Adjustable left atrial appendage implant deployment system

• US 7,152,605 B2
• Filed: 05/16/2003
• Issued: 12/26/2006
• Est. Priority Date: 11/06/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: ev3 Endovascular, Inc. (Medtronic Plc)
• Inventors: Kume, Stewart M., Frazier, Andrew G. C., Kreidler, Marc S., Khairkhahan, Alexander K., Roue, Chad C., Ogi, Darrell H., van der Burg, Erik J., Klenk, Alan R.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US10/441,492
• Publication Number:
  US 20030199923A1
• Time in Patent Office: 1,320 Days
• Field of Search: 606/159, 606/108, 606191-200, 606/213, 606/1, 604 9601-109, 600201-210
• US Class Current: 128/887
• 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 17/122 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 2017/00615 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 2017/00623 Introducing or retrieving devices therefor
• 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: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• 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 2230/0071 : spherical
• 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 adjustable occlusion device for use in a body lumen such as the left atrial appendage. The occlusion device is removably carried by a deployment catheter. The device may be enlarged or reduced to facilitate optimal placement or removal. Methods are also disclosed.

Claims

1. An implantable device implantation system, comprising:

a deployment catheter, having an elongate flexible body with a proximal end and a distal end;

an antirotation lock on the distal end of the body;

a core extending axially through the body; and

a radially expandable implant adapted to matingly engage the antirotation lock on the distal end of the body, wherein the antirotation lock comprises an axial extension, and wherein the axial extension matingly engages with a complementary recess on the implant.

2. An implantable device implantation system as in claim 1, wherein the axial extension is laterally offset.

3. An implantable device implantation system, comprising:

a deployment catheter, having an elongate flexible body with a proximal end and a distal end;

an antirotation lock on the distal end of the body;

a core extending axially through the body; and

a radially expandable implant adapted to matingly engage the antirotation lock on the distal end of the body, wherein the antirotation lock comprises an axial recess, and wherein the axial recess matingly engages with a complementary extension on the implant.

4. An implantable device implantation system as in claim 3, wherein the axial recess is laterally offset.

5. An implantable device implantation system as in claim 3, further comprising a releasable lock for releasably attaching the implant to a deployment line.

6. An implantable device implantation system, comprising:

a deployment catheter, having an elongate flexible body with a proximal end and a distal end;

an antirotation lock on the distal end of the body;

a core extending axially through the body; and

a radially expandable implant adapted to matingly engage the antirotation lock on the distal end of the body, wherein the antirotation lock comprises at least one projection, and wherein the at least one projection matingly engages with a complementary recess corresponding to the at least one projection on the implant.

7. An implantable device implantation system as in claim 6, wherein the projection comprises an axially extending pin.

8. An implantable device implantation system as in claim 6, wherein the projection comprises an axially extending spline.

9. An implantable device implantation system, comprising:

a deployment catheter, having an elongate flexible body with a proximal end and a distal end;

an antirotation lock on the distal end of the body;

a core extending axially through the body; and

a radially expandable implant adapted to matingly engage the antirotation lock on the distal end of the body, wherein the implant comprises at least one projection, and wherein the at least one projection matingly engages with a complementary recess corresponding to the at least one projection on the antirotation lock.

10. An implantable device implantation system as in claim 9, wherein the projection comprises an axially extending pin.

11. An implantable device implantation system as in claim 9, wherein the projection comprises an axially extending spline.

12. An implantation system, comprising:

an implantable device having a proximal end and a distal end and a plurality of supports extending from the proximal end to the distal end, the implantable device being movable between a reduced cross section and an enlarged cross section, wherein the implantable device comprises tissue attachment elements;

a core threadingly engageable with an internally threaded portion of the implantable device and extending proximally therefrom, wherein the core extends through the implantable device and is adapted to apply a distal force to the device to maintain the device in its reduced cross section; and

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

13. An implantation system as in claim 12, wherein the implantable device is self-expanding.

14. An implantation system as in claim 12, wherein the implantable device includes a hub that is internally threaded.

15. An implantation system as in claim 14, wherein the hub is a proximal hub, and a plurality of supports extend distally therefrom.

16. An implantation system as in claim 12, further comprising a deployment catheter, having an elongate flexible body with a proximal end and a distal end, and wherein the core axially extends through the body.

17. An implantation system as in claim 12, wherein the implantable device is sized and configured to be positioned in a left atrial appendage.

18. An implantation system as in claim 12, wherein the barrier comprises ePTFE.

19. A system for containing embolic material within a left atrial appendage, comprising:

a deployment catheter having an inner lumen extending longitudinally therethrough;

a closure device having a proximal end, a distal end, and an intermediate portion positioned between said proximal and distal ends, said closure device having a collapsed configuration and an expanded configuration, said intermediate portion having a radially expanded dimension when said closure device is in said expanded configuration, said radially expanded dimension being sized for engaging an inner surface at the left atrial appendage;

the closure device further comprising a barrier provided along a region of said intermediate portion, said barrier being sized and configured to at least partially block an opening to the left atrial appendage, wherein said barrier is configured to promote tissue ingrowth; and

a line sized to slidably extend proximally from the closure device through said inner lumen, said line being releasably attached to said closure device, wherein said line engages said proximal and distal ends of said closure device;

wherein said barrier is provided along a proximal face of said closure device.

20. The system of claim 19, wherein said barrier comprises a mesh fabric.

21. The system of claim 19, wherein said intermediate portion has a maximum expanded diameter in the range of about 1 cm to about 5 cm.

22. The system of claim 19, further comprising at least one retention element disposed at least along said intermediate portion, said retention element being configured for engaging the inner surface of the left atrial appendage when said closure device is in said expanded configuration.

23. The system of claim 22, wherein said retention element is a barb.

24. The system of claim 19, wherein said intermediate portion of said closure device comprises a plurality of spokes extending between said proximal and distal ends.

25. The system of claim 24, wherein said spokes are configured to bend radially outward for engagement with the inner surface of the left atrial appendage, said spokes being caused to bend radially outward by relative movement of said proximal and distal ends.

26. The system of claim 19, wherein said barrier is configured for facilitating cellular in-growth when said closure device is engaging the inner surface at the left atrial appendage.

27. The system of claim 19, wherein said intermediate portion is sized to engage tissue within the left atrial appendage when said closure device is in said expanded configuration.

28. The system of claim 19, wherein said barrier is provided at least on an exterior surface of said intermediate portion.

29. The system of claim 19, wherein said closure device has a substantially spherical shape when in said expanded configuration.

30. The system of claim 19, wherein an entire length of said intermediate portion between the proximal and distal ends is greater in cross-sectional area than said proximal and distal ends when said closure device is in the expanded configuration.

31. The system of claim 19, wherein said intermediate portion has a maximum transverse dimension in the expanded configuration at about a region of the closure device that engages tissue at the left atrial appendage.