Medical device for modification of left atrial appendage and related systems and methods

• US 10,631,969 B2
• Filed: 02/21/2017
• Issued: 04/28/2020
• Est. Priority Date: 06/17/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Edmiston, Daryl R., Davis, Clark C., Miles, Scott D.
• Primary Examiner(s): Louis, Richard G
• Application Number:
  US15/438,650
• Publication Number:
  US 20170156840A1
• Time in Patent Office: 1,162 Days
• 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 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00597 Implements comprising a membrane
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00942 hydrophilic
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 5/007 for contrast media

Abstract

Devices, methods and systems are provided for occluding an opening within the tissue of a body, such as a left atrial appendage. In one embodiment, a medical device includes an occluder portion and an anchor portion. The occluder portion includes a hub that defines an axis, the occluder portion extending between a proximal end coupled to the hub and a distal end defining an occluder eyelet adjacent thereto. The anchor portion extends between a first end and a second end, the first end coupled to an anchor hub and the second end defining an anchor eyelet adjacent thereto and hingeably coupled to the occluder eyelet. With this arrangement, the anchor hub is moveable along the axis to move the anchor portion between a retracted position and a deployed position upon the occluder portion being in an expanded position.

Claims

1. A medical device for implantation in a left atrial appendage of a heart, the medical device comprising:

an occluder portion having a hub and defining an axis, the occluder portion extending between a proximal end coupled to the hub and a distal end defining an occluder eyelet adjacent thereto; and

an anchor portion extending between a first end and a second end, the first end coupled to an anchor hub and the second end defining an anchor eyelet adjacent thereto and hingeably coupled to the occluder eyelet;

wherein the anchor hub is moveable along the axis relative to the hub to move the anchor portion between a retracted position and a deployed position upon the occluder portion being in an expanded position.

2. The medical device of claim 1, wherein the anchor portion extends with anchor frame segments, the anchor frame segments including anchoring tines extending therefrom.

3. The medical device of claim 2, wherein the anchoring tines extend with an acute angle relative to the anchor frame segments, the acute angle having a range between about 25 degrees and about 60 degrees.

4. The medical device of claim 2, wherein the anchoring tines extend with a height relative to the anchor frame segments, the height having a range between about 0.020 inches and about 0.050 inches.

5. The medical device of claim 2, wherein the anchoring tines extending from a single strut of the anchor frame segments are spaced a distance from adjacent tines within a range between about 0.060 inches and 0.015 inches.

6. The medical device of claim 1, wherein the anchor frame segments comprise anchoring tines aligned with and extending from struts defining the anchor frame segments, the struts being non-aligned relative to the axis.

7. A medical device for implantation in a left atrial appendage of a heart, the medical device comprising:

a framework having a proximal end and a distal end and defining an axis, the framework extending between a primary hub and a secondary hub, the primary hub and the secondary hub aligned along the axis of the framework, the primary hub extending distally relative to the proximal end of the framework to a primary hub distal end, the framework extending radially outward and distally relative to the primary hub and extending radially inward and proximally toward the secondary hub such that the secondary hub is positioned proximal the distal end of the framework; and

a polymeric member positioned along a proximal side of the framework so as to extend to a polymeric member distal end, wherein the primary hub distal end is positioned proximal the polymeric member distal end.

8. The medical device of claim 7, wherein the framework comprises anchoring tines extending therefrom.

9. The medical device of claim 8, wherein the anchoring tines extend with an acute angle relative to struts of the framework, the acute angle having a range between about 25 degrees and about 60 degrees.

10. The medical device of claim 8, wherein the anchoring tines extend with a height relative to struts of the framework, the height having a range between about 0.020 inches and about 0.050 inches.

11. The medical device of claim 8, wherein the anchoring tines extending from a given strut of the framework are spaced a distance from adjacent tines within a range between about 0.060 inches and 0.015 inches.

12. The medical device of claim 7, wherein the framework comprises anchoring tines aligned with and extending from struts of the framework, the struts being non-aligned relative to the axis.

13. The medical device of claim 7, wherein the framework comprises occluder frame segments and anchor frame segments, the anchor frame segments hingeably coupled to the occluder frame segments.

14. The medical device of claim 13, wherein the anchor frame segments are moveable between a retracted position and a deployed position upon the occluder frame segments being in an expanded position.

15. The medical device of claim 7, wherein the polymeric member is directly coupled to the proximal side of the framework.

16. The medical device of claim 7, wherein the polymeric member comprises at least one of a fabric material and ePTFE.

17. The medical device of claim 16, wherein the polymeric member comprises a hydrophilic coating.

18. A method for occluding a left atrial appendage, the method comprising:

positioning a framework within the left atrial appendage, the framework having a proximal end and a distal end and defining an axis, the framework extending between a primary hub and a secondary hub, the primary hub and the secondary hub aligned along the axis of the framework, the framework extending radially outward and distally relative to the primary hub and extending radially inward and proximally toward the secondary hub such that the secondary hub is positioned proximal the distal end of the framework; and

permanently implanting the framework in the left atrial appendage.

19. The method according to claim 18, further comprising securing the framework to tissue within the left atrial appendage with anchoring tines extending from the framework.

20. The method according to claim 18, further comprising pivoting anchor frame segments of the framework between a retracted position and a deployed position.