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

• US 9,883,864 B2
• Filed: 06/17/2010
• Issued: 02/06/2018
• Est. Priority Date: 06/17/2009
• Status: Active Grant

• Current Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Original Assignee: Coherex Medical, Inc. (Johnson & Johnson)
• Inventors: Miles, Scott D., Davis, Clark C., Edmiston, Daryl R., Linder, Richard J.
• Primary Examiner(s): LOUIS, RICHARD G
• Application Number:
  US12/818,041
• Publication Number:
  US 20100324585A1
• Time in Patent Office: 2,791 Days
• Field of Search: 606200, 606213, 606215
• 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 retracted state to an expanded state while the anchor system remains in a retracted state.

Claims

1. A medical device system for implantation within a left atrial appendage (“

LAA”

) of a heart, the medical device system comprising;

a delivery device having an elongated body extending to a delivery device distal end, the delivery device configured to deliver a medical device releasably coupled adjacent the delivery device distal end, the medical device including;

an occluder portion having a hub defining an axis, the occluder portion including a proximal end and a distal end, the hub extending distally from the proximal end of the occluder portion to a hub distal end, the hub distal end being proximal the distal end of the occluder portion; and

an anchor portion including multiple anchor segments with anchoring tines extending therefrom, the multiple anchor segments extending between a first end and a second end, the first end operably coupled to the occluder portion and the second end coupled to an anchor hub, the anchor hub moveable along the axis relative to the hub such that a portion of the anchor portion is configured to be displaceable through the hub between a retracted position and a deployed position of the anchor portion, wherein, in the deployed position, the anchoring tines are sized to secure the anchor portion to the tissue within the LAA.

2. The medical device system of claim 1, wherein each of the multiple anchor segments comprise a loop portion between the first end and the second end, the loop portion being sized and configured to expand and engage the LAA.

3. The medical device system of claim 1, wherein the proximal end of the occluder portion is coupled with the hub.

4. The medical device system of claim 3, wherein the first end of the multiple anchor segments is coupled to the hub and the second end of each of the multiple anchor segments are coupled together at the anchor hub.

5. The medical device system of claim 3, wherein the anchor portion is coupled to the occluder portion by way of the hub.

6. The medical device system of claim 1, wherein the occluder portion comprises a tissue growth member extending between the proximal end and the distal end of the occluder portion.

7. The medical device system of claim 6, wherein the tissue growth member comprises at least one of foam material and ePTFE.

8. A medical device system for implantation within a left atrial appendage of a heart, comprising:

a delivery device having an elongated body extending to a delivery device distal end, the delivery device configured to deliver a medical device releasably coupled adjacent the delivery device distal end, the medical device including;

an occluder portion including a plurality of occluder segments coupled to a primary hub defining an axis, the primary hub extending distally from a proximal end of the occluder portion to a hub distal end, the hub distal end being proximal a distal end of the occluder portion; and

an anchor portion including a plurality of anchor segments extending between a first end and a second end, the first end operably coupled to the primary hub and the second end coupled to an anchor hub, at least one of the anchor segments including one or more anchoring tines extending therefrom, the one or more anchoring tines sized to secure the anchor portion to the tissue within the left atrial appendage;

wherein the anchor hub is displaceable along the axis independent of, and relative to, the primary hub to deploy the anchor segments from a retracted-anchor state to an expanded-anchor state while the occluder portion remains in a deployed-occluder state, the anchor hub being positioned proximal the primary hub when the anchor segments are in the retracted-anchor state with a portion of the anchor segments extending through the primary hub.

9. The medical device system of claim 8, wherein the anchor segments each comprise a loop portion, the anchor segments being displaceable through the primary hub to move between the retracted-anchor state and the expanded-anchor state.

10. The medical device system of claim 8, wherein the anchor hub is moveable from a first position associated with the retracted-anchor state to a second position adjacent the primary hub to position the anchor segments in the expanded-anchor state.

11. The medical device system of claim 8, wherein the occluder portion comprises a tissue growth member coupled to the occluder segments.

12. A medical device system for implantation within a left atrial appendage (“

LAA”

) of a heart, the medical device system comprising;

a delivery device having an elongated body extending to a delivery device distal end, the delivery device configured to deliver a medical device releasably coupled adjacent the delivery device distal end, the medical device including;

an occluder portion including a proximal end and a distal end, the proximal end coupled to a hub, the hub extending distally to a hub distal end, the hub distal end being proximal the distal end of the occluder portion, the occluder portion configured to move between an occluder-deployed state and an occluder-nondeployed state; and

an anchor portion including multiple anchor segments extending between a first end and a second end, the first end operably coupled to the occluder portion and the second end coupled to an anchor hub, the anchor portion configured to be moved between an anchor-deployed state and an anchor-nondeployed state, at least one of the multiple anchor segments having one or more anchoring tines extending therefrom;

wherein the distal end of the occluder portion is distal of a distal end of the anchor portion when the anchor portion is in the anchor-nondeployed state and the occluder portion is in the occluder-deployed state, wherein a portion of the anchor portion is moveable through the hub upon moving the anchor portion to the anchor-deployed state, and wherein, in the anchor-deployed state, the one or more anchoring tines are sized to secure the anchor portion within the LAA.

13. The medical device system of claim 12, wherein the occluder portion is configured to move to the occluder deployed state while the anchor portion remains in the anchor non-deployed state.

14. The medical device system of claim 12, wherein the multiple anchor segments comprise loop portions extending between the first end and the second end of the multiple anchor segments.

15. The medical device system of claim 14, wherein each of the loop portions of the anchor segments are sized and configured when in the anchor-deployed state to engage tissue in the LAA.

16. The medical device system of claim 12, wherein the second end of the anchor segments are displaceable such that a portion of the anchor segments are moveable through the hub.

17. The medical device system of claim 12, wherein the occluder portion comprises a tissue growth member configured to promote tissue growth therewith.

18. The medical device system of claim 12, wherein the distal end of the anchor portion is distal to the distal end of the occluder portion when the anchor portion is in the deployed-anchor state.

19. A medical device system for implantation within a left atrial appendage of a heart, comprising:

a delivery device having an elongated body extending to a delivery device distal end, the delivery device configured to deliver a medical device releasably coupled adjacent the delivery device distal end, the medical device including;

a hub;

an occluder portion having a plurality of occluder frame segments, the occluder frame segments including a proximal end and a distal end, the proximal end interconnected to the hub such that the hub extends distally to a hub distal end, the hub distal end being proximal the distal end of the occluder frame segments; and

an anchor portion having a plurality of anchor frame segments movable between a constricted state and an expanded state, the anchor portion having anchoring tines extending therefrom, the anchoring tines sized to secure the anchor portion to the tissue within the left atrial appendage, the anchor frame segments extending between a first end and a second end with an intermediate portion therebetween, the first end operably coupled to the occluder portion and the second end of the anchor frame segments coupled to an anchor hub, the anchor hub configured to move distally and proximally relative to the proximal end of the occluder frame segments to move the anchor portion between the expanded state and the constricted state, the second end of the anchor frame segments, while in the constricted state, being configured to be positioned proximal of the proximal end of the occluder frame segments with a portion of the anchor frame segments extending through the hub.

20. The medical device system of claim 19, wherein the intermediate portion of each of the anchor frame segments comprise a loop portion such that, as the anchor hub moves distally, the loop portion expands to engage tissue and anchor the occluder portion.

21. The medical device system of claim 20, wherein the occluder portion comprises a tissue growth member having an inner surface and an outer surface, and wherein the loop portion of each of the anchor frame segments is configured to bias against the inner surface of the occluder portion such that the outer surface of the occluder portion is biased against tissue.

22. The medical device system of claim 19, wherein the occluder portion is moveable between a deployed state and a nondeployed state while the anchor portion remains in the constricted state, the anchor portion being moveable between the constricted state and the expanded state while the occluder portion is in the deployed state.

23. The medical device system of claim 19, wherein the occluder portion comprises a tissue growth member configured to promote tissue growth therewith.

24. The medical device system of claim 23, wherein the anchor frame segments are configured to bias against an inner surface of the tissue growth member such that the outer surface of the tissue growth member directly contacts tissue.

25. A medical device system for implantation within a left atrial appendage (“

LAA”

) of a heart, the medical device system comprising;

a delivery device having an elongated body extending to a delivery device distal end, the delivery device configured to deliver a medical device releasably coupled adjacent the delivery device distal end, the medical device including;

an occluder portion extending from a proximal end to a distal end thereof, the proximal end coupled to a hub, the hub extending distally to a hub distal end, the hub distal end being proximal the distal end of the occluder portion, the occluder portion configured to move between an occluder-deployed state and an occluder-nondeployed state; and

an anchor portion including multiple anchor segments with anchoring tines sized and configured to permanently engage tissue in the LAA to secure the anchor portion thereto, the anchor segments extending between a first end and a second end, the first end operatively coupled to the hub and the second end coupled to an anchor hub, the anchor portion being configured to be moveable through the hub between an anchor-deployed state and an anchor-nondeployed state.

26. The medical device system of claim 25, wherein the anchor portion is independently moveable through the hub when the occluder portion is in the occluder deployed state.

27. The medical device system of claim 25, wherein the occluder portion is independently moveable between the occluder-deployed state and the occluder-nondeployed state when the anchor portion is in the anchor non-deployed state.

28. The medical device system of claim 25, wherein the anchor segments comprise a loop portion with the anchoring tines extending therefrom, the anchoring tines sized and configured to engage tissue in the LAA when the anchor segments are moved to the anchor-deployed state.

29. The medical device system of claim 25, wherein the occluder portion comprises a tissue growth member configured to induce tissue growth therewith.

30. The medical device system of claim 29, wherein the anchor segments are configured to bias against an inner surface of the tissue growth member such that the outer surface of the tissue growth member directly contacts tissue in the LAA.

31. The medical device system of claim 25, wherein the second end of the anchor segments is proximal a proximal end of the occluder portion when the anchor portion is in the anchor-nondeployed state.

32. The medical device system of claim 25, wherein the first end and the second end of the anchor segments are proximal a distal end of the occluder portion.

33. A medical device system for implantation within a left atrial appendage (“

LAA”

) of a heart, the medical device system comprising;

a delivery device having an elongated body extending to a delivery device distal end, the delivery device configured to deliver a medical device releasably coupled adjacent the delivery device distal end, the medical device including;

an occluder portion extending from a proximal end to a distal end thereof, the proximal end of the occluder portion coupled to a hub, the hub defining a bore and an axis therethrough, the hub extending distally to a hub distal end, the hub distal end being proximal the distal end of the occluder portion; and

an anchor portion including multiple anchor segments extending between a first end and a second end, the anchor portion having anchoring tines sized to permanently engage tissue in the LAA to secure the anchor portion to the tissue, the first end operably coupled to the occluder portion and the second end coupled to an anchor hub, the anchor hub moveable along the axis of the hub with a portion of the anchor portion moveable through the hub to move the multiple anchor segments between a retracted position and a deployed position.

34. The medical device system of claim 33, wherein the first end and second end of the anchor segments each are proximal of the distal end of the occluder portion.

35. The medical device system of claim 33, wherein each of the anchor segments comprise a loop portion extending between the first end and the second end of the anchor segments, the loop portion sized and configured to engage the tissue in the LAA when the anchor portion is in the deployed position.

36. The medical device system of claim 35, wherein the anchoring tines are associated with the loop portion, the anchoring tines being oriented and configured to engage the tissue in the LAA.

37. The medical device system of claim 33, further comprising a guide associated with the hub, the guide being configured to maintain alignment of the anchor segments extending through the bore of the hub.

38. The medical device system of claim 33, wherein the occluder portion comprises a tissue growth member with an inner surface and an outer surface, the tissue growth member being configured to induce tissue growth therewith.

39. The medical device system of claim 38, wherein the anchor segments are configured to bias against the inner surface of the tissue growth member such that the outer surface of the tissue growth member directly contacts tissue in the LAA.

40. The medical device system of claim 33, wherein the anchor hub includes a tissue growth member coupled thereto.

41. A medical device system for implantation within a left atrial appendage of a heart, comprising:

a delivery device having an elongated body extending to a delivery device distal end, the delivery device configured to deliver a medical device releasably coupled adjacent the delivery device distal end, the medical device including;

a hub defining an axis;

an occluder portion having a plurality of occluder frame segments, the occluder frame segments including a proximal portion and a distal end, the proximal portion connected to the hub, the hub extending distally to a hub distal end, the hub distal end being proximal the distal end of the occluder frame segments; and

an anchor portion having a plurality of anchor frame segments, the anchor portion including anchoring tines extending therefrom, the anchoring tines sized to secure the anchor portion to the tissue within the left atrial appendage, the anchor frame segments extending between a first end and a second end with an intermediate portion therebetween, the first end operably coupled to the occluder portion and the second end coupled to an anchor hub, the anchor hub moveable along the axis with the intermediate portion displaceable through the hub.

42. The medical device system of claim 41, wherein the intermediate portion of the anchor frame segments is proximal of the distal end of the occluder frame segments when the anchor portion is in a retracted state, and wherein at least a portion of the intermediate portion is distal of the distal end of the occluder frame segments when the anchor portion is in a deployed state.

43. The medical device system of claim 41, wherein the anchoring tines are associated with the intermediate portion of the anchor frame segments, the tines being oriented and configured to engage tissue of the left atrial appendage.

44. The medical device system of claim 43, wherein the anchoring tines extend from a loop portion of the intermediate portion.

45. The medical device system of claim 41, further comprising a guide associated with the hub, wherein the anchor frame segments are moveable through the hub with the guide being located and configured to maintain alignment of the anchor frame segments as they move through the hub.

46. The medical device system of claim 41, wherein the occluder portion comprises a tissue growth member having an inner surface and an outer surface, the tissue growth member being configured to induce tissue growth therewith.

47. The medical device system of claim 46, wherein the anchor frame segments are sized and configured to bias against the inner surface of the tissue growth member such that the outer surface of the tissue growth member directly contacts tissue in the left atrial appendage.

48. The medical device system of claim 41, further comprising a tissue growth member associated with the anchor hub.

49. The medical device system of claim 41, wherein the second end of the anchor frame segments is configured to be positioned adjacent the hub when the anchor portion is in a deployed state.

50. The medical device system of claim 41, wherein the second end of the anchor frame segments is configured to be positioned proximal of the hub when the anchor portion is in a non-deployed state.

51. The medical device system of claim 41, wherein the anchoring tines are associated with the intermediate portion, the anchoring tines extending proximally when the anchor portion is in a fully deployed state and being configured to engage tissue of the left atrial appendage.

52. The medical device system of claim 51, wherein the anchoring tines extend distally when the anchor portion is in a non-deployed state.

53. A medical device system for implantation within a left atrial appendage (“

LAA”

) of a heart, the medical device system comprising;

a delivery device having an elongated body extending to a delivery device distal end, the delivery device configured to deliver a medical device releasably coupled adjacent the delivery device distal end, the medical device including;

an occluder portion extending radially from a proximal end to a distal end thereof, the proximal end coupled to a hub, the hub defining a bore and an axis therethrough, the hub extending distally to a hub distal end such that the hub distal end is proximal the distal end of the occluder portion; and

an anchor portion including multiple anchor segments extending between a first end and a second end with an intermediate portion therebetween, the intermediate portion including anchoring tines sized and oriented to secure the anchor portion inside the LAA, the first end operably coupled to the occluder portion and the second end coupled to an anchor hub, the anchor hub displaceable along the axis to actuate the anchor portion between a deployed state and a retracted state with the occluder portion in a deployed position and with a portion of the intermediate portion displaceable through the bore of the hub.

54. The medical device system of claim 53, wherein the occluder portion comprises a tissue growth member extending between a proximal end and a distal end of the occluder portion.