Individually customized atrial appendage implant device

• US 20030023266A1
• Filed: 07/19/2002
• Published: 01/30/2003
• Est. Priority Date: 07/19/2001
• Status: Abandoned Application

• Current Assignee: Atritech Inc. (Boston Scientific Corporation)
• Original Assignee: Atritech Inc. (Boston Scientific Corporation)
• Inventors: Welch, Jeffrey, Sutton, Gregg S., Borillo, Thomas E.
• Application Number:
  US10/200,565
• Publication Number:
  US 20030023266A1
• Time in Patent Office: Days
• US Class Current: 606/200
• 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 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 34/10 Computer-aided planning, simulation or modelling of surgical operations

Abstract

Implant devices for modifying blood flow between an atrial appendage and its associated atrium, are customized for use in subject atrial appendages. The implant devices are tailored to uniquely match individual anatomical characteristics. Cardiac imaging techniques are used to obtain data on the size, shape and orientation of the subject atrial appendage. The raw imaging data is electronically processed using computer modeling to obtain multi-dimensional anatomical images of the subject atrial appendages. Three-dimensional computer aided design tools are used to generate customized device designs from the anatomical images of the subject atrial appendages.

Claims

1. A method for customizing an implant device for use in an atrial appendage comprising:

collecting anatomical data on said atrial appendage;

generating a model device design from said anatomical data; and

fabricating a customized implant device according to said model device design.

2. The method of claim 1 wherein said collecting anatomical data comprises collecting multi-dimensional data.

3. The method of claim 1 wherein said collecting anatomical data comprises using cardiac imaging techniques to collect raw data.

4. The method of claim 3 wherein said using cardiac imaging techniques comprises using a technique selected from the group of computed tomography, magnetic resonance imaging, and echocardiography.

5. The method of claim 1 wherein generating a model device design from said anatomical data further comprises using a computer aided design software tool to generate said model design.

6. The method of claim 1 wherein generating a model device design from said anatomical data further comprises processing said anatomical data to generate a multi-dimensional image data file.

7. The method of claim 6 wherein generating a model device design from said anatomical data further comprises using a computer aided design software tool to generate said model design from said multi-dimensional image data file.

8. The method of claim 1 wherein fabricating a customized implant device according to said model device design further comprises shaping an inflatable structure.

9. The method of claim 1 wherein fabricating a customized implant device according to said model device design further comprises shaping a spring-biasable structure.

10. The method of claim 1 wherein fabricating a customized implant device according to said model device design further comprises shaping a self-expanding structure.

11. A method for fabricating a custom implant device for use in an atrial appendage comprising:

collecting anatomical data on said atrial appendage;

generating a model design from said anatomical data;

fabricating a shape mold according to said model design; and

fabricating a customized implant device using said shape mold.

12. The method of claim 11 wherein said collecting anatomical data comprises collecting multi-dimensional data.

13. The method of claim 12 wherein said collecting anatomical data comprises using cardiac imaging techniques to collect raw data.

14. The method of claim 13 wherein said using cardiac imaging techniques comprises using a technique selected from the group of computed tomography, magnetic resonance imaging, and echocardiography.

15. The method of claim 12 wherein generating a model design from said anatomical data further comprises using a computer aided design software tool to generate said model design.

16. The method of claim 12 wherein generating a model device design for a shape mold from said anatomical data further comprises processing said anatomical data to generate a multi-dimensional image data file.

17. The method of claim 16 wherein generating a model device design for a shape mold from said anatomical data further comprises using a computer aided design software tool to generate said model design from said multi-dimensional image data file.

18. The method of claim 12 wherein fabricating said shape mold according to said model design further comprises shaping a solid body

19. The method of claim 12 wherein fabricating a customized implant device using said shape mold further comprise placing shape-memory alloy material on said shape mold.

20. The method of claim 19 wherein said shape-memory alloy material comprises nitinol.

21. The method of claim 19 wherein fabricating a customized implant device using said shape mold further comprises heat treating said shape-memory alloy material.

22. The method of claim 19 wherein fabricating a customized implant device using said shape mold further comprises attaching a blood-permeable membrane to said shape-memory alloy material.

23. The method of claim 19 wherein fabricating a customized implant device using said shape mold further comprises attaching a blood impervious membrane to said shape-memory alloy material.

24. A device for modifying blood flow through the ostium of an atrial appendage, wherein the appendage has an irregular geometric shape, comprising:

a body; and

a cover disposed on said body, wherein said cover extends across said ostium, and wherein said body has a shape substantially conforming to said irregular shape of said atrial appendage.

25. The device of claim 24 wherein said body comprises an inflatable structure.

26. The device of claim 24 wherein said body comprises a self-expanding structure.

27. The device of claim 26 wherein a self-expanding structure comprises shape-memory alloy material.

28. The device of claim 27 wherein said shape-memory alloy material comprises a wire mesh.

29. The device of claim 28 wherein said shape-memory alloy material comprises a machined tube structure.

30. The device of claim 24 wherein said body comprises a structure that has been formed using a mold having a shape substantially conforming to said irregular shape of said atrial appendage.

31. The device of claim 24 wherein said cover comprises a filter membrane.

32. The device of claim 24 wherein said cover comprises a blood impervious membrane.

33. An implant device for modifying blood flow through the ostium of an atrial appendage, wherein the appendage has an irregular geometric shape, comprising a water-swellable material body, wherein said body comprises a proximal portion and a distal portion, and wherein said body has a dry shape and a swollen shape.

34. The implant device of claim 33 wherein said swollen shape substantially conforms to said irregular geometric shape of said atrial appendage.

35. The implant device of claim 33 wherein said body dry shape is formed such that on absorbing water said swollen shape substantially conforms to said irregular geometric shape of said atrial appendage

36. The implant device of claim 33 wherein said water-swellable material comprises hydrogels.

37. The implant device of claim 33 wherein said water-swellable material comprises cross linked copolymers.

38. The implant device of claim 37 wherein said cross linked copolymers are based on polymers selected from the group consisting of polyethylene glycol, polyvinyl alcohol, poly acrylamide, and polyvinyl pyrrolidone.