US2008146489A1PendingUtilityA1

Regional delivery of therapeutic agents for the treatment of vascular diseases

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Assignee: PACETTI STEPHEN DPriority: Dec 15, 2006Filed: Dec 15, 2006Published: Jun 19, 2008
Est. expiryDec 15, 2026(~0.4 yrs left)· nominal 20-yr term from priority
Inventors:Stephen D. PacettiPaul ConsignyRonald W. Heil, Jr.Florian N. LudwigDariush DavalianLi ZhaoIrina AstafievaJinping WanFozan El-NounouKatsuyuki MuraseSyed F. A. HossainyRachel BrightJeffrey T. Ellis
A61L 2300/416A61L 2300/112A61L 2300/62A61F 2250/0067A61L 31/16A61K 31/56A61K 31/44A61F 2/82A61M 2025/1086A61M 25/10A61L 29/16A61L 2300/606A61L 2300/41A61K 31/66A61L 2300/252A61L 31/08A61M 2025/105A61K 38/1709A61M 25/1002A61M 2037/0061A61P 9/00A61M 37/0015A61L 2300/40A61L 29/08A61L 2300/216A61M 2037/0023A61K 31/27A61M 2210/12
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Claims

Abstract

The present invention relates to the regional delivery of therapeutic agents for the treatment of vascular diseases wherein regional delivery refers to delivery of a therapeutically effective amount of the therapeutic agent to an area of the vessel that includes not only afflicted tissue but non-afflicted tissue at the periphery of the afflicted tissue as well.

Claims

exact text as granted — not AI-modified
1 . A method of treating a vascular disease, comprising:
 providing a device having a regional delivery interface comprising a therapeutic agent;   contacting the delivery interface with a surface of a segment of a vessel that is known or suspected to include a region that is afflicted with a vascular disease, wherein:
 the delivery interface contacts the vessel segment surface not only at the known or suspected afflicted region but at a non-afflicted region at the periphery of the afflicted region as well; and, 
   delivering the therapeutic agent onto or into the vessel segment surface from the regional delivery interface in contact with the vessel segment surface.   
     
     
         2 . The method of  claim 1 , wherein the regional delivery interface is about 40 mm or more in length. 
     
     
         3 . The method of  claim 2 , wherein the entire length of the regional delivery interface contacts the vessel segment surface. 
     
     
         4 . The method of  claim 2 , wherein two or more segments of the regional delivery interface contact the vessel segment surface provided that one or more of the regional delivery interface segments contact(s) the vessel segment surface at the afflicted regions and one or more regional delivery interface segments contact the vessel segment at the non-afflicted regions of the vessel segment. 
     
     
         5 . The method of  claim 1 , wherein the therapeutic agent comprises a pharmaceutically acceptable composition. 
     
     
         6 . The method of  claim 5 , wherein the pharmaceutically acceptable composition comprises a micelle, a worm micelle, a liposome or a polymerosome. 
     
     
         7 . The method of  claim 5 , wherein the pharmaceutically acceptable composition comprises an oil-in-water emulsion or a water-in-oil-in-water emulsion. 
     
     
         8 . The method of  claim 1  wherein the device comprises a self-expanding structure. 
     
     
         9 . The method of  claim 1 , wherein the device comprises a balloon and the surface of the segment of a vessel is a luminal surface. 
     
     
         10 . The method of  claim 9 , wherein the device further comprises a catheter. 
     
     
         11 . The method of  claim 10 , wherein the balloon is coupled to a distal end of the catheter. 
     
     
         12 . The method of  claim 11 , wherein an outer surface of the balloon is contacted with the luminal surface of the vessel segment by inflation of the balloon. 
     
     
         13 . The method of  claim 12 , wherein the inflated balloon comprises substantially one diameter such that the complete outer surface of the balloon is contacted with the luminal surface. 
     
     
         14 . The method of  claim 12 , wherein the inflated balloon comprises two or more first diameters that define portions of the outer surface of the balloon that are in contact with the luminal surface and one or more second diameters that define portions of the outer surface that are not in contact with the luminal surface, wherein:
 two of the portions of the balloon that are in contact with the luminal surface contact the vessel surface in non-afflicted regions at the periphery of the afflicted region.   
     
     
         15 . The method of  claim 9 , wherein the delivery interface comprises a coating on the outer surface of the balloon, the coating comprising the therapeutic agent. 
     
     
         16 . The method of  claim 9 , wherein the balloon is microporous. 
     
     
         17 . The method of  claim 16 , wherein the therapeutic agent is contained in a fluid used to inflate the balloon. 
     
     
         18 . The method of  claim 9 , wherein the delivery interface comprises a plurality of micro-needles disposed at an outer surface of the balloon. 
     
     
         19 . The method of  claim 1 , wherein the device comprises an implantable medical device and the vessel segment surface is a luminal surface. 
     
     
         20 . The method of  claim 19 , wherein the implantable medical device is a stent. 
     
     
         21 . The method of  claim 1 , wherein the vascular disease is selected from the group consisting of atherosclerosis, restenosis, vulnerable plaque and peripheral arterial disease. 
     
     
         22 . The method of  claim 1 , wherein the therapeutic agent induces apoptosis of macrophages and/or of foam cells. 
     
     
         23 . The method of  claim 22 , wherein the therapeutic agent comprises a bisphosphonate. 
     
     
         24 . The method of  claim 23 , wherein the bisphosphonate is selected from the group consisting of etidronate, clodronate, tiludronate, pamidronate, dimethyl pamidronate, alendronate, ibandronate, risedronate and zeledronate. 
     
     
         25 . The method of  claim 23 , wherein the bisphosphonate comprises a pharmaceutically acceptable composition. 
     
     
         26 . The method of  claim 25 , wherein the pharmaceutically acceptable composition comprises a micelle, a worm micelle, a liposome, or a polymerosome. 
     
     
         27 . The method of  claim 26 , wherein the bisphosphonate is a salt comprising a counter-ion that reduces leakage of the bisphosphonate from the composition. 
     
     
         28 . The method of  claim 27 , where the counter-ion comprises bulk-enhancing groups. 
     
     
         29 . The method of  claim 27 , wherein the counter-ion comprises two positively charged species covalently bonded to a linker group. 
     
     
         30 . The method of  claim 25 , wherein the pharmaceutically acceptable composition comprises a water-in-oil emulsion or a water-in-oil-in-water emulsion. 
     
     
         31 . The method of  claim 25 , wherein the pharmaceutically acceptable composition comprises a coacervate of the bisphosphonate 
     
     
         32 . The method of  claim 31 , wherein the coacervate is a polycationic biopolymer. 
     
     
         33 . The method of  claim 32 , wherein the polycationic biopolymer is chitosan. 
     
     
         34 . The method of  claim 24 , wherein the pharmaceutically acceptable composition comprises a microparticle or a nanoparticle. 
     
     
         35 . The method of  claim 34 , wherein the microparticle or nanoparticle comprises an insoluble salt of the bisphosphonate. 
     
     
         36 . The method of  claim 35 , wherein the insoluble salt is a dicalcium salt. 
     
     
         37 . The method of  claim 34 , wherein the microparticle or nanoparticle comprises a calcium phosphate mineral. 
     
     
         38 . The method of  claim 37 , wherein the calcium phosphate mineral is selected from the group consisting of brushite, octacalcium phosphate, monetite, whitlocktite, tricalcium phosphate and hydroxyapatite. 
     
     
         39 . The method of  claim 38 , wherein the calcium phosphate mineral is hydroxyapatite. 
     
     
         40 . The method of  claim 1 , wherein the therapeutic agent initiates reverse cholesterol transport. 
     
     
         41 . The method of  claim 40 , wherein the therapeutic agent is selected from the group consisting of apolipoprotein A1 and apolipoprotein A1 mimetic peptide. 
     
     
         42 . The method of  claim 1 , wherein the therapeutic agent is an anti-inflammatory agent. 
     
     
         43 . The method of  claim 42 , wherein the anti-inflammatory agent is selected from the group consisting of corticosteroids and statins. 
     
     
         44 . The method of  claim 43 , wherein the corticosteroid is selected from the group consisting of clobetasol and desoxymetasone. 
     
     
         45 . The method of  claim 1 , wherein the therapeutic agent comprises everolimus, rapamycin, biolimus, sirolimus, paclitaxel. 
     
     
         46 . The method of  claim 1 , wherein the therapeutic agent comprises 17-AAG. 
     
     
         47 . A device, comprising:
 a regional delivery interface wherein:
 the regional delivery interface comprises a therapeutic agent, wherein:
 the regional delivery interface contacts a segment of a vessel at one or more regions of the vessel known or suspected to be afflicted with a vascular disease and one or more non-afflicted regions of the vessel at the periphery of the afflicted regions. 
 
   
     
     
         48 . The device of  claim 47 , comprising a catheter. 
     
     
         49 . The device of  claim 48 , wherein the regional delivery interface comprises a balloon coupled to a distal end of the catheter. 
     
     
         50 . The device of  claim 47 , wherein the device comprises an implantable medical device. 
     
     
         51 . The device of  claim 50 , wherein the implantable medical device comprises a stent.

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