# US 10,245,385 B2 · Removable disposable container for medicament delivery and training

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- Number: US 10,245,385 B2
- Document ID: US10245385B2
- Status: Granted
- Kind: B2
- Application number: 14/208,357
- Filed: 2014-03-13
- Published: 2014-09-18
- Granted: 2019-04-02
- Earliest claimed: 2013-03-15
- Assignees: Jbcb Holdings, LLC
- Applicants: Jeff Baker; Mark Bunker; Paul Van der pol; Hou Shi Shuang
- Inventors: Jeff Baker; Mark Bunker; Paul Van der pol; Hou Shi Shuang
- Web page: https://patentgrep.com/patent/US10245385B2

## CPC

- A61M 5/31566: {Means improving security or handling thereof}
- A61M 5/14212: {Pumping with an aspiration and an expulsion action}
- A61M 5/1456: {with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir}
- A61M 5/19: having more than one chamber
- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- A61M 5/2033: {Spring-loaded one-shot injectors with or without automatic needle insertion (multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287)}
- A61M 5/31573: {Accuracy improving means}
- G09B 23/285: {for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas}
- A61M 5/1454: {spring-actuated, e.g. by a clockwork}
- A61M 5/206: {with automatic needle insertion}
- A61M 5/3158: {the component being manually operated or triggered by an axially moving actuator operated by user, e.g. an axially movable injection button}
- A61M 5/3221: {Constructional features thereof, e.g. to improve manipulation or functioning}
- 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 2005/14252: {with needle insertion means}
- A61M 2005/1426: {with means for preventing access to the needle after use}
- A61M 2005/14288: {Infusion or injection simulation}
- A61M 2005/14513: {with secondary fluid driving or regulating the infusion}
- A61M 2005/14533: {cam actuated}
- A61M 2205/18: with alarm
- A61M 2205/3368: Temperature
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/58: Means for facilitating use, e.g. by people with impaired vision
- A61M 2205/6072: Bar codes
- 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)}
- G09B: EDUCATIONAL OR DEMONSTRATION APPLIANCES; APPLIANCES FOR TEACHING, OR COMMUNICATING WITH, THE BLIND, DEAF OR MUTE; MODELS; PLANETARIA; GLOBES; MAPS; DIAGRAMS (devices for psychotechnics or for testing reaction times A61B5/16; games, sports, amusements A63; projectors, projector screens G03B)

## Abstract

Embodiments of the invention include a medicament device configured to provide stepwise instructions for using the device to a user in a particular sequence is provided. The device includes a reusable housing configured to receive a container, the reusable housing including a control interface, the control interface including at least one responsive member reactive to a user input, an actuation member configured to interact with the container, a signal output component associated with the reusable housing; and circuitry associated with the reusable housing configured to control a provision of the stepwise instructions to the user in the particular sequence.

## Claims

### Claim 1

A medicament device configured to provide stepwise instructions for using the device to a user in a particular sequence, the device comprising:
a reusable housing comprising a receptacle for receiving a container, said reusable housing comprising a control interface, the control interface comprising at least one responsive member reactive to a user input;
a container removably receivable within the receptacle, the container comprising a first housing and a second housing, a first spring disposed between the first and second housings, and an injection member or an Injection simulation member associated with a lower portion of the first housing, a first contaminant barrier disposed at a distal portion of the second housing and a second contaminant barrier disposed between the first and second housings;
an actuation member configured to interact with the container;
a signal output component associated with the reusable housing;
circuitry associated with the reusable housing configured to control a provision of the stepwise instructions to the user in the particular sequence;
at least one sensor to detect a condition of the device, wherein the at least one sensor comprises a sensor for detecting a contact between the device and the user; and
a program code module to record an error condition of the device, wherein the error condition comprises an error in using the device based at least in part on an input form the at least one sensor, said error condition comprising at least one of: 1) a use of the device in an incorrect sequence; 2) a failure to complete a step in the use of the device; or 3) a failure to perform one or more steps in the sequence within a predetermined time period, such that a feedback is provided to the user via the signal output component about the use of the device during the use, and sterility of the injection member or injection simulation member is maintained from prior to insertion of the container into the reusable housing through delivery member from the container by at least the first and second contaminant barriers, and sterility of a medicament contained within the first housing is maintained by at least the second contaminant barrier until the medicament is delivered through the injection member.

### Claim 2 (depends on 1)

The medicament device of claim 1, wherein the first spring is disposed between the lower portion of the first housing and a lower portion of the second housing, wherein the first housing is movable relative to the second housing; and a plunger component associated with the first housing, said plunger component being movable relative to the first housing, wherein the actuation member interacts with the container to move the first housing in a first direction relative to the second housing, and the plunger in the first direction relative to the first housing.

### Claim 3 (depends on 2)

The medicament device of claim 2, wherein that activation of the actuation member forces the plunger to move in the first direction relative to the first housing to deliver the medicament to the injection member after the first housing moves in the first direction relative to the second housing to eject the injection member through a first contaminant barrier disposed at a lower portion of the second housing, and the first spring is biased.

### Claim 4 (depends on 3)

The medicament device of claim 3, wherein the first housing moves relative to the second housing in a second direction such that the first spring is released, and the injection member is retracted into the second housing to prevent an unintentional contact with the injection member.

### Claim 5 (depends on 2)

The medicament device of claim 2, wherein the plunger moves relative to the first housing in the first direction to simulate delivery of medicament from the first housing after the first housing moves relative to the second housing in the first direction to eject the injection simulation member from the second housing, and bias the first spring disposed between a lower portion of the first housing and a lower portion of the second housing.

### Claim 6 (depends on 5)

The medicament device of claim 5, wherein activation of the actuation member forces the plunger to move in the first direction relative to the first housing.

### Claim 7 (depends on 5)

The medicament device of claim 5, wherein a first contaminant barrier is disposed at the lower portion of the second housing, and wherein the injection simulation member traverses the first contaminant barrier when the injection simulation member is ejected from the second housing.

### Claim 8 (depends on 5)

The medicament device of claim 5, wherein the first spring is released such that the first housing moves relative to the second housing in the second direction to retract the injection simulation member into the second housing to prevent an unintentional contact with the injection simulation member.

### Claim 9 (depends on 1)

The medicament device of claim 1 comprising a training mode and/or a medicament delivery mode.

### Claim 10 (depends on 1)

The medicament device of claim 1, wherein an output of the device from the signal output component is initiated in response to a predetermined value detected for the condition.

### Claim 11 (depends on 1)

The medicament device of claim 1, wherein the sensor is an orientation sensor, provided to detect an orientation of the device.

### Claim 12 (depends on 11)

The medicament device of claim 11, wherein the signal output component is initiated if the detected orientation of the device meets a predetermined orientation.

### Claim 13 (depends on 1)

The medicament device of claim 1, wherein the signal output component is initiated if the detected contact of the device meets a predetermined contact value.

### Claim 14 (depends on 1)

The medicament device of claim 1, wherein the sensor is a perpendicularity sensor provided to detect the perpendicularity of the device relative to a surface of the user.

### Claim 15 (depends on 14)

The medicament device of claim 14, wherein the signal output component is initiated if the detected perpendicularity of the device meets a predetermined perpendicularity value.

### Claim 16 (depends on 1)

The medicament device of claim 1, wherein the sensor is provided to detect alignment of the device during the medicament delivery simulation.

### Claim 17 (depends on 16)

The medicament device of claim 16, wherein the signal output component is initiated if the detected alignment of the device meets a predetermined alignment value.

### Claim 18 (depends on 1)

The medicament device of claim 1, wherein the sensor is provided to detect a location of the device for the medicament delivery simulation.

### Claim 19 (depends on 12)

The medicament device of claim 12, wherein the signal output component is initiated if the detected location of the device meets a predetermined location value.

### Claim 20 (depends on 1)

The medicament device of claim 1, wherein an output of the device from the signal output component is initiated in response to a predetermined elapsed time value occurring within the particular sequence of stepwise instructions.

### Claim 21 (depends on 20)

The medicament device of claim 20, wherein the predetermined elapsed time value comprises a pause between the steps of the stepwise instructions.

### Claim 22 (depends on 1)

The medicament device of claim 1, wherein an output of the device from the signal output component is initiated when the user performs one or more steps in the particular sequence within a predetermined time period.

### Claim 23 (depends on 1)

The medicament device of claim 1, wherein the container comprises a container information component, wherein said container information component comprises information of a medicament contained in the container.

### Claim 24 (depends on 23)

The medicament device of claim 23, wherein the reusable component comprises a container information component reader, wherein said container information component reader can read information contained in the container information component.

### Claim 25 (depends on 1)

The medicament device of claim 1, wherein the feedback comprises 1) the quality of training or actual medicament delivery; 2) areas of improvement; and/or 3) positive feedback where the user has complied with the use of the device.

### Claim 26

A medicament device configured to provide stepwise instructions for using the device to a user in a particular sequence, the device comprising:
a container comprising a first housing and a second housing, a first spring disposed between the first and second housings, and or an injection simulation member associated with a lower portion of the first housing, said reusable housing comprising a control interface and an actuation member configured to interact with the container;
a reusable housing configured to receive the container;
a signal output component associated with the reusable housing to provide an output to a user;
circuitry associated with the reusable housing configured to control a provision of the stepwise instructions to the user in the particular sequence;
at least one sensor for detecting contact between the device and the user; and
a program code module to detect an error condition based on input from the at least one sensor, wherein the error condition comprises:
1) incorrect positioning or contact between the device and the user for a predetermined time value, or
2) failure to complete a step,
preventing adequate delivery of the medicament.

### Claim 27 (depends on 26)

The medicament device of claim 26, wherein the at least one sensor detects a contact between the reusable housing or the container and the user.

### Claim 28

A medicament device configured to provide stepwise instructions for using the device to a user in a particular sequence, the device comprising:
a reusable housing configured to receive a container, said reusable housing comprising a control interface;
an actuation member configured to interact with the container;
a signal output component associated with the reusable housing to provide an output to a user;
an injection member;
a sensor for detecting a contact with the injection member;
circuitry associated with the reusable housing configured to control a provision of the stepwise instructions to the user in the particular sequence; and
a program code module to record an error condition of the device, wherein the error condition comprises removal of contact with the injection member after actuation of the actuation member, and prior to completion of an injection.

### Claim 29 (depends on 28)

The medicament device of claim 28, further comprising a sensor to detect contact between the device and the user.
