Bioabsorbable self-expanding stent

• US 6,245,103 B1
• Filed: 08/01/1997
• Issued: 06/12/2001
• Est. Priority Date: 08/01/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Stinson, Jonathan S.
• Primary Examiner(s): Willse, David H.
• Assistant Examiner(s): GHERBI, SUZETTE JAIME J
• Application Number:
  US08/904,467
• Time in Patent Office: 1,411 Days
• Field of Search: 623/1, 623/12, 623/1.22, 623/1-8-, 427/2--
• US Class Current: 623/1.22
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61L 31/042 Polysaccharides
• CPC Class Codes: A61L 31/044 Collagen
• CPC Class Codes: A61L 31/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L31/041 takes precedence
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: C08L 1/02 Cellulose; Modified cellulose
• CPC Class Codes: C08L 67/04 Polyesters derived from hydroxycarboxylic acids, e.g. lactones C08L67/06 takes precedence
• CPC Class Codes: C08L 77/00 Compositions of polyamides obtained by reactions forming a carboxylic amide link in the main chain of polyhydrazides C08L79/06; of polyamideimides or polyamide acids C08L79/08; Compositions of derivatives of such polymers
• CPC Class Codes: C08L 85/02 containing phosphorus
• CPC Class Codes: D04C 1/06 Braid or lace serving particular purposes

Abstract

A self-expanding stent formed from helically wound and braided filaments of bioabsorbable polymers such as PLA, PLLA, PDLA, and PGA.

Claims

1. A bioabsorbable implantable stent having a tubular, radially compressible and self-expandable braided and annealed structure comprising:

a first set of between 5 and 18 filaments each of which extends in a helix configuration along a center line and having a first common direction of winding;

a second set of filaments of the same number as the first set, each of which extends in a helix configuration along the center line and having a second common direction of winding;

the second set of filaments crossing the first set of filaments at an axially directed angle of between about 120 and about 150 degrees when in a first free radially expanded state after being annealed but before being loaded on a delivery device so as to form a plurality of interstices between filaments, and further to determine an annealed diameter, D, of the stent in said first free radially expanded state;

each filament comprising at least one of poly-L-lactide, poly-D-lactide, polyglycolide and combinations thereof, and having a substantially solid and substantially uniform cross-section, a tensile strength of from about 40 ksi to about 120 ksi, a tensile modulus of from about 400,000 psi to about 2,000,000 psi, and an average diameter of from about 0.15 mm to about 0.6 mm;

wherein the first set of filaments and second set of filaments act upon one another to create an outwardly directed radial force sufficient to implant the stent in a body vessel upon deployment from the delivery device; and

wherein said radial force, when the stent is radially constrained to a predetermined fraction of the annealed diameter, varies substantially linearly as a function of the annealed diameter, whereby said annealed diameter, D, is selected to provide a desired radial force when the stent is so radially constrained.

2. The stent of claim 1 wherein the stent has a second free radially expanded state after being loaded and then released from a deployment device, the first and second sets of filaments crossing at an axially directed angle of between about 80 and about 145 degrees when in the second free radially expanded state.

3. The stent of claim 1 wherein the stent has a second free radially expanded state after being loaded and then released from a deployment device, the first and second sets of filaments crossing at an axially directed angle of between about 90 and about 100 degrees when in the second free radially expanded state, and a second free state diameter of from about 3 mm to about 6 mm.

4. The stent of claim 2 wherein the axially directed angle is between about 110 degrees and about 120 when in the second free radially expanded state.

5. The stent of claim 2 wherein the stent has an outside diameter when in the second free radially expanded state and the stent exerts an outwardly directed radial force at one half of the outside diameter of from about 40 grams to about 300 grams.

6. The stent of claim 2 wherein the stent has an implanted state after being loaded, released from a deployment device into a body vessel, and then implanted in the body vessel, with the first and second sets of filaments crossing at an axially directed angle of between about 95 and about 105 degrees when the stent is in the implanted state.

7. The bioabsorbable implantable stent of claim 1 wherein the stent is radially constrained to half of its free diameter whereby said predetermined fraction is one-half, and the radial force, RF, exerted by the stent, in grams, as a function of the annealed diameter, D, in mm, is about RF=−

15D+491 ±

20.

8. The bioabsorbable implantable stent of claim 1 wherein the stent is annealed at a temperature of from about 60°

C. to about 180°

C. for a period of time of from about 5 minutes to about 120 minutes.

9. The bioabsorbable implantable stent of claim 1 wherein the stent is annealed at a temperature of from about 1 30°

C. to about 150°

C. for a period of time of from about 10 minutes to about 20 minutes.

10. The bioabsorbable implantable device of claim 1 wherein the stent is annealed to yield a crossing angle of from about 130 degrees to about 150 degrees.

11. The bioabsorbable implantable stent of claim 1 wherein the stent is further disposed in a stent delivery device and the filaments have a crossing angle of from about 30 degrees to about 120 degrees.

12. The bioabsorbable implantable stent of claim 1 wherein the stent is deployed from a delivery system into a body lumen and the filaments have a crossing angle of from about 70 degrees to about 130 degrees.

13. The bioabsorbable implantable stent of claim 1 wherein the stent provides structural integrity to a body lumen for less than about 3 years.

14. The bioabsorbable implantable stent device of claim 1 wherein the stent further comprises polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids) and combinations thereof.

15. The bioabsorbable implantable stent of claim 1 wherein the filaments are mono-filament or multi-filament.

16. The bioabsorbable implantable stent of claim 1 wherein the stent substantially degrades in vivo in from about 1 year to about 2 years.

17. The bioabsorbable implantable stent of claim 1 wherein the filaments comprise polyglycolide and whereby the stent substantially degrades in vivo in a time of from about 3 months to about 1 year.

18. The bioabsorbable implantable stent of claim 1 wherein the filaments further comprise polygluconate, polydioxanone, or combinations thereof and whereby the stent substantially degrade in vivo in from about 1 week to about 3 months.

19. The bioabsorbable implantable stent of claim 1 wherein the stent has at least one end of diminishing diameter so as to function as a filter.

20. The bioabsorbable implantable stent device of claim 1 wherein the filaments are substantially homogeneous in cross section and length.

21. The bioabsorbable implantable stent of claim 1 wherein the filaments have a tensile modulus of from about 400,000 psi to about 1,200,000 psi.

22. The bioabsorbable implantable stent of claim 1 wherein the filaments have a tensile modulus of from about 700,000 psi to about 1,200,000 psi.

23. The bioabsorbable implantable stent of claim 1 wherein the stent includes a plurality of the filaments helically wound and interwoven in a braided configuration to form a tube.

24. A bioabsorbable implantable endoprosthesis comprising:

a first set of filaments each of which extends in a configuration about a center line and having a first common direction of winding;

a second set of filaments each of which extends in a configuration about the center line and having a second common direction of winding;

the second set of filaments crossing the first set of filaments at an axially directed angle of between about 120 and about 150 degrees when in a free radially expanded state after being annealed, to determine an annealed diameter, D, of the endoprosthesis in said free radially expanded state;

each filament comprising a bioabsorbable material having a tensile strength of from about 15 ksi to about 120 ksi, a tensile modulus of from about 200,000 psi to about 2,000,000 psi, and an average thickness of from about 0.15 mm to about 0.6 mm;

wherein the first set of filaments and second set of filaments act upon one another to create an outwardly directed radial force and the bioabsorbable implantable endoprosthesis is adapted to substantially degrade in less than about 3 years; and

wherein said radial force, when the endoprosthesis is radially constrained to a predetermined fraction of the annealed diameter, varies substantially linearly as a function of the annealed diameter, whereby the annealed diameter, D, is selected to provide a desired force when the endoprosthesis is so radially constrained.

25. The bioabsorbable implantable endoprosthesis of claim 24 wherein after the bioabsorbable implantable endoprosthesis is radially constrained to about half of its free radially expanded diameter, whereby said predetermined fraction is one-half, the radial force RF exerted in grams, as a function of the annealed diameter, D in mm, is defined by about RF=−

15D+491±

20.

26. The bioabsorbable implantable endoprosthesis of claim 24 wherein the bioabsorbable implantable endoprosthesis is adapted to provide structural integrity to a body lumen for less than about 3 years.

27. The bioabsorbable implantable endoprosthesis of claim 24 wherein the bioabsorbable implantable endoprosthesis include poly(alpha-hydroxy) acid.

28. The bioabsorbable implantable endoprosthesis of claim 24 wherein the filaments include at least one of polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids) and combinations thereof.

29. The bioabsorbable implantable endoprosthesis of claim 24 wherein the bioabsorbable implantable endoprosthesis substantially degrades in vivo in from about 1 year to about 2 years.

30. The bioabsorbable implantable endoprosthesis of claim 28 wherein the filaments consist of polyglycolide and the bioabsorbable implantable endoprosthesis substantially degrades in vivo in from about 3 months to about 1 year.

31. The bioabsorbable implantable endoprosthesis of claim 28 wherein the filaments include at least one of polygluconate and polydioxanone and the bioabsorbable implantable endoprosthesis substantially degrades in vivo in from about 1 week to about 3 months.

32. The bioabsorbable implantable endoprosthesis of claim 24 wherein the filaments are substantially homogeneous in cross section and length.

33. The bioabsorbable implantable endoprosthesis of claim 24 wherein the filaments form a tube.

34. A bioabsorbable implantable endoprosthesis, including:

a first set of bioabsorbable filaments wound helically in a first common direction;

a second set of bioabsorbable filaments wound in a second common direction different than the first common direction, and cooperating with the first set of filaments to form a prosthesis structure in which the filaments of the first and second sets cross one another at an axially directed angle when in a free radially expanded state after being annealed, to determine an annealed diameter D of the prosthesis structure in the free radially expanded state; and

wherein the first set of filaments and the second set of filaments cooperate to provide an outwardly directed radial force when the prosthesis structure is radially constrained to a diameter less than the annealed diameter D, and wherein said radial force, when the prosthesis structure is radially constrained to a predetermined fraction of the annealed diameter, varies substantially linearly as a function of the annealed diameter, whereby the annealed diameter D is selectable to provide a desired radial force when the prosthesis structure is radially constrained to said predetermined fraction of the annealed diameter.

35. The endoprosthesis of claim 34 wherein:

said axially directed angle is between about 120 degrees and about 150 degrees.

36. The endoprosthesis of claim 34 wherein:

each of the filaments of the first and second sets has a tensile strength of from about 15 ksi to about 120 ksi, a tensile modulus of from about 200,000 psi to about 2,000,000 psi, and an average thickness of from about 0.15 mm to about 0.6 mm.

37. The endoprosthesis of claim 34 wherein:

the prosthesis structure is radially constrained to about half of said annealed diameter D whereby the predetermined fraction is one-half, and the radial force RF exerted in grams, as a function of the annealed diamater D in mm, is defined by the equation RF=−

15D+491+20.

38. The endoprosthesis of claim 34 wherein:

the filaments include at least one of polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids) and combinations thereof.

39. Endoprosthesis of claim 34 wherein:

the first and second common directions of winding are opposite one another.