Self-administration injection system

• US 7,740,612 B2
• Filed: 04/22/2008
• Issued: 06/22/2010
• Est. Priority Date: 07/27/2007
• Status: Active Grant

• Current Assignee: Milestone Scientific Incorporated
• Original Assignee: Milestone Scientific Incorporated
• Inventors: Hochman, Mark N.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): STOHR, LEAH C
• Application Number:
  US12/107,160
• Publication Number:
  US 20090030366A1
• Time in Patent Office: 791 Days
• Field of Search: 604/28, 604/48, 604/504, 604/151, 604/152, 604/154, 604/155, 604/272, 604/31, 604/65, 604/67, 604/121
• US Class Current: 604/121
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/581 by audible feedback
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 5/20 Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically A61M5/142 , A61M5/46 take precedence; hypodermic projectiles F42B12/54
• CPC Class Codes: A61M 5/24 Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic ampoules or carpules A61J1/06
• CPC Class Codes: A61M 5/31546 Electrically operated dose setting, e.g. input via touch screen or plus/minus buttons
• CPC Class Codes: A61M 5/482 Varying injection pressure, e.g. by varying speed of injection
• CPC Class Codes: G09B 23/285 for injections, endoscopy, bronchoscopy, sigmoidscopy, insertion of contraceptive devices or enemas
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

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

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.

2. 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.

3. 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.

4. 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.

5. 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.

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

7. 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.

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

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.

14. 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.

15. 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.

16. 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.

17. 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.

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.