Suture-based systems and methods for treating septal defects

• US 7,846,179 B2
• Filed: 09/01/2005
• Issued: 12/07/2010
• Est. Priority Date: 09/01/2005
• Status: Expired due to Fees

• Current Assignee: Promed, Inc.
• Original Assignee: Ovalis, Inc.
• Inventors: Belef, W. Martin, Ginn, Richard S., Jabba, Ronald J., Carson, Dean
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): DOWE, KATHERINE MARIE
• Application Number:
  US11/218,794
• Publication Number:
  US 20070049970A1
• Time in Patent Office: 1,923 Days
• Field of Search: 606/139, 606/151, 606/222, 606223-227, 623/2.11, 623/2.36
• US Class Current: 606/222
• 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 17/0401 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 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/0404 Buttons
• CPC Class Codes: A61B 2017/0406 Pledgets
• CPC Class Codes: A61B 2017/0417 T-fasteners
• CPC Class Codes: A61B 2017/0419 H-fasteners
• CPC Class Codes: A61B 2017/0445 cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0448 Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/045 snug fit within the anchor
• CPC Class Codes: A61B 2017/0451 Cams or wedges holding the suture by friction
• CPC Class Codes: A61B 2017/0454 the anchor being crimped or clamped on the suture
• CPC Class Codes: A61B 2017/0456 Surface features on the anchor, e.g. ribs increasing friction between the suture and the anchor
• CPC Class Codes: A61B 2017/0458 Longitudinal through hole, e.g. suture blocked by a distal suture knot
• CPC Class Codes: A61B 2017/0459 Multiple holes in the anchor through which the suture extends and locking the suture when tension is applied
• CPC Class Codes: A61B 2017/0462 One way system, i.e. also tensioning the suture
• CPC Class Codes: A61B 2017/0464 for soft tissue
• CPC Class Codes: A61B 2017/047 : having at least one proximally pointing needle located at the distal end of the instrument, e.g. for suturing trocar puncture wounds starting from inside the body J-shaped suture needles A61B2017/0608
• CPC Class Codes: A61B 2017/0488 : Instruments for applying suture clamps, clips or locks for applying suture anchors A61B2017/0409; for applying wound clamps A61B17/10; for applying ligaturing clamps or clips A61B17/128
• CPC Class Codes: A61B 2017/0496 : for tensioning sutures
• CPC Class Codes: A61B 2017/06052 : Needle-suture combinations in which a suture is extending inside a hollow tubular needle, e.g. over the entire length of the needle hollow suture needles A61B2017/061

Abstract

A system for treating a septal defect having a suture-like implantable treatment apparatus and devices for delivering the implantable treatment apparatus and methods for treating a septal defect are provided. The suture-like apparatus is preferably implantable through a septal wall or portion thereof. The treatment system can include a flexible elongate body member, a delivery device configured to deliver the suture-like apparatus, a stabilization device configured to stabilize the delivery device and a positioning device configured to position the delivery device in a desired location. The suture-like device can include a suture body coupled with one or more lock devices or anchor devices.

Claims

1. In a method of closing a patent foramen ovale in a septal wall of the heart, the improvement comprising:

advancing an elongate flexible outer tubular member having an inner lumen through the vasculature of a patient and into proximity with the patient'"'"'s heart;

advancing the outer tubular member into the patient'"'"'s heart and into proximity with the septum secundum of a patent foramen ovale, the outer tubular member housing in its inner lumen a first and a second inner elongate tubular member in a first constrained configuration, each inner elongate tubular member having a lumen and a substantially sharp distal end and each inner tubular member having, respectively, a first and second suture body in its lumen each inner elongate tubular member further having a distal portion, a proximal portion, and a non-linear intermediate portion located therebetween, wherein a longitudinal axis of each distal portion is substantially parallel to a longitudinal axis of each proximal portion;

advancing the first and second inner elongate tubular members distally out of the inner lumen of the outer tubular member such that the first and second inner elongate tubular members deflect from the first constrained configuration to a second expanded configuration wherein the distal portion of each of the inner elongate tubular members is spaced away from the other and the distal portions and sharp distal ends extend in a distal direction and transverse to the septum secundum prior to penetrating the septum secundum;

advancing said first and second tubular members distally so that each of them penetrates the septum secundum and the septum primum; and

deploying said first and second suture bodies from within the first and second inner elongate tubular members respectively.

2. The method of claim 1, further comprising simultaneously penetrating at least a portion of the septal wall in different locations with the first and second inner elongate tubular members.

3. The method of claim 2, wherein the each have a distal portion, a proximal portion and a curved intermediate portions are each curved.

4. The method of claim 3, wherein the distal and proximal portions of each inner elongate member are substantially straight.

5. The method of claim 1, wherein the first and second inner elongate members are coupled together.

6. The method of claim 1, further comprising penetrating through the septal wall comprising the septum secundum and the septum primum simultaneously with the first and second inner elongate members.

7. The method of claim 6, wherein the first portion of the first and second suture bodies each comprises an anchor device.

8. The method of claim 1, further comprising deploying a first portion of a first suture body having an anchor device thereon from an inner lumen of the first inner elongate tubular member on a first side of the septal wall and deploying a first portion of a second suture body having an anchor device thereon from an inner lumen of the second inner elongate tubular member on the first side of the septal wall.

9. The method of claim 8, further comprising retracting the first and second inner elongate tubular members from the septal wall to deploy a second portion of the first and second suture bodies on a second side of the septal wall.

10. The method of claim 9, further comprising deploying a lock device on the second portion of the first suture body.

11. The method of claim 10, wherein the lock device comprises a coil-like body.

12. The method of claim 11, wherein the coil-like body is configured to compress the first and second suture bodies.

13. The method of claim 11, wherein deploying the lock device comprises pushing the coil-like body off of a distal end of the outer tubular member.

14. The method of claim 11, wherein the coil-like body comprises two or more coiled segments and is deflectable between a first configuration where each coiled segment is substantially oriented about a main axis of the body and a second configuration where at least one coiled segment is deflected to be oriented about an off axis of the body offset from the main axis.

15. The method of claim 11, wherein the coil-like body comprises a plurality of coil-like segments, the first suture body being routed between at least two coil-like segments.

16. The method of claim 15, further comprising inserting a restraining member into the coil-like body prior to delivering the lock device, wherein the restraining member increases the spacing between the at least two coil-like segments through which the first suture body is routed.

17. The method of claim 15, wherein deploying the lock device comprises removing a restraining member from the coil-like body to allow the coil-like body to introduce a relatively more tortuous path to the first suture body.

18. The method of claim 17, wherein the coil-like body is configured to compress the first suture body between the at least two coil-like segments upon removal of the restraining member.

19. The method of claim 10, wherein the lock device comprises an outer body having an inner lumen and an inner body configured to fit within the inner lumen of the outer body.

20. The method of claim 19, wherein the inner body is deformable between an expanded and a compressed configuration and biased towards the expanded configuration.

21. The method of claim 20, wherein deploying the lock device comprises removing a tubular restraining member from between the outer body and the inner body such that the inner body is free to expand and compress the first suture body against the outer body.

22. The method of claim 21, wherein the inner body is a coil-like body.

23. The method of claim 21, wherein the inner body is a stent-like body.

24. The method of claim 21, wherein deploying the lock device comprises advancing the lock device from within the inner lumen of the first elongate tubular member to allow the coil-like body to deflect from the first configuration to the second configuration.

25. The method of claim 21, wherein deploying the lock device further comprises deploying a wing member from the coil-like body, wherein the wing member is configured to anchor the first suture body.

26. The method of claim 19, wherein the outer body is deformable between an expanded and a compressed configuration and biased towards the compressed configuration.

27. The method of claim 26, wherein deploying the lock device comprises:

removing a tubular restraining member from between the outer body and the inner body such that the outer body is free to compress the first suture body against the inner body.

28. The method of claim 10, wherein the lock device comprises an inner body and an outer tubular body, the inner body being located within an inner lumen of the outer tubular body.

29. The method of claim 28, wherein deploying the lock device comprises compressing the first suture body between the inner body and the outer tubular body.

30. The method of claim 29, wherein the inner body is a deformable tubular body having an inner lumen, the inner tubular body being deformable between a first relatively flattened configuration and a second relatively unflattened configuration, the inner tubular body being biased towards the second configuration.

31. The method of claim 30, further comprising:

inserting a restraining member into the inner lumen of the inner tubular body to deform the body into the first configuration prior to deploying the lock device; and

placing the first suture body between the inner tubular body and the outer tubular body.

32. The method of claim 31, wherein deploying the lock device further comprises removing the restraining member to allow the inner body to deform to the second configuration.

33. The method of claim 31, wherein at least one of the inner tubular body and outer tubular body comprises a guide configured to maintain the first suture body in a predetermined location within the outer tubular body.

34. The method of claim 29, wherein the outer body is deformable between a first relatively flattened configuration and a second relatively unflattened configuration, the outer body being biased towards the first configuration.

35. The method of claim 34, wherein the outer tubular body is a first outer tubular body, the method further comprising:

inserting the lock device into an inner lumen of a second outer tubular body configured to maintain the first outer tubular body in the second configuration prior to deploying the lock device; and

placing the first suture body between the inner body and the first outer tubular body.

36. The method of claim 35, wherein deploying the lock device further comprises removing the second outer tubular body to allow the first outer tubular body to deform to the first configuration.

37. The method of claim 35, wherein at least one of the inner body and the first outer tubular body comprises a guide configured to maintain the first suture body in a predetermined location within the first outer tubular body.

38. The method of claim 10, wherein the lock device comprises a slotted tubular body being deformable between a first configuration where a slot is open an amount sufficient to allow passage of the first suture body therethrough and a second configuration where the slot is configured to compress the first suture body, the slotted tubular body being biased towards the second configuration.

39. The method of claim 38, further comprising compressing the tubular body to place the slot in the first configuration prior to deploying the lock device.

40. The method of claim 39, wherein the slot is oriented in a direction substantially parallel with a central axis of the tubular body.

41. The method of claim 38, wherein deploying the lock device comprises allowing the lock device to deform from the first configuration to the second configuration.

42. The method of claim 38, further comprising rotating a first end of the tubular body with respect to a second end of the tubular body to place the slot in the first configuration prior to deploying the lock device.

43. The method of claim 42, wherein the slot is oriented in a direction non-parallel to a central axis of the tubular body.

44. The method of claim 43, wherein the tubular body comprises a castellation and wherein rotating a first end of the tubular body comprises:

placing a tubular rotation member into contact with the castellation; and

rotating the tubular rotation member while in contact with the castellation.

45. The method of claim 38, wherein the slotted tubular body comprises a plurality of slots, each slot having the same orientation with respect to the tubular body.

46. The method of claim 38, wherein the slotted tubular body comprises a plurality of slots, at least two slots having different orientations with respect to the tubular body.

47. The method of claim 38, wherein the slot is oriented substantially parallel to a central axis of the tubular body.

48. The method of claim 47, wherein the slot is deflected into an inner lumen of the tubular body in the first configuration.

49. The method of claim 48, wherein deploying the lock device comprises removing a restraining member from within the slot to allow the slot to deflect from the first configuration to the second configuration.

50. The method of claim 10, wherein the lock device comprises a slotted tubular body being deformable between a first configuration where the slot is open an amount sufficient to allow the first suture body to pass therethrough relatively unimpeded and a second configuration where the slot is relatively more closed than the first configuration such that the first suture body passes through a relatively more tortuous path than in the first configuration, the deformable body being biased towards the second configuration.

51. The method of claim 50, further comprising axially stretching the lock device to place the slotted tubular body in the first configuration prior to deploying the lock device.

52. The method of claim 51, wherein deploying the lock device comprises allowing the slotted tubular body to deform to the second configuration.

53. The method of claim 10, wherein the lock device comprises a plate-like body having a deflectable arm member and an open inner portion, the arm member being configured to compress the first suture body within the open inner portion.

54. The method of claim 53, wherein the arm member is deflectable between a first configuration where the arm member lies outside a major plane of the body and the open portion is large enough to allow the first suture body to pass therethrough and a second configuration where the arm member lies substantially within the major plane of the body, the body being biased towards the second configuration.

55. The method of claim 54, wherein deploying the lock device comprises removing a restraining member from within the open portion to allow the arm member to deflect towards the second configuration.

56. The method of claim 10, wherein the lock device comprises a deformable body comprising two slots and a strut located therebetween.

57. The method of claim 56, further comprising:

routing the first suture body through each slot prior to deploying the lock device; and

deforming the deformable body to a first configuration so that the first suture body can pass through the slots.

58. The method of claim 57, wherein the deformable body is deformable between the first configuration and a second configuration where the first suture body is routed through a relatively more tortuous path, the deformable body being biased towards the second configuration.

59. The method of claim 58, wherein the deformable body is deformable between the first configuration and a second configuration where the first suture body is compressed by at least one slot.

60. The method of claim 58, wherein deploying the lock device comprises allowing the deformable body to deform from the first configuration to the second configuration.

61. The method of claim 60, further comprising removing a restraining member from within the slots to allow the deformable body to deform from the first configuration to the second configuration.

62. The method of claim 60, wherein the first inner elongate tubular member is configured to maintain the deformable body in the first configuration when the deformable body is located within the inner lumen of the first inner elongate tubular member.

63. The method of claim 60, wherein the deformable body comprises a plurality of struts, each strut being located between two slots.

64. The method of claim 63, wherein the first suture body is routed through each slot.

65. The method of claim 64, wherein the first suture body is routed on opposite sides of adjacent struts.

66. The method of claim 9, further comprising deploying the lock device on both the second portion of the first suture body and the second portion of the second suture body.

67. In a medical system for closing a patent foramen ovale, the improvement comprising:

an elongate flexible outer tubular member having a proximal and a distal end and having an inner lumen and configured for advancement through the vasculature of a patient; and

a first and a second inner elongate tubular member housed in said outer tubular member, each inner elongate tubular member having a substantially sharp extending in a distal direction and configured to pierce septal tissue in a septal wall of the heart;

wherein the first and second inner elongate tubular members are configured to be slidably housed within the inner lumen of the outer tubular member in a configuration such that the distal ends of the first and second inner elongate tubular members are in relative proximity to each other, and wherein the first and second inner elongate tubular members are configured to deflect, upon advancement from within the inner lumen, such that the distal ends of the first and second inner elongate tubular members are spaced a relatively greater distance from each other than when housed within the inner lumen, and wherein each inner elongate tubular member further has a distal portion, a proximal portion, and a non-linear intermediate portion located therebetween, wherein a longitudinal axis of each distal portion is substantially parallel to a longitudinal axis of each proximal portion.

68. The system of claim 67, wherein the first and second coupled together.

69. The system of claim 68, wherein the inner elongate members each have a distal portion, a proximal portion and a curved intermediate portions are each curved.

70. The system of claim 69, wherein the distal and proximal portions of each inner elongate member are substantially straight.

71. The system of claim 68, further comprising implantable closure devices housed within an inner lumen of the first inner elongate member and an inner lumen of the second inner elongate member, wherein the closure devices comprise a suture having an anchor device at its distal end.

72. The system of claim 71, further comprising a lock device coupled with the first and second inner elongate members, wherein the lock device is configured to be deployed over a proximal portion of the suture of implantable closure device.

73. The system of claim 72, wherein the lock device comprises a coil-like body.

74. The system of claim 67, wherein

said intermediate portion is at an angle to said proximal and distal portions.