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Compositions and methods for coating medical implants

a technology of medical implants and compositions, applied in the direction of prosthesis, catheters, therapy, etc., can solve the problems of increasing morbidity for patients, over $2 billion annually, and major healthcare problems affecting the infection of medical implants

Inactive Publication Date: 2007-11-22
ANGIOTECH INT AG (CH)
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention provides methods and compositions for preventing infections associated with medical implants. The invention involves releasing a chemotherapeutic agent from the implant, which reduces or inhibits the growth or transmission of foreign organisms. The released chemotherapeutic agent can be an anthracycline, fluoropyrimidine, folic acid antagonist, podophylotoxin, camptothecin, hydroxyurea, or platinum complex. The invention can be applied to a wide variety of medical implants, such as catheters, heart valves, cardiac pacemakers, and ocular implants. The released chemotherapeutic agent can be present on the implant at a concentration lower than the typical dosage used in cancer treatment. The invention helps to prevent infections and improve the safety and effectiveness of medical implants."

Problems solved by technology

Infections associated with medical implants represent a major healthcare problem.
Hospital acquired infections (nosocomial infections) are the 11th leading cause of death in the US and cost over $2 billion annually.
Once a medical implant becomes colonized by bacteria, it must frequently be replaced resulting in increased morbidity for the patient and increased cost to the healthcare system.
Often the infected device serves as a source for a disseminated infection which can lead to significant morbidity or even death.
One difficulty with these devices, however, is that they can become colonized by bacteria resistant to the antibiotic coating.
This can result in at least two distinct clinical problems.
First, the device serves as a source of infection in the body with the resulting development of a local or disseminated infection.
Secondly, if an infection develops, it cannot be treated with the antibiotic(s) used in the device coating.
The development of antibiotic-resistant strains of microbes remains a significant healthcare problem, not just for the infected patient, but also for the healthcare institution in which it develops.

Method used

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  • Compositions and methods for coating medical implants
  • Compositions and methods for coating medical implants
  • Compositions and methods for coating medical implants

Examples

Experimental program
Comparison scheme
Effect test

example 1

MIC Determination by Microtitre Broth Dilution Method

[0332] A. Mic Assay of Various Gram Negative and Positive Bacteria

[0333] MIC assays were conducted essentially as described by Amsterdam, D. 1996. Susceptibility testing of antimicrobials in liquid media, p. 52-111. In Loman, V., ed. Antibiotics in laboratory medicine, 4th ed. Williams and Wilkins, Baltimore, Md. Briefly, a variety of compounds were tested for antibacterial activity against isolates of P. aeruginosa, K. pneumoniae, E. coli, S. epidermidus and S. aureus in the MIC (minimum inhibitory concentration assay under aerobic conditions using 96 well polystyrene microtitre plates (Falcon 1177), and Mueller Hinton broth at 37° C. incubated for 24 h. (MHB was used for most testing except C721 (S. pyogenes), which used Todd Hewitt broth, and Haemophilus influenzae, which used Haemophilus test medium (HTM)) Tests were conducted in triplicate. The results are provided below in Table 1.

TABLE 1Minimum Inhibitory Concentrations...

example 2

Catheter

Dip Coating

Non-Degradable Polymer

[0336] A coating solution is prepared by dissolving 20 g ChronoFlex AI 85A (CT Biomaterials) in 100 mL DMAC:THF (40:60) at 50° C. with stirring. Once dissolved, the polymer solution is cooled to room temperature. 20 mg mitoxantrone is added to 2 mL of the polyurethane solution. The solution is stirred until a homogenious mixture is obtained. Polyurethane 7 French tubing is dipped into the polymer / drug solution and then withdrawn. The coated tube is air dried (80° C.). The sample is then dried under vacuum to further reduce the residual solvent in the coating.

example 3

Catheter

Dip Coating

Degradable Polymer

[0337] A coating solution is prepared by dissolving 2 g PLG (50:50) in 10 mL dichloromethane:methanol (70:30). Once dissolved, 20 mg mitoxantrone is added to the polymer solution. Once the solution is a homogeneous solution, polyurethane 7 French tubing is dipped into the solution and then withdrawn. The coated tube is air dried. The sample is then dried under vacuum to further reduce the residual solvent in the coating.

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PUM

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Abstract

Medical implants are provided which release an anthracycline, fluoropyrimidine, folic acid antagonist, podophylotoxin, camptothecin, hydroxyurea, and / or platinum complex, thereby inhibiting or reducing the incidence of infection associated with the implant.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a divisional of U.S. patent application Ser. No. 10 / 447,309, filed May 27, 2003, which claims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional Patent Application No. 60 / 383,419, filed May 24, 2002, which applications are incorporated herein by reference in their entireties.BACKGROUND [0002] 1. Technical Field [0003] The present invention relates generally to pharmaceutical compositions, methods, and devices, and more specifically, to compositions and methods which reduce the likelihood of an infection associated with a medical implant. [0004] 2. Description of the Related Art [0005] Infections associated with medical implants represent a major healthcare problem. For example, 5% of patients admitted to an acute care facility develop a hospital acquired infection. Hospital acquired infections (nosocomial infections) are the 11th leading cause of death in the US and cost over $2 billion annually. Nosocomial inf...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/513A61P31/00A61F2/16A61N1/375A61F2/18A61F2/20A61F2/24A61L27/00A61L27/34A61L27/54A61L29/00A61L29/16A61L31/10A61L31/16
CPCA61L27/34A61L27/54A61L29/085A61L2300/404A61L2300/416A61L29/16A61P31/00A61P43/00
Inventor HUNTER, WILLIAM L.GRAVETT, DAVID M.TOLEIKIS, PHILIP M.LIGGINS, RICHARD T.LOSS, TROY A. E.
Owner ANGIOTECH INT AG (CH)
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