Catheter Composition and Uses Thereof

a catheter and composition technology, applied in the field of catheters, can solve the problems of serious peritonitis, serious infection of the urogenital tract, and none of the clinically proven problems to be completely satisfactory

Inactive Publication Date: 2006-11-16
GENENTECH INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0027] The present invention discloses solutions unique in their ability to meet the above needs, which are not based on anti-coagulation, anti-thrombotic, or chelating activities and do not involve the use of antibiotics, for which mammals can develop resistance. The present invention solves the needs set forth herein by using a plasminogen activator in conjunction with a disinfectant used as a preservative, mainly an organic alcohol that serves in this capacity. The resulting composition not only has fibrinolytic activity, but also prevents pathogen growth, especially in clotted catheters, and has passed USP standards.
[0031] The preferred amount of benzyl alcohol, a preferred alcohol herein, is about 0.8-1.1%. This range and the broader range of about 0.5 to 1.2% are enough to inhibit microbe growth but preserve stability and function of the plasminogen activator. An advantage of these alcohols is that they do not lead to antibiotic resistance.

Problems solved by technology

Such systems also include catheters and drains that are involved in peritoneal dialysis for those with terminal kidney failure, which, if infected, can lead to peritonitis with serious consequences.
It is now generally acknowledged that indwelling catheterization in medical, surgical, gynecological, urological and other patients can lead to serious infection of the urogenital tract.
A number of methods for reducing the risk of infection have been developed that incorporate anti-infective agents into medical devices, none of which have been clinically proven to be completely satisfactory.
This sustained release may be problematic to achieve, in that a mechanism for dispersing anti-infective agent over a prolonged period of time may be required, and the incorporation of sufficient amounts of anti-infective agent may adversely affect the surface characteristics of the device.
The difficulties encountered in providing effective anti-microbial protection increase with the development of drug-resistant pathogens.
Furthermore, heparin has no anti-microbial activity, and, in addition, if not carefully controlled, it can carry the anti-coagulation process too far, thereby presenting a risk of hemorrhage.
Heparin can also result in antibody formation, leading to a serious autoimmune condition of heparin-induced thrombocytopenia (HIT), which depletes platelets and further increases risk of bleeding.
Unlike these particular microbes, gram-negative bacilli do not adhere well to fibrin and fibronectin.
Their major limitations, besides infection, are thrombosis and inadequate blood flow.
However, Schenk et al. utilized 2 mg of alteplase plus SWFI (sterile water for injection, USP), which does not prevent growth of bacteria.
Central venous access device (CVAD) occlusions or blockages due to formation of a blood clot (thrombus) within or at the tip of the CVAD catheter are a common problem that can block the administration of therapies to patients.

Method used

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  • Catheter Composition and Uses Thereof
  • Catheter Composition and Uses Thereof
  • Catheter Composition and Uses Thereof

Examples

Experimental program
Comparison scheme
Effect test

example 2

Summary

[0101] Testing was performed as disclosed above for anti-microbial effectiveness to evaluate the efficacy of 0.8% benzyl alcohol as a preservative in 2 mg / mL of ACTIVASE® t-PA against the USP requirements. This sample met the requirements of the USP anti-microbial effectiveness test.

Materials, Equipment, and Procedures

[0102] The sample was ACTIVASE®) t-PA (2 mg / mL) in a vial with 0.8% benzyl alcohol. Specifically, the diluent was sterile water plus the appropriate amount of benzyl alcohol for a final concentration of 0.8%.

[0103] The challenge organisms were those described in Example 1.

[0104] Media, supplies, and major equipment were the same as noted in Example 1.

[0105] The procedure used was the same as that described in Example 1 and the incubation conditions were as in Table 1. The acceptance criteria and interpretation were the same as in Example 1.

Results

[0106] The results were the same as in Table 4 and Table 5 for calculated initial concentration of challen...

example 3

Summary

[0110] Testing was performed as disclosed above for anti-microbial effectiveness to evaluate the efficacy of 0.9% benzyl alcohol as a preservative in 2 mg / mL of ACTIVASE® t-PA against the USP requirements. This sample met the requirements of the USP anti-microbial effectiveness test.

Materials, Equipment, and Procedures

[0111] The sample was ACTIVASE® t-PA (2 mg / mL) in a vial with 0.9% benzyl alcohol. Specifically, the diluent was sterile water plus the appropriate amount of benzyl alcohol for a final concentration of 0.9%.

[0112] The challenge organisms were those described in Example 1.

[0113] Media, supplies, and major equipment were the same as noted in Example 1.

[0114] The procedure used was the same as that described in Example 1 and the incubation conditions were as in Table 1. The acceptance criteria and interpretation were the same as in Example 1.

Results

[0115] The results were the same as in Table 4 and Table 5 for calculated initial concentration of challeng...

example 4

Summary

[0120] Testing was performed as disclosed above for anti-microbial effectiveness to evaluate the efficacy of 1.0% benzyl alcohol as a preservative in 2 mg / mL of ACTIVASE® t-PA against the USP requirements. This sample met the requirements of the USP anti-microbial effectiveness test.

Materials, Equipment, and Procedures

[0121] The sample was ACTIVASE® t-PA (2 mg / mL) in a vial with 1.0% benzyl alcohol. Specifically, the diluent was sterile water plus the appropriate amount of benzyl alcohol for a final concentration of 1.0%.

[0122] The challenge organisms were those described in Example 1.

[0123] Media, supplies, and major equipment were the same as noted in Example 1.

[0124] The procedure used was the same as that described in Example 1 and the incubation conditions were as in Table 1. The acceptance criteria and interpretation were the same as in Example 1.

Results

[0125] The results were the same as in Table 4 and Table 5 for calculated initial concentration of challeng...

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Abstract

A composition useful for removal of fibrin-bound blood clots from a catheter comprises water, a fibrinolytically effective amount of a plasminogen activator, and a preservatively effective amount of a bacteriostatic organic alcohol. The composition does not comprise a chelating agent.

Description

RELATED APPLICATIONS [0001] This application is a divisional application of U.S. application Ser. No. 10 / 304,666, filed Nov. 25, 2002, claiming priority under 35 USC 119(e) to provisional application No. 60\333,369 filed Nov. 26, 2001, the contents of which are incorporated herein by reference.BACKGROUND OF THE INVENTION [0002] 1. Field of the Invention [0003] The present invention relates to the field of indwelling medical devices, in particular catheters, as well as to the field of methods and compositions for flushing, locking, priming, and coating these medical devices. The invention also relates to pharmaceutical preparations useful in increasing catheter flow and preventing infection in catheters with the potential for fibrin deposition or with preexisting fibrin-bound clots. [0004] 2. Description of Related Disclosures [0005] Delivery systems are widely used in medicine as a means for introducing liquid material that might include medicaments, nutrition, or other active agent...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K38/48A61KA61L33/00A61K31/45A61K38/00A61K38/49A61K39/395A61LA61MA61M1/00A61M21/00A61M25/00A61M31/00A61M37/00
CPCA61K38/49A61K2300/00A61P41/00A61P7/02
Inventor SEMBA, CHARLES P.
Owner GENENTECH INC
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