Systems and methods for preparing autologous fibrin glue

Abstract

The invention provides a system for preparing an autologous solid-fibrin web suitable for regenerating tissue in a living organism. The system includes a sealed primary container containing a separation medium and a low-density high-viscosity liquid. The separation medium is capable of separating red blood cells from plasma when the container contains blood and is centrifuged, and the primary container has a first pressure. The system further includes a sealed secondary container containing a calcium-coagulation activator. The secondary container has a second pressure that is less than the first pressure. The system also comprises a transfer device including a cannula having a first end and a second end. The first and second ends are capable of puncturing the sealed primary and secondary containers in order to provide fluid communication between the first and second containers. The low-density high-viscosity liquid of the primary container is capable of blocking flow through the cannula upon entering therein.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS [0001] This application is a continuation of and claims priority to U.S. application Ser. No. 10 / 053,247 filed on Jan. 15, 2002, which is a continuation-in-part of and claims priority to U.S. application Ser. No. 09 / 446,729 filed on Mar. 3, 2000, now U.S. Pat. No. 6,368,298, which is a 35 U.S.C. § 371 application of and claims priority to international application no. PCT / IT98 / 00173 filed Jun. 24, 1998, which claims priority to Italian application no. M197A001490 filed Jun. 24, 1997. This application claims priority to each of the applications mentioned above. [0002] This patent application fully incorporates by reference the subject matter of each of the above-identified patent applications to which this application claims priority. The entire disclosure of each patent application is considered to be part of the accompanying application.BACKGROUND OF THE INVENTION [0003] The present invention relates to systems, kits and methods for preparing...

AI Technical Summary

Problems solved by technology

Such known kits involve the use of material of human or animal origin, which, owing to its origin, could result in possible viral contamination and in serious risks for the receiver of the fibrin glue.

Several procedures have already been described for obtaining extemporary autologous fibrin glue, but no “ready to use” kit is available on the market although some relevant references can be found in the patent literature.

These activators are of human or animal nature and therefore still involve the risk of rejection and / or viral infections for the patient.

The method disclosed in this reference requires a long time for obtaining the plasma concentrate necessary for the subsequent preparation of autologous fibrin glue and the apparatus is expensive and not disposable.

The method does not disclose using a calcium-coagulation activator, and requires a pre-concentration step.

This practice, however, exposes the sample to environmental contaminants.

Frequently the high-density, undesirable, lower-fraction red blood cells contaminate the aspirated sample.

To avoid this problem, the pipette is frequently maintained a safe distance from the meniscus (i.e. the separator between the plasma and red blood cells), thereby resulting in an incomplete transfer of the sample.

The incomplete transfer of the desirable fraction results in lower than optimum volume yield and non-stoichiometric ratios of the sample reagents and those in the second container.

This second condition can be a serious source of performance variation of the product.

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