Endoluminal delivery system

• US 20070060998A1
• Filed: 06/01/2006
• Published: 03/15/2007
• Est. Priority Date: 06/01/2005
• Status: Active Grant

• Current Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Original Assignee: Board of Trustees of the Leland Stanford Junior University (Stanford Management Co.)
• Inventors: White, John, Butterwick, Alexander, Ng, Martin, Mitra, Ashish
• Granted Patent: US 7,955,372 B2
• Time in Patent Office: Days
• US Class Current: 623/1.110
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/30448 using adhesives
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/62 Encapsulated active agents, e.g. emulsified droplets
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence

Abstract

An endoluminal delivery system is provided having an endoluminal prosthesis sized to fit through a body lumen in a first unexpanded state, where a second state is an expanded relative to the first state. At least one delivery capsule is incorporated to the outer wall of the endoluminal prosthesis, where each one of the delivery capsules has a predetermined delivery pressure. There is at least one reactant in the delivery capsule, where the endoluminal prosthesis is expanded from the first state to the second state to expand the endoluminal prosthesis against the body lumen and induce the predetermined delivery pressure to the delivery capsule, and deliver the reactants to the body lumen according to desired positioning and timing. At least one containment band incorporated to the outer wall of the endoluminal prosthesis and positioned near the delivery capsules to localize the reactants.

Claims

1. ) An endoluminal delivery system, comprising:

a. an endoluminal prosthesis having a first state and a second state, wherein said endoluminal prosthesis is sized to fit through a body lumen in said first state and said second state is expanded relative to said first state;

b. at least one delivery capsule incorporated to the outer wall of said endoluminal prosthesis wherein each one of said delivery capsules has a predetermined delivery pressure; and

c. at least one reactant in said delivery capsule, wherein said endoluminal prosthesis is expanded from said first state to said second state to expand said endoluminal prosthesis against said body lumen and induce said predetermined delivery pressure to said delivery capsule according to desired positioning and timing to deliver said reactant to said body lumen.

2. ) The endoluminal delivery system of claim 1, further comprises at least one containment band incorporated to the outer wall of said endoluminal prosthesis and positioned near said delivery capsule to localize said reactant.

3. ) The endoluminal delivery system of claim 2, wherein said containment band comprises a non-permeable layer on an outer surface, or on an inner surface, or an outer surface and an inner surface.

4. ) The endoluminal delivery system of claim 2, wherein said containment band comprises absorbent material to absorb said reactants and receive tissue growth therein.

5. ) The endoluminal delivery system of claim 2, wherein said containment band envelopes said delivery capsule.

6. ) The endoluminal delivery system of claim 2, wherein said containment band has a span exposing a region of said delivery capsule.

7. ) The endoluminal delivery system of claim 1, wherein said body lumen is selected from a group consisting of cardiac chambers, cardiac valves, arteries, veins, nasal passages, sinuses, trachea, bronchi, oral cavity, esophagus, small intestine, large intestine, anus, ureters, bladder, urethra, vagina, uterus, fallopian tubes, or auditory canals.

8. ) The endoluminal connector of claim 1, wherein said reactant in said delivery capsules comprise at least an adhesive fluid, or at least a tissue growth promoting fluid, or at least an adhesive fluid and a tissue growth promoting fluid.

9. ) The endoluminal delivery system of claim 1, wherein said reactant is selected from a group consisting of cyanoacrylates (including 2-octyl cyanoacrylate, n-butyl cyanoacrylate, iso-butyl-cyanoacrylate, methyl-2- or ethyl-2-cyanoacrylate), albumin based sealants, fibrin glues, resorcinol-formaldehyde glues, gelatin-resorcinol-formaldehyde, ultraviolet-light-curable glues, styrene-derivatized (styrenated) gelatin, poly(ethylene glycol) diacrylate (PEGDA), carboxylated camphorquinone in phosphate-buffered saline (PBS), hydrogel sealants—

eosin based primer having a copolymer of polyethylene glycol with acrylate end caps with a sealant of polyethylene glycol plus polylactic acid, collagen-based glues, polymethylmethacrylate, vascular endothelial growth factor, fibroblast growth factor, hepatocyte growth factor, connective tissue growth factor, placenta-derived growth factor, angiopoietin-1 or granulocyte-macrophage colony-stimulating factor.

10. ) The endoluminal delivery system of claim 1, wherein said delivery capsules have a plurality of predetermined release pressures.

11. ) The endoluminal delivery system of claim 1, wherein said delivery capsules are arranged in a pattern according to said release pressures, or arranged according to said reactant, or arranged according to said delivery pressures and according to said reactant to release said reactant when subject to said predetermined pressures.

12. ) The endoluminal delivery system of claim 1, wherein said delivery capsules are arranged in a noninterference pattern, wherein said delivery capsules do not interfere with each other when in said first state or in said second state.

13. ) The endoluminal delivery system of claim 1, wherein said delivery capsules environ said endoluminal prosthesis.

14. ) The endoluminal delivery system of claim 1, wherein said delivery capsules contain or appose a delivery capsule puncture barb.

15. ) The endoluminal delivery system of claim 1, wherein said delivery capsules have an exit aperture.

16. ) The endoluminal delivery system of claim 1, wherein said delivery capsule further comprise an inelastic element on said delivery capsule to breach said delivery capsule when said endoluminal prosthesis expands to said second state.

17. ) The endoluminal delivery system of claim 1, wherein said delivery capsules are perforated.

18. ) The endoluminal delivery system of claim 1, wherein said delivery capsules further comprise an impermeable backing barrier.

19. ) The endoluminal delivery system of claim 1, wherein said delivery capsules further comprise an absorbent base.

20. ) The endoluminal delivery system of claim 1, wherein said delivery capsules release a first volume of said reactant when subject to a first pressure and release a second volume of said reactant when subject to a second pressure.

21. ) The endoluminal delivery system of claim 1, wherein said endoluminal prosthesis is sized to fit through a stent and sized to fit through said body lumen whereby bridging a stent migration gap from said stent to said body lumen.

22. ) The endoluminal delivery system of claim 1, wherein said endoluminal prosthesis is a shape memory or superelastic alloy held by a sheath in said first state.

23. ) The endoluminal delivery system of claim 1, wherein said endoluminal prosthesis comprises said delivery capsules juxtaposed in a generally tube shape.

24. ) A method of using an endoluminal delivery system, comprising:

a. providing a body lumen;

b. inserting an endoluminal delivery system to said body lumen, wherein said endoluminal delivery system holds at least one delivery capsule having predetermined release pressure, and having at least one reactant in said delivery capsule;

c. inserting an expandable balloon to said endoluminal delivery system; and

d. pressurizing said expandable balloon to a predetermined pressure to expand said expandable endoluminal delivery system and induce said predetermined pressure to said delivery capsule against said body lumen to release a predetermined volume of said reactant according to desired positioning and timing that is localized to deliver said reactant to said body lumen.

25. ) An endoluminal delivery system, comprising:

a. an endoluminal prosthesis inserted to a body lumen;

b. at least one delivery capsule having predetermined release pressure incorporated to said endoluminal prosthesis; and

c. at least one reactant in said delivery capsule.