Time dependent drug delivery apparatus

• US 10,335,545 B2
• Filed: 08/14/2012
• Issued: 07/02/2019
• Est. Priority Date: 01/31/2012
• Status: Active Grant

• Current Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Original Assignee: West Pharma. Services IL, Ltd. (West Pharmaceutical Services Incorporated)
• Inventors: Cabiri, Oz
• Primary Examiner(s): Zhang, Jenna
• Application Number:
  US14/372,384
• Publication Number:
  US 20150011965A1
• Time in Patent Office: 2,513 Days
• CPC Class Codes: A61M 2205/276 preventing unwanted use
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3368 Temperature
• CPC Class Codes: A61M 2205/36 related to heating or cooling
• CPC Class Codes: A61M 2205/3613 by body heat
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/702 automatically during use
• CPC Class Codes: A61M 2205/8212 with means or measures taken for minimising energy consumption
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 5/14244 adapted to be carried by the patient, e.g. portable on the body
• CPC Class Codes: A61M 5/14248 of the skin patch type
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media
• CPC Class Codes: G16H 20/13 delivered from dispensers
• CPC Class Codes: G16H 40/60 for the operation of medical equipment or devices
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A drug delivery apparatus provides autonomous variable rate delivery of a substance. In some embodiments, the delivery apparatus may be programmable. In some embodiments, the delivery apparatus may be disposable. Optionally the rate of delivery may be dependent on a temperature of a component of the apparatus. Optionally, there may be a time delay between activation of the apparatus and delivery power of the substance.

Claims

1. A drug delivery apparatus, comprising:

a drug reservoir that stores a drug therein;

a temperature sensitive component that is at least one of the drug, the drug reservoir, or a power source that powers the drug delivery apparatus;

a temperature sensor in thermal communication with the temperature sensitive component to sense a temperature of the temperature sensitive component;

a transcutaneous device;

a pump coupled to the transcutaneous device to deliver the drug via the transcutaneous device; and

processor that;

(i) receives from the temperature sensor an initial sensed temperature of the temperature sensitive component prior to initial delivery of the drug,

(ii) calculates a time delay for the temperature sensitive component to reach, starting from the initial sensed temperature, a predetermined working temperature that is between 100 C and 37°

C., and

(iii) initiates initial delivery of the drug by the drug delivery apparatus following expiration of the calculated time delay, regardless of the temperature of the temperature sensitive component following expiration of the calculated time delay.

2. The drug delivery apparatus of claim 1, wherein the temperature sensitive component is one of the drug, the power source, or the drug reservoir.

3. The drug delivery apparatus of claim 1, wherein the processor controls delivery rate of the drug based upon an output of the temperature sensor.

4. The drug delivery apparatus of claim 1, further comprising a memory coupled to the processor.

5. The drug delivery apparatus of claim 4, wherein the processor controls delivery rate of the drug by the pump based upon output of the temperature sensor and instructions programmed into the memory.

6. The drug delivery apparatus of claim 4, further comprising a programming interface coupled to the memory.

7. The drug delivery apparatus of claim 1, further comprising an insertion mechanism coupled to the transcutaneous device and controlled by the processor to insert the transcutaneous device.

8. The drug delivery apparatus of claim 1, further comprising an insertion mechanism controlled by the processor to insert the transcutaneous device after the calculated time delay.

9. The drug delivery apparatus of claim 1, further comprising a deactivation mechanism deactivating the apparatus after delivery of at least a prescribed quantity of the drug.

10. The drug delivery apparatus of claim 9, wherein the deactivation mechanism performs at least one of protecting a needle, preparing the apparatus for disposal, or permanently disabling the apparatus.

11. The drug delivery apparatus of claim 1, further comprising a user interface that is operable to decrease and increase a rate of drug delivery.

12. The drug delivery apparatus of claim 11, wherein the user interface is operable to increase the rate of drug delivery up to about 200%.

13. The drug delivery apparatus of claim 11, wherein the user interface is operable to increase the rate of drug delivery up to about 50%.

14. The drug delivery apparatus of claim 1, further comprising a heater that heats at least one component of the drug delivery apparatus or the drug.

15. The drug delivery apparatus of claim 1, wherein the predetermined working temperature is room temperature.

16. The drug delivery apparatus of claim 15, wherein room temperature is between 20°

C. and 30°

C.

17. A portable drug delivery apparatus configured to be attached against the skin of a recipient for delivering a drug to the recipient, comprising:

a temperature sensitive component that is at least one of a drug to be delivered to the recipient or a power source that powers the drug delivery apparatus;

a temperature sensor in thermal communication with the temperature sensitive component to sense a temperature of the temperature sensitive component;

a transcutaneous device;

a pump coupled to the transcutaneous device to deliver the drug via the transcutaneous device; and

a processor that;

(i) receives from the temperature sensor an initial sensed temperature of the temperature sensitive component prior to initial delivery of the drug,

(ii) calculates a time delay for the temperature sensitive component to reach, starting from the initial sensed temperature and based a heat transfer from at least one of the skin of the recipient and air in proximity to the drug delivery device to the temperature sensitive component, a predetermined working temperature that is between 10°

C. and 40°

C., and

(iii) initiates initial delivery of the drug by the drug delivery apparatus following expiration of the calculated time delay, regardless of the temperature of the temperature sensitive component following expiration of the calculated time delay.

18. The portable drug delivery apparatus of claim 17, wherein the processor receives from the temperature sensor the initial sensed temperature of the temperature sensitive component while the recipient is at a medical institution and initiates the initial delivery of the drug after the recipient leaves the medical institution.

19. The drug delivery apparatus of claim 17, wherein the predetermined working temperature is between room temperature and body temperature.

20. The drug delivery apparatus of claim 19, wherein body temperature is between 36°

C. and 38°

C.