Vascular catheter, system, and method

• US 20060173475A1
• Filed: 02/01/2005
• Published: 08/03/2006
• Est. Priority Date: 02/01/2005
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Jenson, Mark L., Drasler, William J., Lafontaine, Daniel M.
• Granted Patent: US 7,854,755 B2
• Time in Patent Office: Days
• US Class Current: 606/159
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/22097 Valve removal in veins
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts

Abstract

A catheter including an elongate body, a first cutting head and a second cutting head both having a blade, where the blades moves relative each other to provide a shearing action for cardiac tissue. The catheter can further include a stent positioned over an inflatable balloon, where the inflatable balloon can deploy the expandable stent over sheared cardiac tissue. The catheter can further be included in a system having a sheath, where at least a part of the catheter resides in the lumen of the sheath. The sheath further includes a cardiac valve and an expandable filter. The sheath can move relative the cardiac valve and the expandable filter to deploy the cardiac valve and at least a portion of the expandable filter proximal the inflatable balloon and the expandable stent.

Claims

1. A catheter, comprising:

an elongate body having a first lumen extending between a proximal end and a distal end of the elongate body;

a first cutting head having a blade and an elongate pulling member, the first cutting head positioned proximal the distal end of the elongate body with the elongate pulling member extending through the first lumen, wherein the elongate pulling member slides within the first lumen to move the first cutting head relative the distal end of the elongate body; and

a second cutting head having a blade, the second cutting head positioned adjacent the distal end of the elongate body between the distal end and the first cutting head, where the blade of the first cutting head moves relative the blade of the second cutting head to provide a shearing action for cardiac tissue.

2. The catheter of claim 1, the second cutting head further including an elongate pushing member, wherein elongate pushing member slides within the first lumen to move the second cutting head relative the distal end of the elongate body and the first cutting head, the elongate pulling member arranged concentrically with the elongate pushing member in the first lumen.

3. The catheter of claim 1, wherein the first cutting head includes a first end and a second end, the second end having the blade with a cutting edge, and wherein the second cutting head has the blade with a cutting edge in alignment with the cutting edge of the blade of the first cutting head, the first cutting head moving relative the second cutting head to slide the cutting edge of the blade of the first cutting head past the cutting edge of the blade of the second cutting head.

4. The catheter of claim 3, wherein the first cutting head has a conical shape with the first end having a diameter less than the second end.

5. The catheter of claim 1, wherein the elongate body further includes;

a second lumen extending between the proximal end and the distal end of the elongate body;

an inflatable balloon positioned adjacent the distal end of the elongate body and proximal to the second cutting head, the inflatable balloon in fluid tight communication with the second lumen; and

an expandable stent positioned over at least a portion of the inflatable balloon, where the inflatable balloon deploys the expandable stent over sheared cardiac tissue.

6. The catheter of claim 5, further including an annular push ring positioned between the second cutting head and the inflatable balloon for contacting and moving at least a portion of the sheared cardiac tissue.

7. The catheter of claim 5, further including:

a sheath having a lumen, wherein at least part of the elongate body resides in the lumen of the sheath;

a cardiac valve including a support frame having an outer surface, an inner surface defining a lumen and a cover over at least the outer surface of the support frame, the cover includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen of the cardiac valve, the cardiac valve releasably positioned within the lumen of the sheath with the elongate body of the catheter extending through the lumen and the reversibly sealable opening; and

an expandable filter positioned within the lumen of the sheath adjacent the elongate body and proximal the cardiac valve, wherein the sheath moves relative the cardiac valve and the expandable filter to deploy the cardiac valve and at least a portion of the expandable filter proximal the inflatable balloon and the expandable stent.

8. The catheter of claim 7, wherein the support frame of the cardiac valve expands to increase a diameter of the lumen as the sheath moves relative the cardiac valve and the expandable filter to deploy the cardiac valve.

9. The catheter of claim 7, further including a retention line releasably coupled to the support frame, wherein the retention line extends through the lumen of the sheath past the proximal end of the elongate body.

10. The catheter of claim 7, wherein the sheath includes a first sheath end and a second sheath end, the first sheath end positioned between the inflatable balloon and the second sheath end, and wherein the expandable filter includes a first filter end adjacent the first sheath end, the first filter end having a first diameter when positioned between the sheath and the elongate body that expands to a second diameter when the sheath moves relative the cardiac valve and the expandable filter to deploy at least the first filter end.

11. An system, comprising:

an elongate catheter body having a first lumen and a second lumen extending between a proximal end and a distal end of the elongate body;

a first cutting head having a blade and an elongate pulling member, the first cutting head positioned proximal the distal end of the elongate body with the elongate pulling member extending through the first lumen, wherein the elongate pulling member slides within the first lumen to move the first cutting head relative the distal end of the elongate body;

a second cutting head having a blade, the second cutting head positioned adjacent the distal end of the elongate body between the distal end and the first cutting head;

an inflatable balloon positioned adjacent the distal end of the elongate body and proximal to the second cutting head, the expandable balloon member in fluid tight communication with the second lumen;

an expandable stent positioned over at least a portion of the inflatable balloon, where the blade of the first cutting head moves relative the blade of the second cutting head to provide a shearing action for cardiac tissue and the inflatable balloon deploys the expandable stent over sheared cardiac tissue;

a sheath having a lumen, wherein at least part of the elongate body resides in the lumen of the sheath;

a cardiac valve including a support frame having an outer surface, an inner surface defining a lumen and a cover over at least the outer surface of the support frame, the cover includes surfaces defining a reversibly sealable opening for unidirectional flow of a liquid through the lumen of the cardiac valve, wherein the cardiac valve releasably positioned within the lumen of the sheath and has the elongate body of the catheter extending through the lumen and the reversibly sealable opening; and

an expandable filter positioned within the lumen of the sheath adjacent the elongate body and proximal the cardiac valve, wherein the sheath moves relative the cardiac valve and the expandable filter to deploy the cardiac valve and at least a portion of the expandable filter proximal the inflatable balloon and the expandable stent.

12. The system of claim 11, wherein the first cutting head includes a first end and a second end, the second end having the blade with a cutting edge, and wherein the second cutting head includes the blade with a cutting edge in alignment with the cutting edge of the blade of the first cutting head, the first cutting head moving relative the second cutting head to slide the first cutting edge past the second cutting edge.

13. The system of claim 12, wherein the first cutting head has a conical shape with the first end having a diameter less than the second end.

14. The system of claim 11, the second cutting head further including an elongate pushing member, wherein elongate pushing member slides within the first lumen to move the second cutting head relative the distal end of the elongate body and the first cutting head, the elongate pulling member arranged concentrically with the elongate pushing member in the first lumen.

15. The system of claim 11, further including an annular push ring positioned between the second cutting head and the inflatable balloon for contacting and moving at least a portion of the sheared cardiac tissue.

16. The system of claim 11, wherein the support frame of the cardiac valve expands to increase a diameter of the lumen as the sheath moves relative the cardiac valve and the expandable filter to deploy the cardiac valve.

17. The system of claim 11, further including a retention line releasably coupled to the support frame, wherein the retention line extends through the lumen of the sheath past the proximal end of the elongate body.

18. The system of claim 11, wherein the sheath includes a first sheath end and a second sheath end, the first sheath end positioned between the inflatable balloon and the second sheath end, and wherein the expandable filter includes a first filter end adjacent the first sheath end, the first filter end having a first diameter when positioned between the sheath and the elongate body that expands to a second diameter when the sheath moves relative the cardiac valve and the expandable filter to deploy at least the first filter end.

19. A method, comprising:

positioning at least part of a catheter having a first cutting head with a blade and a second cutting head with a blade at a predetermined location; and

moving the blade of the first cutting head relative the blade of the second cutting head to shear cardiac tissue at the predetermined location.

20. The method of claim 19, further including inflating an inflatable balloon to deploy an expandable stent over sheared cardiac tissue.

21. The method of claim 20, wherein the catheter further includes a sheath having a cardiac valve and an expandable filter at least partially housed within the sheath, wherein the method further includes:

deploying the cardiac valve and at least a portion of the expandable filter from the sheath proximal the inflatable balloon and the expandable stent.

22. The method of claim 20, wherein moving the blade of the first cutting head relative the blade of the second cutting head includes:

shearing a cardiac valve leaflet of the cardiac tissue; and

moving the sheared cardiac valve leaflet with the catheter.

23. The method of claim 22, wherein moving the sheared cardiac valve leaflet with the catheter includes:

moving the sheared cardiac tissue with an annular push ring positioned between the second cutting head and the inflatable balloon.

24. The method of claim 19, wherein positioning at least part of the catheter at the predetermined location positioning at least part of the catheter at least partially within an artery.

25. The method of claim 20, wherein positioning at least part of the catheter at the predetermined location positioning at least part of the catheter at least partially within an aorta;

and

moving the blade of the first cutting head relative the blade of the second cutting head to shear at least one aortic valve leaflet.

26. The method of claim 25, wherein inflating the inflatable balloon to deploy the expandable stent includes inflating the inflatable balloon to deploy the expandable stent over the sheared at least one aortic valve leaflet.

27. A method, comprising:

providing an elongate body having a first lumen and a second lumen extending between a proximal end and a distal end of the elongate body;

positioning a first cutting head having a blade proximal the distal end of the elongate body;

positioning a second cutting head having a blade adjacent the distal end of the elongate body between the distal end and the first cutting head;

positioning an inflatable balloon adjacent the distal end of the elongate body and proximal to the second cutting head, the expandable balloon member in fluid tight communication with the second lumen; and

positioning an expandable stent over at least a portion of the inflatable balloon, where the blade of the first cutting head moves relative the blade of the second cutting head to provide a shearing action.

28. The method of claim 27, wherein the first cutting head further includes an elongate pulling member, wherein positioning the first cutting head includes extending the elongate pulling member through the first lumen such that the elongate pulling member slides within the first lumen to move the first cutting head relative the distal end of the elongate body.

29. The method of claim 27, wherein the second cutting head further including an elongate pushing member, wherein positioning the second cutting head includes extending the elongate pushing member through the first lumen such that the elongate pushing member slides within the first lumen to move the second cutting head relative the distal end of the elongate body and the first cutting head.

30. The method of claim 27, further including positioning an annular push ring positioned between the second cutting head and the inflatable balloon.

31. The method of claim 27, further including:

positioning a sheath having a lumen over at least a part of the elongate body;

positioning a cardiac valve within the lumen of the sheath; and

positioning an expandable filter within the lumen of the sheath adjacent the elongate body and proximal the cardiac valve, wherein the sheath moves relative the cardiac valve and the expandable filter to deploy the cardiac valve and at least a portion of the expandable filter proximal the inflatable balloon and the expandable stent.