Systems and methods for treating septal defects

• US 8,758,401 B2
• Filed: 09/30/2011
• Issued: 06/24/2014
• Est. Priority Date: 09/06/2001
• Status: Expired due to Fees

• Current Assignee: Promed, Inc.
• Original Assignee: Promed, Inc.
• Inventors: Abbott, Ryan, Belef, W. Martin, Carson, Dean, Doshi, Rajiv, Jabba, Ronald J.
• Primary Examiner(s): Erezo, Darwin
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US13/250,671
• Publication Number:
  US 20120022587A1
• Time in Patent Office: 998 Days
• Field of Search: 606/213, 606/139, 606/142, 606/143, 606/151, 606/185, 606/215
• US Class Current: 606/213
• 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, the patent foramen ovale defined by a septum primum and a septum secundum with a tunnel separating them, comprising:

moving an elongate delivery device with respect to an elongate body member to position an open distal end of the elongate delivery device in proximity with the septal wall, wherein a grasping device is coupled with the elongate body member and the elongate delivery device, the elongate body member and elongate delivery device each being configured for insertion into the vasculature;

grasping opposite sides of the septum secundum with opposing members of a grasping device such that the opposing members are each in contact with an opposite side of the septum secundum, the opposing members being pivotally coupled together and being non-releasably coupled to the elongate delivery device, wherein a first one of the opposing members is a rigid arm-like member having a first end pivotally coupled with the elongate body member and a second end pivotally coupled with the elongate delivery device;

creating a hole through 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 through the hole 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 to at least partially close the tunnel.

2. The method of claim 1, wherein a second one of the opposing members is the elongate body member.

3. The method of claim 1, wherein the opposing members are pivotally coupled together with a hinge.

4. The method of claim 3, wherein the elongate 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 elongate delivery device by way of the hinge.

5. The method of claim 3, wherein the elongate body member comprises an elongate open channel extending along a length of the side of the elongate body member proximal to the hinge, the elongate open channel being configured to receive a side of the elongate delivery device.

6. The method of claim 5, wherein the elongate body member comprises a lumen having an open distal end located proximal to the elongate open channel, the elongate delivery device being slidably housed within the lumen.

7. The method of claim 1, further comprising, prior to grasping opposite sides of the septum secundum, moving the elongate delivery device with respect to the elongate body member to cause the arm-like member to pivot and move a distal region of the elongate delivery device relatively further away from the elongate body member.

8. The method of claim 3, wherein grasping opposite sides of the septum secundum comprises distally advancing the elongate delivery device with respect to the elongate body member such that at least a portion of a distal region of the elongate delivery device arcs outward away from the elongate body member and such that the septum secundum is grasped between the arm-like member and a second one of the opposing members.

9. The method of claim 8, wherein distally advancing the elongate delivery device with respect to the elongate body member causes the open distal end of the elongate delivery device to rotate about the hinge such that the open distal end is brought into an orientation that faces the septum secundum.

10. The method of claim 8, wherein distally advancing the elongate delivery device with respect to the elongate body member causes the open distal end of the elongate 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.

11. The method of claim 8, wherein, prior to moving the elongate delivery device with respect to the elongate body member to cause the arm-like member to pivot and move the distal region of the delivery device further away from the elongate body member, a longitudinal axis of the distal region of the elongate delivery device, measured at the distal end of the elongate delivery device, is substantially parallel to a longitudinal axis of a distal region of the elongate body member and is not substantially parallel to an axis normal to the surface of the septum secundum.

12. The method of claim 11, wherein distally advancing the elongate delivery device further with respect to the elongate body member to cause the distal region of the elongate delivery device to arc outwards away from the elongate body member also causes the longitudinal axis of the distal region of the elongate delivery device to move transverse to the longitudinal axis of the distal region of the elongate body member.

13. The method of claim 11, 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.

14. The method of claim 11, wherein distally advancing the elongate delivery device further with respect to the elongate body member to cause the distal region of the elongate delivery device to arc outwards away from the elongate body member also causes the longitudinal axis of the distal region of the elongate delivery device to move substantially parallel to an axis normal to the surface of the septum secundum.

15. The method of claim 1, further comprising:

expanding a centering device within the tunnel; and

centering the needle with respect to a first and second sidewall of the tunnel prior to creating the hole.