Therapeutic system with an adaptor for an infusion set

• US 10,155,085 B2
• Filed: 02/18/2015
• Issued: 12/18/2018
• Est. Priority Date: 08/20/2012
• Status: Active Grant

• Current Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Original Assignee: Roche Diagnostics Operations Incorporated (Roche Holding AG)
• Inventors: Gescheit, Illai J., Neta, Avraham, Yodfat, Ofer
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): FREDRICKSON, COURTNEY B
• Application Number:
  US14/624,744
• Publication Number:
  US 20150157788A1
• Time in Patent Office: 1,399 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2005/14268 with a reusable and a disposable component
• CPC Class Codes: A61M 2005/1587 suitable for being connected to an infusion line after insertion into a patient
• CPC Class Codes: A61M 2039/1072 with a septum present in the connector
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6027 Electric-conductive bridges closing detection circuits, with or without identifying elements, e.g. resistances, zener-diodes
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 39/10 Tube connectors; Tube couplings A61M39/02 takes precedence; connecting needles to syringes or hubs A61M5/34; connecting catheter tubes to hubs A61M25/0014
• CPC Class Codes: A61M 39/1011 Locking means for securing connection; Additional tamper safeties A61M39/16 takes precedence
• 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 5/16804 Flow controllers
• CPC Class Codes: G16H 20/17 delivered via infusion or injection

Abstract

A therapeutic system in an exemplary embodiment comprises a fluid delivery device having a fluid reservoir, an outlet port with a lumen for outputting fluid from the reservoir, a pump for pumping the fluid through the lumen and a controller for controlling the therapeutic system. The therapeutic system may also comprise an adaptor for an infusion set, the adaptor having a plug operable for attaching to the outlet port, and wherein the adaptor has an adaptor septum operable for being pierced by the lumen when attached to the outlet port. The therapeutic system comprises an infusion set recognition system, wherein the controller is operable to query the infusion set recognition system for infusion set data, wherein the infusion set data comprises an infusion set type, wherein the controller is operable to operate the pump to provide a basal dosage of the fluid if the infusion set type is not recognized.

Claims

1. A therapeutic system comprising:

a fluid delivery device, wherein the fluid delivery device comprises;

a fluid reservoir for storing a fluid;

an outlet port with a lumen for outputting the fluid from the reservoir, wherein the outlet port is formed on an exterior surface of the fluid delivery device;

a pump for pumping the fluid through the lumen;

a controller for controlling the therapeutic system, wherein the controller is operable for regulating the pumping of fluid through the lumen;

an adaptor for an infusion set, wherein the adaptor comprises a plug operable for attaching to the outlet port, and wherein the adaptor comprises an adaptor septum operable for being pierced by the lumen when attached to the outlet port;

an infusion set recognition system, wherein the controller is further operable to query the infusion set recognition system for infusion set data, wherein the infusion set data comprises an infusion set type, wherein the controller is further operable to operate the pump to provide a basal dosage of the fluid if the infusion set type is not recognized;

a tube port which comprises a tube port lumen;

a tube with a first end and a second end, wherein the first end is connected to the adaptor and the second end is connected to the tube port; and

a hub operable for attaching to the tube port, wherein the hub comprises a hub cannula, a hub cannula septum, and an adhesive layer for attaching to an outer surface of a subject, wherein the hub cannula septum is operable for being pierced by the tube port lumen when the hub is attached to the tube port, and wherein the hub is further operable for attaching to the outlet port, wherein the hub cannula septum is operable for being pierced by the lumen.

2. The therapeutic system of claim 1, wherein the infusion set recognition system is one of an RFID system, a bar code reader, a hologram recognition system, an electronic plug incorporated into the outlet port, a mechanical coupling arrangement or a combination thereof.

3. The therapeutic system of claim 1, wherein the therapeutic system further comprises the infusion set, wherein the infusion set further comprises an information carrier for storing the infusion set data, wherein the infusion set recognition system is adapted for retrieving the infusion set data from the information carrier by querying the infusion set.

4. The therapeutic system of claim 3, wherein the infusion set data comprises any one of the following:

sterility state, therapeutic system compatibility data or code, approved use data or code, lot number, batch number, hose diameter, manufacturer, approved therapy data or code, and combinations thereof.

5. The therapeutic system of claim 3, wherein the infusion set recognition system is further operable for writing usage data to the information carrier, wherein the usage data comprises any one of the following:

prior use and cumulative use, wherein the infusion set adaptor is further operable to query previously written usage data.

6. The therapeutic system of claim 5, wherein the controller is operable to disable and/or display a warning on a display in accordance with the previously written usage data.

7. The therapeutic system of claim 1, wherein the controller comprises a memory, wherein the controller is operable for recording utilization data of the infusion set and the infusion set data in the memory.

8. The therapeutic system of claim 7, wherein the therapeutic system is operable for sending the utilization data and the infusion set data to a computer system.

9. The therapeutic system of claim 1, wherein the infusion set data further comprises a software update, and wherein the controller is operable for controlling the operation of the pump in accordance with the software update.

10. The therapeutic system of claim 1, wherein the therapeutic system further comprises a cradle for supporting the fluid delivery device, wherein the cradle and the fluid delivery device are operable for forming an interlocking connection for removably affixing the fluid delivery device to the cradle, wherein the cradle comprises an adhesive layer for attaching to the outer surface of a subject, wherein the cradle further comprises a passageway operable for attaching to the outlet port and for receiving a cannula with a cannula septum operable for being pierced by the lumen when attached to the outlet port.

11. The therapeutic system of claim 1, wherein the adaptor further comprises a tube mount operable for mounting to an infusion set tube.

12. The therapeutic system of claim 1, wherein the therapeutic system further comprises the infusion set attached to the adaptor.

13. The therapeutic system of claim 1, wherein the tube is any one of the following:

is spiral shaped, is contained within a spring loaded spool, has a convoluted shape, and is attached to an elastic strap.

14. The therapeutic system of claim 1, wherein the outlet port further comprises a first electrical connector, and wherein the adaptor further comprises a second electrical connector operable for forming an electrical connection with the first electrical connector for transmitting a sensor signal to the processor.

15. The therapeutic system of claim 1, wherein the therapeutic system further comprises the infusion set, wherein the infusion set comprises a sensor.

16. The therapeutic system of claim 15, wherein the sensor is an occlusion sensor or a flow sensor, wherein the controller is further operable to:

receive the sensor signal from the sensor;

detect an occlusion condition using the sensor signal; and

generate a warning message if the occlusion condition is detected.

17. The therapeutic system of claim 15, wherein the sensor is a subcutaneous sensor;

wherein the controller is further operable to receive the sensor signal;

wherein the controller is further operable to perform any one of the following;

log the sensor signal; and

adjust the pumping of fluid through the lumen in accordance with the sensor signal.

18. The therapeutic system of claim 1, wherein the therapeutic system further comprises a network adaptor for communicating with a computer, wherein the controller is further operable to identify an alert condition and send an alert notification message to the computer using the network adaptor.

19. The therapeutic system of claim 1, wherein the fluid delivery device comprises a reusable portion and a disposable portion, wherein the reusable portion comprises:

the pump, a memory, and a processor; and

wherein the disposable portion comprises the fluid reservoir.

20. The therapeutic system of claim 1, wherein the therapeutic system further comprises a support garment operable for supporting the fluid delivery device.

21. The therapeutic system of claim 1, wherein the fluid delivery system is an insulin pump.

22. A therapeutic system comprising:

a fluid delivery device, wherein the fluid delivery device comprises;

a fluid reservoir for storing a fluid;

an outlet port with a lumen for outputting the fluid from the reservoir, wherein the outlet port is formed on an exterior surface of the fluid delivery device;

a pump for pumping the fluid through the lumen;

a controller for controlling the therapeutic system, wherein the controller is operable for regulating the pumping of fluid through the lumen;

an adaptor for an infusion set, wherein the adaptor comprises a plug operable for attaching to the outlet port, and wherein the adaptor comprises an adaptor septum operable for being pierced by the lumen when attached to the outlet port;

wherein the adaptor is operable for supporting the fluid delivery device, wherein the adaptor and the fluid delivery device are operable for forming an interlocking connection for removably affixing the fluid delivery device to the adaptor;

wherein the adaptor comprises a tube mount operable for mounting a tube of the infusion set, wherein the tube mount has a first axis, wherein the plug has a second axis, wherein when the first axis and the second axis are projected onto a plane through the first axis the first axis and the second axis form an angle between 30 and 150 degrees,

wherein the tube has a first end and a second end, wherein the first end is connected to the adaptor via the tube mount and the second end is connected to a tube port, wherein the tube port comprises a tube port lumen; and

a hub operable for attaching to the tube port, wherein the hub comprises an adhesive layer for attaching to an outer surface of a subject, wherein the hub comprises a hub cannula and a hub cannula septum, wherein the hub cannula septum is operable for being pierced by the tube port lumen when the hub is attached to the tube port, and wherein the hub is further operable for attaching to the outlet port, wherein the hub cannula septum is operable for being pierced by the lumen.

23. The therapeutic system of claim 22, wherein the tube mount is a Luer-lock.

24. A kit comprising:

a fluid delivery device, wherein the fluid delivery device comprises;

a fluid reservoir for storing a fluid;

an outlet port with a lumen for outputting the fluid, wherein the outlet port is formed on an exterior surface of the fluid delivery device;

a pump for pumping the fluid through the lumen;

a controller for controlling the therapeutic system, wherein the controller is operable to regulate the pumping of fluid through the lumen;

an adaptor for an infusion set, wherein the adaptor comprises a plug operable for attaching to the outlet port, wherein the outlet port comprises an adaptor septum operable for being pierced by the lumen;

a cradle for supporting the fluid delivery device, wherein the cradle and the fluid delivery device are operable for forming an interlocking connection for removably affixing the fluid delivery device to the cradle, wherein the cradle comprises an adhesive layer for attaching to an outer surface of a subject, wherein the cradle further comprises a passageway operable for attaching to the outlet port and for receiving a cannula with a cannula septum operable for being pierced by the lumen, wherein the kit enables the user to operate the fluid delivery device mounted on the outer surface of the subject or in an a remote mode where the fluid delivery device is connected to the infusion set;

a tube with a first end and a second end, wherein the first end is connected to the adaptor, where the second end is connected to a tube port, wherein the tube port comprises a tube port lumen; and

a hub operable for attaching to the tube port, wherein the hub comprises an adhesive layer for attaching to an outer surface of a subject, wherein the hub comprises a hub cannula and a hub cannula septum, wherein the hub cannula septum is operable for being pierced by the tube port lumen when the hub is attached to the tube port, and wherein the hub is further operable for attaching to the outlet port, wherein the hub cannula septum is operable for being pierced by the lumen.