Variable expansion frame system for deploying medical devices and methods of use

• US 6,245,087 B1
• Filed: 08/03/1999
• Issued: 06/12/2001
• Est. Priority Date: 08/03/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embolx, Inc.
• Inventors: Addis, Bruce
• Primary Examiner(s): Jackson, Gary
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US09/365,991
• Time in Patent Office: 679 Days
• Field of Search: 606/200, 606/108, 606/194, 606/170, 606/159, 604/96, 604/104-106, 604/95
• 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 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/2215 having an open distal end
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• 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 2230/0008 elliptical or oval
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

An expansion frame system for deploying medical devices in a patient'"'"'s body cavity. The system typically includes an inner wire disposed within a lumen of an outer wire. Distal ends of the inner and outer wires are attached to a substantially circular frame at first and second points. During use, the outer wire is displaced relative to the inner wire, causing the circular frame to rotate about an axis perpendicular to the line defined by the first and second points. Medical devices, such as a filter, a stent, an occluder or a manometer, can be mounted on the circular frame. The diameter of the expansion frame can be varied to achieve optimal contact with the luminal wall of the body cavity. Methods of using the expansion frame system for temporary or permanent placement of a medical device is disclosed.

Claims

1. A variable diameter expansion frame, comprising:

an outer wire having a proximal end, a distal end, and a lumen therebetween;

an inner wire having a proximal end and a distal end, the inner wire being disposed within the lumen of the outer wire, the inner wire slideable relative to the outer wire; and

a substantially circular frame attached at a first circumferential point to the distal end of the outer wire, and attached at a second circumferential point to the distal end of the inner wire, the first circumferential point being disposed approximately 180°

from the second circumferential point,

wherein, during use, the outer wire is displaced relative to the inner wire, and the circular frame is caused to rotate about an axis perpendicular to the line defined by the first and second circumferential points.

2. The expansion frame of claim 1, wherein the outer wire has a hole through its wall near the distal end, and wherein the inner wire passes through the hole in the outer wire.

3. The expansion frame of claim 2, further comprising a force biasing element disposed about the distal end of the inner wire and biasing the second circumferential point of the circular frame away from the hole of the outer wire.

4. The expansion frame of claim 3, wherein the force biasing element is a spring.

5. The expansion frame of claim 1, further comprising a filter mesh disposed about the circular frame.

6. The expansion frame of claim 1, further comprising an impermeable membrane disposed about the circular frame.

7. The expansion frame of claim 1, further comprising a syringe having a barrel and a plunger, wherein the proximal end of the inner wire passes through a distal surface of the plunger and is mounted on the barrel.

8. The expansion frame of claim 7, wherein the outer wire is mounted on the distal surface of the plunger.

9. The expansion frame of claim 7, further comprising a locking mechanism capable of fixing the displacement between the plunger and the barrel.

10. The expansion frame of claim 1, further comprising an angioplasty catheter adapted to receive and be guided by the outer wire of the expansion frame.

11. The expansion frame of claim 1, further comprising an stent deployment catheter adapted to receive and be guided by the outer wire of the expansion frame.

12. The expansion frame of claim 1, further comprising an atherectomy catheter adapted to receive and be guided by the outer wire of the expansion frame.

13. The expansion frame of claim 1, further comprising an imaging catheter adapted to receive and be guided by the outer wire of the expansion frame.

14. A method for deploying a medial device within a body, comprising the steps of:

providing an expansion frame comprising an outer wire, an inner wire, and a substantially circular frame attached at a first point to a distal end of the outer wire, and attached at a second point to a distal end of the inner wire, the inner wire being disposed within the lumen of the outer wire, the inner wire slideable relative to the outer wire;

introducing the expansion frame into a lumen within the body of a patient;

advancing the expansion frame to a region of interest; and

retracting a proximal end of the outer wire relative to a proximal end of the inner wire,

wherein the circular frame rotates about an axis perpendicular to the line defined by the first and second point, and the circular frame thereby circumferentially engages the luminal wall.

15. The method of claim 14, wherein the expansion frame further comprises a filter mesh disposed about the circular frame.

16. The method of claim 14, wherein the expansion frame further comprises an impermeable membrane disposed about the circular frame.

17. The method of claim 14, wherein the lumen is a vessel.

18. The method of claim 17, wherein the vessel is an artery.

20. The method of claim 18, wherein the artery is an aorta.

21. The method of claim 18, wherein the artery is a carotid artery.

22. The method of claim 14, further comprising the step of performing an endoluminal procedure upstream of the expansion frame.

23. The method of claim 22, wherein embolic materials are dislodged during the procedure and captured by the expansion frame.

24. The method of claim 14, wherein the expansion frame is introduced through an incision by direct access.

25. The method of claim 14, wherein the expansion frame is introduced percutaneously.

26. The method of claim 14, wherein a radiopaque marker is mounted on the circular frame.

27. The method of claim 14, further comprising the step of verifying the position of the frame using fluoroscopy.

28. The method of claim 22, wherein the endoluminal procedure is performed by advancing an endoluminal instrument over the outer wire.

29. The method of claim 28, wherein the endoluminal instrument is an angioplasty catheter adapted to receive and be guided by the outer wire of the expansion frame.

30. The method of claim 28, wherein the endoluminal instrument is a stent deployment catheter adapted to receive and be guided by the outer wire of the expansion frame.

31. The method of claim 28, wherein the endoluminal instrument is an atherectomy catheter adapted to receive and be guided by the outer wire of the expansion frame.

32. The method of claim 28, wherein the endoluminal instrument is an imaging catheter adapted to receive and be guided by the outer wire of the expansion frame.

33. The method of claim 30, wherein the stent deployment catheter comprises:

a self-expanding stent disposed about the outer wire; and

a sheath disposed about the stent, wherein the sheath is retracted to release the stent.

34. The method of claim 17, wherein the step of introducing the expansion frame into the vessel comprises advancing the expansion frame through an introducer.

35. The method of claim 34, wherein the introducer comprises a cannula.

36. The method of claim 34, wherein the introducer is a port on a cannula.

37. The method of claim 36, wherein the port is separate from a lumen of the cannula.

19. An expansion frame system, comprising:

a cannula having a proximal end, a distal end, a first lumen therebetween, and a side port communicating with a second lumen which extends to the distal end of the cannula; and

a variable diameter expansion frame comprising an outer wire having a proximal end and a distal end, an inner wire having a proximal end and a distal end, the inner wire being disposed within the lumen of the outer wire, the inner wire slideable relative to the outer wire, and a substantially circular frame attached at a first circumferential point to the distal end of the outer wire, and attached at a second circumferential point to the distal end of the inner wire, the first circumferential point being disposed approximately 180°

from the second circumferential point,

wherein, during use, the expansion frame is advanced through the side port of the cannula and is deployed within the lumen of a vessel.

38. The expansion frame of claim 19, wherein during use, the outer wire is displaced relative to the inner wire and the circular frame is caused to rotate about an axis perpendicular to the line defined by the first and second circumferential points.

39. The expansion frame of claim 19, wherein the second lumen communicates with the first lumen.

40. The expansion frame of claim 19, wherein the cannula is an arterial cannula.

41. The expansion frame of claim 19, wherein the side port further comprises a hemostatic valve.

42. The expansion frame of claim 19, wherein the second lumen is separate from the first lumen and communicates at a distal end with a port.