Intra-vaginal devices and methods for treating fecal incontinence

• US 9,974,635 B2
• Filed: 02/14/2014
• Issued: 05/22/2018
• Est. Priority Date: 02/14/2013
• Status: Active Grant

• Current Assignee: Pelvalon, Inc.
• Original Assignee: Pelvalon, Inc.
• Inventors: Rosen, Miles Harris, Herbowy, Steven Lawrence, Goor, Jared, Brooks, III, Narvel M.
• Primary Examiner(s): Kuhlman, Catherine B
• Application Number:
  US14/181,576
• Publication Number:
  US 20140275744A1
• Time in Patent Office: 1,558 Days
• Field of Search: 600 29- 31, 600 37, 128834-841
• CPC Class Codes: A61F 2/0027 inflatable
• CPC Class Codes: A61F 2/0031 for constricting the lumen; Support slings for the urethra
• CPC Class Codes: A61F 2/005 with pressure applied to urethra by an element placed in the vagina
• CPC Class Codes: A61F 2250/0007 for adjusting length

Abstract

Disclosed herein are devices and methods for intra-vaginal bowel control.

Claims

1. An intravaginal device for the control of stool passage, the device comprising:

a collapsible stabilizing body including a plurality of segments interconnected by joints and configured to modulate between an open state and a collapsed state by movement of the segments about the joints,

an expandable body positioned above the stabilizing body, the expandable body configured to provide a non-extended state and an extended state, the expandable body configured to push against a recto-vaginal septum of a user in the extended state;

a locking mechanism configured to maintain the collapsible stabilizing body in the open state upon engagement of the locking mechanism and permit the collapsible stabilizing body to collapse upon disengagement of the locking mechanism; and

a support structure mounted to the stabilizing body to support a first portion of the expandable body, the support structure being configured to collapse or fold when the stabilizing body moves from the open state to the collapsed state, and the support structure being configured to support the first portion of the expandable body on at least one surface of the support structure when the stabilizing body is in the open state and the expandable body is in the extended state.

2. The device of claim 1, wherein the interconnected segments, in the open state of the stabilizing body, form a loop with a generally oval shape.

3. The device of claim 1, wherein the interconnected segments, in the collapsed state of the stabilizing body, form a loop with multiple generally oval shapes.

4. The device of claim 1, wherein in the collapsed state of the stabilizing body the segments have a lengthwise mid-point that is approximately half-way between a distal joint and proximal joint, wherein a width at this midpoint in the collapsed state of the stabilizing body is narrower than a width of a space spanned by the segments both proximal and distal to the midpoint.

5. The device of claim 4, wherein in the collapsed state of the stabilizing body, the approximate lengthwise midpoint forms a local minimum in the profile of the device.

6. The device of claim 1, wherein the expandable body is configured to protrude into the rectum by pushing against a recto-vaginal septum of a user in the extended state.

7. The device of claim 1, wherein:

in the open state of the stabilizing body, the device has a first width, a first length, and a first height; and

in the collapsed state of the stabilizing body, the device has a second width, a second length, and a second height, the second width being 50% less than the first width, the second length being greater than the first length, and the second height being substantially the same as the first height.

8. The device of claim 1, wherein the stabilizing body is comprised of multiple interconnected segments that are joined together to form a loop.

9. The device of claim 1, wherein the stabilizing body comprises multiple interconnected segments that are joined by joints, wherein at least one of the joints comprises an elastomeric material.

10. The device of claim 1, wherein at least a portion of at least some of the plurality of segments have an arcuate shape.

11. The device of claim 1, wherein the plurality of segments is arranged symmetrically about an axis that extends between the locking mechanism and the expandable body.

12. The device of claim 1, wherein the expandable body is positioned above a joint between interconnected segments.

13. The device of claim 1, wherein the expandable body is positioned above a joint located opposite to the locking mechanism.

14. The device of claim 13, wherein the expandable body is an inflatable balloon, extending from the joint in a generally perpendicular direction from a plane of the interconnected segments, wherein the joint is located between the balloon and a soft cushion material.

15. The device of claim 1, wherein, in the open state of the stabilizing body, a portion of the collapsible stabilizing body has an arcuate shape and a portion of the collapsible stabilizing body has a linear shape.

16. The device of claim 15, wherein, in the open state of the stabilizing body, the expandable body is positioned above the linearly shaped portion of the collapsible stabilizing body.

17. The device of claim 1, wherein the expandable body is attached to a periphery of the intravaginal device.

18. The device of claim 1, wherein the collapsible stabilizing body is configured to provide an interconnected frame forming a structural perimeter of the device.

19. The device of claim 18, wherein the interconnected frame is comprised of metal segments, joined together and surrounded by a soft cushioning material.

20. The device of claim 18, wherein the collapsible stabilizing body comprises at least 3 interconnected joints that are configured to be constrained to one degree of freedom of angular motion.

21. The device of claim 1, wherein the collapsible stabilizing body is configured to resist out-of-plane bending.

22. The device of claim 1, wherein joints of the interconnected segments are configured to constrain the interconnected segments to rotational motion in a plane of the frame.

23. The device of claim 1, wherein the expandable body is coupled to the collapsible stabilizing body by a flexible coupling.

24. The device of claim 1, wherein the expandable body comprises a support member that is connected to the collapsible stabilizing body, wherein the support member spans less than 50% of a distance across a longitudinal span of the stabilizing body in the open state of the stabilizing body.

25. The device of claim 1, wherein:

in the open state of the stabilizing body, the collapsible stabilizing body has a first width and a first length; and

in the collapsed state of the stabilizing body, the collapsible stabilizing body has a second width and a second length, the second width being less than the first width and the second length being greater than the first length.

26. The device of claim 1, wherein the plurality of segments comprises at least six segments.

27. The device of claim 1, wherein the plurality of segments comprises at least four segments.

28. The device of claim 1, wherein the device has an outer profile, and wherein the interconnected segments deviate from the outer profile at a proximal portion of the stabilizing body.

29. The device of claim 1, further comprising an encapsulating material disposed around the collapsible stabilizing body, the encapsulating material having a first thickness between the interconnected segments and an exterior surface of the stabilizing body in regions disposed away from the expandable body and a second thickness between the interconnected segments and an exterior surface of the stabilizing body in regions disposed proximate to the expandable body, the second thickness being greater than the first thickness.

30. The device of claim 1, further comprising a tensile element attached to the locking mechanism, the tensile element configured to permit disengagement of the locking mechanism via application of force to the tensile element.

31. The device of claim 30, wherein the tensile element is operatively connected to an inflation lumen that communicates with the expandable body.

32. The device of claim 30, wherein the tensile element comprises a string, tube, cable, wire, or cord.

33. The device of claim 1, wherein the plurality of segments includes:

a first arcuate segment;

a second arcuate segment moveably connected to the first arcuate segment;

a third segment having an arcuate portion and a linear portion, the third segment being moveably connected to the first segment; and

a fourth segment having an arcuate portion and a linear portion, the fourth segment being moveably connected to both the third segment and the second segment.

34. The device of claim 1, wherein the plurality of segments includes:

a first arcuate segment;

a second arcuate segment moveably connected to the first arcuate segment and disposed opposite to the first arcuate segment along an axis;

a third arcuate segment moveably connected to the first arcuate segment;

a fourth arcuate segment moveably connected to the second arcuate segment and disposed opposite to the third arcuate segment along the axis;

a fifth linear segment moveably connected to the third arcuate segment; and

a sixth linear segment moveably connected to the fourth arcuate segment and disposed opposite to the fifth linear segment along the axis.

35. The device of claim 1, wherein the plurality of segments comprises lateral arms with midpoints, wherein the midpoints can be moved from the open state to a collapsed state wherein in the collapsed state the distance between opposing midpoints is reduced by ≥

50%.

36. The device of claim 1, wherein the stabilizing body and the support structure are configured to collapse in a common plane.

37. The device of claim 1, wherein the support structure defines a slot in which a post extending from the stabilizing body is positioned to cause the support structure to collapse as the stabilizing body collapses.

38. The device of claim 1, wherein the support structure covers an entire area of one side of the expandable body.

39. A method of controlling stool passage in a user, the method comprising

inserting an intra-vaginal device in the user'"'"'s vagina, the device comprising a collapsible stabilizing body including a plurality of segments interconnected by joints, a support structure mounted to the stabilizing body, and an expandable body, the collapsible stabilizing body being in a collapsed state during insertion, and the support structure being in a collapsed or folded state during insertion;

moving the interconnected segments about the joints to modulate the collapsible stabilizing body from the collapsed state to an open state and to move the support structure from the collapsed or folded state to an expanded state;

locking the collapsible stabilizing body in the open state;

extending the expandable body against a recto-vaginal septum of the vagina to at least partially occlude the user'"'"'s rectum, the support structure being in the expanded state and supporting a first portion of the extended expandable body on at least one surface of the support structure; and

retracting the expandable body while the stabilizing body is open to permit stool to pass through the rectum.

40. The method of claim 39, further comprising applying force to a tensile element attached to the locking mechanism, unlocking the collapsible stabilizing body from the open state.

41. The method of claim 40, wherein tensile element is part of an inflation tube.

42. The method of claim 39, wherein the interconnected segments and the support structure move in a common plane when the interconnected segments and the support structure move to their open and expanded states, respectively.

43. The method of claim 39, wherein the support structure defines a slot in which a post extending from the stabilizing body is positioned to cause the support structure to move into the expanded state as the stabilizing body moves to the open state.

44. The method of claim 39, wherein the support structure covers an entire area of one side of the expandable body.

48. The device of claim 40, wherein the stabilizing body has a generally ovular shape.

45. An intravaginal device for the control of stool passage of an adult human female user, the device comprising,

an expandable body;

an intravaginal stabilizing body supporting the expandable body to maintain position and stability of the expandable body in the user'"'"'s vagina during repeated expansions of the expandable body in an extension direction to contact the user'"'"'s rectovaginal septum to at least partially occlude the rectum, the stabilizing body comprising a locking mechanism, the stabilizing body having a collapsed configuration and a stable open configuration in which the stabilizing body is held open by the locking mechanism; and

a support structure mounted to the stabilizing body to support a first portion of the expandable body, the support structure being configured to collapse or fold when the stabilizing body moves from the open configuration to the collapsed configuration, and the support structure being configured to support the first portion of the expandable body on at least one surface of the support structure when the stabilizing body is in the open configuration and the expandable body is expanded.

46. The device of claim 45, wherein the stabilizing body comprises a plurality of arms connected to form a loop.

47. The device of claim 46, wherein the stabilizing body comprises 4 arms.

49. The device of claim 46, wherein the stabilizing body is configured to collapse along its length as it moves from the open configuration to the collapsed configuration.

50. The device of claim 45, wherein, in the open configuration, the expandable body is disposed at a location of the stabilizing body having a width less than the maximum width of the stabilizing body.

51. The device of claim 45, wherein a thickness of the stabilizing body in the extension direction is less than the length of the expandable body in the extension direction.

52. The device of claim 45, wherein, in the collapsed configuration of the stabilizing body, the expandable body is supported so that it is disposed in a space between portions of the stabilizing body.

53. The device of claim 45, wherein the stabilizing body comprises two arms connected by a hinge, the locking mechanism configured to prevent or permit movement of the hinge.

54. The device of claim 53, wherein the locking mechanism comprises a latch that is configured to move into and out of a pocket positioned proximate to the hinge between two arms, wherein the latch being positioned in the pocket prevents the two arms from moving relative to one another.

55. The device of claim 54, wherein the hinge and the latch are configured to rotate about a same point.

56. The device of claim 54, wherein the latch is connected to the stabilizing body by a pin joint and is configured to rotate into the pocket.

57. The device of claim 45, wherein the locking mechanism comprises a rotatable joint positioned between two arms configured to allow the opening or closing of the stabilizing body upon rotation of the joint.

58. The device of claim 45, wherein the locking mechanism comprises at least one resilient member extending across the stabilizing body, holding the stabilizing body open when the resilient member is in a resting state.

59. The device of claim 58, wherein, in the resting state, the resilient member is configured to hold the stabilizing body open to a degree greater than a degree to which the stabilizing body is open when the device is inserted in the patient'"'"'s vaginal cavity.

60. The device of claim 45, wherein the locking mechanism comprises a detent on an end of a first arm configured to catch on a feature of an end of a second arm.

61. The device of claim 60, wherein the detent comprises at least one of a spring loaded ball or a leaf spring.

62. The device of claim 60, wherein the feature comprises at least one of an edge of the second arm or a feature shaped to mate with the detent.

63. The device of claim 45, wherein the device comprises a stable collapsed configuration and a stable open configuration.

64. The device of claim 63, wherein the stabilizing body comprises a plurality of arms, and at least two of the plurality of arms have a first configuration in which the at least two arms extend inwardly towards a center of the stabilizing body and a second configuration in which the at least two arms extend outwardly away from the center of the stabilizing body.

65. The device of claim 45, wherein the locking mechanism comprises a bistable component extending between a first arm and a second arm of the stabilizing body.

66. The device of claim 65, wherein the bistable component comprises a hinge connecting the first arm and the second arm.

67. The device of claim 66, wherein a resilient member extends between a first end of the first arm and a second end of the second arm, the resilient member configured to be in a first tensioned state when the stabilizing body is in the open configuration or the collapsed configuration and a second tensioned state when moving between the open and collapsed configurations, wherein the second tensioned state is higher than the first tensioned state.

68. The device of claim 45, wherein the device is configured to collapse into two sections in the collapsed configuration.

69. The device of claim 45, wherein the device is configured to collapse into more than two sections in the collapsed configuration.

70. The device of claim 45, wherein the locking mechanism comprises an opening on a first end of a first arm configured to catch an extension on a second end of a second arm.

71. The device of claim 45, wherein the stabilizing body is configured to collapse by folding together.

72. The device of claim 45, wherein the stabilizing body comprises two hinges configured to allow the stabilizing body to fold.

73. The device of claim 72, wherein the stabilizing body comprises two additional hinges configured to allow the folded stabilizing body to straighten.

74. The device of claim 73, wherein the two additional hinges are joints, rotatable to allow folding of the stabilizing body.

75. The device of claim 45, wherein the stabilizing body comprises a shape memory alloy comprising a transition temperature other than body temperature.

76. The device of claim 75, wherein the shape memory alloy is configured to change shape upon application of temperature or current.

77. The device of claim 45, wherein the locking mechanism comprises at least two internal structures with flexible portions, movable relative to one another, configured to facilitate device collapse upon alignment of the flexible portions.

78. The device of claim 45, wherein the stabilizing body comprises multiple frame segments with a tensile member passed through the frame segments.

79. The device of claim 45, wherein the locking mechanism comprises a hinge with a sheath movable to cover or expose the hinge.

80. The device of claim 79, wherein the sheath is configured to prevent motion of the hinge when the sheath covers the hinge.

81. The device of claim 45, further comprising a triggering mechanism configured to transition the stabilizing body to the collapsible state.

82. The device of claim 81, wherein the triggering mechanism is located proximate to an inflation lumen connected to the expandable body.

83. The device of claim 82, wherein the triggering mechanism is coupled to the inflation lumen.

84. The device of claim 81, wherein the device comprises an elastomeric portion distal to the triggering mechanism.

85. The device of claim 45, wherein the stabilizing body and the support structure are configured to collapse in a common plane.

86. The device of claim 45, wherein the support structure defines a slot in which a post extending from the stabilizing body is positioned to cause the support structure to collapse as the stabilizing body collapses.

87. The device of claim 45, wherein the support structure covers an entire area of one side of the expandable body.

88. A method of selectively occluding a rectum to inhibit stool passage in a female user, the method comprising

inserting an intravaginal device into the user'"'"'s vagina, the device comprising a stabilizing body, a support structure mounted to the stabilizing body, and an expandable body, the stabilizing body being in a collapsed configuration during insertion, and the support structure being in a collapsed or folded state during insertion;

moving the stabilizing body from the collapsed configuration to an open configuration such that the support structure moves from the collapsed or folded state to an expanded state;

engaging vaginal anatomy with the stabilizing body in the open configuration to stably support the expandable body;

locking the stabilizing body in the open configuration;

extending the expandable body against a recto-vaginal septum of the vagina body during the engaging step to at least partially occlude the user'"'"'s rectum, the support structure being in the expanded state and supporting a first portion of the extended expandable body on at least one surface of the support structure; and

retracting the expandable body while the stabilizing body is in the open configuration to permit stool to pass through the rectum.

89. The method of claim 88, further comprising pulling on a distal portion of the intravaginal device, thereby causing the stabilizing body to collapse from the open configuration to the collapsed configuration.

90. The method of claim 89, further comprising removing the device from the user'"'"'s vagina.

91. The method of claim 89, wherein pulling on a distal portion of the intravaginal device comprises pulling on a tensile element attached to a distal portion of the device.

92. The method of claim 91, wherein the tensile element comprises a string, cord, or reinforced tube.

93. The method of claim 88, wherein the extending step comprises inflating the expandable body to a pressure of 40-150 mm Hg.

94. The method of claim 88, wherein the engaging step comprises engaging internal vaginal anatomy to stably support the expandable body proximal to the vagina'"'"'s perineal body while maintaining slack in the vagina wall.

95. The method of claim 88, wherein the engaging step comprises distending lateral walls of the vagina proximate to the expandable body less than in areas not proximate to the expandable body.

96. The method of claim 88, wherein the stabilizing body and the support structure move in a common plane when the stabilizing body and the support structure move to their open configuration and expanded state, respectively.

97. The method of claim 88, wherein the support structure defines a slot in which a post extending from the stabilizing body is positioned to cause the support structure to move into the expanded state as the stabilizing body moves to the open configuration.

98. The method of claim 88, wherein the support structure covers an entire area of one side of the expandable body.