Hydrogel vaso-occlusive device

• US 20020193812A1
• Filed: 05/06/2002
• Published: 12/19/2002
• Est. Priority Date: 05/04/2001
• Status: Abandoned Application

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: Dieck, Martin S., Ken, Christopher G.M., Patel, Tina J.
• Application Number:
  US10/138,528
• Publication Number:
  US 20020193812A1
• Time in Patent Office: Days
• US Class Current: 606/151
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61L 24/0031 Hydrogels or hydrocolloids
• CPC Class Codes: A61L 24/02 containing inorganic materials
• CPC Class Codes: A61L 24/04 containing macromolecular materials
• CPC Class Codes: A61L 2430/36 for embolization or occlusion, e.g. vaso-occlusive compositions or devices

Abstract

Methods and apparatus usable for performing vaso-occlusion at a site of abnormal blood flow in the body. The methods typically comprise treatments for occluding abnormal blood flow in the body, and can be applied to treatment for aneurysms, AVMs, fistulas, ruptured blood vessels and benign or malignant tumors.

Claims

1. A vaso-occlusive device for implantation into the vasculature of a patient comprising:

at least one polymer capable of taking a form that can pass through a delivery device to a site of abnormal blood flow, whereupon the at least one polymer assumes a vaso-occluding shape at the site.

2. A vaso-occlusive device as in claim 1, wherein said at least one polymer includes a single polymer.

3. A vaso-occlusive device as in claim 1, wherein the form that can pass through the delivery device comprises a solid or a liquid.

4. A vaso-occlusive device as in claim 3, wherein the solid is selected from the shapes consisting of a strip, rod, sheet, roll, tube, ribbon, string, and coil.

5. A vaso-occlusive device as in claim 1, wherein said at least one polymer includes at least two polymers, the polymers each form a solid and are affixed in a form that can pass through a delivery device and that each differentially responds to an environmental condition.

6. A vaso-occlusive device as in claim 5, wherein the environmental condition is selected from the group consisting of temperature, pH, solvency, pressure, electrical field, and energy source.

7. A vaso-occlusive device as in claim 1, wherein the vaso-occluding shape is selected from the group consisting of a coil, a circle, a half circle, a cone, a twisted sheet, a rod having bends, an amorphous shape, a tangle of filaments, and a helix.

8. A vaso-occlusive device as in claim 1, wherein the at least one polymer is selected from the group consisting of polyacrylamide (PAAM), poly (N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly (ethylene oxide), poly (vinylalcohol), poly (ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), Polylactide (PLA), Polyglycolide (PGA), Poly(lactide-co-glycolide) PLGA, Poly(e-caprolactone), Polydiaoxanone, Polyanhydride, Trimethylene carbonate, Poly(β

-hydroxybutyrate), Poly(g-ethyl glutamate), Poly(DTH-iminocarbonate), Poly(bisphenol A iminocarbonate), Poly(orthoester) (POE), Polycyanoacrylate (PCA), Polyphosphazene, Polyethyleneoxide (PEO), Polyethylglycol (PEG), Polyacrylacid (PAA), Polyacrylonitrile (PAN), Polyvinylacrylate (PVA), Polyvinylpyrrolidone (PVP), Polyglycolic lactic acid (PGLA), a co-polymer of two or more polymers, and a blend of two or more polymers.

9. A vaso-occlusive device as in claim 1, wherein the at least one polymer comprises a natural polymer.

10. A vaso-occlusive device as in claim 9, wherein the natural polymer can be selected from the group consisting of collagen, silk, fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin, ovalbumin, heparin sulfate, starch, agar, heparin, alginate, fibronectin, fibrin, elastin, silk-elastin, pectin, keratin, copolymers thereof, and a blend of polymers.

11. A vaso-occlusive device as in claim 1, further comprising a bioactive agent reactive at the site of implantation.

12. A vaso-occlusive device as in claim 11, wherein the bioactive agent comprises an agent selected from the group consisting of a protein factor, a growth factor, an inhibiting factor, an endothelization factor, an extracellular matrix-forming factor, a cell adhesion factor, a tissue adhesion factor, an immunological factor, a healing factor, a vascular endothelial growth factor, a scarring factor, a tumor suppressor, an antigen-binding factor, an anti-cancer factor, a monoclonal antibody, a monoclonal antibody against a growth factor, a drug, a drug producing cell, a cell regeneration factor, a progenitor cell of the same type as vascular tissue, and an a progenitor cell that is histiologically different from vascular tissue.

13. A vaso-occlusive device as in claim 12, wherein the bioactive agent is a tissue adhesion factor and the tissue adhesion factor is selected from the group consisting of a fibrin, collagen, albumin, cyanoacrylate, fibrinogen, chitosan, and gelatin-genipin.

14. A vaso-occlusive device as in claim 1, further comprising a radio pacifier.

15. A vaso-occlusive device as in claim 14, wherein the radio pacifier comprises an agent that provides visibility of the device under an imaging technique.

16. A vaso-occlusive device as in claim 14, wherein the radio pacifier comprises an agent selected from the group consisting of a contrast media or a metal powder.

18. A method as in claim 17, wherein the device comprises at least two polymers that have a differential sensitivity to an environmental condition, and said method includes contacting the at least two polymers to form an article for delivery;

and delivering the article to a site in the patient;

wherein the article is exposed to an environmental condition at the site in the patient or during delivery of the article.

19. A method as in claim 17, wherein contacting comprises a process selected from the group consisting of molding, extruding, heating, cooling, shaping, pressurizing, mixing, copolymerizing, affixing, blending and casting.

20. A method of forming a vaso-occlusive device as in claim 17, further comprising integrating a bioactive agent into said at least one polymer for contact and reactivity with material at a site of implantation.

21. A method as in claim 20, wherein the bioactive agent comprises an agent selected from the group consisting of a protein factor, a growth factor, an inhibiting factor, an endothelization factor, an extracellular matrix-forming factor, a cell adhesion factor, a tissue adhesion factor, an immunological factor, a healing factor, a vascular endothelial growth factor, a scarring factor, a tumor suppressor, an antigen-binding factor, an anti-cancer factor, a monoclonal antibody, a monoclonal antibody against a growth factor, a drug, a drug producing cell, a cell regeneration factor, a progenitor cell of the same type as vascular tissue, and an a progenitor cell that is histiologically different from vascular tissue.

22. A method as in claim 20, further comprising integrating a radio pacifier into one or more polymers for detection of the device in the patient by imaging.

24. A method as in claim 23, wherein the at least one polymer is selected from the group consisting of polyacrylamide (PAAM), poly (N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly (ethylene oxide), poly (vinylalcohol), poly (ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), Polylactide (PLA), Polyglycolide (PGA), Poly(lactide-co-glycolide) PLGA, Poly(e-caprolactone), Polydiaoxanone, Polyanhydride, Trimethylene carbonate, Poly(β

-hydroxybutyrate), Poly(g-ethyl glutamate), Poly(DTH-iminocarbonate), Poly(bisphenol A iminocarbonate), Poly(orthoester) (POE), Polycyanoacrylate (PCA), Polyphosphazene, Polyethyleneoxide (PEO), Polyethylglycol (PEG), Polyacrylacid (PAA), Polyacrylonitrile (PAN), Polyvinylacrylate (PVA), Polyvinylpyrrolidone (PVP), Polyglycolic lactic acid (PGLA), a co-polymer of two or more polymers, and a blend of two or more polymers.

25. A method as in claim 23, further comprising integrating a bioactive agent into the vaso-occlusive device for contact and reactivity with material at the site of implantation.

26. A method as in claim 25, wherein the bioactive agent is selected from the group consisting of a protein factor, a growth factor, an inhibiting factor, an endothelization factor, an extracellular matrix-forming factor, a cell adhesion factor, a tissue adhesion factor, an immunological factor, a healing factor, a vascular endothelial growth factor, a scarring factor, a tumor suppressor, an antigen-binding factor, an anti-cancer factor, a monoclonal antibody, a monoclonal antibody against a growth factor, a drug, a drug producing cell, a cell regeneration factor, a progenitor cell of the same type as vascular tissue, and an a progenitor cell that is histiologically different from vascular tissue.

27. A method as in claim 23, further comprising integrating a radio pacifier into the vaso-occlusive device for imaging the device after implantation.

28. A vaso-occlusive device as in claim 1 wherein said at least one polymer includes a hydrogel polymer.

29. A vaso-occlusive device as in claim 28 wherein said at least one polymer includes at least two hydrogel polymers.

30. A vaso-occlusive device as in claim 1 wherein said at least one polymer includes at least two natural polymers.

31. A vaso-occlusive device as in claim 1 wherein said at least one polymer includes at least one natural polymer and at least one hydrogel polymer.

32. A method as in claim 17 wherein said at least one polymer, copolymer or blended polymer includes at least two hydrogel polymers.

33. A method as in claim 17 wherein said at least one polymer, copolymer or blended polymer includes at least one hydrogel and at least one natural polymer.

34. A method as in claim 17 wherein said at least one polymer, copolymer or blended polymer includes at least two natural polymers.

17. A method of making a vaso-occlusive device for implantation into the vasculature of a patient comprising:

contacting at least one polymer, copolymer or blended polymer to form a pre-implantation hydrogel polymer, and

hydrating the hydrogel polymer either before or during implantation into the patient through a delivery device.

23. A method of treating a patient having abnormal blood flow comprising:

implanting in the patient at the site of the abnormal blood flow a device comprising at least one polymer capable of being delivered through a delivery device to an implantation site comprising abnormal blood flow in a patient, whereupon after implantation of the device in the patient the device forms a vaso-occlusive shape.