Catheter locking solution having antimicrobial and anticoagulation properties

• US 9,248,093 B2
• Filed: 06/09/2010
• Issued: 02/02/2016
• Est. Priority Date: 06/11/2009
• Status: Active Grant

• Current Assignee: Becton, Dickinson & Co
• Original Assignee: Becton, Dickinson & Co
• Inventors: Kelley, John J. III, Valdes, Thelma I.
• Primary Examiner(s): Haghighatian, Mina
• Application Number:
  US12/797,336
• Publication Number:
  US 20100318040A1
• Time in Patent Office: 2,064 Days
• US Class Current: 1/1
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/167 having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
• CPC Class Codes: A61K 31/245 Amino benzoic acid types, e.g. procaine, novocaine salicylic acid esters A61K31/60
• CPC Class Codes: A61K 31/445 Non condensed piperidines, e.g. piperocaine
• CPC Class Codes: A61K 31/47 Quinolines; Isoquinolines
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: 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
• CPC Class Codes: A61L 2300/402 Anaestetics, analgesics, e.g. lidocaine
• CPC Class Codes: A61L 2300/404 Biocides, antimicrobial agents, antiseptic agents
• CPC Class Codes: A61L 2300/42 Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 29/06 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/14 Materials characterised by their function or physical properties , e.g. lubricating compositions
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61L 33/0041 characterised by the choice of an antithrombatic agent other than heparin heparinoïd A61L33/08; polypeptides A61L33/12
• CPC Class Codes: A61L 33/04 Use of organic materials, e.g. acetylsalicylic acid
• CPC Class Codes: A61L 33/068 obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds A61L33/062 takes precedence
• CPC Class Codes: A61M 2025/0019 Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement
• CPC Class Codes: 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
• CPC Class Codes: A61M 25/00 Catheters; Hollow probes dilators A61M29/00; peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00 ; for measuring or testing A61B; materials for catheters A61L29/00
• CPC Class Codes: A61P 23/02 Local anaesthetics
• CPC Class Codes: A61P 31/04 : Antibacterial agents
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors

Abstract

The present invention includes a catheter locking solution having both antimicrobial and anticoagulant properties including a local anesthetic and a viscosifying agent. The local anesthetic of the present invention may be an amino amide; an amino ester; an aminoacylanilide; an aminoalkyl benzoate; an amino carbonate; an N-phenylamidine compound; an N-aminoalkyl amid; an aminoketone, or combinations and mixtures thereof. In a particular embodiment of the present invention, the local anesthetic is tetracaine or dibucaine.

Claims

1. A catheter locking solution comprising:

a local anesthetic selected from the group consisting of dibucaine, tetracaine, and a combination thereof, in an amount effective to reduce microbial growth and coagulation in an implanted catheter; and

a viscosifying agent, the catheter locking solution having a viscosity of less than or equal to 4 mPa·

s.

2. The catheter locking solution of claim 1, further comprising an additional local anesthetic, different from the local anesthetic, selected from the group consisting of an amino amide;

an amino ester;

an aminoacylanilide;

an aminoalkyl benzoate;

an amino carbonate;

an N-phenylamidine compound;

an N-aminoalkyl amide;

an aminoketone, or combinations and mixtures thereof.

3. The catheter locking solution of claim 1, further comprising an additional local anesthetic, different from the local anesthetic, selected from the group consisting of dibucaine, tetracaine, bupivacaine, ropivacaine, etidocaine, lidocaine, prilocaine, procaine, novocaine, choloroprocaine, propoxycaine, chlorocaine, mepivacaine, xylocaine, benzocaine, chloroprocaine, cyclomethycaine, dimethocaine, popoxycaine, proparacaine, articaine, carticaine, levobupivacaine, piperocaine, trimecaine, hexylcaine, benoxinate, butucaine, diperodon, phenacaine, falicaine, dyclonine, pramoxine, dimethisoquien, and combinations and mixtures thereof.

4. The catheter locking solution of claim 1, wherein the local anesthetic is present in an amount of 0.05 mg/mL-100 mg/mL.

5. The catheter locking solution of claim 1, wherein the local anesthetic is present in an amount of 0.24 mg/mL-28.2 mg/mL.

6. The catheter locking solution of claim 1, wherein the viscosifying agent is selected from the group consisting of polyethylene glycol, glycerin, polygeline, or any mixture thereof.

7. The catheter locking solution of claim 1, wherein the local anesthetic is tetracaine and the viscosifying agent is polyethylene glycol.

8. The catheter locking solution of claim 1, wherein the local anesthetic is dibucaine and the viscosifying agent is polyethylene glycol.

9. The catheter locking solution of claim 1, further comprising an antimicrobial agent other than the local anesthetic.

10. The catheter locking solution of claim 1, further comprising an anticoagulation agent other than the local anesthetic.

11. A pre-filled syringe comprising a syringe containing a locking solution, said locking solution comprising:

a local anesthetic selected from the group consisting of dibucaine, tetracaine, and a combination thereof, in an amount effective to reduce microbial growth and coagulation in an implanted catheter; and

a viscosifying agent,

the catheter locking solution having a viscosity of less than or equal to 4 mPa·

s.

12. The pre-filled syringe of claim 11, further comprising an additional local anesthetic, different from the local anesthetic, selected from the group consisting of an amino amide;

an amino ester;

an aminoacylanilide;

an aminoalkyl benzoate;

an amino carbonate;

an N-phenylamidine compound;

an N-aminoalkyl amide;

an aminoketone, or combinations and mixtures thereof.

13. The pre-filled syringe of claim 11, further comprising an additional local anesthetic, different from the local anesthetic, selected from the group consisting of dibucaine, tetracaine, bupivacaine, ropivacaine, etidocaine, lidocaine, prilocaine, procaine, novocaine, choloroprocaine, propoxycaine, chlorocaine, mepivacaine, xylocaine, benzocaine, chloroprocaine, cyclomethycaine, dimethocaine, popoxycaine, articaine, carticaine, levobupivacaine, piperocaine, trimecaine, hexylcaine, benoxinate, butucaine, proparacaine, diperodon, phenacaine, falicaine, dyclonine, pramoxine, dimethisoquien, and combinations and mixtures thereof.

14. The pre-filled syringe of claim 11, wherein the local anesthetic is present in an amount of 0.05 mg/mL-100 mg/mL.

15. The pre-filled syringe of claim 11, wherein the local anesthetic is present in an amount of 0.24 mg/mL-28.2 mg/mL.

16. The pre-filled syringe of claim 11, wherein the viscosifying agent is selected from the group consisting of polyethylene glycol, glycerin, polygeline, or any mixture thereof.

17. The pre-filled syringe of claim 11, wherein the local anesthetic is tetracaine and the viscosifying agent is polyethylene glycol.

18. The pre-filled syringe of claim 11, wherein the local anesthetic is dibucaine and the viscosifying agent is polyethylene glycol.

19. The pre-filled syringe of claim 11, further comprising an antimicrobial agent other than the local anesthetic.

20. The pre-filled syringe of claim 11, further comprising an anticoagulation agent other than the local anesthetic.

21. A catheter comprising a tube defining a lumen therethrough, wherein at least a portion of the lumen is infused with a catheter locking solution, said catheter locking solution comprising:

a local anesthetic selected from the group consisting of dibucaine, tetracaine, and a combination thereof, in an amount effective to reduce microbial growth and coagulation in an implanted catheter; and

a viscosifying agent,

the catheter locking solution having a viscosity of less than or equal to 4 mPa·

s.

22. The catheter of claim 21, wherein the catheter locking solution further comprises an additional local anesthetic, different from the local anesthetic, selected from the group consisting of an amino amide;

an amino ester;

an aminoacylanilide;

an aminoalkyl benzoate;

an amino carbonate;

an N-phenylamidine compound;

an N-aminoalkyl amide;

an aminoketone, or combinations and mixtures thereof.

23. The catheter of claim 21, wherein the catheter locking solution further comprises an additional local anesthetic, different from the local anesthetic, selected from the group consisting of dibucaine, tetracaine, bupivacaine, ropivacaine, etidocaine, lidocaine, prilocaine, procaine, novocaine, choloroprocaine, propoxycaine, chlorocaine, mepivacaine, xylocaine, benzocaine, chloroprocaine, cyclomethycaine, dimethocaine, popoxycaine, articaine, carticaine, levobupivacaine, piperocaine, trimecaine, hexylcaine, benoxinate, butucaine, proparacaine, diperodon, phenacaine, falicaine, dyclonine, pramoxine, dimethisoquien, and combinations and mixtures thereof.

24. A catheter locking solution comprising:

a local anesthetic having anticoagulant and antimicrobial activity, wherein the local anesthetic is tetracaine; and

a viscosifying agent, wherein the viscosifying agent is polyethylene glycol,

wherein the local anesthetic is present in an amount of 0.24 mg/mL-28.2 mg/mL, and

the catheter locking solution having a viscosity of less than or equal to 4 mPa·

s.

25. A catheter locking solution comprising:

a local anesthetic having anticoagulant and antimicrobial activity, wherein the local anesthetic is dibucaine; and

a viscosifying agent, wherein the viscosifying agents is polyethylene glycol, wherein the local anesthetic is present in an amount of 0.24 mg/mL-28.2 mg/mL,

the catheter locking solution having a viscosity of less than or equal to 4 mPa·

s.

26. A method of reducing microbial activity and coagulation in a catheter, the method comprising:

providing a catheter having an interior surface and an exterior surface; and

infusing, into at least a portion of the interior surface, a catheter locking solution comprising a local anesthetic selected from the group consisting of dibucaine, tetracaine, and a combination thereof, in an amount effective to reduce microbial growth and coagulation in an implanted catheter and a viscosifying agent.

27. The method of claim 26, further comprising reinfusing said interior surface of said catheter with the catheter locking solution after a designated time, wherein said designated time is less than one week.

28. The method of claim 26, wherein the interior surface of the catheter has an internal volume and said infusing includes infusing the interior surface with an amount of the lock solution sufficient to fill between about 80% and 100% of the internal volume of the interior surface.

29. The method of claim 26, wherein the interior surface of the catheter is infused between 1 and 1000 times.