# US 10,369,228 B2 · Method and composition for alleviating or preventing ischemic tissue damage

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- Number: US 10,369,228 B2
- Document ID: US10369228B2
- Status: Granted
- Kind: B2
- Application number: 14/811,024
- Filed: 2015-07-28
- Published: 2015-11-26
- Granted: 2019-08-06
- Earliest claimed: 2009-03-26
- Applicants: Jeffrey E. Thomas
- Inventors: Jeffrey E. Thomas
- Web page: https://patentgrep.com/patent/US10369228B2

## CPC

- A61K 47/46: Ingredients of undetermined constitution or reaction products thereof, e.g. skin, bone, milk, cotton fibre, eggshell, oxgall or plant extracts
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/0085: {Brain, e.g. brain implants; Spinal cord}
- A61K 31/198: Alpha-amino acids, e.g. alanine or edetic acid [EDTA] (betaine A61K31/205; proline A61K31/401; tryptophan A61K31/405; histidine A61K31/4172; peptides not degraded to individual amino acids A61K38/00)
- A61K 31/21: Esters, e.g. nitroglycerine, selenocyanates
- A61K 33/26: Iron; Compounds thereof
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- 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)

## Abstract

A method for increasing collateral circulation includes providing a pharmaceutically acceptable synthetic cerebrospinal fluid that has a density different than that of the patient's naturally-occurring cerebrospinal fluid. The synthetic cerebrospinal fluid includes a vasodilator. The method further includes administering the synthetic cerebrospinal fluid to an intrathecal space of a patient through a lumbar access point to reach the intrathecal space of a patient.

## Claims

### Claim 1

A method for increasing collateral circulation in a patient comprising:
providing a pharmaceutically acceptable synthetic cerebrospinal fluid comprising a density-altering agent, wherein the synthetic cerebrospinal fluid has a density different from a density of naturally-occurring cerebrospinal fluid, and wherein the density-altering agent comprises about 5 to about 8.25 percent by volume of dextrose;
mixing a vasodilator with the synthetic cerebrospinal fluid; placing the patient in a head-down position, wherein the vasodilator is selected from at least one member of the group consisting of nitroglycerine, nitroprusside, a nitroprusside salt, sodium nitroprusside, arginine, and mixtures thereof, and
administering said synthetic cerebrospinal fluid to an intrathecal space of the patient using a lumbar access point to access said intrathecal space, wherein the density of the synthetic cerebrospinal fluid is sufficient to enable the spread of the synthetic cerebrospinal fluid throughout the brain of the patient.

### Claim 2

A method for treating an individual suspected of having a cerebrovascular event comprising:
providing a quantity of synthetic cerebrospinal fluid having a density different from the density of the individual's naturally-occurring cerebrospinal fluid, wherein the quantity of synthetic cerebrospinal fluid comprises a density-altering agent comprising about 5 to about 8.25 percent by volume of dextrose;
mixing a vasodilator with the quantity of synthetic cerebrospinal fluid to form a synthetic cerebrospinal fluid vasodilator mixture, wherein vasodilator comprises nitroglycerine, nitroprusside, a nitroprusside salt, sodium nitroprusside, arginine, and mixtures thereof;
placing the individual in a Trendelenburg position; and
administering the synthetic cerebrospinal fluid vasodilator mixture to an intrathecal space of the individual.

### Claim 3 (depends on 2)

The method of claim 2, wherein the density of the synthetic cerebrospinal fluid is greater than the density of the individual's naturally-occurring cerebrospinal fluid.

### Claim 4 (depends on 2)

The method of claim 2, wherein the density of the synthetic cerebrospinal fluid is less than the density of the individual's naturally-occurring cerebrospinal fluid.

### Claim 5 (depends on 2)

The method of claim 2, further comprising establishing a path for communication of the mixture to the individual's subarachnoid space.

### Claim 6

A method for treating or inhibiting ischemic damage comprising:
providing a pharmaceutically acceptable carrier fluid having a first density, said first density being different than a specific density of a patient's naturally-occurring cerebrospinal fluid, wherein the carrier fluid comprises a density-altering agent comprising about 5 to about 8.25 percent by volume of dextrose;
mixing a vasodilator with the said carrier fluid, wherein the vasodilator is selected from at least one member of the group consisting of nitroglycerine, nitroprusside, a nitroprusside salt, sodium nitroprusside, arginine, and mixtures thereof; and
administering said carrier fluid to an intrathecal space of a patient placed in a Trendelenburg position; wherein said first density of said carrier fluid facilitates transfusion of the vasodilator throughout the intrathecal space of the patient.

### Claim 7 (depends on 6)

The method of claim 6, wherein the vasodilator is present in amounts from about 0.25 mg/ml to about 4 mg/ml.

### Claim 8 (depends on 6)

The method of claim 6, wherein the carrier fluid has an acidic pH.

### Claim 9 (depends on 6)

The method of claim 6, wherein the carrier fluid further comprises a neuroprotectant.

### Claim 10 (depends on 9)

The method of claim 9, wherein the neuroprotectant comprises spin trap agents, free radical scavengers, or anti-inflammatory agents.

### Claim 11 (depends on 6)

The method of claim 6, wherein the method further comprises administering the carrier fluid to the intrathecal space of the patient using a lumbar access point to reach the intrathecal space.