Systems and methods for sustained medical infusion and devices related thereto

• US 20070106218A1
• Filed: 04/03/2006
• Published: 05/10/2007
• Est. Priority Date: 11/07/2005
• Status: Active Grant

• Current Assignee: Roche Diabetes Care Inc. (Roche Holding AG)
• Original Assignee: Medingo Ltd. (Roche Holding AG)
• Inventors: Yodfat, Ofer, Iddan, Gavriel, Neta, Avi
• Granted Patent: US 7,935,104 B2
• Time in Patent Office: Days
• US Class Current: 604/131
• 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 liquid 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 well and in the body, liquid is transferred from the reservoir to the body, via the tube and the cannula, under control of the controller and transceiver.

Claims

1. A method for sustained medical infusion with controlled rate injection of a liquid into a body of a patient, the method comprising the steps of:

providing a first separate reusable unit, comprising;

a controller for managing operations,

a transceiver for communication,

an engine for generating motion for a fluid transfer system, and

a first portion of the fluid transfer system, the fluid transfer system becoming operative for transfer of liquid when the first portion is operatively coupled to a secondary portion of the fluid transfer system;

providing a second separate depletable unit, comprising;

a secondary portion of the fluid transfer system, for coupling to the first portion,

a reservoir for storing a liquid to be infused, a tube to enable communicating fluid from the reservoir to the body of the patient, and

at least one source of energy for delivery of power to the first unit when the first unit is operatively coupled to the second unit;

providing a third unit, comprising;

a cannula and a trocar fitted to the cannula; and

providing a fourth separate remote control unit, comprising;

a transceiver for communication with the first unit,

at least one memory for storing at least one of one or more computer programs, data, and instructions,

a control module coupled to the memory and to the transceiver, and operative for receiving, executing, and emitting data and instructions, and

an I/O user interface for communication of data with a user and with of the first unit,

wherein;

upon emission of appropriate instructions from the fourth unit,

operatively coupling the first unit and the second unit,

and disposing the cannula in the body,

power is supplied to the engine for generating motion for the fluid transfer system, and liquid is transferred from the reservoir to the body.

2. The method according to claim 1, wherein said second separate depletable unit includes a well, and wherein the cannula couples to the well for insertion into the body to provide fluid communication between the well and the body.

3. The method according to claim 1, wherein the second unit further comprises a rotatable member, for receiving the third unit, said rotatable member provides fluid communication between the tube and the cannula.

4. The method according to claim 2, wherein the second unit further comprises a rotatable member in fluid communication with the well, and wherein the rotatable member receives the third unit.

5. The method according to claim 1, wherein the reusable unit further comprises a safety device.

6. The method according to claim 5, wherein the safety device includes a pressure sensor monitoring a pressure in the tube.

7. The method according to claim 6, wherein the pressure sensor comprises a piezoelectric sensor positioned adjacent the tube.

8. The method according to claim 7, wherein the piezoeclectric sensor is mounted proximate the tube.

9. The method according to claim 1, further comprising monitoring a pressure of the tube.

10. The method according to claim 1, wherein monitoring a pressure of the tube comprises monitoring signals produced by a piezoelectric sensor positioned adjacent the tube.

11. The method according to claim 10, further comprising determining whether an occlusion has affected flow in the tube, or weather the tube lacks an adequate amount of fluid.

12. The method according to claim 1, wherein:

at least one of the first unit and the second unit are each configured as flexible, skin-compliant envelopes, and

at least the second unit is releasable adherable to the skin of the patient.

13. The method according to claim 1, wherein:

the first portion of the fluid transfer system exerts pressure on the tube upon the first unit being operatively coupled to the second unit.

14. The method according to claim 1, wherein:

the reservoir is filled manually, and/or

air is purged manually out of at least one of the reservoir and the tube.

15. The method according to claim 1, wherein:

the reservoir is filled manually, and/or

air is purged manually out of at least one of the reservoir, the tube, and the well.

16. The method according to claim 1, wherein:

the cannula is insertable into the body at any desired angle.

17. The method according to claim 1, wherein:

the cannula is insertable into the body at a desired angle ranging from zero to 90 degrees.

18. The method according to claim 1, wherein:

at least one sensor is disposed on at least one of the first unit and the second unit to provide feedback signals to the controller.

19. The method according to claim 1, wherein:

at least one sensor is disposed in both the first unit and the second unit to provide feedback signals to the controller.

20. A medical infusion system providing sustained infusion with controlled rate injection of a liquid into a body of a patient, the system comprising:

a first separate reusable unit, comprising;

a controller for managing operations,

a transceiver for communication,

an engine for generating motion for a fluid transfer system, and

a first portion of the fluid transfer system, the fluid transfer system becoming operative for transfer of liquid when the first portion is operatively coupled to a secondary portion of the fluid transfer system;

a second separate depletable unit, comprising;

a secondary portion of the fluid transfer system, for operative coupling to the first portion,

a reservoir for holding a liquid to be infused,

a tube to enable communicating fluid between the reservoir and the body of the patient, and

at least one source of energy for delivery of power to the first unit when the first unit is operatively coupled to the second unit;

a third unit, comprising;

a cannula for insertion into the body of the patient, a trocar fitted to the cannula; and

a fourth separate remote control unit, comprising;

a transceiver for communication with the first unit,

at least one memory for storing at least one of one or more computer programs, data, and instructions,

a control module coupled to the memory and to the transceiver, and operative for receiving, executing, and emitting data and instructions, and

an I/O user interface for communication of data with a user and for sending instructions from the user to the controller,

wherein;

upon emission of appropriate instructions from the fourth unit,

operatively coupling the first unit and the second unit,

and the cannula being disposed in the body,

power is supplied to the engine for generating motion for the fluid transfer system, and liquid is transferred from the reservoir to the body.

21. The system according to claim 20, wherein the second separate depletable unit includes a well, and wherein the cannula couples to the well for insertion into the body to provide fluid communication between the well and the body.

22. The system according to claim 20, wherein the depletable unit further comprises a rotatable member for receiving the third unit, said rotatable member provides fluid communication between the tube and the cannula.

23. The system according to claim 21, wherein the depletable unit further comprises a rotatable member in fluid communication with the well, and wherein the rotatable member receives the third unit.

24. The system according to claim 20, wherein the reusable unit further comprises a safety device.

25. The system according to claim 24, wherein the safety device includes a pressure sensor monitoring a pressure in the tube.

26. The system according to claim 25, wherein the pressure sensor comprises a piezoelectric sensor positioned adjacent the tube.

27. The system according to claim 26, wherein the piezoeclectric sensor is mounted proximate the tube.

28. A medical infusion system providing sustained medical infusion with controlled rate injection of a liquid into a body of a patient, the system comprising:

a first separate reusable unit, comprising;

a controller for managing operations,

an engine for generating motion for a fluid transfer system, and

a first portion of the fluid transfer system operated by the engine, the fluid transfer system becoming operative for transfer of liquid when operatively coupled to a secondary portion; and

a second separate depletable unit capable of operative coupling to the first unit, comprising;

a reservoir for holding a liquid to be infused,

a tube for communicating liquid from the reservoir,

a secondary portion of the fluid transfer system, for operatively coupling to the first portion, upon operative connection of the second unit with the first unit; and

at least one source of energy for delivery of power to the first unit when the first unit is operatively coupled to the second unit.

29. The system according to claim 28, wherein the second unit further includes a well for receiving fluid from the reservoir via the tube.

30. The system according to claim 28, wherein the depletable unit further comprises a rotatable member for receiving the third unit, said rotatable member provides fluid communication between the tube and the cannula.

31. The system according to claim 29, wherein the depletable unit further comprises a rotatable member in fluid communication with the well, and wherein the rotatable member receives the third disposable unit.

32. The system according to claim 28, wherein the reusable unit further comprises a safety device.

33. The system according to claim 32, wherein the safety device includes a pressure sensor monitoring a pressure in the tube.

34. The system according to claim 33, wherein the pressure sensor comprises a piezoelectric sensor positioned adjacent the tube.

35. The system according to claim 34, wherein the piezoeclectric sensor is mounted proximate the tube.

36. The system according to claim 28, further comprising a third unit comprising:

a cannula for coupling to the well of the second unit and for insertion into the body; and

a trocar fitted to the cannula.

37. The system according to claim 28, further comprising a fourth separate remote control unit, comprising:

a transceiver for communication with the first unit,

at least one memory for storing at least one of one or more computer programs, data, and instructions,

a control module coupled to the memory and to the transceiver, and operative for receiving, executing, and emitting data and instructions, and

an I/O user interface for communication of data with a user and for sending instructions to the first unit.

38. The system according to claim 37, wherein upon emission of appropriate instructions from the fourth unit, operatively coupling the first unit and the second unit, and the cannula being disposed in the well and the body, power is supplied to the engine for generating motion for the fluid transfer system and liquid is transferred from the reservoir to the body.

39. A reusable unit for a medical infusion system providing sustained medical infusion with controlled rate injection of a liquid into a body of a patient, the first unit comprising:

a controller for managing operations,

an engine for generating motion for a fluid transfer system, and

a first portion of the fluid transfer system, the fluid transfer system becoming operative for transfer of liquid when the first portion is operatively coupled to a secondary portion provided for in a operatively coupled second unit.

40. The reusable unit according to claim 39, further comprising a transceiver for communication with a remote unit.

41. The system according to claim 39, wherein the reusable unit further comprises a safety device.

42. The system according to claim 41, wherein the safety device includes a pressure sensor monitoring a pressure in a tube of the second unit.

43. The system according to claim 42, wherein the pressure sensor comprises a piezoelectric sensor positioned adjacent the tube.

44. The system according to claim 43, wherein the piezoeclectric sensor is mounted proximate the tube.

45. A depletable unit for a medical infusion system for operative coupling with a reusable unit for a system providing sustained medical infusion with controlled rate injection of a liquid into a body of a patient, the first unit comprising:

a secondary portion of a fluid transfer system, for operative coupling to a first portion of the fluid transfer system included in the reusable unit of the system,

a reservoir for holding a liquid to be infused,

a tube for communicating fluid from the reservoir, and

at least one source of energy for delivery of power to the reusable unit when the depletable unit is operatively coupled to the reusable unit.

46. The depletable unit according to claim 45, further comprising a well for receiving liquid from the reservoir via the tube.

47. The method according to claim 45, wherein the depletable unit further comprises a rotatable member in for receiving the third unit, said rotatable member provides fluid communication between the tube and the cannula.

48. The method according to claim 47, wherein the depletable unit further comprises a rotatable member in fluid communication with the well, and wherein the rotatable member receives the third disposable unit.