Methods, systems and devices for reducing the size of an internal tissue opening

• US 8,167,894 B2
• Filed: 08/08/2007
• Issued: 05/01/2012
• Est. Priority Date: 08/09/2006
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Miles, Scott D., Davis, Clark C., Fox, DeWayne C., Edmiston, Daryl R., Linder, Richard J.
• Primary Examiner(s): McDermott, Corrine M
• Assistant Examiner(s): MASHACK, MARK F
• Application Number:
  US11/836,123
• Publication Number:
  US 20080119891A1
• Time in Patent Office: 1,728 Days
• Field of Search: 606/213, 606/139, 606/142, 606/151, 606/200, 623/1.11, 623/1.23
• US Class Current: 606/139
• 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 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00084 Temperature
• CPC Class Codes: A61B 2017/00407 Ratchet means
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00579 Barbed implements
• CPC Class Codes: A61B 2017/00588 Rigid or stiff implements, e.g. made of several rigid parts linked by hinges
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00601 Implements entirely comprised between the two sides of the opening
• 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 2017/0061 Implements located only on one side of the opening
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00623 Introducing or retrieving devices therefor
• CPC Class Codes: A61B 2017/00654 entirely comprised between the two sides of the opening
• CPC Class Codes: A61B 2017/00858 high friction, non-slip on handles A61B2017/00429
• CPC Class Codes: A61B 2017/00862 elastic or resilient for sutures A61B2017/0618
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/00884 : enhancing wound closure
• CPC Class Codes: A61B 2017/12054 : Details concerning the detachment of the occluding device from the introduction device

Abstract

A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a multi-cellular body portion operatively associated with a first anchor and a second anchor. The closure device can be configured to apply lateral force to tissue of the internal tissue opening for tissue approximation. The closure device can have a substantially flat aspect, and have a depth that is substantially greater than the thickness of a majority of the members forming the closure device. The closure device can also include an in-growth material. The delivery device can include an actuating assembly configured to partially deploy the closure device by a first movement, and deploy a second portion of the closure device by a second movement. The delivery device can also include a release assembly to selectively release or disconnect the closure device from the delivery device.

Claims

1. A system for treating a hole defined in a tissue structure between a left atrium and a right atrium of a heart, the hole defining an axis oriented axially through the hole, the system comprising:

a handle body;

a catheter coupled to said handle body;

a tip portion extending from a distal end of said catheter;

a tether system coupled to said handle body and extending through said catheter, said tether system including a first tether and a second tether, the first and second tethers each including a coil defining a lumen with a first wire and a second wire each extending through the lumen of the coil; and

a medical device including a frame, said frame configured to assume a substantially flat configuration oriented substantially parallel to, or extending substantially along, the axis of the hole while in an intended, as-deployed state within the tissue structure, said frame including a central portion with at least a distal anchor and a first proximal anchor and a second proximal anchor extending from said central portion, each of said distal anchor, said first proximal anchor and said second proximal anchor configured to extend substantially coplanar with said central portion, said distal anchor configured to extend in the left atrium and said first and second proximal anchors configured to extend in the right atrium, said first proximal anchor configured to be directly coupled to said first tether and said second proximal anchor configured to be directly coupled to said second tether, said first and second proximal anchors configured to deflect proximally and continually extend substantially coplanar with said central portion as the tip portion moves distally over the first and second tethers toward the first and second proximal anchors;

wherein the second wire includes a loop and the first wire is configured to engage with the loop of the second wire to couple the medical device and maintain the medical device taut against the coil.

2. The system of claim 1, wherein said distal anchor, said first proximal anchor and said second proximal anchor are maintained substantially coplanar with said central portion in a non-deployed, constricted state within said tip portion of said catheter.

3. The system of claim 1, wherein said tether system further comprises a third tether, said third tether directly coupled to said central portion to facilitate moving said medical device between a constricted configuration and an expanded configuration.

4. The system of claim 3, wherein said first tether and said second tether are configured to facilitate deflection of said first and second proximal anchors in a proximal direction when moving said medical device from a deployed configuration to an undeployed configuration within said tip portion such that said first proximal anchor and said second proximal anchor enter said tip portion before said central portion enters said tip portion.

5. The system of claim 1, wherein said first and second proximal anchors and said central portion maintain said substantially flat configuration when moving said medical device between a deployed configuration and an undeployed configuration.

6. The system of claim 1, wherein the medical device comprises a tissue growth promoting member attached to said frame.

7. The system of claim 6, wherein said tissue growth promoting member is attached to said frame such that said tissue growth promoting member extends substantially out of plane relative to said substantially flat configuration of said frame.

8. The system of claim 1, wherein said medical device comprises a tissue growth promoting member attached to said frame, said tissue growth promoting member including a length dimension, a width dimension and a height dimension, the length dimension and the height dimension configured to extend substantially transverse to the axis of the hole and the width dimension configured to have at least one portion extending substantially parallel to the axis of the hole, the height dimension of the tissue growth promoting member configured to extend substantially out of plane relative to said substantially flat configuration of said frame, and the length dimension and the height dimension being substantially different from one another.

9. The system of claim 8, wherein the width dimension is smaller than the height dimension.

10. The system of claim 1, wherein said medical device comprises a tissue growth promoting member attached to said frame, said tissue growth promoting member having an elongated structure configured to be oriented substantially transverse to the axis of the hole and configured to be oriented across a width of the hole, said elongated structure having a height dimension configured to extend substantially out of plane relative to said substantially flat configuration of said frame to be in contact with the tissue structure.

11. The system of claim 1, wherein said medical device comprises a tissue growth promoting member attached to said frame, said tissue growth promoting member comprises a polyurethane foam.

12. The system of claim 1, wherein said medical device comprises a tissue growth member having an elongated structure, the elongated structure configured to be oriented on the medical device so as to be transverse to the axis of the hole and extend across an entire width of the hole in the tissue structure.

13. The system of claim 1, wherein the first proximal anchor and the second proximal anchor each define an eyelet, each eyelet configured to receive the loop of the second wire with the first wire extending through the loop to facilitate a locking arrangement between the tether system and the medical device.

14. The system of claim 1, wherein the loop of the second wire extends through an aperture defined in the medical device.

15. The system of claim 1, wherein the coil comprises a polymeric material formed thereon.

16. The system of claim 1, wherein, upon release of the medical device from the first and second tethers, the first wire is configured to be moved from the loop of the second wire.

17. The system of claim 1, wherein the coil is configured to effectively push the medical device to move the medical device from a constricted state within the tip portion to the intended, as deployed state.

18. The system of claim 1, wherein the first wire and the second wire are configured to effectively pull the medical device to move the medical device from the deployed state to a constricted state within the tip portion.