NEEDLE CANNULA POSITION AS AN INPUT TO OPERATIONAL CONTROL OF AN INJECTION DEVICE

• US 20160296699A1
• Filed: 04/10/2015
• Published: 10/13/2016
• Est. Priority Date: 04/10/2015
• Status: Active Grant

• Current Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: Medimop Medical Projects Ltd. (West Pharmaceutical Services Incorporated)
• Inventors: CABIRI, Oz
• Granted Patent: US 9,744,297 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 5/1626 Needle protectors therefor in combination with syringes A61M5/3202; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• 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 5/2033 Spring-loaded one-shot injectors with or without automatic needle insertion multishot dosing syringes A61M5/31525, needle insertion only A61M5/3287
• CPC Class Codes: A61M 5/2046 Media being expelled from injector by gas generation, e.g. explosive charge
• CPC Class Codes: A61M 5/2053 Media being expelled from injector by pressurised fluid or vacuum for infusion A61M5/145, A61M5/155
• CPC Class Codes: A61M 5/2066 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/3202 Devices for protection of the needle before use, e.g. caps A61M5/50 takes precedence; for infusion spikes A61M5/1626; protectors for sharps A61B50/3001
• CPC Class Codes: A61M 5/3204 Needle cap remover, i.e. devices to dislodge protection cover from needle or needle hub, e.g. deshielding devices
• CPC Class Codes: A61M 5/326 Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
• CPC Class Codes: A61M 5/50 having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile retractable needles or needle protectors with means for preventing re-use A61M5/321
• CPC Class Codes: A61M 5/5086 for indicating if defective, used, tampered with or unsterile
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A method is disclosed for state sensing and controlling of a multi-state drug delivery device. In some embodiments a power switch is reused as a state sensor. Optionally the state sensor may be toggled by user actions and/or the movements of parts of the device, for example needle and/or a protective element. Optionally, drug discharge and/or status indication is controlled in accordance with sensor output. In some embodiments control is by means of a processor. Alternatively or additionally, control is by means of simple physical circuits.

Claims

1. A method of reusing a power switch as a sensor to indicate multiple stages of operation of a delivery drug delivery device comprising:

providing a device where the power switch interrupts a power supply circuit;

toggling of the switch to activate the device;

engaging the device to a subject, said engaging causing a further toggling the switch while the device remains activated;

initiating discharge of the drug in response to said further toggling of the switch.

2. The method of claim 1, wherein during when said power supply is interrupted, substantially no power is consumed by the device.

3. The method of claim 1, wherein said action is triggered when said further toggling occurs in a predefined time period after said toggling and wherein an alternative action is triggered if said further toggling occurs previous to said time period.

4. The method of claim 1, wherein said action is triggered when a plunger movement is within a predetermined range in a predefined time period and wherein an alternative action is triggered when said plunger movement is outside of said predetermined range in said predetermined time period.

5. The method of claim 1, wherein said initiating occurs in response to said further toggling in a predefined time period after said toggling and wherein an alternative action is triggered if said further toggling does not occur within said time period.

6. The method of claim 1, wherein said toggling is by removing a protective element from the device, said protective element inhibiting said engaging of the device to a subject.

7. The method of claim 1, further comprising:

disengaging of said device from said subject causing yet another toggling of said switch;

indicating to a user of a completion of delivery via a coded output to in response to said yet another toggling of said switch.

8. The method of claim 1, further comprising:

disengaging of said device from said subject causing yet another toggling of said switch;

stopping discharge of the drug in response to said yet another toggling.

9. A method of staged operation of an autoinjector comprising:

sensing a change in position of an injection needle;

determining a state of the autoinjector in response to said sensing, and indicating said state to a user with a coded output.

10. The method of claim 9, wherein said change in position includes inserting said needle past a skin contact surface of the autoinjector into a subject and wherein said coded output indicates that the autoinjector is operating properly.

11. The method of claim 10, further comprising:

removing a protective element from the autoinjector by a user, said removing causing connecting of a power supply circuit thereby activating the autoinjector;

further indicating via another coded output to the user a ready state of the device in response to said activating.

12. The method of claim 11, further comprising:

engaging by a user of said device to a subject after said further indicating, and

wherein said inserting a needle is a result of said engaging.

13. The method of claim 11, further comprising:

initiating discharging of the drug in response to said sensing of said change in position.

14. The method of claim 13, further comprising:

disengaging of said device in response to a completion of said discharging, said disengaging including retraction of said needle with respect to a skin contact surface.

15. The method of claim 14, further comprising:

sensing said retracting or manual retracting or disconnecting from the skin and signaling via a further coded output to a user said completion of operation of the device, said signaling in response to said sensing of said retracting.

16. A status sensor assembly for a multi-stage drug delivery device comprising:

a first power supply circuit;

a processor;

a power switch isolating said first power supply circuit from said processor when the device is in an inactive stage and wherein in response to toggling of said power switch when the device is in said inactive stage said power supply circuit is connected to said processor, supplying power to said processor;

said processor programmed to initiate an activated stage of the device in response to said supplying of power to the processor;

a trigger assembly positioned to re-toggle said power switch upon engagement of the device to a subject;

a sensor circuit indicating to said processor said re-toggling of said switch, said processor programmed to switch the device to a discharging stage in response to said indicating of said re-toggling;

a driver responsive to said processor, said driver discharging the drug from the device when the device is in the discharge stage.

17. The assembly of claim 16, further comprising:

a second power supply circuit, said second power supply circuit supplying no power to the processor when said device is in said inactive stage, said second power supply circuit responsive to said processor for supplying power to the processor in a discharging stage.

18. The assembly of claim 16, wherein in said inactive stage, substantially no power is supplied to said processor.

19. The assembly of claim 16, further comprising:

a protective element, inhibiting engagement of the device to a subject said protective element connected to said power switch for performing said toggling when said protective element is removed from the device.