Systems and methods for treating septal defects

• US 7,678,132 B2
• Filed: 06/07/2006
• Issued: 03/16/2010
• Est. Priority Date: 09/06/2001
• Status: Expired due to Fees

• Current Assignee: Promed, Inc.
• Original Assignee: Ovalis, Inc.
• Inventors: Belef, W. Martin, Doshi, Rajiv, Jabba, Ronald J., Abbott, Ryan, Carson, Dean
• Primary Examiner(s): Manahan; Todd E
• Assistant Examiner(s): Bachman; Lindsey
• Application Number:
  US11/422,864
• Publication Number:
  US 20060217763A1
• Time in Patent Office: 1,378 Days
• Field of Search: 606/139, 606/151, 606/213, 606/215, 606/142, 606/153, 623/23.72
• US Class Current: 606/215
• 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 17/064 Surgical staples, i.e. penetrating the tissue
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• 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 2017/0649 Coils or spirals
• CPC Class Codes: A61B 2017/22047 Means for immobilising the guide wire in the patient
• CPC Class Codes: A61B 2017/2926 Details of heads or jaws
• CPC Class Codes: A61B 2017/306 holding by means of suction

Abstract

A system for treating a septal defect having an implantable treatment apparatus and devices for delivering the implantable treatment apparatus and methods for treating a septal defect are provided. The implantable treatment 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 implantable apparatus, a stabilization device configured to stabilize the body member and a positioning device configured to position the delivery device in a desired location.

Claims

1. A method of treating a patent foramen ovale in septal tissue of a septal wall with a treatment system, the patent foramen ovale defined by a septum primum and a septum secundum with a tunnel separating them, and the treatment system comprising an elongate body member, an elongate delivery device, and a grasping device comprising a rigid arm-like member with a first end pivotally coupled with the body member and a second end pivotally coupled with the delivery device by way of a hinge, wherein the body member comprises an elongate open channel extending along a length of the side of the body member proximal to the hinge, the elongate open channel being configured to receive a side of the delivery device, and the body member further comprises a lumen having an open distal end located proximal to the elongate open channel, the delivery device being slidably housed within the lumen, wherein the body member and the delivery device are each configured for insertion into the vasculature, the method comprising:

moving the delivery device with respect to the body member to cause the arm-like member to pivot and move a distal region of the delivery device relatively further away from the body member;

grasping opposite sides of the septum secundum with opposing surfaces of the grasping device such that the opposing surfaces are each in contact with an opposite side of the septum secundum, the opposing surfaces being non-releasably coupled to a delivery device, wherein a first one of the opposing surfaces is located on the arm-like member;

piercing a hole in the septum secundum and septum primum, with a needle having a lumen which houses a closure device, while grasping the septum secundum; and

deploying the closure device such that a first end of the closure device is in contact with the septum primum and a second end of the closure device is in contact with the septum secundum.

2. The method of claim 1, wherein the closure device is an implantable device configured to at least partially close the tunnel between the septum secundum and a septum primum.

3. The method of claim 2, further comprising delivering the implantable device through the hole.

4. The method of claim 1, further comprising moving the delivery device with respect to the body member to position an open distal end of the delivery device in proximity with the septal wall before piercing the hole.

5. The method of claim 4, wherein piercing the hole in the septum secundum comprises advancing the needle member out of the delivery device through the open distal end of the delivery device.

6. The method of claim 1, wherein grasping the septum secundum comprises compressing the septum secundum between the opposing surfaces.

7. The method of claim 1, wherein the hole is located in the septal wall in a location adjacent the patent foramen ovale tunnel.

8. The method of claim 1, wherein the hole is created at a predetermined distance from the limbus.

9. The method of claim 8, wherein the hole is centered with respect to a first and second sidewall of a patent foramen ovale tunnel.

10. The method of claim 1, wherein a second one of the opposing surfaces is located on the body member.

11. The method of claim 1, wherein the delivery device is pivotally coupled directly to the arm-like member.

12. The method of claim 1, wherein a second opposing surface is located on a flexible, elongate member slidably coupled with the body member.

13. The method of claim 1, wherein the delivery device comprises a rigid tubular distal tip, and wherein the second end of the arm-like member is pivotally coupled with the rigid tubular distal tip of the delivery device by way of the hinge.

14. The method of claim 1, further comprising, after moving the delivery device with respect to the body member and prior to grasping opposite sides of the septum secundum, bringing the arm-like member into contact with the septum secundum.

15. The method of claim 14, wherein the arm-like member is brought into contact with the limbus of the septum secundum.

16. The method of claim 14, further comprising, after bringing the arm-like member into contact with the septum secundum, distally advancing the delivery device with respect to the body member to grasp the septum secundum between the arm-like member and a second opposing surface.

17. The method of claim 16, further comprising, after distally advancing the delivery device with respect to the body member to grasp the septum secundum and prior to piercing a hole in the septum secundum and septum primum, distally advancing the delivery device further with respect to the body member to cause at least a portion of the distal region of the delivery device to arc outwards away from the body member.

18. The method of claim 17, wherein distally advancing the delivery device further with respect to the body member causes an open distal end of the delivery device to rotate about the hinge.

19. The method of claim 18, wherein distally advancing the delivery device further with respect to the body member causes the open distal end of the delivery device to rotate about the hinge such that the open distal end is brought into an orientation that faces the septum secundum.

20. The method of claim 18, wherein distally advancing the delivery device further with respect to the body member causes the open distal end of the delivery device to rotate with respect to the arm member about the hinge such that the needle can be advanced along an axis normal to a right atrial surface of the septum secundum.

21. The method of claim 17, wherein, prior to moving the delivery device with respect to the body member to cause the arm-like member to pivot and move a distal region of the delivery device relatively further away from the body member, a longitudinal axis of the distal region of the delivery device, measured at the distal end of the delivery device, is substantially parallel to a longitudinal axis of a distal region of the body member and is not substantially parallel to an axis normal to the surface of the septum secundum.

22. The method of claim 21, wherein distally advancing the delivery device further with respect to the body member to cause the distal region of the delivery device to arc outwards away from the body member also causes the longitudinal axis of the distal region of the delivery device to move transverse to the longitudinal axis of the distal region of the body member.

23. The method of claim 21, wherein distally advancing the delivery device further with respect to the body member to cause the distal region of the delivery device to arc outwards away from the body member also causes the longitudinal axis of the distal region of the delivery device to move approximately perpendicular to the longitudinal axis of the distal region of the body member.

24. The method of claim 21, wherein distally advancing the delivery device further with respect to the body member to cause the distal region of the delivery device to arc outwards away from the body member also causes the longitudinal axis of the distal region of the delivery device to move substantially parallel to an axis normal to the surface of the septum secundum.