Stress urinary incontinence implant and device for deploying same

Abstract

A suburethral implant for treating stress urinary incontinence (SUI) includes an elongated plate-like member which is slightly curved in transverse cross-section, and a pair of spaced apart arms having hooked ends or barbs which extend from the plate-like member. A device for deploying the suburethral implant for treating SUI includes a vaginal probe for insertion in the vaginal canal of a patient, and a urethra locator probe for the simultaneous insertion in the urethra of a patient. The urethra probe is spaced apart from and overlies the vaginal probe. The vaginal probe includes a wall in which is formed an exit port. A suburethral implant introducer assembly is extendable and retractable through the exit port on the vaginal probe. The introducer assembly has a distal end on which is removably mounted a suburethral implant. The introducer assembly is extendable through the exit port to pierce the vaginal canal wall of the patient in order to position the suburethral implant in proximity to the patient's urethra. The hooked ends or barbs on the arms of the suburethral implant engage the tissue surrounding the patient's urethra and are affixed thereto during deployment of the implant. The introducer assembly is then retracted into the vaginal probe, whereby the implant is released from the introducer assembly and remains affixed to tissue in proximity to the patient's urethra.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an implant for treating stress urinary incontinence (SUI) formed in accordance with one form of the present invention.

FIG. 2 is a perspective view of an implant for treating SUI formed in accordance with a second form of the present invention.

FIG. 2A is a perspective view of the implant of the present invention shown in FIG. 1 folded in an undeployed state.

FIG. 2B is a perspective view of a third form of the implant of the present invention.

FIG. 3 is a perspective view of an implant used for treating SUI formed in accordance with a fourth form of the present invention.

FIG. 3A is a perspective view of the implant of the present invention shown in FIG. 3 folded in an undeployed state.

FIG. 4 is a front perspective view of a device formed in accordance with the present invention for deploying an implant, such as those shown in FIGS. 1-3, for treating SUI.

FIG. 5 is a rear perspective view of the device of the present invention shown in FIG. 4.

FIG. 6 is a front perspective view of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device.

FIGS. 7 is an enlarged, front perspective view of a portion of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 8 is a front perspective view of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 9 is an enlarged front perspective view of a portion of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 10 is an enlarged rear perspective view of a portion of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 11 is a partial cross-sectional view of the device of the present invention shown in FIGS. 4 and 5.

FIG. 12 is an enlarged cross-sectional view of a portion of the device of the present invention shown in FIGS. 4 and 5 for deploying an implant for treating SUI.

FIG. 13 is an enlarged cross-sectional view of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 14 is an enlarged cross-sectional view of a portion of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 15 is a cross-sectional view of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 16 is an enlarged cross-sectional view of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 17 is a front perspective view of a portion of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 18 is a cross-sectional view of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 19 is a side view of a portion of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 20 is a front perspective view of a portion of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 21 is a rear perspective view of a portion of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

FIG. 22 is a rear perspective view of certain components of the device of the present invention shown in FIGS. 4 and 5 and illustrating the operation of the device in deploying an implant for treating SUI.

Claims

1. A suburethral implant for treating stress urinary incontinence, which comprises: a main body for supporting a patient's urethra, the main body including an elongated plate-like member having a longitudinal axis along which the plate-like member extends, and opposite lateral side portions; anda pair of spaced apart arms extending from the plate-like member, each arm having a tissue engaging portion.

2. A suburethral implant for treating stress urinary incontinence as defined by claim 1, wherein the plate-like member of the main body is concave in transverse cross-section.

3. A suburethral implant for treating stress urinary incontinence as defined by claim 1, wherein the plate-like member of the main body includes a plurality of openings formed through the thickness thereof.

4. A suburethral implant for treating stress urinary incontinence as defined by claim 3, wherein the plate-like member of the main body is at least partially formed from a mesh material.

5. A suburethral implant for treating stress urinary incontinence as defined by claim 1, wherein the tissue engaging portion of each arm includes a barb to facilitate securing the suburethral implant to tissue in proximity to the patient's urethra.

6. A suburethral implant for treating stress urinary incontinence as defined by claim 1, wherein the tissue engaging portion of each arm includes a hook to facilitate securing the suburethral implant to tissue in proximity to the patient's urethra.

7. A suburethral implant for treating stress urinary incontinence as defined by claim 1, wherein at least each arm is formed from one of a resilient, elastically deformable material and a material having shape memory properties.

8. A suburethral implant for treating stress urinary incontinence as defined by claim 7, wherein the suburethral implant is foldable to an undeployed state in which the arms and the plate-like member of the main body extend generally along the longitudinal axis of the plate-like member, and wherein the suburethral implant is unfoldable to a deployed state in which the arms extend in a transverse direction to the longitudinal axis along which the plate-like member extends.

9. A suburethral implant for treating stress urinary incontinence as defined by claim 7, wherein each arm includes a spring portion.

10. A suburethral implant for treating stress urinary incontinence as defined by claim 9, wherein the spring portion of each arm includes a curved portion defining an open pocket.

11. A suburethral implant for treating stress urinary incontinence as defined by claim 10, wherein each arm extends from a respective lateral side portion of the plate-like member of the main body; wherein each arm includes a first side and a second side opposite the first side; and wherein the plate-like member includes a first portion extending outwardly from the first side of the arms in a first direction along the longitudinal axis of the plate-like member, and a second portion extending outwardly from the second side of the arms in a second direction along the longitudinal axis of the plate-like member which is opposite to the first direction, the suburethral implant being foldable in a first undeployed state, wherein the second portion is at least partially received by the open pockets defined by the curved portions of the arms such that the arms and second portion of the plate-like member extend generally in the second direction along the longitudinal axis of the plate-like member, the suburethral implant being unfoldable in a second deployed state, wherein the second portion of the plate-like member is not received by the-open pockets defined by the curved portions of the arms such that the arms extend in a transverse direction to the longitudinal axis in which the first and second portions of the plate-like member extend.

12. A suburethral implant for treating stress urinary incontinence as defined by claim 1, wherein the plate-like member has a longitudinal length between about 0.5 mm and about 10 mm.

13. A suburethral implant for treating stress urinary incontinence as defined by claim 12, wherein the plate-like member has a longitudinal length of about 3 mm.

14. A suburethral implant for treating stress urinary incontinence as defined by claim 12, wherein the plate-like member has a longitudinal length of about 2 mm.

15. A suburethral implant for treating stress urinary incontinence, which comprises: a main body for supporting a patient's urethra, the main body including a V-shaped member generally residing in and extending along a longitudinal plane; anda pair of spaced apart arms extending from the V-shaped member, each arm having a tissue engaging portion.

16. A suburethral implant for treating stress urinary incontinence as defined by claim 15, wherein the V-shaped member and each arm are integrally formed from a single, selectively shaped, rod-like member.

17. A suburethral implant for treating stress urinary incontinence as defined by claim 16, wherein the rod-like member is formed from a Nitinol wire.

18. A suburethral implant for treating stress urinary incontinence as defined by claim 15, wherein the V-shaped member includes a pair of legs, and a flexible apex joint joining the legs together.

19. A suburethral implant for treating stress urinary incontinence as defined by claim 18, which further comprises: flexible arm joints, each flexible arm joint being situated on a respective leg of the V-shaped member and interconnecting a respective leg of the V-shaped member with one of the arms of the pair of spaced apart arms.

20. A suburethral implant for treating stress urinary incontinence as defined by claim 15, wherein at least one of the V-shaped member and each arm is formed from one of a resilient, elastically deformable material and a material having shape memory properties.

21. A suburethral implant for treating stress urinary incontinence as defined by claim 20, wherein the suburethral implant is foldable to an undeployed state in which the arms and the V-shaped member extend generally along the longitudinal plane of the V-shaped member, and wherein the suburethral implant is unfoldable to a deployed state in which the arms extend in a transverse direction to the longitudinal plane in which the V-shaped member generally resides.

22. A suburethral implant for treating stress urinary incontinence as defined by claim 15, wherein the tissue engaging portion of each arm includes a barb to facilitate securing the suburethral implant to tissue in proximity to the patient's urethra.

23. A suburethral implant for treating stress urinary incontinence as defined by claim 15, wherein the tissue engaging portion of each arm includes a hook to facilitate securing the suburethral implant to tissue in proximity to the patient's urethra.

24. A suburethral implant for treating stress urinary incontinence, which comprises: a main body for supporting a patient's urethra; anda pair of spaced apart arms extending from the main body, each arm having a tissue engaging portion.

25. A suburethral implant for treating stress urinary incontinence as defined by claim 24, wherein the tissue engaging portion of each arm includes a barb to facilitate securing the suburethral implant to tissue in proximity to the patient's urethra.

26. A suburethral implant for treating stress urinary incontinence as defined by claim 24, wherein the tissue engaging portion of each arm includes a hook to facilitate securing the suburethral implant to tissue in proximity to the patient's urethra.

27. A suburethral implant for treating stress urinary incontinence as defined by claim 24, wherein at least one of the main body and the pair of arms is formed from one of a resilient, elastically deformable material and a material having shape memory properties.

28. A suburethral implant for treating stress urinary incontinence as defined by claim 27, wherein the suburethral implant is foldable to an undeployed state in which the arms and the main body extend generally co-axially, and wherein the suburethral implant is unfoldable to a deployed state in which the arms extend in a transverse direction from the main body.

29. A device for deploying a suburethral implant for treating stress urinary incontinence, which comprises: a vaginal probe for insertion into the vaginal canal of a patient, the vaginal probe having a wall, the wall having formed through the thickness thereof a suburethral implant introducer assembly exit port;a urethra locator probe for insertion into the urethra of a patient, the urethra probe being spaced apart from and overlying the vaginal probe; anda suburethral implant introducer assembly, the suburethral implant introducer assembly being extendable and retractable with respect to the vaginal probe through the introducer assembly exit port, the introducer assembly having a distal end on which is removably mounted a suburethral implant;wherein the urethra locator probe is receivable by a patient's urethra for positioning the urethra in a desired location with respect to the vaginal probe; and wherein the introducer assembly is extendable with respect to the vaginal probe to pierce a wall of the vaginal canal of the patient and to position a suburethral implant removably mounted thereon in proximity to the patient's urethra, and retractable with respect to the vaginal probe, whereby the suburethral implant is removed from the introducer assembly and remains affixed to tissue in proximity to the patient's urethra.

30. A device for deploying a suburethral implant as defined by claim 29, which further comprises: a housing, the vaginal probe and urethra locator probe being mounted on the housing and extending therefrom, the housing having a wall and defining a cavity interiorly of the housing, at least a portion of the introducer assembly being selectively situated in the housing; anda trigger arm pivotally joined to and moveable with respect to the housing, the trigger arm being operatively coupled to the introducer assembly, the introducer assembly being extendable and retractable with respect to the vaginal probe in response to pivotal movement of the trigger arm.

31. A device for deploying a suburethral implant as defined by claim 30, which further comprises: an insertion depth stop, the insertion depth stop being mounted on the housing and being engageable with a patient's body near an orifice of the patient's urethra to prevent over-insertion of at least one of the urethra locator probe and the vaginal probe into respectively at least one of the patient's urethra and the vaginal canal.

32. A device for deploying a suburethral implant as defined by claim 31, wherein the insertion depth stop includes a plunger mounted on the housing and spring biased to reciprocatingly move on the housing.

33. A device for deploying a suburethral implant as defined by claim 32, wherein the urethra locator probe includes a rod having a non-traumatizing free end which is receivable in a patient's urethra, and wherein the plunger of the insertion depth stop is reciprocatingly slidably mounted on the rod of the urethra locator probe.

34. A device for deploying a suburethral implant as defined by claim 32, which further comprises: an insertion depth indicator, the insertion depth indicator being responsive to movement of the plunger and indicating the relative depth of insertion of at least one of the urethra locator probe and the vaginal probe into respectively at least one of the patient's urethra and vaginal canal.

35. A device for deploying a suburethral implant as defined by claim 34, wherein the insertion depth indicator includes an elongated member having opposite first and second longitudinal axial ends, the first end being operatively linked to the plunger and reciprocatingly slidable within the housing upon movement of the plunger, the housing having an indicator window defined by an opening formed through the thickness of the housing-wall, at least the second axial end of the elongated member being aligned with the indicator window opening and viewable by a surgeon therethrough to indicate the relative depth of desired deployment of the suburethral implant in a patient's body.

36. A device for deploying a suburethral implant as defined by claim 29, wherein the suburethral implant introducer assembly includes an inner introducer feeder, and an outer introducer sheath surrounding the inner introducer feeder, the introducer feeder having a distal end remotely situated from the housing when the introducer is in its extended state, the suburethral implant being removably mounted on the distal end of the introducer feeder.

37. A device for deploying a suburethral implant as defined by claim 36, wherein the introducer feeder includes an inner tubular member having a split free end including a first portion and a second portion transversely adjacent to the first portion; and wherein the introducer sheath includes an outer tubular member having an axially extending bore in which is slidably received the inner tubular member of the introducer feeder.

38. A device for deploying a suburethral implant as defined by claim 37, wherein at least the split free end of the introducer feeder is formed from one of an elastically deformable material and a material having shape memory properties to provide the first and second portions of the split free end with a resilient tendency to separate transversely from each other in a spaced apart condition.

39. A device for deploying a suburethral implant as defined by claim 30, which further comprises: a mechanism situated in the housing cavity for extending and retracting the suburethral implant introducer assembly with respect to the vaginal probe, the mechanism being operatively linked to the trigger arm and the introducer assembly and causing the suburethral implant introducer assembly to extend and retract with respect to the vaginal probe in response to pivotal movement of the trigger arm with respect to the housing.

40. A device for deploying a suburethral implant as defined by claim 39, wherein the mechanism includes a toothed rack member, the housing defining a guide channel situated within the housing cavity for receiving the toothed rack member, the toothed rack member being reciprocatingly slidable within the guide channel, and a pinion gear assembly, the pinion gear assembly being operatively linked to the trigger arm and rotating in response to pivotal movement of the trigger arm, the toothed rack member engaging the pinion gear assembly and reciprocatingly sliding within the guide channel in response to rotation of the pinion gear assembly, the introducer assembly being operatively linked to the toothed rack member and extending and retracting with respect to the vaginal probe in response to reciprocatingly slidable movement of the toothed rack member within the guide channel.

41. A device for deploying a suburethral implant as defined by claim 40, wherein the pinion gear assembly includes a first pinion gear and a second pinion gear, the second pinion gear being co-axially disposed and fixedly mounted to the first pinion gear so that the first and second pinion gears rotate together, each of the first and second pinion gears having a toothed outer diameter, the toothed outer diameter of the first pinion gear being greater than the toothed outer diameter of the second pinion gear; and wherein the trigger arm includes a toothed outer surface, the toothed outer surface engaging the second pinion gear, the first pinion gear engaging the toothed rack member.

42. A device for deploying a suburethral implant as defined by claim 41, which further comprises: an anti-backup mechanism operatively linked to the trigger arm.

43. A device for deploying a suburethral implant as defined by claim 42, wherein the anti-backup mechanism includes a toothed pawl mounted to one of the housing and the trigger arm, and a toothed ratchet mounted to the other of the housing and the trigger arm, the toothed pawl non-lockingly engaging the toothed ratchet to allow pivotal movement of the trigger arm when the trigger arm is pivoted in a first rotational direction, the toothed pawl lockingly engaging the toothed ratchet to selectively prevent pivotal movement of the trigger arm when the trigger arm is pivoted in a second rotational direction which is opposite to the first rotational direction.

44. A device for deploying a suburethral implant as defined by claim 43, wherein the trigger arm includes a resilient leg extending outwardly from a surface thereof, the resilient leg having a free end, the toothed pawl being situated at the free end thereof; and wherein the housing includes the toothed ratchet situated in proximity to the trigger arm, the resilient leg being biased toward the toothed ratchet to effect engagement of the toothed pawl with the toothed ratchet.

45. A device for deploying a suburethral implant as defined by claim 30, which further comprises: a fluid conduit, the fluid conduit having an axial bore extending longitudinally therethrough and a first open axial end and a second open axial end which is situated opposite to the first open axial end, the first and second open axial ends being in fluid communication with the axial bore, the fluid conduit extending between the housing and a fluid output port formed through the thickness of the wall of the vaginal probe, the housing having a fluid input port formed through the thickness of the housing wall, the first open axial end of the fluid conduit being in fluid communication with and being situated in proximity to the fluid input port formed on the housing wall, the second open axial end of the fluid conduit being in fluid communication with and being situated in proximity to the fluid output port formed on the vaginal probe.

46. A device for deploying a suburethral implant as defined by claim 45, wherein the fluid output port is co-extensively situated at the introducer assembly exit port.

47. A device for deploying a suburethral implant as defined by claim 38, which further comprises: a mechanism situated in the housing cavity for extending and retracting the suburethral implant introducer assembly with respect to the vaginal probe, the mechanism being operatively linked to the trigger arm and the introducer assembly and causing the suburethral implant introducer assembly to extend and retract with respect to the vaginal probe in response to pivotal movement of the trigger arm with respect to the housing.

48. A device for deploying a suburethral implant as defined by claim 47, wherein the mechanism includes a toothed rack member, the housing defining a guide channel situated within the housing cavity for receiving the toothed rack member, the toothed rack member being reciprocatingly slidable within the guide channel, and a pinion gear assembly, the pinion gear assembly being operatively linked to the trigger arm and rotating in response to pivotal movement of the trigger arm, the toothed rack member engaging the pinion gear assembly and reciprocatingly sliding within the guide channel in response to rotation of the pinion gear assembly, the introducer assembly being operatively linked to the toothed rack member and extending and retracting with respect to the vaginal probe in response to reciprocatingly slidable movement of the toothed rack member within the guide channel.

49. A device for deploying a suburethral implant as defined by claim 48, wherein the mechanism further includes an introducer sheath mounting member, the introducer sheath mounting member being reciprocatingly slidable within the guide channel in response to movement of the toothed rack member therein and being fixedly secured to the introducer sheath; and wherein the housing includes a stop member disposed in proximity to the guide channel, the introducer sheath mounting member being selectively contactable with the stop member to prevent further movement of the introducer sheath in a direction out of the introducer assembly exit port.

50. A device for deploying a suburethral implant as defined by claim 49, wherein the mechanism further includes an introducer feeder mounting member, the introducer feeder mounting member being reciprocauingly slidable within the guide channel in response to movement of the toothed rack member therein, and being fixedly secured to the introducer feeder, the introducer feeder mounting member being spaced in the guide channel apart from the introducer sheath mounting member by a predetermined distance and being selectively operatively linked to the introducer sheath mounting member so that the introducer sheath and introducer feeder move together in response to movement of the toothed rack member in the guide channel when the introducer sheath mounting member is not in contact with the stop member, and so that the introducer feeder moves independently of the introducer sheath in response to movement of the toothed rack member in the guide channel when the introducer sheath mounting member is in contact with and prevented from further movement in at least one direction by the stop member.

51. A device for deploying a suburethral implant as defined by claim 50, wherein the mechanism further includes a linkage fixedly secured to the introducer sheath mounting member and selectively releasably secured to the introducer feeder mounting member.

52. A device for deploying a suburethral implant as defined by claim 51, wherein the linkage includes a proximate end affixed to the introducer sheath mounting member and a resilient distal end situated opposite to the proximate end, and a protrusion situated on the distal end thereof; and wherein the introducer feeder mounting member includes a recess formed in a surface thereof, the protrusion being selectively received by the recess to selectively operatively link the introducer sheath mounting member and the introducer feeder mounting member.

53. A device for deploying a suburethral implant as defined by claim 37, wherein the inner tubular member of the introducer feeder has formed therein an axially extending bore, and wherein the device further comprises: a fluid conduit, the fluid conduit having an axial bore formed longitudinally therethrough and a first open axial end and a second open axial end which is situated opposite to the first open axial end, the first and second open axial ends being in fluid communication with the axial bore of the fluid conduit, the fluid conduit extending between the housing and the introducer assembly exit port formed through the thickness of the wall of the vaginal probe, the housing having a fluid input port formed through the thickness of the housing wall, the first open axial end of the fluid conduit being in fluid communication with and being situated in proximity to the fluid input port formed on the housing wall, the second open axial end of the fluid conduit being in fluid communication with and being situated at the introducer assembly exit port formed on the vaginal probe, the fluid conduit being at least partially received by the axially extending bore of the inner tubular member of the introducer feeder.

54. A device for deploying a suburethral implant as defined by claim 29, wherein the distal end of the suburethral implant introducer assembly is formed with a tissue piercing tip to pierce the vaginal canal wall and penetrate tissue in proximity to the patient's urethra.

55. A device for deploying a suburethral implant as defined by claim 29, wherein the distal end of the suburethral implant introducer assembly is formed with a tip shaped to removably seat at least a portion of a suburethral implant.

56. A device for deploying a suburethral implant as defined by claim 55, wherein the suburethral implant includes arms having at least one of hooked ends and barbs, and wherein the tip of the distal end of the introducer assembly includes an edge and has formed in the edge diametrically opposed recesses, each recess receiving a respective one of the hooked end and barb of an arm of the suburethral implant.

57. A method of deploying a suburethral implant at a desired location in a patient's body, which comprises the steps of: inserting a vaginal probe into the vaginal canal of a patient, the vaginal probe including a wall, the wall having formed through the thickness thereof a suburethral implant introducer exit port;inserting a urethra locator probe into the urethra of the patient, the urethra locator probe being spaced apart from and overlying the vaginal probe;extending a suburethral implant introducer assembly through the introducer assembly exit port, the introducer assembly having a distal end on which is removably mounted a suburethral implant;deploying the suburethral implant at a location in proximity to a patient's urethra; andretracting the suburethral implant introducer assembly through the introducer assembly exit port formed in the vaginal probe.

58. A method of deploying a suburethral implant as defined by claim 57, which further comprises the steps of: contacting an insertion depth stop with a patient's body near an orifice of the patient's urethra, the depth stop being operatively linked to at least one of the vaginal probe and the urethra locator probe and thereby preventing an over-insertion of at least one of the urethra locator probe and the vaginal probe into respectively at least one of the patient's urethra and vaginal canal.

59. A method of deploying a suburethral implant as defined by claim 58, which further comprises the step of: indicating with an insertion depth indicator the relative depth of insertion of at least one of the urethra locator probe and the vaginal probe into respectively at least one of the patient's urethra and vaginal canal, the insertion depth indicator being operatively linked to the insertion depth stop.

60. A method of deploying a suburethral implant as defined by claim 57, wherein the suburethral implant introducer assembly includes an inner introducer feeder and an outer introducer sheath surrounding and at least partially covering the inner introducer feeder, the introducer feeder having a distal end portion on which is removably mounted the suburethral implant, and wherein the method further comprises the steps of: simultaneously extending the introducer sheath and the introducer feeder outwardly from the introducer assembly exit port; andextending the inner introducer feeder and not extending the introducer sheath so that the distal end portion of the inner introducer feeder is uncovered by the introducer sheath as the introducer assembly is extended from the introducer assembly exit port.

61. A method of deploying a suburethral implant as defined by claim 60, wherein at least the distal portion of the introducer feeder is formed of at least two separable portions, and wherein the step of deploying the suburethral implant further includes the step of separating the at least two separable portions of the at least distal portion of the introducer feeder, the suburethral implant removably mounted on the distal end engaging the patient's body in proximity to the patient's urethra.

62. A method of deploying a suburethral implant as defined by claim 57, which further comprises the step of: prior to or simultaneously with the step of extending the suburethral implant introducer assembly from the introducer assembly exit port, ejecting anesthesia through the introducer assembly exit port.

63. A method of deploying a suburethral implant at a desired location in a patient's body, which comprises the steps of: securing a portion of the patient's vaginal canal in a first position;securing a portion of the patient's urethra in a second position relative to the first position of the portion of the patient's vaginal canal;extending a suburethral implant introducer assembly through the patient's vaginal canal at the portion thereof secured in the first position toward the portion of the patient's urethra secured in the second position, the suburethral implant introducer assembly having a distal end on which is removably mounted a suburethral implant;deploying the suburethral implant at a location in proximity to a patient's urethra; andretracting the suburethral implant introducer assembly from the patient's vaginal canal.

64. A method of deploying a suburethral implant as defined by claim 63, wherein the distal end of the suburethral implant introducer assembly includes a tissue piercing tip, and wherein the method further comprises the step of: piercing a wall of the patient's vaginal canal at the portion thereof secured in the first position with the tissue piercing tip of the suburethral implant introducer assembly.