Controllable drug delivery system and method of use

Patent metadata

Field	Value
Publication number	US-10646652-B2
Application number	US-201515315829-A
Country	US
Kind code	B2
Filing date	Jun 3, 2015
Priority date	Jun 3, 2014
Publication date	May 12, 2020
Grant date	May 12, 2020

Abstract

A drug delivery system is disclosed that includes a drug delivery device having a reservoir, a delivery cannula having a proximal end in fluid communication with the reservoir and a distal end to be received within a patient, and one or more controllable elements. The drug delivery system may further include one or more sensors coupled to the drug delivery device, and a controller coupled to the one or more sensors and the one or more controllable elements. The controller may be configured to use the one or more sensors to determine a condition or an operational state of the drug delivery device. Furthermore, the controller may be configured to control the controllable element based on the condition or the operational state of the drug delivery device and/or identity information stored in a memory onboard the device. A method for use with a drug delivery device is also disclosed.

First claim

What is claimed is:

1. A drug delivery system comprising:
a drug delivery device comprising
a reservoir,
a delivery cannula having a proximal end in fluid communication with the reservoir during use of the drug delivery device and a distal end to be received within a patient during use of the drug delivery device,
a removable sterile barrier, and
a lock;

a sensor coupled to the drug delivery device and configured to detect movement of the removable sterile barrier; and
a controller coupled to the sensor and the lock, the controller being configured to:
use the sensor to determine if the removable sterile barrier has been removed from the drug delivery device prior to use of the drug delivery device, and
activate the lock to have a locked state or maintain the lock in the locked state if the removable sterile barrier has been removed from the drug delivery device prior to use of the drug delivery device.

2. The drug delivery system of claim 1 , comprising an output unit coupled to the controller, wherein
the controller is configured to:
(a) activate the output unit if the removable sterile barrier has not been removed from the drug delivery device prior to use of the drug delivery device,
(b) use the sensor to determine if the removable sterile barrier has been removed from the drug delivery device subsequent to (a),
(c) determine if a time period has elapsed since removal of the removable sterile barrier, and
(d) activate the lock to have the locked state if the removable sterile barrier has been removed from the drug delivery device and the time period has elapsed.

3. The drug delivery system of claim 1 , comprising a circuit having a low-energy state and a high-energy state.

4. The drug delivery system of claim 3 , wherein the controller is configured to:
(a) determine if the drug delivery device is ready for use,
(b) use the sensor to determine if the removable sterile barrier has been removed from the drug delivery device subsequent to (a), and
(c) switch the circuit from the low-energy state to the high-energy state if the removable sterile barrier has been removed from the drug delivery device.

5. The drug delivery system of claim 1 , comprising a heating element configured to heat a medicament in the reservoir or the delivery cannula when activated.

6. The drug delivery system of claim 5 , comprising an output unit coupled to the controller, wherein the controller is configured to:
(a) activate the output unit if the removable sterile barrier has not been removed from the drug delivery device prior to use of the drug delivery device,
(b) use the sensor to determine if the removable sterile barrier has been removed from the drug delivery device subsequent to (a), and
(c) activate the heating element if the removable sterile barrier has been removed from the drug delivery device.

7. The drug delivery system of claim 1 , the drug delivery device comprising:
a housing containing the reservoir and the delivery cannula; and
the removable sterile barrier disposed about a distal end of the housing, the removable sterile barrier having at least one roll inhibiting exterior side surface.

8. The drug delivery system of claim 7 , the removable sterile barrier having a triangular cross section.

9. The drug delivery system of claim 7 , the removable sterile barrier having a planar distal end surface, the at least one roll inhibiting exterior side surface being perpendicular to the planar distal end surface.

10. The drug delivery system of claim 7 , the removable sterile barrier including a cover member and a tubular member, the cover member covering an open end of the tubular member, the tubular member including a plurality of outwardly protruding ribs to be gripped by the patient when removing the removable sterile barrier from the housing.

11. The drug delivery system of claim 7 , at least one of the controller or the sensor being housed within the removable sterile barrier.

12. The drug delivery system of claim 1 , the drug delivery device comprising:
a controllable element;
a memory configured to store identity information representative of at least one of an identity of the patient, an identity of the drug delivery device, or an identity of a medicament to be stored within the reservoir; and
wherein the controller is coupled to the memory and the controllable element, the controller being configured to control the controllable element based on the identity information.

13. The drug delivery system of claim 12 ,
the removable sterile barrier having at least one roll inhibiting exterior side surface.

14. The drug delivery system of claim 13 , the removable sterile barrier having a planar distal end surface, the at least one roll inhibiting exterior side surface being perpendicular to the planar distal end surface.

15. The drug delivery system of claim 13 , the removable sterile barrier including a cover member and a tubular member, the cover member covering an open end of the tubular member, the tubular member including a plurality of outwardly protruding ribs to be gripped by the patient when removing the removable sterile barrier from the housing.

16. The drug delivery system of claim 1 , wherein the removable sterile barrier is disposed about the distal end of the delivery cannula.

Assignees

• Amgen Inc

Inventors

• Mccullough Adam B
• Tamtoro Ferry
• Yang Huaying
• Lee Mark Ka Lai
• Yin Desheng
• Gibson Scott R
• Busby Donald
• Shultz Peter V
• Kogler Keith P
• Taha Basel Hasan
• Ward Jimmie L
• Folk Christopher R
• Badelt Steven William

Classifications

• G16H40/00

  ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices · CPC title

• G16H20/17

  delivered via infusion or injection · CPC title

• G16H40/63

  for local operation · CPC title

• A61M5/5086

  for indicating if defective, used, tampered with or unsterile · CPC title

• A61M2005/3267

  Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body · CPC title