MULTIPLE COMPARTMENT HYPODERMIC DEVICES

• US 3,810,469 A
• Filed: 05/24/1972
• Issued: 05/14/1974
• Est. Priority Date: 05/24/1972
• Status: Expired due to Term

• Current Assignee: Alfred A. Hurschman
• Original Assignee: Alfred A. Hurschman
• Inventors: Hurschman, Alfred A.
• Primary Examiner(s): Gaudet, Richard A.
• Assistant Examiner(s): McGowan, J. C.
• Application Number:
  US05/256,407
• Time in Patent Office: 720 Days
• Field of Search: 128/215,216,218R,218P,218NV,218F,218M,218D,218DF,272,220 215/47,52,56 206/63.2R,56R,47A
• US Class Current: 604/88
• CPC Class Codes: A61M 2005/3123 having air entrapping or venting means, e.g. purging channels in pistons
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/288 by piercing without internal pressure increase A61M5/283 takes precedence

Abstract

A multichamber hypodermic ampoule of the contained needle type and a method of assembling and filling such an ampoule are disclosed. The ampoule includes multiple chambers for premixing a powdered medicament with a diluent and injecting the mixture. One end of one chamber is closed by a plunger and the other end of that chamber is closed by a first pierceable diaphragm. A hollow needle is operatively associated with the plunger and is initially contained within that chamber. The first pierceable diaphragm is slidably mounted in one end of a second chamber which contains the diluent, and the other end of that chamber is closed by a second pierceable diaphragm. The plunger is provided with a first cylindrical portion having a plurality of axially extending and radially projecting ribs, and is provided with a second cylindrical portion which is adapted to form a seal with the chamber. The ampoule is assembled and filled by affixing the first diaphragm to one end of the first chamber, slidably mounting the first diaphragm in one end of the second chamber, filling the second chamber with a diluent, affixing the second diaphragm to the other end of the second chamber, staking the pointed end of a needle in said first diaphragm, partially filling the first chamber with a medicament to be lyophilized, and partially inserting the plunger in the first chamber so that passageways defined by the ribs permit vapor to be sublimed from the chamber during a lyophilization process. When lyophilization is complete and the medicament in the first chamber is in a powdered or freeze-dried condition, the plunger is fully inserted to seal the ampoule and to contact the head of the needle.

Claims

1. A multichamber hypodermic ampoule comprising a first cylinder;

a first diaphragm sealed to and closing one end of said first cylinder;

a plunger slidably disposed in the other end of the first cylinder to provide a first chamber between said plunger and said first diaphragm;

said plunger comprising a cylindrical plug having a first cylindrical portion which comprises means to effect a substantially liquid-tight seal with said first cylinder, and having a second cylindrical portion which comprises means engaging said first cylinder, and means providing at least one passageway along an axial extent of said second cylindrical portion;

a hypodermic needle disposed in said first chamber for movement with said plunger toward said first diaphragm and having an open end adjacent said plunger and an opposite pointed discharge end adjacent said first diaphragm;

a powdered medicament in said first chamber;

a second cylinder axially aligned with said first cylinder and having one end closed by insertion of said first diaphragm therein with a peripheral portion of the first diaphragm in axial alignment with the inner surface thereof;

a second diaphragm closing the other end of said second cylinder;

said first and second diaphragms and second cylinder, together, defining a second chamber; and

a fluid medicament in said second chamber;

whereby said fluid and solid medicaments may be mixed preparatory to making an injection by first moving said plunger and needle sufficiently toward said first diaphragm to project the pointed end of the needle through said first diaphragm to establish communication between the two chambers and by then moving said first cylinder, first diaphragm, plunger, and needle as a unit toward said second diaphragm to progressively reduce the volume of said second chamber substantially to zero and thereby express said liquid medicament through the neeDle into the first chamber while bringing said first and second diaphragms substantially into engagement and disposing the pointed end of said needle in position to project said needle through said second diaphragm upon further movement of said plunger toward said first and second diaphragms.

2. A multichamber hypodermic ampoule according to claim 1, wherein said second cylindrical portion is adjacent said hypodermic needle.

3. A multichamber hypodermic ampoule according to claim 1, wherein said second cylindrical portion includes a plurality of radially projecting ribs which engage said first cylinder and wherein passageways along said axial extent are defined by adjacent ribs.

4. A multichamber hypodermic ampoule according to claim 1, wherein said cylindrical plug has an axially projecting portion extending from said first cylindrical portion, the axial extent of said projecting portion being greater than the axial extent of said first diaphragm but being less than the combined axial extents of said first and second diaphragms.

5. A multichamber hypodermic ampoule according to claim 1, wherein said plug is provided with radially extending lip means at one end of said first cylindrical portion and spaced from said second cylindrical portion.

6. A multichamber hypodermic ampoule according to claim 1, wherein said second cylindrical portion is adjacent said hypodermic needle and includes a plurality of radially projecting ribs which engage said first cylinder, wherein passageways along said axial extent are defined by adjacent ribs, wherein said cylindrical plug has an axially projecting portion extending from said first cylindrical portion, the axial extent of said projecting portion being greater than the axial extent of said first diaphragm but being less than the combined axial extents of said first and second diaphragms, and wherein said plug is provided with radially extending lip means at one end of said first cylindrical portion and spaced from said second cylindrical portion.