# US 2021/0275784 A1 · Method of treatment for various diseases

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- Number: US 2021/0275784 A1
- Document ID: US20210275784A1
- Status: Published application
- Kind: A1
- Application number: 17/329,765
- Filed: 2021-05-25
- Published: 2021-09-09
- Earliest claimed: 2012-11-02
- Assignees: Neurotronic, Inc.
- Applicants: Neurotronic, Inc.
- Inventors: Lixiao Wang
- Web page: https://patentgrep.com/patent/US20210275784A1

## CPC

- A61K 31/19: Carboxylic acids, e.g. valproic acid (salicylic acid A61K31/60)
- A61M 25/1002: {characterised by balloon shape (A61M25/1006, A61M25/1009 take precedence)}
- A61B 18/06: caused by chemical reaction {, e.g. moxaburners}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61K 31/045: Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61M 5/007: {for contrast media}
- A61M 5/142: Pressure infusion, e.g. using pumps
- A61M 5/172: electrical or electronic
- A61M 25/1011: {Multiple balloon catheters}
- A61M 29/02: Dilators made of swellable material {(balloon catheters for angioplasty A61M25/104)}
- A61N 7/022: {intracavitary}
- A61B 2018/00285: {Balloons}
- A61B 2018/00494: {Stomach, intestines or bowel}
- A61B 2018/00511: {Kidney}
- A61B 2018/00541: {Lung or bronchi}
- A61B 2018/00577: {Ablation}
- A61B 2018/0212: {using an instrument inserted into a body lumen, e.g. catheter}
- A61B 2018/044: {the surgical action being effected by a circulating hot fluid}
- A61B 2018/046: {in liquid form}
- A61B 2018/048: {in gaseous form}
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2025/1052: {for temporarily occluding a vessel for isolating a sector}
- A61M 2202/02: Gases
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)

## Abstract

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, nonalcoholic fatty liver 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.

## Claims

### Claim 1

A method for treating a body lumen, the method comprising:
inserting a first delivery catheter into a first treatment site in a splenic artery, a hepatic artery, a common hepatic artery, a hepatic celiac artery, a left hepatic artery, a right hepatic artery, a proper hepatic artery, a renal artery, a main renal artery, a main renal branch artery, an extra-renal artery, or an extra-renal branch artery;
infusing a chemical formulation and/or delivering energy from the first delivery catheter to a tissue of the body lumen at the first treatment site, wherein the chemical formulation infused and/or the energy delivered is effective to injure and/or damage the tissue at the first treatment site;
withdrawing the first delivery catheter from the first treatment site;
inserting a second delivery catheter that is the same or different as the first delivery catheter into a second treatment site in a splenic artery, a hepatic artery, a common hepatic artery, a hepatic celiac artery, a left hepatic artery, a right hepatic artery, a proper hepatic artery, a renal artery, a main renal artery, a main renal branch artery, an extra-renal artery, or an extra-renal branch artery, wherein the second treatment site is a different treatment site than the first treatment site;
infusing a chemical formulation and/or delivering energy from the second delivery catheter to a tissue of the body lumen at the second treatment site, wherein the chemical formulation infused and/or the energy delivered is effective to injure and/or damage the tissue at the second treatment site; and
withdrawing the second delivery catheter from the second treatment site;
wherein the injury and/or damage to the tissue at the first treatment site and to the tissue at the second treatment site is effective to have a benefit of reduction of body weight, reduction of HbA1c (A1c) and/or glucose level, reducing blood pressure, or a combination thereof.

### Claim 2 (depends on 1)

The method of claim 1, wherein the injury and/or damage to the tissue at the first treatment site and to the tissue at the second treatment site is effective to have a benefit of reduction of body weight.

### Claim 3 (depends on 1)

The method of claim 1, wherein the injury and/or damage to the tissue at the first treatment site and to the tissue at the second treatment site is effective to have a benefit of reduction of HbA1c (A1c) and/or glucose level.

### Claim 4 (depends on 1)

The method of claim 1, wherein the injury and/or damage to the tissue at the first treatment site and to the tissue at the second treatment site is effective to have a benefit of reducing blood pressure.

### Claim 5 (depends on 1)

The method of claim 1, wherein the method further comprises:
inserting a third delivery catheter that is the same or different as the first or second delivery catheter into a third treatment site in a splenic artery, a hepatic artery, a common hepatic artery, a hepatic celiac artery, a left hepatic artery, a right hepatic artery, a proper hepatic artery, a renal artery, a main renal artery, a main renal branch artery, an extra-renal artery, or an extra-renal branch artery, wherein the third treatment site is a different treatment site than the first and second treatment site;
infusing a chemical formulation and/or delivering energy from the third delivery catheter to a tissue of the body lumen at the third treatment site, wherein the chemical formulation infused and/or the energy delivered is effective to injure and/or damage the tissue at the third treatment site; and
withdrawing the third delivery catheter from the third treatment site;
wherein the injury and/or damage to the tissue at the first, second, and third treatment sites is effective to have a benefit of reduction of body weight, reduction of HbA1c (A1c) and/or glucose level, reducing blood pressure, or a combination thereof.

### Claim 6 (depends on 5)

The method of claim 5, wherein the injury and/or damage to the tissue at the first, second, and third treatment sites is effective to have a benefit of reduction of body weight.

### Claim 7 (depends on 5)

The method of claim 5, wherein the injury and/or damage to the tissue at the first, second, and third treatment sites is effective to have a benefit of reduction of HbA1c (A1c) and/or glucose level.

### Claim 8 (depends on 5)

The method of claim 5, wherein the injury and/or damage to the tissue at the first, second, and third treatment sites is effective to have a benefit of reducing blood pressure.

### Claim 9 (depends on 5)

The method of claim 5, further comprising:
inserting a fourth delivery catheter that is the same or different as the first, second, or third delivery catheter into a fourth treatment site in a splenic artery, a hepatic artery, a common hepatic artery, a hepatic celiac artery, a left hepatic artery, a right hepatic artery, a proper hepatic artery, a renal artery, a main renal artery, a main renal branch artery, an extra-renal artery, or an extra-renal branch artery, wherein the fourth treatment site is a different treatment site than the first, second, and third treatment sites;
infusing a chemical formulation and/or delivering energy from the fourth delivery catheter to a tissue of the body lumen at the fourth treatment site, wherein the chemical formulation infused and/or the energy delivered is effective to injure and/or damage the tissue at the fourth treatment site; and
withdrawing the fourth delivery catheter from the fourth treatment site;
wherein the injury and/or damage to the tissue at the first, second, third, and fourth treatment sites is effective to have a benefit of reduction of body weight, reduction of HbA1c (A1c) and/or glucose level, reducing blood pressure, or a combination thereof.

### Claim 10 (depends on 9)

The method of claim 9, wherein the injury and/or damage to the tissue at the first, second, third, and fourth treatment sites is effective to have a benefit of reduction of body weight.

### Claim 11 (depends on 9)

The method of claim 9, wherein the injury and/or damage to the tissue at the first, second, third, and fourth treatment sites is effective to have a benefit of reduction of HbA1c (A1c) and/or glucose level.

### Claim 12 (depends on 9)

The method of claim 9, wherein the injury and/or damage to the tissue at the first, second, third, and fourth treatment sites is effective to have a benefit of reducing blood pressure.

### Claim 13 (depends on 1)

The method of claim 1, wherein the first and/or second delivery catheter is a balloon catheter and the method further comprises:
inflating the first delivery catheter after the insertion to the first treatment site and deflating the first delivery catheter prior to the withdrawing from the first treatment site; and/or
inflating the second delivery catheter after the insertion to the second treatment site and deflating the second delivery catheter prior to the withdrawing from the second treatment site.

### Claim 14 (depends on 1)

The method of claim 1, wherein the method comprises infusing the chemical formulation from the first and/or second delivery catheter to the tissue of the body lumen at the first and/or second treatment site.

### Claim 15 (depends on 14)

The method of claim 14, wherein the chemical formulation comprises ethanol, acetic acid, ethanol and water, an ethanol/water azeotrope, or ethanol and acetic acid.

### Claim 16 (depends on 14)

The method of claim 14, wherein the chemical formulation comprises ethanol.

### Claim 17 (depends on 1)

The method of claim 1, wherein the method comprises delivering energy from the first and/or second delivery catheter to the tissue of the body lumen at the first and/or second treatment site.

### Claim 18 (depends on 17)

The method of claim 17, wherein the energy is chosen from radiofrequency, cryoablation, microwave, laser, ultrasound, high intensity focused ultrasound, and combinations thereof.

### Claim 19 (depends on 17)

The method of claim 17, wherein the energy comprises radiofrequency energy.

### Claim 20 (depends on 17)

The method of claim 17, wherein the energy comprises ultrasound energy.

### Claim 21 (depends on 17)

The method of claim 17, wherein the energy comprises vapor condensation of at least some of the chemical formulation to a liquid.

### Claim 22 (depends on 1)

The method of claim 1, wherein the first and/or second delivery catheter comprises a needle catheter or a needle-based catheter.

### Claim 23 (depends on 1)

The method of claim 1, further comprising flushing the first and/or second treatment sites with saline or water.

### Claim 24 (depends on 1)

The method of claim 1, further comprising flushing the first and/or second delivery catheter with saline or water.

### Claim 25

A method for treating a body lumen, the method comprising:
inserting a first delivery catheter into a first treatment site in a splenic artery, a common hepatic artery, a hepatic celiac artery, a left hepatic artery, a right hepatic artery, a proper hepatic artery, a renal artery, a main renal artery, a main renal branch artery, an extra-renal artery, or an extra-renal branch artery;
infusing a chemical formulation and/or delivering energy from the first delivery catheter to a tissue of the body lumen at the first treatment site, wherein the chemical formulation infused and/or the energy delivered is effective to injure and/or damage the tissue at the first treatment site;
withdrawing the first delivery catheter from the first treatment site;
inserting a second delivery catheter that is the same or different as the first delivery catheter into a second treatment site in a splenic artery, a common hepatic artery, a hepatic celiac artery, a left hepatic artery, a right hepatic artery, a proper hepatic artery, wherein the second treatment site is a different treatment site than the first treatment site;
infusing a chemical formulation and/or delivering energy from the second delivery catheter to a tissue of the body lumen at the second treatment site, wherein the chemical formulation infused and/or the energy delivered is effective to injure and/or damage the tissue at the second treatment site; and
withdrawing the second delivery catheter from the second treatment site.

### Claim 26 (depends on 25)

The method of claim 25, wherein the energy is chosen from radiofrequency, cryoablation, microwave, laser, ultrasound, high intensity focused ultrasound, and combinations thereof.

### Claim 27 (depends on 25)

The method of claim 25, wherein the energy comprises radiofrequency energy.

### Claim 28 (depends on 25)

The method of claim 25, wherein the first and/or second delivery catheter is a balloon catheter and the method further comprises:
inflating the first delivery catheter after the insertion to the first treatment site and deflating the first delivery catheter prior to the withdrawing from the first treatment site; and/or
inflating the second delivery catheter after the insertion to the second treatment site and deflating the second delivery catheter prior to the withdrawing from the second treatment site.

### Claim 29 (depends on 25)

The method of claim 25, wherein the method comprises infusing the chemical formulation from the first and/or second delivery catheter to the tissue of the body lumen at the first and/or second treatment site.

### Claim 30 (depends on 29)

The method of claim 29, wherein the chemical formulation comprises ethanol, acetic acid, ethanol and water, an ethanol/water azeotrope, or ethanol and acetic acid.

### Claim 31 (depends on 29)

The method of claim 29, wherein the chemical formulation comprises ethanol.

### Claim 32 (depends on 31)

The method of claim 31, wherein the first and/or second delivery catheter comprises a needle catheter or a needle-based catheter.

### Claim 33 (depends on 25)

The method of claim 25, wherein the first and/or second delivery catheter comprises a needle catheter or a needle-based catheter.

### Claim 34 (depends on 25)

The method of claim 25, further comprising flushing the first and/or second treatment sites with saline or water.

### Claim 35 (depends on 25)

The method of claim 25, further comprising flushing the first and/or second delivery catheter with saline or water.

### Claim 36 (depends on 33)

The method of claim 33, wherein the needle-based balloon delivery catheter comprises:
a proximal end;
a distal end;
a wire lumen;
a formulation infusion lumen and/or a vacuum lumen; and
a flushing port.

### Claim 37 (depends on 29)

The method of claim 29, wherein the formulation is delivered into the body lumen wall.
