Jet injector with data logging system for use in compliance and dose monitoring programs

• US 6,817,986 B2
• Filed: 04/15/2002
• Issued: 11/16/2004
• Est. Priority Date: 04/13/2001
• Status: Expired due to Fees

• Current Assignee: Novo Nordisk A/S
• Original Assignee: Avant Medical Corporation
• Inventors: Slate, John B., Burk, Michael W., Gorton, Lanny A.
• Primary Examiner(s): Nguyen, Anhtuan T.
• Assistant Examiner(s): Maynard, Jennifer J.
• Application Number:
  US10/123,870
• Publication Number:
  US 20020188419A1
• Time in Patent Office: 946 Days
• Field of Search: 604/68, 604/93.01, 604/115, 604/130, 604/137, 604/174, 604/176, 604/181, 604/187, 604/131-155, 604/69-72, 128/DIG.1, 128/DIG.12, 600/431-435, 600/458
• US Class Current: 604/68
• CPC Class Codes: A61M 2005/2013 triggering of discharging means by contact of injector with patient body
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• 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 5/30 Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
• CPC Class Codes: A61M 5/425 Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
• CPC Class Codes: Y10S 128/01 Motorized syringe

Abstract

An integral data logging system for a jet injector includes at least one electrical switch that changes state (e.g. from OFF to ON) during an injection procedure. The switch(es) are connected to an electrical circuit having a microprocessor, a clock and an electronic memory. When a switch changes state, this information along with the applicable date and time is recorded in the electronic memory. A communications link is provided to upload the stored data to a remote computer for subsequent manipulation and analysis to determine compliance with a prescribed dosing regimen. In one implementation, the injection duration is logged by using a trigger release switch and an end-of-stroke switch. The end-of-stroke switch is configured to change state after the drive bar of the injector transits through the injector tube. The injection duration is indicative of dose amount and can be used to distinguish between valid and invalid injections.

Claims

1. A system for determining the time duration (Δ

t) of an injection for use in a compliance monitoring program, said system comprising;

a fluid medicament injector having a first switch for changing states at the start of the injection and a second switch for changing states at the end of the injection; and

an electronic clock connected to said first and second switches to establish an injection start time (t_o) in response to said first switch changing states and an injection end time (t_e) in response to said second switch changing states, said start time (t_o) and said end time (t_e) for calculating the time duration (Δ

t) where Δ

t=t_e−

t_o;

wherein said injector has a trigger to initiate the injection and said first switch is a trigger release.

2. A system as recited in claim 1 further comprising a microprocessor and electronic memory mounted on said injector to electronically store said injection start time (t_o) and said injection end time (t_e).

3. A system as recited in claim 2 wherein said microprocessor is configured to compare said time duration (Δ

t) to a predetermined time duration to determine whether the injection is valid.

4. A system as recited in claim 2 further comprising a communications link mounted on said injector to upload data stored in said electronic memory.

5. A system as recited in claim 1 wherein said injector comprises:

a substantially hollow tube having a distal end and a proximal end;

a conductive element positioned inside said tube near said distal end; and

a conductive drive bar mounted inside said tube for distal movement during the injection from a first position near said proximal end to a second position in contact with said conductive element to close said second switch.

6. An integral vacuum control and data logging system for a fluid medicament injector having an injector tip, said system comprising:

an electrical power source;

a vacuum pump for producing a suction at the injector tip;

at least one switch mounted on said injector for changing state during an injection procedure; and

an electrical circuit for selectively passing a current from said power source to said vacuum pump and for establishing the time at which said switch changes states during the injection procedure, said time for use in a compliance monitoring program;

wherein said at least one switch comprises a first switch for arming the injector, a second switch for changing state in response to the firing of the injector and a third switch for changing state upon the completion of an injection and wherein said electrical circuit is configured to pass current from said power source to said vacuum pump in response to a state change of said first switch and stop current flow to said vacuum in response to a state change of said third switch.

7. A system as recited in claim 6 wherein said time includes the date, hour and minute.

8. A system as recited in claim 7 wherein said injector is formed as a substantially hollow tube having a distal end and a proximal end, a conductive element is positioned inside said tube near said distal end, and a conductive drive bar is mounted inside said tube for distal movement during the injection from a first position near said proximal end to a second position in contact with said conductive element to close said third switch.

9. A system as recited in claim 6 wherein said electrical circuit comprises a microprocessor and electronic memory to electronically store said time.

10. A system as recited in claim 6 further comprising a communications link to upload data stored in said electronic memory.

11. A system for preventing injections from an injector having a tip when the injector tip is not in contact with a surface, said system for use in a compliance monitoring program, said system comprising:

a safety mounted on said injector, said safety being reconfigurable between a first configuration wherein said injector is prevented from firing and a second configuration wherein said injector is armed;

a vacuum pump for establishing a vacuum at the injector tip to hold the injector tip against the surface during an injection;

a sensor for determining whether a predetermined vacuum level is present at the injector tip indicating that the injector tip is in contact with the surface; and

a means responsive to said sensor for reconfiguring said safety to arm said injector when said predetermined vacuum level is present at the injector tip;

wherein said sensor measures a vacuum level to determine whether said predetermined vacuum level is present at the injector tip.

12. A system as recited in claim 11 wherein said reconfiguring means comprises a pneumatic actuator.

13. A system as recited in claim 11 wherein said injector includes a firing cap to initiate an injection and said safety prevents movement of the firing cap when said safety is in said first configuration.

14. A system for preventing injections from an injector having a tip when the injector tip is not in contact with a surface, said system for use in a compliance monitoring program, said system comprising:

a safety mounted on said injector, said safety being reconfigurable between a first configuration wherein said injector is prevented from firing and a second configuration wherein said injector is armed;

a vacuum pump for establishing a vacuum at the injector tip to hold the injector tip against the surface during an injection;

a sensor for determining whether a predetermined vacuum level is present at the injector tip indicating that the injector tip is in contact with the surface; and

a means responsive to said sensor for reconfiguring said safety to arm said injector when said predetermined vacuum level is present at the injector tip;

wherein said sensor measures a motor current of said vacuum pump to determine whether said predetermined vacuum level is present at the injector tip.