Controlled release infusion system

• US 4,534,758 A
• Filed: 07/15/1983
• Issued: 08/13/1985
• Est. Priority Date: 07/15/1983
• Status: Expired due to Fees

• Current Assignee: Eli Lilly and Company
• Original Assignee: Eli Lilly and Company
• Inventors: Sperry, Charles R., Harris, Dale C., Hargrove, William W., Akers, Michael J.
• Primary Examiner(s): Yasko, John D.
• Assistant Examiner(s): Lester, Michelle
• Application Number:
  US06/514,268
• Time in Patent Office: 760 Days
• Field of Search: 604/30-33, 604/56, 604/80-85, 604/122, 604/245-249, 604/405, 604/411, 604/414, 137/38, 137/512, 137/588, 141/21, 141/302, 141/306, 141/319, 141/320
• US Class Current: 604/85
• CPC Class Codes: A61M 39/223 Multiway valves
• CPC Class Codes: A61M 5/1409 in series, e.g. first substance passing through container holding second substance, e.g. reconstitution systems needle sets A61M5/162
• CPC Class Codes: A61M 5/162 Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14

Abstract

Valved adaptors are disclosed permitting the introduction of a drug-containing vial in the delivery tube of an I.V. administration set. The adaptors have a three position operation characterized by a bypass mode, a dilution mode, and a delivery mode, the adaptors being manually changed from mode to mode. The disclosed adaptors include gravity operated valves, reciprocating spool valves, and rotating spool valves, each including a spike to penetrate the stopper of a vial and a vent to permit air to escape the vial as liquid is introduced to dilute the vial contents.

Claims

1. Apparatus for connecting a vial in the delivery tube of an intravenous administration set, the set including a source of fluid connected to one end of the delivery tube, the other end of which is adapted to be inserted in a patient, the apparatus comprising:

a valve having three operating positions and including bypass means operable in the first operating position for conducting fluid from the fluid source toward the patient, dilution means operable in the second operating position for admitting fluid from the source to the vial while permitting air to escape from the vial, and delivery means operable in the third operating position for directing the fluid from the source to pass through the vial and dilute the contents thereof while directing fluid leaving the vial to proceed through the delivery tube toward the patient.

2. The apparatus of claim 1 further comprising a reciprocating spool contained within the valve and axially slideable with respect thereto to provide said bypass, dilution, and delivery functions.

3. The apparatus of claim 1 further comprising a rotating spool within the valve pivotable with respect thereto to provide said bypass, dilution, and delivery functions.

4. The apparatus of claim 1 in which the valve provides a plurality of fixed chambers and means within the chambers responsive to gravity and movement of the valve to provide said bypass, dilution, and delivery functions.

5. The apparatus of claim 1 further comprising flexible conduit means situated between the valve and the source of fluid for permitting agitation of the vial after the admission of an initial preselected amount of fluid from the source.

6. In an intravenous administration set comprising a container containing a fluid, a delivery tube connected to the container for dispensing fluid therefrom, means for connecting the delivery tube to a patient, a drip chamber situated in the delivery tube for permitting the determination of the administration rate of the fluid, and control means for controlling the administration rate of the fluid, the improvement comprising:

a valved adaptor for connecting a vial to the delivery tube to permit administration of the contents of the vial to the patient, the valved adaptor comprising a body, and means within the body operable between a first, second, and third position, said first position enabling the delivery of the container fluid to the patient so that the container fluid bypasses the vial, said second position enabling the dilution of the contents of the vial with said fluid, and said third position enabling the delivery of the diluted contents of the vial.

7. The valve adaptor of claim 6 wherein the vial is closed by means of a seal and the valve adapter further comprises penetration means for penetrating the seal of a vial, the penetration means including at least a pair of openings providing an entry into and an exit from the vial.

8. The valved adaptor of claim 6 further comprising first means for manually actuating the adaptor to said second position and second means for manually actuating the adaptor to said third position.

9. The valve adaptor of claim 8 wherein said second means for manually actuating the adaptor to said third position comprises means within the actuator responsive to gravity for automatically effecting the change to said third position in response to a change in the attitude of the valve body.

10. A system for the sterile administration of medicine comprising:

a source of liquid, means to inject the liquid into a patient, means forming a passageway between the source of liquid and the injection means, control means for controlling the administration rate of the liquid to the patient, indicating means for indicating the delivery rate of liquid to the patient, and valve means for introducing the contents of a vial serially in the passageway between the source of liquid and the injection means, the valve means having three operating positions and including bypass means operable in the first operating position for conducting liquid from the liquid source toward the patient, dilution means operable in the second operating position for diluting the contents of the vial with liquid from said source, and delivery means operable in the third operating position for deliverying the diluted contents of the vial to the passageway.

11. For use with an I.V. administration set comprising a liquid source, means for injecting the liquid into a patient, and means forming a passageway from the source to the injection means, a valved adaptor for connecting a vial to the passageway, said valved adaptor having three operating positions including a first position providing bypass means for conducting liquid from the liquid source toward the patient, a manually actuable second position providing dilution means for admitting liquid from the source to the vial to dilute the contents thereof and for permitting air to escape from the vial while the admitting occurs, and an automatically actuable third position providing delivery means for directing the liquid from the source through the vial and on to the patient in response to a change in the attitude of the valved adaptor accomplished by manual movement of the valved adaptor.