Systems and methods for sustained medical infusion and devices related thereto

• US 9,039,679 B2
• Filed: 10/18/2013
• Issued: 05/26/2015
• Est. Priority Date: 11/07/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Yodfat, Ofer, Neta, Avi, Iddan, Gavriel J.
• Primary Examiner(s): Sirmons, Kevin C
• Assistant Examiner(s): Hall, Deanna K
• Application Number:
  US14/057,840
• Publication Number:
  US 20140058318A1
• Time in Patent Office: 585 Days
• Field of Search: 604/890.1, 604/151, 604/93.01
• US Class Current: 604/890.1
• 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 2205/3569 sublocal, e.g. between console and disposable
• CPC Class Codes: A61M 2205/3576 with non implanted data transmission devices, e.g. using external transmitter or receiver
• CPC Class Codes: A61M 2209/01 Remote controllers for specific apparatus
• CPC Class Codes: A61M 5/1413 Modular systems comprising interconnecting elements
• CPC Class Codes: A61M 5/14232 Roller 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 5/16854 by monitoring line pressure
• CPC Class Codes: A61M 5/172 electrical or electronic A61M5/16804, A61M5/16831 take precedence

Abstract

Embodiments of the invention are directed to systems, methods and devices for sustained medical infusion with controlled rate injection of a fluid into a body. Such a system may include a first separate reusable unit, a second separate depletable unit a third separate disposable unit having a cannula, and may include a fourth separate remote control unit. Emission of appropriate instructions from the fourth unit, when the first unit, the second unit, and the third unit are coupled together in associative operation and disposed on the skin, power is supplied to an engine for generating motion to a fluid transfer system, and when the cannula is inserted in the body, fluid is transferred from the reservoir to the body, via the tube and the cannula.

Claims

1. A medical device for delivering therapeutic fluid to a body of a patient, the device comprising:

a first unit comprising a first portion of a fluid transfer system;

a second unit coupleable to the first unit, the second unit comprising a reservoir for holding the therapeutic fluid, and a second portion of the fluid transfer system coupleable to the first portion of the fluid transfer system when the first unit is coupled to the second unit;

a cradle configured for releasably receiving the first unit, the cradle comprising a releasable mechanism for coupling both the first and second units when engaged; and

a cannula unit coupleable to the second unit, the cannula unit comprising a cannula for insertion into the body of the patient;

wherein upon coupling the first, second, and cannula units, and insertion of the cannula into the body of the patient, fluid communication is established from the reservoir to the body, via the cannula, without the use of tubing external to the coupled first and second units.

2. The device according to claim 1, wherein at least one of the first and second units comprises a flexible, skin-compliant envelope.

3. The device according to claim 1, wherein the first unit is coupleable to a different second unit.

4. The device according to claim 3, wherein the different second unit comprises a different reservoir for holding a different therapeutic fluid.

5. The device according to claim 3, wherein the reservoir of the second unit has a first reservoir size, and the different second unit comprises a different reservoir having a second reservoir size different from the first reservoir size.

6. The device according to claim 3, wherein the second unit comprises an energy source having a first size, and the different second unit comprises a different energy source having a second size different from the first size.

7. The device according to claim 1, wherein the cannula is configured for insertion into the body at any desired angle.

8. The device according to claim 1, further comprising:

a pumping mechanism for delivering the therapeutic fluid from the reservoir to the body of the patient;

one or more sensors for monitoring the fluid delivery; and

a controller connected to the one or more sensors and the pumping mechanism for controlling the pumping mechanism based on one or more signals generated by the one or more sensors.

9. The device according to claim 8, wherein the one or more sensors comprise a flow sensor.

10. The device according to claim 8, wherein the one or more sensors comprise a rotation sensor for sensing a rotation of the pumping mechanism.

11. The device according to claim 8, wherein the one or more sensors comprise a pressure sensor for sensing a pressure of the fluid transfer system.

12. The device according to claim 11, wherein the controller is configured to detect an occlusion or a leak based on a pressure signal generated by the pressure sensor.

13. The device according to claim 11, wherein the one or more sensors further comprises a fluid flow sensor.

14. The device according to claim 1, wherein the cannula unit does not increase a width of the device when coupled to the second unit.

15. The device according to claim 1, wherein the cannula unit does not increase a height of the device above the body of the patient when coupled to the second unit.

16. The device according to claim 1, wherein the reservoir comprises a collapsible bladder.

17. The device according to claim 1, wherein the reservoir comprises a self-sealing port.

18. The device according to claim 1, wherein the reservoir is pre-filled with the therapeutic fluid.

19. The device according to claim 1, wherein the second unit defines a well through which the cannula unit is coupleable thereto.

20. The device according to claim 19, further comprising a removable seal for sealing the well of the second unit before coupling the cannula unit to the second unit.

21. The device according to claim 19, further comprising a vent tube configured to provide fluid communication from the well to an exterior of the second unit.

22. The device according to claim 1, wherein at least one of the first and second units further comprises an adhesive layer for adhering the device to the patient'"'"'s body.

23. The device according to claim 22, wherein at least one of the first and second units further comprises a removable cover layer for covering the adhesive layer prior to adhering the device to the patient'"'"'s body.

24. The device according to claim 1, further comprising a transceiver for communicating with an external device.

25. The device according to claim 1, wherein the first unit is reusable and the second unit is disposable.