Expandable medical device with improved spatial distribution

• US 20020068969A1
• Filed: 09/07/2001
• Published: 06/06/2002
• Est. Priority Date: 10/16/2000
• Status: Active Grant

• Current Assignee: Innovational Holdings, LLC
• Original Assignee: Conor Medsystems Incorporated
• Inventors: Eigler, Neal L., Shanley, John F., Edelman, Elazer R.
• Granted Patent: US 6,764,507 B2
• Time in Patent Office: Days
• US Class Current: 623/1.16
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2250/0004 adjustable
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir

Abstract

An expandable medical device having a plurality of elongated struts, the plurality of elongated struts being joined together by ductile hinges to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter. The plurality of struts and ductile hinges are arranged to improve the spatial distribution of the struts which is particularly important when delivering beneficial agents with the struts. The improved strut arrangement expands to a substantially parallelogram shape for improved beneficial agent distribution to the surrounding tissue. A beneficial agent may be loaded into openings within the struts or coated onto the struts for delivery to the tissue.

Claims

1. An expandable medical device comprising:

a plurality of elongated struts, the plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, wherein adjacent ones of the plurality of elongated struts are substantially parallel when the cylinder is at the first diameter and the adjacent elongated struts form V-shapes when the cylinder is at the second diameter; and

a plurality of pivots joining the plurality of struts together in the substantially cylindrical device, wherein only one pivot interconnects each two adjacent elongated struts and the pivots are each located offset from a line bisecting the V-shapes formed by the elongated struts when the cylinder is at the second diameter.

2. The device of claim 1, wherein the elongated struts are substantially L-shaped struts and the plurality of pivots connect an end of a short leg of the L-shaped strut to an end of a long leg of an adjacent L-shaped strut.

3. The device of claim 2, wherein an orientation of every other adjacent L-shaped strut is inverted with respect to the remaining L-shaped struts.

4. The device of claim 2, wherein the L-shaped struts are nested and the long legs of the L-shaped struts are substantially parallel when the cylinder is at the first diameter.

5. The device of claim 1, wherein the plurality of pivots are ductile hinges and wherein a width of the ductile hinges is smaller than a width of the elongated struts.

6. The device of claim 5, wherein the ductile hinges are tapered.

7. The device of claim 5, wherein the ductile hinges have a taper of about 0.1 to about 0.2 inches per inch.

8. An expandable medical device comprising:

a plurality of elongated struts, the plurality of elongated struts joined together to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, wherein adjacent ones of the plurality of elongated struts are substantially parallel when the cylinder is at the first diameter and the adjacent elongated struts form V-shapes when the cylinder is at the second diameter; and

a plurality of ductile hinges connecting the plurality of struts together in the substantially cylindrical device, wherein only one ductile hinge interconnects each two adjacent elongated struts and the ductile hinges are each located offset from a line bisecting the V-shapes formed by the elongated struts when the cylinder is at the second diameter, the ductile hinges having a hinge width which is smaller than a strut width such that as the device is expanded from the first diameter to the second diameter the ductile hinges experience plastic deformation while the struts are not plastically deformed.

9. The device of claim 8, wherein the elongated struts are substantially L-shaped struts and the plurality of ductile hinges connect an end of a short leg of the L-shaped strut to an end of a long leg of an adjacent L-shaped strut.

10. The device of claim 9, wherein an orientation of every other adjacent L-shaped strut is inverted with respect to the remaining L-shaped struts.

11. The device of claim 9, wherein the L-shaped struts are nested and the long legs of the L-shaped struts are substantially parallel when the cylinder is at the first diameter.

12. The device of claim 9, wherein the ductile hinges are tapered.

14. The device of claim 13, wherein portions of the plurality of bridging members are configured to remain substantially parallel during expansion.

15. The device of claim 13, wherein the plurality of cylindrical members further comprise a beneficial agent for delivery to tissue.

16. The device of claim 15, wherein the beneficial agent is in the form of a coating.

17. The device of claim 15, wherein the beneficial agent is provided in openings in the plurality of cylindrical members.

18. The device of claim 15, wherein the beneficial agent is paclitaxel, or an analogue or derivative thereof.

19. The device of claim 15, wherein the beneficial agent is rapamycin, or an analogue or derivative thereof.

20. The device of claim 15, wherein the plurality of bridging members further comprise a beneficial agent for delivery to tissue.

21. The device of claim 13, wherein the expandable device is configured for radial expansion while an overall length of the device remains substantially constant.

22. The device of claim 13, wherein adjacent ones of the plurality of cylindrical members are inverted.

24. The device of claim 23, wherein portions of the plurality of bridging members are configured to remain substantially parallel during expansion.

25. The device of claim 23, wherein the plurality of cylindrical members further comprise a beneficial agent for delivery to tissue.

26. The device of claim 23, wherein the expandable device is configured for radial expansion while an overall length of the device remains substantially constant.

28. The device of claim 27, wherein the beneficial agent is affixed in a plurality of openings formed in the plurality of elongated struts.

29. The device of claim 27, wherein the beneficial agent is coated on the plurality of struts.

30. The device of claim 27, wherein the plurality of elongated struts are arranged to form a plurality of chevrons having alternating orientations.

31. The device of claim 27, wherein the plurality of elongated struts are interconnected with bridging elements to form the substantially parallelogram shapes.

13. An expandable medical device comprising:

a plurality of cylindrical members which are expandable from a cylinder having a first diameter to a cylinder having a second diameter, each of the plurality of cylindrical members comprising;

a plurality of L-shaped struts; and

,

a plurality of ductile hinges, wherein each of the plurality of L-shaped struts is joined to an adjacent L-shaped strut by a ductile hinge, and wherein a width of the ductile hinges is smaller than a width of the L-shaped struts such that as the plurality of cylindrical members are expanded from the first diameter to the second diameter the ductile hinges experience plastic deformation while the L-shaped struts are not plastically deformed; and

a plurality of bridging members connecting the L-shaped struts of adjacent cylindrical members to form an expandable device configured for radial expansion while a longitudinal distance between ends of the plurality of cylindrical members does not increase.

23. An expandable medical device comprising:

a plurality of struts each having a long leg, a short leg connected to the long leg, and a connecting point, wherein the long leg has a length longer than a length of the short leg;

a plurality of pivots joining the long leg of one strut to the short leg of an adjacent strut to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, wherein as the substantially cylindrical device is expanded from the first diameter to the second diameter the pivots bend; and

a plurality of bridging members connected to the connecting points of struts in one row and to the connecting points of struts in an adjacent row to form an expandable device configured such that a total length of the bridging members remains substantially constant during radial expansion.

27. An expandable medical device comprising:

a plurality of elongated struts, the plurality of elongated struts joined together by pivoting connections to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, wherein adjacent ones of the plurality of elongated struts are substantially parallel when the cylinder is at the first diameter and the adjacent elongated struts form a plurality of substantially parallelogram shapes when the cylinder is at the second diameter.

32. An expandable medical device for delivery of a beneficial agent, the device comprising:

a plurality of elongated struts, the plurality of elongated struts joined together by pivoting connections to form a substantially cylindrical device which is expandable from a cylinder having a first diameter to a cylinder having a second diameter, wherein adjacent ones of the plurality of elongated struts are substantially parallel when the cylinder is at the first diameter and the adjacent elongated struts form a plurality of substantially parallelogram shapes when the cylinder is at the second diameter;

a beneficial agent affixed to the plurality of struts for delivery to tissue.

33. The device of claim 32, wherein the beneficial agent is affixed in a plurality of openings formed in the plurality of elongated struts.

34. The device of claim 32, wherein the beneficial agent is coated on the plurality of struts.

35. The device of claim 32, wherein the plurality of elongated struts are arranged to form a plurality of chevrons having alternating orientations.

36. The device of claim 32, wherein the plurality of elongated struts are interconnected with bridging elements to form the substantially parallelogram shapes.

37. The device of claim 32, wherein the expandable medical device has a coverage ratio of about 12% to about 20%.

38. The device of claim 32, wherein the beneficial agent is paclitaxel, or an analogue or derivative thereof.

39. The device of claim 32, wherein the beneficial agent is rapamycin, or an analogue or derivative thereof.