Apparatuses and methods for treating biological tissue to mitigate calcification

Abstract

An apparatus for treating fixed biological tissue to inhibit calcification of the biological tissue following implantation thereof in a mammalian body. The apparatus includes a container for placing the biological tissue in contact with a treatment solution, structure to induce relative tissue / solution movement, and structure to heat the solution. The relative movement may be induced by shaking a container in which the tissue is immersed in the treatment solution, or by stirring the solution within the container. The movement may also be induced by flowing a treatment solution past the tissue to be treated. The tissue may be free to move in the treatment container, or may be restrained from gross movements. The flow may be part of a circulation system having a reservoir, with a heater being provided to heat the treatment solution in the reservoir. Alternatively, a treatment apparatus, including a fluid circulation system if desired, may be enclosed in an incubator. The tissue may be mounted in a planar configuration generally parallel to the direction of fluid flow. A flow column having a plurality of sections divided by perforated baffles may be used to treat multiple tissues at once.

Description

RELATED APPLICATIONS[0001]The present application is a divisional of U.S. application Ser. No. 08 / 874,180, filed Jun. 13, 1997, now U.S. Pat. No. 5,931,969, entitled “Methods and Apparatuses for Treating Biological Tissue to Mitigate Calcification,” which is a continuation-in-part of U.S. application Ser. No. 08 / 812,506, filed Mar. 7, 1997, now abandoned, which is a <?insert-end id="INS-S-00001" ?>continuation of U.S. application Ser. No. 08 / 282,358, filed Jul. 29, 1994, now abandoned.[0002]Notice: More than one reissue application has been filed for the reissue of U.S. Pat. No. 6,210,957. The reissue applications are application Ser. Nos. 10 / 406,354 (the present application), and 10 / 834,399, all of which are divisional reissues of U.S. Pat. No. 6,210,957. <?insert-end id="INS-S-00002" ?>FIELD OF THE INVENTION[0003]The present invention pertains generally to apparatuses for preparing biomedical materials, and more particularly to an apparatus for preparing preserved biol...

AI Technical Summary

Benefits of technology

The present invention provides a method and apparatus for treating biological tissue to prevent calcification after implantation in a mammalian body. The method involves immersing the tissue in a treatment solution and inducing relative movement between the tissue and solution to promote even distribution of the treatment solution. The treatment solution can be heated to enhance the treatment process. The apparatus includes a flow container with a tissue mount for positioning the tissue and restraining its movement, and means for heating the treatment solution. The apparatus may also include a baffle to create a uniform flow profile over the cross-section of the flow container. The technical effects of the invention include improved treatment outcomes and reduced risk of complications associated with calcification.

Problems solved by technology

Such calcification is undesirable in that it may result in deterioration of the mechanical properties of the tissue and / or tissue failure.

However, pediatric patients who receive mechanical valve implants require long term treatment with anticoagulant medications and such anticoagulation is associated with increased risk of hemorrhage.

As those skilled in the art will appreciate, such tissue replacement frequently causes substantial trauma to the patient, occasionally resulting in the patient's death.

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