Apparatuses and methods for treating biological tissue to mitigate calcification
First Claim
1. An apparatus for treating at least partially fixed biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
- a flow container;
a reservoir containing treatment fluid suitable for fixing the tissue;
a fluid input to the container;
a fluid output from the container;
a tissue mount for positioning the at least partially fixed biological tissue within the container between the input and ouput output and restrain its gross movement therein; and
means for heating the fluid to a temperature greater than body temperature (>
37°
C.) comprising a heater for heating fluid in the reservoir.
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Accused Products
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.
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Citations
72 Claims
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1. An apparatus for treating at least partially fixed biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
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a flow container;
a reservoir containing treatment fluid suitable for fixing the tissue;
a fluid input to the container;
a fluid output from the container;
a tissue mount for positioning the at least partially fixed biological tissue within the container between the input and ouput output and restrain its gross movement therein; and
means for heating the fluid to a temperature greater than body temperature (>
37°
C.) comprising a heater for heating fluid in the reservoir. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8)
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9. An apparatus for treating at least partially fixed biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
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a piece of at least partially fixed biological tissue;
a container suitable for containing tissue treatment fluid and immersing the piece of at least partially fixed biological tissue in the fluid;
a shaker for causing treatment fluid movement within the container;
means for heating the treatment fluid and tissue within the container; and
means for restraining the immersed tissue from gross movement within the container. - View Dependent Claims (10, 11)
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12. An apparatus for treating at least partially faced fixed biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
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a piece of at least partially fixed biological tissue, a container suitable for containing tissue treatment fluid and immersing the piece of at least partially fixed biological tissue in the fluid, means for causing treatment fluid movement within the container comprising a stirrer immersed in the treatment fluid, means for heating the treatment fluid; and
means for restraining the immersed tissue from gross movement within the container. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. An apparatus for treating an at least partially fixed sheet of biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
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treatment fluid suitable for fixing the tissue;
a container suitable for containing the tissue treatment fluid having a fluid input and a fluid output;
a system for continuously flowing the treatment fluid through the flow container between the input and output;
a tissue mount for positioning the at least partially fixed sheet of biological tissue within the container between the input and output and restrain its gross movement therein, the tissue mount being adapted to mount the tissue sheet in a planar configuration substantially parallel to the direction of flow of the treatment fluid, the sheet of biological tissue being immersed in the continuous flow of treatment fluid; and
means for heating the treatment fluid. - View Dependent Claims (24, 25, 26, 27)
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28. An apparatus for treating at least partially fixed biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
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a flow container divided into at least two sections in series separated by perforated baffles;
a supply of treatment fluid;
a fluid input to the container;
a fluid output from the container;
at least one tissue mount in each section for positioning the at least partially fixed biological tissue within the container between the input and output and restrain its gross movement therein; and
means for heating the fluid. - View Dependent Claims (29)
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30. An apparatus for treating at least partially fixed biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
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a flow container;
a supply of treatment fluid;
a fluid input to the container;
a fluid output from the container;
a tissue mount for positioning the at least partially fixed biological tissue within the container between the input and output and restrain its gross movement therein;
means for heating the fluid; and
at least one baffle positioned in the flow container and upstream of the tissue mount, the baffle being configured to create a substantially uniform downstream flow profile over a cross-section of the flow container. - View Dependent Claims (31)
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32. An apparatus for treating at least partially fixed biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
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a flow container comprising an upstanding tube;
a supply of treatment fluid;
a fluid input to the container at a lower end of the tube;
a fluid output from the container at an upper end of the tube;
a tissue mount for positioning the at least partially fixed biological tissue within the container between the input and output and restrain its gross movement therein;
means for heating the fluid; and
a velocity reducer above the inlet aperture, and a flow straightener above the velocity reducer and below the first tissue mount.
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33. An apparatus for treating at least partially fixed biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
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a container suitable for containing tissue treatment fluid;
means for causing treatment fluid movement within the container including a stirrer immersed in the treatment fluid;
means for heating the treatment fluid; and
means for restraining the immersed tissue from gross movement within the container. - View Dependent Claims (34, 35)
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36. An apparatus for treating at least partially fixed biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, comprising:
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a flow container suitable for containing tissue treatment fluid;
a system for flowing treatment fluid through the flow container, wherein the flow container has a cross-section oriented substantially normal to the direction of flow of the treatment fluid;
means for restraining the tissue from gross movement within the flow container comprising a mount for mounting the tissue in a planar configuration substantially parallel to the direction of flow of the treatment fluid;
a baffle positioned upstream of the mount which creates a substantially uniform downstream flow profile over the container cross-section in the region of the mount; and
means for heating fluid. - View Dependent Claims (37)
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38. A method for treating biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, the method comprising:
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fixing the tissue in a fixative solution; and
prior to implantation, heat treating the fixed tissue in a glutaraldehyde solution at a temperature in the range of 45-55°
C. for a period of time. - View Dependent Claims (39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49)
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50. A method for treating biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, the method comprising:
fixing the tissue in a glutaraldehyde solution while heating the glutaraldehyde solution to a temperature in the range of about 50°
C.±
1°
C. for a period of time.- View Dependent Claims (51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61)
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62. A method for treating biological tissue to inhibit calcification of the tissue following implantation in a mammalian body, the method comprising:
prior to fixing the tissue, heat treating the tissue in a saline solution only to a temperature of about 50°
C.±
1°
C. for a period of time.- View Dependent Claims (63, 64, 65, 66, 67, 68, 69, 70, 71, 72)
Specification