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Claims for Patent: 4,968,299

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Claims for Patent: 4,968,299

Title: Method and device for injection
Abstract:A dual-chamber cylinder ampoule is used for the mixture of a sensitive, solid medicament, with liquid which is caused to flow calmly through the medicament in order to avoid any shaking and mechanical influence. The mixing is preferably carried out at a pressure above atmospheric. An injection device for the preparation of an injection solution and a following injection of such solution includes first and second tubular members for enclosing and holding a dual-chamber cylinder ampoule, in which the dry medicament is kept separated from the liquid. When the two tubular members are being screwed together the liquid is calmly and gently mixed with the dry medicament and dissolves it, and the resulted solution can thereafter be injected by means of the dosage and administration mechanism, provided in one tubular member, through a needle arranged at the front end of the other tubular member.
Inventor(s): Ahlstrand; Bo (Djursholm, SE), Florin-Robertsson; Ebba (Stockholm, SE), Fryklund; Linda (Sollentuna, SE), Hjertman; Birger (Vallingby, SE), Strom; Anders (Saltsjo-Boo, SE)
Assignee: KabiVitrum AB (Stockholm, SE)
Application Number:07/212,647
Patent Claims: 1. A method of preparing a solution, emulsion, or suspension in a fluid of one or more sensitive medicaments for one or more subsequent injections using a multi-chamber cylindrical ampoule including at least a first chamber of a variable volume for containing the sensitive medicament, said first chamber being sealed at its front end by a membrane penetrable to an injection needle and delimited at its rear end by a first movable member, and a second chamber formed in said cylindrical ampoule for containing the fluid and being defined at its front end by said first movable member and at its rear end by a second movable member, and a connecting passage arranged in a wall of said cylindrical ampoule between said first and second chambers for providing a communication therebetween, said method comprising the steps of:

providing a holder member for holding said cylindrical ampoule therein, said holder member including a first and a second part, said first and second part including corresponding threaded means thereon;

inserting said cylindrical ampoule into one of said parts of said holder member;

connecting said first and second parts by screwing said corresponding threaded means;

simultaneously with said screwing, effecting movement of said second movable member with said fluid towards said first movable member for causing movement of said first movable member along the wall of said cylindrical ampoule for opening said connecting passageway;

continuing screwing of said parts of said holder member whereby a slow, gentle and constant flow of said fluid controlled by the screwing operation is provided from said second into said first chamber for the dissolution, suspension or emulsification of the sensitive medicament in said first chamber.

2. The method according to claim 1, wherein said fluid and said sensitive medicament are brought into contact with one another at a pressure above atmospheric.

3. The method according to claim 1, wherein said membrane is penetrated by the injection needle only after the medicament has been dissolved, emulsified or suspended in said fluid.

4. A method of dissolution of a sensitive solid substance by a liquid substance in a container in which each of said substances is being kept in one of two separate chambers of variable volume, said chambers being capable of passing liquid from said chamber containing said liquid into said chamber containing said sensitive, solid substance through a passageway communicating said chambers upon actuation by an external member, said method comprising the steps of:

providing an encasing member having two parts, said two parts being connectable through corresponding threaded means;

positioning said container in one of said two parts of said encasing member;

applying said two parts of said encasing member for interconnection;

causing longitudinal displacement of said second chamber filled with said liquid towards said first chamber by means provided in said second part of said encasing member upon screwing movement of said two encasing members to effect movement of said first chamber, whereupon effecting an actuation and opening of a liquid communication between said first and second chamber through said passageway for slowly and gently passing said liquid from said second to said first chamber, the flow of said liquid being steadily controlled by said screwing movement, whereby the mixing and the dissolution of said sensitive, solid substance by said liquid substance is protected against shaking and other mechanical influence.

5. An injection device for the preparation of a solution, emulsion or suspension of a sensitive, solid substance in a fluid and a subsequent injection, with said solid, sensitive medicament and said fluid being kept separately, said device comprising:

a dual-chamber cylindrical member, with a first chamber for containing said sensitive, solid substance having a bottom defined by a needle penetrable member and a top defined by a first movable member, a second chamber for containing said fluid having a bottom defined by said first movable member and a top defined by a second movable member, and a connecting passage formed in the wall of said cylindrical member for communicating said first and second chambers, said connecting passage being located entirely within said first chamber and closed off from said second chamber by said first movable member and openable upon external actuation; and

a first and a second tubular member, said tubular members including threaded means for interconnection of said first and second members for encasing said dual-chamber cylindrical member therein, said first tubular member being adapted for holding said cylindrical member therein and having means for exposing said penetrable member to a needle injection;

said second tubular member housing means for effecting longitudinal movement of said second movable member with said fluid and of said first movable member to open said connecting passageway for passing said fluid from said second to said first chamber upon screwing operation of said two tubular members onto each other, said screwing operation controlling passing of said fluid into said second chamber for dissolution of said sensitive, solid substance, whereby said dissolution and a subsequent handling of the dissoluted substance is maintained in a gentle, slow and lenient manner, preventing any deterioration of the sensitive medicament by mechanical influence.

6. The injection device according to claim 5, wherein said means for effecting longitudinal movement comprises a piston arranged in said other tubular member and wherein said means for exposing said penetrable member includes an opening provided in said one tubular member alignable with said penetrable member.

7. A injection device for the preparation of an injection solution of degradation-sensitive substances and a subsequent injection of the solution, comprising:

a dual-chamber container for separate containing of the constituents of the injection solution and means for bringing the constituents together to be mixed and dissolved, said container including a tubular member being sealed at its front end by a needle penetrable member which defines a bottom of a first chamber with a variable volume, and a first movable member disposed in said tubular member defining a top of said first chamber, said first chamber containing the solid constituents of the injection solution, and a second chamber having a bottom defined by said first movable member and a top defined by a second movable member, said second chamber containing the liquid constituents of the injection solution, and said means for bringing said liquid and solid constituents together including a connecting passage in a wall of said tubular member arranged to be closed by said first movable member in a separated state of said constituents;

holding means adapted for insertion of said dual-chamber container therein, said holding means including a first and a second part, each provided with corresponding threaded means for connecting said first and second parts together;

said needle penetrable member being exposed at a front end of said first part of said holding means for penetration by an injection needle, said second part of said holding means being provided with means for effecting movement of said second movable member towards said first movable member, causing movement of said liquid constituent and of said first movable member for opening of said connecting passageway, upon screwing of said first and second parts onto each other, whereby said liquid constituent flows from said second chamber into said first chamber to mix with said solid constituents, wherein the flow of said liquid is controlled by screwing of said first and second parts; and

means for injection of said solution.

8. A device according to claim 7, wherein said means for injection comprising a dosing device connected to said second part of said holding means.

9. A device according to claim 8, wherein said dosing device is brought into a starting position when screwed together with said parts of said holding means, said dosing device being provided with means for effecting said longitudinal displacement of said second movable member.

10. A device according to claim 7, further comprising:

a holder for an injection needle connectable to said front end of said first part of said holding means.

11. A device according to claim 7, wherein said means for injection comprises a plunger rod connected to said means for effecting movement of said second movable member.
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