Stent and method and apparatus for forming and delivering the same

• US 5,902,317 A
• Filed: 08/19/1997
• Issued: 05/11/1999
• Est. Priority Date: 06/01/1994
• Status: Expired due to Fees

• Current Assignee: NMT Medical Incorporated
• Original Assignee: Nitinol Medical Technologies Incorporated
• Inventors: Rabkin, Dmitry, Simon, Morris A., Kleshinski, Stephen J.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/912,842
• Time in Patent Office: 630 Days
• Field of Search: 606/194, 606/191, 606/198, 606/192, 606/195, 606/197, 623/1, 623/12, 623/2, 604/96, 604/104
• US Class Current: 623/1.18
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2002/9534 for repositioning of stents
• CPC Class Codes: A61F 2210/0023 operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
• CPC Class Codes: A61F 2210/009 magnetic
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0017 Angular shapes
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A stent comprising a wire skeletal frame, the frame being adapted to assume a first condition in which the frame is relatively rigid and substantially tubular in configuration and a second condition in which the frame is flexible, of reduced stress, and collapsible, such that in the second condition walls of the frame are adapted to be positioned against each other to form a stent diameter substantially equal to the combined thickness of the frame walls in abutting engagement with each other, the frame in its second condition being substantially devoid of bias therein urging the frame to assume the first configuration.

Claims

1. A stent for insertion in a body vessel comprising an elongate body member having a longitudinal axis with a skeletal frame formed to define an elongate chamber which extends through said body member, the skeletal frame being formed to assume a first collapsed configuration toward said longitudinal axis for insertion in said body vessel and to expand radially outward from said collapsed configuration to a second expanded configuration to contact and apply radial force to said body vessel, said skeletal frame further being formed to define a plurality of interconnected open cells with each of said cells including two substantially parallel, spaced side walls which are substantially parallel to said longitudinal axis in both the first collapsed configuration and the second expanded configuration of said skeletal frame and end walls extending between said sidewalls at an angle to said longitudinal axis, said cells being arranged around said elongate chamber with sidewalls of adjacent cells arranged in adjacent coextensive relationship, said cells joined together by an attachment connecting adjacent, coextensive cell sidewalls, this being the only connection between said cells, said skeletal frame further including a first area including cells which are designed differently from cells in at least a second area of said skeletal frame to cause different radial forces to be applied to said body vessel by said first and second areas in the expanded configuration of said skeletal frame.

2. The stent according to claim 1 wherein said cells in said first area of said skeletal frame are larger than the cells in said second area of the skeletal frame.

3. The stent according to claim 1 wherein the endwalls of the cells in said first area of the skeletal frame are formed at a greater angle to the longitudinal axis of said body member than are the endwalls of the cells in the second area of said skeletal frame.

4. A stent comprising an elongate body member having a longitudinal axis and a skeletal frame formed to define an elongate chamber which extends through said body member, the body member being formed of thermal shape memory material which defines a plurality of interconnected, open cells forming the skeletal frame of said body member, each of said cells including two substantially parallel, spaced, straight side portions which are substantially parallel to said longitudinal axis and end wall means extending between said side portions at an angle to said longitudinal axis, said cells being joined together only along the lengths of said straight side portions, the shape memory material having a temperature transformation level above which said skeletal frame assumes a first expanded configuration relative to said longitudinal axis and below which said cell end wall means permit the space between straight side portions of said cell to decrease to permit movement of said straight portions toward said longitudinal axis to collapse said skeletal frame to a second collapsed configuration, said cell end wall means operating at a temperature above said temperature transformation level when said skeletal frame is in the second collapsed configuration to expand the skeletal frame to the first expanded configuration, and sleeve means disposed around said elongate body and operating to expand with said skeletal frame when said skeletal frame assumes said first expanded configuration and to collapse with said skeletal frame when said skeletal frame assumes the second collapsed configuration.

5. A stent for insertion in a body vessel comprising an elongate body means having a longitudinal axis, a first end, a second end, and an elongate chamber extending through said body means between said first and second ends, the body means being formed of thermal shape memory material which is relatively pliable at temperatures below a transition temperature to permit said body means to be collapsed toward said longitudinal axis to a collapsed configuration, for insertion in said body vessel, said thermal shape memory material operating to expand said body means radially outward from said collapsed configuration toward an expanded memory configuration in response to said transition temperature to contact and apply force to said body vessel, said body means operating at said transition temperature to expand said first end radially outwardly from said longitudinal axis for a greater distance than said second end is radially expanded.

6. An expandable cellular device for insertion in a body vessel comprising an elongate skeletal frame formed to define an elongate chamber with a central longitudinal axis, said skeletal frame having a first end and a second end and being formed to assume a first collapsed configuration toward said longitudinal axis when confined for insertion in said body vessel and to expand radially outward from said collapsed configuration to a second expanded configuration when released within said body vessel, the skeletal frame being formed by a plurality of interconnected open cells with the cells adjacent to the first end of said skeletal frame forming a generally cylindrical end section in the second expanded configuration of said skeletal frame, the interconnected cells between said generally cylindrical end section and said second end tapering inwardly toward said central longitudinal axis to form the skeletal frame with a substantially conical section in the second expanded configuration terminating at said second end, said cells in said cylindrical end section being larger in size than the cells in the substantially conical section to cause said skeletal frame in said expanded second configuration to taper inwardly toward said second end.

11. The expandable cellular device of claim 6 wherein said cells in at least said cylindrical end section are formed of thermal shape memory material which is relatively pliable at temperatures below a transition temperature to permit said cylindrical end section to be collapsed toward said longitudinal axis to a collapsed configuration for insertion in said body vessel and which expands radially outward from said collapsed configuration toward an expanded memory configuration in response to temperatures above said transition temperature.

12. The expandable cellular device of claim 11 wherein all cells in said skeletal frame are formed of said thermal shape memory material.

13. The expandable cellular device of claim 11 wherein said cells in said generally cylindrical end section include two spaced, straight side portions and end wall means extending between said side portions at an angle to said central longitudinal axis, said cells in said generally cylindrical end section being joined together only along the lengths of said straight side portions.

7. An expandable cellular device for insertion in a body vessel comprising an elongate skeletal frame formed to define an elongate chamber with a central longitudinal axis, said skeletal frame having a first end and a second end and being formed to assume a first collapsed configuration toward said longitudinal axis for insertion in said body vessel and to expand radially outward from said collapsed configuration to a second expanded configuration, the skeletal frame being formed by a plurality of interconnected open cells with the cells adjacent to the first end of said skeletal frame forming a generally cylindrical end section in the second expanded configuration of said skeletal frame, the interconnected cells between said generally cylindrical end section and said second end tapering inwardly toward said central longitudinal axis to form the skeletal frame with a substantially conical section in the second expanded configuration terminating at said second end, the cells forming said substantially conical section being smaller in size than the cells forming said generally cylindrical end section.

8. The expandable cellular device of claim 7 wherein each of said cells in said generally cylindrical end section includes two substantially parallel, spaced, straight side portions which are substantially parallel to said central longitudinal axis and end wall means extending between said side portions at an angle to said central longitudinal axis, said cells in said generally cylindrical end section being joined together only along the lengths of said straight side portions.

9. An expandable cellular device for insertion in a body vessel comprising an elongate skeletal frame formed to define an elongate chamber with a central longitudinal axis, said skeletal frame having a first end and a second end and being formed to assume a first collapsed configuration toward said longitudinal axis for insertion in said body vessel and to expand radially outward from said collapsed configuration to a second expanded configuration, the skeletal frame being formed by a plurality of interconnected open cells with the cells adjacent to the first end of said skeletal frame forming a generally cylindrical end section in the second expanded configuration of said skeletal frame, the interconnected cells between said generally cylindrical end section and said second end tapering inwardly toward said central longitudinal axis to form the skeletal frame with a substantially conical section in the second expanded configuration terminating at said second end, each of said cells in said generally cylindrical end section including two substantially parallel, spaced, straight side portions which are substantially parallel to said central longitudinal axis and end wall means extending between said side portions at an angle to said central longitudinal axis, said cells in said generally cylindrical end section being joined together only along the lengths of said straight side portions, the skeletal frame in said generally cylindrical end section being formed of thermal shape memory material.

10. The expandable cellular device of claim 9 wherein the cells forming said substantially conical section are smaller in size than the cells forming said generally cylindrical end section.