Systems and methods for closing internal tissue defects

• US 20050267495A1
• Filed: 05/17/2004
• Published: 12/01/2005
• Est. Priority Date: 05/17/2004
• Status: Abandoned Application

• Current Assignee: Ovalis, Inc.
• Original Assignee: Gateway Edi (Cognizant Technology Solutions Corp.)
• Inventors: Ginn, Richard S., Karratt, Joseph
• Application Number:
  US10/847,747
• Publication Number:
  US 20050267495A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• 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 17/08 Wound clamps or clips, i.e. not or only partly penetrating the tissue suture bridges A61B17/0466; Devices for bringing together the edges of a wound
• CPC Class Codes: A61B 17/1227 Spring clips
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/061 hollow or tubular suture extending inside a hollow needle A61B2017/06052; hollow sutures A61B2017/06185
• CPC Class Codes: A61B 2017/0649 Coils or spirals
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

Abstract

A delivery system having a steerable delivery device and an elastic clip for treating an internal tissue defect, such as septal defects and the like, is provided. The clip can be deformable between a relaxed state and a stressed state and biased towards the relaxed state. The delivery device can include a flexible tubular needle with a lumen for housing the clip while in the stressed state. When used to treat a septal defect, the needle is advancable through overlapping tissue flaps and a pusher member is advancable within the needle lumen to push the clip distally such that one end of the clip is deployed and engages a tissue flap. The needle can then be retracted allowing the clip to deploy over both flaps of tissue, where the biasing force returns the clip to the relaxed state drawing the tissue flaps together and closing the septal defect.

Claims

1. An apparatus for closing a septal defect, comprising:

an elastic clip having a first end, a second end and a body therebetween, the body having a longitudinal axis extending along its length;

wherein the clip is biased towards a relaxed state where each end is adjacent to the other, and wherein upon application of a mechanical stress the clip is deformable from the relaxed state to a stressed state where each end extends in a direction away from the other placing the body in torsion about the longitudinal axis.

2. The apparatus of claim 1, wherein the clip is formed from a shape memory material.

3. The apparatus of claim 2, wherein the clip is formed from nitinol and the Austenite finish temperature is below human body temperature.

4. The apparatus of claim 1, wherein the first and second ends of the clip overlap each other.

5. The apparatus of claim 1, wherein the body has a multi-sided shape while in the relaxed state.

6. The apparatus of claim 1, wherein the body has a curved shape while in the relaxed state.

7. The apparatus of claim 6, wherein the body is curved about a central axis while in the relaxed state.

8. The apparatus of claim 7, wherein the body is curved circularly about the central axis while in the relaxed state.

9. The apparatus of claim 1, wherein the clip is deformable upon application of the mechanical stress between each end such that each end moves laterally away from the other.

10. The apparatus of claim 9, wherein the body is curved about at least one axis and the clip is deformable upon initial application of the mechanical stress such that each end moves laterally away from the other along the axis.

11. The apparatus of claim 9, wherein the clip is biased to return to the relaxed state upon removal of the mechanical stress.

12. The apparatus of claim 1, wherein the body is elliptical in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

13. The apparatus of claim 1, wherein the body is circular in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

14. The apparatus of claim 1, wherein the body is rectangular in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

15. The apparatus of claim 1, wherein each end of the clip is substantially blunt.

16. The apparatus of claim 1, wherein a surface of the body is roughened to engage human body tissue.

17. The apparatus of claim 1, wherein the body is substantially straightened in the stressed state.

18. The apparatus of claim 1, wherein the body is adapted to close a septal defect.

19. The apparatus of claim 1, wherein the body has a substantially straight midsection.

20. The apparatus of claim 19, wherein a first portion of the body including the first end is curved about a first axis, and a second portion of the body including the second end is curved about a second axis, and the midsection is located between the first and second portions.

21. An apparatus for closing a septal defect, comprising:

an elastic clip having a first substantially blunt end, a second substantially blunt end and a body therebetween, the clip being biased towards a relaxed state where the body is coiled, wherein upon application of a mechanical stress the clip is deformable from the relaxed state to a stressed state where the body is straightened such that each end extends in a direction at least partially away from the other.

22. The apparatus of claim 21, wherein the body has a first coiled segment and a second coiled segment, the first coiled segment being coiled at least 360 degrees while in the relaxed state.

23. The apparatus of claim 21, wherein the clip is deformable upon application of the mechanical stress between each end such that each end moves laterally away from the other placing the body in torsion about a longitudinal axis of the body.

24. The apparatus of claim 23, wherein the body is curved about at least one axis and the clip is deformable upon initial application of the mechanical stress such that each end moves laterally away from the other substantially along the axis.

25. The apparatus of claim 22, wherein the body has a second coiled segment being coiled at least 360 degrees while in the relaxed state, the second coiled segment having a smaller perimeter than the first.

26. The apparatus of claim 25, wherein the clip lies substantially within a plane while in the relaxed state and is deformable upon application of a mechanical stress between each coiled segment such that each segment moves laterally away from the other and out of the plane placing the body in torsion about a longitudinal axis of the body.

27. The apparatus of claim 26, wherein the first coiled segment is coiled about at least one axis and the second coiled segment is coiled about at least one different axis.

28. The apparatus of claim 27, wherein the first coiled segment is substantially circular and the second coiled segment is substantially circular.

29. The apparatus of claim 25, wherein the clip is deformable upon application of a mechanical stress between each coiled segment such that the second coiled segment passes within the first coiled segment.

30. The apparatus of claim 29, wherein the first coiled segment is coiled about at least one axis and the second coiled segment is coiled about at least one different axis.

31. The apparatus of claim 30, wherein the first coiled segment is substantially circular and the second coiled segment is substantially circular.

32. The apparatus of claim 21, wherein the body is elliptical in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

33. The apparatus of claim 21, wherein the body is circular in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

34. The apparatus of claim 21, wherein the body is substantially rectangular in a radial cross-section taken along a plane, wherein a longitudinal axis of the body is normal to the plane.

35. The apparatus of claim 34, wherein one side of the rectangular body is longer than at least one other side of the body, and the longer side is roughened to engage human body tissue.

36. The apparatus of claim 21, wherein a surface of the body is roughened to engage human body tissue.

37. The apparatus of claim 21, wherein the body is substantially straightened in the stressed state.

38. A medical device for closing a septal defect, comprising:

a flexible elongate tubular body having a distal end with an opening therein, a proximal end and an inner lumen;

a flexible elongate tubular needle having a sharp, open distal end, a proximal end and an inner lumen, the needle being slidable within the inner lumen of the body; and

a flexible elongate pusher member having a distal end and a proximal end, the pusher member being slidable within the inner lumen of the needle;

wherein the opening in the distal end of the body is sized to allow the needle to pass therethrough.

39. The device of claim 38, further comprising a rigid distal tip on the distal end of the body.

40. The device of claim 38, wherein the tubular needle is formed of a nitinol alloy.

41. The device of claim 38, wherein the pusher member is formed of a nitinol alloy.

42. The device of claim 38, further comprising:

a wire coupled with the distal end of the body and extending proximally along the body; and

a bias member housed within the body, the bias member configured to apply a bias to the body along a longitudinal axis;

wherein the wire is capable of bending the device upon application of a force to the wire in a proximal direction.

43. The device of claim 42, wherein the bias member is a coil spring.

44. The device of claim 42, wherein the tubular needle has a region configured to provide increased flexibility.

45. The device of claim 44, wherein a plurality of apertures are provided in the needle.

46. The device of claim 44, wherein the needle is provided with a helically wound segment.

47. The device of claim 44, wherein the region of increased flexibility is located on the needle in a location coincidental with the bias member.

48. The device of claim 42, wherein the wire is coupled with the distal region of the body in a location offset from a center axis of the body.

49. The device of claim 48, wherein the wire is coupled with the distal region of the body at a first guide member.

50. The device of claim 49, wherein the bias member is housed between a first and a second abutment which are located proximal to the first guide member.

51. The device of claim 50, wherein the first abutment is on a second guide member and the second abutment is on a third guide member.

52. The device of claim 51, wherein the first, second and third guide members have openings therein such that the needle can pass therethrough.

53. The device of claim 52, wherein the first, second and third guide members are adapted to guide the needle therethrough.

54. The device of claim 51, wherein the body is reinforced in a region corresponding to the location of the bias member.

55. The device of claim 54, wherein the body comprises a relatively stiff braided material in the reinforced region.

56. The device of claim 38, further comprising a clip configured to close a septal defect.

57. The device of claim 56, wherein the clip is housed in the inner lumen of the needle and wherein the open distal end of the needle is sized to allow the clip to pass therethrough.

58. The device of claim 57, wherein the distal end of the pusher member is adapted to contact the clip and push the clip distally within the inner lumen of the needle.

59. The device of claim 58, wherein the clip is biased towards a relaxed state for closing the septal defect and wherein the clip is deformed to a stressed state.

60. The device of claim 59, wherein the needle is adapted to house the clip in the stressed state.

61. The device of claim 38, wherein the needle and pusher member are controllable from the proximal end of the body.

62. The device of claim 61, wherein the wire is controllable with an actuator at the proximal end of the body.

63. A steerable system for closing a septal defect, comprising:

a flexible elongate tubular body having an inner lumen;

a wire coupled with the body in a distal section of the body, the wire extending along a portion of the distal section and along an intermediate section of the body, wherein the intermediate section is proximal to the distal section; and

a bias member housed between two abutments within the intermediate section of the body, the bias member configured to apply a bias to the abutments along a longitudinal axis of the body;

wherein the wire is capable of bending the body upon application of a force to the wire in a proximal direction.

64. The system of claim 63, wherein the wire is coupled with the distal section of the body in a location offset from a center axis of the body.

65. The system of claim 64, wherein the wire is coupled with the distal section of the body at a first guide member.

66. The system of claim 65, wherein the first abutment is on a second guide member located between the distal section and the intermediate section, and wherein the second abutment is on a third guide member located between the intermediate section and a proximal section of the body, wherein the proximal section is located proximal to the intermediate section.

67. The system of claim 66, wherein the body is reinforced in the intermediate section.

68. The system of claim 67, wherein the body comprises a relatively stiff braided material in the intermediate section.

69. The system of claim 63, wherein the wire is controllable from the proximal end of the body.

70. The system of claim 63, wherein the bias member is a coil spring.

71. The system of claim 63, further comprising:

a flexible elongate tubular needle having a sharp, open distal end, a proximal end and an inner lumen, the needle being slidable within the inner lumen of the body; and

a flexible elongate pusher member having a distal end and a proximal end, the pusher member being slidable within the inner lumen of the needle;

wherein the distal section of the body has a rigid distal end with an opening adapted to allow the needle to pass therethrough.

72. The system of claim 71, wherein the first, second and third guide members have openings therein such that the needle can pass therethrough.

73. The system of claim 72, wherein the first, second and third guide members are adapted to guide the needle therethrough.

74. The system of claim 71, further comprising a clip adapted to close a septal defect.

75. The system of claim 74, wherein the clip is housed in the inner lumen of the needle and wherein the open distal end of the needle is adapted to allow the clip to pass therethrough.

76. The system of claim 75, wherein the distal end of the pusher member is adapted to contact the clip and push the clip distally within the inner lumen of the needle.

77. The system of claim 76, wherein the clip is biased towards a relaxed state for closing the septal defect and wherein the clip is deformable to a stressed state.

78. The system of claim 77, wherein the needle is adapted to house the clip in the stressed state.

79. The system of claim 71, wherein the needle and pusher member are controllable from the proximal end of the body.

80. The system of claim 71, wherein the tubular needle has a region configured to provide increased flexibility.

81. The system of claim 80, wherein a plurality of apertures are provided in the needle.

82. The system of claim 80, wherein the needle is provided with a helically wound segment.

83. The system of claim 80, wherein the region of increased flexibility is located on the needle in a location coincidental with the intermediate section of the body.

84. A method of closing a septal defect, comprising:

advancing a delivery device into proximity with a septal defect, the delivery device comprising a flexible elongate tubular body having an inner lumen and a distal end with an opening therein;

slidably advancing a flexible elongate tubular needle having an inner lumen and a sharp, open distal end, from within the inner lumen of the body such that the needle pierces and penetrates a first and a second tissue flap of the septal defect, wherein a flexible elongate pusher member is housed within the inner lumen of the needle, the pusher member having a distal end in contact with an elastic clip housed within the inner lumen of the needle;

slidably advancing the pusher member to deploy a first end of the elastic clip from the open distal end of the needle;

retracting the needle from tissue flaps such that the clip is deployed over the tissue flaps; and

at least partially closing an opening between the flaps with the clip.

85. The method of claim 84, wherein the step of retracting the needle further comprises holding the pusher member in a static position relative to the tissue flaps while retracting the needle.

86. The method of claim 84, further comprising advancing a guide catheter into proximity with the septal defect prior to advancing the delivery device, wherein the delivery device is advanced within an inner lumen of the guide catheter.

87. The method of claim 84, further comprising controllably advancing the pusher member with an actuator.

88. The method of claim 84, further comprising controllably advancing the needle with an actuator.

89. The method of claim 84, wherein the opening between the flaps is completely closed with the clip.

90. The method of claim 84, wherein the septal defect is a patent foramen ovale (PFO).

91. The method of claim 84, further comprising deforming the clip into a stressed state and placing the clip into the distal end of the inner lumen of the needle prior to advancing the delivery device into proximity with the septal defect.

92. The method of claim 91, wherein the clip is biased to return to the relaxed state upon deployment from the needle.

93. The method of claim 91, wherein the clip comprises a body and a first and second end located adjacent to and at least partially opposing each other.

94. The method of claim 93, wherein the clip is coiled into at least two 360 degree coiled segments.

95. The method of claim 84, wherein advancing the delivery device into proximity further comprises:

steering the delivery device into proximity with the septal defect using a wire coupled with the distal end of the delivery device and extending proximally within the body of the delivery device.

96. The method of claim 95, wherein steering the delivery device comprises:

applying a force in a proximal direction to the wire such that the delivery device bends in an elbow region where a bias member applies a bias to the delivery device body along a longitudinal axis of the delivery device body.

97. The method of claim 96, wherein advancing the delivery device into proximity further comprises:

steering the delivery device within a blood vessel in the patient'"'"'s body while advancing the delivery device through the patient'"'"'s blood vessel.