Barrier device for ostium of left atrial appendage

• US 8,221,445 B2
• Filed: 09/24/2004
• Issued: 07/17/2012
• 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: Hauser, Robert G, van Tassel, Robert A
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): BACHMAN, LINDSEY MICHELE
• Application Number:
  US10/948,217
• Publication Number:
  US 20050049573A1
• Time in Patent Office: 2,853 Days
• Field of Search: 606/200, 606/108, 606/151, 606/191, 606/198, 623/1.11, 623/11.11, 604/500, 604506-508, 604104-106
• US Class Current: 606/200
• 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 thrombus in the atrial appendage of a patient from entering the blood stream, said method comprising:

providing a membrane between the atrial appendage and the atrium;

securing the membrane over an ostium of the atrial appendage by extending at least two engagement members substantially radially outwardly from adjacent an edge of the membrane into the atrial appendage through the ostium of the atrial appendage;

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

further securing the membrane over the ostium of the atrial appendage adhesively;

thereby;

blocking blood flow to prevent thrombus from flowing between the atrial appendage and the atrium.

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

providing a membrane between the atrial appendage and the atrium;

securing the membrane over an ostium of the atrial appendage by extending at least two engagement members substantially radially outwardly from adjacent an edge of the membrane into the atrial appendage through the ostium of the atrial appendage;

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

further attaching the membrane to the ostium with an adhesive;

thereby;

blocking blood flow to prevent thrombus from flowing between the atrial appendage and the atrium.

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

providing a membrane between the atrial appendage and the atrium;

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

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

providing a means for centering the membrane over the ostium of the atrial appendage to provide a seal, by attaching a centering rim to the membrane for insertion into the ostium of the atrial appendage;

thereby;

blocking blood flow to prevent thrombus from flowing between the atrial appendage and the atrium.

4. 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 at least two engagement members substantially outwardly from adjacent an edge of the filter membrane into the atrial appendage through the ostium of the atrial appendage;

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

further securing the filter membrane over the ostium of the atrial appendage adhesively;

thereby;

filtering blood flow to prevent thrombus from flowing between the atrial appendage and the atrium.

5. A method of preventing atrial appendage thrombus from entering the blood stream 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 at least two engagement members substantially radially outwardly from adjacent an edge of the filter membrane into the atrial appendage through the ostium of the atrial appendage;

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

further attaching the filter membrane to the ostium with an adhesive;

thereby;

filtering blood flow to prevent thrombus from flowing between the atrial appendage and the atrium.

6. A method of preventing atrial appendage thrombus from entering the blood stream 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 at least two engagement members substantially radially outwardly from adjacent an edge of the filter membrane into the atrial appendage through the ostium of the atrial appendage;

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

providing a means for centering the filter membrane over the ostium of the atrial appendage to provide a seal, by attaching a centering rim to the filter membrane for insertion into the ostium of the atrial appendage;

thereby;

filtering blood flow to prevent thrombus from flowing between the atrial appendage and the atrium.

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

providing a membrane;

securing the 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;

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

further securing the membrane over the ostium of the atrial appendage adhesively;

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.

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

providing a membrane;

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

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; and

vacuuming the atrial appendage for removing thrombus from therein and for collapsing the membrane;

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.

9. A method for preventing atrial appendage thrombus from entering the blood stream comprising:

providing a membrane;

securing the 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;

radially 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; and

providing a means for centering the membrane over the ostium to provide a good seal, by attaching a centering rim to the membrane for insertion into the ostium of the atrial appendage;

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.

10. A method for preventing atrial appendage thrombus from entering the blood stream comprising:

providing a membrane;

securing the 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;

radially 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; and

attaching markers to the membrane for observing the position of the membrane as it is placed in the ostium of the atrial appendage;

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.

11. A method for preventing atrial appendage thrombus from entering the blood stream comprising:

providing a membrane;

securing the 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;

radially 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; and

attaching sensors to the membrane for providing information about the patient;

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.