Multi-layer device with gap for treating a target site and associated method

Patent metadata

Field	Value
Publication number	US-9427304-B2
Application number	US-25889908-A
Country	US
Kind code	B2
Filing date	Oct 27, 2008
Priority date	Oct 27, 2008
Publication date	Aug 30, 2016
Grant date	Aug 30, 2016

Abstract

A medical device includes a multi-layered structure comprising an inner layer disposed within an outer layer, wherein each of the inner and outer layers has respective inner and outer surfaces. The multi-layered structure further comprises at least offset located between the inner and outer layers or formed in the inner and/or outer layers to define at least one gap therebetween such that a majority of the outer surface of the inner layer is spaced apart from the inner surface of the outer layer. The multi-layered structure is configured to be deployed within a lumen such that at least a portion of the outer layer is configured to engage the lumen and the at least one gap is configured to promote thrombosis between the inner and outer layers.

First claim

That which is claimed:

1. A medical device for treating a vascular abnormality in a lumen, the medical device comprising:
a multi-layered structure comprising an inner layer disposed within an outer layer and having proximal and distal ends, wherein the inner layer is a first fabric comprising a plurality of braided strands comprising an elastic metallic alloy and the outer layer is a second fabric comprising a plurality of braided strands, the first fabric being discrete from the second fabric, each of the inner and outer layers having a respective longitudinal opening extending between the proximal and distal ends so as to define respective inner and outer surfaces, wherein the multi-layered structure further comprises at least one offset comprising a surface distortion formed helically or annularly in only one of the inner or outer layers, the at least one offset extending between the outer surface of the inner layer and the inner surface of the outer layer to define a gap between the inner and outer layers, wherein a majority of the outer surface of the inner layer is spaced apart from the inner surface of the outer layer by the at least one offset, and wherein the multi-layered structure is configured to be deployed within the lumen such that at least a portion of the outer surface of the outer layer is configured to engage an inner surface of the lumen and the at least one gap is configured to allow blood flow therethrough so as to promote thrombosis between the inner and outer layers.

2. The medical device of claim 1 , wherein the inner and outer layers comprise an occlusive material.

3. The medical device of claim 1 , wherein the braided strands of the outer layer comprises a non-metallic material.

4. The medical device of claim 1 , wherein the outer layer comprises braided strands of an elastic metallic alloy.

5. The medical device of claim 1 , wherein the multi-layered structure comprises an expanded heat set configuration, and wherein the multi-layered structure is configured to be constrained to a smaller diameter than the expanded heat set configuration for delivery within a catheter.

6. The medical device of claim 1 , wherein each of the inner and outer layers is tubular in configuration, and wherein the inner layer is coaxially disposed within the outer layer.

7. The medical device of claim 1 , further comprising a plurality of gaps defined between the proximal and distal ends of the multi-layered structure.

8. The medical device of claim 1 , wherein the at least one surface distortion is the shape of a corrugation formed on only one of the outer surface of the inner layer or the inner surface of the outer layer.

9. The medical device of claim 1 , wherein the at least one surface distortion comprises a flute formed on only one of the outer surface of the inner layer or the inner surface of the outer layer.

10. The medical device of claim 1 , further comprising a plurality of offsets formed in only one of the inner or outer layer.

11. The medical device of claim 10 , wherein the plurality of offsets comprise surface distortions formed in only one of the inner or outer layers, and wherein the inner layer is disposed within the outer layer in an overlying relationship so as to define a plurality of gaps therebetween.

12. The medical device of claim 1 , wherein the medical device further comprises occlusive material disposed within at least a portion of the gap between the inner and outer layers.

13. The medical device of claim 1 , wherein the multi-layered structure is a stent graft configured to engage the lumen upstream and downstream of an aneurysm.

14. The medical device of claim 1 , wherein the at least one gap is configured to increase turbulence of blood flow in and around the gap so as to promote thrombosis between the inner and outer layers whereby blood flow within the gap is eliminated.

15. The medical device of claim 1 , wherein the at least one offset is formed in the outer surface of the inner layer.

16. The medical device of claim 1 , wherein the at least one offset is defined in the inner layer.

17. The medical device of claim 1 , wherein the at least one offset is formed in the inner surface of the outer layer.

18. The medical device of claim 1 , wherein the inner layer comprises a braided tubular surface having a first outer diameter, and wherein the at least one offset projects from the braided tubular surface to define a second outer diameter different than the first outer diameter.

19. A medical device for treating a vascular abnormality, comprising:
a tubular shaped inner layer, comprising:
proximal and distal ends;
a first fabric comprising a plurality of braided strands comprising an elastic metallic alloy; and
inner and outer surfaces;

a tubular shaped outer layer, comprising:
proximal and distal ends;
a second fabric comprising a plurality of braided strands; and
inner and outer surfaces; and

at least one offset feature extending between the outer surface of the inner layer and the inner surface of the outer layer to form at least one gap to accommodate blood flow between the outer and inner layers, the at least one offset feature being formed helically or annularly from only one of the inner and outer layers, wherein the medical device is configured to be deployed within a lumen such that at least a portion of the outer surface of the outer layer is configured to engage an inner surface of the lumen.

20. The medical device of claim 19 , wherein the at least one offset feature comprises a corrugation formed on only one of the outer surface of the inner layer or the inner surface of the outer layer.

21. The medical device of claim 19 , wherein the at least one offset feature comprises a flute formed on only one of the outer surface of the inner layer or the inner surface of the outer layer.

22. The medical device of claim 19 , wherein the at least one offset feature is formed only in the inner layer.

Assignees

• Kariniemi Ryan
• Heidner Matthew C
• Oslund John C
• St Jude Medical Cardiology Div Inc

Inventors

• Kariniemi Ryan
• Heidner Matthew C
• Oslund John C

Classifications

• A61F2/07 Primary

  Stent-grafts · CPC title

• A61F2/89

  the wire-like elements comprising two or more adjacent rings flexibly connected by separate members · CPC title

• A61F2220/0058

  soldered or brazed or welded · CPC title

• A61F2220/005

  using adhesives · CPC title

• A61F2/95

  Instruments specially adapted for placement or removal of stents or stent-grafts · CPC title