Systems and methods for sustained medical infusion and devices related thereto

• US 7,935,104 B2
• Filed: 04/03/2006
• Issued: 05/03/2011
• 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: Neta, Avi, Iddan, Gavriel J., Yodfat, Ofer
• Primary Examiner(s): Sirmons; Kevin C
• Assistant Examiner(s): Hall; Deanna K
• Application Number:
  US11/397,115
• Publication Number:
  US 20070106218A1
• Time in Patent Office: 1,856 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 infusion system providing sustained infusion with a controlled rate of injection of a fluid 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 fluid 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 the fluid to be infused,

a tube to enable fluid communication from the reservoir, and

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

a third separate unit, comprising;

a cannula for insertion into the body of the patient,

and

a penetrating needle fitted to the cannula and configured to be removed from the cannula after insertion of the cannula into the body;

wherein after insertion, the cannula is arranged immediately adjacent coupled first and second units and projects away from a side or bottom of the coupled first and second units;

and

a fourth separate remote control unit, comprising;

a transceiver for communication with the first separate reusable 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 at least one memory and the transceiver, and operative for receiving, executing, and/or emitting data and/or 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 separate remote control unit,

operatively coupling the first separate reusable unit and the second separate depletable unit, and

the cannula being disposed in the body and in fluid communication with the reservoir,

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

2. The system according to claim 1, 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.

3. The system according to claim 1, wherein the second separate depletable unit further comprises a joint configured to rotate and receive the third separate unit, said joint providing fluid communication between the tube and the cannula.

4. The system according to claim 1, wherein the first separate reusable unit further comprises a safety sensor.

5. The system according to claim 4, wherein the safety sensor comprises a pressure sensor monitoring a pressure in the tube.

6. The system according to claim 5, wherein the pressure sensor comprises a piezoelectric sensor positioned adjacent the tube.

7. The system according to claim 6, wherein the piezoelectric sensor is mounted proximate the tube.

8. The system according to claim 1, wherein the fluid transfer system comprises a pump.

9. The system according to claim 1, wherein the penetrating needle comprises a trocar.

10. The system according to claim 1, further comprising a flow sensor.

11. The system according to claim 1, wherein the first separate reusable unit comprises one or more rechargeable batteries, the one or more rechargeable batteries are chargeable by connection to an external battery charger via a charging port.

12. The system according to claim 1, wherein,

the second separate depletable unit includes delivery contacts electrically connected to the at least one source of energy;

the first separate reusable unit includes receiving contacts connected to the controller; and

wherein when the first separate reusable unit is operatively coupled to the second separate depletable unit, the delivery contacts are coupled to the receiving contacts to deliver power to the first separate reusable unit.

13. The system according to claim 12, wherein at least one of the delivery contacts and the receiving contacts is spring loaded.

14. The system according to claim 1, wherein the first separate reusable unit further comprises an alarm.

15. The system according to claim 1, wherein the cannula is configured for insertion into the skin at any desired angle.

16. The system according to claim 1, wherein the second separate depletable unit comprises a cradle for releasably receiving the first separate reusable unit.

17. The system according to claim 1, wherein at least the second separate depletable unit is releasably adherable to the skin.

18. The system according to claim 1, wherein the communication between the first separate reusable unit and the fourth separate remote control unit is wireless.

19. The system according to claim 1, wherein the third separate unit is configured for insertion through the second separate depletable unit to establish fluid communication therebetween.

20. The system according to claim 1, wherein at least one of the first separate reusable unit and the fourth separate remote control unit includes a USB port.

21. The system according to claim 1, wherein the first separate reusable unit includes an I/O pad.

22. The system according to claim 1, further comprising a cannula driver configured to engage the cannula enabling cannula insertion into a well and/or rotation of the cannula.

23. The system according to claim 1, wherein at least one of the first separate reusable unit and the second separate depletable unit includes a seal ensuring sealing when the first separate reusable unit is coupled to the second separate depletable unit.

24. The system according to claim 23, wherein the seal comprises an O-ring.

25. The system according to claim 1, wherein the therapeutic fluid comprises insulin.

26. A medical infusion system providing sustained infusion with a controlled rate of injection of a fluid 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 pump, and

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

a second separate depletable unit, comprising;

a secondary portion of the pump, for operative coupling to the first portion,

a reservoir for holding the fluid to be infused,

a tube to enable fluid communication from the reservoir, and

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

a third separate unit, comprising;

a cannula for insertion into the body of the patient,

and

a penetrating needle fitted to the cannula and configured to be removed from the cannula after insertion of the cannula into the body;

wherein after insertion, the cannula is arranged immediately adjacent coupled first and second units and projects away from a side or bottom of the coupled first and second units;

and

a fourth separate remote control unit, comprising;

a transceiver for communication with the first separate reusable 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 at least one memory and to the transceiver, and operative for receiving, executing, and/or emitting data and/or 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 separate remote control unit,

operatively coupling the first separate reusable unit and the second separate depletable unit, and

the cannula being disposed in the body,

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

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

a reusable unit comprising at least a controller, a transceiver and a first portion of a pump;

a disposable unit comprising at least a reservoir, an exit port and a second portion of the pump;

a cannula unit comprising a subcutaneously insertable cannula and a penetrating needle fitted thereto, wherein;

the cannula unit is configured to directly couple to the disposable unit,

upon coupling the cannula unit and the disposable unit, the cannula projects away from a side or bottom of the coupled reusable and disposable units,

and

the penetrating needle is configured to be removed from the cannula after insertion of the cannula into the body;

and

a remote control unit comprising at least a remote controller, a remote transceiver, a memory, at least one button and a display;

wherein;

upon coupling of the reusable unit and the disposable unit, the first portion of the pump operatively couples to the second portion of the pump, enabling transfer of the therapeutic fluid from the reservoir to the exit port; and

upon coupling of the cannula unit and the disposable unit, and insertion of the cannula into the body of the patient, fluid communication is established from the exit port to the body, via the cannula.

28. The system according to claim 27, wherein the first portion of the pump includes a motor and one or more gears.

29. The system according to claim 27, wherein transfer of therapeutic fluid from the reservoir to the body of the patient is operable via an I/O pad located on the reusable unit and/or on the remote control unit.

30. A medical infusion system providing sustained infusion with controlled rate injection of a fluid 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 fluid 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, and

a reservoir for holding the fluid to be infused;

a third separate unit, comprising;

a cannula for insertion into the body of the patient,

and

a penetrating needle fitted to the cannula and configured to be removed from the cannula after insertion of the cannula into the body,

wherein after insertion, the cannula is arranged immediately adjacent coupled first and second units and projects away from a side or bottom of the coupled first and second units;

and

a fourth separate remote control unit, comprising;

a transceiver for communication with the first separate reusable 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 at least one memory and to the transceiver, and operative for receiving, executing, and/or emitting data and/or instructions,

and

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

31. A medical infusion system providing sustained infusion with controlled rate injection of a fluid 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 fluid 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, and

a reservoir for holding the fluid to be infused;

a third separate unit, comprising;

a cannula for insertion into the body of the patient,

and

a penetrating needle fitted to the cannula and configured to be removed after insertion of the cannula into the body,

wherein after insertion, the cannula provides fluid delivery to the patient without the use of tubing external to coupled first and second units;

and

a fourth separate remote control unit, comprising;

a transceiver for communication with the first separate reusable 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 at least one memory and to the transceiver, and operative for receiving, executing, and/or emitting data and/or instructions, and

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

32. A medical infusion system providing sustained infusion with controlled rate injection of a fluid 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 fluid 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 the fluid to be infused;

a third separate unit, comprising;

a cannula for insertion into the body of the patient;

and

a penetrating needle fitted to the cannula and configured to be removed after insertion of the cannula into the body,

wherein after insertion, the cannula provides fluid delivery to the patient without the use of tubing external to coupled first and second units;

and

a fourth separate remote control unit, comprising;

a transceiver for communication with the first separate reusable 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 at least one memory and to the transceiver, and operative for receiving, executing, and/or emitting data and/or 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 separate remote control unit,

operatively coupling the first separate reusable unit and the second separate depletable unit, and

insertion of the cannula into the body,

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

33. A medical system delivering therapeutic fluid to a body of a patient, the system comprising:

a reusable unit comprising at least a controller, a transceiver and a first portion of a pump;

a disposable unit comprising at least a reservoir, an exit port, and a second portion of the pump;

a cannula unit comprising a subcutaneously insertable cannula and a penetrating needle fitted thereto, wherein;

the cannula unit is configured to directly couple to the disposable unit; and

the penetrating needle is configured to be removed from the cannula after insertion of the cannula into the body;

and

a remote control unit comprising at least a remote controller, a remote transceiver, a memory, at least one button and a display;

wherein;

upon coupling of the reusable unit and the disposable unit, the first portion of the pump operatively couples to the second portion of the pump, enabling transfer of the therapeutic fluid from the reservoir to the exit port; and

upon coupling of the cannula unit to the disposable unit and insertion of the cannula into the body of the patient, fluid communication is established from the exit port to the body via the cannula, without the use of tubing external to the coupled reusable and disposable units.

34. The system according to claim 33, wherein:

the disposable unit further comprises a tube configured to transfer the therapeutic fluid from the reservoir to the exit port, and

the tube is substantially contained within the disposable unit.