Device and method for the automatic initiation of an injection

• US 8,012,120 B2
• Filed: 09/13/2007
• Issued: 09/06/2011
• Est. Priority Date: 09/13/2007
• Status: Active Grant

• Current Assignee: Avant Medical Corporation
• Original Assignee: Avant Medical Corporation
• Inventors: Slate, John B., Burk, Michael W.
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): Snyder; Melissa A
• Application Number:
  US11/855,018
• Publication Number:
  US 20090076443A1
• Time in Patent Office: 1,454 Days
• Field of Search: 604 65- 67, 604/68, 604/500, 604/505
• US Class Current: 604/67
• CPC Class Codes: A61M 2005/2073 preventing premature release, e.g. by making use of a safety lock
• CPC Class Codes: A61M 2205/13 with means for the detection of operative contact with patient, e.g. lip sensor
• 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

Abstract

A system and method to automatically initiate an injection procedure of a medicament into a patient. In the system, a delivery assembly includes an injector for infusing the medicament into the patient. Further, the system includes a monitor for detecting a parameter characteristic of the procedure, for instance, a pressure indicative of a partial vacuum between the injector and the injection site, a pressure exerted by the patient against the delivery assembly, a conductance, a capacitance, or an optical blood reading. Also, the system includes a timer for determining compliance of the parameter within a predetermined range during a first time interval. In response to the timer, an actuator initiates the injection procedure at the expiration of the first time interval. Further, the actuator may stop the injection procedure if the parameter is outside the predetermined range during a second time interval.

Claims

1. A system for automatically initiating an injection procedure for injection of a fluid medicament into a patient which comprises:

a fluid delivery assembly having an injector for infusing a predetermined volume of the medicament into the patient;

a control element for setting a predetermined range of values of an operational parameter characteristic of the procedure and a first time interval “

Δ

t₁”

;

the control element also for detecting the operational parameter characteristic of the procedure and for determining continued compliance of the operational parameter at a value, in the predetermined range, during a first time interval “

Δ

t₁”

, wherein the detected operational parameter is indicative of an interaction between the system and the patient beginning before infusion of the medicament into the patient; and

an actuator connected to the fluid delivery assembly, and responsive to the control element, for initiating the injection procedure by the fluid delivery assembly at the expiration of the first time interval “

Δ

t₁”

.

2. A system as recited in claim 1 wherein the fluid delivery assembly is operable to infuse the fluid medicament during a second time interval “

Δ

t₂”

, and wherein the actuator stops the injection procedure during the second time interval “

Δ

t₂”

when it is determined the operational parameter is outside the predetermined range.

3. A system as recited in claim 2 wherein the first time interval “

Δ

t₁”

is contiguous with the second time interval “

Δ

t₂”

.

4. A system as recited in claim 2 wherein the control element is reset after expiration of the second time interval “

Δ

t₂”

.

5. A system as recited in claim 1 wherein the injector is a needleless injector, and the operational parameter is a pressure value indicative of a partial vacuum established between the injector and an injection site on the patient.

6. A system as recited in claim 1 wherein the injector is a needle, and the operational parameter is a reaction pressure exerted by the patient against the fluid delivery assembly.

7. A system as recited in claim 1 wherein the operational parameter is selected from a group consisting of a conductance, a capacitance and an optical blood reading.

8. A system as recited in claim 1 wherein the fluid delivery assembly comprises:

a fluid chamber for holding the fluid medicament, wherein the fluid chamber is in fluid communication with the injector; and

a plunger positioned in the fluid chamber for advancement therethrough to expel fluid therefrom through the injector.

9. A system as recited in claim 8 further comprising a drive mechanism for advancing the plunger.

10. A system for automatically initiating an injection procedure for injection of a fluid medicament into a patient which comprises:

a means for infusing a predetermined volume of the medicament into the patient;

a means for setting a predetermined range of values of an operational parameter characteristic of the procedure and a first time interval “

Δ

t₁”

;

a means for detecting the operational parameter characteristic of the procedure, wherein the detected operational parameter is indicative of an interaction between the system and the patient beginning before infusion of the medicament into the patient;

a means for determining continued compliance of the operational parameter at a value in a predetermined range during the first time interval “

Δ

t₁”

; and

an actuator connected to the infusing means, and responsive to the determining means, for initiating the injection procedure by the infusing means at the expiration of the first time interval “

Δ

t₁”

.

11. A system as recited in claim 10 wherein the infusing means is operable to infuse the fluid medicament during a second time interval “

Δ

t₂”

, and wherein the actuator stops the injection procedure during the second time interval “

Δ

t₂”

when it is determined the operational parameter is outside the predetermined range.

12. A system as recited in claim 11 wherein the first time interval “

Δ

t₁”

is contiguous with the second time interval “

Δ

t₂”

.

13. A system as recited in claim 10 wherein the infusing means includes a needleless injector, and the operational parameter is a pressure value indicative of a partial vacuum established between the injector and an injection site on the patient.

14. A system as recited in claim 10 wherein the operational parameter is selected from a group consisting of a conductance, a capacitance, an optical blood reading, and a reaction pressure exerted by the patient against the fluid delivery assembly.

15. A method for automatically initiating an injection procedure for injection of a fluid medicament into a patient which comprises the steps of:

providing a system including a fluid delivery assembly having an injector, a monitor, a timer electronically connected to the monitor, and an actuator connected to the fluid delivery assembly;

setting the monitor with a predetermined range of values of an operational parameter characteristic of the procedure and setting the timer with a first time interval “

Δ

t₁”

;

positioning the injector at an injection site on the patient;

detecting with the monitor the operational parameter characteristic of the procedure, wherein the detected operational parameter is indicative of an interaction between the system and the patient beginning before infusion of the medicament into the patient;

determining continued compliance of the operational parameter at a value in a predetermined range, during the first time interval “

Δ

t₁”

;

initiating with the actuator, in response to the determining step, the injection procedure by the fluid delivery assembly at the expiration of the first time interval “

Δ

t₁”

; and

infusing with the injector a predetermined volume of the medicament into the patient during the injection procedure.

16. A method as recited in claim 15 wherein the infusing step occurs during a second time interval “

Δ

t₂”

, and wherein the method further comprises the steps of;

ascertaining that the operational parameter is outside the predetermined range during the second time interval “

At₂”

; and

stopping the infusing step during the second time interval “

Δ

t₂”

in response to the ascertaining step.

17. A method as recited in claim 16 wherein the first time interval “

Δ

t₁”

is contiguous with the second time interval “

Δ

t₂”

.

18. A method as recited in claim 16 wherein the first time interval “

Δ

t₁”

is less than approximately two seconds.

19. A method as recited in claim 15 wherein the injector is a needleless injector, and wherein the operational parameter is selected from a group consisting of a conductance, a capacitance, an optical blood reading, a pressure value indicative of a partial vacuum established between the injector and an injection site on the patient, and a reaction pressure exerted by the patient against the fluid delivery assembly.