Additive transfer device

United States Patent m

Genese

[ii] 4,161,178 [45] Jul. 17,1979

[54] ADDITIVE TRANSFER DEVICE

[75] Inventor: Joseph N. Genese, Waukegan, 111.

[73] Assignee: Abbott Laboratories, North Chicago, 111.

[21] Appl. No.: 858,493
[22] Filed: Dec. 8,1977

[51] Int. C1.2 A61J 1/00

[52] U.S. CI 128/272.3; 141/329

[58] Field of Search 128/272.3, 272, 218 M,

128/218 R, 232; 141/329

[56] References Cited

U.S. PATENT DOCUMENTS

3,158,155 11/1964 Myerson et al 128/272 X

3,788,369 1/1974 Killinger 128/272.3 X

3,826,260 7/1974 Killinger 128/272

3,844,284 10/1974 Schoenfeld et al 128/232

3,872,867 3/1975 Killinger 128/272 X

3,987,791 10/1976 Chittenden et al 128/272.3

4,059,112 11/1977 Tischlinger 128/272.3

FOREIGN PATENT DOCUMENTS 1456517 11/1976 United Kingdom 128/272.3

Primary Examiner—Robert E. Bagwill

Attorney, Agent, or Firm—Robert L. Niblack; Neil E.

Hamilton

[57] ABSTRACT

An additive transfer device for storing and transferring of a medicament to a solution container such as an I. V. bag having an exposed port. The transfer device is accommodated in the neck of an additive container having a pierceable sealing element. A holder member for a doubled pointed end piercing member engages a cap covering the tubular neck and affords a movement of the piercing member toward the sealing element to pierce it. Guide means extend from the holder member and fit over the tubular port of the I.V. bag. When the opposing pointed end of the piercing element is pierced through the I.V. port, communication can be made between the additive container and the I.V. bag. In a preferred manner, the contents of the additive container are expelled by collapsing the walls which force the medicament into the I.V. bag by means of the piercing element.

14 Claims, 5 Drawing Figures

ADDITIVE TRANSFER DEVICE
BACKGROUND OF THE INVENTION

This invention relates to a device for storing and 5 transferring a medicament to a flexible container such as an I.V. bag. More particularly, the invention relates to an additive transfer device wherein a holder member for a piercing member is orientated and carried into a cap of an additive container of the collapsible type to iO afford a piercing through a sealing element held between the cap and the container neck.

Additive transfer units of the type concerned with in this invention are described in U.S. Pat. Nos. 3,033,202; 3,788,369; 3,826,260; 3,828,779; 3,938,520 as well as 15 3,987,791. Many of the units described in these patents, for example in Nos. 3,033,202; 3,938,520 and 3,987,791, are not specifically directed to a device for making an addition to a flexible I.V. bag. In the instance of U.S. Pat. Nos. 3,788,369 and 3,838,779 which are so directed, 20 a specially designed closure for a vial or a large, multicomponent device is indicated as well as in U.S. Pat. No. 3,826,260. The prior art nowhere provides a simplified and compact transfer unit for making additions to an I.V. flexible container. In particular, the prior art 25 does not provide a simplified additive device for use with an I.V. bag wherein a container cap serves as a means to secure a pierceable diaphragm in the neck of an additive container and also afford alignment and movement of a hollow piercing member to cause the 30 piercing member to pierce through the diaphragm seal in the neck of a container and afford communication between the additive container and the I.V. bag. The opposing end of the piercing cannula is then inserted through the bag port and the contents of the container 35 expelled by collapsing the container wall.

It is an advantage of the present invention to afford a novel additive transfer device which is specifically adapted for use with a flexible I.V. container. Other advantages are an additive transfer unit which can be 40 employed with a small volume, collapsible container; utilizes a minimum number of parts and a minimum number of interfitting components; can be activated in a fast manner while having one of the components serve multiple functions. 45

SUMMARY OF THE INVENTION

The foregoing advantages are accomplished and the shortcomings of the prior art are overcome by the present additive transfer unit which is employed with an 50 additive container having a flexible wall. A pierceable diaphragm seals an opening in the neck of the container and is preferably retained therein by means of a cap for the container. A holder member is integrally fixed to a piercing member and carries the piercing member 55 toward the pierceable diaphragm. Guide means extend from the holder member for surrounding an exposed, pierceable closure of an I.V. flexible bag. Activating means is preferably provided by a threaded engagement of the holder member in the container cap so that upon 60 movement of the holder toward the cap, one end of the piercing member will pierce through the diaphragm seal in the container neck. A cover extending over the holder and enclosing the guide means will be removed and the end of the piercing member adjacent the guide 65 means will be inserted through the bag port. The contents of the additive container can then be forced into the bag by collapsing the wall or walls of the additive

2

container. In a preferred manner, the pierceable diaphragm is in the form of a disc member held captive by the container cap at the end of the neck and the cap is internally threaded to receive the external threads of the holder which are in the form of a projecting stem for engaging the container cap.

BRIEF DESCRIPTION OF DRAWING

A better understanding of the additive transfer unit of this invention will be afforded by reference to the drawing wherein:

FIG. 1 is a perspective view of the additive transfer device and an I.V. flexible bag with the transfer unit orientated with the additive port of the bag.

FIG. 2 is an assembly view of the additive transfer unit with the cover member offset from the additive container.

FIG. 3 is a view in side elevation of the additive transfer device with a portion broken away to show the piercing member in the inactivated position.

FIG. 4 is a view similar to FIG. 3 showing the additive transfer unit of this invention with the piercing element penetrating through the diaphragm of the additive container.

FIG. 5 is a view similar to FIG. 4 except with the cover removed, a portion of the container broken away to show the additive fluid and with the container shown in phantom lines in a completely collapsed condition.

DESCRIPTION OF THE EMBODIMENT

Proceeding to a detailed description of one embodiment of the invention, the additive transfer unit 10, as shown in FIG. 1, is illustrated in orientation with a solution container in the form of an I.V. bag 11. Bag 11 is of the type described in U:S. Pat. No. 3,915,212 entitled "Flexible Medicinal Fluid Container Having a Combined Fill Adrninistration Port and Reinforced Hanger" and is commonly assigned. It has the usual protruding additive port 14 in the form of a pierceable closure and an administration port 12. Transfer device 10 includes an additive container 15 of the kind described in U.S. Pat. No. 3,844,284 entitled "Disposable Douche" except that in place of the nozzle, a holder member 25 with a guide 35 is provided to surround the pierceable closure 14 on I.V. bag 11. Container 15 is of the collapsible type and includes a series of collapsible walls such as 16 and 17.

As best seen in FIGS. 2 and 3, additive container 15 has a threaded neck 18 with a pierceable diaphragm 23 seated over the end thereof and held thereon by means of internally threaded cap 38.

Piercing member 26 is integrally secured to holder member 25 by means of externally threaded stem 39. Piercing member 26 has opposing piercing points 30 and 31 and is hollow to provide a channel 28 for the passage of flowable medicament therethrough. A centrally positioned passage 40 is provided in cap 38 and is internally threaded to receive threaded stem 39 which is of a smaller transverse dimension than guide 35. A cover 36 is placed over guide 35 and encloses piercing point 30 extending from guide 35. Guide 35 is a hollow cylindrical portion which is dimensioned to fit loosely around the circular, pierceable closure 14 of bag 11.

Referring to FIG. 5, it will be noted that container 15 holds a fluid medicament agent 46 which in this instance is a liquid. In order to expel agent 46, container walls 16 and 17 will collapse upon themselves to result in a configuration as shown in phantom lines.