Barrier device for ostium of left atrial appendage

• US 6,949,113 B2
• Filed: 12/03/2002
• Issued: 09/27/2005
• 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): NGUYEN, ANH TUAN TUONG
• Application Number:
  US10/308,032
• Publication Number:
  US 20030120337A1
• Time in Patent Office: 1,029 Days
• Field of Search: 606/1, 606/108, 606/151, 606/191, 606/200, 604/104, 623/1.1, 623/11.11
• 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 membrane structure for blocking an atrial appendage ostium, said atrial appendage having a wall, said membrane structure comprising:

a membrane; and

a plurality of prongs extending substantially outwardly from adjacent an edge of the membrane for extending into the atrial appendage through the ostium and piercing the wall of the atrial appendage substantially adjacent the ostium to secure the membrane in place;

thereby blocking the ostium of the atrial appendage with the membrane such that no blood enters the atrial appendage to form a thrombus and no thrombus escapes the atrial appendage.

2. A membrane structure for blocking an atrial appendage ostium as in claim 1 wherein:

said prongs are memory alloy prongs that expand to the desired shape inside of the atrial appendage to pierce the atrial appendage wall to firmly hold the membrane over the ostium.

3. A membrane structure for blocking an atrial appendage ostium as in claim 1 wherein:

a bulb on the tip of each of the prongs prevents the prongs from impaling the atrial appendage walls prematurely during deployment.

4. A membrane structure for blocking an atrial appendage ostium as in claim 1 wherein:

the prongs are attached to the membrane in a circle such that the prongs will center the membrane over the ostium.

5. A membrane structure for blocking an atrial appendage ostium as in claim 1, further comprising:

a stent between the membrane and the prongs to engage the diameter of the ostium of the atrial appendage to hold the membrane securely in place over the ostium.

6. A membrane structure for blocking an atrial appendage ostium as in claim 1 further comprising:

a plurality of stent legs attached to the membrane and extending inside of the atrial appendage through the ostium of the atrial appendage.

7. A membrane structure for blocking an atrial appendage ostium as in claim 6 wherein:

the stent legs are memory alloy stent legs that expand to the desired shape inside of the atrial appendage to firmly hold the membrane over the ostium.

8. A membrane structure for blocking an atrial appendage ostium as in claim 1 further comprising:

an adhesive on the membrane for securing the membrane over the ostium of the atrial membrane.

9. A membrane structure for blocking an atrial appendage ostium as in claim 1 wherein:

a vacuum removes thrombus from the atrial appendage and reduces the volume of the atrial appendage by suction.

10. A membrane structure for blocking an atrial appendage ostium as in claim 1 further comprising:

a collapsible stent for insertion into the ostium such that the stent expands and engages the circumference of the ostium, the membrane being collapsible and being attached across the lumen of the stent such that opening the stent stretches the membrane across the lumen of the stent thus blocking the ostium.

11. A membrane structure for blocking an atrial appendage ostium as in claim 1 further comprising:

an anticoagulant drug on the membrane to prevent thrombosis.

12. A membrane structure for blocking an atrial appendage ostium as in claim 1 wherein:

an ablative chemical injected into the atrial appendage ablates myocardial tissue thus preventing electrical propagation of atrial fibrillation.

13. A membrane structure for blocking an atrial appendage ostium as in claim 1 wherein:

the membrane is a porous membrane to encourage endothelial cells to grow in the pores of the membrane thus providing a cell wall over the membrane to prevent thrombosis.

14. A membrane structure for blocking an atrial appendage ostium as in claim 1 wherein:

the membrane is a metal mesh to encourage endothelial cells to grow in the pores of the membrane thus providing a cell wall over the membrane to prevent thrombosis.

15. A membrane structure for blocking an atrial appendage ostium as in claim 1 further comprising:

a substance that seals the membrane against leakage.

16. A membrane structure for blocking an atrial appendage ostium as in claim 1 further comprising:

a substance that fills the atrial appendage and reduces its volume.

17. A membrane structure for blocking an atrial appendage ostium as in claim 1 further comprising:

a coagulant that coagulates blood in the atrial appendage such that blood cannot escape the atrial appendage.

18. A membrane structure for blocking an atrial appendage ostium as in claim 1 further comprising:

a means for centering the membrane over the ostium of the atrial appendage.

19. A membrane structure for blocking an atrial appendage ostium as in claim 18 wherein the means for centering the membrane over the ostium comprises:

a centering rim on the membrane for placement in the ostium.

20. A membrane structure for blocking an atrial appendage ostium as in claim 18 wherein the means for centering the membrane over the ostium comprises:

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

21. A membrane structure for blocking an atrial appendage ostium as in claim 1 further comprising at least one sensor attached to the membrane for monitoring a patient.

22. A membrane structure for obstructing an opening in the body of a patient, said membrane comprising:

a membrane adapted to be lodged against the opening;

prongs adjacent an edge of the membrane extending substantially outwardly for attaching the membrane to body tissue on the opposite side of the opening from the membrane substantially adjacent the opening for securing the membrane over the opening; and

a catheter for minimally invasively inserting the membrane over the opening to block the opening.

23. A membrane structure for obstructing an opening in the body of a patient as in claim 22 wherein:

the membrane covers a false aneurysm.

24. A membrane structure for obstructing an opening in the body of a patient as in claim 22 wherein:

the membrane covers a fistula.

25. A membrane structure for obstructing an opening in the body of a patient as in claim 22 wherein:

the membrane covers an ostium of an atrial appendage.

26. Apparatus for filtering blood flowing between an atrial appendage and an atrium of a patient comprising:

a filter membrane adapted to be positioned across an ostium of the atrial appendage configured to allow blood flow while preventing thrombus from flowing between the atrial appendage and the atrium; and

a support structure attached to the filter having a plurality of prongs extending substantially outwardly from adjacent an edge of the filter membrane for extending into the atrial appendage through the ostium and piercing the wall of the atrial appendage substantially adjacent the ostium to secure the filter membrane in position across the ostium of the atrial appendage.

27. Apparatus as defined in claim 26, wherein the support structure further comprises a plurality of engagement members extending through the ostium and engaging the walls of the atrial appendage such that the filter membrane is held across the ostium.

28. Apparatus as defined in claim 27, wherein the engagement members are made from a material having shape-memory characteristics and which are expandable to the desired shape inside of the atrial appendage to secure the filter membrane over the ostium.

29. Apparatus as defined in claim 26, wherein each of the prongs has a removable atraumatic tip to prevent piercing the atrial appendage wall prematurely during deployment.

30. Apparatus as defined in claim 26, wherein the engagement members are attached to the filter membrane in a circular configuration such that the engagement members will center the filter membrane across the ostium.

31. Apparatus as defined in claim 26, wherein the support member further comprises an expandable structure which engages the interior of the ostium of the atrial appendage when expanded to hold the filter membrane securely in place across the ostium.

32. Apparatus as defined in claim 31, wherein the expandable structure further comprises engagement members configured to engage the atrial appendage wall to secure the filter membrane across the ostium.

33. Apparatus as defined in claim 26, wherein the support structure further comprises an adhesive on the filter membrane for securing the filter membrane over the ostium of the atrial appendage.

34. Apparatus as defined in claim 26, wherein the filter membrane is flexible, the support structure further comprising a collapsible support member for insertion into the ostium such that the collapsible support member expands and engages the circumference of the ostium, and attaching the filter membrane across a portion of the collapsible support member, such that opening the collapsible support member stretches the filter membrane across the ostium.

35. Apparatus as defined in claim 26, wherein an anticoagulant drug is applied on the filter membrane to prevent thrombosis.

36. Apparatus as defined in claim 26, wherein the filter membrane has a porous structure.

37. Apparatus as defined in claim 26, wherein the filter membrane is a metal mesh.

38. Apparatus as defined in claim 26, wherein the support structure has a means for centering the filter membrane over the ostium of the atrial appendage.

39. Apparatus as defined in claim 38, wherein the means for centering the filter membrane over the ostium comprises a centering rim for placement in the ostium.