Modular skin-adherable system for medical fluid delivery

• US 8,568,361 B2
• Filed: 04/07/2009
• Issued: 10/29/2013
• Est. Priority Date: 04/09/2008
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Dan, Yair, Arnold, Ofer, Neta, Avraham, Shalev, Yossi
• Primary Examiner(s): Stigell, Theodore
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/937,044
• Publication Number:
  US 20110160652A1
• Time in Patent Office: 1,666 Days
• Field of Search: 600/365, 604/152, 604/155, 604/385.13, 604/513
• US Class Current: 604/155
• CPC Class Codes: A61M 2005/1402 Priming
• CPC Class Codes: A61M 2005/14252 with needle insertion means
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/14573 with a replaceable reservoir for quick connection/disconnection with a driving system
• CPC Class Codes: A61M 2005/314 Flat shaped barrel forms, e.g. credit card shaped
• CPC Class Codes: A61M 2205/186 the sound being acoustically amplified, e.g. by resonance
• CPC Class Codes: A61M 2205/3306 Optical measuring means
• CPC Class Codes: A61M 2205/3317 Electromagnetic, inductive or dielectric measuring means
• CPC Class Codes: A61M 2205/3365 Rotational speed
• CPC Class Codes: A61M 2205/3389 Continuous level detection A61M2205/3393 takes precedence
• CPC Class Codes: A61M 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• 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 5/14248 of the skin patch type
• 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
• CPC Class Codes: A61M 5/1684 by detecting the amount of infusate remaining, e.g. signalling end of infusion
• CPC Class Codes: A61M 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence

Abstract

Disclosed is a portable therapeutic fluid dispensing device. The fluid dispensing device includes a reusable part (100) comprising a reusable part housing including at least a controller and a first portion (186) of a driving mechanism, and a disposable part (200) comprising a disposable part housing including at least a reservoir (220) to retain therapeutic fluid, an outlet port to which the therapeutic fluid is dispensed, a fluid conduit providing fluid communication between the reservoir and the outlet port, and a second portion (112) of the driving mechanism. At least a portion of the disposable part housing defines at least a portion of the reservoir. Also, the second portion of the driving mechanism is mechanically couplable to the first portion of the driving mechanism upon connection of the disposable part to the reusable part.

Claims

1. A portable therapeutic fluid dispensing device comprising:

a reusable part comprising;

a controller,

a first portion of a driving mechanism, and

a reusable part housing containing at least the controller and the first portion of the driving mechanism;

and

a disposable part comprising;

a reservoir to retain therapeutic fluid,

an outlet port to which the therapeutic fluid is dispensed,

a fluid conduit providing fluid communication between the reservoir and the outlet port,

a second portion of the driving mechanism comprising;

a piston;

a piston rod mechanically coupled to the piston at a first end of the piston rod, the piston rod being at least partially threaded; and

an engagement member configured for threaded engagement with the piston rod, the engagement member being further configured to selectively enable controlled displacement of the piston rod within at least the reservoir via the threaded engagement, and substantially unrestricted displacement of the piston rod within at least the reservoir;

and

a disposable part housing containing at least the reservoir, the outlet port, the fluid conduit and the second portion of the driving mechanism;

wherein the second portion of the driving mechanism is mechanically couplable to the first portion of the driving mechanism upon connection of the disposable part and the reusable part.

2. The fluid dispensing device of claim 1, wherein at least a portion of the disposable part housing defines at least a portion of the reservoir.

3. The fluid dispensing device of claim 1, wherein the disposable part housing includes a skin-adherable base configured to receive the reusable part housing.

4. The fluid dispensing device of claim 1, wherein:

at least one of the reusable part and the disposable part further comprises at least one chassis to provide structural support for one or more components of at least one of the reusable part and disposable part, and

the at least one chassis is received in at least one of the reusable part housing and the disposable part housing.

5. The fluid dispensing device of claim 1, further comprising a reusable part chassis and a disposable part chassis, wherein at least one of the reusable part chassis, the reusable part housing, the disposable part chassis and the disposable part housing includes at least one gasket to establish a sealing condition at least between the reusable part and the disposable part upon connection of the reusable part and the disposable part.

6. The fluid dispensing device of claim 1, wherein the first portion of the driving mechanism comprises at least one of:

a motor;

one or more cogwheels actuated by the motor; and

a drive sleeve in mechanical connection with at least one of the motor and the one or more cogwheels such that rotational force transferred by the at least one of the motor and the one or more cogwheels causes rotational movement of the drive sleeve.

7. The fluid dispensing device of claim 6, wherein the one or more cogwheels comprise part of a planetary gear system, the planetary gear system further comprising a housing having an interior which is at least partially threaded to mesh with the one or more cogwheels housed therein.

8. The fluid dispensing device of claim 6, wherein:

the drive sleeve comprises a hollow cylinder,

at least a portion of the hollow cylinder includes a plurality of teeth defined along an external circumference of the at least the portion of the hollow cylinder,

and

the plurality of teeth are configured to mechanically interact with the one or more cogwheels of the first portion of the driving mechanism.

9. The fluid dispensing device of claim 1, wherein:

the second portion of the driving mechanism further comprises a driving tip mechanically coupled to the piston rod at a second end of the piston rod,

and

the driving tip is configured to mechanically interact with the first portion of the driving mechanism upon connection of the reusable part and the disposable part.

10. The fluid dispensing device of claim 9, wherein the piston includes a cavity to receive the first end of the piston rod.

11. The fluid dispensing device of claim 10, wherein the cavity of the piston is connectable to the first end of the piston rod such that upon connection, the cavity and the first end form a snap-fit connection.

12. The fluid dispensing device of claim 9, wherein:

the driving tip includes a plurality of ridges spaced apart from one another along the circumference of the tip,

the first portion of the driving mechanism further comprises a drive sleeve,

and

the driving tip is receivable within the drive sleeve.

13. The fluid dispensing device of claim 12, wherein the drive sleeve includes a plurality of grooves within the sleeve which are configured to receive the plurality of ridges of the driving tip.

14. The fluid dispensing device of claim 13, wherein the grooves within the drive sleeve are substantially parallel to the longitudinal axis of the drive sleeve.

15. The fluid dispensing device of claim 1, wherein the engagement member is configured to remain substantially stationary within the disposable part during displacement of the piston rod within at least the reservoir.

16. The fluid dispensing device of claim 1, wherein:

the engagement member comprises a first opening and a second opening, and

at least a portion of the second opening is threaded to enable the threaded engagement with the piston rod.

17. The fluid dispensing device of claim 16, wherein the first opening and the second opening are adjoined.

18. The fluid dispensing device of claim 16, wherein the engagement member includes an extension piece extending from the engagement member operable when actuated to cause the engagement member to move from a first position, in which the piston rod is placed in the first opening enabling substantially unrestricted linear movement of the piston rod within at least the reservoir, to a second position, in which the piston rod is placed in the second opening enabling linear movement of the piston rod within at least the reservoir only upon rotation of the piston rod.

19. The fluid dispensing device of claim 18, wherein the engagement member is displaceable from the first position to the second position by one of:

automatic displacement upon connection of the reusable part and the disposable part, and manual displacement.

20. The fluid dispensing device of claim 18, wherein the extension piece is actuated by an actuator, resulting from connection of the reusable part and the disposable part.

21. The fluid dispensing device of claim 20, wherein the actuator comprises a planetary gear system having one or more cogwheels of the first portion of the driving mechanism.

22. The fluid dispensing device of claim 1, wherein at least a portion of the reservoir is lubricated to reduce friction between the piston and walls of the reservoir.

23. The fluid dispensing device of claim 1, wherein the reservoir includes cross-sectional configuration selected from the group consisting of:

an oval configuration, an elliptical configuration, a multi-curved configuration and a substantially rectangular configuration.

24. The fluid dispensing device of claim 1, wherein the fluid conduit includes a channel defined within the disposable part housing.

25. The fluid dispensing device of claim 1, wherein the fluid conduit comprises at least one elastic region.

26. The fluid dispensing device of claim 25, wherein:

the disposable part further comprises a disposable part chassis receivable within the disposable part housing,

the at least one elastic region comprises a tube accommodated in the disposable part chassis, and

an end of the tube includes a nipple connectable to the disposable part housing to enable fluid communication between the reservoir and the tube upon assembly of the disposable part chassis into the disposable part housing.

27. The fluid dispensing device of claim 1, wherein the reusable part housing includes an aperture defined on an external surface of the reusable part housing, the aperture leading into an internal cavity defined in the reusable part housing to enable air passage into the internal cavity.

28. The fluid dispensing device of claim 1, wherein the reusable part further comprises one or more user-actuated switches to specify control instructions for a processor of the controller, the control instructions being related to operation of the fluid dispensing device.

29. The fluid dispensing device of claim 1, wherein the reusable part further comprises a Printed Circuit Board (PCB) having at least one rigid portion and at least one flexible portion.

30. The fluid dispensing device of claim 1, wherein:

the disposable part further comprises a power source;

and

the reusable part further comprises;

electrical connectors configured to electrically couple to the power source of the disposable part upon connection of the reusable part and the disposable part;

and

at least one electronic component in electrical communication with the power source through the electrical connectors.

31. The fluid dispensing device of claim 30, wherein the second connecting end of the each of the electrical connectors includes a resilient connecting end configured as a spring.

32. The fluid dispensing device of claim 1, wherein the reusable part further comprises a mechanism to monitor fluid levels inside the reservoir, the mechanism including:

at least one energy source;

at least one energy detector to detect energy emitted by the at least one energy source, the at least one energy detector further configured to generate a signal to be processed by a processor; and

a regulator to regulate the level of energy received by the at least one energy detector based, at least in part, on the fluid level in the reservoir.

33. The fluid dispensing device of claim 32, wherein:

the regulator comprises the piston rod displaceable within an inner channel defined in a drive sleeve of the first portion of the driving mechanism,

the at least one energy source and the at least one energy detector are positioned opposite each other and on opposite sides the drive sleeve, and

the drive sleeve includes at least one opening establishing an optical path between the at least one energy source and the at least one energy detector when the piston rod does not block the at least one opening.

34. The fluid dispensing device of claim 1, wherein the reusable part further comprises a mechanism to monitor fluid levels inside the reservoir, the mechanism including:

a magnetic coil surrounding at least a portion of a drive sleeve of the first portion of the driving mechanism, the drive sleeve being configured to receive the piston rod such that the piston rod is displaceable within an inner channel defined in the sleeve;

wherein;

at least a portion of the piston rod includes metallic material; and

displacement of the piston rod within the drive sleeve causes a change in the inductance level of the magnetic coil corresponding to a position of the piston rod within the drive sleeve, the position of the piston rod within the drive sleeve corresponding to a respective fluid level in the reservoir.

35. The fluid dispensing device of claim 1, further comprising an occlusion sensor to detect occlusion in a fluid path from the reservoir to a body of a user.

36. The fluid dispensing device of claim 35, wherein the occlusion sensor comprises:

a first portion disposed within the reusable part, the first portion including at least a sensing element and a spring biased platform; and

a second portion disposed within the disposable part, the second portion including at least a track formed in a disposable part chassis received within the disposable part housing, the track configured to accommodate at least a portion of a flexible fluid delivery tube of the fluid conduit.

37. The fluid dispensing device of claim 9, further comprising a handle having a first end removably connectable to the driving tip, and a second end configured to be gripped by a user, the handle being configured to facilitate pushing and pulling the piston rod into and away from the reservoir.

38. The fluid dispensing device of claim 1, further comprising an analyte sensor to monitor analyte concentration levels in a body of a patient.

39. The fluid dispensing device of claim 38, further comprising a subcutaneously insertable cannula configured to deliver dispensed therapeutic fluid into the body of the patient, the subcutaneously insertable cannula including the analyte sensor.

40. A fluid dispensing system comprising:

the portable fluid dispensing device of claim 1;

a remote control unit to control operation of at least the fluid dispensing device; and

a skin-adherable cradle connectable to the fluid dispensing device such that the fluid dispensing device can be removably connected to the skin-adherable cradle.

41. The fluid dispensing system of claim 40, wherein the remote control unit further comprises an analyte sensor to determine analyte concentration levels in a body of a user.

42. The fluid dispensing system of claim 41, wherein:

the remote control unit further comprises a port to receive a test strip containing a blood sample of the user, and

the analyte sensor is configured to determine the analyte concentration level in the blood of the user.

43. A portable therapeutic fluid dispensing device comprising:

a reusable part comprising;

a controller;

a first portion of a driving mechanism comprising at least a rotatable drive sleeve; and

a reusable part housing containing at least the controller and the first portion of the driving mechanism;

and

a disposable part comprising;

a reservoir to retain therapeutic fluid,

an outlet port to which the therapeutic fluid is dispensed,

a fluid conduit providing fluid communication between the reservoir and the outlet port,

a second portion of the driving mechanism comprising;

a piston,

a piston rod mechanically coupled to the piston at a first end of the piston rod, and

a driving tip mechanically coupled to the piston rod at a second end of the piston rod, the driving tip being receivable within the drive sleeve upon connection of the reusable part and the disposable part;

and

a disposable part housing containing at least the reservoir, the outlet port, the fluid conduit and the second portion of the driving mechanism.

44. The fluid dispensing device of claim 43, wherein the drive sleeve comprises a substantially hollow cylinder.

45. The fluid dispensing device of claim 43, wherein the first portion of the driving mechanism further comprises a motor.

46. The fluid dispensing device of claim 45, wherein at least a portion of the drive sleeve includes a plurality of teeth defined along an external circumference of the at least the portion of the drive sleeve, the plurality of teeth configured to mechanically interact with one or more cogwheels actuated by the motor.

47. The fluid dispensing device of claim 43, wherein the driving tip comprises a plurality of ridges spaced apart from one another along the circumference of the tip.

48. The fluid dispensing device of claim 47, wherein the drive sleeve includes a plurality of grooves within the sleeve, the grooves being configured to receive the plurality of ridges of the driving tip.

49. The fluid dispensing device of claim 48, wherein the grooves within the drive sleeve are substantially parallel to the longitudinal axis of the drive sleeve.

50. The fluid dispensing device of claim 48, wherein the grooves are spaced apart from one another to substantially correspond to the spacing of the plurality of ridges of the driving tip.

51. The fluid dispensing device of claim 43, wherein the second portion of the driving mechanism further comprises an engagement member coupled to the piston rod, the engagement member configured to selectively enable controlled displacement of the piston rod and substantially unrestricted displacement of the piston rod within at least the reservoir of the disposable part.

52. A fluid dispensing system comprising:

the portable fluid dispensing device of claim 43;

a remote control unit to control operation of at least the fluid dispensing device; and

a skin-adherable cradle connectable to the fluid dispensing device such that the fluid dispensing device can be removably connected to the skin-adherable cradle.