# US 7,740,612 B2 · Self-administration injection system

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- Number: US 7,740,612 B2
- Document ID: US7740612B2
- Status: Granted
- Kind: B2
- Application number: 12/107,160
- Filed: 2008-04-22
- Published: 2009-01-29
- Granted: 2010-06-22
- Earliest claimed: 2007-07-27
- Assignees: Milestone Scientific, Inc.
- Inventors: Mark N. Hochman
- Web page: https://patentgrep.com/patent/US7740612B2

## CPC

- A61M 5/20: Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically (A61M5/142 takes precedence)
- G09B 23/285: {for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas}
- G16H 20/17: delivered via infusion or injection
- A61M 5/24: Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or cartridges, e.g. automatic
- A61M 5/31546: {Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons}
- A61M 5/482: {Varying injection pressure, e.g. by varying speed of injection}
- A61M 2205/3584: using modem, internet or Bluetooth®
- A61M 2205/50: with microprocessors or computers
- A61M 2205/502: User interfaces, e.g. screens or keyboards
- A61M 2205/505: Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
- A61M 2205/52: with memories providing a history of measured variating parameters of apparatus or patient
- A61M 2205/581: by audible feedback
- 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)
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

Self-injection system allows a user to inject a drug from a cartridge carrying unique identification information, into any one of a plurality of injection sites. Tissue at each injection site is associated with at least one injection parameter, such as flow-rate, that is different for each site. A scanner reads the identification information of the cartridge and cooperates with a central processing unit to determine the validity of the drug in order to permit an injection procedure to commence. The central processing unit has a memory for storing the different injection parameters and controls a drive unit for driving fluid from the cartridge and through a needle into the selected tissue, at the injection parameter that is associated with the user selected tissue for the injection.

## Claims

### Claim 1

A self-administration injection apparatus for allowing a user to inject a fluid medicament into a selected tissue of the user at a level of at least one injection parameter that the user finds comfortable and can set for an injection process, the apparatus comprising:
a platform;
a fluid medicament containing cartridge carrying unique identification information about the medicament, the cartridge being disposable and detachably connected to the platform;
a cartridge holder capable of accepting the fluid medicament containing cartridge and being connected to the platform;
a handpiece with tubing connected to at least one of the cartridge and cartridge holder, and a needle connected to the tubing, the handpiece being held by the user for manual insertion of the needle into a selected tissue of the user at any one of a plurality of injection sites, the tissue at each injection site being associated with at least one injection parameter that is different for each injection site;
an identification reader connected to the platform for reading the unique identification information of the medicament containing cartridge;
a drive unit in the platform for driving fluid medicament from the cartridge, through the tubing and the needle, and into a selected tissue of the user at the one of the injection sites selected by the user, during the injection process, and at the injection parameter that is associated with the selected tissue at the injection site that is selected by the user;
a drive unit control for controlling the drive unit to drive medicament from the cartridge at the injection parameter;
a central processing unit connected to the identification reader for cooperating with the identification reader to obtain information regarding at least one of the medicament in the cartridge and the injection parameter, based on the unique identification information of the cartridge, the central processing unit being connected to the drive unit control for performing the injection process at one of the injection parameters corresponding to the injection site selected by the user;
a memory connected to the central processing unit for storing a plurality of the different injection parameters associated with tissues at the plurality of injection sites for the user;
information output means connected to the central processing unit for providing information to the user about the injection process;
operation input means connected to the central processing unit and being operated by the user to selecting the injection site for the injection process and for controlling initiation of the injection process, the central processing unit responding to a user selection of one of the injection sites to control the injection process to proceed at the injection parameter for the associated tissue at the selected injection site;
up-loading means for up-loading and for storing additional information including at least one of injection parameters, medicament information, general information and instructions to said central processing unit and memory, of additional information and additional injection profiles with different injection parameters associated with tissues at the plurality of injection sites; and
the central processing unit being programmed to perform a training session to determine from the user, a user-selected level of at least one of the injection parameters that the user finds comfortable for an injection process into the selected tissue, and for storing the level in the memory, the central processing unit causing each injection process to be performed at not greater than the level of the at least one of the injection parameters that the user finds comfortable.

### Claim 2 (depends on 1)

The apparatus of claim 1, including an injection schedule calendar stored in the memory, a clock for determining a current time, and reminder means programmed into the central processing unit for reminding the user when a next injection process is due by activation of the information output means.

### Claim 3 (depends on 1)

The apparatus of claim 1, including a sensor for sensing at least one injection parameter for each injection process, an injection schedule calendar stored in the memory, a clock for determining a current time, reminder means programmed into the central processing unit for reminding the user when a next injection process is due by activation of the information output means, the central processing unit including data recording means for recording a time when each injection process is performed and the injection parameter for each injection process and creating injection data for each injection and for storing the injection data in the memory.

### Claim 4 (depends on 1)

The apparatus of claim 1, including medical history information about the user stored in the memory, a sensor for sensing the at least one injection parameter for each injection process including an amount of medicament injected, an injection schedule calendar stored in the memory, a clock for determining a current time, reminder means programmed into the central processing unit for reminding the user when a next injection process is due by activation of the information output means, the central processing unit including data recording means for recording a time when each injection process is performed and the injection parameter for each injection process including the amount of medicament injected, and creating injection data for each injection and for storing the injection data in the memory, the apparatus including communication means for communicating the injection data from the apparatus so that a medical practitioner for the user can access the injection information.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the information output means includes a visual display for providing the user with a visual indication of each injection site to facilitate a user selection of the selected injection site for an injection process and other information related to the injection process.

### Claim 6 (depends on 1)

The apparatus of claim 1, wherein the information output means includes auditory information for providing the user information related to the injection process.

### Claim 7 (depends on 1)

The apparatus of claim 1, including user profile data concerning a level of at least one of the injection parameters that the user finds comfortable for an injection process, stored in the memory, the central processing unit causing each injection process to be performed at not greater than the level of the at least one of the injection parameters that the user finds comfortable.

### Claim 8 (depends on 1)

The apparatus of claim 1, wherein the central processing unit is programmed to perform one or more of the training sessions to determine from the user, a use-selected level of at least one of the injection parameters that the user finds comfortable for an injection process for each of the tissues, and for storing the levels in the memory, the central processing unit causing each injection process to be performed at not greater than the user-selected level of the at least one of the injection parameters that the user finds comfortable for each tissue.

### Claim 9 (depends on 1)

The apparatus of claim 1, wherein the central processing unit is programmed so that the at least one injection parameter that is set to the user-selected level that the user finds comfortable during the training session, is changeable to a different level by the user using the operation input means during an injection process to further improve the user's comfort.

### Claim 10 (depends on 1)

The apparatus of claim 1, wherein the central processing unit is programmed so that at least one of the injection parameters is changeable to a different level by the user using the operation input means during an injection process to further improve the user's comfort.

### Claim 11 (depends on 1)

The apparatus of claim 1, wherein the at least one injection parameter that is set to the user-selected level that the user finds comfortable during the training session, is at least one of pressure and flow rate of the fluid medicament during the injection process.

### Claim 12 (depends on 1)

The apparatus of claim 1, wherein the central processing unit is programmed so that the at least one injection parameter that is set to the user-selected level that the user finds comfortable during the training session or another one of the injection parameters is changeable to a different user-selected level by the user using the operation input means during an injection process to further improve the user's comfort, the at least one injection parameter that is set to the user-selected level or that is changes during the injection process being at least one of pressure and flow rate of the fluid medicament during the injection process.

### Claim 13

A self-administration injection apparatus for allowing a user to inject a fluid medicament into a selected tissue of the user at a level of at least one injection parameter that the user finds comfortable and can set for an injection process, the apparatus comprising:
a platform;
a fluid medicament containing cartridge that is disposable and is detachably connected to the platform;
a cartridge holder capable of accepting the fluid medicament containing cartridge and being connected to the platform;
a handpiece with tubing connected to at least one of the cartridge and cartridge holder, and a needle connected to the tubing, the handpiece being held by the user for manual insertion of the needle into a selected tissue of the user at any one of a plurality of injection sites, the tissue at each injection site being associated with at least one injection parameter that is different for each injection site;
a drive unit in the platform for driving fluid medicament from the cartridge, through the tubing and the needle, and into a selected tissue of the user at the one of the injection sites selected by the user, during the injection process, and at the injection parameter that is associated with the selected tissue at the injection site that is selected by the user;
a drive unit control for controlling the drive unit to drive medicament from the cartridge at the injection parameter;
a central processing unit connected to the drive unit for control performing of the injection process at one of the injection parameters corresponding to the injection site selected by the user;
a memory connected to the central processing unit for storing a plurality of the different injection parameters associated with tissues at the plurality of injection sites for the user; and
operation input means connected to the central processing unit and being operated by the user to selecting the injection site for the injection process and for controlling initiation of the injection process, the central processing unit responding to a user selection of one of the injection sites to control the injection process to proceed at the injection parameter for the associated tissue at the selected injection site;
the central processing unit being programmed to perform a training session to determine from the user, a user-selected level of at least one of the injection parameters that the user finds comfortable for an injection process into the selected tissue, and for storing the level in the memory, the central processing unit causing each injection process to be performed at not greater than the level of the at least one of the injection parameters that the user finds comfortable.

### Claim 14 (depends on 13)

The apparatus of claim 13, wherein the central processing unit is programmed so that the at least one injection parameter that is set to the user-selected level that the user finds comfortable during the training session, is changeable to a different level by the user using the operation input means during an injection process to further improve the user's comfort.

### Claim 15 (depends on 13)

The apparatus of claim 13, wherein the central processing unit is programmed so that at least one of the injection parameters is changeable to a different level by the user using the operation input means during an injection process to further improve the user's comfort.

### Claim 16 (depends on 13)

The apparatus of claim 13, wherein the at least one injection parameter that is set to the user-selected level that the user finds comfortable during the training session, is at least one of pressure and flow rate of the fluid medicament during the injection process.

### Claim 17 (depends on 13)

The apparatus of claim 13, wherein the central processing unit is programmed so that the at least one injection parameter that is set to the user-selected level that the user finds comfortable during the training session or another one of the injection parameters is changeable to a different user-selected level by the user using the operation input means during an injection process to further improve the user's comfort, the at least one injection parameter that is set to the user-selected level or that is changes during the injection process being at least one of pressure and flow rate of the fluid medicament during the injection process.

### Claim 18

A self-administration injection apparatus used by an individual user on oneself in which parameters of the injection are defined contemporaneously with the injection by said user based on a subjective pain response of the user during said injection, the apparatus comprising:
a platform;
a fluid medicament containing cartridge that is disposable and is detachably connected to the platform;
a cartridge holder capable of accepting the fluid medicament containing cartridge and being connected to the platform;
a handpiece with tubing connected to at least one of the cartridge and cartridge holder, and a needle connected to the tubing, the handpiece being held by the user for manual insertion of the needle into a selected tissue of the user at any one of a plurality of injection sites, the tissue at each injection site being associated with at least one injection parameter that is different for each injection site;
a drive unit in the platform for driving fluid medicament from the cartridge, through the tubing and the needle, and into a selected tissue of the user at the one of the injection sites selected by the user, during the injection process, and at the injection parameter that is associated with the selected tissue at the injection site that is selected by the user;
a drive unit control for controlling the drive unit to drive medicament from the cartridge at the injection parameter;
a central processing unit connected to the drive unit for control performing of the injection process at one of the injection parameters corresponding to the injection site selected by the user;
a memory connected to the central processing unit for storing a plurality of the different injection parameters associated with tissues at the plurality of injection sites for the user; and
operation input means connected to the central processing unit and being operated by the user to selecting the injection site for the injection process and for controlling initiation of the injection process, the central processing unit responding to a user selection of one of the injection sites to control the injection process to proceed at the injection parameter for the associated tissue at the selected injection site;
the central processing unit being programmed to perform a training session to determine from the user, a user-selected level of at least one of the injection parameters that the user finds comfortable for an injection process into the selected tissue, and for storing the level in the memory, the central processing unit causing each injection process to be performed at not greater than the level of the at least one of the injection parameters that the user finds comfortable.
