# US 10,864,330 B2 · System and method for safety syringe

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 10,864,330 B2
- Document ID: US10864330B2
- Status: Granted
- Kind: B2
- Application number: 15/801,259
- Filed: 2017-11-01
- Published: 2018-05-03
- Granted: 2020-12-15
- Earliest claimed: 2016-11-01
- Assignees: Credence Medsystems, Inc.
- Applicants: Credence MedSystems, Inc.
- Inventors: Gary Steese-Bradley; Stephen H. Diaz; Alan E. Shluzas; John F. Shanley; Jeff Tillack; Dan Thayer; John Merhige
- Web page: https://patentgrep.com/patent/US10864330B2

## CPC

- A61M 5/3221: {Constructional features thereof, e.g. to improve manipulation or functioning}
- A61M 5/178: Syringes
- A61M 5/2066: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 5/2448: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 5/28: Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
- A61M 5/284: {comprising means for injection of two or more media, e.g. by mixing}
- A61M 5/3137: {with finger grip means, e.g. for easy manipulation of the syringe rod}
- A61M 5/3148: {Means for causing or aiding aspiration or plunger retraction}
- A61M 5/31501: {Means for blocking or restricting the movement of the rod or piston (A61M5/5013 takes precedence)}
- A61M 5/31511: {Piston or piston-rod constructions, e.g. connection of piston with piston-rod (A61M5/5066 takes precedence)}
- A61M 5/31513: {Piston constructions to improve sealing or sliding}
- A61M 5/3202: {Devices for protection of the needle before use, e.g. caps (A61M5/50 takes precedence; protectors for sharps A61B50/3001)}
- A61M 5/322: {Retractable needles, i.e. disconnected from and withdrawn into the syringe barrel by the piston (devices for protecting guide needles in combination with catheters A61M25/0612)}
- A61M 5/3234: {Fully automatic needle retraction, i.e. in which triggering of the needle does not require a deliberate action by the user}
- A61J 1/2006: {Piercing means}
- A61J 1/2096: {Combination of a vial and a syringe for transferring or mixing their contents}
- A61M 5/3232: {Semi-automatic needle retraction, i.e. in which triggering of the needle retraction requires a deliberate action by the user, e.g. manual release of spring-biased retraction means}
- A61M 5/3293: {characterised by features of the needle hub}
- A61M 2005/3223: {Means impeding or disabling repositioning of used needles at the syringe nozzle}
- A61M 2005/323: {Connection between plunger distal end and needle hub proximal end, e.g. stud protruding from the plunger}
- A61M 2005/3231: {Proximal end of needle captured or embedded inside piston head, e.g. by friction or hooks}
- A61M 2005/3241: {Needle retraction energy is accumulated inside of a hollow plunger rod}
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}
- A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE

## Abstract

A system for mixing drug products and injecting includes a syringe body, proximal and distal stopper members disposed in the syringe body, a plunger member, and a needle hub assembly coupled to the distal needle interface of the syringe body. The proximal and distal stopper members form a proximal drug chamber between there between and a distal drug chamber between the distal stopper member and a distal end of the syringe body. The plunger member includes a needle retention feature, an energy-storage member, and an energy-storage member latching member all disposed in disposed in a plunger interior. First and second sizes of the respective proximal and distal drug chambers can be modified by movement of the proximal and distal stopper members relative to the syringe body. The needle is at least partially retractable into plunger interior upon manipulation of the plunger member relative to the syringe body.

## Claims

### Claim 1

A system for mixing drug products and injecting, comprising:
a syringe body defining a proximal opening 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 defining a plunger interior and configured to be manually manipulated to insert the proximal stopper member relative to the syringe body, the plunger member including
a needle retention feature disposed in the plunger interior,
an energy-storage member disposed in the plunger interior, and
an energy-storage member latching member disposed in the plunger interior; and
a needle hub assembly coupled to the distal needle interface of the syringe body, the needle hub assembly including
a needle having a needle proximal end feature,
a hub, and
a needle latching member configured to couple the needle to the hub,
wherein first and second sizes of the respective proximal and distal drug chambers can be modified by movement of the proximal and distal stopper members relative to the syringe body,
wherein the needle is at least partially retractable into plunger interior upon manipulation of the plunger member relative to the syringe body to transform the energy-storage member latching member from a latched state to an unlatched state,
wherein the proximal and distal stopper members each includes a respective concaved surface,
wherein the concave surface of the proximal stopper member faces a proximal direction,
wherein the concave surface of the distal stopper member faces a distal direction, and
wherein the distal stopper has a bushing disposed adjacent the concave surface of the distal stopper member, the bushing comprising
a funnel disposed at a distal end of the bushing, the funnel tapering in a proximal direction, such that an inner diameter of a distal end of the funnel is larger than an inner diameter of a proximal end of the funnel, and
a receiving space disposed at a proximal end of the bushing.

### Claim 2 (depends on 1)

The system of claim 1, wherein the needle is configured to pierce entirely through at least the distal stopper member to be retracted into the plunger interior.

### Claim 3 (depends on 1)

The system of claim 1, wherein the proximal and distal drug chambers respectively contain first and second components of a drug to be mixed together prior to injecting into a patient.

### Claim 4 (depends on 1)

The system of claim 1, wherein the funnel is configured to receive the needle proximal end feature and guide the needle into coaxial alignment with the distal stopper member.

### Claim 5 (depends on 1)

The system of claim 1, the proximal stopper having a screw disposed adjacent the concave surface of the proximal stopper member, the screw comprising
a funnel disposed at a distal end of the screw, the funnel tapering in a proximal direction, such that an inner diameter of a distal end of the funnel is larger than an inner diameter of a proximal end of the funnel, and
an elongate sealing space disposed at a proximal end of the screw.

### Claim 6 (depends on 1)

The system of claim 1, wherein the concave surface of the proximal stopper member comprises a thread.

### Claim 7 (depends on 1)

The system of claim 1, wherein the proximal and distal stopper members each includes a respective opposing surface,
wherein the opposing surface of the proximal stopper member faces a distal direction, and
wherein the opposing surface of the distal stopper member faces a proximal direction, and
wherein the respective opposing surfaces of the proximal and distal stopper members define the proximal drug chamber.

### Claim 8 (depends on 7)

The system of claim 7, where the respective opposing surfaces of the proximal and distal stopper members are each a concave surface, a planar surface, a convex surface, or a convex conical surface.

### Claim 9 (depends on 7)

The system of claim 7, the proximal and distal stoppers comprising respective first and second polymer coatings on respective opposing surfaces thereof, such that the proximal drug chamber is defined by the syringe body and the first and second polymer coatings.

### Claim 10 (depends on 1)

The system of claim 1, wherein the distal drug chamber contains a partial vacuum.

### Claim 11 (depends on 10)

The system of claim 10, wherein the distal stopper member comprises a proximal gate having a closed configuration wherein the needle proximal end feature cannot pass through the proximal gate, and an open configuration wherein the needle proximal end feature can pass through the proximal gate.

### Claim 12 (depends on 11)

The system of claim 11, wherein the proximal gate comprises a pair of movable arms operatively coupled to a pair of spring elements, the pair of spring elements biasing the proximal gate in the closed configuration.

### Claim 13 (depends on 11)

The system of claim 11, wherein the needle proximal end feature comprises a proximal shoulder that cannot past through the proximal gate in the closed configuration, but can pass through the proximal gate in the open configuration.

### Claim 14 (depends on 13)

The system of claim 13, wherein the proximal gate comprises a pair of movable arms operatively coupled to a pair of self-energizing hinges.

### Claim 15 (depends on 14)

The system of claim 14, wherein the needle comprises a distal shoulder that cannot past through the proximal gate in the closed configuration, but can pass through the proximal gate in the open configuration, and wherein the distal shoulder is distal of the proximal shoulder.

### Claim 16 (depends on 1)

The system of claim 1, wherein the system has
a transport configuration wherein the needle proximal end feature is disposed in the distal drug chamber,
a transfer configuration wherein the needle proximal end feature has at least partially pierced the distal stopper member and is at least partially disposed in the proximal drug chamber, and
a mixed configuration wherein the proximal and distal stopper members are in contact with each other, thereby transferring a first drug component from the proximal drug chamber to the distal drug chamber to mix the first drug component with a second drug component in the distal drug chamber.

### Claim 17 (depends on 16)

The system of claim 16, the syringe body comprising a position indicator configured to be adjacent with a distal end of the distal stopper when the system is in the mixed configuration.

### Claim 18 (depends on 16)

The system of claim 16, the plunger member comprising a retention clip configured to be selectively coupled to the syringe body when the system is in the mixed configuration to prevent proximal movement of the plunger member relative to the syringe body.

### Claim 19 (depends on 18)

The system of claim 18, wherein the retention clip is configured to generate an audible signal when the retention clip is selectively coupled to the syringe body.

### Claim 20 (depends on 16)

The system of claim 16, wherein the needle comprises:
a distal end opening;
a middle opening disposed in the distal drug chamber when the system is in the transport, transfer, and mixed configurations; and
a proximal opening disposed in the proximal drug chamber when the system is in the transfer configuration.

### Claim 21 (depends on 20)

The system of claim 20, wherein the needle further comprises a plurality of proximal openings, the proximal opening being one of the plurality of proximal openings, wherein at least some of the plurality of proximal openings are disposed in the proximal drug chamber when the system is in the transfer configuration, and wherein at least some of the plurality of proximal openings are configured to be occluded by the proximal stopper member when the system is in the mixed configuration.

### Claim 22 (depends on 21)

The system of claim 21, the proximal stopper member comprising a plug configured to occlude at least some of the plurality of proximal openings when the system is in the mixed configuration.

### Claim 23 (depends on 22)

The system of claim 22, wherein a length of the plug is greater than a distance between a proximal most opening of the plurality of proximal openings and a distal most opening of the plurality of proximal openings.

### Claim 24

A method for mixing and injecting medicine into a patient, comprising: providing a system comprising a syringe body defining a proximal opening and a distal needle interface at a distal end thereof, proximal and distal stopper members disposed in the syringe body, forming a proximal medicine chamber between the proximal and distal stopper members and a distal medicine chamber between the distal stopper member and the distal end of the syringe body, wherein the proximal and distal stopper members each includes a respective concave surface, wherein the concave surface of the proximal stopper member faces a proximal direction, and wherein the concave surface of the distal stopper member faces a distal direction, a plunger member defining a plunger interior and configured to be manually manipulated to insert the proximal stopper member relative to the syringe body, and a needle member having a distal needle tip, a medicine passage, a plurality of transfer openings, and a proximal end; and wherein the distal stopper has a bushing disposed adjacent the concave surface of the distal stopper member, the bushing comprising a funnel disposed at a distal end of the bushing, the funnel tapering in a proximal direction, such that an inner diameter of a distal end of the funnel is larger than an inner diameter of a proximal end of the funnel, and a receiving space disposed at a proximal end of the bushing; advancing the plunger member to pierce the proximal end of the needle member through the distal stopper to allow the passage of a first medicine component from the proximal medicine chamber through the medicine passage, and into the distal medicine chamber to allow mixing of the first medicine component with a second medicine component in the distal medicine chamber to form a mixed medicine; advancing the plunger member to inject the mixed medicine into a patient; and automatically retracting the distal needle tip into the syringe body when the mixed medicine has been injected into the patient.