Chemical ablation formulations and methods of treatments for various diseases
Embodiments of the present invention are directed to the treatment of hypertension, diabetes, obesity, heart failure, end-stage renal disease, digestive disease, urological disease, cancers, tumors, pains, asthma, pulmonary arterial hypertension, and chronic obstructive pulmonary disease by delivering of an effective amount of formulations at desired temperature to target tissue. The formulations include gases, vapors, liquids, solutions, emulsions and suspensions of one or more ingredients. The temperature may enhance safety and efficacy of the formulations for the treatments. The amounts of the formulation and/or energy are effective to injury or damage the tissues to have a benefit of symptom relive.
1. A method of treating a blood vessel, the method comprising:
inserting a delivery catheter to a treatment site in a blood vessel, the delivery catheter comprising
a first balloon mounted near a distal end of a catheter shaft, the catheter shaft comprising an infusion lumen and an inflation lumen, the inflation lumen being in fluid communication with the first balloon, a distal end of the infusion lumen terminating at one or more openings distal to the first balloon; and
a radiopaque marker on the catheter shaft distal to the first balloon;
inflating the first balloon, wherein after the first balloon inflation the distal end of the catheter shaft is approximately centered in the blood vessel;
infusing a chemical formulation at the treatment site through the one or more openings, the chemical formulation comprising ethanol, or ethanol and water, or acetic acid and water, or an ethanol/water azeotrope, wherein the infusing of the chemical formulation is effective to injure or damage nerve tissue at the treatment site, wherein the chemical formulation is about 1 wt % to about 100 wt % acetic acid and/or at least about 10 wt % ethanol;
deflating the first balloon; and
withdrawing the delivery catheter from the blood vessel;
wherein the method treats a disease chosen from hypertension, diabetes, obesity, end-stage renal disease, and a combination thereof.
2. The method of claim 1 wherein the delivery catheter further includes a second balloon mounted near the distal end of the catheter shaft distal to the one or more openings and wherein the method further comprises inflating the first balloon and the second balloon to form a treatment window in the blood vessel from the first balloon to the second balloon that comprises the treatment site.
3. The method of claim 1 , wherein the chemical formulation comprises a gas, vapor, liquid, solution, emulsion, or suspension of one or more ingredients.
4. The method of claim 1 , wherein the chemical formulation is infused to the nerve tissue at a temperature in the range of −40° C. to 140° C.
5. The method of claim 1 , wherein the chemical formulation is infused to the nerve tissue at a pressure in the range of from 1 to 12 ATM.
6. The method of claim 3 , wherein the chemical formulation further comprises one or more ingredients selected from water, saline, hypertonic saline, phenol, methanol, absolute alcohol, isopropanol, propanol, butanol, isobutanol, ethylene glycol, glycerol, lactic acid, propyl iodide, isopropyl iodide, ethyl iodide, methyl acetate, ethyl acetate, ethyl nitrate, isopropyl acetate, ethyl lactate, lipiodol, urea, and derivatives and combinations thereof.
7. The method of claim 1 , wherein the chemical formulation comprises a therapeutic agent chosen from sodium channel blockers, tetrodotoxin, saxitoxin, decarbamoyl saxitoxin, vanilloids, neosaxitoxin, lidocaine, conotoxins, cardiac glycosides, digoxin, glutamate, staurosporine, amlodipine, verapamil, cymarin, digitoxin, proscillaridin, quabain, veratridine, domoic acid, oleandrin, carbamazepine, aflatoxin, guanethidine, and guanethidine sulfate.
8. The method of claim 1 , wherein the delivery catheter is a needle-based delivery catheter, a needle-based balloon catheter, a double balloon catheter, a multiple segment balloon catheter, an infusion catheter, or a combination thereof.
9. The method of claim 1 , further comprising delivering energy at the treatment site in the vessel lumen to the nerve tissue of the vessel lumen.
10. The method of claim 9 , wherein the energy is chosen from radiofrequency, cryoablation, microwave, laser, ultrasound, and high-intensity focused ultrasound, heat from a liquid or solution of the formulation, and heat from vapor condensation of the formulation.
11. The method according to claim 9 , wherein the energy delivered to the nerve tissue is in an amount of from about 2 cal/g to about 150 cal/g.
12. The method according to claim 9 , wherein the chemical formulation is infused at the treatment site during, before, or after the energy is delivered to the nerve tissue.
13. The method according to claim 1 , wherein an amount of the chemical formulation infused at the treatment site is in the range of 0.2 microliters to 200 milliliters.
14. The method according to claim 1 , wherein the chemical formulation is infused at the treatment site for about 2 seconds to about 60 minutes.
15. The method according to claim 1 , wherein the chemical formulation comprises ethanol and acetic acid.
16. The method according to claim 1 , wherein the chemical formulation is about 1 wt % to about 100 wt % acetic acid.
17. The method according to claim 1 , wherein the chemical formulation is at least about 10 wt % ethanol.
18. The method according to claim 1 , wherein the chemical formulation comprises water and ethanol.
19. The method according to claim 1 , wherein the chemical formulation comprises a water/ethanol azeotrope.
20. The method according to claim 1 , wherein the first balloon comprises a material chosen from a polyamide, a nylon, a polyether block amide, a polyester, a polyethylene terephthalate, a copolymer thereof, or a mixture thereof.
21. The method of claim 2 , wherein the delivery catheter is free of balloons between the first balloon and the second balloon.