Method and apparatus for manufacturing wound tube bundles

Winding – tensioning – or guiding – Composite article winding – On externally toothed core

Reexamination Certificate

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Details

C156S172000, C210S321800, C242S437300

Reexamination Certificate

active

06273355

ABSTRACT:

FIELD OF THE INVENTION
The invention relates to a method and apparatus for manufacturing wound tube bundles. More particularly, the invention is directed to the manufacture of a tube bundle for a blood cardioplegia delivery device.
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 guide deposits the tube 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 an apparatus for manufacturing a wound tube bundle for use in medical device applications. The apparatus includes a tube, a tube shuttle, a winding core, a shuttle driver, and a core driver. The tube shuttle is shaped to receive and distribute the tube around the winding core. 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 the second winding disk is attached to a second end of the body. The first winding disk and the second winding disk are shaped to accept tube from the tube shuttle. The shuttle driver and core driver are configured to rotate the shuttle and the winding core to distribute the tube on the winding core in layers. Each layer has a plurality of rows wound onto and distributed around the core. Each row is substantially parallel to the other rows and is also substantially parallel to the longitudinal axis of the core. The shuttle driver rotates the tube shuttle about a shuttle axis in a circular winding motion to wind tube onto the core. The core driver incrementally rotates the winding core about a longitudinal axis of the core, the longitudinal axis being substantially perpendicular to and substantially intersecting the shuttle axis. The core driver can be configured to incrementally rotate the winding core one increment after each full rotation of the tube shuttle around the winding core. The apparatus can also include a computer control to control the tube shuttle and winding core. The computer control is preferably configured to regulate at least one of the rate, degree and timing of the rotation.
The apparatus can also include a tube bobbin for holding a length of the tube and for dispensing the tube to the tube shuttle. The bobbin can be connected to a bobbin driver. The bobbin driver incrementally rotates the tube bobbin. The bobbin driver can be connected to a computer control. The computer control regulates the rotation of the bobbin. Preferably, the computer control regulates at least one of the rate, degree and timing.
The apparatus can also include a means for providing a constant tension to the tube as the tube is unwound from the bobbin.
The winding disks can also have a plurality of fins extending radially from a peripheral edge of the first and second winding disks. The plurality of fins define a plurality of primary notches. The primary notches are configured to accept tube and hold the tube in position as it is wound onto the winding core. The plurality of fins can also define a plurality of secondary notches. The secondary notches are shaped to receive tube from the tube shuttle. The primary and secondary notches each have a length measured from the fin's peripheral edge towards the central axis. The length of the primary notches is greater than the length of the secondary notches. The plurality of fins can also define a plurality of tertiary notches shaped to receive tube from the tube shuttle. The length of the tertiary notches being less than the length of the primary and secondary notches.
The winding core can also have cutting pads to better facilitate winding and cutting. The cutting pads are positioned such that a first cutting pad is attached opposite the body on the first winding disk and a second cutting pad is attached opposite the body on the second winding disk.
In a second aspect, the invention is an apparatus for manufacturing a wound tube bundle for use in medical device applications. The apparatus includes a tube and a tube shuttle, as described above, and a winding core. 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 define a plurality of primary notches shaped to receive tube from the tube shuttle. The fins can further define a plurality of secondary notches shaped to receive tube from the tube shuttle. The primary and secondary notches each have a length as measured from the peripheral edge towards the central axis. The length of the primary notches is greater than the length of the secondary notches. The fins can still further 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 third aspect, the invention is an apparatus for manufacturing a wound tube bundle. The apparatus includes a tube and a tube shuttle, as described above, and a winding core. The winding core has a body with 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 the second winding disks are shaped to accept tube from the tube shuttle and have a

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