Pro-healing agent formulation compositions, methods and treatments

Patent metadata

Field	Value
Publication number	US-9242005-B1
Application number	US-50786006-A
Country	US
Kind code	B1
Filing date	Aug 21, 2006
Priority date	Aug 21, 2006
Publication date	Jan 26, 2016
Grant date	Jan 26, 2016

Abstract

Pro-healing agent formulation compositions, methods and treatments for enhancing vascular healing are disclosed herein. In some embodiments, a pro-healing agent is encapsulated, suspended, disposed within or loaded into a biodegradable carrier for sustained-release delivery to a denuded or damaged endothelium treatment area in a blood vessel. In some applications, the pro-healing agent can accelerate re-endothelialization of a denuded vascular region. In some applications, the pro-healing agent can assist in the regaining of endothelium functionality. The formulation can be delivered by a delivery assembly such as an infusion catheter, a porous balloon catheter, a needle injection catheter, a double balloon catheter or the like.

First claim

What is claimed is:

1. A method comprising:
introducing a catheter device to a denuded or damaged endothelium treatment area in a blood vessel of a human subject, wherein the catheter device comprises a porous balloon and a cover member for covering a porous surface of the balloon, the cover member having a window through which a portion of the porous surface is exposed to allow for targeted delivery of a fluid solution through the porous surface;
isolating the denuded or damaged endothelium treatment area in the blood vessel, wherein isolating comprises aligning the window with the denuded or damaged endothelium treatment area such that the porous surface is exposed to the treatment area; and
after isolating, delivering the fluid solution to the denuded or damaged endothelium treatment area through the porous surface, the fluid solution comprising a pro-healing agent disposed within a biodegradable carrier, wherein the pro-healing agent is an extra-cellular binding protein, and wherein the pro-healing agent has a property that accelerates re-endothelialization, and wherein the carrier is one of a liposome, a polymerosome, a micelle or a particle.

2. The method of claim 1 , wherein the particle is one of a microsphere, a nanosphere, a microrod or a nanorod.

3. The method of claim 1 , wherein the pro-healing agent has a characteristic selected from the group consisting of (a) providing docking sites for endothelium progenitor cells and (b) chemoattracting endothelium progenitor cells.

4. The method of claim 1 wherein the extra-cellular binding protein is selected from the group consisting of arginine-glycine-aspartic acid peptide sequence (RGD), cyclic RGD, serine-isoleucine-lysine-valine-alanine-valine, and tyrosine-isoleucine-glycine-serine-arginine.

5. The method of claim 1 wherein the extra-cellular binding protein is a growth factor.

6. The method of claim 5 wherein the growth factor is selected from the group consisting of isoforms of vasoendothelial growth factor, fibroblast growth factor, Del 1, hypoxia inducing factor, monocyte chemoattractant protein, nicotine, platelet derived growth factor, insulin-like growth factor 1, transforming growth factor, hepatocyte growth factor, estrogens, follistatin, proliferin, prostaglandin E1 and E2, tumor necrosis factor, interleukin 8, hematopoietic growth factors, erythropoietin, granulocyte-colony stimulating factors and platelet-derived endothelial growth factor.

7. The method of claim 1 wherein the extra-cellular binding protein is a hormone.

8. The method of claim 7 wherein the hormone is estradiol.

9. The method of claim 1 wherein the cover member is a sheath positioned outside of the balloon.

10. The method of claim 1 wherein the cover member is a liner positioned inside of the balloon.

11. The method of claim 1 wherein the extra-cellular binding protein is an anti-inflammatory.

12. A method comprising:
isolating a damaged vascular segment in a human subject using a catheter device, the catheter device having a first balloon and a second balloon positioned at opposite ends of an inflatable cannula, wherein isolating comprises (1) positioning the first balloon proximal to the damaged vascular segment, (2) positioning the second balloon distal to the damaged vascular segment, and (3) separately inflating the first balloon and the second balloon; and
indirectly increasing endothelial functionality of the damaged vascular segment by delivering a solution comprising a pro-healing agent disposed within a biodegradable carrier to the isolated vascular segment between the first balloon and the second balloon of the catheter device, wherein the pro-healing agent is a growth factor, and wherein the pro-healing agent has a property that accelerates re-endothelialization, and wherein the carrier is one of a liposome, a polymerosome, a micelle, or a particle.

13. The method of claim 12 , wherein the particle is one of a microsphere, a nanosphere, a microrod or a nanorod.

14. The method of claim 12 , wherein delivering further comprises inflating the inflatable cannula to drive the solution comprising the pro-healing agent into the isolated vascular segment.

15. The method of claim 12 , wherein the pro-healing agent has a characteristic selected from the group consisting of (a) providing docking sites for endothelium progenitor cells and (b) chemoattracting endothelium progenitor cells.

16. A method of treatment comprising:
isolating a lumen of a blood vessel in a human subject; and
delivering a solution comprising a pro-healing agent disposed within a biodegradable carrier to a treatment site within the isolated lumen of the blood vessel, wherein delivering comprises targeting delivery of the solution to the treatment site by delivering the solution through only a portion of a catheter device positioned adjacent to the treatment, and
wherein the pro-healing agent is adapted to indirectly (a) accelerate re-endothelialization of a denuded vascular segment relative to non-treatment induced re-endothelialization or (b) rehabilitate endothelial functionality of a damaged vascular segment relative to non-treatment induced rehabilitation, wherein the pro-healing agent is an extra-cellular binding protein, and wherein the pro-healing agent has a property that accelerates re-endothelialization, and wherein the carrier is one of a liposome, a polymerosome, a micelle or a particle.

17. The method of claim 16 , wherein the particle is one of a microsphere, a nanosphere, a microrod or a nanorod.

18. The method of claim 16 , wherein the catheter device used to deliver the pro-healing agent is one of a porous balloon catheter, or a double balloon catheter.

19. The method of claim 16 , wherein the pro-healing agent has a characteristic selected from the group consisting of (a) providing docking sites for endothelium progenitor cells and (b) chemoattracting endothelium progenitor cells.

20. The method of claim 16 wherein the catheter device comprises a porous balloon and a sheath positioned over the porous balloon, the sheath having a window to expose only a portion of the porous balloon adjacent to the treatment site such that delivery of the solution is targeted to the treatment site.

21. The method of claim 16 wherein the catheter device comprises a first balloon and a second balloon positioned at opposite ends of an inflatable cannula, wherein the first balloon, the second balloon and the inflatable cannula are inflatable using separate inflation cannulas.

Assignees

• Hossainy Syed
• Ludwig Florian Niklas
• Pacetti Stephen
• Consigny Paul
• El-Nounou Fozan
• Glauser Thierry
• Desnoyer Jessica
• Abbott Cardiovascular Systems

Inventors

• Hossainy Syed
• Ludwig Florian Niklas
• Pacetti Stephen
• Consigny Paul
• El-Nounou Fozan
• Glauser Thierry
• Desnoyer Jessica

Classifications

• A61K9/0019 Primary

  Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00) · CPC title

• A61M31/00

  Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008}) · CPC title

• A61K47/42 Primary

  Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein (oligopeptides having up to five amino acids {A61K47/183}; polyamino acids A61K47/34) · CPC title

• A61M5/178

  Syringes · CPC title

• A61K47/48

  Human Necessities · mapped topic