Anti-aerosoling drug reconstitution device

• US 5,088,996 A
• Filed: 05/18/1987
• Issued: 02/18/1992
• Est. Priority Date: 04/16/1984
• Status: Expired due to Fees

• Current Assignee: ING Limited (ANZ Group Holdings Ltd.)
• Original Assignee: Robert E. Smith, Rudolph J. Kopfer
• Inventors: Smith, Robert E., Kopfer, Rudolph J.
• Primary Examiner(s): KONOPKA, PAUL
• Application Number:
  US07/052,175
• Time in Patent Office: 1,737 Days
• Field of Search: 604/56, 604/82, 604/83, 604/87, 604/88, 604/92, 604/125, 604/201, 604/407, 604/411, 604/414, 604/415, 604/416, 141/2, 141/19, 141/25-28, 141/329, 141/330, 141/369, 141/370, 141/372, 141/375, 141/383, 141/385, 141/386, 215/249, 215/247, 215/6
• US Class Current: 604/415
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2065 having aligning and guiding means
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: Y10S 215/03 Medical

Abstract

The present invention comprehends the provision of a fluid tight holding chamber which accumulates solution from the vial that aspirates during mixing or drawing fluid from the vial or is pressured out of the syringe upon extraction of the cannula from the vial. The holding chamber is defined in conjunction with the vial septum by a shield cap that surrounds and seals to the neck of the vial. The shield cap defines a guide for the cannula of the syringe and directs the cannula through a sealing member, the holding chamber, the septum and into the vial. One aspect of the invention provides a sleeve portion on the shield cap that receives and retains the syringe barrel. An arm is provided on the sleeve portion and has a notch that holds the syringe barrel in a predetermined position during shipment and storage of the assembly.

Claims

1. A shield structure for preventing exposure to a solution aspirating from a chamber in a vial that has a septum which is penetrable by a cannula on a syringe which is usable to withdraw solution from a vial and deliver withdrawn solution to a patient, said cannula being attached to a barrel of a syringe to establish communication through a puncture opening in the septum made by said cannula between the inside of the vial and a fluid retaining reservoir defined by the syringe barrel, said shield structure comprising:

a body portion having a vial end, a syringe end, and a surface between the ends of the body portion defining an internal fluid holding chamber, said body portion having an opening in the vial end in communication with said chamber;

means for connecting the body portion to a vial so that a vial septum sealingly closes the opening in the body portion and the surface of the body portion and septum cooperatively bound and make fluid tight the holding chamber; and

second means at the syringe end of the body portion for removably, sealingly admitting the cannula with the attached barrel into said fluid tight internal holding chamber and for resealing the holding chamber upon the removal of the cannula from the fluid tight internal holding chamber and separation of the cannula from the body portion so that said cannula with the attached barrel can be moved relative to the body portion and vial for passage through said second means, the fluid tight internal holding chamber, the septum and into the vial, the passage of the cannula through the septum forming a puncture opening in the septum to establish communication between the barrel and vial,

whereby said cannula with the attached barrel can be removably directed into the vial to reconstitute in and withdraw medicament in the vial from the vial and into the barrel;

said syringe being separable as a unit consisting of the barrel and cannula from the vial and entire shield structure for administration of the solution to a patient in conventional manner so that any solution remaining in the vial that aspirates through the puncture opening upon the cannula withdrawing from the septum is substantially confined in the fluid tight internal holding chamber, thereby protecting the user of the syringe from exposure to the aspirating solution.

2. The shield structure according to claim 1 wherein the syringe end of the body portion has a cavity opening away from the vial end for conforming to and guidingly accepting a portion of a syringe as the cannula on a syringe is directed through the internal holding chamber towards the vial.

3. The shield structure according to claim 1 wherein said vial has a neck and said connecting means comprises a cap at the vial end of the body portion that can be placed over a vial neck and a locking ring surrounding the cap on a vial neck in an assembled position for the shield structure and vial to maintain the cap on a vial neck.

4. The shield structure according to claim 1 wherein said body portion is made from a moldable plastic material.

5. The shield structure according to claim 1 wherein said second means comprises an imperforate self-sealing wall that is penetrable by the cannula.

6. The shield structure according to claim 1 wherein the holding chamber is defined at least partially by a wall on the body portion intermediate the syringe end and vial end and having an opening extending completely therethrough, a sealing member is provided, and means mount the sealing member on said wall so that the sealing member seals the opening in the wall, said sealing member being readily penetrable by the cannula and self-sealing upon removal of the cannula from the body portion.

7. The shield structure according to claim 1 wherein a bleeder vent is provided, means mount the bleeder vent to the body portion for communication between the holding chamber and the atmosphere, said bleeder vent permitting pressure reduction in the holding chamber, and filter means are provided in the vent for filtering harmful materials attempting to escape from the holding chamber.

8. The shield structure according to claim 1 wherein a cylindrical sleeve is provided, means are provided for attachment of the cylindrical sleeve to the syringe, and means are provided for mating said sleeve closely telescopingly with the body portion for guiding movement of the syringe toward and away from the vial.

9. The shield structure according to claim 2 including a deformable annular ring and means for fixedly seating the annular ring in the cavity in the syringe end of the body portion, said ring engageable with the syringe for sealing between the syringe and the body portion.

10. The shield structure according to claim 3 wherein said vial has an enlarged rim defining a shoulder, said vial end of the body portion has a cylindrical configuration and a radially inwardly projecting rib, said locking ring compressibly forcing the rib into radially overlapping relationship with the shoulder in the assembled position of the shield structure and vial to prohibit axial separation of a vial and the shield structure.

11. The shield structure according to claim 10 wherein said vial end of the body portion has a plurality of axial slits which permit axial compression of the cap and allow expansion of the cap radially outwardly to assist placement of the vial end of the body portion over the vial neck.

12. The shield structure according to claim 1 wherein a sleeve portion is integrally formed on the syringe end of the body portion, the sleeve portion of the body has an arm axially extending from the sleeve portion for engaging a flange on a syringe to retain the syringe and the cannula in a fixed position relative to the body portion.

13. The shield structure according to claim 3 wherein notches are formed on the cap for preventing the locking ring from backing off of said cap.

14. The shield structure of claim 1 wherein means are formed on said body portion for retaining a syringe barrel in a fixed position relative to the shield structure.

15. The shield structure as claimed in claim 14 wherein a closure is tethered to said retaining means, said closure seating in the end of the syringe barrel during storage and shipment of the shield assembly.

16. The shield structure as claimed in claim 15 wherein said closure has an arm integrally formed on said sleeve portion.

17. The shield structure as claimed in claim 16 wherein at least one notch is formed in said arm for engaging with a flange on said syringe barrel to retain the syringe in a fixed predetermined position.

18. A vial assembly for connection with a syringe having a cannula and an associated fluid retaining barrel with an outer surface, to allow delivery of solution into and withdrawal of solution from a vial without exposure of a user of the syringe to the solution, said vial assembly comprising:

a vial having a chamber for retaining a supply of solution;

a septum on said vial penetrable by said cannula;

a shield structure having a syringe end, a vial end and a surface defining a fluid holding chamber;

means for connecting the shield structure to the vial so that the holding chamber surface and vial septum cooperatively define a fluid tight internal holding chamber and for permitting the syringe to be entirely separated from the shield structure, said vial chamber and internal holding chamber being substantially sealed from each other by the septum to prevent inadvertent passage of solution in said vial chamber into the holding chamber; and

first means at the syringe end of the shield structure for removably admitting the cannula into the holding chamber, for self-sealing to maintain said holding chamber fluid tight to prevent the passage of fluid out of the fluid tight holding chamber upon removal of the cannula from the holding chamber and separation of the cannula from the shield structure, and for preventing the solution from contacting the outer surface of the barrel wherein it might be contacted by a user of the syringe,

said fluid tight internal holding chamber capturing solution that escapes from the vial during filling of the vial and upon withdrawal of the cannula with its associated barrel from the vial

said syringe being usable in conventional manner upon being separated from said shield structure to administer the solution in the barrel to a patient and without exposing a user of the syringe to the escaped solution.

19. The vial assembly according to claim 18 wherein means are provided at the syringe end of the shield structure for accepting and guiding a portion of the syringe as the cannula is directed relative to the body portion towards and away from the holding chamber and said first means comprises a sealing member on a surface bounding the cavity.

20. The vial assembly according to claim 18 wherein a seal is provided and means removably attach the seal at the syringe end of the shield structure to prevent contamination of the holding chamber.

21. The vial assembly according to claim 20 wherein said cannula has a fixed hub, there is a cavity at the syringe end of the body to receive the fixed hub, the cavity is defined by a peripheral wall and said peripheral wall has a plurality of ribs extending into the cavity, there being means on the hub to engage said ribs so that the ribs are grippingly engaged with the hub and the barrel can be rotated relative to the hub with the cannula hub pressed into the cavity to tighten the cannula hub onto the barrel.

22. A method of mixing a solution in and drawing a liquid solution from a chamber in a vial having a protective septum using a syringe with a cannula and an associated barrel and aspirating a portion of the solution outside the vial without exposing a user to the aspirated portion of the solution, said method comprising the steps of:

attaching a shield structure that is entirely separable from the syringe and vial which shield structure comprises a cap having a surface defining a fluid holding chamber with an opening that is sealed by the vial septum with the shield structure and syringe attached to make the holding chamber fluid tight and wherein the septum prevents inadvertent communication of solution between the holding chamber and the vial chamber;

moving the syringe relative to the shield structure having the holding chamber and thereby extending the cannula through a self-sealing member, through the fluid tight internal holding chamber, through the septum and into the vial;

discharging a first medicament from the syringe into a second medicament in the vial;

mixing the first and second medicaments to form a liquid solution;

drawing the liquid solution from the vial into the syringe barrel through the cannula;

pulling the cannula out of the septum of the vial so that the discharge end of the cannula is situated in the fluid tight internal holding chamber;

expelling a portion of the solution in the syringe into the fluid tight internal holding chamber so that the expelled solution is safely confined in the holding chamber; and

removing the syringe including the cannula and barrel from the shield structure through said self-sealing member so that the syringe and shield structure are completely separated, one from the other, and so that the syringe is available for intravenous injection of the solution in a conventional manner.

23. A method of drawing a liquid solution from a chamber in a vial having a protective septum using a syringe with a cannula and an associated barrel and aspirating a portion of the solution outside the vial without exposing a user to the aspirated portion of the solution, said method comprising the steps of:

attaching a shield structure that is separable from the syringe and vial and comprises a cap which in conjunction with the vial septum defines a fluid tight holding chamber bounded partially by said vial septum onto the vial in fluid tight relation so that the septum blocks communication of solution from the vial chamber into the holding chamber;

moving the syringe relative to the shield structure having the holding chamber and thereby extending the cannula through a self-sealing member on the shield structure, through the fluid tight internal holding chamber, through the septum and into the vial;

drawing liquid solution from the vial into the syringe barrel through the cannula;

pulling the cannula out of the septum of the vial so that the discharge end of the cannula is situated in the fluid tight internal holding chamber;

expelling a portion of the solution in the syringe into the fluid tight internal holding chamber; and

separating the syringe including the cannula and barrel as a unit from the shield structure,

whereby said syringe can be used in conventional manner to administer the solution in the barrel to a patient and said fluid tight internal holding chamber substantially confines the expelled portion of the solution safely away from the syringe user.