System and method for safety syringe

Patent metadata

Field	Value
Publication number	US-2023147715-A1
Application number	US-202218091959-A
Country	US
Kind code	A1
Filing date	Dec 30, 2022
Priority date	Feb 22, 2019
Publication date	May 11, 2023
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

What is claimed is:

1 . An injection system, comprising:
a syringe body defining a proximal opening at a proximal end thereof and a distal needle interface at a distal end thereof; proximal and distal stopper members disposed in the syringe body, forming a proximal drug chamber between the proximal and distal stopper members and a distal drug chamber between the distal stopper member and the distal end of the syringe body; a plunger member configured to be manually manipulated to insert the proximal stopper member relative to the syringe body, wherein the plunger member has a smooth exterior surface; a fluid conveying assembly; and a finger flange comprising an anti-retraction mechanism, the anti-retraction mechanism having
a brake tab configured to provide an opposing force to the plunger member to prevent proximal movement thereof relative to the brake tab, and
a retention feature configured to maintain the anti-retraction mechanism in a recess in the finger flange.

2 . The system of claim 1 , wherein the finger flange further comprises another recess configured to mount the finger flange on a flange of the syringe body.

3 . The system of claim 1 , wherein the anti-retraction mechanism further comprises a plurality of fit tabs configured to reduce a tolerance between the recess and a dimension of the anti-retraction mechanism.

4 . The system of claim 1 , wherein the anti-retraction mechanism is a metal clip.

5 . The system of claim 1 , wherein the brake tab is an elastic and self-energizing pawl.

6 . The system of claim 5 , wherein the brake tab is disposed at an acute angle in a distal direction relative to a plane of the anti-retraction mechanism.

7 . The system of claim 6 , wherein the acute angle and an elasticity of the brake tab increases a frictional force against the plunger member upon retraction in a proximal direction.

8 . The system of claim 6 , wherein the acute angle and an elasticity of the brake tab cause the brake tab to exerts an outward force through the anti-retraction mechanism to an inner wall of the finger flange when the plunger member is retracted in a proximal direction.

9 . The system of claim 1 , wherein the finger flange further comprises an opening having an edge configured to interfere with and retain the anti-retraction mechanism in the recess.

10 . The system of claim 1 , wherein the anti-retraction mechanism has a “C” shape.

11 . The system of claim 1 , wherein the anti-retraction mechanism has an “O” shape.

12 . The system of claim 1 , wherein the anti-retraction mechanism prevents removal of the plunger member from the syringe body after the plunger member has been inserted into the syringe body.

13 . The system of claim 1 , wherein the opposing force comprises a frictional force and a reaction force.

14 . The system of claim 1 , wherein the brake tab is configured to penetrate the smooth exterior surface of plunger member when the plunger member moves proximally relative to anti-retraction mechanism.

15 . A multiple chamber safe injection system, comprising:
a syringe body defining a syringe body interior and a distal coupling member at a distal end thereof; proximal and distal stopper members disposed in the syringe body interior, forming a proximal chamber between the proximal and distal stopper members and a distal chamber between the distal stopper member and the distal end of the syringe body; a plunger member configured to be manually manipulated to insert the proximal stopper member relative to the syringe body; a mix tube disposed in the syringe body interior; and a vent plug disposed at least partially in the distal coupling member and defining a plurality of channels configured to allow a gas to exit the syringe body interior while forming a liquid tight seal.

16 . An autoinjector system, comprising:
a disposable injection system comprising
an injection system body having proximal and distal ends, and an injection system body interior therebetween,
a stopper member disposed in the injection system body interior,
a plunger member coupled to the stopper member,
a finger flange coupled to the injection system body at the proximal end thereof,
a needle hub assembly coupled to the injection system body at the distal end thereof, and
a rigid needle shield coupled to the needle hub assembly; and
a reusable drive system, comprising
a drive system body having a drive system body interior,
a plunger actuator/pusher to move the plunger member distally relative to the injection system body when the injection system is mounted in the drive system, and
a flange holder/carriage to move the injection system distally or proximally relative to the drive system body when the injection system is mounted in the drive system.

17 . The system of claim 16 , the drive system further comprising:
a first motor to move the plunger actuator/pusher; a second motor to move the flange holder/carriage; a controller operatively coupled to the first and second motors; a display operatively coupled to the controller; and a sensor operative coupled to the controller.

18 . The system of claim 17 , wherein the sensor is selected from the group consisting of an accelerometer, a contact sensor, a position sensor, a gyroscope, a thermometer, and a skin contact sensor.

19 . The system of claim 17 , wherein the drive system comprises a plurality of sensors.

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

• A61M2005/3114

  Filling or refilling · CPC title

• A61M5/31596

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

• A61M5/2066

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

• A61M2005/3132

  having flow passages for injection agents at the distal end of the barrel to bypass a sealing stopper after its displacement to this end due to internal pressure increase · CPC title

• A61M5/284

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