CA1204731A - System for mixing and delivering medical liquids to the charge of a hypodermic needle - Google Patents

System for mixing and delivering medical liquids to the charge of a hypodermic needle

Info

Publication number
CA1204731A
CA1204731A CA000420479A CA420479A CA1204731A CA 1204731 A CA1204731 A CA 1204731A CA 000420479 A CA000420479 A CA 000420479A CA 420479 A CA420479 A CA 420479A CA 1204731 A CA1204731 A CA 1204731A
Authority
CA
Canada
Prior art keywords
ampule
port
way valve
closure
mixture
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired
Application number
CA000420479A
Other languages
French (fr)
Inventor
Goran Sjonell
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Application granted granted Critical
Publication of CA1204731A publication Critical patent/CA1204731A/en
Expired legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F33/00—Other mixers; Mixing plants; Combinations of mixers
    • B01F33/50—Movable or transportable mixing devices or plants
    • B01F33/501—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use
    • B01F33/5011—Movable mixing devices, i.e. readily shifted or displaced from one place to another, e.g. portable during use portable during use, e.g. hand-held
    • B01F33/50111—Small portable bottles, flasks, vials, e.g. with means for mixing ingredients or for homogenizing their content, e.g. by hand shaking
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/712—Feed mechanisms for feeding fluids
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/7176—Feed mechanisms characterised by the means for feeding the components to the mixer using pumps
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/718—Feed mechanisms characterised by the means for feeding the components to the mixer using vacuum, under pressure in a closed receptacle or circuit system
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/71805—Feed mechanisms characterised by the means for feeding the components to the mixer using valves, gates, orifices or openings
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/71—Feed mechanisms
    • B01F35/717—Feed mechanisms characterised by the means for feeding the components to the mixer
    • B01F35/71805—Feed mechanisms characterised by the means for feeding the components to the mixer using valves, gates, orifices or openings
    • B01F35/718051—Feed mechanisms characterised by the means for feeding the components to the mixer using valves, gates, orifices or openings being adjustable
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01F—MIXING, e.g. DISSOLVING, EMULSIFYING OR DISPERSING
    • B01F35/00—Accessories for mixers; Auxiliary operations or auxiliary devices; Parts or details of general application
    • B01F35/75—Discharge mechanisms
    • B01F35/754—Discharge mechanisms characterised by the means for discharging the components from the mixer
    • B01F35/75465—Discharge mechanisms characterised by the means for discharging the components from the mixer using suction, vacuum, e.g. with a pipette
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends

Abstract

ABSTRACT OF THE DISCLOSURE

The invention refers to a method of mixing, for example, cytostatica stored in an ampule provided with a rubber closure or corresponding closure, with, for example, sterile water stored in a second ampule provided with a closure. A first tube of hypodermic needle shape, which is connected by a hose connection to a first port of a multi-way valve, is pierced through the closure of one ampule and a second tube of hypodermic needle shape, which is connected by a hose connection to a second port of the multi-way valve, is pierced through the closure of the second ampule. The interior of the ampules is interconnected by a hose connection, the two respective ends of which have the shape of hypodermic needles and are pierced each through one closure. A pump means in the form of a self-expanding bellows or hypodermic syringe is connected to a third port of the multi-way valve. By said pump means and alternating adjustment of the multi-way valve, the substance in one ampule is transferred to the second ampule, in which the two substances are mixed with each other, and the mixture is sucked into the pump means.

Description

~Z~3~

Method of mixing one substance with another substance This invention relates to a method of mixing one substance, for example cytostatica, with another substance, for example sterile water. These substances, which are used in medical care, are transported and stored in ampules, which are seal-ingly closed with a rubber cover or membrane.

Cytostatica are used in medical care for the treatment of patients suffering from cancer, either by intravenous injection or from a drop bottle. Cytostatica are delivered in powder state in an ampule of the aforesaid kind and must be mixed, prior to their administration, with a liquid, for example sterile water, alcohol, physical saline solution or some other solution. The liquid, too, is delivered in an ampule of the kind referred to above. At present, the two substances are intermixed in such a manner, that the liquid by means of the hypodermic syringe to be used for the injection is sucked from the ampule up into the syringe and is delivered to the dry ampule, viz. the ampule containing the cytostatica. In this ampule the cytostatica content is mixed with liquid to the desired concentration, and the mixture thereafter is sucked into the syringe. Prior to the injection,the syringe is emptied of air possibly included therein. This emptying normally is carried out in the established manner by holding the syringe in vertical position, with the hypodermic needle pointing upward, and pressing the plunger inward until liquid can be observed in the needle point.

It is easily understood that the afore-described method of intermixing the two substances implies great risks of spillage ,. . .

'73~

in the form of droplets and splash as well as of contamination of the surrounding air, due to the outflow of gas from the ampules.

Cykostatica a.o. have proved toxic and to negatively affect healthy persons. The personnel handling this substance are exposed to great risks of inhaling such cancerogenous subst-ances or by direct contact to be infected with them. In order to reduce this risk, anl also the risk involved with the handling of other toxic substances, claims have been raised that the preparatory handling of the substances and the filling, for example of hypodermic syringes, shall take place in evaporation hoods.

The present invention has the object to eliminate the ris~s of contaminating the surrounding and infecting the personnel, who handle these substances when ~hey are mixing ~oxic subst-ances e.g. of the aforesaid type for their subsequent use, for example injection.

The invention is described in greater detail in the following, by way of an embodiment thereof and with reference to the accompanying drawings, in which Fig. 1 in a very schematic manner shows the equipment accord-ing to the invention for carrying out the method, Fig. 2 also in a very schematic manner shows the same equip-ment, but with the ampules seen in a lateral view, and ~ig. 3 shows a slightly different equipment.

Fig. 1 shows two ampules 1 and 2 whereof one, for example 13 contains cytostatica, and the second ampule contains sterile water. These ampules are positioned by press fit in depress-ions provided~ for example, in a frigolite plate and are fixed therein. On this frigolite plate 3 also a multi-way valve 4 is attached, for example by press fit, in a depression in the plate, or it is secured therein by glueing.

., ~Z0~73 The multi-way valve 4 comprises ~our ports whereof a first one 5 is connected by a hose 6 to a hypodermic needle 7, which is pierced down into the ampule 1 through a rubber closure ô sealing the ampule 1 hermetically. A second port 9 is connected ~ia a hose 10 to the second ampule 2, in that a hypo-dermic needle 11 attache~ to the other end of the hose 10 is pierced down, in the same manner as the needle 7, into the ampule 2 through a rubber closure 12 sealing hermetically said ampule 2. A hose 1~, which is provided at each end with a needle 14 and, respectively, 15 similar to a hypodermic needle, interconnects the interior of the two ampules, in that the needles 14 and 15 are pierced through the rubber closures 8 andg respectively, 12. The multi-way valve 4 further comprises a third port 10, into uhich the opening of a hypodermic syringe 17 can be sealingly introduced.

The method of mixing the cytostatic powder in the ampule 1 wi~h the sterile water in ampule 2 is as follows:
A certain amount of air is supplied into the system, which is ass-embled of the.hoses and ampules, through the hose 10 by means of the hypodermic syringe 17, which with its opening has been attached sealingly in the port 16. The amount of air is ad-justed, for example, by adjusting the handle 18 on the multi-way valve. ~his air supply has the object to facilitate the subsequent sucking of water ou~ of the ampule 2 via the hypo-dermic needle 11, hose 10, and port 9 into the syringe 17.
The handle 18 now is adjusted so that ~he port 5 opens, while the ports 9 and 19 are closed, and the water is injected from the syringe into the ampule 1. The handle again is adjusted so that the port 9 opens (the ports 5 and 19 are closed), and a new batch of water is sucked into the syringe 17. The handle 18 is again adjusted so as to open the port 5, and said new batch is injected into the ampule 1. This procedure is repeated until all liquid has been transferred from the ampule 2 to the ampule lo The resulting mixture in ampule 1 then can be sucked into the syringe 17 L~

~Z~473~

At the embodiment shown, the multi-way valve 4 is provided with a fourth port ~9, which by a hose 20 is connected directly to an ;nfusion unit 21. The mixture contained in the syringe 17 can be supplied direc~ly to ~he infusion unit 21 via the hose 20, in that the handle 18 is adjusted so that the ports 5 and 9 are closed and the port 10 opens. During this entire procedure no gas or liquid could penetrate out of the equip-ment, viz. syringe, hoses and ampules.

When the hypodermic syringe is to be used for injection, subsequen~ to the filling of the syringe the opening thereof preferably can be inserted into a sealing cap 22 ~Pig. 1), which closes the opening and is a~tached in a suitable manner to $he plate 3. When the syringe 17 is to be transported to its place of use, the sealing cap, which still is attached on the syringe 17, is broken off in a simple way from the plate 3. Neither during this entire procedure of syringe filling with the mixture is there any risk of liquid or gas penetrating out of the equipment described.

When the mixture has been transferred to the infusion unit 21, or the syringe 17 together with the sealing cap 22 has been removed from the plate 3~ the entire equipment, i.e. ampules, plate, hoses and valve (if appropriate, wi~h the syringe remaining thereon), is discarded.

In some cases it could be convinient to direc~ly inject the liquid in the patient, in which case the infusion unit 21 is deleted and the hose 20 is provided with a cannula. The liquid is then injected by means of the syringe 17 or the bellows 23, described later on.

Instead of a hypodermic syringe 17, a pump means 23 can be used~ which then is connected to the third port 16 of ~he ~ulti-way valve 4. The pump means 23 in principle may consist of a self-expanding bellows, for example of plastic, which preferably is attached on the multi-way valve 4 or on the plate 3 in vertically upright position. The two substances ~0 lZ~)4~3~

here are mixed in the same way as in the case of the syringe 17 being used. The pump means, v z.the bellows 23, is compressed and thereafter at its exp~nsion sucks up liquid in the ampule 2 via the hypodermic needle 11, hose 10 and port 9. Due to the adjusting of the handle 18 and the compression of the bellows, the liquid is transferred to the ampule 1, in which the mixing takes place. Thereafter the bellows is permitted to expand, whereby the mixture is sucked up into the ampule 1. This condition corresponds to the syringe 17 in filled state, with the difference, however, that the utilization of a bellows does not imply the risk which may arise at the utilization of a syringe, viz. that the syringe unintentionally may loosen from the multi-way valve 4 and thereby with its content con-taminate the surrounding. When the system is equipped with a bellows, the hose 20, for example, can be provided with a connection (not shown), at which a hypodermic syringeto be used can be attached. The syringethen can be filled by sucking up with the same the mixture from the bellows.

It is not absolutely necessary to supply a certain amount of air to the system prior to the sucking of liquid into the syringe,but the liquid can be sucked directly into the syringe whereby a certain pressure balance in the system takes place in that air is sucked into the ampules in holes about;the hypodermic needles.

As mentioned above, the invention has been described with reference to an embodiment thereof. The equipment used, of course, can be varied within the scope of the invention.
The plate with hoses and valve and the sealing cap can be delivered in sets, with recesses for ampules of varying size. The hypodermic needles 7,11 and the needles 14,15, of course, may have a design other than that shown. Hypodermic needles in this connection are to be understood to be tubes pointed at one end and easy to penetrate through the rubber closures of the ampules.

Claims (6)

The embodiments of the invention in which an exclusive property or privilege is claimed are defined as follows:
1. A method of mixing one substance, for example cytostatica, stored in an ampule provided with a rubber closure or corresponding closure, with a second substance, for example sterile water, stored in a second ampule provided with a rubber closure or corresponding closure, characterized in that a first tube or hypodermic needle shape, which is connected by a connection to a first port of a multi-way valve, is pierced through the closure or one ampule, that a second tube of hypodermic needle shape, which is connected by a connection to a second port of the multi-way valve, is pierced through the closure of said second ampule, that the interior of each respective ampule is connected to an enclosed space outside the ampule by means of a needle of hypodermic needle shape and pierced each through one rubber closure, that a pump means is connected to a third port of the multi-way valve, by which pump means and alternating adjustment of the multi-way valve the substance in one ampule is transferred to the second ampule, in which the two sub-stances are mixed with each other, and the mixture finally is sucked into the pump means.
2. A method as defined in claim 1, characterized in that a connection is connected to a fourth port of the multi-way valve, which connection can be connected to an infusion unit, whereby the mixture by the pump means can be transferred directly via the multi-way valve to the infusion unit.
3. A method as defined in claim 1, characterized in that a connection is connected to a fourth port of the multi-way valve, which connection can be connected to a cannula, whereby the mixture by the pumps means can be transferred directly via the multi-way valve to the patient.
4. A method as defined in claim 1, 2 or 3, characterized in that the pump means receiving the mixture consists of a hypodermic syringe, which from the third port can be moved to and with its opening inserted into a sealing cap located to the side of the third port and closing said opening.
5. A method as defined in claims 1, 2 or 3, wherein the pump means receiving the mixture consists of a hypodermic syringe which, from the third port, can be moved to and with its opening inserted into a sealing cap located to the side of the third port and closing said opening; and further characterized in that the sealing cap with the syringe attached thereto is removed from its attachment for transporting the syringe subsequent to its filling with the mixture.
6. A method as defined in claim 1, characterized in that the pump means receiving the mixture is a self-expanding bellows, and the mixture is delivered therefrom via a fourth port of the multi-way valve.
CA000420479A 1982-01-29 1983-01-28 System for mixing and delivering medical liquids to the charge of a hypodermic needle Expired CA1204731A (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE8200504A SE427245B (en) 1982-01-29 1982-01-29 PROCEDURE FOR MIXING A SUBSTANCE, EX CYTOSTATICS, STORED IN A SUBSTANCES OR EQUIVALENT AMPULA, WITH ANOTHER SUBSTANCE, EX STERILATED WATER, LIKASA SUBSTANCED IN A SUBSTANCES OR OTHER SUBSTANCES
SE8200504-2 1982-01-29

Publications (1)

Publication Number Publication Date
CA1204731A true CA1204731A (en) 1986-05-20

Family

ID=20345870

Family Applications (1)

Application Number Title Priority Date Filing Date
CA000420479A Expired CA1204731A (en) 1982-01-29 1983-01-28 System for mixing and delivering medical liquids to the charge of a hypodermic needle

Country Status (14)

Country Link
US (1) US4509861A (en)
EP (1) EP0085663B1 (en)
JP (1) JPS58169452A (en)
AR (1) AR229636A1 (en)
AT (1) ATE23795T1 (en)
AU (1) AU1090883A (en)
BR (1) BR8300418A (en)
CA (1) CA1204731A (en)
DE (1) DE3367847D1 (en)
DK (1) DK33683A (en)
ES (1) ES278852Y (en)
FI (1) FI830285L (en)
NO (1) NO830293L (en)
SE (1) SE427245B (en)

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Also Published As

Publication number Publication date
FI830285L (en) 1983-07-30
SE427245B (en) 1983-03-21
NO830293L (en) 1983-08-01
EP0085663A3 (en) 1984-09-05
DK33683A (en) 1983-07-30
AU1090883A (en) 1983-08-04
ES278852Y (en) 1985-03-01
FI830285A0 (en) 1983-01-27
US4509861A (en) 1985-04-09
DE3367847D1 (en) 1987-01-15
EP0085663B1 (en) 1986-11-26
BR8300418A (en) 1983-11-01
DK33683D0 (en) 1983-01-28
JPS58169452A (en) 1983-10-05
EP0085663A2 (en) 1983-08-10
AR229636A1 (en) 1983-09-30
ATE23795T1 (en) 1986-12-15
ES278852U (en) 1984-08-01

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