Method and device for left atrial appendage occlusion

• US 6,152,144 A
• Filed: 11/06/1998
• Issued: 11/28/2000
• Est. Priority Date: 11/06/1998
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Appriva Medical, Inc. (Medtronic Plc)
• Inventors: Lesh, Michael D., van der Burg, Erik J.
• Primary Examiner(s): Dawson, Glenn K.
• Application Number:
  US09/187,200
• Time in Patent Office: 753 Days
• Field of Search: 606/1, 606/151, 606/108, 606/191.2, 623/1, 623/11, 623/12, 128/898
• US Class Current: 128/898
• 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 17/12136 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 2017/00575 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 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both 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 2017/00632 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

Abstract

A device and method for obliterating or occluding a body cavity or passageway, in particular, the left atrial appendage of a patient'"'"'s heart. The procedure can be carried out intraoperatively, but is preferably carried out percutaneously by use of a delivery catheter to position an occluding device adjacent a patient'"'"'s left atrial appendage. The occluding device may prevent the passage of embolic or other material to or from the left atrial appendage by volumetrically filling the appendage, closing the opening of the appendage with an occluding member, or pulling the tissue around the opening of the appendage together and fixing it in a closed state.

Claims

1. A method of occluding a left atrial appendage of a patient comprising:

a) providing a device for occluding a body cavity comprising;

an occluding member, and

a retention member secured to the occluding member;

b) providing a delivery catheter having a proximal end and a distal end;

c) advancing the delivery catheter percutaneously through the patient'"'"'s vasculature to a chamber within the patient'"'"'s left atrium;

d) advancing the distal end of the delivery catheter and the device for occluding a body cavity adjacent the left atrial appendage; and

e) deploying the device for occluding a body cavity such that the occluding member substantially obstructs the passage of embolic material to and from the left atrial appendage.

2. The method of claim 1 wherein thrombotic or fibrotic material is removed from the patient'"'"'s left atrial appendage prior to deployment of the device for occluding a body cavity.

3. The method of claim 2 wherein the thrombotic or fibrotic material is removed from the patient'"'"'s left atrial appendage by aspiration through an aspiration lumen of a catheter having a port in the distal end thereof in fluid communication with the aspiration lumen which is operatively connected at its proximal end to a vacuum source.

4. The method of claim 1 wherein the retention member comprises an expandable member configured to engage an inside surface of the left atrial appendage and the device for occluding a body cavity is at least partially deployed by expanding the expandable member within the left atrial appendage so as to engage at least a portion of an inner surface of the left atrial appendage.

5. The method of claim 1 wherein the retention member comprises a tissue penetrating shaft configured to penetrate and be secured to tissue of the left atrial appendage and the device for occluding a body cavity is at least partially deployed by penetrating the tissue of the left atrial appendage with the tissue penetrating shaft such that the tissue penetrating shaft is mechanically secured thereto.

6. The method of claim 1, wherein the retention member comprises a shaft having at least one radially extending member extending radially therefrom and configured to engage an inside surface of a patient'"'"'s left atrial appendage and the device for occluding a body cavity is at least partially deployed by expanding the at least one radially expanding member from a constrained configuration so as to engage the tissue of the left atrial appendage.

7. The method of claim 6 wherein the at least one radially expanding member is comprised of a pseudoelastic alloy which is self expanding from a constrained configuration.

8. A method of occluding a left atrial appendage as in claim 1, wherein the occluding member comprises a self expandable frame.

9. A method of occluding a left atrial appendage as in claim 8, further comprising a barrier on the frame.

10. A method of occluding a left atrial appendage as in claim 9, wherein the barrier has a pore size of up to about 0.04 inches.

11. A method of occluding a left atrial appendage as in claim 9, wherein the barrier comprises a polymer selected from the group consisting of Dacron, Nylon, TFE, PTFE, ePTFE, and polyurethane.

12. A method of occluding a left atrial appendage as in claim 1, wherein the retention member comprises a self expandable wire structure.

13. A method of occluding a left atrial appendage as in claim 12, further comprising a polymer on the wire structure.

14. A method of occluding a left atrial appendage as in claim 1, wherein the first advancing step comprises advancing the delivery catheter through the right femoral vein.

29. A method of occluding a left atrial appendage as in claim 1, wherein the device comprises a plurality of tissue engagement members, and the method further comprises the step of engaging tissue with the tissue engagement members.

15. A method of occluding a left atrial appendage of a patient, comprising the steps of:

providing a delivery catheter having a proximal end and a distal end, and a device for occluding a body cavity thereon, the device comprising an occluding member and a retention member secured to the occluding member;

advancing the delivery catheter into a chamber within the patient'"'"'s left atrium;

positioning the device for occluding a body cavity adjacent the left atrial appendage; and

deploying the device for occluding a body cavity such that the occluding member substantially obstructs the passage of embolic material to and from the left atrial appendage.

16. The method of claim 15, wherein thrombotic or fibrotic material is removed from the patient'"'"'s left atrial appendage prior to deployment of the device for occluding a body cavity.

17. The method of claim 16, wherein the thrombotic or fibrotic material is removed from the patient'"'"'s left atrial appendage by aspiration through an aspiration lumen of a catheter having a port in the distal end thereof in fluid communication with the aspiration lumen which is operatively connected at its proximal end to a vacuum source.

18. The method of claim 15, wherein the retention member comprises an expandable member configured to engage an inside surface of the left atrial appendage and the device for occluding a body cavity is at least partially deployed by expanding the expandable member within the left atrial appendage so as to engage at least a portion of an inner surface of the left atrial appendage.

19. The method of claim 15, wherein the retention member comprises a tissue penetrating shaft configured to penetrate and be secured to tissue of the left atrial appendage and the device for occluding a body cavity is at least partially deployed by penetrating the tissue of the left atrial appendage with the tissue penetrating shaft such that the tissue penetrating shaft is mechanically secured thereto.

20. A method of occluding a left atrial appendage as in claim 15, wherein the occluding member comprises a self expandable frame.

21. A method of occluding a left atrial appendage as in claim 20, further comprising a barrier on the frame.

22. A method of occluding a left atrial appendage as in claim 21, wherein the barrier comprises a polymer selected from the group consisting of Dacron, Nylon, TFE, PTFE, ePTFE, and polyurethane.

23. A method of occluding a left atrial appendage as in claim 21, wherein the barrier has a pore size of up to about 0.04 inches.

24. A method of occluding a left atrial appendage as in claim 15, wherein the retention member comprises a self expandable wire structure.

25. A method of occluding a left atrial appendage as in claim 24, further comprising a polymer on the wire structure.

26. A method of occluding a left atrial appendage as in claim 15, wherein the advancing step comprises advancing the delivery catheter through the right femoral vein.

27. A method of occluding a left atrial appendage as in claim 15, wherein the advancing step comprises advancing the delivery catheter to the left atrial appendage intraoperatively.

28. A method of occluding a left atrial appendage as in claim 15, wherein the device comprises a plurality of tissue engagement members, and the method further comprises the step of engaging tissue with the tissue engagement members.