Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2002-03-04
2004-02-03
Kennedy, Sharon (Department: 3762)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S534000
Reexamination Certificate
active
06685674
ABSTRACT:
SUMMARY OF THE INVENTION
In various embodiments, the present invention provides an infusion hub assembly, comprising: a wing having a hole passing therethrough; a hub received in the hole in the wing, the hub having a bore passing therethrough, with an upper portion of the circular hub having an attachment surface thereon; an infusion cannula extending downwardly away from the wing, the infusion cannula being in fluid communication with the bore passing through the hub; a cover having a bore passing therethrough with an inner attachment surface adapted to mate with the attachment surface on the upper portion of the hub; and a septum positioned in alignment with the bore passing through the cover.
In various embodiments, the upper portion of the hub is circular and has an attachment surface extending circumferentially therearound. In various embodiments, this attachment surface comprises a lip extending circumferentially therearound.
The present infusion hub assembly comprises a cover having a bore through which an insertion needle is positioned when initially positioning the wing of the assembly on a patient's skin with the infusion cannula extending subcutaneously. In various embodiments, the cover holds a septum therein to advantageously seal the pathway into the patient (when the insertion needle is not piercing therethrough).
In various embodiments, the cover is dimensioned to be snap-fit over the infusion hub. In various embodiments, the cover has a central bore through which the insertion needle passes when the assembly is positioned subcutaneously.
Thereafter, the novel rotatable infusion housing is attached onto the top of the cover. In various embodiments, the rotatable housing has an attachment surface adapted to mate with an outer attachment surface on the upper portion of the cover. Thus, in various embodiments, the rotatable housing is also dimensioned to be snap-fit over the cover, which is in turn snap-fit over the infusion hub.
In various aspects, the attachment surface on both the cover and the rotatable housing comprises a recess extending circumferentially therearound. These recesses mate with lips extending from an upper portion of the infusion hub and the cover, respectively. In various aspects, the infusion hub and the rotatable housing are circular such that the rotatable housing can turn freely, while still providing continuous infusion of medication (or other desired fluid substances) subcutaneously into the patient.
In various embodiments, the rotatable housing comprises a curved needle passing at least partially through a radial bore in the rotatable housing, wherein a first end of the curved needle is positioned to extend downwardly into the bores in the cover and the hub when the rotatable housing is attached to the cover. Additionally, an infusion tube is received into the radial bore of the rotatable housing in fluid communication with the curved needle.
Advantages of having a rotatable infusion housing which can turn freely, while still providing continuous infusion subcutaneously into the patient include: (i) avoiding kinks in the infusion tube, and (ii) avoiding having to tape the infusion housing to the patient, thus (iii) permitting the patient to position an infusion pump (which feeds fluid into the infusion tube) at different locations one the patient's body.
In another aspect of the invention, the present invention provides an infusion connector set comprising: a proximal connector; a septum received in the proximal connector; a distal connector; a septum received in the distal connector; and a flanged needle which penetrates both the septums in the proximal and distal connectors when the proximal and distal connectors are connected together.
It is to be understood, however, that reference made herein to a “proximal” and “distal” connector is only exemplary. Thus, the flanged needle may instead move to various positions within the distal connector rather than within the proximal connector. Accordingly, the present invention refers to a “first” and a “second” connector. In various embodiments, the “first” connector is the “proximal” connector and the “second” connector is the “distal” connector. In alternate embodiments, the connectors are reversed such that the “first” connector is the “distal” connector and the “second” connector is the “proximal” connector.
In various embodiments, the flanged needle is slidably movable within a slot in the distal connector. In various aspects, the flanged needle may be moved to a position at which the needle does not penetrate the proximal septum in the proximal connector, yet is still held within the proximal connector.
Thus, when the proximal and distal connectors are fastened together, the needle provides a fluid path therethrough. When the distal connectors is uncoupled from the proximal connector, the septum in the distal connector will seal (since the flanged needle is held within the proximal connector, and thus is no longer in contact with the septum in the distal connector).
In various embodiments, the flange of the flanged needle protrudes through the slot in the distal connector such that an operator may grab onto the flange and move the flanged needle along in the slot in the distal connector. Thus, the flanged needle may conveniently be moved to a position in which the needle no longer penetrates the septum in the proximal connector. Thus, the septum in the proximal connector will seal itself, preventing contamination or exposure to the substance being delivered through the infusion tubing.
An advantage of having the proximal and distal connector easily disconnectable from one another (with their respective septums sealing the fluid path through both connectors) is that it facilitates switching between different infusion lines.
A further advantage of providing the distal connector with its own septum is that a patient can manually disconnect the proximal and distal connectors and then inject a syringe (containing an alternate medication or substance) through the septum in the distal connector, and into the patient.
In various embodiments, the infusion connector set further comprises a retainer mounted at the distal end of the proximal connector. In various embodiments, this retainer closes the distal end of the slot in the proximal connector, such that movement of the flanged needle is retained to back and forth movement within the proximal connector.
In various embodiments, the proximal and distal connectors are dimensioned such that one connector may be inserted into the other, and then rotated into an interlocked position. This may be achieved by providing one of the connectors with at least one tab extending therefrom, and the other of the connectors with at least one recess therein. The at least one recess is dimensioned to receive the at least one tab therein when the proximal and distal connectors are connected together. In various embodiments, the connector comprising the at least one tab is the proximal connector, and the connector comprising the at least one slot is the distal connector.
Still other features and advantages of the present invention will become apparent to those skilled in the art from a reading of the following detailed description of embodiments constructed in accordance therewith, taken in conjunction with the accompanying drawings.
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Douglas Joel S.
Hugo Robert L.
Zhang Cynthia
Burns Doane Swecker & Mathis L.L.P.
Kennedy Sharon
Sterling Medivations, Inc.
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