MEDICAL DEVICE FOR MODIFICATION OF LEFT ATRIAL APPENDAGE AND RELATED SYSTEMS AND METHODS

• US 20100324588A1
• Filed: 06/17/2010
• Published: 12/23/2010
• 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., Miles, Scott D., Davis, Clark C., Linder, Richard J.
• Granted Patent: US 9,693,780 B2
• Time in Patent Office: Days
• US Class Current: 606/198
• 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 2017/00309 Cut-outs or slits
• CPC Class Codes: A61B 2017/00327 with actuating members moving in opposite directions
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/0069 with universal joint, cardan joint
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device

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 system for use in occluding an opening in the tissue of a body includes a handle, a catheter coupled with the handle and a medical device disposed within a lumen of the catheter. The medical device includes an anchor system having a plurality of anchor segments coupled with an anchor hub. The medical device further includes an occluder system having a plurality of occluder segments coupled with an occluder hub. A first actuator is configured to displace the occluder hub independent of, and relative to, the anchor hub to deploy the occluder system from a refracted state to an expanded state while the anchor system remains in a retracted state.

Claims

1. A method of modifying a left atrial appendage of a heart, the method comprising:

advancing a medical device with a catheter of a delivery system through the vasculature and into the left atrial appendage of the heart, the medical device including an occluder portion coupled to a hub and an anchor portion operably coupled to the occluder portion;

deploying the occluder portion from the delivery system within the LAA;

moving the deployed occluder portion within the LAA;

confirming a preferred position of the deployed occluder portion within the LAA;

moving the anchor portion between a retracted position and a deployed position subsequent to confirming the preferred position of the deployed occluder portion; and

engaging tissue within the LAA with the anchor portion to anchor the occluder portion in the preferred position within the LAA.

2. The method as recited in claim 1, wherein moving the anchor portion comprises moving a portion of anchor segments of the anchor portion through a bore of the hub to the deployed position so that the anchor segments engage tissue in the LAA.

3. The method as recited in claim 1, wherein moving the anchor portion comprises everting a portion of the anchor portion from the retracted position to the deployed position.

4. The method as recited in claim 1, wherein moving the anchor portion comprises rolling-out the anchor portion from the retracted position to the deployed position.

5. The method as recited in claim 1, wherein moving the anchor portion comprises inverting a portion of the anchor portion from the deployed position to the retracted position.

6. The method as recited in claim 1, wherein moving the anchor portion comprises rolling-in the anchor portion from the deployed position to the retracted position.

7. The method as recited in claim 1, wherein moving the anchor portion comprises moving engaging members that extend from anchor segments of the anchor portion between a tissue-nonengaging position and a tissue-engaging position subsequent to deploying the occluder portion.

8. The method as recited in claim 7, wherein moving the anchor portion comprises pulling an extension of the anchor segments proximally, the extension extending radially inward and proximally from adjacent the engaging members, to move the engaging members from the tissue-engaging position to the tissue-nonengaging position.

9. The method as recited in claim 7, wherein moving the anchor portion comprises pushing an extension of the anchor segments distally, the extension extending radially inward and proximally from adjacent the engaging members, to move the engaging members from the tissue-nonengaging position to the tissue-engaging position.

10. The method as recited in claim 7, wherein moving the anchor portion comprises orienting the engaging members proximally when in the tissue engaging position and orienting the engaging members distally when in the non-tissue engaging position.

11. The method as recited in claim 7, wherein moving the anchor portion comprises orienting the engaging members in a first orientation when in the tissue-engaging position and orienting the engaging members in a second orientation when in the tissue-nonengaging position.

12. The method as recited in claim 7, wherein moving the anchor portion comprises guiding the anchor segments and engaging members with a guide to maintain alignment of the anchor segments while moving the anchor portion between the refracted position and the deployed position.

13. The method as recited in claim 7, wherein engaging tissue within the LAA comprises engaging the tissue with the engaging members and biasing an inner surface of a tissue growth member of the occluder portion with the anchor segments such that the outer surface of the tissue growth member is directly contacting the tissue within the LAA.

14. The method as recited in claim 1, further comprising refracting the anchor portion to the refracted position subsequent to engaging tissue with the anchor portion.

15. The method as recited in claim 14, further comprising re-confirming a preferred position of the deployed occluder after moving the deployed occluder portion within the LAA.

16. The method as recited in claim 1, further comprising releasing the catheter from the medical device.

17. The method as recited in claim 1, further comprising withdrawing the catheter from the heart and vasculature.

18. The method as recited in claim 1, wherein confirming a preferred position comprises selecting the preferred position for the deployed occluder portion over multiple positions within the LAA.

19. The method as recited in claim 18, wherein moving the anchor portion comprises selectively anchoring the deployed occluder portion based on selecting the preferred position over multiple positions within the LAA.

20. The method as recited in claim 1, wherein moving the anchor portion comprises selectively anchoring the deployed occluder portion by selecting the preferred position for the deployed occluder portion over multiple positions within the LAA.

21. A medical device delivery system, comprising:

a medical device having an occluder portion and an anchor portion;

a catheter including tethers extending therethrough, the tethers being releaseably coupled to the medical device; and

a handle system coupled to the catheter and coupled to the tethers, the handle system including a mode switch movable between a first position and a second position, the mode switch including one or more key holes, wherein the one or more key holes, while the mode switch is in the first position, are configured to allow actuation of the anchor portion of the medical device and wherein the one or more key holes, while the mode switch is in the second position, are configured to prevent actuation of the anchor portion of the medical device.

22. The medical device delivery system of claim 21, wherein the mode switch, when in the first position, is configured to prevent release of the medical device from the tethers, and, when in the second position, is configured to enable release of the medical device from the tethers.

23. The medical device delivery system of claim 21, wherein the handle system further comprises an occluder handle portion including an occluder release slider, wherein the mode switch is secured to the occluder handle portion.

24. The medical device delivery system of claim 23, wherein the handle system further comprises a float handle portion including a float rod fixed thereto, the float rod being configured to be slidingly coupled to the occluder handle portion through one of the one or more key holes of the mode switch.

25. The medical device delivery system of claim 23, wherein the handle system further comprises an anchor handle portion including an anchor release slider and an anchor rod, the anchor rod being operatively coupled with the anchor portion of the medical device and configured to be slidingly coupled with one of the one or more key holes of the mode switch.

26. The medical device delivery system of claim 25, wherein the handle system further comprises a release enable switch coupled to the anchor handle portion and extending from a release rod, the release rod extending through the anchor handle portion and configured to extend through one of the one or more key holes of the mode switch, the release rod being coupled to the occluder release slider and the anchor release slider to enable release of the medical device.

27. The medical device delivery system of claim 21, wherein the handle system further comprises a float handle portion configured to withdraw the catheter from the medical device while the tethers maintain connection to the medical device.

28. The medical device delivery system of claim 27, wherein the float handle portion is actuatable upon the mode switch being in the second position and the anchor portion of the medical device is moved to a deployed position.

29. The medical device delivery system of claim 21, wherein the mode switch is moveable to the second position when the anchor portion of the medical device is in a deployed position.

30. The medical device delivery system of claim 29, wherein the mode switch is configured to enable release of the medical device in the second position.

31. A medical device delivery system, comprising:

a medical device having an occluder portion and an anchor portion;

a catheter including an occluder tether and an anchor tether extending therethrough, the occluder tether being releaseably coupled to the occluder portion and the anchor tether being releasably coupled to the anchor portion; and

a handle system coupled to the catheter, the handle system including;

an occluder handle portion coupled to the occluder tether;

an anchor handle portion coupled to the anchor tether;

a mode switch movable between a first position and a second position, wherein the mode switch, when in the first position, is configured to independently move the anchor portion between a deployed position and a refracted position while the occluder portion remains in a deployed state, and wherein the mode switch, when in the second position, is configured to prevent movement of the anchor portion of the medical device.

32. The medical device delivery system of claim 31, further comprising a release switch, the release switch being configured to enable substantially simultaneous release of the occluder tether and the anchor tether from the occluder portion and the anchor portion, respectively, of the medical device.

33. A medical device for modifying a left atrial appendage (“

LAA”

) of a heart, the medical device comprising;

a hub;

an occluder portion coupled to the hub and configured to be moved between an occluder-nondeployed position and an occluder-deployed position;

an anchor portion operably coupled to the occluder portion and configured to be moved, independent of movement of the occluder portion, between an anchor-nondeployed position and an anchor-deployed position while the occluder portion is in the occluder-deployed position;

wherein the medical device is configured to be moveable throughout the LAA while the occluder portion is in the occluder-deployed position and the anchor portion is in the anchor-nondeployed position, to multiple different positions within the LAA, to determine a preferred position for selective anchoring of the occluder portion at the preferred position within the LAA.