CA2626601A1 - Grafts and stent grafts having a radiopaque beading - Google Patents
Grafts and stent grafts having a radiopaque beading Download PDFInfo
- Publication number
- CA2626601A1 CA2626601A1 CA002626601A CA2626601A CA2626601A1 CA 2626601 A1 CA2626601 A1 CA 2626601A1 CA 002626601 A CA002626601 A CA 002626601A CA 2626601 A CA2626601 A CA 2626601A CA 2626601 A1 CA2626601 A1 CA 2626601A1
- Authority
- CA
- Canada
- Prior art keywords
- beading
- radiopaque
- implantable prosthesis
- graft
- graft device
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/18—Materials at least partially X-ray or laser opaque
Abstract
A device and method provides a graft having a layer of synthetic non-metallic material including a first surface and a second surface spaced apart from the first surface. The device further inckudes a beading coupled to the layer and a radiopaque agent coupled to the beading. Another device and method provides a implantable prosthesis having a stent frame, a first inner layer and a second outer layer defining a central axis. The implantable prosthesis further includes a beading coupled to at least one the layers.
Description
GALUT.8 AND BE~ADIN~~
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Claims (47)
1. A graft device comprising:
a layer of synthetic non-metallic material having a first surface and a second surface spaced apart from the first surface;
a beading coupled to at least one of the first surface and the second surface of the layer; and a radiopaque agent coupled to the beading to form a radiopaque beading.
a layer of synthetic non-metallic material having a first surface and a second surface spaced apart from the first surface;
a beading coupled to at least one of the first surface and the second surface of the layer; and a radiopaque agent coupled to the beading to form a radiopaque beading.
2. The graft device according to claim 1, wherein the layer of synthetic non-metallic material forms an elongated substantially tubular member, the second surface forming the outer surface of the tubular member, and further wherein the radiopaque beading is spirally wrapped about the outer surface.
3. The graft device according to any one the above claims, wherein the radiopaque beading defines a substantially rectangular cross-sectional area.
4. The graft device according to claim 3, wherein the substantially rectangular cross-sectional area has a length ranging from about 1 millimeter to about 2 millimeters and a width ranging from about 100 microns to about 500 microns.
5. The graft device according to claim 4, wherein a side of the radiopaque beading defining the length of the cross-sectional area is coupled to at least one of the first surface and the second surface of the layer.
6. The graft device according to any one the above claims, wherein the radiopaque beading is tensioned and chemically bonded to the layer.
7. The graft device according to any one the above claims, wherein the radiopaque beading is sintered to the layer.
8. The graft device according any one the above claims, wherein the radiopaque beading includes a radiopaque material embedded in a polyurethane material.
9. The graft device according any one the above claims, wherein the radiopaque beading includes a radiopaque core disposed within a polytetrafluoroethylene shell.
10. The graft device according to any one the above claims, wherein the radiopaque material includes 20% by weight of Barium Sulfate.
11. The graft device according to any one the above claims, wherein the synthetic non-metallic material comprises a material selected from a group consisting essentially of Dacron, polyester, PTFE, ePTFE, polyurethane, polyurethane-urea, siloxane, and combinations thereof.
12. The graft device according to any one the above claims, wherein the radiopaque beading is formed from a paste having about 20% tantalum powder.
13. The graft device according to any one the above claims, wherein the radiopaque beading is formed from a paste having about 20% to about 40% Barium Sulfate.
14. The graft device according to any one the above claims, wherein the radiopaque beading is a tape comprised of about 40% tantalum powder and about 60% PTFE.
15. The graft device according to any one the above claims, wherein the radiopaque agent is at least partially embedded in the beading.
16. The graft device according to any one the above claims, wherein the beading comprises a continuous strip disposed helically about the device.
17. A method of forming a graft device comprising:
disposing a radiopaque agent in a polymeric shell;
compressing the radiopaque agent and shell to form a billet;
extruding the billet so as to form a radiopaque beading; and wrapping the beading about a graft material so as to define a graft device.
disposing a radiopaque agent in a polymeric shell;
compressing the radiopaque agent and shell to form a billet;
extruding the billet so as to form a radiopaque beading; and wrapping the beading about a graft material so as to define a graft device.
18. The method of claim 17, wherein the wrapping includes preloading the beading about the graft.
19. The method according to any one of claims 17-18, further comprising applying a solvent to at least one of the beading and the graft material.
20. A method of observing a position of a graft in a body, the method comprises:
disposing a graft having a radiopaque beading in a body;
exposing the body to an electromagnetic energy; and fluoroscopically observing at least a portion of the beading to determine the position of the graft in the body.
disposing a graft having a radiopaque beading in a body;
exposing the body to an electromagnetic energy; and fluoroscopically observing at least a portion of the beading to determine the position of the graft in the body.
21. A method of verifying orientation of a graft in a mammalian body subsequent to implantation of such graft in the mammalian body without an incision into the body, the method comprising:
directing electromagnetic energies at the implanted graft; and forming an image on a display medium that shows the portion as a helically wound beading about the graft, the beading having greater contrast than another portion of the implanted graft.
directing electromagnetic energies at the implanted graft; and forming an image on a display medium that shows the portion as a helically wound beading about the graft, the beading having greater contrast than another portion of the implanted graft.
22. A implantable prosthesis device comprising:
a stent frame having a first inner layer and a second outer layer defining a central axis; and a beading coupled to at least one the layers.
a stent frame having a first inner layer and a second outer layer defining a central axis; and a beading coupled to at least one the layers.
23. The implantable prosthesis of claim 22, wherein the beading comprises a continuous strip disposed helically about the prosthesis.
24. The implantable prosthesis of claim 22, wherein the beading comprises a plurality of distinct segments disposed about the prosthesis.
25. The implantable prosthesis according to any one of claims 22-24, wherein the beading is generally circumferentially disposed about the central axis.
26. The implantable prosthesis according to any one of claims 22-25, wherein first and second layers are made of a synthetic non-metallic material.
27. The implantable prosthesis according to claim 26, wherein the synthetic non-metallic material of at least one of the layers comprises a material selected from a group consisting essentially of Dacron, polyester, PTFE, ePTFE, polyurethane, polyurethane-urea, siloxane, and combinations thereof.
28. The implantable prosthesis according to any one of claims 22-27, wherein the beading is configured to be peeled.
29. The implantable prosthesis according to any one of claims 22-28, further comprising a radiopaque agent coupled to the beading to form a radiopaque beading.
30. The implantable prosthesis according to claim 29, wherein the implantable prosthesis has first inner layer of synthetic non-metallic material and a second outer layer of non-metallic material spaced from the first layer, the radiopaque beading being disposed between the first and second layers.
31. The implantable prosthesis according to claim 29, wherein the radiopaque beading defines a substantially rectangular cross-sectional area.
32. The implantable prosthesis according to claim 31, wherein the substantially rectangular cross-sectional area has a length ranging from about 1 millimeter to about 2 millimeters and a width ranging from about 100 microns to about 500 microns.
33. The implantable prosthesis according to any one of claims 31-32, wherein a side of the beading defining the length of the cross-sectional area is coupled to at least one of the layers.
34. The implantable prosthesis according to any one of claims 29-33, wherein the radiopaque beading is coupled to the stent, tensioned and chemically bonded to at least one of the layers.
35. The implantable prosthesis according to any one of claims 29-34, wherein the radiopaque beading is sintered to at least one of the layers.
36. The implantable prosthesis according to anyone of claims 29-35, wherein the radiopaque beading includes a radiopaque material embedded in a polyurethane material.
37. The implantable prosthesis according to any one of claims 29-36, wherein the radiopaque beading includes a radiopaque core disposed within a polytetrafluoroethylene shell.
38. The implantable prosthesis according to any one of claims 29-37, wherein the radiopaque beading includes 20% by weight of Barium Sulfate.
39. The implantable prosthesis according to any one of claims 29-37, wherein the radiopaque beading is formed from a paste having about 20% tantalum powder.
40. The implantable prosthesis according to any one of claims 29-39, wherein the radiopaque beading is formed from a paste having about 20% to about 40% Barium Sulfate.
41. The implantable prosthesis according to any one of claims 29-40, wherein the radiopaque beading is a tape of 40% tantalum powder and 60% PTFE.
42. A method of forming an implantable prosthesis device comprising:
disposing a radiopaque agent in a polymeric shell;
compressing the radiopaque agent and shell to form a billet;
extruding the billet so as to form a radiopaque beading; and wrapping the beading about a graft material so as to define an implantable prosthesis device.
disposing a radiopaque agent in a polymeric shell;
compressing the radiopaque agent and shell to form a billet;
extruding the billet so as to form a radiopaque beading; and wrapping the beading about a graft material so as to define an implantable prosthesis device.
43. The method of claim 42, wherein the wrapping includes preloading the beading about the implantable prosthesis.
44. The method of any one of claims 42-43, further comprising applying a solvent to at least one of the beading and graft.
45. A method of observing a position of a graft comprises:
disposing a graft on a body;
observing the portion of the beading on the body surface.
disposing a graft on a body;
observing the portion of the beading on the body surface.
46. A method of verifying orientation of a implantable prosthesis in a mammalian body subsequent to implantation of such implantable prosthesis in the mammalian body without an incision into the body, the method comprising:
directing electromagnetic energies at the implanted implantable prosthesis;
blocking some of electromagnetic energies through a portion of the implantable prosthesis; and forming an image on a display medium that shows the portion as a helically wound beading about the implantable prosthesis, the beading having greater than an ePTFE material.
directing electromagnetic energies at the implanted implantable prosthesis;
blocking some of electromagnetic energies through a portion of the implantable prosthesis; and forming an image on a display medium that shows the portion as a helically wound beading about the implantable prosthesis, the beading having greater than an ePTFE material.
47. A method of observing a position of a implantable prosthesis in a body, the method comprises:
disposing a implantable prosthesis having a radiopaque beading in the body;
exposing the body to an electromagnetic energy; and fluoroscopically observing at least a portion of the beading to determine the position of the implantable prosthesis in the body.
extruding the composite so as to form a radopaque beading 49. The method of claim 48 further comprising forming the composite into a billet.
50. The method according to any one of claims 48-49, further comprising expanding the beading to form a tape.
disposing a implantable prosthesis having a radiopaque beading in the body;
exposing the body to an electromagnetic energy; and fluoroscopically observing at least a portion of the beading to determine the position of the implantable prosthesis in the body.
extruding the composite so as to form a radopaque beading 49. The method of claim 48 further comprising forming the composite into a billet.
50. The method according to any one of claims 48-49, further comprising expanding the beading to form a tape.
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2006
- 2006-11-09 CA CA002626601A patent/CA2626601A1/en not_active Abandoned
- 2006-11-09 WO PCT/US2006/060704 patent/WO2007056762A2/en active Application Filing
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- 2006-11-09 EP EP06839788A patent/EP1945139A4/en not_active Withdrawn
- 2006-11-09 US US12/092,561 patent/US20090171436A1/en not_active Abandoned
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EP1945139A4 (en) | 2010-01-27 |
US20090171436A1 (en) | 2009-07-02 |
EP1945139A2 (en) | 2008-07-23 |
WO2007056762A3 (en) | 2008-01-10 |
JP2013059643A (en) | 2013-04-04 |
WO2007056762A2 (en) | 2007-05-18 |
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