Safety, packaging, injection and disposal system for pre-filled pharmaceutical vials

• US 5,067,948 A
• Filed: 09/27/1990
• Issued: 11/26/1991
• Est. Priority Date: 09/27/1990
• Status: Expired due to Fees

• Current Assignee: Habley Medical Technology Corporation
• Original Assignee: Habley Medical Technology Corporation
• Inventors: Foster, Clark B., Haber, Terry M.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): SMITH, CHALIN A
• Application Number:
  US07/589,133
• Time in Patent Office: 425 Days
• Field of Search: 604/21, 604/93, 604/118, 604/121, 604/181, 604/182, 604/183, 604/184, 604/187, 604/192, 604/197-201, 604/204, 604/205, 604/218, 604/220, 604/225-226 , 604/231-234, 604/86, 604/87, 604/88, 604/259, 604/213, 604/236, 604/237, 81/3.25
• US Class Current: 604/213
• CPC Class Codes: A61M 2005/31598 having multiple telescopically sliding coaxial pistons encompassing volumes for components to be mixed
• CPC Class Codes: A61M 5/008 Racks for supporting syringes or needles A61M5/001 takes precedence
• CPC Class Codes: A61M 5/1782 Devices aiding filling of syringes in situ combination of a vial and a syringe for transferring or mixing their contents A61J1/2096, filling of medical containers in general B65B3/003
• CPC Class Codes: A61M 5/2448 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: A61M 5/31511 Piston or piston-rod constructions, e.g. connection of piston with piston-rod A61M5/5066 takes precedence

Abstract

A vial holding syringe (84) includes a barrel (6) having a bore (12), a sealable needle end (8) and an open plunger end (10). A plunger (16) is mounted within the bore and includes an elongated hollow stem (18), having an interior (36) sized to hold a conventional vial (4), and a piston (20). The stem includes a hollow piercing member (46) having a piercing end (48), opposite the membrane (42) covering the vial ,and an outer end (50), adjacent a one-way valve (70) to permit passage of the medication (80) within the vial from the vial, through the hollow piercing member and through the one-way valve into a variable volume region (67) of the bore between the needle end of the barrel and the piston. An opening (14) at the needle end of the barrel is initially sealed by a cap (66). To use, the plunger is pulled part way from the bore to create a partial vacuum within the variable volume region. During this process, the diaphragm of the vial is driven onto the piercing end of the piercing member. This causes the contents of the vial to be expelled from the vial and into the variable volume region under the influence of the partial vacuum formed within the variable volume region. The cap is then removed, a hollow needle (82) is mounted to the barrel and the injection is given.

Claims

1. A vial holding syringe structure, the vial of the type having a pierceable membrane at one end, the syringe structure comprising:

a barrel having a bore, a sealable needle end and a plunger end;

a plunger including a stem, having inner and outer ends, and a piston sized to sealingly engage the bore, the plunger slidably mounted within the barrel at the plunger end for reciprocal movement between a depressed position, with the inner end towards the needle end, and a retracted position, with the inner end spaced apart from the needle end, the barrel and plunger defining a variable volume region at the needle end, a partial vacuum being created in the variable volume region when the plunger moves towards the retracted position;

the stem having an interior sized to house the vial; and

means for transferring the contents of the vial along a path to the variable volume region when the variable volume region is at the partial vacuum, the transferring means including a one-way valve along said path to permit the contents of the vial to flow into the variable volume region but not the reverse without any manipulation by the user, the one-way valve being formed as part of the piston;

whereby the transferred contents of the vial in the variable volume region can be injected through a hollow needle, mounted to the needle end, by the manipulation of the plunger.

2. The syringe structure of claim 1 wherein the barrel has an opening, communicating with the variable volume region, at the needle end, and further comprising cap means for selectively sealing the opening.

3. The syringe structure of claim 1 wherein the piston seal includes a piston mounted to the inner end of the stem.

4. The syringe structure of claim 1 wherein the transferring means includes a hollow piercing member having a piercing end positioned within the interior of the stem opposite the pierceable membrane of the vial.

5. The syringe structure of claim 4 wherein the transferring means includes a vial stop mounted to the barrel and extending into the interior of the stem so to engage the vial when the plunger is moved towards the retracted position so the piercing end of the piercing member is driven through the pierceable membrane of the vial.

6. The syringe structure of claim 1 further comprising means for securing the plunger in the depressed position.

7. A vial holding syringe structure, the vial of the type having a pierceable membrane at one end, the syringe structure comprising:

a barrel having a bore, a sealable needle end and a plunger end;

a plunger including a stem, having inner and outer ends, and a piston seal sized to sealingly engage the bore, the plunger slidably mounted within the barrel at the plunger end for reciprocal movement between a depressed position, with the inner end towards the needle end, and a retracted position, with the inner and spaced apart from the needle end, the barrel and plunger defining a variable volume region at the needle end, a partial vacuum being created in the variable volume region when the plunger moves towards the retracted position;

the stem having an interior sized to house the vial; and

means for transferring the contents of the vial along a path to the variable volume region when the variable volume region is at the partial vacuum;

the transferring means including;

a hollow piercing member having a piercing end positioned within the interior of the stem opposite the pierceable membrane of the vial; and

a vial stop mounted to the barrel and extending into the interior of the stem so to engage the vial when the plunger is moved towards the retracted position so the piercing end of the piercing member is driven through the pierceable membrane of the vial;

whereby the transferred contents of the vial in the variable volume region can be injected through a hollow needle, mounted to the needle end, by the manipulation of the plunger.

8. The syringe structure of claim 7 wherein the vial stop includes a vial stop element, hingedly mounted to the barrel adjacent aligned openings in the barrel and the stem for movement between an internal position, extending into the interior of the stem, and an external position, external of the bore of the barrel.

9. The syringe structure of claim 8 wherein the vial stop includes a projection carried by the barrel for maintaining the vial stop element in the internal position.

10. A via holding syringe structure, the vial of the type having a pierceable membrane at one end and a removable protective cap covering the pierceable membrane, the syringe structure comprising:

a barrel having a bore, a sealable needle end and a plunger end;

a plunger including a stem, having inner and outer ends, and a piston seal sized to sealingly engage the bore, the plunger slidably mounted within the barrel at the plunger end for reciprocal movement between a depressed position, with the inner end towards the needle end, and a retracted position, with the inner and spaced apart from the needle end, the barrel and plunger defining a variable volume region at the needle end, a partial vacuum being created in the variable volume region when the plunger moves towards the retracted position;

the stem having an interior sized to house the vial;

means for transferring the contents of the vial along a path to the variable volume region when the variable volume region is at the partial vacuum; and

means for retaining the protective cap at an outer surface of the barrel;

whereby the transferred contents of the vial in the variable volume region can be injected through a hollow needle, mounted to the needle end, by the manipulation of the plunger.

11. The syringe structure of claim 10 wherein the protective cap retainer means includes means for removing the protective cap from the vial.

12. A vial holding syringe structure, the vial of the type having a pierceable membrane at one end, the syringe structure comprising:

a barrel having a bore, a sealable needle end, and a plunger end;

a plunger including a stem, having inner and outer ends, and a piston sized to sealingly engage the bore, the piston being mounted to the outer end of the stem, the plunger slidably mounted within the barrel at the plunger end for reciprocal movement between a depressed position, with the inner end towards the needle end, and a retracted position, with the inner end spaced apart from the needle end, the barrel and plunger defining a variable volume region at the needle end, a partial vacuum being created in the variable volume region when the plunger moves towards the retracted position;

the stem having an interior sized to house the vial;

the barrel having an opening, communicating with the variable volume region, at the needle end;

means for selectively sealing said opening; and

means for transferring the contents of the vial along a path to the variable volume region when the variable volume region is at the partial vacuum, the transferring means including a hollow piercing member, having a piercing end, positioned within the interior of the stem opposite the pierceable membrane of the vial, and a one-way valve, formed as a part of the piston and positioned along said path to permit the contents of the vial to flow into the variable volume region;

whereby the transferred contents of the vial in the variable volume region can be injected through a hollow needle, mounted to the needle end, by the manipulation of the plunger.

13. A medicine container holding syringe structure comprising:

a barrel having a bore, a sealable needle end and a plunger end;

a plunger including a stem, having inner and outer ends, and a piston sized to sealingly engage the bore, the plunger slidably mounted within the barrel at the plunger end for reciprocal movement between a depressed position, with the inner end towards the needle end, and a retracted position, with the inner end spaced apart from the needle end, the barrel and plunger defining a variable volume region at the needle end, a partial vacuum being created in the variable volume region when the plunger moves towards the retracted position;

the stem having an interior sized to house the medicine container;

the barrel having a selectively sealable opening, communicating with the variable volume region, at the needle end; and

means for transferring the contents of the medicine container along a path to the variable volume region when the variable volume region is at the partial vacuum, the transferring means including a one-way valve along said path to permit the contents of the vial to flow into the variable volume region but not the reverse without any manipulation by the user, the oneway valve being formed as a part of the piston;

whereby the transferred contents of the medicine container in the variable volume region can be injected through a hollow needle, mounted to the needle end, by the manipulation of the plunger.