Barrier device for ostium of left atrial appendage

• US 6,551,303 B1
• Filed: 10/27/1999
• Issued: 04/22/2003
• Est. Priority Date: 10/27/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Atritech Inc. (Boston Scientific Corporation)
• Inventors: Van Tassel, Robert A., Hauser, Robert G.
• Primary Examiner(s): Hayes, Michael J.
• Assistant Examiner(s): Thissell, Jeremy
• Application Number:
  US09/428,008
• Time in Patent Office: 1,273 Days
• Field of Search: 604/500, 604/506-508, 604/104, 604/105, 604/106, 128/898, 606/200
• US Class Current: 604/508
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• 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 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• 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 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2017/00044 Sensing electrocardiography, i.e. ECG
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• 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 2230/008 paraboloidal

Abstract

A membrane applied to the ostium of an atrial appendage for blocking blood from entering the atrial appendage which can form blood clots therein is disclosed. The membrane also prevents blood clots in the atrial appendage from escaping therefrom and entering the blood stream which can result in a blocked blood vessel, leading to strokes and heart attacks. The membranes are percutaneously installed in patients experiencing atrial fibrillations and other heart conditions where thrombosis may form in the atrial appendages. A variety of means for securing the membranes in place are disclosed. The membranes may be held in place over the ostium of the atrial appendage or fill the inside of the atrial appendage. The means for holding the membranes in place over the ostium of the atrial appendages include prongs, stents, anchors with tethers or springs, disks with tethers or springs, umbrellas, spiral springs filling the atrial appendages, and adhesives. After the membrane is in place a filler substance may be added inside the atrial appendage to reduce the volume, help seal the membrane against the ostium or clot the blood in the atrial appendage. The membranes may have anticoagulants to help prevent thrombosis. The membranes be porous such that endothelial cells cover the membrane presenting a living membrane wall to prevent thrombosis. The membranes may have means to center the membranes over the ostium. Sensors may be attached to the membrane to provide information about the patient.

Claims

1. A method of preventing atrial appendage thrombus from entering the blood stream comprising:

securing a membrane over an ostium of the atrial appendage by extending prongs from adjacent an edge of the membrane into the atrial appendage through the ostium; and

piercing the wall of the atrial appendage with the prongs extending into the atrial appendage wall substantially adjacent the ostium to secure the membrane in place;

thereby;

blocking the atrial appendage ostium with the membrane preventing blood from entering the atrial appendage and forming thrombus therein and preventing thrombus formed therein from leaving.

2. A method of preventing atrial appendage thrombus from entering the blood stream as in claim 1 further comprising:

centering the membrane over the ostium by attaching the prongs adjacent the edge of the membrane substantially in a circle such that the prongs will position the membrane over the ostium without leaving gaps between the ostium and the membrane.

3. A method of preventing atrial appendage thrombus from entering the blood stream as in claim 1 further comprising:

extending a stent between the membrane and the prongs to engage the ostium of the atrial appendage for securing the membrane to the ostium.

4. A method of preventing atrial appendage thrombus from entering the blood stream as in claim 1 further comprising:

securing the membrane over the ostium of the atrial appendage by extending stent legs into the atrial appendage through the ostium of the atrial appendage to hold the membrane snugly against the ostium of the atrial appendage.

5. A method of preventing atrial appendage thrombus from entering the blood stream as in claim 1 further comprising:

attaching the membrane to the ostium of the atrial appendage by extending a collapsible stent into the ostium such that the stent expands and engages the circumference of the ostium and attaching a collapsible membrane across the lumen of the stent such that opening the stent stretches the membrane across the lumen of the stent thus blocking the ostium.

6. A method of preventing atrial appendage thrombus from entering the blood stream as in claim 1 further comprising:

coating the membrane with an anticoagulant drug to prevent thrombosis.

7. A method of preventing atrial appendage thrombus from entering the blood stream as in claim 1 further comprising:

providing a porous membrane for encouraging endothelial cells to grow in the membrane thus providing a cell wall over the membrane to prevent thrombosis.

8. A method of preventing atrial appendage thrombus from entering the blood stream as in claim 1 further comprising:

injecting a blood coagulating substance into the atrial appendage to clot the blood therein and prevent it from flowing out of the atrial appendage.

9. A method of preventing atrial appendage thrombus from entering the blood stream as in claim 1 further comprising:

injecting an ablative chemical into the atrial appendage to ablate myocardial tissue thus preventing electrical propagation of atrial fibrillation.

10. A method for preventing atrial appendage thrombus from entering the blood stream as in claim 1 further comprising:

providing a means for centering the membrane over the ostium of the atrial appendage to provide a good seal.

11. A method of obstructing an opening in the body of a patient, said method comprising:

minimally invasively inserting a membrane in the opening by use of a catheter to block the opening; and

securing the membrane in place by the membrane lodging against the opening and providing prongs adjacent an edge of the membrane extending substantially outwardly for attaching the membrane to body tissue on the opposite side of the opening substantially adjacent the opening.

12. A method of obstructing an opening in the body of a patient as in claim 11 wherein the securing comprises:

securing the membrane over a false aneurysm.

13. A method of obstructing an opening in the body of a patient as in claim 11 wherein the securing comprises:

securing the membrane over a fistula.

14. A method of obstructing an opening in the body of a patient as in claim 11 wherein the securing comprises:

securing the membrane over an ostium of an atrial appendage.

15. A method of preventing thrombus in the atrial appendage of a patient from entering the blood stream, said method comprising:

providing a filter membrane between the atrial appendage and the atrium;

securing the filter membrane over an ostium of the atrial appendage by extending engagement members substantially outwardly from adjacent an edge of the filter membrane into the atrial appendage through the ostium of the atrial appendage; and

piercing the wall of the atrial appendage with the engagement members extending into the atrial appendage wall substantially adjacent the ostium to secure the filter membrane in place;

thereby;

filtering blood flow to prevent thrombus from flowing out of the atrial appendage.

16. The method as defined in claim 15, wherein the plurality of engagement members is attached adjacent the edge of the filter membrane in a substantially circular configuration, the method further comprising:

centering the filter membrane over the ostium by the engagement members positioning the filter membrane relative to the ostium.

17. The method as defined in claim 15, further comprising:

expanding a cylindrical support member to which the filter membrane and the engagement members are attached, to engage the ostium of the atrial appendage for securing the filter membrane across the ostium.

18. The method as defined in claim 15, further comprising:

attaching the filter membrane and the engagement members to a portion of a collapsible structure;

attaching the filter membrane to the ostium of the atrial appendage by extending the collapsible structure into the ostium and expanding the collapsible structure;

such that;

the collapsible structure expands and engages the circumference of the ostium; and

the filter membrane is stretched across the ostium.

19. The method as defined in claim 15, further comprising:

coating the filter membrane with an anticoagulant drug to prevent thrombosis.

20. The method as defined in claim 15, wherein the filter membrane is structured to encourage endothelial cells to grow in the filter membrane thus providing a cell wall over the filter membrane to prevent thrombosis.

21. The method as defined in claim 15, further comprising:

providing a means for centering the filter membrane over the ostium of the atrial appendage to provide a good seal.

22. A method of preventing atrial appendage thrombus from entering the blood stream comprising:

blocking an atrial appendage ostium with a membrane preventing blood from entering the atrial appendage and forming thrombus therein and preventing thrombus formed therein from leaving; and

injecting a blood coagulating substance into the atrial appendage to clot blood therein and prevent blood from flowing out of the atrial appendage.