CA2274290A1 - Delivery system for multi-component pharmaceuticals, and prefilled protosyringe for use therein - Google Patents

Delivery system for multi-component pharmaceuticals, and prefilled protosyringe for use therein Download PDF

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Publication number
CA2274290A1
CA2274290A1 CA002274290A CA2274290A CA2274290A1 CA 2274290 A1 CA2274290 A1 CA 2274290A1 CA 002274290 A CA002274290 A CA 002274290A CA 2274290 A CA2274290 A CA 2274290A CA 2274290 A1 CA2274290 A1 CA 2274290A1
Authority
CA
Canada
Prior art keywords
syringe
vial
needle
protosyringe
hub
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.)
Abandoned
Application number
CA002274290A
Other languages
French (fr)
Inventor
David L. Reynolds
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.)
Duoject Medical Systems Inc
Original Assignee
Duoject Medical Systems Inc
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 Duoject Medical Systems Inc filed Critical Duoject Medical Systems Inc
Priority to CA002274290A priority Critical patent/CA2274290A1/en
Priority to PCT/CA2000/000699 priority patent/WO2000076449A1/en
Priority to AU53816/00A priority patent/AU766408B2/en
Priority to CA002377394A priority patent/CA2377394A1/en
Priority to EP20000938404 priority patent/EP1183002A1/en
Publication of CA2274290A1 publication Critical patent/CA2274290A1/en
Abandoned legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096Combination of a vial and a syringe for transferring or mixing their contents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/1406Septums, pierceable membranes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS 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
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14Details; Accessories therefor
    • A61J1/20Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006Piercing means
    • A61J1/201Piercing means having one piercing end

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

A protosyringe for containing a liquid component in a delivery system for a multiple component needle coupling of a syringe filled with the liquid component. The protosyringe is used in conjunction with a transfer mechanism containing a double end needle assembly to transfer liquid to a vial containing a further component of the pharmaceutical which is then drawn back into the protosyringe. The transfer mechanism or part of it is then removed and discarded, including the vial and at least that end of the needle assembly penetrating the vial, so as to leave the syringe filled with both components and either presenting a needle coupling comprised by part of the needle assembly retained on the protosyringe, or presenting the original needle coupling of the syringe.

Description

This invention relates to delivery systems for pharmaceuticals containing two more components, in which separately stored components are combined immediately prior to use to provide a syringe from which the combined or reconstituted pharmaceutical can be delivered.
One such system is described in published International Patent Application W097/25015, in which a pharmaceutical vial is connected to a "protosyringe" by a transfer arrangement which enables a liquid (such as sterile water) stored in the protosyringe to be delivered to the vial, for admixture with the contents of the latter and which are then drawn back into the protosyringe, whereupon the protosyringe, together with certain elements of the transfer mechanism which convert it into a syringe, is detached from the remainder of the transfer mechanism and is ready for use upon application of a needle or other injection means. It is of course important that sterility be maintained during this procedure, and to this end the transfer arrangement makes use of an axially movable hub which provides a sheathed and detachable needle to penetrate the vial, and a needle cannula or other instrumentality to broach the protosyringe. The needle is retained in a discarded portion of the transfer mechanism, its detachment leaving a standard needle coupling or luer lock on a portion of the transfer mechanism retained on the protosyringe in order to convert it into a complete syringe.
Such a standard needle coupling has a central tapered spigot defining an axial liquid passage, and an outer sleeve provided with an internal thread for engaging flanges of a needle hub and drawing a socket in the hub into fluid tight engagement with the spigot.
One of the most widely used liquid components in such multiple component pharmaceuticals is sterile water, and for economy and simple certification, a suitable form of prepackaged water is desirable. This may make it desirable in certain cases to utilize not a protosyringe as defined in W097/25015, but an actual low cost syringe, such as the moulded plastic syringes widely utilized in the pharmaceutical industry.
I have found that by a simple addition of a specially designed cap, such syringes may not only be converted into protsyringes suitable for use in systems disclosed in W097/25015, but also that with such a syringe, a simplified transfer arrangement is possible which dispenses with the need for an axially movable hub, but nonetheless retains the advantage that the needle used to establish communication with the vial is retained within the discarded transfer mechanism components.
According to the invention, there is provided a liquid containing protosyringe comprising firstly a syringe prefilled with a liquid and having at a delivery end a standard needle coupling of the type having a central tapered spigot defining a liquid passage communicating with the interior of the syringe and an outer cylindrical sleeve provided with an internal thread for engaging flanges of a needle hub to draw a socket defined in the hub into fluid tight engagement with the spigot; and a secondary cap engaged with the coupling, the cap comprising a hub for engagement with the sleeve, a penetrable closure drawn onto the spigot by the hub, and a cylindrical collar surrounding the penetrable closure to present a disk-like axial external zone of the closure for penetration by a needle or cannula.
The invention extends to a delivery system for a multiple component pharmaceutical product, comprising a protosyringe as set forth above, the liquid filling which is one component of the product, at least one pharmaceutical vial containing a further component of the product, and having a neck end closed by a penetrable closure, and a transfer mechanism comprising a first socket at one end for receiving the cap and delivery end of the protosyringe, a second socket at an opposite end for receiving the closure and neck end of the vial, and a double ended needle assembly for penetrating
2 respectively the penetrable closure of the vial and the cap so as to place the syringe and the vial in communication, such that liquid from the syringe can be transferred to the vial to take up the component stored in the vial and then re-aspirated into the syringe, whereafter removal at least part of the transfer mechanism from the protosyringe will leave a syringe presenting a standard needle coupling ready to receive a needle or equivalent instrumentality.
Preferably, at least a portion of the needle assembly penetrating the penetrable closure of the vial is removed and discarded, retained within a discarded portion of the transfer mechanism. In one embodiment, that portion of the needle assembly which penetrates the vial closure is pulled away from the remainder to leave a standard needle coupling as disclosed in W097/25015 while in another embodiment the cap applied to the prefilled syringe is retained in the transfer mechanism together with the entire needle assembly so as to leave the prefilled syringe containing the combined contents of the syringe and the vial.
Further features of the invention will be apparent from the following description with reference to the accompanying drawings, in which:
Figure 1 is an assembled elevational view of a first embodiment of pharmaceutical delivery system incorporating a protosyringe in accordance with the invention, prior to activation;
Figure 2 is an enlarged detail of certain parts of the system of Figure 1;
Figure 3 is a cross-sectional view of one of the parts shown in Figure 2;
Figure 4 is an elevational view of a second embodiment of pharmaceutical delivery system incorporating a protosyringe
3 in accordance with the invention, prior to activation;
Figure 5 is an exploded view of parts of the system of Figure
4;
Figure 6, 7, 8, 9 and 10 illustrate successive stages in the deployment of the embodiment of Figure 4 to provide a syringe prefilled with a two component medicament.
Referring to the drawings, the embodiment shown in Figures 1-3 is similar in most respects to that shown in Figure 21 of W097/25015, except that the "protosyringe" shown in that embodiment is replaced by the combination of a syringe 2 with a special cap 4 which in effect converts it into a protosyringe. Such an arrangement has the advantage that the syringe may be, for example, a mass produced moulded plastic syringe as shown, incorporating a standard needle coupling or luer lock comprising a conical spigot 6 with a central passage 8 communicating with the syringe body surrounded by cylindrical sleeve 10 with internal threads 12 for coupling with flanges on the hub of a needle.
Instead of a needle, the syringe, filled with a liquid component of the pharmaceutical, typically but not necessarily sterile water, is capped by the cap 4, which as best seen in Figures 2 and 3, compresses a luer extension 14 with flanges 16 which engages the threads 12, a penetrable rubber disk seal 18, and an annular aluminum collar 19 which clamps the assembly together to produce a cylindrical head with a penetrable seal comparable to that of the bottomless vials exemplified as protosyringes in W097/25015. When the assembly is activated, a needle or cannula within a rubber sheath 20 penetrates the seal 18 as the head formed by the cap is forced up into a cap 22 attached to a hub 24 past a detent 26.
Preferably the cap 22 is dimensioned so that once the head passes the detent 26 it can rotate freely in the cap, thus preventing the syringe 2 from being unscrewed from the cap 4.
Alternatively, the ribs 28 shown on the hub could be omitted so that the hub can rotate freely within the transfer assembly 30 (see Figure 1). The transfer assembly comprises screw connected cylindrical parts 32 and 34, the part 32 defining a socket for the syringe 2, and the part 34 a socket for the neck end and penetrable seal of a vial 36. The penetrable seal of the vial 36 is penetrated by a needle within a sheath 38 as the head formed by the cap 4 is forced into the cap 22 and projects the hub 24 upwardly such that a hub 40 of the needle is gripped by claws 42 formed within cylindrical part 34.
At this point, the needle assembly formed by the hub 24 has established communication between the syringe 2 and the vial 36 so that liquid from the syringe may be projected into the vial to mix with, dissolve or suspend the contents of the latter, the content of the vial then being aspirated back into the syringe. At this point, the part 34 of the transfer assembly may be unscrewed from the part 32, at which point the claws 42 gripping the hub 40 pull the latter off the hub 24, leaving exposed a standard needle coupling (not shown) hitherto covered by the hub 4. The needle that penetrates the vial is thus retained within the portion of the transfer assembly that is discarded with the vial.
It should be understood that the vial 36 may be removed and replaced by a further vial or vials, if additional components are to be introduced into the syringe.
The structure of the cap 4 may also be varied. The extension 14 may be of plastic or metal, and certain of the parts might possibly be formed integrally, consistent with the function of providing a cylindrical head converting the syringe to a protosyringe, which head provides an external annular surface engageable with the transfer mechanism, and a penetrable seal which will seal hermetically the needle coupling of the syringe.
5 In the embodiment just described, the cap 4 remains locked to the syringe 2 even after the system is activated, and indeed steps are taken to prevent disengagement of the syringe 2.
In a variation, the cap 4 is locked against rotation relative to the transfer mechanism for example by providing longitudinal ribs on the interior of the cap 22, so that instead of separating the components of the transfer mechanism to complete activation of the system, the syringe 2 is simple unscrewed from the transfer mechanism, the whole of which is then discarded.
Such an arrangement however permits the transfer mechanism to be simplified, as further illustrated with reference to Figures 4-10.
As compared to Figures 1 and 2, the parts 32 and 34 of the transfer assembly are formed on one piece or permanently connected, and the hub 24 and associated parts are omitted and replaced by a standard needle connection 50 to which is mounted the hub 54 of a double ended needle 52. The cap 22 is integral with the part 32 of the transfer assembly instead of the hub 24. The assembly is typically shipped with the head of the protosyringe formed by the syringe 2 and cap 4 (which may be identical to those of the previous embodiment) inserted part way into the cap 22 so that the lower end 56 of the needle 52 does not penetrate the seal. The socket for the vial 36 formed by the part 34 is closed by a flip-off closure 60.
In use, the closure 60 is flipped off, as is any flip-off disc 62 over the penetrable seal of the vial 36 (see Figure
6). The vial 36 is then pushed into its socket (see Figure
7) causing an upper end 64 of the needle 52 to penetrate the closure of the vial and forcing the transfer mechanism down so that the needle end 56 penetrates the seal 18, placing the vial and syringe in communication. The plunger 66 of the vial is used to proj ect liquid from the syringe into the vial to mix with, dissolve or suspend the component of the pharmaceutical contained in the vial (see Figure 8), which is then drawn back into the vial (Figure 9), at which point the syringe 2 is unscrewed from the cap 4, which together with the needle 52, is retained in the transfer mechanism which is discarded with the vial.

Claims (7)

CLAIMS:
1. A liquid filled protosyringe comprising firstly a syringe prefilled with a liquid and having at a delivery end a standard needle coupling of the type having a central tapered spigot defining a liquid passage communicating with the interior of the syringe and an outer cylindrical sleeve provided with an internal thread for engaging flanges of a needle hub to draw a socket defined in the hub into fluid tight engagement with the spigot; and secondly a cap engaged with the coupling, the cap comprising a hub for engagement with the sleeve, a penetrable closure drawn onto the spigot by the hub, and a cylindrical collar surrounding the penetrable closure to present a disk-like axial external zone of the closure for penetration by a needle or cannula.
2. A syringe according to claim 1, wherein the penetrable closure is of elastomeric material, and the collar is of a aluminum, crimped onto the closure and the hub to secure them together.
3. A syringe according to claim 1 or 2, wherein the hub has flanges for engagement with the sleeve.
4. A delivery system for a multiple component pharmaceutical product, comprising a protosyringe as set forth above, the liquid filling which is one component of the product; at least one pharmaceutical vial containing a further component of the product, and having a neck end closed by a penetrable closure; and a transfer mechanism comprising a first socket at one end for receiving the cap and delivery end of the protosyringe, a second socket at an opposite end for receiving the closure and neck end of the vial, and a double ended needle assembly for penetrating respectively the penetrable closure of the vial and the cap so as to place the syringe and the vial in communication, such that liquid from the syringe can be transferred to the vial to take up the component stored in the vial and then reaspirated into the syringe, whereafter removal at least part of the transfer mechanism from the protosyringe will leave a syringe presenting a standard needle coupling ready to receive a needle or equivalent instrumentality.
5. A delivery system according to claim 4, wherein the at least of the transfer mechanism which is removable includes at least a portion of the needle assembly for penetrating the closure of the vial.
6. A delivery system according to claim 4 or 5, wherein that portion of the needle assembly for penetrating the vial is a press fit on a standard needle coupling comprised by the remainder of the needle assembly, and is retained by the portion of the transfer mechanism that is removable.
7. A delivery system according to claim 4 or 5, wherein the cap applied to the syringe is retained in the transfer mechanism that is removable.
CA002274290A 1999-06-09 1999-06-09 Delivery system for multi-component pharmaceuticals, and prefilled protosyringe for use therein Abandoned CA2274290A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
CA002274290A CA2274290A1 (en) 1999-06-09 1999-06-09 Delivery system for multi-component pharmaceuticals, and prefilled protosyringe for use therein
PCT/CA2000/000699 WO2000076449A1 (en) 1999-06-09 2000-06-09 Syringe device for assembly of a multi-component pharmaceutical
AU53816/00A AU766408B2 (en) 1999-06-09 2000-06-09 Syringe device for assembly of a multi-component pharmaceutical
CA002377394A CA2377394A1 (en) 1999-06-09 2000-06-09 Syringe device for assembly of a multi-component pharmaceutical
EP20000938404 EP1183002A1 (en) 1999-06-09 2000-06-09 Syringe device for assembly of a multi-component pharmaceutical

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CA002274290A CA2274290A1 (en) 1999-06-09 1999-06-09 Delivery system for multi-component pharmaceuticals, and prefilled protosyringe for use therein

Publications (1)

Publication Number Publication Date
CA2274290A1 true CA2274290A1 (en) 2000-12-09

Family

ID=4163625

Family Applications (2)

Application Number Title Priority Date Filing Date
CA002274290A Abandoned CA2274290A1 (en) 1999-06-09 1999-06-09 Delivery system for multi-component pharmaceuticals, and prefilled protosyringe for use therein
CA002377394A Abandoned CA2377394A1 (en) 1999-06-09 2000-06-09 Syringe device for assembly of a multi-component pharmaceutical

Family Applications After (1)

Application Number Title Priority Date Filing Date
CA002377394A Abandoned CA2377394A1 (en) 1999-06-09 2000-06-09 Syringe device for assembly of a multi-component pharmaceutical

Country Status (4)

Country Link
EP (1) EP1183002A1 (en)
AU (1) AU766408B2 (en)
CA (2) CA2274290A1 (en)
WO (1) WO2000076449A1 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1558194A1 (en) * 2002-11-08 2005-08-03 Duoject Medical Systems Inc Pharmaceutical delivery systems and methods for using same
US10918790B2 (en) * 2015-12-22 2021-02-16 Guangzhou Bioseal Biotech Co., Ltd. Dual syringe with funnel feeding kit

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BE791634A (en) * 1971-11-20 1973-05-21 Hoechst Ag TWO-CHAMBER SYRINGE
US4898209A (en) * 1988-09-27 1990-02-06 Baxter International Inc. Sliding reconstitution device with seal
US5624402A (en) * 1994-12-12 1997-04-29 Becton, Dickinson And Company Syringe tip cap
WO1997025015A1 (en) 1996-01-11 1997-07-17 Duoject Medical Systems Inc. Delivery system for pharmaceuticals packed in pharmaceutical vials
US6090092A (en) * 1997-12-04 2000-07-18 Baxter International Inc. Sliding reconstitution device with seal

Also Published As

Publication number Publication date
WO2000076449A1 (en) 2000-12-21
AU766408B2 (en) 2003-10-16
AU5381600A (en) 2001-01-02
CA2377394A1 (en) 2000-12-21
EP1183002A1 (en) 2002-03-06

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