Chemical ablation and method of treatment for various diseases
Embodiments of the present invention provide a device and a method for treating at least one of hypertension, pulmonary arteries, diabetes, obesity, heart failure, end-stage renal disease, digestive disease, urological disease, cancers, tumors, pain, asthma or chronic obstructive pulmonary disease by delivering an effective amount of a formulation to a tissue. In embodiments of the present invention, the formulation may include at least one of a gas, a vapor, a liquid, a solution, an emulsion, or a suspensions of one or more ingredients. In embodiments of the present invention, amounts of the formulation and/or energy are effective to injure or damage tissue, nerves, and nerve endings in order to relieve disease symptoms.
1. A method for treating at least two diseases chosen from hypertension, diabetes, end-stage renal disease, and obesity, the method comprising:
inserting a balloon delivery catheter into a body lumen, comprising inserting the balloon delivery catheter into treatment sites in a main renal artery and an extra-renal artery branch;
inflating the balloon delivery catheter at each of the treatment sites;
delivering heat and/or energy to the wall of the body lumen adjacent the nerves or nerve endings at each of the treatment sites, wherein an amount of the heat and/or energy delivered is effective to injure or damage the nerves or nerve endings to relieve symptoms of the treated disease comprising lowering blood pressure, lowering glucose level, reducing weight, or a combination thereof;
deflating the balloon delivery catheter at each of the treatment sites; and
withdrawing the balloon delivery catheter from the body lumen.
2. The method of claim 1 , wherein the method comprises infusing a formulation from the inflated balloon delivery catheter to a wall of the body lumen adjacent to nerves or nerve endings at each of the treatment sites.
3. The method of claim 2 , wherein the formulation comprises one or more ingredients chosen from ethanol and acetic acid.
4. The method of claim 2 , wherein the formulation comprises a gas or vapor chosen from oxygen, nitrogen, helium, argon, air, carbon dioxide, nitric oxide, water, phenol, methanol, ethanol, absolute alcohol, isopropanol, propanol, butanol, isobutanol, ethylene glycol, glycerol, acetic acid, lactic acid, propyl iodide, isopropyl iodide, ethyl iodide, methyl acetate, ethyl acetate, ethyl nitrate, isopropyl acetate, and ethyl lactate, and mixtures thereof.
5. The method of claim 2 , wherein the formulation comprises a therapeutic agent for nerve denervation, wherein the therapeutic agent is chosen from sodium channel blockers, tetrodotoxins, saxitoxins, decarbamoyl saxitoxins, vanilloids, neosaxitoxins, lidocaines, conotoxins, cardiac glycosides, digoxins, glutamates, staurosporines, amiodipines, verapamils, cymarins, digitoxins, proscillaridins, quabains, veratridines, domoic acids, oleandrins, carbamazepines, aflatoxins, guanethidines, guanethidine sulfates, and a combination thereof.
6. The method of claim 2 , wherein the formulation consists of ethanol.
7. The method of claim 2 , wherein the formulation comprises a gas, vapor, liquid, solution, emulsion, suspensions of one or more ingredients, or a combination thereof.
8. The method of claim 2 , wherein the formulation comprises a vapor of one or more ingredients and heat is generated by condensation of the vapor into liquid on the wall of the body lumen adjacent the nerves or nerve endings at each of the treatment sites, or wherein the formulation comprises a liquid, solution, emulsion, or suspension, and heat is transferred from the formulation to the wall of the body lumen adjacent the nerves or nerve endings at each of the treatment sites, or a combination thereof.
9. The method of claim 2 , wherein the formulation is at a temperature ranging from −40° C. to 140° C.
10. The method of claim 2 , wherein pressure of the formulation during infusion ranges from 0.1 atm to 14 atm.
11. The method of claim 2 , wherein an amount of the formulation infused to each of the treatment sites ranges from 0.2 microliters to 200 milliliters.
12. The method of claim 2 , wherein the balloon delivery catheter comprises:
a proximal end;
a distal end;
a wire lumen;
a balloon inflation lumen;
a formulation infusion lumen and/or a vacuum lumen; and
an expandable balloon.
13. The method of claim 2 , wherein the formulation is 1 wt % to 100 wt % acetic acid.
14. The method of claim 1 , wherein the method comprises delivering the heat/energy to the wall of the body lumen adjacent the nerves or nerve endings at each of the treatment sites and the method further comprises infusing a formulation from the inflated balloon delivery catheter to a wall of the body lumen adjacent to nerves or nerve endings at each of the treatment sites effective to decrease the temperature of the wall of the body lumen adjacent the nerves or nerve endings at each of the treatment sites.
15. The method of claim 1 , wherein the method comprises delivering energy to the wall of the body lumen adjacent the nerves or nerve endings at each of the treatment sites.
16. The method of claim 1 , wherein the method delivers an amount of heat and/or energy to the wall of the body lumen adjacent the nerves or nerve endings at each of the treatment sites ranging from 2 cal/g to 150 cal/g.
17. The method of claim 1 , wherein the method comprises inserting the balloon delivery catheter into the body lumen for 2 seconds to 60 minutes.
18. The method of claim 1 , wherein the balloon delivery catheter is chosen from a single balloon delivery catheter, a double balloon delivery catheter, a dumbbell balloon infusion catheter, a needle or needle-based balloon delivery catheter, and combinations thereof.
19. The method of claim 1 , further comprising flushing distal portions of the body lumen with saline or water.
20. The method of claim 1 , wherein the at least two diseases comprise hypertension and diabetes.
21. The method of claim 1 , wherein the at least two diseases comprise hypertension and obesity.
22. The method of claim 1 , wherein the at least two diseases comprise diabetes and obesity.
23. The method of claim 1 , wherein the method results in renal norepinephrine reduction of at least 40%.
24. The method of claim 1 , further comprising
performing the method with the treatment sites comprising a common hepatic artery; and
performing the method with the treatment sites comprising a hepatic artery, a hepatic celiac artery, a hepatic artery branch, a right hepatic artery, a left hepatic artery, a common hepatic artery, a splenic hepatic artery, a hepatic celiac artery, or a combination thereof.
25. The method of claim 1 , wherein the method results in renal norepinephrine reduction of at least 90%.
26. The method of claim 1 , further comprising performing the method with the treatment sites comprising a hepatic artery, a hepatic celiac artery, a hepatic artery branch, a right hepatic artery, a left hepatic artery, a common hepatic artery, a proper hepatic artery, a hepatic celiac artery, a celiac artery, a splenic artery, a gastric artery, a right gastric artery, a left gastric artery, a gastroduodenal artery, an esophageal branch artery, or a combination thereof.
27. A method for treating at least two diseases chosen from hypertension, diabetes, end-stage renal disease, and obesity, the method comprising:
inserting a balloon delivery catheter into a body lumen, comprising inserting the balloon delivery catheter into treatment sites in a main renal artery and a common hepatic artery;
inflating the balloon delivery catheter at each of the treatment sites;
delivering heat and/or energy to the wall of the body lumen adjacent the nerves or nerve endings at each of the treatment sites, wherein an amount of the heat and/or energy delivered is effective to injure or damage the nerves or nerve endings to relieve symptoms of the treated disease comprising lowering blood pressure, lowering glucose level, reducing weight, or a combination thereof;
deflating the balloon delivery catheter at each of the treatment sites; and
withdrawing the balloon delivery catheter from the body lumen.
28. A method for treating at least two diseases chosen from hypertension, diabetes, end-stage renal disease, and obesity, the method comprising:
inserting a balloon delivery catheter into a body lumen, comprising inserting the balloon delivery catheter into treatment sites comprising
a main renal artery and an extra-renal artery branch, or
a main renal artery and an extra-renal artery, or
a combination thereof;
inflating the balloon delivery catheter at each of the treatment sites;
delivering heat, a formulation, and/or energy to the wall of the body lumen adjacent the nerves or nerve endings at each of the treatment sites, wherein an amount of the heat, formulation, and/or energy delivered is effective to injure or damage the nerves or nerve endings to relieve symptoms of the treated disease comprising lowering blood pressure, lowering glucose level, reducing weight, or a combination thereof;
deflating the balloon delivery catheter at each of the treatment sites; and
withdrawing the balloon delivery catheter from the body lumen.
29. The method of claim 28 , wherein the formulation comprises ethanol.
30. The method of claim 28 , wherein the treatment sites comprise a common hepatic artery.