Balloon catheter systems for delivery of dry drug delivery vesicles to a vessel in the body

• US 8,696,644 B2
• Filed: 12/30/2010
• Issued: 04/15/2014
• Est. Priority Date: 12/30/2009
• Status: Active Grant

• Current Assignee: Caliber Therapeutics, LLC
• Original Assignee: Caliber Therapeutics, Inc. (Orchestra Biomed Incorporated)
• Inventors: Baumbach, William R., Sherman, Darren R., Burgermeister, Robert
• Primary Examiner(s): Schmidt, Emily
• Assistant Examiner(s): Anderson, Michael J
• Application Number:
  US12/982,760
• Publication Number:
  US 20110166547A1
• Time in Patent Office: 1,202 Days
• Field of Search: 604/99.04, 604/101.02, 604/103.01, 604/509, 424/489
• US Class Current: 604/509
• CPC Class Codes: A61K 31/00 Medicinal preparations containing organic active ingredients
• CPC Class Codes: A61K 31/436 the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
• CPC Class Codes: A61K 9/107 Emulsions ; Emulsion preconcentrates; Micelles composition of emulsions A61K47/00
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/626 Liposomes, micelles, vesicles
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/1018 Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10182 Injector syringes
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/10187 Indicators for the level of inflation or deflation
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

Devices and methods for balloon delivery of rapamycin and other hydrophobic compounds to the wall of blood vessels. Balloon catheters, such as those used for balloon angioplasty, are modified with the addition of a reservoir of dry micelles, disposed at a suitable location within the balloon or catheter. The reservoir may be installed within the angioplasty balloon, within a lumen in communication with the angioplasty balloon, either as a loose or packed powder or as a film coating. The micelle preparation is reconstituted and the micelles are mobilized when the aqueous solution used to inflate the balloons is injected into the catheter. The micelles are infused into tissue surrounding the balloon when pressurized fluid within the balloon leaks through the wall of the balloon.

Claims

1. A method for delivery of drugs or therapeutic agents to a vessel within the body of a patient, said method comprising the steps of:

providing a catheter system comprising;

a balloon catheter comprising a catheter body with a distal end adapted for insertion into the vasculature of a patient, a porous balloon disposed on the distal end, and a proximal end adapted for connection to a fluid source, and a lumen extending from the proximal end to the balloon;

a storage chamber with a reservoir of dry drug delivery vesicles;

an inflator;

a coiled tube suspension chamber in fluid communication with an inflator;

a valve operable to selectively connect the suspension chamber to the storage chamber or the lumen of the catheter;

operating the valve to align the inflator and coiled tube suspension chamber with the storage chamber;

forcing fluid from the inflator into the storage chamber to reconstitute the dry drug delivery vesicles in the dry drug delivery vesicles storage chamber and create a suspension of drug delivery vesicles;

using the inflator, drawing the suspension of drug delivery vesicles into the suspension chamber;

operating the valve to align the suspension chamber and inflator with the catheter lumen;

operating the inflator to force additional fluid through suspension chamber to the catheter, thereby forcing the suspension of drug delivery vesicles, through the wall of the balloon and into body tissue surrounding the balloon.

2. The method of claim 1, wherein the drug delivery vesicles comprise micelles loaded with rapamycin or rapamycin analogs.

3. The method of claim 1, wherein the drug delivery vesicles comprise micelles loaded ABT-578, zotarolimus, everolimus, biolimus A9, deforolimus, temsirolimus, tacrolimus, pimcrolimus, nitric oxide synthase, C3 exoenzyme, RhoA inhibitors, tubulusin, A3 agonists, CB2 agonists, 17-AAG, Hsp90 antagonists, tyrphostins, cathepsin S inhibitors, paclitaxel, dexamethasone, ceramides, dimethyl sphingosine, ether-linked diglycerides, ether-linked phosphatidic acids, sphinganines, estrogens, taxol, taxol analogs, actinomycin D, prostaglandins, vitamin A, probucol, Batimastat, Statins, Trapidil, mitomycin C or Cytochalasin B.