Device for drug delivery

• US 10,238,795 B2
• Filed: 06/30/2016
• Issued: 03/26/2019
• Est. Priority Date: 08/01/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Iddan, Gavriel J., Gescheit, Illai
• Primary Examiner(s): Bouchelle, Laura
• Application Number:
  US15/198,169
• Publication Number:
  US 20160303312A1
• Time in Patent Office: 999 Days
• CPC Class Codes: A61M 2005/1405 Patient controlled analgesia [PCA]
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2205/071 hand operated
• CPC Class Codes: A61M 2209/045 for filling, e.g. for filling reservoirs
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14232 Roller pumps
• CPC Class Codes: A61M 5/1424 Manually operated pumps
• 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 5/1454 spring-actuated, e.g. by a clockwork
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir

Abstract

Disclosed is an ambulatory therapeutic fluid delivery device. The device includes at least one housing connectable to a cannula, the at least one housing retaining a reservoir to hold the therapeutic fluid. The device also includes a mechanically powered pumping mechanism to cause delivery of at least some of the fluid from the reservoir, and a power-transfer mechanism to transfer manually-delivered power provided by a user to mechanically actuate the pumping mechanism.

Claims

1. A portable ambulatory therapeutic fluid delivery device for delivering a therapeutic fluid in bolus doses into a body of a patient, the device comprising:

at least one housing connectable to a cannula, the at least one housing including a reservoir for storing a therapeutic fluid;

a mechanically powered pumping mechanism for delivering one or more bolus doses of the therapeutic fluid from the reservoir to the body of the patient through the cannula, wherein the pumping mechanism is configured to operate without using electrically-generated power; and

a power-transfer mechanism for transferring manual power provided by a user to mechanically actuate the pumping mechanism, and

wherein the at least one housing includes;

a disposable part housing including at least a majority of the reservoir and an outlet port for enabling passage of the fluid to the body of the patient, and

a reusable part housing removably attachable to the disposable part, the reusable part housing including at least a portion of the pumping mechanism and the power-transfer mechanism,

wherein the delivery device is operable upon attachment of the reusable part housing and the disposable part housing, and

wherein the reservoir is configured to be filled with the therapeutic fluid prior to attachment of the disposable part to the reusable part.

2. A method of delivering a therapeutic fluid in bolus doses into a body of a patient, comprising utilizing the portable ambulatory therapeutic fluid delivery device according to claim 1 to deliver the therapeutic fluid in bolus doses into the body of the patient.

3. The method of claim 2 further comprising filling and/or replacing the disposable part of the housing.

4. The device according to claim 1, wherein the therapeutic fluid includes one or more of:

insulin, pramlintide acetate and exenatide.

5. The device according to claim 1, wherein the power-transfer mechanism comprises a user-actuated rotatable wheel.

6. The device according to claim 1, wherein the power-transfer mechanism comprises a user-actuated rotatable wheel and one or more gears for transferring power between the wheel and the pumping mechanism.

7. The device according to claim 1, wherein the pumping mechanism comprises a piston coupled to the reservoir.

8. The device according to claim 1, further comprising a limiter which prevents displacement of the pumping mechanism or the power-transfer mechanism beyond a pre-set spatial position.

9. The device according to claim 1, wherein the pumping mechanism comprises a peristaltic pump configured for pumping fluid from the reservoir.

10. The device according to claim 1, wherein the actuator includes a spring configured to operate the pumping mechanism upon activation of the spring by the patient.

11. The device according to claim 1, further comprising a limiter for limiting displacement of the pumping mechanism, wherein the actuator includes a spring configured to operate the pumping mechanism upon activation of the spring by the patient, and the device, wherein the limiter prevents the spring from moving beyond a predetermined position such that upon release of the spring, the spring causes delivery of therapeutic fluid by the pumping mechanism corresponding with a predetermined amount.

12. The device according to claim 1, wherein the pumping mechanism comprises an inflatable air container configured for driving fluid from the reservoir.

13. The device according to claim 1, wherein the power-transfer mechanism comprises at least one air injection device for delivering air to the pumping mechanism.

14. The device according to claim 1, wherein the power-transfer mechanism comprises at least one air injection device for delivering air to the pumping mechanism, the at least one air injection device comprises:

an air tube in communication with the pumping mechanism; and

an air compression chamber in communication with the air tube, the air compression chamber including a displaceable plunger, wherein upon movement of the plunger by the patient, air is displaced from the air compression chamber into the pumping mechanism through the air tube.

15. The device according to claim 1, further comprising an indicator for indicating operation of the pumping mechanism.

16. The device according to claim 1, further comprising an indicator for indicating operation of the pumping mechanism, and wherein the indicator includes one or more of:

an audible indicator for producing a sound and a visual indicator for producing a visual signal.

17. The device according to claim 1, further comprising a counter for displaying a value representative of an amount of therapeutic fluid delivered by operation of the device.

18. The device according to claim 1, further comprising a measurement unit for determining an extent of fluid delivered.

19. The device according to claim 1, further comprising an optical unit for detecting one or more markings disposed on the actuator, wherein detection of the one or more markings corresponds to a pre-determined amount of fluid delivered.

20. The device according to claim 1, wherein the at least one housing is configured for receiving different size reservoirs.