Systems for gel-based medical implants

• US 20060286141A1
• Filed: 12/15/2004
• Published: 12/21/2006
• Est. Priority Date: 12/15/2003
• Status: Abandoned Application

• Current Assignee: Endolumen Therapeutics Incorporated
• Original Assignee: Endolumen Therapeutics Incorporated
• Inventors: Campbell, Todd D.
• Application Number:
  US10/587,580
• Publication Number:
  US 20060286141A1
• Time in Patent Office: Days
• US Class Current: 424/423
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/114 Nitric oxide, i.e. NO
• CPC Class Codes: A61L 31/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: C08L 5/04 Alginic acid; Derivatives thereof

Abstract

Systems, including methods and apparatus, for medical implants including a gel.

Claims

1. A coated stent, comprising:

a stent latticework; and

an alginate coating disposed on the stent latticework.

7. The coated stent of claim 1 further comprising:

a therapeutic component dispersed within the alginate coating, wherein the therapeutic component acts as source of a therapeutic agent, and wherein the alginate coating controls elution of the therapeutic agent from the alginate coating.

8. The coated stent of claim 7, wherein the therapeutic component is selected from the group consisting of an anti-coagulant, an anti-platelet drug, an anti-thrombotic drug, an anti-proliferant, an inhibitory agent, an anti-stenotic substance, heparin, a heparin peptide, an anti-cancer drug, an anti-inflammatant, nitroglycerin, L-arginine, an amino acid, a nutraceutical, an enzyme, a nitric oxide synthase, a diazeniumdiolate, matrix metalloproteinase, a nitric oxide donor, rapamycin, a rapamycin analog, paclitaxel, a paclitaxel analog, a coumadin therapy, a lipase, and a combination thereof.

9. The coated stent of claim 1 further comprising:

a cellular component dispersed within the alginate coating, wherein the cellular component controllably releases a therapeutic agent when the coated stent is deployed within a vessel of a mammalian body.

11. The coated stent of claim 9, wherein the released therapeutic agent includes nitric oxide.

2-6. -6. (canceled)

10. (canceled)

12. (canceled)

13. A method of treating a vessel in a mammalian body, the method comprising:

providing a stent latticework;

coating the stent latticework with an alginate solution to form a coated stent having an alginate coating disposed on the stent latticework;

positioning the coated stent within the vessel;

deploying the coated stent; and

eluting a therapeutic agent from the alginate coating.

17. The method of claim 13, wherein the alginate coating includes one of a therapeutic component or a cellular component.

20. The method of claim 13 further comprising:

determining a ratio of mannuronate alginate subunits and guluronate alginate subunits to provide a predetermined elution characteristic of the alginate coating;

mixing mannuronate alginate subunits, guluronate alginate subunits, an alginate solvent, and one of a therapeutic component or a cellular component to form an alginate solution with the determined ratio of mannuronate alginate subunits and guluronate alginate subunits;

adding an alginate linking agent to the alginate solution; and

coating the stent latticework with the alginate solution.

22. The method of claim 13 further comprising:

selecting at least one of a therapeutic component and a cellular component; and

mixing the selected at least one component into the alginate solution prior to coating the stent latticework.

23. The method of claim 13 further comprising:

harvesting a viable cellular component from the mammalian body; and

mixing the harvested viable cellular component into the alginate solution prior to coating the stent latticework.

14-16. -16. (canceled)

18-19. -19. (canceled)

21. (canceled)

24-25. -25. (canceled)

26. An alginate coating for an implantable medical device, the alginate coating comprising:

an alginate matrix; and

at least one of a therapeutic component and a cellular component dispersed within the alginate matrix.

27. (canceled)

28. An alginate implant for treating a vessel in a mammalian body, the alginate implant comprising:

an alginate matrix in contact with an endoluminal wall of the vessel; and

a central lumen axially extending through the alginate matrix.

39. The alginate implant of claim 28, wherein the implant is configured as at least one of a stent and a cap for vulnerable plaque.

29-38. -38. (canceled)

40. A method of treating a vessel in a mammalian body, the method comprising:

forming an alginate implant within the vessel, the alginate implant in contact with an endoluminal wall of the vessel and having a central lumen axially extending through the alginate implant; and

eluting a therapeutic agent from one of a therapeutic component or a cellular component dispersed within the alginate implant.

49. The method of claim 40 further comprising:

determining a ratio of mannuronate alginate subunits and guluronate alginate subunits to provide a predetermined elution characteristic of the alginate implant;

combining mannuronate alginate subunits, guluronate alginate subunits, the alginate solvent, and the therapeutic component or the cellular component to form the alginate solution with the determined ratio of mannuronate alginate subunits and guluronate alginate subunits;

adding an alginate linking agent into the alcinate solution; and

injecting the alginate solution into a portion of the vessel with an implant formation catheter.

41-48. -48. (canceled)

50-52. -52. (canceled)

53. A system for forming an alginate implant in a mammalian body, the system comprising:

an implant formation catheter having a catheter body;

a formation balloon attached to the catheter body near a distal end of the catheter body; and

an alginate-delivery lumen within the catheter body, wherein an alginate implant is formed from an alginate solution injected through the alginate-delivery lumen into a cavity between the formation balloon and an endoluminal wall of the vessel when the formation balloon is inflated.

54-58. -58. (canceled)

59. A method of forming an alginate implant in a vessel of a mammalian body, the method comprising:

positioning an implant formation catheter in the vessel, the implant formation catheter having a catheter body;

inflating a distal occlusion balloon attached to the catheter body near a distal end of the catheter body;

inflating a proximal occlusion balloon attached to the catheter body proximal to the distal balloon;

inflating a medial formation balloon attached to the catheter body between the distal occlusion balloon and the proximal occlusion balloon;

injecting an alginate solution through an alginate-delivery lumen into a cavity formed between the inflated distal occlusion balloon, the inflated proximal occlusion balloon, the inflated medial formation balloon, and an endoluminal wall of the vessel; and

hardening the alginate solution to form the alginate implant.

60-62. -62. (canceled)

63. A method of forming an alginate implant in a vessel of a mammalian body, the method comprising:

positioning an implant formation catheter at a first location in the vessel, the implant formation catheter having a catheter body;

inflating an angioplasty balloon attached to the catheter body near a distal end of the catheter body, the angioplasty balloon having an alginate linking agent disposed on a surface of the angioplasty balloon;

depositing the alginate linking agent on an endoluminal wall of the vessel;

deflating the angioplasty balloon;

repositioning the implant formation catheter at a second location in the vessel, the second location in the vessel distal to the first location in the vessel;

re-inflating the angioplasty balloon;

inflating a formation balloon attached to the catheter body proximal to the angioplasty balloon;

injecting an alginate solution through an alginate-delivery lumen into a cavity formed between the formation balloon and an endoluminal wall of the vessel; and

hardening the alginate solution to form the alginate implant, wherein the alginate solution is hardened by the alginate linking agent deposited on the endoluminal wall of the vessel.

64-67. -67. (canceled)

68. A method of forming an alginate implant in a vessel of a mammalian body, the method comprising:

inserting an implant formation catheter into the vessel, the implant formation catheter having at least one formation balloon;

injecting an alginate solution into a cavity formed between the formation balloon and an endoluminal wall of the vessel when the formation balloon is inflated;

hardening the alginate solution to form the alginate implant; and

withdrawing the implant formation catheter from the vessel, wherein the formed alginate implant is in contact with the endoluminal wall of the vessel and includes a central lumen axially extending through the alginate implant.

69. An alginate bioreactor for treating a mammalian body, the alginate bioreactor comprising:

an alginate matrix; and

one of a therapeutic component or a cellular component dispersed within the alginate matrix, wherein a therapeutic agent is eluted from the alginate matrix after the alginate bioreactor is formed within the body.

71. The alginate bioreactor of claim 69, wherein the alginate bioreactor is formed in a portion of the mammalian body, the portion of the mammalian body selected from the group consisting of a heart, a liver, a pancreas, a kidney, an eyeball, a pericardial space, a cerebral spinal space, a periorganic space, an organ, a vessel, and a tissue.

77. The alginate bioreactor of claim 69, wherein the eluted therapeutic agent is selected from the group consisting of vascular endothelial growth factor, a biological anti-inflammatory agent, vitamin C, acetylsalicylic acid, a lipid lowering compound, a high-density lipoprotein cholesterol, a streptokinase, a kinase, a thrombolytic agent, an anti-thrombotic agent, a blood-thinning agent, a coumadin material, an anti-cancer agent, an angiogenic agent, an anti-angiogenic agent, an anti-rejection agent, a hormone, a therapeutic component, a cellular component, and a combination thereof.

70. (canceled)

72-76. -76. (canceled)

78. A method of treating a medical condition in a mammalian body, the method comprising:

forming an alginate bioreactor within a portion of the mammalian body, the alginate bioreactor including an alginate matrix; and

eluting a therapeutic agent from one of a therapeutic component or a cellular component dispersed within the alginate bioreactor.

79-97. -97. (canceled)