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

• US 7,608,087 B1
• Filed: 11/12/2002
• Issued: 10/27/2009
• Est. Priority Date: 08/03/1999
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Addis, Bruce
• Primary Examiner(s): Nguyen; Anhtuan T
• Assistant Examiner(s): DOWE, KATHERINE MARIE
• Application Number:
  US10/293,030
• Time in Patent Office: 2,541 Days
• Field of Search: 606/200, 606113-114, 604528-532
• 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 method for deploying a medical device within a body, comprising the steps of:

introducing a cannula into a blood vessel;

inserting an expansion frame system through a first lumen of the cannula into the blood vessel, the expansion frame system comprising an outer wire having a second lumen and a longitudinal axis, an inner wire disposed axially through the second lumen, and a frame fixedly attached at a first circumferential point on the frame to a distal end of the outer wire, and fixedly attached at a second circumferential point on the frame to a distal end of the inner wire, wherein the outer wire and inner wire extend, starting from the first and second circumferential points respectively, in a generally proximal direction, wherein the first circumferential point is circumferentially displaced from the second circumferential point, and wherein the outer wire is axially displaceable relative to the inner wire; and

displacing a proximal end of the outer wire axially relative to a proximal end of the inner wire to rotate the frame as a whole about an axis that is substantially perpendicular to the longitudinal axis to expand the frame diametrically so as to circumferentially engage the endolumenal surface of the blood vessel; and

wherein the outer wire and inner wire are attached at their distal-most tips to the first and second circumferential points, respectively, and the inner wire has a stiffness sufficient to avoid buckling while rotating the frame.

2. The method of claim 1, wherein the blood vessel is an aorta.

3. The method of claim 1, wherein the blood vessel is a carotid artery.

4. The method of claim 1, wherein the blood vessel is a femoral artery.

5. The method of claim 1, wherein the expansion frame system further comprises a filter mesh disposed about the frame.

6. The method of claim 1, wherein the expansion frame system further comprises an impermeable membrane disposed about the frame.

7. The medical device of claim 1, wherein the frame is limited to only two attachment points.

8. The medical device of claim 7, wherein the second point is circumferentially offset from the first point by at least 30 degrees.

9. Apparatus suitable for filtering emboli from a patient'"'"'s blood vessel during an open surgical procedure, comprising:

an elongated member having an axial lumen and a distal region having a distal end, a longitudinal axis, and an opening;

a support hoop fixedly attached at a first circumferential point to the distal end of the elongated member;

a suspension member extending through the axial lumen and the opening and fixedly attached to the support hoop at a second circumferential point thereof so as to couple the support hoop to the distal region so that the support hoop is disposed obliquely relative to the longitudinal axis, wherein the second circumferential point is at least 30 degrees away from the first circumferential point and wherein the elongated member and suspension member extend, starting from the first and second circumferential points respectively, in a generally proximal direction; and

a blood permeable sac affixed to the support hoop so that the support hoop forms a mouth of the blood permeable sac;

whereby the elongated member is displaceable axially relative to the suspension member to rotate the support hoop as a whole about an axis perpendicular to the longitudinal axis; and

wherein the outer wire and inner wire are attached at their distal-most tips to the first and second circumferential points, respectively, and the inner wire has a stiffness sufficient to avoid buckling while rotating the frame.

10. The apparatus of claim 9, wherein the blood permeable sac comprises a biocompatible material.

11. The apparatus of claim 9, wherein the blood permeable sac comprises a plurality of pores.

12. The apparatus of claim 9, wherein the support hoop includes an articulation region.

13. The apparatus of claim 9, wherein the apparatus has a deployed state in which the support hoop is configured to engage an interior wall of the patient'"'"'s blood vessel, and a delivery state in which the support hoop is configured to permit insertion through a delivery sheath to the interior of the patient'"'"'s blood vessel.

14. The apparatus of claim 9, wherein the elongated member is a guidewire.

15. The medical device of claim 9, wherein the frame is limited to only two attachment points.

16. A medical device comprising:

a cannula having a proximal end, a distal end, and a first lumen therebetween;

an outer wire having a second lumen and dimensioned to pass through the first lumen;

an inner wire having a longitudinal axis, said inner wire disposed axially through the second lumen, whereby the outer wire is displaceable axially relative to the inner wire;

a frame fixedly attached at a first point on the frame to a distal end of the outer wire, and fixedly attached at a second point on the frame to a distal end of the inner wire, wherein the second point is positioned at least 30 degrees from the first point and wherein the outer wire and inner wire extend, starting from the first and second points respectively, in a generally proximal direction;

wherein axial displacement of the outer wire relative to the inner wire causes rotation of the frame as a whole about a rotation axis perpendicular to the longitudinal axis; and

wherein the outer wire and inner wire are attached at their distal-most tips to the first and second circumferential points, respectively, and the inner wire has a stiffness sufficient to avoid buckling while rotating the frame.

17. The medical device of claim 16, wherein the cannula is an arterial return cannula.

18. The medical device of claim 16, wherein the proximal end of the cannula branches into an arterial return lumen and a side port.

19. The medical device of claim 18, wherein the side port has a third lumen that merges and communicates with the first lumen of the cannula.

20. The medical device of claim 18, wherein the side port has a third lumen that extends distally and remains separate from the first lumen of the cannula.

21. The medical device of claim 16, wherein the frame is inserted through the first lumen of the cannula.

22. The medical device of claim 16, wherein the frame further comprises a filter mesh disposed about the frame.

23. The medical device of claim 16, wherein the frame further comprises an impermeable membrane disposed about the frame.

24. The medical device of claim 16, wherein the first point attaches to a first lateral edge of the frame and the second point attaches a second lateral edge of the frame wherein the first and second lateral edges are on corresponding opposite sides of the longitudinal axis.

25. The medical device of claim 16, wherein rotation of the whole frame is unidirectional.

26. The medical device of claim 16, wherein the rotation axis is perpendicular to a plane that extends through the longitudinal axis and at least one of the first and second points.

27. The medical device of claim 16, wherein the frame is limited to only two attachment points.

28. A medical device comprising:

a cannula having a proximal end, a distal end, and a first lumen therebetween;

an outer wire having a second lumen and dimensioned to pass through the first lumen;

an inner wire having a longitudinal axis, said inner wire disposed axially through the second lumen, whereby the outer wire is displaceable axially relative to the inner wire;

a frame fixedly attached at a first point on the frame to a distal end of the outer wire, and fixedly attached at a second point on the frame to a distal end of the inner wire, wherein the second point is positioned at least 30 degrees from the first point and wherein the outer wire and inner wire are attached at their distal-most tips to the first and second points, respectively, and the inner wire has a stiffness sufficient to avoid buckling while rotating the frame P1 wherein axial displacement of the outer wire relative to the inner wire causes rotation of the frame as a whole about a rotation axis perpendicular to the longitudinal axis.