Surgical template and surgical method employing same

• US 5,997,554 A
• Filed: 03/14/1997
• Issued: 12/07/1999
• Est. Priority Date: 06/14/1995
• Status: Expired due to Fees

• Current Assignee: Dexterity Surgical, Inc. (Wave Sync Corp.)
• Original Assignee: Medworks Corporation
• Inventors: Thompson, Ronald J.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US08/818,391
• Time in Patent Office: 998 Days
• Field of Search: 606/103, 606/96, 606/148-150, 600/29, 604/174, 604/175, 128/DIG. 26
• US Class Current: 606/148
• 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 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/06109 Big needles, either gripped by hand or connectable to a handle
• CPC Class Codes: A61B 2017/00805 Treatment of female stress urinary incontinence
• CPC Class Codes: A61B 2017/0409 Instruments for applying suture anchors
• CPC Class Codes: A61B 2017/0412 having anchoring barbs or pins extending outwardly from suture anchor body
• CPC Class Codes: A61B 2017/0414 having a suture-receiving opening, e.g. lateral opening
• CPC Class Codes: A61B 2017/0437 the barbs being resilient or spring-like
• CPC Class Codes: A61F 2/005 with pressure applied to urethra by an element placed in the vagina

Abstract

A template for guiding the placement of a fixation device during a surgical procedure. The template comprises:

(a) a body portion; and

(b) at least one guide disposed in a predetermined spacial relationship to the body portion;

wherein the template is configured such that at least a portion of the template may be aligned within the vagina of a patient such that the guide may be employed to direct the placement of a fixation device or other medical instrument through at least a portion of the tissue adjacent the vagina. A surgical method employing this template is also provided, along with an urethral sling used in conjunction with one embodiment of the template.

Claims

1. A template for guiding the placement of a fixation device during a surgical procedure, said template comprising:

(a) a body portion; and

(b) at least one guide disposed in a predetermined spacial relationship to said body portion;

said template adapted to be aligned at least partially within the vagina of a patient such that said guide may be employed to direct the placement of a fixation device or other medical instrument through at least a portion of the tissue adjacent the vagina.

2. The template of claim 1, wherein the template is configured such that when said template is aligned within the vagina, said at least one guide may be employed to direct placement of a fixation device or other medical instrument at least a portion of the tissue adjacent the vagina in a predetermined 5 relationship to a landmark within the patient'"'"'s body.

3. The template of claim 2, wherein said landmark comprises the UVJ.

4. The template of claim 2, wherein said template is configured such that a portion of the anatomical structure of a patient'"'"'s vaginal region directs alignment of the template at least partially within the patient'"'"'s vagina such that said at least one guide may be employed to direct placement of a fixation device or other medical instrument through at least a portion of the tissue adjacent the vagina in a predetermined relationship to a landmark within the patient'"'"'s body.

5. The template of claim 1, further comprising at least one wing member, and wherein said at least one guide is provided on said wing member.

6. The template of claim 1, wherein said template further comprises an elongate member which may be inserted into a patient'"'"'s urethra.

7. The template of claim 5, wherein said template further comprises an elongate member which may inserted into a patient'"'"'s urethra.

8. The template of claim 6, wherein said elongate member comprises a catheter secured to said body.

9. The template of claim 7, wherein said elongate member comprises a catheter secured to said body.

10. The template of claim 1, wherein said body comprises a trough of arcuate cross-section.

11. The template of claim 2, wherein said body comprises a trough of arcuate cross-section, and wherein said wing member extends away from one side of said trough.

12. The template of claim 11, wherein said body comprises a trough of arcuate cross-section, and wherein said trough is configured such that a patient'"'"'s urethra may be positioned within said trough, thereby positioning said wing member adjacent the urethra.

13. The template of claim 10, wherein said body further comprises an alignment member, and wherein said template has an elongate member secured to said alignment member, wherein said elongate member may be inserted into a patient'"'"'s urethra, wherein said trough and said alignment member each have a longitudinal axis, and wherein the longitudinal axis of said alignment member is parallel to the longitudinal axis of said trough.

14. The template of claim 13, wherein the longitudinal axis of said alignment member is parallel to and above the longitudinal axis of said trough.

15. The template of claim 1, wherein said template has a pair of wing members, each of said wing members having at least one guide, and wherein said template is alignable within the vagina of a patient such that said one of said wing members is positioned adjacent either side of the urethra with said guides positioned such that they may be employed to direct the placement of a fixation device through the tissue adjacent the urethra.

16. The template of claim 15 wherein said body comprises a trough of arcuate cross-section, and wherein said wing members extend away from opposite sides of said trough.

17. The template of claim 1, wherein said at least one guide is chosen from the group consisting of:

an aperture, a slot, a notch, a protrusion and a visible indicia.

18. The template of claim 5 wherein said at least one guide is chosen from the group consisting of:

an aperture, a slot, a notch, a protrusion and a visible indicia.

19. The template of claim 6 wherein said at least one guide is chosen from the group consisting of:

an aperture, a slot, a notch, a protrusion and a visible indicia.

20. The template of claim 17, wherein said guide comprises a light source.

21. The template of claim 20, wherein said template is configured to be alignable within the vagina of a patient such that a beam of light may be projected from said light source through a predetermined region of the periurethral tissue, thereby transilluminating said predetermined region of the periurethral tissue.

22. The template of claim 21, wherein said template further comprises at least one wing member, said wing member having a topside and an underside, said template configured to be alignable within the vagina such that the topside of said wing member will be positioned against the vaginal mucosa adjacent the urethra, and wherein a beam of light may be projected from said light source, away from the topside of said wing member, and through the periurethral tissue adjacent the topside of the wing member.

23. The template of claim 22, wherein said at least one guide further comprises a protrusion extending away from the topside of said wing member, and wherein said light source is provided on said protrusion.

24. The template of claim 20, wherein said light source comprises a translucent region through which a beam of light may be projected.

25. The template of claim 17, wherein said at least one guide comprises a protrusion, wherein said template is configured to be alignable within the vagina of a patient such that said protrusion will displace a predetermined region of the periurethral tissue of the patient.

26. The template of claim 25, wherein a plurality of said protrusions are provided, said protrusions positioned adjacent to one another such that the region between said protrusions can be visualized from within the abdominal cavity of the patient by observation of the regions of the periurethral tissue displaced by adjacent protrusions.

27. The template of claim 26, further comprising at least one wing member, and wherein said plurality of protrusions are provided on said wing member.

28. The template of claim 27, wherein said wing member has a topside and an underside, said template configured to be alignable within the vagina such that the topside of said wing member will be positioned against the vaginal mucosa adjacent the urethra, and wherein said protrusions extend away from the topside of said wing member.

29. The template of claim 17, wherein said at least one guide member comprises a slot sized so as to permit a cutting tool to be inserted therethrough in order to create an incision in the periurethral tissue of a patient during a continence procedure.

30. The template of claim 18, wherein said at least one guide member comprises a slot sized so as to permit a cutting tool to be inserted therethrough in order to create an incision in the periurethral tissue of a patient during a continence procedure.

31. The template of claim 30, wherein said slot is positioned on said wing member such that said template may be aligned within the vagina of a patient with said slot extending substantially parallel to the patient'"'"'s urethra.

32. The template of claim 29, further comprising an elongate member which may be inserted into a patient'"'"'s urethra, said alignment member having a longitudinal axis, and wherein said slot extends substantially parallel to the longitudinal axis of said alignment member.

33. The template of claim 30, further comprising a pair of wing members, wherein a slot is provided on each of said wing members, and wherein said wing members and said slots are configured such that when said template is aligned within the vagina of a patient, a cutting tool may be inserted through said slots in order to create an incision in the periurethral tissue adjacent either side of the patient'"'"'s urethra.

34. The template of claim 17, wherein said at least one guide member comprises an aperture through which a fixation device may be passed during a urethropexy procedure.

35. The template of claim 18, wherein said at least one guide member comprises an aperture through which a fixation device may be passed during a urethropexy procedure.

36. The template of claim 34, wherein said template has at least two of said apertures.

37. The template of claim 36, wherein two of said apertures are connected to one another by a slit.

38. The template of claim 35, wherein said template has at least two of said apertures provided on said wing member, and wherein two of said apertures are connected to one another by a slit.

39. The template of claim 38, further comprising a pair of wing members, and wherein each wing member has at least two of said apertures connected to one another by a slit.

40. The template of claim 1, further comprising a support strut, said strut configured such that a fixation device may be secured about said strut during an urethropexy procedure.

41. The template of claim 40, wherein said support strut is removable, and wherein a fixation device secured about said strut during an urethropexy procedure can be released therefrom when said strut is removed from said template.

42. The template of claim 40, wherein said template further comprises at least one wing member, and wherein said support strut is positioned on said wing member.

43. The template of claim 42, wherein a pair of said guides are provided on said wing member, and wherein said guides comprise apertures.

44. The template of claim 43, wherein said apertures are connected to one another by a slit, and wherein said support strut is positioned atop at least a portion of said slit, thereby blocking communication between said apertures.

45. The template of claim 44, wherein said support strut is removable.

46. The template of claim 44, wherein said wing member has a topside and an underside, wherein said template is configured to be alignable within the vagina of a patient such that the topside of said wing member will be positioned against the vaginal mucosa adjacent the urethra, and wherein said support strut extends away from the underside of said wing member.

47. The template of claim 1, wherein at least a portion of said template is expandable.

48. The template of claim 47, wherein said template is configured such that at least the expandable portion of said template may be inserted into a patient'"'"'s vagina in an at least partially unexpanded condition, and thereafter expanded so as to urge said expandable portion against the interior wall of the vagina and to urge said at least one guide against a predetermined region of the periurethral tissue.

49. The template of claim 48, wherein said expandable portion is inflatable.

50. The template of claim 49, wherein expandable portion comprises a balloon which may be inflated with a fluid.

51. The template of claim 50, wherein said guide comprises a protrusion, and wherein said protrusion is configured such that said protrusion will displace a predetermined region of the periurethral tissue of the patient when the expandable portion of said template is expanded within the vagina of a patient, and wherein the displacement will be visible within the abdominal cavity of the patient.

52. The template of claim 51, wherein said template has a plurality of said protrusions.

53. A template for guiding the placement of a fixation device during a surgical procedure to correct incontinence, said template comprising:

(a) a body portion;

(b) at least one guide disposed in a predetermined spacial relationship to said body;

said template adapted to be aligned at least partially within the vagina of a patient such that said guide may be employed to direct the placement of a fixation device through the periurethral tissue at a predetermined location.

54. The template of claim 53, wherein said template is configured such that when said template is aligned at least partially within a vagina of a patient, said guide will be positioned adjacent the periurethral tissue at a predetermined location.

55. The template of claim 53, wherein said template is configured such that alignment of the template at least partially within a vagina of a patient is directed by a portion of the anatomical structure of the patient'"'"'s vaginal region.

56. The template of claim 55, wherein said template is configured such that alignment of the template at least partially within a vagina of a patient is directed by the patient'"'"'s urethra.

57. The template of claim 56, wherein said template further has an elongate member which may be positioned within the urethra of a patient so as to align the template at least partially within the patient'"'"'s vagina with said guide positioned adjacent the periurethral tissue at a predetermined location.

58. The template of claim 56, wherein the body of said template comprises an arcuate trough, said trough configured such that a patient'"'"'s urethra and the periurethral tissue beneath the urethra may be positioned within said trough so as to align the template at least partially within the patient'"'"'s vagina with said guide positioned adjacent the periurethral tissue at a predetermined location.

59. The template of claim 56, wherein said guide is chosen from the group consisting of:

an aperture, a slot, a notch, a protrusion and a visible indicia.

60. The template of claim 57, wherein said template further comprises a wing member, and wherein said guide is positioned on said wing member.

61. A surgical method of connecting at least a portion of the tissue adjacent a patient'"'"'s vagina relative to a structure within the patient'"'"'s body, comprising:

(a) providing a vaginal template, said template having at least one guide for ensuring proper positioning of a fixation device;

(b) aligning at least a portion of said template within the vagina of a patient; and

(c) connecting a portion of the tissue adjacent a patient'"'"'s vagina relative to a structure within the patient'"'"'s body with a fixation device by;

connecting one portion of said fixation device relative to said structure within the patient'"'"'s body; and

passing another portion of said fixation device through at least a portion of the tissue adjacent the patient'"'"'s vagina, using said guide to direct placement of the fixation device through the tissue.

62. The surgical method of claim 61, wherein at least a portion of said template is aligned within the patient'"'"'s vagina such that said at least one guide is positioned in a predetermined relationship to an anatomical landmark within the patient'"'"'s body.

63. The surgical method of claim 61, wherein said template is configured such that alignment of said template is directed by the patient'"'"'s urethra.

64. The surgical method of claim 61, wherein said fixation device is chosen from the group consisting of:

a filamentatious member, and an urethral sling.

65. The surgical method of claim 64, wherein said fixation device comprises a filamentatious member, and wherein said filamentatious member is chosen from the group consisting of:

a suture, a thread and a wire.

66. The surgical method of claim 61, wherein said structure within the patient'"'"'s body is chosen from the group consisting of:

the pubic bone, the periosteum of the pubic bone, the pubic symphysis, Cooper'"'"'s ligament, and the rectus fascia.

67. The surgical method of claim 61, wherein said fixation device is connected relative to said structure by suturing, and wherein said structure is chosen from the group consisting of:

the periosteum of the pubic bone, the pubic symphysis, Cooper'"'"'s ligament, and the rectus fascia.

68. The surgical method of claim 61, wherein said fixation device is connected relative to the pubic bone by connecting said fixation device to an anchor secured to the pubic bone.

69. The surgical method of claim 61, wherein a portion of said fixation device is placed through the periurethral tissue without entering the patient'"'"'s vagina.

70. The surgical method of claim 61, wherein said template comprises a body portion, and said at least one guide is disposed in a predetermined spacial relationship to said body portion.

71. The surgical method of claim 70, wherein said at least one guide is chosen from the group consisting of:

an aperture, a slot, a notch, and a visible indicia.

72. The surgical method of claim 71, wherein said at least one guide comprises an aperture, and wherein said fixation device is passed through the periurethral tissue at a predetermined location defined by said aperture, and thereafter through said aperture into the patient'"'"'s vagina.

73. The surgical method of claim 72, wherein said at least one guide comprises a protrusion, wherein said template is aligned at least partially within the patient'"'"'s vagina so that said protrusion displaces a portion of the periurethral tissue, said displacement visible from within the patient'"'"'s abdominal cavity, and wherein said fixation device is passed through the periurethral tissue from within the abdominal cavity using said tissue displacement to direct placement of the fixation device.

74. The method of claim 73, wherein at least a portion of said template is expandable, and further comprising the step of expanding said expandable portion of said template after said template has been aligned within the vagina, wherein said expansion urges said protrusion against the periurethral tissue in order to provide said displacement.

75. The method of claim 61, wherein at least a portion of said template is expandable, and further comprising the step of expanding said expandable portion of said template after said template has been aligned within the vagina.

76. The surgical method of claim 73, wherein said at least one guide comprises a slot, and further comprising the steps of inserting cutting device into said slot and creating an incision in a portion of the tissue adjacent the patient'"'"'s vagina using said slot to guide said cutting device, and wherein said fixation device is passed through the periurethral tissue through said incision.

77. The surgical method of claim 76, wherein said slot is positioned adjacent the periurethral tissue at a predetermined location when said template is aligned within the patient'"'"'s vagina, and wherein said cutting device creates an incision in the periurethral tissue which extends into the space of Retzius, and has a length substantially corresponding to the length of said slot.

78. A method for directing placement of a fixation device through at least a portion of a patient'"'"'s periurethral tissue during a surgical procedure to correct incontinence, comprising:

(a) providing a vaginal template, said template having at least one guide for ensuring proper positioning of said fixation device;

(b) aligning at least a portion of said template within the vagina of a patient; and

(c) passing a portion of said fixation device through at least a portion of the patient'"'"'s periurethral tissue, using said guide to direct placement of the fixation device therethrough.

79. The method of claim 78, wherein an anatomical structure of the patient'"'"'s body directs alignment of at least a portion of said template within the vagina, such that said guide is located in a predetermined relationship to an anatomical landmark within the patient'"'"'s body.

80. The method of claim 78, wherein said template aligned at least partially within the patient'"'"'s vagina by inserting a portion of said template into the patient'"'"'s urethra.

81. The method of claim 80, wherein said template has a catheter, and said catheter is inserted into the patient'"'"'s urethra.