Intralumenally implantable frames

• US 20070021826A1
• Filed: 07/17/2006
• Published: 01/25/2007
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Flagle, Jacob, Case, Brian, Garrison, Michael
• Granted Patent: US 7,658,759 B2
• Time in Patent Office: Days
• US Class Current: 623/1.150
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• 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 2002/91575 connected peak to trough
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0054 V-shaped

Abstract

Implantable frames for use in body passages are provided herein. The implantable frames comprise one or more of certain preferred structural features that are generally applicable to frames comprising a plurality of curved and straight member portions that together define an interior lumen extending along a longitudinal axis between a proximal end and a distal end. The implantable frames have an exterior surface comprising a plurality of openings between the interior lumen and the exterior surface, and preferably include one or more undulating hoop members attached to one or more longitudinal connecting members. The implantable frames can be formed from any suitable material, but preferably comprise material permitting the frame to radially self-expand from a radially compressed configuration to a radially expanded configuration. The implantable frames are useful for endolumenal implantation within a body vessel, for example as a stent or as a support frame of an implantable valve.

Claims

1. An implantable frame defining a substantially cylindrical lumen extending between a proximal end and a distal end along a longitudinal axis, the implantable frame having an exterior surface area with a plurality of openings, the implantable frame moveable between a compressed configuration and an expanded configuration, the implantable frame comprising:

a proximal undulating hoop member having plurality of struts and bends, a distal undulating hoop member having a plurality of struts and bends, and a plurality of longitudinal connecting members connecting the proximal undulating hoop member to the distal undulating hoop member;

where each longitudinal connecting member is connected to at least one bend of the proximal undulating hoop member and at least one bend of the distal undulating hoop member; and

where the ratio between the length of the implantable frame and the length of the longitudinal connecting members is about 1.50 to about 2.00, the length of the implantable frame measured from the inflection point of the most distal bend in the distal hoop member and the inflection point of the most proximal bend in the proximal hoop member.

2. The implantable frame of claim 1, wherein the ratio is between about 1.65 and 1.75.

3. The implantable frame of claim 1, wherein each bend of the proximal undulating hoop member is attached to at least one longitudinal connecting member.

4. The implantable frame of claim 1, wherein the proximal undulating hoop member comprises a first array of (n) bends positioned longitudinally proximal to a second array of up to (n/2) bends;

and the distal proximal undulating member comprises a third array of up to (n/2) bends positioned longitudinally proximal to a fourth array of (n) bends, where (n) is an integer equal to 2 or greater.

5. The implantable frame of claim 1, where the longitudinal connecting members have substantially equal length, and where the implantable frame comprises at least one closely-spaced pair of circumferentially adjacent longitudinal connecting members, where the distance between the closely paired longitudinal connecting members is less than about 25% of the length of the pair of longitudinal connecting members.

6. The implantable frame of claim 1, the implantable frame having an external surface area in the expanded configuration that comprises a pair of mirror image interstitial openings symmetrically positioned with respect to the longitudinal axis of the implantable frame, each interstitial opening perimetrically defined by the proximal undulating hoop joined to the distal undulating hoop by a pair of circumferentially adjacent longitudinal connecting members.

7. The implantable frame of claim 1, where the proximal undulating hoop member comprises a first strut and a second strut connected by a single bend, and further comprising a proximal bridging member connecting the first strut and the second strut.

8. The implantable frame of claim 1, wherein the implantable frame is self-expanding.

9. The implantable frame of claim 1, wherein the implantable frame in the expanded configuration is characterized by two or more symmetry planes containing the longitudinal axis of the implantable frame.

10. The implantable frame of claim 1, where the longitudinal connecting members have substantially equal length, and where the implantable frame comprises (n) closely-spaced pairs of circumferentially adjacent longitudinal connecting members, where the distance between the closely paired longitudinal connecting members is less than about 25% of the length of the pair of longitudinal connecting members, (n) being an integer of 1-8.

11. The implantable frame of claim 1, where the implantable frame comprises a plurality of substantially parallel longitudinal connecting members each having a substantially equal length and each extending between a proximal hoop member and a distal hoop member, including a first longitudinal connecting member circumferentially adjacent to a second longitudinal connecting member, the second longitudinal connecting member positioned between the first longitudinal connecting member and a third longitudinal connecting member, wherein

a. the circumferential distance between the first longitudinal connecting member and the second longitudinal connecting member is less than about 25% of the length of the longitudinal connecting members;

and

b. the circumferential distance between the first longitudinal connecting member and the third longitudinal connecting member is greater than 25% of the length of the longitudinal connecting members

12. The implantable frame of claim 1, where the proximal hoop member comprises a first strut, the plurality of longitudinal connecting members have a substantially equal length and include a first longitudinal connecting member extending between the proximal hoop member and the distal hoop member, and the proximal undulating hoop member comprises a first bend having a semi-circular configuration extending between the first longitudinal connecting member and the first strut, the first bend subtending an arc having a radius centered on the distal side of the proximal hoop member.

13. The implantable frame of claim 12, where each longitudinal connecting member is substantially parallel to the longitudinal axis, and the first bend subtends an angle of between about 135°

and about 175°

between the first longitudinal connecting member and the first strut segment.

14. An implantable frame defining a substantially cylindrical lumen extending between a proximal end and a distal end along a longitudinal axis, the implantable frame having an exterior surface area with a plurality of openings, the implantable frame comprising:

a proximal undulating hoop member having plurality of struts and bends, including a first strut segment;

a distal undulating hoop member having a plurality of struts and bends; and

a plurality of longitudinal connecting members of substantially equal length connecting the proximal undulating hoop member and the distal undulating hoop member, including a first longitudinal connecting member extending between the proximal hoop member and the distal hoop member, the proximal undulating hoop member comprising a first bend having a semi-circular configuration extending between the first longitudinal connecting member and the first strut, the first bend subtending an arc having a radius centered on the distal side of the proximal hoop member or on the proximal side of the distal hoop member.

15. The implantable frame of claim 14, where each longitudinal connecting member is substantially parallel to the longitudinal axis, and the first bend subtends an angle of between about 135°

and about 175°

between the first longitudinal connecting member and the first strut segment.

16. The implantable frame of claim 14, where the implantable frame comprises no more than two hoop members and the ratio between the length of the implantable frame and the length of the first longitudinal connecting member is between about 1.5 and about 2.0, the length of the implantable frame measured from the inflection point of the most distal bend in the distal hoop member and the inflection point of the most proximal bend in the proximal hoop member.

17. The implantable frame of claim 14, where the implantable frame comprises a shape memory metal.

18. An implantable frame defining a substantially cylindrical lumen extending between a proximal end and a distal end along a longitudinal axis, the implantable frame having an exterior surface area with a plurality of openings, the implantable frame comprising:

a plurality of substantially parallel longitudinal connecting members each having a substantially equal length and each extending between a proximal hoop member and a distal hoop member, including a first longitudinal connecting member circumferentially adjacent to a second longitudinal connecting member, the second longitudinal connecting member circumferentially positioned between the first longitudinal connecting member and a third longitudinal connecting member, wherein

a. the circumferential distance between the first longitudinal connecting member and the second longitudinal connecting member is less than about 25% of the length of the longitudinal connecting members; and

b. the circumferential distance between the first longitudinal connecting member and the third longitudinal connecting member is greater than 25% of the length of the longitudinal connecting members.

19. The implantable frame of claim 18, where the ratio between the length of the implantable frame and the length of the longitudinal connecting members is about 1.50 and about 2.00, the length of the implantable frame measured from the inflection point of the most distal bend in the distal hoop member and the inflection point of the most proximal bend in the proximal hoop member.

20. The implantable frame of claim 18, where the implantable frame has (2i) symmetry planes containing the longitudinal axis, and (4i) to (8i) longitudinal connecting members, where (i) is an integer equal to 1 or greater.