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Method of manufacturing a blood oxygenation system

  • US 5,753,173 A
  • Filed: 10/02/1996
  • Issued: 05/19/1998
  • Est. Priority Date: 10/25/1993
  • Status: Expired due to Fees
First Claim
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1. A method of forming an integral blood oxygenating and heat exchanging apparatus, the method comprising the following steps:

  • (a) providing a separation medium for separating blood and gas while allowing oxygen and carbon dioxide transfer across the separation medium, the separation medium having opposite ends;

    (b) providing a heat exchanging barrier for keeping blood and heat exchanging fluid separate while allowing heat transfer therebetween and across the heat exchanging barrier, the heat exchanging barrier having opposite ends;

    (c) thermal forming at least one sheet of thermoplastic material to form a housing for receiving the separation medium and the heat exchanging barrier with the opposite ends of the separation medium and the heat exchanging barrier generally adjacent and generally aligned, the step of thermal forming at least one sheet of thermoplastic material including;

    (I) forming potting channels in the at least one sheet of thermoplastic material for directing uncured potting compound adjacent the opposite ends of the separation medium and the heat exchanging barrier; and

    (ii) forming at least one overflow reservoir having a depth-defining inlet positioned in fluid communication with a corresponding one of said potting channels to define a depth of the potting compound adjacent the opposite ends of the separation medium and the heat exchanging barrier;

    (d) placing the separation medium and the heat exchanging barrier between the at least one sheet in side-by-side relationship;

    (e) sealing at least one sheet together to form an assembly comprising the housing, the separation medium and the heat exchanging barrier;

    (f) placing the assembly in a centrifuge;

    (g) spinning the assembly in the centrifuge around a substantially vertical axis of rotation with the opposite ends of the separation medium and the heat exchanging barrier along opposite sides of the axis of rotation;

    (h) inserting a sufficient volume of uncured potting compound into each of said potting channels while the assembly is spinning in the centrifuge so that some of the uncured potting compound flows from each of said potting channels into and along overflow reservoir inlets extending radially inward toward said axis of rotation, said uncured potting compound flowing from each of said overflow reservoir inlets into a corresponding one of said at least one overflow reservoir such that the depth of the uncured potting compound adjacent the opposite ends of the separation medium and the heat exchanging barrier forms a parabolic curve defined by the depth-defining inlets;

    (I) allowing the uncured potting compound to solidify and cure while continuing said spinning of the assembly in the centrifuge to form a solidified potting compound; and

    (j) cutting the at least one sheet of thermoplastic material and the solidified potting compound to expose the opposite ends of the separation medium and the heat exchanging barrier;

    the steps of providing the separation medium and the heat exchanging barrier include positioning the opposite ends of the separation medium and the heat exchanging barrier so that the opposite ends of the separation medium and the heat exchanging barrier will be at a sufficiently equal depth within the potting compound relative to the parabolic curve.

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