Systems and Methods for Treating Septal Defects with Capture Devices and Other Devices

• US 20080154286A1
• Filed: 12/21/2006
• Published: 06/26/2008
• Est. Priority Date: 12/21/2006
• Status: Abandoned Application

• Current Assignee: Ovalis, Inc.
• Original Assignee: Ovalis, Inc.
• Inventors: Belef, W. Martin, Jabba, Ronald J., Moore, David, Abbott, Ryan, Carson, Dean, Nielsen, James
• Application Number:
  US11/614,814
• Publication Number:
  US 20080154286A1
• Time in Patent Office: Days
• US Class Current: 606/139
• 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 17/0467 Instruments for cutting sutures surgical cutting instruments A61B17/32
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/0483 Hand-held instruments for holding sutures A61B17/0469 takes precedence; other holders for needles or sutures A61B17/06061; surgical forceps A61B17/28; surgical pincettes A61B17/30
• CPC Class Codes: A61B 17/0485 Devices or means, e.g. loops, for capturing the suture thread and threading it through an opening of a suturing instrument or needle eyelet
• CPC Class Codes: A61B 17/0487 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 17/0625 the needle being specially adapted to interact with the manipulator, e.g. being ridged to snap fit in a hole of the manipulator A61B17/06109 takes precedence
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/0404 Buttons
• 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 2017/0472 Multiple-needled, e.g. double-needled, instruments
• CPC Class Codes: A61B 2017/0608 J-shaped
• CPC Class Codes: A61B 2017/06095 pliable
• CPC Class Codes: A61B 2017/06176 with protrusions, e.g. barbs

Abstract

Systems, devices and methods for treating internal tissue defects, such as septal defects, are provided. An exemplary method of treating an internal tissue defect, specifically a method of closing a patent foramen ovale (PFO), can include passing a closure element from a right atrium through a septal wall in a first location and into the left atrium. A capture device, which can be configured as a snare-like device, can be used to capture the closure element in the left atrium and pull the closure element back through the septal wall in a different, second location, such that the closure element is routed over the PFO. The closure element can then be anchored and/or locked against the septal wall such that the PFO is at least partially closed.

Claims

1. A method for treating a patent foramen ovale (PFO), comprising:

passing a first portion of a closure element from a first atrium of a subject through a first opening in a septal wall into a second atrium of the subject;

capturing the first portion of the closure element with a capture device;

passing the first portion of the closure element from the second atrium through a second opening in the septal wall into the first atrium; and

at least partially closing the PFO with the closure element.

2. The method of claim 1, wherein the capture device comprises an elongate, flexible body, the method further comprising:

inserting a first elongate tubular member having a substantially sharp distal end and an inner lumen through the septal wall to create the second opening prior to capturing the closure element, wherein the inner lumen of the first elongate tubular member has an open distal end and is configured to slidably receive the capture device.

3. The method of claim 2, wherein the capture device is a snare-like device, the method further comprising:

advancing a looped portion of the snare-like device distally through the open distal end, the looped portion being configured to capture the closure element.

4. The method of claim 3, wherein the looped portion of the snare-like device is deformable between a closed configuration and an open configuration and biased towards the open configuration.

5. The method of claim 4, wherein the looped portion transitions from the closed configuration to the open configuration upon advancement of the looped portion through the open distal end of the elongate tubular member.

6. The method of claim 5, wherein the looped portion deflects from a substantially undeflected position into a position substantially parallel with the septal wall upon advancement of the looped portion through the open distal end.

7. The method of claim 6, wherein the looped portion comprises a distal wedge-shaped catch portion and a proximal tapered portion.

8. The method of claim 7, wherein the surface of the wedge-shaped catch portion is textured.

9. The method of claim 7, wherein the proximal tapered portion is configured to facilitate transition of the looped portion from the open configuration to the closed configuration.

10. The method of claim 6, wherein the snare body in the looped portion is coiled.

11. The method of claim 6, wherein passing the first portion of the closure element from the first atrium of the subject through the first opening in the septal wall into a second atrium of the subject comprises:

inserting a second elongate tubular member having an open, substantially sharp distal end and an inner lumen through the septal wall to create the first opening, wherein the inner lumen of the second elongate tubular member is configured to house the closure element.

12. The method of claim 11, further comprising:

advancing the first portion of the closure element from within the inner lumen of the second elongate member such that at least part of the first portion of the closure element is within the looped portion of the snare-like device.

13. The method of claim 12, wherein capturing the first portion of the closure element with the snare-like device comprises proximally retracting the snare-like device such that the looped portion deflects back to the substantially undeflected position and captures the first portion of the closure element.

14. The method of claim 13, wherein capturing the first portion of the closure element with the snare-like device further comprises proximally retracting the snare-like device such that the looped portion transitions back to the closed configuration.

15. The method of claim 13, wherein capturing the first portion of the closure element with the snare-like device further comprises distally advancing a collet over the looped portion of the snare-like device such that the looped portion transitions back to the closed configuration.

16. The method of claim 14, wherein passing the first portion of the closure element from the second atrium through the second opening in the septal wall into the first atrium comprises proximally retracting the snare-like device and first elongate member from the second atrium through the second opening in the septal wall into the first atrium with the captured first portion of the closure element.

17. The method of claim 16, further comprising:

releasing a proximal end of the closure element from the second elongate member, the proximal end comprising an anchor device, and proximally retracting the snare-like device to at least partially close the tunnel.

18. The method of claim 17, further comprising:

placing a lock device over the part of the first portion of the closure element exposed in the first atrium.

19. The method of claim 18, further comprising:

placing a lock device over the part of the first portion of the closure element exposed in the first atrium and a second portion of the closure element extending between the second elongate member and the first opening.

20. The method of claim 11, further comprising:

positioning the first and second elongate members in an off-axis orientation prior to inserting the first and second elongate members through the septal wall.

21. The method of claim 20, wherein the first elongate tubular member is slidably disposed within an inner lumen of a third elongate tubular member having an open distal end and the second elongate tubular member is slidably disposed within an inner lumen of a fourth elongate tubular member having an open distal end, the third and fourth elongate tubular members being slidably disposed within an inner lumen of an elongate body member having an open distal end.

22. The method of claim 21, wherein the distal ends of the third and fourth elongate members are coupled to an orientation device that is coupled to an elongate support portion of the body member.

23. The method of claim 22, wherein positioning the first and second elongate members in an off-axis orientation comprises distally advancing the third and fourth elongate members such that the orientation device moves the distal ends of the third and fourth elongate members apart.

24. The method of claim 22, wherein positioning the first and second elongate members in an off-axis orientation comprises distally advancing the third and fourth elongate members such that the orientation device moves the distal ends of the third and fourth elongate members apart and faces the distal ends of the third and fourth elongate members towards the septal wall.

25. The method of claim 24, wherein the orientation device comprises at least one pivot member coupled with the third elongate member by way of a first arm member and the fourth elongate member by way of a second arm member.

26. The method of claim 1, wherein the closure element comprises a distal end configured to facilitate capture by the capture device.

27. The method of claim 26, wherein the distal end of the closure element is curved.

28. The method of claim 26, wherein the distal end of the closure element is bent.

29. The method of claim 1, wherein a distal portion of the closure element is configured to facilitate capture by the capture device.

30. The method of claim 29, wherein the distal portion of the closure element comprises a plurality of protrusions.

31. The method of claim 29, wherein the plurality of protrusions are located at different positions along the length of the closure element.

32. The method of claim 29, wherein the distal portion of the closure element is configured in a serpentine-like manner.

33. The method of claim 29, wherein the distal portion of the closure element is configured in a coil-like manner.

34. The method of claim 29, wherein the distal portion of the closure element is configured in a sawtooth-like manner.

35. The method of claim 29, wherein the closure element is configured as a suture.

36. The method of claim 1, wherein the closure element has a substantially sharp distal end and wherein passing the first portion of the closure element from the first atrium of the subject through the first opening in the septal wall into a second atrium of the subject comprises:

inserting the distal end of the closure element through the septal wall to create the first opening.

37. The method of claim 36, wherein the capture device has a substantially sharp distal end and wherein passing the first portion of the closure element from the second atrium through the second opening in the septal wall into the first atrium comprises:

inserting the distal end of the capture device through the septal wall to create the second opening.

38. The method of claim 1, wherein the capture device has a substantially sharp distal end and wherein passing the first portion of the closure element from the second atrium through the second opening in the septal wall into the first atrium comprises:

inserting the distal end of the capture device through the septal wall to create the second opening.

39. The method of claim 1, wherein the capture device comprises an elongate, flexible body, the method further comprising:

inserting a first elongate tubular member having a substantially sharp distal end and an inner lumen through the septal wall to create the second opening prior to passing a first portion of a closure element from the first atrium of the subject through a first opening in a septal wall into the second atrium of the subject, wherein the inner lumen of the first elongate tubular member has an open distal end and is configured to slidably receive the capture device.

40. The method of claim 39, wherein the first elongate tubular member is advanced through the second opening while contained within the inner lumen of an outer tubular member having an open distal end.

41. The method of claim 39, wherein a distal portion of the first elongate tubular member is deformable between a substantially straight configuration and a curved configuration.

42. The method of claim 40, wherein the distal portion of the first elongate tubular member is biased towards the curved configuration.

43. The method of claim 42, further comprising:

advancing the first elongate member through the open distal end of the outer tubular member to allow the distal portion of the first elongate member to transition to the curved configuration.

44. The method of claim 43, further comprising:

proximally retracting the first elongate member while in the curved configuration to create the first opening in the septal wall.

45. The method of claim 44, wherein capturing the closure element occurs prior to passing the first portion of the closure element through the septal wall.

46. The method of claim 45, wherein the capture device is a snare-like device, the method further comprising:

advancing a looped portion of the snare-like device distally through the open distal end of the first elongate member prior to passing the first portion of the closure element through the first opening, the looped portion being configured to capture the closure element.

47. The method of claim 46, further comprising advancing the first portion of the closure element through an open distal end of a second elongate tubular member having an inner lumen, wherein the first portion of the closure element is positioned to allow capture by the snare-like device.

48. The method of claim 47, wherein passing a first portion of a closure element from a first atrium of a subject through a first opening in a septal wall into a second atrium of the subject comprises:

proximally retracting the looped portion of the snare-like device into the inner lumen of the first elongate member after capturing the closure element in the looped portion; and

distally advancing the first elongate member through the first opening into the second atrium with the captured first portion of the closure element.

49. The method of claim 48, wherein passing at least a part of the first portion of the closure element from the second atrium through the second opening in the septal wall into the first atrium comprises:

proximally retracting the first elongate member into the inner lumen of the outer tubular member such that the curved distal portion of the first elongate member transitions back to the substantially straight configuration; and

proximally retracting the first elongate member and outer tubular member back through the second opening into the first atrium with the captured first portion of the closure element.

50. The method of claim 49, further comprising:

releasing a proximal end of the closure element from the second elongate member, the proximal end comprising an anchor device, and proximally retracting the snare-like device to at least partially close the tunnel.

51. The method of claim 50, further comprising:

placing a lock device over the part of the first portion of the closure element exposed in the first atrium.

52. The method of claim 49, further comprising:

placing a lock device over the part of the first portion of the closure element exposed in the first atrium and a second portion of the closure element extending between the second elongate member and the first opening.

53. The method of claim 1, wherein the first atrium is a right atrium and the second atrium is a left atrium.

54. The method of claim 1, wherein the first atrium is a left atrium and the second atrium is a right atrium.

55. The method of claim 1, wherein at least partially closing the PFO with the closure element comprises closing the PFO to a degree that prevents a substantial amount of blood from passing through the PFO.