Endoprosthesis having graft member and exposed welded end junctions, method and procedure

• US 5,549,663 A
• Filed: 03/09/1994
• Issued: 08/27/1996
• Est. Priority Date: 03/09/1994
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Cottone, Robert J. Jr.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): SNOW, BRUCE EDWARD
• Application Number:
  US08/208,612
• Time in Patent Office: 902 Days
• Field of Search: 623/1, 623/12, 606/198, 606/194, 606/195, 606/108
• US Class Current: 623/1.22
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/072 Encapsulated stents, e.g. wire or whole stent embedded in lining
• 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 2220/0058 soldered or brazed or welded
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: Y10T 29/49801 Shaping fiber or fibered material

Abstract

An endoprosthesis is provided which includes a stent component and a graft component capturing a portion of the stent component. The stent component is made of generally malleable material arranged to provide the stent component with a collapsed transluminal positioning configuration and an expanded, deployed configuration. The stent component has adjacent end windings that are welded together. In a preferred arrangement, a plurality of these welds define a spine-like welded arrangement, and a number of these arrangements are positioned generally circumferentially around the ends of the stent component. The graft component extends generally between the welded end portions of the stent component, with limited overlap being possible. Also provided is a method for forming this endoprosthesis and a procedure by which the endoprosthesis is implanted by deployment with a suitable expansion device.

Claims

1. An implantable transluminal endoprosthesis, comprising:

a malleable strand having a generally helical configuration to form a stent component having a plurality of full circle windings along a generally helically axis, the stent component having an interior surface and an exterior surface, the stent component extending the length of the endoprosthesis;

said malleable strand including a repeating pattern of undulations that follow said generally helical axis, said pattern of undulations having a plurality of substantially equally sized and shaped bendable segments having legs alternating with bendable connecting portions to impart radial expandability to the endoprosthesis;

said endoprosthesis having an unexpanded transluminal insertion circumference and an expanded deployed circumference which is greater than said unexpanded circumference;

said plurality of full circle windings being generally adjacent to each other, and said bendable segments being positioned in a generally closed orientation with respect to each other at said unexpanded circumference and in a generally opened orientation with respect to each other and with respect to said bendable connecting portions at said expanded circumference;

said stent component having end lengths, each said end length having a plurality of welds joining the end windings to their respective adjacent winding in order to define welded end lengths of the stent component;

a graft component having an inner member and an outer member closely overlying said interior surface and exterior surface respectively of said stent component such that a portion of each of said welded end lengths is covered by said graft component inner and outer members and such that a substantial axially extending portion of each of said welded end lengths protrudes longitudinally beyond said graft component and said graft member covers at least the central portion of the stent component, said central portion being between said welded end lengths of the stent component; and

said graft component exhibits compliance adequate to radially expand with the stent member and a low recoil percentage once thus expanded.

2. The endoprosthesis in accordance with claim 1, wherein said outer member of the graft component has a length at least as great as that of the inner member of the graft component, and said inner and outer graft members are adhered together with a portion of said stent component incorporated therebetween.

3. The endoprosthesis in accordance with claim 1, wherein said graft component covers not greater than approximately one quarter of said welded end length.

4. The endoprosthesis in accordance with claim 2, wherein said graft component covers not greater than approximately one quarter of said welded end length.

5. The endoprosthesis in accordance with claim 1, wherein said recoil of the graft component is no greater than about seven percent.

6. The endoprosthesis in accordance with claim 1, wherein said plurality of welds are patterned as a plurality of weld spines generally circumferentially spaced around the end lengths, each of said weld spines having a pitch angle substantially along said generally helical axis of the stent component.

9. The endoprosthesis in accordance with claim 1, wherein said plurality of welds impart increased hoop strength to said end lengths of the stent component which is greater than the hoop strength of the remainder of the endoprosthesis.

12. The endoprosthesis in accordance with claim 1, further including barbs secured to the stent component at said welded end lengths.

13. The endoprosthesis in accordance with claim 1, wherein said stent component malleable material is made of an energy-sensitive material, and said stent component expands diametrically when subjected to energy to which the malleable material is sensitive.

7. An implantable transluminal endoprosthesis, comprising:

a malleable strand having a generally helical configuration to form a stent component having a plurality of full circle windings along a generally helically axis, the stent component having an interior surface and an exterior surface, the stent component extending the length of the endoprosthesis;

said malleable strand including a repeating pattern of undulations that follow said generally helical axis, said pattern of undulations having a plurality of substantially equally sized and shaped bendable segments having legs alternating with bendable connecting portions to impart radial expandability to the endoprosthesis;

said endoprosthesis having an unexpanded transluminal insertion circumference and an expanded deployed circumference which is greater than said unexpanded circumference;

said plurality of full circle windings being generally adjacent to each other, and said bendable segments being positioned in a generally closed orientation with respect to each other at said unexpanded circumference and in a generally opened orientation with respect to each other and with respect to said bendable connecting portions at said expanded circumference;

said stent component having end lengths, each said end length having a plurality of welds joining the end windings to their respective adjacent winding in order to define welded end lengths of the stent component, wherein said welds are fusion welds;

a graft component having an inner member and an outer member closely overlying said interior surface and exterior surface respectively of said stent component such that a portion of each of said welded end lengths is covered by said graft component inner and outer members and such that a substantial axially extending portion of each of said welded end lengths protrudes longitudinally beyond said graft component and said graft member covers at least the central portion of the stent component, said central portion being between said welded end lengths of the stent component; and

said graft component exhibits compliance adequate to radially expand with the stent member and a low recoil percentage once thus expanded.

8. The endoprosthesis in accordance with claim 7, wherein the fusion welds are formed within a substantially closed atmosphere of inert gas.

10. An implantable transluminal endoprosthesis, comprising:

a malleable strand having a generally helical configuration to form a stent component having a plurality of full circle windings along a generally helically axis having a pitch angle, the stent component having an interior surface and an exterior surface, the stent component extending the length of the endoprosthesis;

said malleable strand including a repeating pattern of undulations that follow said generally helical axis, said pattern of undulations having a plurality of substantially equally sized and shaped bendable segments having legs alternating with bendable connecting portions to impart radial expandability to the endoprosthesis;

said endoprosthesis having an unexpanded transluminal insertion circumference and an expanded deployed circumference which is greater than said unexpanded circumference;

said plurality of full circle windings being generally adjacent to each other, and said bendable segments being positioned in a generally closed orientation with respect to each other at said unexpanded circumference and in a generally opened orientation with respect to each other and with respect to said bendable connecting portions at said expanded circumference;

said stent component having end lengths, each said end length having plurality of welds joining the end windings to their respective adjacent winding order to define welded end lengths of the stent component;

a graft component having an inner member and an outer member closely overlying said interior surface and exterior surface respectively of said stent component such that a portion of each of said welded end lengths is covered by said graft component inner and outer members and such that a substantial axially extending portion of each of said welded end lengths protrudes longitudinally beyond said graft component and said graft member covers at least the central portion of the stent component, said central portion being between said welded end lengths of the stent component;

said graft component includes fibers wound at a given pitch angle which approximates said pitch angle of the stent component; and

said graft component exhibits compliance adequate to radially expand with the stent member and a low recoil percentage once thus expanded.

11. An implantable transluminal endoprosthesis, comprising:

a malleable strand having a generally helical configuration to form a stent component having a plurality of full circle windings along a generally helically axis, the stent component having an interior surface and an exterior surface, the stent component extending the length of the endoprosthesis;

said malleable strand including a repeating pattern of undulations that follow said generally helical axis, said pattern of undulations having a plurality of substantially equally sized and shaped bendable segments having legs alternating with bendable connecting portions to impart radial expandability to the endoprosthesis;

said endoprosthesis having an unexpanded transluminal insertion circumference and an expanded deployed circumference which is greater than said unexpanded circumference;

said plurality of full circle windings being generally adjacent to each other, and said bendable segments being positioned in a generally closed orientation with respect to each other at said unexpanded circumference and in a generally opened orientation with respect to each other and with respect to said bendable connecting portions at said expanded circumference;

said stent component having end lengths, each said end length having a plurality of welds joining the end windings to their respective adjacent winding order to define welded end lengths of the stent component;

a graft component having an inner member and an outer member closely overlying said interior surface and exterior surface respectively of said stent component such that a portion of each of said welded end lengths is covered by said graft component inner and outer members and such that a substantial axially extending portion of each of said welded end lengths protrudes longitudinally beyond said graft component and said graft member covers at least the central portion of the stent component, said central portion being between said welded end lengths of the stent component;

said outer member of the graft component is treated with a drug or an anticoagulant; and

said graft component exhibits compliance adequate to radially expand with the stent member and a low recoil percentage once thus expanded.