Device for containing embolic material in the LAA having a plurality of tissue retention structures

• US 20040034366A1
• Filed: 08/15/2003
• Published: 02/19/2004
• Est. Priority Date: 11/08/1999
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: EV3 Sunnyvale Incorporated
• Inventors: Lesh, Michael D., De Cicco, Dino, Frazier, Andrew G. C., Kreidler, Marc S., Khairkhahan, Alexander K., Roue, Chad C., van der Burg, Erik J.
• Granted Patent: US 6,994,092 B2
• Time in Patent Office: Days
• US Class Current: 606/119
• 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 17/12031 complete occlusion
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00557 inflatable A61B2017/22051 takes precedence
• 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 2017/00592 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 2017/00615 Implements with an occluder on one side of the opening and holding means therefor on the other
• CPC Class Codes: A61B 2017/00619 Locking means for locking the implement in expanded state
• CPC Class Codes: A61B 2017/00628 T-shaped occluders
• CPC Class Codes: A61B 2017/00632 Occluding a cavity, i.e. closing a blind opening
• CPC Class Codes: A61B 2017/081 : Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/1205 : Introduction devices
• CPC Class Codes: A61F 2002/018 : made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0071 : spherical
• CPC Class Codes: A61F 2230/0076 : ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 : paraboloidal
• CPC Class Codes: A61M 2025/1054 : having detachable or disposable balloons
• CPC Class Codes: A61M 2210/125 : Heart
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00

Abstract

Disclosed is an occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device includes an occlusion member and a plurality of tissue retention structures. The tissue retention structures inhibits movement of the device from the left atrial appendage. Methods are also disclosed.

Claims

1. A device for implantation within an opening in the body, comprising:

a frame having a proximal end and a distal end and a longitudinal axis defined therebetween, the frame being enlargeable from a reduced cross section to an enlarged cross section, wherein the frame comprises a plurality of supports, and wherein when the frame is in its enlarged cross section, each of the supports is spaced apart from an adjacent support by a gap that extends from the proximal end to the distal end of the frame; and

at least one tissue retention structure for retaining the device in the tubular structure and to limit relative movement between tissue and the device, the at least one tissue retention structure being integrally formed with a corresponding support, wherein the at least one tissue retention structure lies generally along the same longitudinal axis as the frame when the frame is in its reduced cross section and projects generally outward away from the corresponding support when the frame is in its enlarged cross section;

wherein the at least one tissue retention structure inclines radially outward approximately tangentially away from the corresponding support when the frame is in its enlarged cross section.

2. A device as in claim 1, wherein the at least one tissue retention structure comprises a plurality of barbs.

3. A device as in claim 1, wherein the at least one tissue retention structure and the corresponding support are cut from a single ribbon, sheet or tube stock.

4. A device as in claim 1, wherein the plurality of supports form a curve when the frame is in its enlarged cross section, and the at least one tissue retention structure inclines radially outward at approximately a tangent to the curve of a corresponding support.

5. A device as in claim 1, wherein the frame comprises a proximal hub and a distal hub, with the plurality of supports extending between the proximal and distal hubs.

6. A device as in claim 1, further comprising a barrier on a proximal face of the frame.

7. A device as in claim 1, wherein the at least one tissue anchor is inclined in a proximal direction.

8. A device as in claim 1, comprising a plurality of tissue anchors, wherein all of the tissue anchors are inclined in a proximal direction.

9. A device as in claim 1, wherein a generally axially extending slot extends between each of the supports when the frame is in its reduced cross section, and wherein the at least one tissue retention structure occupies the space in between the supports.

10. A device as in claim 9, wherein the at least one tissue retention structure is substantially flush with the support within the axially extending slot in its reduced cross section.

11. A device as in claim 1, wherein each tissue retention structure extends from a single support.

12. A device for containing embolic material within a left atrial appendage of a patient, comprising:

a proximal hub, a distal hub, and a longitudinal axis extending therethrough;

at least three spokes extending between the proximal hub and the distal hub;

each spoke comprising an elongate, flexible element which is movable from a first orientation in which the element extends generally parallel to the axis at no more than a first distance from the axis, to a second orientation in which at least a portion of the element is inclined with respect to the axis and is separated by at least a second distance from the axis which is greater than the first distance;

a plurality of anchor elements, wherein each anchor element is formed integrally with and extends tangentially from a corresponding spoke when the spokes are in the second orientation; and

a barrier provided at least on a proximal face of the device for containing embolic particles.

13. A device as in claim 12, wherein each of the anchor elements is inclined in a generally proximal direction.

14. A device as in claim 12, wherein each of the spokes is self-expanding.

15. A device as in claim 12, wherein the spokes are made of nickel titanium.

16. A device as in claim 12, wherein moving the spokes from their first orientation to their second orientation causes the spokes to move away from a corresponding anchor element.

17. A device as in claim 12, wherein the barrier comprises ePTFE.

18. A device as in claim 12, wherein when the flexible elements are in their second orientation, each of the spokes is spaced apart from an adjacent spoke by a gap that extends from the proximal hub to the distal hub.

19. A device for containing embolic material within a left atrial appendage of a patient, the device comprising:

a frame having a proximal end and a distal end, a proximal hub and a distal hub, and a plurality of supports extending therebetween, the frame being expandable from a collapsed configuration to an enlarged configuration, with the supports being movable from an axial orientation when the frame is in the collapsed configuration to an inclined orientation when the frame is in the enlarged configuration, wherein the supports include at least one curved or hinged portion when in their inclined orientation; and

a plurality of tissue retention structures, each of said tissue retention structures extending from a single support and extending tangentially from said curved or hinged portion when the frame is in its enlarged configuration, wherein moving the frame from the enlarged configuration to the collapsed configuration draws the corresponding support closer to each tissue retention structure, wherein each of said tissue retention structures and its corresponding support are are integrally formed.

20. A device as in claim 19, wherein each support includes at least one tissue retention structure.

21. A device as in claim 19, wherein each support includes two or more tissue retention structures.

22. A device as in claim 19, further comprising a membrane provided on a proximal face of the frame.

23. A device as in claim 19, further comprising a proximal hub and a distal hub, wherein the plurality of supports extend between the proximal and distal hubs.

24. A device as in claim 19, wherein the supports are made of a shape memory metal.

25. A device for containing embolic material within a left atrial appendage of a patient, comprising:

a frame having a proximal end and a distal end and a longitudinal axis defined therebetween, wherein the frame comprises a plurality of supports,

each support comprising an elongate, flexible element which is movable from a first orientation in which the element extends generally parallel to the axis at no more than a first distance from the axis, to a second orientation in which at least a portion of the element is inclined with respect to the axis and is separated by at least a second distance from the axis which is greater than the first distance;

a plurality of anchor elements, wherein each anchor element is formed integrally with and extends outwardly in a generally proximal direction from a corresponding support when the supports are in the second orientation; and

a barrier provided at least on a proximal face of the device for containing embolic particles.

26. A device as in claim 25, wherein said plurality of anchor elements extend tangentially from the corresponding support.

27. A device as in claim 25, wherein each of the supports is self-expanding.

28. A device as in claim 25, wherein the supports are made of nickel titanium.

29. A device as in claim 25, wherein moving the supports from their first orientation to their second orientation causes the supports to move away from a corresponding anchor element.

30. A device as in claim 25, wherein the barrier comprises ePTFE.

31. A device as in claim 25, wherein when the flexible elements are in their second orientation, each of the supports is spaced apart from an adjacent support by a gap that extends from the proximal end to the distal end.

32. A device as in claim 25, further comprising a proximal hub at its proximal end.

33. A device as in claim 25, further comprising a distal hub at its distal end.

34. A device as in claim 25, wherein the plurality of anchor elements are substantially flush with the support.

35. A device for implantation within an opening in the body, comprising:

a frame having a proximal end and a distal end and a longitudinal axis defined therebetween, the frame being enlargeable from a reduced cross section to an enlarged cross section, wherein the frame comprises a plurality of supports, and wherein when the frame is in its enlarged cross section, each of the supports is spaced apart from an adjacent support by a gap; and

at least one tissue retention structure for retaining the device in the tubular structure and to limit relative movement between tissue and the device, the at least one tissue retention structure being integrally formed with a corresponding support;

wherein the at least one tissue retention structure extends outwardly in a proximal direction from the corresponding support when the frame is in its enlarged cross section, and;

a barrier on at least a proximal face of the frame.

36. A device as in claim 35, wherein the at least one tissue retention structure occupies an opening between the supports and is substantially flush with the support within the opening.

37. A device as in claim 35, comprising a plurality of tissue anchors, wherein all of the tissue anchors extend outwardly in a proximal direction.

38. A device as in claim 35, wherein each tissue retention structure extends from a single support.

39. A device as in claim 35, wherein the gap extends from the proximal end to the distal end of the frame.