circumferential path.

3. The staple of claim 1, wherein the staple generally defines a helix extending along a helical path, the engagement portion forming an end of the helix without generally deviating from the helical path.

4. The staple of claim 1, wherein the staple is formed from a generally stiff wire formed into a helical shape.

5. The staple of claim 4, wherein a cross section of the wire generally flattens out toward the engagement portion of the staple.

6. The staple of claim 1, wherein the engagement portion is extended in the longitudinal direction, relative to the remainder of the staple, for better engagement with the staple advancing device.

7. A surgical treatment device, comprising:

an implantable surgical staple having a main body generally in the form of a coil, the main body having a sharp, tissue-penetrating tip at one end thereof and an engagement portion at an opposite end thereof, the engagement portion being constructed to engage a staple advancing device for longitudinal and rotational advancement of the staple into an implanted configuration, wherein the staple has a generally circular shape defining a circumferential path when viewed from an end of the staple, the engagement portion being generally disposed along the circumferential path, the staple being composed of a biocompatible material;

delivery structure for supporting the surgical staple and delivering the surgical staple to a desired anatomical site of a patient;

movement structure, operatively coupled with the delivery structure, for moving anatomical tissue into position for engagement by the staple; and

a staple advancing device for rotationally and longitudinally advancing the staple through the anatomical tissue to hold the anatomical tissue in a desired configuration.

8. The surgical treatment device of claim 7, wherein the staple advancing device comprises a cylindrical body disposed generally parallel to the staple, rotation of the cylindrical body causing rotation of the staple through the anatomical tissue.

9. The surgical treatment device of claim 8, wherein the amount and direction of rotation of the cylindrical body causes rotation of the staple in a like amount and direction.

10. The surgical treatment device of claim 8, wherein the cylindrical body defines a recessed portion, the recessed portion engaging the engagement end of the staple for driving the staple through the anatomical tissue.

11. The surgical treatment device of claim 8, wherein the cylindrical body defines a generally hollow interior, the surgical treatment device further comprising viewing apparatus disposed within the hollow interior, the viewing apparatus allowing an operator of the surgical treatment device to view implantation of the staple in the anatomical tissue.

12. The surgical treatment device of claim 11, wherein the viewing apparatus comprises a cystoscope.

13. The surgical treatment device of claim 11, wherein the viewing apparatus extends within the coil of the staple.

14. The surgical treatment device of claim 8, further comprising a raised portion attached to the cylindrical body, rotational engagement of the raised portion by the fingers of an operator of the surgical treatment device causing rotation of the cylindrical body and implantation of the staple.

15. The surgical treatment device of claim 7, further comprising a hood disposed over the staple, the hood covering the sharp, tissue-penetrating tip of the staple during initial insertion of the surgical treatment device into a patient.

16. The surgical treatment device of claim 7, wherein the movement structure comprises a vacuum device for moving anatomical tissue into position for engagement by the staple.

17. A surgical treatment device, comprising:

delivery structure for supporting a coil-shaped surgical staple and delivering the coil-shaped surgical staple to a desired anatomical site of a patient;

movement structure, operatively coupled with the delivery structure, for moving anatomical tissue into position with respect to the coil-shaped surgical staple; and

a staple advancing device for rotating the coil-shaped surgical staple into the anatomical tissue to hold the anatomical tissue in a desired configuration.

18. The surgical treatment device of claim 17, wherein the movement structure comprises a vacuum device for drawing desired tissue into a new anatomical position.

19. The surgical treatment device of claim 18, wherein the vacuum device comprises a syringe.

20. The surgical treatment device of claim 18, wherein the vacuum device comprises a vacuum pump.

21. The surgical treatment device of claim 18, wherein the movement structure comprises a blocking device, operatively coupled with the vacuum device, for preventing the vacuum device from applying vacuum to a portion of the anatomy of the patient.

22. The surgical treatment device of claim 21, wherein the blocking device comprises an inflatable mechanism.

23. The surgical treatment device of claim 22, wherein the inflatable mechanism is a first inflatable mechanism, the surgical treatment device further comprising a pilot inflatable mechanism, operably coupled with the first inflatable mechanism, for indicating inflation of the first inflatable mechanism.

24. The surgical treatment device of claim 21, wherein the blocking device comprises a balloon constructed for insertion into the bladder of the patient, further wherein the anatomical tissue is at least a portion of the bladder neck and/or urethra.

25. The surgical treatment device of claim 18, wherein the vacuum device comprises a generally cylindrical member defining vacuum apertures.

26. The surgical treatment device of claim 18, where the vacuum device is generally concentrically disposed with respect to the advancing device.

27. The surgical treatment device of claim 17, wherein the movement structure is physically connected to the delivery structure.

28. The surgical treatment device of claim 17, being constructed for use in minimally invasive surgical procedures.

29. The surgical treatment device of claim 17, wherein the delivery structure and advancing device together comprise a plurality of concentrically disposed generally cylindrical members.

30. The surgical treatment device of claim 29, wherein at least one of the cylindrical members extends through the coil-shaped surgical staple along its axis.

31. The surgical treatment device of claim 29, wherein the delivery structure and staple advancing device are constructed for removal from the patient by simple withdrawal from the patient, said withdrawal from the patient automatically causing disengagement of the staple advancing mechanism from the coil-shaped surgical staple.

32. A method of treating urinary incontinence in a patient, the method comprising:

inserting a surgical treatment device into at least the urethra of the patient;

applying a vacuum with the surgical treatment device to draw at least a urethra portion and/or bladder neck portion of the patient into a desired configuration;

delivering a coil-shaped surgical staple to the patient with the device, the staple holding the desired configuration; and

withdrawing the device from the patient.

33. The method of claim 32, further comprising:

inserting a balloon into the bladder of the patient;

inflating the balloon;

blocking application of vacuum to at least the bladder with the balloon;

deflating the balloon; and

withdrawing the balloon from the patient.

34. Urinary incontinence treatment apparatus, comprising:

means for applying a vacuum to draw at least a urethra portion and/or bladder neck portion of a patient into a desired configuration;

means for delivering a coil-shaped surgical staple to the patient, the staple holding the desired configuration; and

means for withdrawing the means for delivering from the patient such that the coil-shaped surgical staple remains within the patient.

35. The apparatus of claim 34, further comprising:

means for blocking application of vacuum to at least the bladder; and

means for withdrawing the means for blocking from the patient.

36. The apparatus of claim 34, further comprising means for viewing implantation of the coil-shaped surgical staple, the means for viewing being operably coupled to the means for delivering.

37. Apparatus for implanting a staple into a patient, the staple generally defining a spiral shape, the apparatus comprising:

a first generally cylindrical member, the staple being disposed generally concentrically over the first cylindrical member;

a second generally cylindrical member disposed generally concentrically over the first cylindrical member, rotation of the second cylindrical member by an operator of the apparatus causing rotation of the staple into anatomical tissue of the patient.

38. The apparatus of claim 37, wherein the second generally cylindrical member comprises a cutout portion for engaging and driving the staple.

39. The apparatus of claim 37, wherein rotation of the second generally cylindrical member away from the staple releases the staple from engagement with the second generally cylindrical member such that the apparatus can be withdrawn from the patient.

40. The apparatus of claim 37, further comprising at least one vacuum aperture extending through the first generally cylindrical member, the at least one vacuum aperture being constructed and disposed to apply vacuum pressure to anatomical tissue of the patient where the staple is to be delivered.

41. The apparatus of claim 40, further comprising a vacuum source fluidly coupled with the at least one vacuum aperture, the vacuum source being disposed at a proximal end of the first generally cylindrical member, the vacuum source applying vacuum through the first generally cylindrical member to the at least one vacuum aperture, the at least one vacuum aperture being disposed at a distal end of the first generally cylindrical member.

42. The apparatus of claim 40, further comprising an inflatable balloon operably coupled with the vacuum aperture.

43. The apparatus of claim 40, further comprising a hood disposed over the staple during insertion of the apparatus into the patient.

44. The apparatus of claim 40, further comprising a viewing device received within the first generally cylindrical member, the viewing device being constructed to view a region at a distal end of the first generally cylindrical member during a staple-insertion procedure.

45. Apparatus for implanting a staple into a patient, the apparatus comprising:

structure for delivering the staple to a desired anatomical site and implanting the staple at the site; and

structure, operably coupled with the structure for delivering and implanting, for supporting an optical viewing device within a body of the staple during implantation to allow an operator of the apparatus to view the implantation.

46. The apparatus of claim 45, wherein the structure for delivering and implanting is constructed to deliver and implant a staple having a shape in the form of a coil.