Infusion device and method

• US 8,323,245 B2
• Filed: 01/30/2009
• Issued: 12/04/2012
• Est. Priority Date: 01/30/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: List, Hans, Haar, Hans-Peter
• Primary Examiner(s): Lucchesi, Nicholas
• Assistant Examiner(s): Zhang, Jenna
• Application Number:
  US12/362,795
• Publication Number:
  US 20090192461A1
• Time in Patent Office: 1,404 Days
• Field of Search: 604/151, 604/152, 604/154, 368/129, 417/214, 417/326, 748/14
• US Class Current: 604/131
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: F04B 43/0081 systems, control, safety measures
• CPC Class Codes: F04B 43/1253 by using two or more rollers as squeezing elements, the rollers moving on an arc of a circle during squeezing

Abstract

An infusion device with safeguards for protecting a patient from inappropriate infusion during a malfunction comprises a pump, an electronic controller for controlling the pump, and a mechanical stop facility for stopping the pump by mechanically blocking pump motion. The stop facility periodically requires resetting by the controller to continue infusion.

Claims

1. An infusion device having safeguards for protecting a patient from inappropriate infusion during malfunction of an electronic controller, comprising:

a pump;

a transmission coupled to the pump;

a motor coupled to the transmission to operate the pump;

an electronic controller for automatically controlling the motor; and

,

a mechanical stop facility for stopping the pump by mechanically blocking the transmission from operating the pump when the motor is drivingly coupled to the pump, the mechanical blocking comprising mechanically blocking operating motion of the pump to thereby prevent the pump from generating fluid pressure and also thereby stop continued delivery of an infusion,

wherein the mechanical stop facility during operation periodically requires resetting by the electronic controller to continue the infusion and thereby limits the amount of potential overdosing and wherein the mechanical stop facility comprises at least two locking members which alternatively block pump motion, and wherein the mechanical stop facility is reset by moving one of the locking members to disengage from positive locking engagement, which activates at least one other locking member so that the other locking member will block pump motion after a preset period.

2. The infusion device in claim 1 wherein the pump is a peristaltic pump.

3. The infusion device in claim 1 wherein the mechanical stop facility comprises an actuator, preferably a solenoid, for resetting the stop facility by moving at least one of the locking members.

4. The infusion device in claim 1 wherein at least one of the locking members is spring biased which blocks pump motion by positive locking.

5. The infusion device in claim 1 wherein the mechanical stop facility blocks pump motion by locking a driveshaft of the pump.

6. The infusion device as in claim 1 wherein the mechanical stop facility comprises a locking plate.

7. The infusion device as in claim 1 wherein the mechanical stop facility comprises a reversing transmission and is reset by reversing direction of rotation.

8. The infusion device as in claim 1 further comprising, a pump motor coupled to the pump wherein the motor is a DC motor.

9. An infusion device having safeguards for protecting a patient from inappropriate infusion during malfunction of an electronic controller, comprising:

a peristaltic pump;

a transmission coupled to the peristaltic pump;

a motor coupled to the transmission to operate the peristaltic pump;

an electronic controller for automatically controlling the motor; and

,

means for stopping the peristaltic pump by mechanically blocking the transmission from operating the peristaltic pump when the motor is drivingly coupled to the pump and when the means for stopping has not been reset by the electronic controller, the mechanical blocking comprising a positive locking engagement of the transmission with the means for stopping to thereby block operating motion of the pump and thereby prevent the pump from generating fluid pressure and also thereby stop continued delivery of an infusion by the pump;

the means for stopping periodically requiring resetting by the electronic controller during operation to disengage the positive locking engagement of the means for stopping and thereby continue the infusion whereby the amount of potential overdosing is limited.

10. A method for safeguarding an infusion device from excessive infusion during a malfunction, comprising:

resetting a stop facility by an electronic controller for a time interval to prevent the stop facility from blocking a transmission from operating a peristaltic pump, the stop facility operably disposed between a motor and the pump and comprising a first locking member and a second locking member, the second locking member being drivingly coupled to the motor;

supplying power to the peristaltic pump through the electronic controller to operate the peristaltic pump;

continuing to supply power to the peristaltic pump after failure in the electronic controller to cease supplying power to the peristaltic pump; and

,

failing to reset the stop facility by failure in the electronic controller to prevent the stop facility from blocking motion of the peristaltic pump; and

,

engaging the first and second locking members of the stop facility to stop the peristaltic pump by mechanically blocking operating motion of the peristaltic pump and thereby preventing the pump from generating fluid pressure during a failure in the electronic controller that continues to supply power to operate the peristaltic pump when not intended by the electronic controller.

11. The method in claim 10 wherein the stop facility comprises at least one blocking member which blocks pump motion by positive locking.

12. The method in claim 10 wherein the stop facility comprises a spring biased locking member.

13. The method in claim 10 wherein the stop facility comprises a reversing transmission having two limit stops that periodically require a reversing of rotation of the reversing transmission.

14. The method in claim 10 wherein the time interval is selected to limit infusion during failure of the electronic controller to control the maximum amount of unintended infusion.