Device for drug delivery

• US 8,465,460 B2
• Filed: 07/31/2008
• Issued: 06/18/2013
• Est. Priority Date: 08/01/2007
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Iddan, Gavriel J., Gescheit, Illai
• Primary Examiner(s): BOUCHELLE, LAURA A
• Application Number:
  US12/733,009
• Publication Number:
  US 20100292651A1
• Time in Patent Office: 1,783 Days
• Field of Search: 604/131, 604/151, 604/164, 604/155, 604/181, 604/186, 604/207, 604/208, 604/218
• US Class Current: 604/186
• 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 (10). The device includes at least one housing (200) connectable to a cannula (250), the at least one housing retaining a reservoir (220) to hold the therapeutic fluid. The device also includes a mechanically powered pumping mechanism (150) 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;

a counter for displaying a value representative of an amount of therapeutic fluid delivered by operation of the device, the counter comprising a mechanically detachable counter housing configured for attaching and detaching from the at least one housing; and

a cradle securable to the patient'"'"'s skin, wherein the cradle is configured for releasably receiving the at least one housing enabling connection and disconnection of the at least one housing therefrom;

the at least one housing including;

a reservoir for storing a therapeutic fluid;

a pump 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 pump is configured for non-electrical operation; and

an actuator for transferring manual power provided by the patient for operating the pump;

wherein displacement of the pump is limited for delivery, of a bolus dose corresponding to a pre-determined amount.

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

insulin, pramlintide acetate and exenatide.

3. The device of claims 1 wherein the at least one housing includes:

a disposable part housing including at least a part 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 pump and the actuator;

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

4. The device of claim 1, wherein the actuator comprises a user-actuated rotatable wheel and one or more gears for transferring power between the wheel and the pump for causing delivery of a bolus dose in response to rotation of the user-actuated wheel.

5. The device of claim 4, wherein the one or more gears comprise at least one cog wheel in mechanical communication with at least one worm gear and a screw-nut coupled to the worm gear and further coupled to a piston of the pump such that rotation of the worm gear causes displacement of the piston.

6. The device of claim 1, wherein the pump comprises:

a piston coupled to the reservoir, the piston being further coupled to the actuator;

wherein movement of the piston by the actuator results in displacement of the piston for delivery of a bolus dose.

7. The device of claim 6, wherein the pump further comprises a handle coupled to the piston to enable manual displacement of the piston.

8. The device of claim 1, further comprising a limiter for limiting displacement of the pump, wherein the limiter prevents displacement of the pump or the actuator beyond a pre-set spatial position defined by the limiter corresponding to a bolus dose.

9. The device of claim 8, wherein the predetermined amount of a bolus dose is configurable by user adjustment of the limiter.

10. The device of claim 8,

wherein the pump comprises a piston coupled to the reservoir and the actuator;

wherein movement of the piston by the actuator results in displacement of the piston for delivery of a bolus dose; and

wherein the limiter comprises a stationary block for engaging a projection extending from an end of the piston such that upon contact between the stationary block and the projection extending from the end of the piston, further displacement of the piston is prevented.

11. The device of claim 1, wherein the pump comprises a peristaltic pump, wherein the peristaltic pump comprises a rotor coupled to a delivery tube for delivering one or more bolus doses, the rotor further coupled to the actuator such that manual power transferred by the actuator causes rotation of the rotor resulting in displacement, of therapeutic fluid contained within the delivery tube.

12. The device of claim 1, wherein the actuator includes a spiral spring configured to operate the pump upon activation of the spring by the patient, and wherein the actuator further comprises:

at least one gear coupled to the spiral spring, wherein the spiral spring is biased in a first rotational direction; and

a string coupled to the spiral spring for causing rotation of the spiral spring in a second rotational direction for increasing in the tension of the spiral spring, wherein upon release of the string, the spiral spring rotates in the first rotational direction resulting in movement of the actuator resulting in pump operation.

13. The device of claim 12, further comprising a limiter for limiting displacement of the pump, wherein the limiter prevents the string from moving beyond a predetermined position such that upon release of the string, the spiral spring rotates a pre-determined radial distance causing delivery of a bolus dose by the pump corresponding with the predetermined amount.

14. The device of claim 1, wherein the pump comprises an inflatable air container configured for driving fluid from the reservoir, and wherein the actuator comprises at least one air injection device for delivering air to the inflatable air container.

15. The device of claim 14, wherein the at least one air injection device comprises:

an air tube in communication with the inflatable air container; 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 inflatable air container through the air tube.

16. The device of claim 1, further comprising an indicator for indicating operation of the pump.

17. The device of claim 16, wherein the indicator includes one or more of an audible indicator for producing a sound and a visual indicator for producing a visual signal.

18. The device of claim 1, wherein operation of the counter is based on operation of the actuator.

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

20. The device of claim 19, wherein the measurement unit comprises 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.

21. The device of claim 20, wherein the actuator comprises a gear having one or more openings extending from one surface of the gear to the other surface, and wherein the optical unit comprises:

a light source for producing a light beam to illuminate one surface of the gear; and

a light sensor for detecting light passing through the one or more openings.

22. The device of claim 1, wherein the at least one housing is configured for receiving different size reservoirs.

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

at least one housing connectable to a cannula;

a counter for displaying a value representative of an amount of therapeutic fluid delivered by operation of the device, the counter comprising a mechanically detachable counter housing configured for attaching and detaching from the at least one housing; and

a cradle securable to the patient'"'"'s skin, wherein the cradle is configured for releasably receiving the at least one housing for connection and disconnection of the at least one housing therefrom;

the at least one housing including;

a reservoir for storing a therapeutic fluid;

a pump for delivering one or more bolus doses of therapeutic fluid from the reservoir to the body of the patient through the cannula, the pump configured for non-electric operation; and

a user-actuated rotatable wheel; and

one or more gears for transferring force between the rotatable wheel and the pump, wherein the one or more gears are configured for operating the pump resulting in delivery of one or more bolus doses in response to rotation of the user-actuated wheel, wherein displacement of the pump is limited for delivery of a bolus dose corresponding to a pre-determined amount.

24. 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;

a counter for displaying a value representative of an amount of therapeutic fluid delivered by operation of the device, the counter comprising a mechanically detachable counter housing configured for attaching and detaching from the at least one housing; and

a cradle securable to the patient'"'"'s skin, wherein the cradle is configured for releasably receiving the at least one housing enabling connection and disconnection of the at least one housing therefrom;

the at least one housing including;

a reservoir for storing a therapeutic fluid;

a pump for delivery of one or more bolus doses of therapeutic fluid from the reservoir to the body of the patient through the cannula, the pump being configured for non-electrical operation; and

an actuator for transferring manual power provided by the patient for operating the pump, wherein the actuator includes a spiral spring configured for moving the actuator upon release of the spiral spring by the patient, wherein the actuator further comprises;

at least one gear coupled to the spiral spring, wherein the spiral spring is biased in a first rotational direction; and

a string coupled to the spiral spring for causing rotation of the spiral spring in a second rotational direction for increasing tension of the spiral spring, wherein upon release of the string, the spiral spring rotates in the first rotational direction for causing rotation of the at least one gear coupled to the spiral spring, wherein displacement of the pump is limited for delivery of a bolus dose corresponding to a pre-determined amount.

25. 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;

a counter for displaying a value representative of an amount of therapeutic fluid delivered aeration of the device, the counter comprising a mechanically detachable counter housing configured for attaching and detaching from the at least one housing; and

a cradle securable to the patient'"'"'s skin, the cradle is configured for releasably receiving the at least one housing enabling connection and disconnection of the at least one housing therefrom;

the at east one housing including;

a reservoir for storing a therapeutic fluid;

a pump 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 pump is configured for non-electric operation;

an actuator for transferring manual power provided by the patient for operating the pump;

an inflatable air container for causing displacement of the therapeutic fluid from the reservoir; and

at least one manually-actuated air injection device for delivering air to the inflatable air container, wherein displacement of the pump is limited for delivery of a bolus dose corresponding to a pre-determined amount.