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Publication Number

US-12064603-B2

Patent

Publication Date

2024-08-20

Expiration 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.

Core Innovation

The invention relates to an injection system that includes a syringe body with a proximal opening and a distal needle interface, and proximal and distal stopper members disposed in the syringe body. The stopper members form 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 is configured to be manually manipulated to insert the proximal stopper member relative to the syringe body, and the plunger member has a smooth exterior surface.

The injection system further includes a fluid conveying assembly and a finger flange comprising an anti-retraction mechanism. The anti-retraction mechanism includes 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.

The finger flange also includes an opening having an edge configured to interfere with and retain the anti-retraction mechanism in the recess. In additional configurations, the anti-retraction mechanism can include a plurality of fit tabs configured to reduce a tolerance between the recess and a dimension of the anti-retraction mechanism, can have a C shape, and the brake tab can penetrate the smooth exterior surface of the plunger member when the plunger member moves proximally relative to the anti-retraction mechanism.

Claims Coverage

The provided claim set includes four independent claims. Across these claims, the inventive coverage is directed to an injection system with proximal and distal stopper-defined drug chambers and a finger flange anti-retraction mechanism that prevents proximal plunger movement.

Anti-retraction finger flange mechanism cooperating with flange opening edge

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

Fit tabs reducing tolerance between recess and anti-retraction mechanism

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, 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.

C-shaped anti-retraction mechanism

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, wherein the anti-retraction mechanism has a C shape.

Brake tab penetrating smooth plunger exterior during proximal movement

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

Across the independent claims, the core claim coverage is an injection system with proximal and distal stopper-defined drug chambers and a finger flange anti-retraction mechanism that prevents proximal plunger movement. The main distinctions between the independent claims are tolerance-reducing fit tabs, a C shape, and a brake tab configured to penetrate the smooth exterior surface of the plunger.

Stated Advantages

Prevents proximal movement of the plunger member relative to the brake tab.

Maintains the anti-retraction mechanism in a recess in the finger flange.

Interferes with and retains the anti-retraction mechanism in the recess via an opening edge.

Reduces tolerance between the recess and a dimension of the anti-retraction mechanism.

Penetrates the smooth exterior surface of the plunger member to prevent proximal movement.

Documented Applications

Not explicitly described in patent.

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