System and method for safety syringe

Patent metadata

Field	Value
Publication number	US-2020268973-A1
Application number	US-202016798188-A
Country	US
Kind code	A1
Filing date	Feb 21, 2020
Priority date	Feb 22, 2019
Publication date	Aug 27, 2020
Grant date	—

Abstract

A method for preparing a pre-filled multi-chamber injection system includes providing an injection system body, the injection system body defining an open proximal end, a body interior, and an open distal end. The method also includes introducing a first substance into a distal end of the body interior. The method further includes disposing a distal stopper member in the body interior, the distal stopper member and the injection system body defining proximal and distal chambers in the body interior. Moreover, the method includes introducing a second substance into the body interior. In addition, the method includes disposing a proximal stopper member in the body interior. The method also includes inserting an elongate member at least partially into the body interior, the elongate member having a plurality of flow channels for fluidly coupling the proximal and distal chambers. The method further includes coupling a plunger member to the proximal stopper member.

First claim

1 . A method for preparing a pre-filled multi-chamber injection system, the method comprising:
providing an injection system body, the injection system body defining an open proximal end, a body interior, and an open distal end; introducing a first substance into a distal end of the body interior; disposing a distal stopper member in the body interior through the open proximal end of the injection system body, the distal stopper member and the injection system body defining proximal and distal chambers in the body interior, wherein the first substance is disposed in the distal chamber; introducing a second substance into the body interior; disposing a proximal stopper member in the body interior through the open proximal end of the injection system body, such that the proximal stopper member defines a proximal end of the proximal chamber, wherein the second substance is disposed in the proximal chamber; inserting an elongate member at least partially into the body interior, the elongate member having a plurality of flow channels for fluidly coupling the proximal and distal chambers and a proximal end configured to penetrate the distal stopper member; and coupling a plunger member to the proximal stopper member.

2 . The method of claim 1 , wherein introducing the first substance into the distal end of the body interior comprises introducing a liquid into the distal end of the body interior and lyophilizing the liquid.

3 . The method of claim 1 , wherein introducing the first substance into the distal end of the body interior comprises introducing a powder or solid into the distal end of the body interior.

4 . The method of claim 1 , further comprising disposing the injection system body in a rack in a first configuration before disposing the distal stopper member in the body interior,
wherein, when the injection system body is in the first configuration, the distal end of the injection system body is pointed in a downward direction.

5 . The method of claim 4 , further comprising turning the injection system body in the rack to a second configuration before introducing the first substance into the distal chamber through the open distal end
wherein, when the injection system body is in the first configuration, the proximal end of the injection system body is pointed in a downward direction.

6 . The method of claim 5 , further comprising returning the injection system body in the rack to the first configuration before introducing a second substance into the body interior and disposing the proximal stopper member in the body.

7 . The method of claim 6 , wherein the rack comprises a feature to hold the injection method body in the first and second configurations in the rack.

8 . The method of claim 1 , the distal stopper member comprising a funnel therein, the method further comprising the funnel guiding the needle proximal end to a center of the distal stopper member.

9 . The method of claim 8 , the funnel comprising a U-shaped retaining member/detent.

10 . The method of claim 9 , the needle proximal end comprising a 3D arrowhead shape, the method further comprising the 3D arrowhead interfering with the U-shaped retaining member/detent to temporarily prevent distal movement of the distal stopper member.

11 . The method of claim 1 , further comprising lyophilizing the first substance in distal chamber before coupling the needle hub assembly to the distal end of the injection system body.

12 . The method of claim 1 , further comprising utilizing a pressure differential on proximal and distal sides of the proximal stopper member to insert the proximal stopper member into the body interior through the open proximal end of the injection system body.

13 . The method of claim 12 , further comprising maintaining a vacuum in the proximal chamber during insertion of the proximal stopper member into the body interior through the open proximal end of the injection system body.

14 . The method of claim 12 , further comprising disposing the proximal stopper member above the open proximal end of the injection system body before inserting the proximal stopper member into the body interior.

15 . The method of claim 1 , further comprising disposing a tube adjacent the proximal stopper member such that the proximal chamber is fluidly coupled to an atmosphere during insertion of the proximal stopper member into the body interior through the open proximal end of the injection system body.

16 . The method of claim 1 , further comprising maintaining a vacuum in the distal chamber during the method.

17 . The method of claim 1 , further comprising performing one or more steps of the method in a vacuum.

18 . The method of claim 1 , further comprising coupling a flange to the injection system body such that the flange is preventing from moving along a longitudinal axis and the plunger is moveable on the longitudinal axis relative to the flange.

19 . The method of claim 18 , further comprising coupling the plunger to the proximal stopper member to facilitate movement of the proximal stopper member along the longitudinal axis.

20 . The method of claim 1 , wherein the injection system body, the needle hub assembly, and the proximal and distal stopper members are pre-sterilized.

21 . The method of claim 1 , further comprising preparing a plurality of pre-filled multi-chamber injection systems.

22 . The method of claim 1 , further comprising introducing a third substance into the body interior through the open proximal end; and
disposing a second proximal stopper member in the body interior through the open proximal end of the injection system body, such that the second proximal stopper member defines a proximal end of a second proximal chamber, wherein the third substance is disposed in the second proximal chamber.

23 - 58 . (canceled)

Assignees

• Credence Medsystems Inc

Inventors

• Tillack Jeff
• Shluzas Alan E
• Diaz Stephen H
• Steese-Bradley Gary
• Merhige John
• Shanley Conor Edward
• Leung Mina M

Classifications

• A61J1/062 Primary

  Carpules · CPC title

• A61M5/2066

  comprising means for injection of two or more media, e.g. by mixing · CPC title

• A61M5/3291

  Shafts with additional lateral openings · CPC title

• A61M5/31596

  comprising means for injection of two or more media, e.g. by mixing · CPC title

• A61M2005/3114

  Filling or refilling · CPC title