Systems and methods of de-endothelialization

• US 20040153025A1
• Filed: 02/03/2003
• Published: 08/05/2004
• Est. Priority Date: 02/03/2003
• Status: Abandoned Application

• Current Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Original Assignee: Stryker European Operations Holdings, LLC (Stryker Corporation)
• Inventors: Wallace, Michael P., Seifert, Paul S., Lee, Elaine
• Application Number:
  US10/357,940
• Publication Number:
  US 20040153025A1
• Time in Patent Office: Days
• US Class Current: 604/19
• 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 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• 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: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• 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: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104
• CPC Class Codes: A61N 1/28 Apparatus for applying thermoelectric currents
• CPC Class Codes: A61N 1/403 for thermotherapy, e.g. hyperthermia

Abstract

Apparatus and methods for at least partially de-endothelializing a wall of an aneurysm include an elongate core member including one or more fibers on an outer surface of the core member, the one or more fibers carrying a de-endothelialization agent. The core member is introduced into the aneurysm, thereby releasing the fluid from the one or more fibers within the aneurysm, the fluid disrupting at least a portion of the endothelium of the wall of the aneurysm. Alternatively, the core member includes a coating carrying a de-endothelialization agent, the coating being degradable when exposed to blood to release the de-endothelialization agent.

Claims

1. An apparatus for disrupting an endothelium of a wall of an aneurysm or other body lumen, comprising:

an elongate core member having an outer surface, a proximal end, and a distal end having a size and shape for introduction into a body lumen; and

one or more fibers on the outer surface of the core member, the one or more fibers carrying a de-endothelialization agent.

2. The apparatus of claim 1, wherein the core member is expandable.

3. The apparatus of claim 2, wherein the core member is an expandable basket.

4. The apparatus of claim 2, wherein the core member is a balloon.

5. The apparatus of claim 1, wherein the fiber comprises a hydrogel coating carrying the de-endothelialization agent.

6. The apparatus of claim 5, wherein the hydrogel is selected from the group consisting of gels formed from polysaccharides, mucopolysaccharides, polyaminoacids, proteins that support cell growth and healing, polyphosphazines, polyphosphoesters, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, polyvinyl pyrrolidone, polyethyloxazol ine, polyethylene oxide-co-polypropyleneoxide block copolymers, PGA-PEG-PGA block copolymers, PGA-PEG diblock copolymers, acrylates, carboxy alkyl celluloses, partially oxidized cellulose, polymers and oligomers of glycolide and lactide, polylactic acid, polyesters of .alpha.-hydroxy acids, polylactones, polycaprolactones, polyanhydrides, polyorthoesters, polydioxanone, styrene, acrolein and combinations thereof.

7. The apparatus of claim 5, wherein the hydrogel is selected from the group consisting of gels formed from hyaluronic acid, dextran, heparin sulfate, chondroitin sulfate, heparin, agar, starch, alginate, fibronectin, gelatin, collagen, fibrin, pectins, albumin, ovalbumin, collagen-hydroxyethyl-methacrylate (HEMA);

diacrylates, oligoacrylates, methacrylates, dimethacrylates, oligomethoacrylates, PEG-oligoglycolylacrylates, carboxymethyl cellulose, polyesters of lactic acid, polyesters of glycolic acid, poly(.alpha.-hydroxy) acids including polyglycolic acid, poly-DL-lactic, poly-L-lactic acid, and terpolymers of DL-lactide and glycolide, .epsilon.-caprolactone, .epsilon.-caprolactone copolymerized with polyesters, poly(.epsilon.-caprolactone), poly(.delta.-valerolactone), poly(gamma-butyrolactone), and combinations thereof

8. The apparatus of claim 1, wherein the proximal end of the core member is coupled to an elongate member.

9. The apparatus of claim 8, wherein the core member is detachably coupled to the elongate member.

10. The apparatus of claim 9, wherein the core member is detachably coupled to the elongate member by one of a mechanical joint and an electrolytic joint.

11. The apparatus of claim 1, further comprising a tubular member comprising a proximal end and a distal end having a size and shape for insertion into a body lumen, the core member disposed within a lumen of the sheath and being at least partially deployable from the sheath.

12. The apparatus of claim 1, wherein the one or more fibers comprise a fiber extending helically along the outer surface of the core member.

13. The apparatus of claim 1, wherein the one or more fibers comprises a mesh secured to the outer surface of the core member.

14. The apparatus of claim 1, wherein the one or more fibers comprises a porous material, and wherein the de-edothelialization agent comprises a fluid absorbed by the one or more fibers.

15. A method for at least partially de-endothelializing a wall of a treatment site adjacent a body lumen, comprising:

providing an elongate core member comprising one or more fibers on an outer surface of the core member, the one or more fibers carrying a de-endothelialization agent;

introducing the core member into the treatment site, thereby releasing the fluid from the one or more fibers within the treatment site, the fluid disrupting at least a portion of the endothelium of the wall of the treatment site.

16. The method of claim 15, wherein the core member is dipping in a source of de-endothelialization fluid such that the one or more fibers absorb the fluid.

17. The method of claim 15, further comprising advancing a distal end of a tubular member into the body lumen adjacent the aneurysm, the tubular member comprising a lumen extending proximally form the distal end, the core member being introduced into the aneurysm by being deployed from the lumen of the tubular member.

18. The method of claim 17, wherein the core member is inserted into the lumen from a proximal end of the tubular member.

19. The method of claim 15, wherein the core member is coupled to a distal end of an elongate member, and wherein the core member is introduced into the aneurysm by manipulating the elongate member.

20. The method of claim 19, further comprising detaching the core member from the distal end of the elongate member to release the core member within the treatment site.

21. The method of claim 15, further comprising removing the core member from the body lumen after the agent is at least partially released from the one or more fibers.

22. An apparatus for at least partially de-endothelializing a wall of an aneurysm or other body lumen, comprising:

an elongate core member comprising a proximal end, a distal end having a size and shape for introduction into a body lumen, and an outer surface; and

a coating on the outer surface of the core member that is degradable when exposed to bodily fluid, the coating comprising a de-endothelialization agent that is released as the degrades.

23. The apparatus of claim 22, wherein the coating comprises a hydrogel.

24. The apparatus of claim 23, wherein the hydrogel is selected from the group consisting of gels formed from polysaccharides, mucopolysaccharides, polyaminoacids, proteins that support cell growth and healing, polyphosphazines, polyphosphoesters, polyethylene glycol, polyethylene oxide, polyvinyl alcohol, polyvinylpyrrolidone, polyethyloxazoline, polyethylene oxide-co-polypropyleneoxide block copolymers, PGA-PEG-PGA block copolymers, PGA-PEG diblock copolymers, acrylates, carboxy alkyl celluloses, partially oxidized cellulose, polymers and oligomers of glycolide and lactide, polylactic acid, polyesters of alpha.-hydroxy acids, polylactones, polycaprolactones, polyanhydrides, polyorthoesters, polydioxanone, styrene, acrolein and combinations thereof.

25. The apparatus of claim 23, wherein the hydrogel is selected from the group consisting of gels formed from hyaluronic acid, dextran, heparin sulfate, chondroitin sulfate, heparin, agar, starch, alginate, fibronectin, gelatin, collagen, fibrin, pectins, albumin, ovalbumin, collagen-hydroxyethyl-methacrylate (HEMA);

diacrylates, oligoacrylates, methacrylates, dimethacrylates, oligomethoacrylates, PEG-oligoglycolylacrylates, carboxymethyl cellulose, polyesters of lactic acid, polyesters of glycolic acid, poly(.alpha.-hydroxy) acids including polyglycolic acid, poly-DL-lactic, poly-L-lactic acid, and terpolymers of DL-lactide and glycolide, .epsilon.-caprolactone, .epsilon.-caprolactone copolymerized with polyesters, poly(.epsilon.-caprolactone), poly(.delta.-valerolactone), poly(gamma-butyrolactone), and combinations thereof

26. A method for at least partially de-endothelializing a wall of a treatment site adjacent a body lumen, comprising:

introducing an elongate core member into the treatment site, the core member comprising a degradable coating on an outer surface of the core member, the coating comprising a de-endothelialization agent; and

leaving the core member within the treatment site until the coating at least degrades to release the de-endothelialization agent within the treatment site, whereby the agent at least partially de-endothelializes a wall of the treatment site.