Intravascular stent pump

• US 5,735,897 A
• Filed: 01/02/1997
• Issued: 04/07/1998
• Est. Priority Date: 10/19/1993
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Buirge, Andrew W.
• Primary Examiner(s): BRITTINGHAM, DEBRA
• Application Number:
  US08/775,618
• Time in Patent Office: 460 Days
• Field of Search: 623/1, 623/11, 623/12, 600/36, 606/191, 606/194, 606/195, 606/198, 604/892.1
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A multi-layer vascular therapeutic-containing prosthesis designed and arranged to "pump" the therapeutics into the blood stream.

Claims

1. An implantable device constructed and arranged in a laminate structure comprising:

first and second spaced layers of support material, at least one of said layers being fluid permeable,

an intermediate third layer of a matrix material having fluid-swellable characteristics, the intermediate layer being held between the first and second layers, and

a drug or therapeutic contained in the intermediate layer,

wherein said device upon implantation has a predetermined outer diameter selected to correspond substantially with an inner diameter of an implant site, whereby when the device is implanted in a vessel in a body, the drug or therapeutic is pumped into the vessel in response to the swelling of the fluid-swellable matrix material.

2. The device of claim 1 wherein the first and second layers are comprised of polymeric material.

3. The device of claim 2 wherein the polymeric material is selected from the group consisting of polylactics, polyacetates, polyacrylates, polyglycol, polycaprolactones, polyesters, polyethers, polyamides and mixtures thereof.

4. The device of claim 1 in a cylindrical, stent-like configuration.

5. The device of claim 1 wherein at least one of the first and second layers is comprised of polymeric material.

6. The device of claim 1 wherein the intermediate layer is made of a material selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol, polyethylene oxide or polyvinyl alcohol, said intermediate layer being made up in an aqueous solution containing the dissolved drug or therapeutic to be contained therein.

7. A device as in claim 1 wherein the first and second spaced layers are each comprised of a curable and resorbable material and the intermediate third layer and the drug or therapeutic contained in the intermediate layer are resorbable.

8. An implantable intravascular device having a generally cylindrical form constructed and arranged for blood flow therethrough, said device comprising a multi-layer wall, said wall comprising at least:

an inner binding layer of permeable support material;

an outer binding layer of support material, and

an intermediate matrix layer of blood-swellable material, the matrix layer containing therapeutic materials to be dispersed into the blood in response to the swelling of the blood-swellable matrix material,

said device upon implantation having a predetermined outer diameter selected to correspond substantially with an inner diameter of an implant site.

9. The device of claim 8 wherein the inner and outer layers of support material are comprised of polymeric material.

10. The device of claim 8 wherein at least one of the inner and outer layers is comprised of polymeric material.

11. The device of claim 10 wherein the at least one polymeric layer is made of a polymeric material selected from the group consisting of polylactics, polyacetates, polyacrylates, polyglycol, polycaprolactones, polyesters, polyethers, polyamides and mixtures thereof.

12. The device of claim 8 wherein the outer layer is comprised of a polymer, a reactive monomer and a polymerization initiator;

the intermediate layer is comprised of a swellable drug-bearing layer, and the inner layer is comprised of a porous material.

13. The device of claim 8 wherein:

a) the outer layer is comprised of a polymeric material selected from the group consisting of polylactics, polyacetates, polyacrylates, polyglycol, polycaprolactones, polyesters, polyethers, polyamides and mixtures thereof, a reactive monomer and a polymerization initiator;

b) the intermediate layer is comprised of a swellable drug-bearing layer made of a material selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol, polyethylene oxide or polyvinyl alcohol, said intermediate layer being made up in an aqueous solution containing the dissolved drug or therapeutic to be contained therein; and

c) the inner layer is a porous polymeric material comprising a polymer selected from the group consisting of polylactics, polyacetates, polyacrylates, polyglycol, polycaprolactones, polyesters, polyethers, polyamides and mixtures thereof, a reactive monomer, a polymerization initiator and a component selected from the group consisting of microcrystalline salts, simple inorganic salts, sugars, polysaccharides or mixtures thereof in an effective amount to impart porosity to said inner layer.

14. A device as in claim 8 wherein the inner and outer binding layers are curable and resorbable and the intermediate matrix layer containing therapeutic materials is resorbable.

15. An implantable intravascular device having a generally cylindrical form constructed and arranged for blood flow therethrough, said device comprising a multi-layer wall, said wall comprising at least:

a) an inner binding layer of permeable support material, said inner layer being comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate and 2-hydroxy-2-methyl-1-phenyl-1-propanone, and additionally including microcrystalline sodium heparin;

b) an outer binding layer of support material, said outer layer being comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate and 2-hydroxy-2-methyl-1-phenyl-1-propanone; and

c) an intermediate matrix layer of blood-swellable material, the matrix layer containing therapeutic materials to be dispersed into the blood, said intermediate matrix layer being comprised of polyvinylpyrrolidone, water and sodium heparin.

16. An implantable device constructed and arranged in a laminate structure, the device comprising:

first and second spaced layers of support material, at least one of said layers being fluid permeable,

an intermediate third layer of a matrix material having fluid-swellable characteristics, the intermediate layer being held between the first and second layers, and

a drug or therapeutic contained in the intermediate layer,

wherein said device has a first outer diameter prior to implantation in a body and a second outer diameter after implantation, and the outer diameter of the device after implantation corresponds substantially with an inner diameter of an implant site,

whereby when the device is implanted in a body, the drug or therapeutic is pumped into the implant site in response to the swelling of the fluid-swellable matrix material.

17. An implantable device having a generally cylindrical form constructed and arranged for fluid flow therethrough, said device comprising a multi-layer wall, said wall comprising at least:

an inner binding layer of permeable support material;

an outer binding layer of support material, and

an intermediate matrix layer of fluid-swellable material, the matrix layer containing therapeutic materials to be dispersed into an implant site in a body in response to the swelling of the fluid-swellable matrix material, said device having a first outer diameter prior to implantation, and a second outer diameter after implantation, the outer diameter of the device after implantation corresponds substantially with an inner diameter of the implant site.

18. An implantable device constructed and arranged in a laminate structure, comprising:

first and second spaced layers of support material comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate and 2-hydroxy-2-methyl-1-phenyl-1-propanone, at least one of which is fluid permeable and is further comprised of microcrystalline sodium heparin,

an intermediate third of a matrix material having fluid-swellable characteristics, said intermediate layer being comprised of polyvinylpyrrolidone water and sodium heparin, the intermediate layer being held between the first and second layers, and

a drug or therapeutic contained in the intermediate layer, whereby when the device is implanted in a vessel in a body, the drug or therapeutic is pumped into the vessel in response to the swelling of the fluid-swellable matrix material.

19. An implantable intravascular device having a generally cylindrical form constructed and arranged for blood flow therethrough, said device comprising a multi-layer wall, said wall comprising at least:

an inner binding layer of permeable support material, said inner layer being comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate, 2-hydroxy-2-methyl-1-phenyl-1-propanone, and microcrystalline sodium heparin;

an outer binding layer of support material, said outer layer being comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate and 2-hydroxy-2-methyl-1-phenyl-1propanone, and

an intermediate matrix layer of blood-swellable material, the matrix layer being comprised of polyvinylpyrrolidone, water and sodium heparin and further containing therapeutic materials to be dispersed into the blood in response to the swelling of the blood-swellable matrix material.

20. An implantable stent comprising:

a) first and second spaced layers of support material, at least one of said layers being fluid permeable;

b) an intermediate third layer of a material having fluid-swellable characteristics, the intermediate layer being held between the first and second layers, said first, second and third layers being constructed and arranged in a laminate structure; and

c) a drug or therapeutic contained in the intermediate layer,

wherein said stent upon implantation has an outer diameter adapted to fit an inner diameter of an implant site,

whereby when the stent is implanted in a vessel in a body, the drug or therapeutic is pumped into the vessel in response to the swelling of the fluid-swellable material.

21. The implantable stent of claim 20 adapted to be expanded in situ to fit the vessel.

22. The implantable stent of claim 21 wherein the stent is balloon expandable.

23. The implantable stent of claim 21 wherein the stent is self-expanding.

24. The implantable stent of claim 20 wherein at least one of the first and second layers is comprised of polymeric material.

25. The implantable stent of claim 24 wherein the first and second layers are comprised of polymeric material.

26. The implantable stent of claim 24 wherein the polymeric material is selected from the group consisting of polylactics, polyacetates, polyacrylates, polyglycol, polycaprolactones, polyesters, polyethers, polyamides, and mixtures thereof.

27. The implantable stem of claim 20 wherein the intermediate layer is made of a material selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol, polyethylene oxide or polyvinyl alcohol, said intermediate layer being made up in an aqueous solution containing the dissolved drug or therapeutic to be contained therein.

28. A implantable stent of claim 26 wherein the first and second spaced layers are each comprised of a curable and resorbable material and the intermediate third layer and the drug or therapeutic contained in the intermediate layer are resorbable.

29. An implantable intravascular stent having a generally cylindrical form adapted for blood flow therethrough, said stent comprising a multi-layer wall, said wall comprising at least:

an inner binding layer of permeable support material;

an outer binding layer of support material, and

an intermediate layer of blood-swellable material, the intermediate layer containing therapeutic materials to be dispersed into the blood in response to the swelling of the blood-swellable material,

said stent upon implantation having an outer diameter adapted to fit an inner diameter of an implant site.

30. The stent of claim 29 adapted to be expanded to fit the implant site.

31. The stent of claim 30 which is balloon expandable.

32. The stent of claim 30 which is self-expanding.

33. The stent of claim 29 wherein the inner and outer layers of support material are comprised of polymeric material.

34. The stent of claim 29 wherein at least one of the inner and outer layers is comprised of polymeric material.

35. The stent of claim 34 wherein the at least one polymeric layer is made of a polymeric material selected from the group consisting of polylactics, polyacetates, polyacrylates, polyglycol, polycaprolactones, polyesters, polyethers, polyamides and mixtures thereof.

36. The stent of claim 29 wherein:

a) the outer layer is comprised of a polymeric material selected from the group consisting of polylactics, polyacetates, polyacrylates, polyglycol, polycaprolactones, polyesters, polyethers, polyamides and mixtures thereof, a reactive monomer and a polymerization initiator;

b) the intermediate layer is comprised of a swellable drug-bearing layer made of a material selected from the group consisting of polyvinylpyrrolidone, polyethylene glycol, polyethylene oxide or polyvinyl alcohol, said intermediate layer being made up in an aqueous solution containing the dissolved drug or therapeutic to be contained therein; and

c) the inner layer is a porous polymeric material comprising a polymer selected from the group consisting of polylactics, polyacetates, polyacrylates, polyglycol, polycaprolactones, polyesters, polyethers, polyamides and mixtures thereof, a reactive monomer, a polymerization initiator and a component selected from the group consisting of microcrystalline salts, simple inorganic salts, sugars, polysaccharides or mixtures thereof in an effective amount to impart porosity to said inner layer.

37. A stent as in claim 29 wherein the inner and outer binding layers are curable and resorbable and the intermediate matrix layer containing therapeutic materials is resorbable.

38. The stent of claim 29 wherein the outer layer is comprised of a polymer, a reactive monomer and a polymerization initiator;

the intermediate layer is comprised of a swellable drug-bearing layer, and the inner layer is comprised of a porous material.

39. An implantable intravascular stent having a generally cylindrical form constructed and arranged for blood flow therethrough, said stent comprising a multi-layer wall, said wall comprising at least:

a) an inner binding layer of permeable support material, said inner layer being comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate and 2-hydroxy-2-methyl-1-phenyl-1-propanone, and additionally including microcrystalline sodium heparin;

b) an outer binding layer of support material, said outer layer being comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate and 2-hydroxy-2-methyl-1-phenyl-1-propanone; and

c) an intermediate layer of blood-swellable material, the intermediate layer containing therapeutic materials to be dispersed into the blood, said intermediate layer being comprised of polyvinylpyrrolidone, water and sodium heparin.

40. The stent of claim 39 adapted to be expanded to fit the implant site.

41. The stent of claim 40, said stent being balloon expandable.

42. The stent of claim 40, said stent being self-expanding.

43. An implantable stent comprising:

first and second spaced layers of support material, at least one of said layers being fluid permeable,

an intermediate third layer having fluid-swellable characteristics, the intermediate layer being held between the first and second layers, and

a drug or therapeutic contained in the intermediate third layer,

wherein said stent has a first outer diameter prior to implantation in a body and a second outer diameter after implantation, and the outer diameter of the stent after implantation corresponds substantially with an inner diameter of an implant site,

whereby when the stent is implanted in a body, the drug or therapeutic is pumped into the implant site in response to the swelling of the fluid-swellable intermediate third layer.

44. The stent of claim 43 adapted to be expanded to fit the implant site.

45. The stent of claim 44 which is balloon expandable.

46. The stent of claim 45 which is self-expanding.

47. An implantable stent having a generally cylindrical form and being adapted for fluid flow therethrough, said stent comprising a multi-layer wall, said wall comprising at least:

an inner binding layer of permeable support material;

an outer binding layer of support material, and

an intermediate layer of fluid-swellable material, the intermediate layer containing therapeutic materials to be dispersed into an implant site in a body in response to the swelling of the fluid-swellable material, said stent having a first outer diameter prior to implantation, and a second outer diameter after implantation, wherein the outer diameter of the stent after implantation corresponds substantially with an inner diameter of the implant site.

48. The stent of claim 47 adapted to be expanded to fit the implant site.

49. The stent of claim 48 which is balloon expandable.

50. The stent of claim 48 which is self-expanding.

51. An implantable stent comprising:

first and second spaced layers of support material comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate and 2-hydroxy-2-methyl-1-phenyl-1-propanone, at least one of which is fluid permeable and is further comprised of microcrystalline sodium heparin,

an intermediate third layer having fluid-swellable characteristics, said intermediate layer being comprised of polyvinylpyrrolidone, water and sodium heparin, the intermediate layer being held between the first and second layers, and

a drug or therapeutic contained in the intermediate layer, whereby when the stent is implanted in a vessel in a body, the drug or therapeutic is pumped into the vessel in response to the swelling of the fluid-swellable material.

52. The stent of claim 51 adapted to be expanded to fit the implant site.

53. The stent of claim 52 which is balloon expandable.

54. The stent of claim 52 which is self-expanding.

55. An implantable intravascular stent having a generally cylindrical form adapted for blood flow therethrough, said stent comprising a multi-layer wall, said wall comprising at least:

an inner binding layer of permeable support material, said inner layer being comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate, 2-hydroxy-2-methyl-1-phenyl-1-propanone, and microcrystalline sodium heparin;

an outer binding layer of support material, said outer layer being comprised of poly-D,L-lactic acid, ethylene glycol dimethacrylate and 2-hydroxy-2-methyl-1-phenyl-1-propanone, and

an intermediate layer of blood-swellable material, the intermediate layer being comprised of polyvinylpyrrolidone, water and sodium heparin and further containing therapeutic materials to be dispersed into the blood in response to the swelling of the blood-swellable material.

56. The stent of claim 55 adapted to be expanded to fit the implant site.

57. The stent of claim 56 which is balloon expandable.

58. The stent of claim 56 which is self-expanding.