Delivery and administration of compositions using interventional catheters

Abstract

Systems and methods for delivery of therapeutic and/or diagnostic compositions to an interventional site having diseased or newly treated tissue are provided. Integrated interventional catheter systems incorporating surfaces coated with a diagnostic or therapeutic composition, or ports for infusing a diagnostic or therapeutic composition prior to, during or following an interventional procedure are provided.

I claim: 
     
         1 . An interventional device comprising:
 (a) a catheter;   (b) at least one of an angioplastic device, an operating head for removal of material, and a delivery device for placement of implantable devices positioned at or near a distal end of the catheter;   (c) a surface positioned at or near a distal end of the catheter configured for contacting tissue at a site of intervention; and   (d) a composition comprising a therapeutic and/or diagnostic composition associated with the surface providing release or uptake of the composition when the surface contacts tissue at the site of intervention.   
     
     
         2 . The interventional device of  claim 1 , comprising an operating head for removal of material, wherein the operating head is selected from the group consisting of: a cutter assembly, a scraping mechanism, a coring mechanism, a helical screw mechanism, a laser ablative mechanism, a high frequency ultrasound source, a radio frequency (RF) source, a thermal source, and an electrical source. 
     
     
         3 . The interventional device of  claim 1 , comprising a delivery device for placement of implantable stents. 
     
     
         4 . The interventional device of  claim 1 , wherein the surface is on an inflatable device positioned at or near a distal end of the catheter. 
     
     
         5 . The interventional device of  claim 4 , wherein the inflatable device incorporates structures on its outer surface selected from the group consisting of: blades, pins, surface protuberances, abrasives, rough edges and microneedles. 
     
     
         6 . The interventional device of  claim 1 , additionally comprising an inflatable device positioned at or near a distal end of the catheter incorporating pores or ports that, when the inflatable device is inflated, allow passage of fluids. 
     
     
         7 . The interventional device of  claim 1 , additionally comprising at least one material removal port at or near a distal end of the catheter for aspirating fluid containing debris from an intervention site. 
     
     
         8 . The interventional device of  claim 1 , wherein the catheter comprises a sealed infusion lumen and a sealed aspiration lumen. 
     
     
         9 . An interventional device comprising:
 (a) a catheter having an infusion lumen connected to an infusate source;   (b) at least one of an angioplastic device, an operating head for removal of material, and a delivery device for placement of implantable devices positioned at or near a distal end of the catheter; and   (c) an inflatable device having pores or ports allowing passage of fluids containing therapeutic and/or diagnostic substances positioned at or near a distal end of the catheter.   
     
     
         10 . The interventional device of  claim 9 , comprising an operating head for removal of material, wherein the operating head is selected from the group consisting of: a cutter assembly, a scraping mechanism, a coring mechanism, a helical screw mechanism, a laser ablative mechanism, a high frequency ultrasound source, a radio frequency (RF) source, a thermal source, and an electrical source. 
     
     
         11 . The interventional device of  claim 9 , comprising a delivery device for placement of implantable stents. 
     
     
         12 . The interventional device of  claim 9 , wherein the catheter comprises a sealed infusion lumen and a sealed aspiration lumen. 
     
     
         13 . A method for administering a therapeutic and/or diagnostic composition to an internal lumen or cavity prior to, during or following an interventional procedure, comprising:
 (a) delivering the working head of an interventional catheter to the site of an interventional procedure;   (b) operating the working head to at least partially displace or remove an obstruction from an internal lumen or cavity;   (c) contacting a surface mounted on a component of the interventional catheter to tissue at the site of the interventional procedure prior to, during or following operation of the working head, wherein the surface comprises a therapeutic and/or diagnostic composition.   
     
     
         14 . The method of  claim 13 , wherein the interventional site is selected from the group consisting of: blood vessels and vascular cavities, gastrointestinal cavities, lumens or cavities in male and female reproductive organs and the urinary tract, gas exchange cavities, and nasal and sinus cavities. 
     
     
         15 . The method of  claim 13 , wherein the interventional procedure involves enlarging an opening in an obstructed or partially obstructed lumen or cavity. 
     
     
         16 . The method of  claim 13 , wherein the surface is provided on an inflatable device. 
     
     
         17 . The method of  claim 16 , wherein the inflatable device additionally has ports for infusion of the therapeutic and/or diagnostic composition. 
     
     
         18 . The method of  claim 13 , additionally comprising rotating and/or translating and/or vibrating the surface during contacting of the surface to tissue. 
     
     
         19 . The method of  claim 13 , wherein the therapeutic and/or diagnostic composition comprises a composition selected from the group consisting of: thrombolytic compositions; anti-restenosis compositions; anti-aggregation compositions; anti-proliferation compositions; growth factors; wound healing compositions; anti-thrombogenic compositions; antioxidants; angiogenic compositions and factors; anti-angiogenic compositions and factors; compositions that block smooth muscle cell proliferation; anti-inflammatory compositions; calcium entry blockers; antineoplastic compositions; antimitotic compositions; immunosuppressant compositions; antimicrobial compositions; anesthetic compositions; nitric oxide donors; anti-coagulants; vascular cell growth promoters; vascular cell growth inhibitors; cholesterol-lowering compositions; vasodilating compositions; compositions that interfere with endogenous vasoactive mechanisms; survival genes; and polynucleotide sequences. 
     
     
         20 . The method of  claim 13 , wherein the therapeutic and/or diagnostic composition comprises a composition selected from the group consisting of: anti-thrombogenic compositions, heparin, heparin derivatives, urokinase, PPACK (dextrophenylalanine proline arginine chloromethylketone), antioxidants, probucol, retinoic acid; angiogenic and anti-angiogenic compositions and factors, compositions that block smooth muscle cell proliferation, rapamycin, angiopeptin, monoclonal antibodies capable of blocking smooth muscle cell proliferation, anti-inflammatory compositions, dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, acetyl salicylic acid, mesalamine, calcium entry blockers, verapamil, diltiazem, nifedipine, antineoplastic/antiproliferative/anti-mitotic compositions, paclitaxel, 5-fluorouracil, methotrexate, doxorubicin, daunorubicin, tacrolimus, cyclosporine, cisplatin, vinblastine, vincristine, epothilones, endostatin, angiostatin, thymidine kinase inhibitors. Immunosuppressants, sirolimus (rapamycin), antimicrobials, triclosan, cephalosporins, aminoglycosides, nitorfurantoin, anesthetic compositions, lidocaine, bupivacaine, ropivacaine, nitric oxide (NO) donors, lisidomine, molsidomine, L-arginine, NO-protein adducts, NO-carbohydrate adducts, polymeric or oligomeric NO adducts, anti-coagulants, D-Phe-Pro-Arg chloromethyl ketone, RGD peptide-containing compounds, antithrombin compounds, platelet receptor antagonists, anti-thrombin antibodies, anti-platelet receptor antibodies, enoxaparin, hirudin, Warfarin, Dicumarol, aspirin, prostaglandin inhibitors, platelet inhibitors, antiplatelet factors, vascular cell growth promotors, growth factors, growth factor receptor antagonists, transcriptional activators and translational promotors, vascular cell growth inhibitors, growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bi- (or multi-) functional molecules comprising a growth factor and a cytotoxin, bi- (or multi-) functional molecules comprising an antibody and a cytotoxin, cholesterol-lowering compositions, vasodilating compositions, compositions which interfere with endogenous vascoactive mechanisms, survival genes which protect against cell death, anti-apoptotic Bcl-2 family factors, Akt kinase, and combinations thereof. 
     
     
         21 . The method of  claim 13 , wherein the therapeutic and/or diagnostic composition comprises a proteinaceous composition selected from the group consisting of: angiogenic factors and other molecules able to induce angiogenesis, acidic and basic fibroblast growth factors, vascular endothelial growth factor, HIF-1, epidermal growth factor, transforming growth factor-alpha and -beta, platelet-derived endothelial growth factor, platelet-derived growth factor, tumor necrosis factor-alpha, hepatocyte growth factor, insulin-like growth factor, cell cycle inhibitors, CDK inhibitors, anti-restenosis compositions, p15, p16, p18, p19, p21, p27, p53, p57, Rb, nFkB and E2F decoys, thymidine kinase, combinations thereof, protein fragments and peptides thereof, and polynucleotide sequences encoding recited proteins, peptides and fragments. 
     
     
         22 . The method of  claim 13 , wherein the therapeutic and/or diagnostic composition comprises a composition selected from the group consisting of: therapeutic polynucleotide sequences, such as sense and anti-sense, as well as modified and unmodified DNA and RNA molecules and fragments, DNA coding for an anti-sense RNA, or DNA coding for tRNA or rRNA to replace defective or deficient endogenous molecules, that have a therapeutic effect after being taken up by a cell.