Intralumenally-implantable frames

• US 7,625,399 B2
• Filed: 10/10/2006
• Issued: 12/01/2009
• Est. Priority Date: 04/24/2003
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated)
• Inventors: Case, Brian C., Flagle, Jacob A., Garrison, Michael L.
• Primary Examiner(s): McDermott; Corrine M
• Assistant Examiner(s): STEWART, JASON-DENNIS NEILKEN
• Application Number:
  US11/545,746
• Publication Number:
  US 20070038291A1
• Time in Patent Office: 1,148 Days
• Field of Search: 623 115- 117, 623/1.32, 623/1.24, 623/1.22
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• 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 2002/068 Modifying the blood flow model, e.g. by diffuser or deflector
• CPC Class Codes: A61F 2002/91508 the meander having a difference in amplitude along the band
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• 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 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0037 differing in height or in length
• CPC Class Codes: A61F 2250/0039 differing in diameter

Abstract

Implantable frames for use in body passages are provided herein. The implantable frames can include a plurality of hoop members joined by a plurality of longitudinal connecting members to form a tubular frame defining a cylindrical lumen. The plurality of longitudinal connecting members may include one or more pairs of closely-spaced longitudinal connecting members aligned substantially parallel to the longitudinal axis of the implantable frame. The circumferential distance between the closely-spaced longitudinal connecting members preferably subtends an angle less than (2π/n) radians, where (n) is an integer equal to the total number of longitudinal connecting members connecting two longitudinally adjacent hoop members.

Claims

1. A method of intraluminally supporting a body vessel comprising the steps of:

inserting an implantable frame into the body vessel in a radially compressed state, translating the implantable frame to a point in the body vessel and expanding the implantable frame within the body vessel to an expanded state, the implantable frame in the expanded state defining a lumen extending between a proximal end and a distal end along a longitudinal axis, the implantable frame having a substantially cylindrical exterior surface area with a plurality of openings, the implantable frame moveable between a compressed state and an expanded state, the implantable frame in the expanded state comprising;

a plurality of longitudinally-spaced hoop members comprising a first hoop member and a second hoop member axially adjacent to the first hoop member, wherein the first and second hoop members comprise a plurality of interconnected struts and bends arranged in an undulating shape; and

a plurality of (n) longitudinal connecting members joining the first hoop member to the second hoop member, the plurality of (n) longitudinal connecting members comprising a first longitudinal connecting member closely-spaced with respect to a separate second longitudinal connecting member such that an angle less than (2π

/n) radians is subtended by a hypothetical arc extending circumferentially along the exterior surface area of the implantable frame between a first radius extending from the longitudinal axis to the first longitudinal connecting member and a second radius extending from the longitudinal axis to the second longitudinal connecting member, where (n) is an integer equal to 2 or greater, the first and second longitudinal connecting members being disposed parallel to each other and extending across an entire space separating the first and second hoop members, wherein the first closely spaced longitudinal connecting member has a first end attached to an apex of a bend connecting circumferentially adjacent struts of the first hoop member, and the second closely spaced longitudinal connecting member has a first end attached to the same apex of the same bend connecting circumferentially adjacent struts of the first hoop member.

2. The method of claim 1, wherein the first hoop member and the second hoop member are joined by 2-16 longitudinal connecting members of substantially equal length.

3. The method of claim 2, wherein n is an integer equal to 8-16, and each hoop member includes (n/2) pairs of closely-spaced longitudinal connecting members.

4. The method of claim 2, wherein the plurality of hoop members consists of the first hoop member and the second hoop member.

5. The method of claim 1, wherein the first hoop member has a total of (m) struts and the plurality of longitudinal connecting members includes a total of (2m) longitudinal connecting members connected to the first hoop member, wherein (in) is an integer equal to 2-8.

6. The method of claim 1, wherein each pair of closely spaced longitudinal connecting members is symmetrically positioned across the lumen from an opposably positioned pair of closely spaced longitudinal connecting members.

7. The method of claim 1, wherein each of the plurality of hoop members have a substantially equal radius and are concentrically aligned along the longitudinal axis.

8. The method of claim 1, wherein each of the plurality of hoop members have a ratio of bends to struts of 2:

1 to 3;

1.

9. The method of claim 1, wherein each of the bends in the first hoop member is connected to at least one longitudinal connecting member.

10. The method of claim 1, wherein each longitudinal connecting member is substantially equal in length and is positioned substantially parallel to the longitudinal axis when the frame is in the expanded state.

11. The method of claim 1, where the implantable frame comprises at least one closely spaced pair of longitudinal connecting members, where the shortest circumferential distance between the closely paired longitudinal connecting members is less than about 15% of the length of the closely spaced pair of longitudinal connecting members.

12. The method of claim 1, wherein the plurality of longitudinal connecting members consists of a plurality of pairs of substantially parallel, closely-spaced longitudinal connecting members joining the first hoop member and the second hoop member.

13. The method of claim 1, wherein the frame further comprises at least one longitudinal attachment member attached to the first hoop member, where the longitudinal attachment member is not connected to the second ring.

14. The method of claim 13, wherein the longitudinal attachment member is positioned circumferentially between a pair of closely spaced longitudinal connecting members.

15. The method of claim 1, wherein the frame further comprises a lateral support arm connecting a first strut of the first hoop member to a second strut of the first hoop member, wherein the first strut is circumferentially adjacent to the second strut.

16. The method of claim 1, wherein the implantable frame includes a bioactive agent.

17. The method of claim 1, wherein the implantable frame is expanded within a vein and the implantable frame has two hoop members each having an equal number of struts of substantially equal length;

wherein each hoop member has a total of (m) struts and the plurality of longitudinal connecting members includes a total of (2m) longitudinal connecting members connected to each hoop member, wherein (m) is an integer equal to 2-8;

wherein each of the hoop members has a substantially equal radius and are concentrically aligned along the longitudinal axis;

wherein each of the plurality of hoop members have a ratio of bends to struts of 2;

1 to 3;

1;

wherein each of the bends in the first hoop member is connected to at least one longitudinal connecting member;

wherein the shortest circumferential distance between the closely paired longitudinal connecting members is less than about 15% of the length of the closely spaced pair of longitudinal connecting members;

wherein the frame further comprises at least one longitudinal attachment member attached to the first hoop member, where the longitudinal attachment member does not connect the first hoop member to another hoop member;

wherein the longitudinal attachment member is positioned both longitudinally and circumferentially between a pair of separate closely spaced longitudinal connecting members attached to the same bend of at least one hoop member;

wherein the frame further comprises a lateral support arm connecting a first strut of the first hoop member to a second strut of the first hoop member, wherein the first strut is circumferentially adjacent to the second strut; and

wherein the lateral support arm comprises a single bend connecting a pair of lateral support struts.

18. The method of claim 1, wherein the first closely spaced longitudinal connecting member has a second end attached to a strut interconnection member connecting two circumferentially adjacent struts of the second hoop member, and the second closely spaced longitudinal connecting member has a second end attached to the same strut interconnection member connecting circumferentially adjacent struts of the second hoop member, the strut interconnection member comprising:

a first bend extending from the second ends of the first and second closely spaced longitudinal connecting members; and

a second bend extending from the second end of the first closely spaced longitudinal connecting member to one of the circumferentially adjacent struts; and

a third bend extending from the second end of the second closely spaced longitudinal connecting member to the other circumferentially adjacent struts.

19. A method of intraluminally supporting a body vessel comprising the steps of:

inserting an implantable frame into the body vessel in a radially compressed state, translating the implantable frame to a point within a vein and expanding the implantable frame within the vein to an expanded state, the implantable frame defining a lumen extending between a proximal end and a distal end along a longitudinal axis, the implantable frame having a substantially cylindrical exterior surface area with a plurality of openings, the implantable frame moveable between a compressed state and an expanded state, the implantable frame comprising;

a first undulating hoop member and a second undulating hoop member axially adjacent to the first undulating hoop member, the first and second hoop members comprising a plurality of interconnected struts and bends arranged in an undulating shape; and

a plurality of (n) longitudinal connecting members joining the first undulating hoop member to the second undulating hoop member, the plurality of (n) longitudinal connecting members comprising a first longitudinal connecting member closely spaced with respect to a separate second longitudinal connecting member such that an angle less than (2π

/n) radians is subtended by a hypothetical arc extending circumferentially along the exterior surface area of the implantable frame between a first radius extending from the longitudinal axis to the first longitudinal connecting member and a second radius extending from the longitudinal axis to the second longitudinal connecting member, where (n) is an integer equal to 4-12, the first and second longitudinal connecting members being disposed parallel to each other and extending across an entire space separating the first and second hoop members, wherein the first closely spaced longitudinal connecting member has a first end attached to an apex of a bend connecting circumferentially adjacent struts of the first hoop member, and the second closely spaced longitudinal connecting member has a first end attached to the same apex of the same bend connecting circumferentially adjacent struts of the first hoop member.

20. The method of claim 19, wherein the first closely spaced longitudinal connecting member has a second end attached to a strut interconnection member connecting two circumferentially adjacent struts of the second hoop member, and the second closely spaced longitudinal connecting member has a second end attached to the same strut interconnection member connecting circumferentially adjacent struts of the second hoop member, the strut interconnection member comprising:

a first bend extending from the second ends of the first and second closely spaced longitudinal connecting members; and

a second bend extending from the second end of the first closely spaced longitudinal connecting member to one of the circumferentially adjacent struts; and

a third bend extending from the second end of the second closely spaced longitudinal connecting member to the other circumferentially adjacent struts.

21. A method of implanting a medical device within a body vessel comprising the steps of:

a. providing an implantable frame in a radially compressed configuration, the implantable frame defining a cylindrical lumen centered around a longitudinal axis, the implantable frame comprising a first hoop member joined to a second hoop member longitudinally adjacent to the first hoop member by a plurality of (n) longitudinal connecting members, the first and second hoop members comprising a plurality of interconnected struts and bends arranged in an undulating shape, wherein the plurality of longitudinal connecting members are oriented substantially parallel to the longitudinal axis and comprising a first longitudinal connecting member closely spaced with respect to a separate second longitudinal connecting member, such that an angle less than (2π

/n) radians is subtended by a hypothetical arc extending circumferentially along the exterior surface area of the implantable frame between a first radius extending from the longitudinal axis to the first longitudinal connecting member and a second radius extending from the longitudinal axis to the second longitudinal connecting member, where (n) is an integer equal to 2 or greater, the first and second longitudinal connecting members being disposed parallel to each other and extending across an entire space separating the first and second hoop members, wherein the first closely spaced longitudinal connecting member has a first end attached to an apex of a bend connecting circumferentially adjacent struts of the first hoop member, and the second closely spaced longitudinal connecting member has a first end attached to the same apex of the same bend connecting circumferentially adjacent struts of the first hoop member;

b. placing the radially compressed implantable frame within a vein; and

c. expanding the implantable frame within the vein to place the implantable frame at a point of treatment within the vein.

22. The method of claim 21, wherein the first closely spaced Longitudinal connecting member has a second end attached to a strut interconnection member connecting two circumferentially adjacent struts of the second hoop member, and the second closely spaced longitudinal connecting member has a second end attached to the same strut interconnection member connecting circumferentially adjacent struts of the second hoop member, the strut interconnection member comprising:

a first bend extending from the second ends of the first and second closely spaced longitudinal connecting members; and

a second bend extending from the second end of the first closely spaced longitudinal connecting member to one of the circumferentially adjacent struts; and

a third bend extending from the second end of the second closely spaced longitudinal connecting member to the other circumferentially adjacent struts.