Method and device for recanalizing and grafting arteries

• US 5,725,568 A
• Filed: 06/27/1995
• Issued: 03/10/1998
• Est. Priority Date: 06/27/1995
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Hastings, Roger N.
• Primary Examiner(s): JONES, MARYBETH O
• Application Number:
  US08/495,791
• Time in Patent Office: 987 Days
• Field of Search: 623/1, 604/93, 606/191-198
• US Class Current: 623/1.21
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/12195 comprising a curable material
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 2017/22082 after introduction of a substance
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/945 hardenable, e.g. stents formed in situ
• CPC Class Codes: A61F 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/30583 filled with hardenable fluid, e.g. curable in-situ
• CPC Class Codes: A61F 2210/0085 hardenable in situ, e.g. epoxy resins
• CPC Class Codes: A61L 2300/252 Polypeptides, proteins, e.g. glycoproteins, lipoproteins, cytokines
• CPC Class Codes: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/414 Growth factors
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/18 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 : Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 33/06 : of esters containing only carbon, hydrogen and oxygen, which oxygen atoms are present only as part of the carboxyl radical
• CPC Class Codes: C08L 75/04 : Polyurethanes
• CPC Class Codes: C08L 83/04 : Polysiloxanes

Abstract

The present invention provides an apparatus and method for repairing a diseased vessel at the site of an aneurysm, graft or stenosis. A polymeric self-hardening or self-curing material is introduced into the diseased area. The material is delivered via catheter and allowed to polymerize or cure in situ forming a foam plug in the vessel. A lumen is then created through the foam plug by such means as an atherectomy catheter, to recanalize the vessel. The polymeric material may also be hardened in situ by change in pH or ionic concentration, organic solvents, by permeation of a secondary material capable of precipitation, or by exposure to heat, light or laser energy. In blood, the device may be hardened through a cooperative effect of coagulation, precipitation or ionization. The device can be made of biodegradable material impregnated with growth factors, mitogenic factors or other determinants. The catheter itself may be an ultrasonic imaging catheter.

Claims

1. A medical device comprising a biocompatible polymeric material which is adapted to be delivered in a first state to a repair site in a vessel, said material being adapted to fill the repair site in its first state and being further adapted to be hardened in situ to form a plug at the repair site, said plug being adapted to have to lumen formed therein in situ, whereby said vessel is recanalized and a polymeric graft is created therein.

2. The device of claim 1 wherein the polymeric material comprises a self polymerizing polymeric foam.

3. The device of claim 1 wherein the polymeric material is adapted to be hardened in situ by chemical means.

4. The device of claim 1 wherein the polymeric material is a moisture curable material selected from the group consisting of cyanoacrylates, polyisocyanates, polyurethane prepolymers, UV curable acrylates, and moisture-curing silicones.

5. The device of claim 4 wherein the polymeric material further includes bioactive components.

6. The device of claim 5 wherein the bioactive components are selected from the group consisting of collagen, fibrin, albumin, β

Fibroblastic Growth Factor, angiogenic factors, RGD adhesion sequences, antibiotics and mixtures thereof.

7. A medical device comprising a biocompatible polymeric material which is adapted to be delivered in a first state to a repair site in a vessel, said polymeric material comprising an infusion of a solution of a synthetic or biological polymer which precipitates in-vivo, said material being adapted to fill the repair site in its first state and being further adapted to be hardened to form a plug at the repair site, said hardened material being further adapted to have a lumen formed therein, whereby a lumen is formed in said plug, thereby recanalizing file vessel and creating a polymeric graft therein.

8. The device of claim 7 wherein the infusion comprises normally insoluble proteins or polysaccharides in non-physiologic solution.

9. The device of claim 7 wherein the infusion comprises synthetic polymers in a non-aqueous but water miscible solvent.

10. A method for recanalizing and grafting a vessel, the method comprising the steps of:

a. providing a polymeric material;

b. delivering the polymeric material to a site needing repair in a vessel by means of a catheter, thereby forming a plug in said vessel; and

c. canalizing the plug, whereby a stent is formed and the vessel is recanalized.

11. The method of claim 10 wherein the plug is canalized by catheter means.

12. The method of claim 11 wherein the catheter means further comprises an atherectomy means and the plug is canalized by said atheterctomy means.

13. Apparatus for recanalizing and grafting a vessel in a body, the apparatus comprising:

a. a source of a biocompatible polymeric material, said material being adapted to be delivered in a first state to a repair site in the vessel, and filling the vessel at the repair site in its first state and being further adapted to be hardened in situ to a second state to form a plug at the repair site;

b. a delivery catheter comprising delivery means located therein for delivering said material in its first state to the repair site in the vessel; and

c. a second catheter comprising canalizing means located therein for forming a lumen in said material after hardening;

whereby a polymeric graft is formed and the vessel is recanalized.

14. The apparatus of claim 13 wherein the polymeric material is biodegradable.

15. The apparatus of claim 13 wherein the polymeric material is non-biodegradable.

16. The apparatus of claim 13 wherein the polymeric material includes growth factors and other mitogenic agents.

17. The apparatus of claim 13 wherein the polymeric material is self hardening.

18. The apparatus of claim 13 wherein the polymeric material is adapted to be hardened by chemical means.

19. The apparatus of claim 13 wherein the polymeric material is adapted to be hardened by means of light or heat energy.

20. The apparatus of claim 13 wherein the polymeric material is comprised of a material selected from the group consisting of caprolactone, polylactic acid and mixtures thereof.

21. The apparatus of claim 20 wherein the polymeric material further includes a bioactive material.

22. The apparatus of claim 13 wherein the polymeric material is delivered through an infusion of a solution of a synthetic or biological polymer which precipitates in-vivo.

23. The apparatus of claim 22 wherein the infusion comprises normally insoluble proteins or polysaccharides in non-physiologic solution.

24. The apparatus of claim 22 wherein the infusion comprises synthetic polymers in non-aqueous but water miscible solvent.