Intraluminal drug eluting prosthesis method

• US 5,997,468 A
• Filed: 08/04/1997
• Issued: 12/07/1999
• Est. Priority Date: 02/28/1990
• Status: Expired due to Fees

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Wolff, Rodney G., Hull, Vincent W.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/905,747
• Time in Patent Office: 855 Days
• Field of Search: 623/1, 623/11, 623/12, 600/36, 606/194, 606/195, 606/198, 604/890.1, 604/891.1
• US Class Current: 600/36
• CPC Class Codes: A61F 2/852 Two or more distinct overlapping stents
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61F 2250/0063 Nested prosthetic parts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: D04C 1/02 made from particular materials
• CPC Class Codes: D10B 2509/06 Vascular grafts; stents

Abstract

A prosthesis for insertion into a lumen to limit restenosis of the lumen. The prosthesis carries restenosis-limiting drugs which elute after the device is positioned in the lumen.

Claims

1. A method for making a device for local intralumenal administration of drugs comprising:

(a) providing a plurality of a first, structural filament;

(b) providing a second, bioabsorbable polymeric filament having a drug compounded therein;

(c) weaving the first, structural filaments and the second, bioabsorbable polymeric filament into a tubular, open-ended body, said first and second filaments woven helically along a center line of the tubular body as a common axis and woven in opposing helical directions such that the tubular body is variable in radial diameter under axial movement of opposite ends of the body relative to each other and woven with at least a portion of the second, bioabsorbable filament exposed at an exterior surface of the tubular body;

(d) providing a catheter;

(e) loading the woven body into the catheter;

(f) providing a radially expandable stent; and

(e) loading the stent into the catheter adjacent to the woven body.

2. The method of claim 1 wherein the step of loading the stent into the catheter includes the steps of loading the stent onto a balloon and placing the stent and balloon into the catheter.

3. The method of claim 1 wherein the step of loading the stent into the catheter includes the steps of mounting the stent onto a release mechanism and placing the mounted stent into the catheter.

4. A method for making a device for local intralumenal administration of drugs comprising:

(a) providing a plurality of a first, structural filament;

(b) providing a second, bioabsorbable polymeric filament having a drug compounded therein,

(c) weaving the first, structural filaments and the second, bioabsorbable polymeric filament into a tubular, open-ended body, said first and second filaments woven helically along a center line of the tubular body as a common axis and woven in opposing helical directions such that the tubular body is variable in radial diameter under axial movement of opposite ends of the body relative to each other and woven with at least a portion of the second, bioabsorbable filament exposed at an exterior surface of the tubular body;

(d) providing a catheter having a balloon at a distal end thereof;

(e) providing a radially expandable stent;

(f) mounting the stent on the balloon; and

(g) mounting the woven body onto the mounted stent and balloon.

5. A method for making a device for local intralumenal adminstration of drugs comprising:

(a) providing a catheter having a distal end;

(b) providing a radially expandable stent;

(c) providing a plurality of a first, structural filament;

(d) providing a second, bioabsorbable polymeric filament having a drug compounded therein;

(e) weaving the first, structural filaments and the second, bioabsorbable polymeric filament into a tubular, open-ended body, said first and second filaments woven along a center line of the tubular body as a common axis such that the tubular body is variable in radial diameter and woven with at least a portion of the second, bioabsorbable filament exposed at an exterior surface of the tubular body;

(f) loading the woven body into the distal end of the catheter; and

(g) loading the stent into the catheter adjacent to the woven body.

6. The method of claim 5 wherein the step of loading the woven body into the catheter includes pulling the woven body longitudinally.

7. The method of claim 5 wherein the step of weaving the filaments includes forming junctures between the filaments and then bonding the filaments together at the junctures to prevent the filaments from sliding relative to each other.

8. The method of claim 7 wherein the step of bonding the filaments includes the heating the filaments to a melting temperature.

9. The method of claim 5 wherein the step of weaving the filaments includes forming junctures between the filaments and then kinking the filaments at the junctures to prevent the filaments from sliding relative to each other.

10. The method of claim 9 wherein the step of kinking the filaments includes of heating the filaments.

11. The method of claim 5 wherein the second, bioabsorbable polymeric filament is provided as a high surface area multifilar filament comprised of a plurality of strands.

12. The method of claim 5 wherein the step of loading the stent into the catheter includes the steps of loading the stent onto a balloon and placing the stent and balloon into the catheter.

13. The method of claim 5 wherein the step of loading the stent into the catheter includes the steps of mounting the stent onto a release mechanism and placing the mounted stent into the catheter.

14. A method for making a device for local intralumenal administration of drugs comprising;

(a) providing a catheter having a balloon at a distal end thereof;

(b) providing a radially expandable stent;

(c) providing a plurality of a first, structural filament;

(d) providing a second, bioabsorbable polymeric filament having a drug compounded therein;

(e) weaving the first, structural filaments and the second, bioabsorbable polymeric filament into a tubular, open-ended body, said first and second filaments woven along a center line of the tubular body as a common axis such that the tubular body is variable in radial diameter and woven with at least a portion of the second, bioabsorbable filament exposed at an exterior surface of the tubular body;

(f) mounting the stent on the balloon; and

(g) mounting the woven body onto the mounted stent and balloon.

15. The method of claim 14 wherein the step of weaving the filaments includes forming junctures between the filaments and then bonding the filaments together at the junctures to prevent the filaments from sliding relative to each other.

16. The method of claim 15 wherein the step of bonding the filaments includes the heating the filaments to a melting temperature.

17. The method of claim 14 wherein the step of weaving the filaments includes forming junctures between the filaments and then kinking the filaments at the junctures to prevent the filaments from sliding relative to each other.

18. The method of claim 17 wherein the step of kinking the filaments includes of heating the filaments.

19. The method of claim 14 wherein the second, bioabsorbable polymeric filament is provided as a high surface area multifilar filament comprised of a plurality of strands.

20. A method for making a device for local intralumenal administration of drugs comprising;

(a) providing a catheter having a balloon at a distal end thereof;

(b) providing a radially expandable stent;

(c) providing a plurality of a first, structural filament;

(d) providing a second, bioabsorbable polymeric filament having a drug compounded therein;

(e) weaving the first, structural filaments and the second, bioabsorbable polymeric filament into a tubular, open-ended body, said first and second filaments woven along a center line of the tubular body as a common axis such that the tubular body is variable in radial diameter and woven with at least a portion of the second, bioabsorbable filament exposed at an exterior surface of the tubular body; and

(f) mounting the stent and the woven body onto the balloon.