Chemical apparatus and process disinfecting – deodorizing – preser – Blood treating device for transfusible blood
Reexamination Certificate
1999-05-06
2001-07-10
Sykes, Angela D. (Department: 3762)
Chemical apparatus and process disinfecting, deodorizing, preser
Blood treating device for transfusible blood
C422S048000, C604S006090, C604S006140, C210S500230, C210S500360, C096S010000
Reexamination Certificate
active
06258321
ABSTRACT:
FIELD OF THE INVENTION
The invention relates to a cardioplegia delivery device and method of its use to deliver either warm or cold cardioplegia fluids to the heart. More particularly, the invention is directed to an apparatus and method of using a cardioplegia delivery device having a wound fiber bundle.
BACKGROUND OF THE INVENTION
The use of hollow fiber bundles as mass transfer devices and energy transfer devices in the field of medical technology is well-known. For example, wound hollow fiber bundles have been used as blood oxygenators and dialyzers. The typical winding pattern for hollow fiber bundles can be described as a helical wind, where the tubes are wrapped around a rotating cylinder. One such winding technique is described in U.S. Pat. No. 4,975,247 by Badolato et al., which describes the means by which to wind a hollow fiber oxygenator with specialized winding equipment. Badolato et al. describes winding a single fiber or fiber ribbon onto a rotating core using a fiber guide which reciprocates along a line parallel to the axis of the core. The fiber is deposited spirally around the core as the fiber guide reciprocates and the core rotates.
Typical winding techniques such as that described in the Badolato patent are limited to large, for example, 2.0 inch diameter cores. If the core is smaller, the fiber will slide off of the core as the tubing is wound. If the core has a 2.0 inch or larger diameter, contact surface friction will maintain the fiber in place as the fiber is wound. Unfortunately, the relatively large diameter results in a larger priming volume which is undesirable for most medical applications. The increased priming volume results in increased levels of hemodilution which can be deleterious to the patient. In certain instances, the increased priming volume can prohibit the use of the device on smaller adults and children.
Alternatively, hollow fiber bundles may be wound with fiber mats which are not subject to the winding problems of fibers or fiber ribbons, discussed above. Specifically, neither core diameter nor the specific angle at which fibers must be wound around the core to maintain the fiber's position relative to the central axis of the core are factors when using woven fiber mats. As a matter of fact, when a fiber bundle is made using a fiber mat the bundle can be formed around a core with a relatively small diameter and the fibers can be substantially parallel to the axis of the core. However, fiber mats are expensive because of the additional complexities of the weaving process. Further, weaving typically precludes the direct cost control over the manufacturing process that exists when a bundle is wound from a single fiber or fiber ribbon. Therefore, it would be desirable to have a winding technique and apparatus which combines low cost, low prime volume and direct control over production without the disadvantages associated with present winding techniques or wound fiber mat device designs.
SUMMARY OF THE INVENTION
In one aspect, the invention is a transfer device. The transfer device includes a wound tube bundle, a housing, a potting material, a first fluid inlet, a first fluid outlet, a second fluid inlet and a second fluid outlet.
The wound tube bundle includes a plurality of tubes. Each of the tubes has an outer surface and a lumen. The plurality of tubes is derived from a tube being wound around a winding core and then cut to divide the original tube into a plurality of tubes. The tubes can be a microporous membrane hollow fiber. Suitable materials for the tubes may include cuprammonium rayon, viscose rayon, cellulose acetate, polyvinyl alcohol, ethylene vinyl alcohol, polysulfone, polypropylene or polymethyl-methacrylate. The winding core has a body, a first winding disk and a second winding disk. The first winding disk is attached to a first end of the body and a second winding disk is attached to a second end of the body. The winding core may also have a first cutting pad attached to the first winding disk and a second cutting pad secured to the second winding disk. The first and second winding disks have a peripheral edge and a central axis that substantially coincide with a longitudinal axis of the winding core. A plurality of fins extend from the peripheral edge of the winding disks towards the central axis. The fins define a plurality of primary notches which secure the plurality of tubes. The housing surrounds the wound tube bundle and has a first end and a second end. The potting material is disposed at the first and second ends of the housing. The potting material seals the first and second ends of the wound tube bundle to the housing. The potting material, the outer surface of the tubes and the housing cooperate to form a first fluid chamber. A first fluid inlet and first fluid outlet communicate with the first fluid chamber. A second fluid inlet communicates with the lumen of the plurality of tubes at the first end of the housing. A second fluid outlet communicating with the lumen of the plurality of tubes at the second end of the housing.
The fins can also define a plurality of secondary notches shaped to receive tube from the tube shuttle. The primary and secondary notches each having a length measured from the peripheral edge towards the central axis. The length of the primary notches being greater than the length of the secondary notches. The fins can also define a plurality of tertiary notches shaped to receive tube from the tube shuttle. The tertiary notches also have a length as measured from the peripheral edge towards the central axis. The length of the tertiary notches is less than the length of the secondary notches.
In a second aspect, the invention is a transfer device. The transfer device includes a wound tube bundle, a housing, a potting material, a first fluid inlet, a first fluid outlet, a second fluid inlet, and a second fluid outlet.
The wound tube bundle has a plurality of tubes, as described above. The winding core has a body, a first winding disk and a second winding disk. The first winding disk is attached to the first end of the body and the second winding disk is attached to the second end of the body. The winding core can also include a first cutting pad secured to the first winding disk and a second cutting pad secured to the second winding disk. The first and second winding disks have a diameter greater than a diameter of the body. Winding tube onto the winding core forms a space between the diameter of the body and the diameter of the first and second winding disks. The housing, potting material, first fluid inlet, first fluid, second fluid inlet and second fluid outlet are as described above.
In a third aspect, the invention is a method for manufacturing a transfer device. The method includes providing a winding core, winding a tube from end to end around the winding core, fitting the wound bundle into a housing, sealing the first and second ends of the housing using a potting material, cutting the ends of the bundle to expose a lumen within the tubes, and attaching a first end cap and a second end cap.
The winding core has a body, a first winding disk attached to a first end of the body and a second winding disk attached to a second end of the body. The first and second winding disks have a peripheral edge and a central axis that substantially coincides with a longitudinal axis of the winding core. The first and second winding disks further have a plurality of fins extending from the peripheral edge towards the central axis, the fins defining a plurality of primary notches shaped to receive tube. The housing is shaped to accept the tube bundle. The housing has a first end, a second end, a first fluid inlet and a first fluid outlet. The potting material is disposed at the first and second ends of the housing such that the potting material, the outer surface of the tubes and the housing form a first fluid chamber. The first fluid inlet and the first fluid outlet communicate with the first fluid chamber. The first end cap having a second fluid inlet attached to the first end of the housi
Joseph Russell
Van Driel Michael R.
Bianco Patricia
Dideco S.P.A.
Popovich & Wiles, P.A.
Sykes Angela D.
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