# US 10,117,971 B2 · Antimicrobial compositions and methods for locking catheters

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- Number: US 10,117,971 B2
- Document ID: US10117971B2
- Status: Granted
- Kind: B2
- Application number: 15/845,241
- Filed: 2017-12-18
- Published: 2018-05-10
- Granted: 2018-11-06
- Earliest claimed: 2006-02-28
- Assignees: Becton, Dickinson and Company
- Applicants: Becton, Dickinson and Company
- Inventors: Minh Quang Hoang
- Web page: https://patentgrep.com/patent/US10117971B2

## CPC

- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- A01N 31/02: Acyclic compounds
- A61K 31/045: Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
- A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)}
- A61K 31/155: Amidines ([IMAGE cpc-sch-A61K-1029.gif]), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
- 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 31/205: Amine addition salts of organic acids; Inner quaternary ammonium salts, e.g. betaine, carnitine
- A61K 31/496: Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
- A61K 31/60: Salicylic acid; Derivatives thereof
- A61K 31/612: having the hydroxy group in position 2 esterified, e.g. salicylsulfuric acid (fosfosal A61K31/661)
- A61K 33/38: Silver; Compounds thereof
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/32: Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers {, poly(meth)acrylates, or polyvinyl pyrrolidone}
- A61K 47/34: Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence)
- A61L 29/08: Materials for coatings
- A61L 29/085: {Macromolecular materials}
- A61L 29/106: {Inorganic materials other than carbon}
- A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions}
- A61K 2300/00: Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
- A61L 2/18: Liquid substances
- A61L 2/186: Peroxide solutions
- A61L 2103/05: Living organisms or biological materials
- A61L 2103/15: Laboratory, medical or dentistry appliances, e.g. catheters or sharps
- A61L 2300/206: Biguanides, e.g. chlorohexidine
- A61L 2300/21: Acids
- A61L 2300/214: Amino acids
- A61L 2300/216: with other specific functional groups, e.g. aldehydes, ketones, phenols, quaternary phosphonium groups
- A61L 2300/404: Biocides, antimicrobial agents, antiseptic agents
- A61L 2300/42: Anti-thrombotic agents, anticoagulants, anti-platelet agents
- A61M 2025/0056: {provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir}
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- A01N: PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF (preservation of food or foodstuff A23); BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES (preparations for medical, dental or toiletry purposes which kill or prevent the growth or proliferation of unwanted organisms A61K); PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
- 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)}

## Abstract

Antimicrobial compositions for use in locking catheters and other devices are provided. In some embodiments, the composition includes at least one alcohol, at least one biocidal agent which is not an alcohol, and one or more poloxamers; in other embodiments, the composition comprises at least one poloxamer and at least one alcohol. The composition can provide long-lasting antimicrobial activity. Methods of using the composition are also provided.

## Claims

### Claim 1

A catheter containing a locking solution comprising an antimicrobial composition, the antimicrobial composition comprising:
a poloxamer; and
at least 10 weight percent of an alcohol on a basis of total weight of the antimicrobial composition.

### Claim 2 (depends on 1)

The catheter of claim 1, wherein the poloxamer is represented by the formula
HO(C2H4O)a(C3H6O)b(C2H4O)aOH
where a is at least 12 and b is an integer such that the hydrophilic portion represented by (C2H4O) constitutes about 50 to about 90% by weight of the entire polymer.

### Claim 3 (depends on 2)

The catheter of claim 2, wherein the average molecular weight of the poloxamer is between about 2,000 to about 18,000 daltons.

### Claim 4 (depends on 3)

The catheter of claim 3, wherein the poloxamer is selected from the group consisting of poloxamer 188, poloxamer 237, and poloxamer 407.

### Claim 5 (depends on 1)

The catheter of claim 1, wherein the poloxamer is present in an amount of about 0.01 wt. % to about 5 wt. %, based on the weight of the antimicrobial composition.

### Claim 6 (depends on 1)

The catheter of claim 1, wherein the alcohol is a C1-C6 lower alcohol.

### Claim 7 (depends on 6)

The catheter of claim 6, wherein the C1-C6 lower alcohol is a mixture of isopropyl alcohol and ethanol.

### Claim 8 (depends on 7)

The catheter of claim 7, wherein the C1-C6 lower alcohol is a mixture of isopropyl alcohol and ethanol and is present in an amount of about 50 to about 95% by weight of the antimicrobial composition.

### Claim 9 (depends on 1)

The catheter of claim 1, further comprising an additive selected from the group consisting of an anticoagulant, saline, water, and combinations thereof.

### Claim 10 (depends on 9)

The catheter of claim 9, wherein the anticoagulant is selected from the group consisting of acetylsalicylic acid, anti-thrombin III, citric acid disodium salt, citric acid monopotassium salt, citric acid monosodium salt, citric acid tripotassium salt, citric acid trisodium salt, citric acid, coumadin, coumarin, di-ammonium hydrogen citrate, di-ammonium tartrate, ethylenediaminetetraacetic acid (EDTA) diammonium salt, EDTA dipotassium salt, EDTA disodium salt, EDTA tetrasodium salt, EDTA tripotassium salt, EDTA trisodium salt, ethylene glycol-O,O′-bis(2-aminoethyl)-N,N,N′,N′-tetraacetic acid, ethylenebis(oxyethylenenitrilo)tetraacetic acid, EDTA, heparin, hirudin, hirulog, ibuprofen, indomethacin, L-tartaric acid dipotassium salt, L-tartaric acid disodium salt, L-tartaric acid monosodium salt, N-(2-hydroxyethyl)ethylenediamine-N,N′,N′-triacetic acid trisodium salt, nicoumalone, nitrilotriacetic acid, phenprocoumon, potassium hydrogen D-tartrate, potassium sodium tartrate, prostaglandins, protamine sulfate, protein C/protein S, streptokinase, sulfinpyrazone, tissue plasminogen activator (TPA), urokinase, and warfarin.

### Claim 11 (depends on 10)

The catheter of claim 10, wherein the anticoagulant is ethylenediaminetetraacetic acid.

### Claim 12

A catheter comprising a coating comprising an antimicrobial composition, the antimicrobial composition comprising:
0.1 weight percent on a basis of total weight of the antimicrobial composition to 2 weight percent of a poloxamer;
at least 10 weight percent of a C1-C6 lower alcohol on a basis of total weight of the antimicrobial composition; and
an anticoagulant.

### Claim 13 (depends on 12)

The catheter of claim 12, wherein the anticoagulant is selected from the group consisting of acetylsalicylic acid, anti-thrombin III, citric acid disodium salt, citric acid monopotassium salt, citric acid monosodium salt, citric acid tripotassium salt, citric acid trisodium salt, citric acid, coumadin, coumarin, di-ammonium hydrogen citrate, di-ammonium tartrate, ethylenediaminetetraacetic acid (EDTA) diammonium salt, EDTA dipotassium salt, EDTA disodium salt, EDTA tetrasodium salt, EDTA tripotassium salt, EDTA trisodium salt, ethylene glycol-O,O′-bis(2-aminoethyl)-N,N,N′,N′-tetraacetic acid, ethylenebis(oxyethylenenitrilo)tetraacetic acid, EDTA, heparin, hirudin, hirulog, ibuprofen, indomethacin, L-tartaric acid dipotassium salt, L-tartaric acid disodium salt, L-tartaric acid monosodium salt, N-(2-hydroxyethyl)ethylenediamine-N,N′,N′-triacetic acid trisodium salt, nicoumalone, nitrilotriacetic acid, phenprocoumon, potassium hydrogen D-tartrate, potassium sodium tartrate, prostaglandins, protamine sulfate, protein C/protein S, streptokinase, sulfinpyrazone, tissue plasminogen activator (TPA), urokinase, and warfarin.

### Claim 14

A method for providing disinfection of an implanted catheter comprising a lumen and a wall, the method comprising:
introducing a locking solution comprising an antimicrobial composition into the lumen of the catheter, the antimicrobial composition comprising:
a poloxamer; and
at least 10 weight percent of an alcohol on a basis of total weight of the antimicrobial composition.

### Claim 15 (depends on 14)

The method of claim 14, wherein the alcohol is a C1-C6 lower alcohol.

### Claim 16 (depends on 15)

The method of claim 15, wherein the C1-C6 lower alcohol is a mixture of isopropyl alcohol and ethanol.

### Claim 17 (depends on 15)

The method of claim 15, wherein the C1-C6 lower alcohol is a combination of isopropyl alcohol and ethanol to a total in the range of 50 to 95 wt %, based on the weight of the antimicrobial composition.

### Claim 18 (depends on 14)

The method of claim 14, wherein the antimicrobial composition is maintained in the lumen of the catheter for a period of time ranging from about 48 hours to about one week.

### Claim 19 (depends on 14)

The method of claim 14, wherein the antimicrobial composition penetrates the wall of the catheter.

### Claim 20 (depends on 14)

The method of claim 14, wherein the antimicrobial composition further comprises an anticoagulant selected from the group consisting of acetylsalicylic acid, anti-thrombin III, citric acid disodium salt, citric acid monopotassium salt, citric acid monosodium salt, citric acid tripotassium salt, citric acid trisodium salt, citric acid, coumadin, coumarin, di-ammonium hydrogen citrate, di-ammonium tartrate, ethylenediaminetetraacetic acid (EDTA) diammonium salt, EDTA dipotassium salt, EDTA disodium salt, EDTA tetrasodium salt, EDTA tripotassium salt, EDTA trisodium salt, ethylene glycol-O,O′-bis(2-aminoethyl)-N,N,N′,N′-tetraacetic acid, ethylenebis(oxyethylenenitrilo)tetraacetic acid, EDTA, heparin, hirudin, hirulog, ibuprofen, indomethacin, L-tartaric acid dipotassium salt, L-tartaric acid disodium salt, L-tartaric acid monosodium salt, N-(2-hydroxyethyl)ethylenediamine-N,N′,N′-triacetic acid trisodium salt, nicoumalone, nitrilotriacetic acid, phenprocoumon, potassium hydrogen D-tartrate, potassium sodium tartrate, prostaglandins, protamine sulfate, protein C/protein S, streptokinase, sulfinpyrazone, tissue plasminogen activator (TPA), urokinase, and warfarin.