Catheter assembly including monitoring capabilities

• US 10,433,790 B2
• Filed: 09/23/2016
• Issued: 10/08/2019
• Est. Priority Date: 09/25/2015
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Ofek, Gidon, Allen, Blake, McFarland, Todd P., Francis, Samuel A., Hamatake, Bret
• Primary Examiner(s): Gedeon, Brian T
• Application Number:
  US15/275,059
• Publication Number:
  US 20170086746A1
• Time in Patent Office: 1,110 Days
• Field of Search: None
• CPC Class Codes: A61B 5/0022 Monitoring a patient using a global network, e.g. telephone networks, internet
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• CPC Class Codes: A61B 5/024 Detecting, measuring or recording pulse rate or heart rate A61B5/0205, A61B5/021 take precedence
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/14542 for measuring blood gases A61B5/14551 takes precedence
• CPC Class Codes: A61B 5/283 Invasive
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/412 Detecting or monitoring sepsis
• CPC Class Codes: A61B 5/6852 Catheters
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2230/04 Heartbeat characteristics, e.g. ECG, blood pressure modulation
• CPC Class Codes: A61M 2230/50 Temperature
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 39/284 Lever clamps
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A catheter assembly or other elongate tubular device for use in establishing vascular or other access within the body of a patient is disclosed. The catheter assembly is equipped with one or more sensors that enable monitoring of one or more physiological aspects of the patient or physical aspect of the catheter assembly itself when the catheter assembly is disposed within the patient. Such aspects include central venous pressure, body temperature, ECG heart signals, oxygen levels, ultrasound data, glucose, etc. The catheter assembly includes the ability to wirelessly transmit or otherwise forward data relating to the detected physiological parameters to another location, such as a patient electronic medical record, smartphone or other mobile device, nurse station, etc. Catheter assemblies configured to detect the frequency of catheter flushing, flushing quality, etc., are also disclosed.

Claims

1. A catheter assembly for insertion into a body of a patient, the catheter assembly comprising:

an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end;

a bifurcation hub operably attached to the catheter tube;

an extension leg operably attached to the bifurcation hub, the bifurcation hub and extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube;

at least one sensor included with at least one of the bifurcation hub, the extension leg, and a proximal end of the catheter tube, the at least one sensor;

disposed outside of the body of the patient; and

configured to detect at least one of a physiological aspect of the patient and a physical aspect of the catheter assembly; and

a communication module configured to wirelessly transmit data sensed by the at least one sensor to a receipt location, the communication module included in a securement device that is configured to attach to a skin surface of the patient, the securement device configured to removably secure the catheter assembly to the patient.

2. The catheter assembly as defined in claim 1, wherein the communication module is included on a printed circuit board, the printed circuit board included with the securement device.

3. The catheter assembly as defined in claim 1, wherein the receipt location includes a smartphone, a storage device, a patient electronic medical record, a mobile device, a computer server, a laptop computer, a nurse station, and a printer.

4. The catheter assembly as defined in claim 1, wherein the at least one sensor includes a pressure sensor, an oxygen sensor, a temperature sensor, an ultrasound transducer, an electrical sensor configured to detect ECG signals, and a glucose sensor.

5. The catheter assembly as defined in claim 2, wherein the at least one sensor is disposed in the bifurcation hub.

6. The catheter assembly as defined in claim 1, wherein the communication module is configured to transmit the data sensed by the at least one sensor via at least one of Bluetooth, Wi-Fi, near-field communication, and radiofrequency signals.

7. The catheter assembly as defined in claim 1, wherein the at least one sensor is configured to detect when the catheter assembly is being flushed with fluid.

8. The catheter assembly as defined in claim 7, wherein the at least one sensor includes a flush sensor that is configured to be activated when a component is operably connected to the catheter assembly.

9. The catheter assembly as defined in claim 8, wherein the flush sensor includes a lever that is configured to be displaced when the component is operably connected to the catheter assembly.

10. The catheter assembly as defined in claim 9, wherein the flush sensor is included in at least one of a luer connector and a needleless connector included with the catheter assembly.

11. The catheter assembly as defined in claim 10, further comprising a pressure sensor that is configured to operate with the flush sensor to detect when the catheter assembly is being flushed with fluid.

12. The catheter assembly as defined in claim 1, further comprising at least one light disposed on the catheter assembly, the at least one light configured to operate in conjunction with the at least one sensor to alert a user as to an aspect of the at least one sensor.

13. The catheter assembly as defined in claim 1, wherein the at least one sensor further comprises a pressure sensor and a temperature sensor, the pressure sensor and the temperature sensor configured to sense a respiratory rate, a heart rate, and a body temperature of the patient in order to determine whether a sepsis condition is present.

14. The catheter assembly as defined in claim 1, further comprising a battery configured to power at least one of the at least one sensor and a printed circuit board included with the catheter assembly.

15. The catheter assembly as defined in claim 14, wherein the battery is included in the securement device that is configured to attach to the skin surface of the patient, the securement device configured to removably secure the catheter assembly to the patient.

16. The catheter assembly as defined in claim 15, wherein the securement device includes first and second electrical contacts that are configured to operably connect with corresponding electrical contacts of the catheter assembly.

17. A catheter assembly for insertion into a body of a patient, the catheter assembly comprising:

an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end;

a bifurcation hub operably attached to the catheter tube;

an extension leg operably attached to the bifurcation hub, the bifurcation hub and the extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube;

a plurality of sensors included with the catheter assembly, a first sensor of the plurality of sensors included with the bifurcation hub and configured to detect at least one of a physiological aspect of the patient and a physical aspect of the catheter assembly, and a second sensor of the plurality of sensors including an electrical sensor configured to detect an ECG signal of a heart of the patient; and

a communication module configured to wirelessly transmit data sensed by the at plurality of sensors.

18. The catheter assembly as defined in claim 17, wherein the electrical sensor is included within the bifurcation hub.

19. The catheter assembly as defined in claim 17, wherein the electrical sensor is disposed in a wall of the catheter tube proximate the distal end of the catheter tube.

20. The catheter assembly as defined in claim 17, further comprising a battery configured to power at least one of the plurality of sensors and a printed circuit board included with the catheter assembly.

21. The catheter assembly as defined in claim 20, wherein the battery is included in a securement device that is configured to attach to a skin surface of the patient, the securement device configured to removably secure the catheter assembly to the patient.

22. The catheter assembly as defined in claim 21, wherein the securement device includes first and second electrical contacts that are configured to operably connect with corresponding electrical contacts of the catheter assembly.

23. A catheter assembly for insertion into a body of a patient, the catheter assembly comprising:

an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end;

a pressure indicator disposed in fluid communication with the catheter assembly, the pressure indicator configured to move from a first position to a second position when a predetermined fluid pressure is present in a fluid passageway, at least the second position of the pressure indicator being visually discernable by a user;

the pressure indicator included in a pressure detection module that is removably attached to the catheter assembly, the pressure detection module including the fluid passageway.

24. The catheter assembly as defined in claim 23, wherein the pressure detection module is configured to be interposed between a proximal end of the catheter assembly and a syringe, the syringe configured to operably connect with the fluid passageway of the pressure detection module.

25. A catheter assembly for insertion into a body of a patient, the catheter assembly comprising:

an elongate catheter tube defining at least one lumen extending between a proximal end and a distal end;

a bifurcation hub operably attached to the catheter tube;

an extension leg operably attached to the bifurcation hub, the bifurcation hub and the extension leg defining at least one fluid passageway in fluid communication with the at least one lumen of the catheter tube;

at least one sensor included with a proximal portion of the catheter assembly, the at least one sensor configured to detect a physical aspect of the catheter assembly;

a communication module configured to wirelessly transmit data sensed by the at least one sensor to a receipt location; and

a battery configured to power at least one of the at least one sensor and the communication module included with the catheter assembly, the battery included in a securement device that is configured to removably secure the catheter assembly to the patient.

26. The catheter assembly as defined in claim 25, wherein the physical aspect includes a state of occlusion of the catheter tube.

27. The catheter assembly as defined in claim 26, wherein the at least one sensor includes a pressure sensor.

28. The catheter assembly as defined in claim 25, wherein the physical aspect includes a flushing state of the catheter tube and wherein the at least one sensor includes a flush sensor.

29. The catheter assembly as defined in claim 25, wherein the at least one sensor includes a pressure sensor and wherein the physical aspect includes a malposition of the distal end of the catheter tube.

30. The catheter assembly as defined in claim 29, further comprising an ECG sensor configured to assist in detecting the malposition of the distal end of the catheter tube.

31. A catheter flush sensor assembly for detecting fluid flushing of a lumen of a catheter tube inserted into a body of a patient, the flush sensor assembly comprising:

a detection module operably connected with the catheter tube and disposed exterior to the body of the patient and configured to detect when a medical component is at least indirectly operably connected to the catheter tube;

a processor configured to process data relating to the detection of the at least indirect connection of the medical component to the catheter tube; and

a visual indicator included on a surface of the flush sensor assembly and disposed exterior to the body of the patient, the visual indicator designed to indicate a flushing status of the lumen of the catheter tube.

32. The catheter flush sensor assembly as defined in claim 31, wherein the detection module includes a flush sensor disposed in a cavity of a luer connector of the catheter flush sensor assembly, the flush sensor configured to actuate when the medical component is received within the cavity of the luer connector.

33. The catheter flush sensor assembly as defined in claim 32, wherein the flush sensor assembly includes a lever urged to a first position by a spring, the lever movable to a second position when the medical component is received within the cavity of the luer connector.

34. The catheter flush sensor assembly as defined in claim 31, wherein the visual indicator is a LED light array.

35. The catheter flush sensor assembly as defined in claim 34, wherein the LED light array includes a green LED light that indicates less than 10 hours have elapsed since a previous flushing procedure was detected, a yellow LED light that indicates more than 10 hours but less than 12 hours have elapsed since the previous flushing procedure, and a red LED light that indicates that more than 12 hours have elapsed since the last flushing procedure.

36. The catheter flush sensor assembly as defined in claim 34, wherein the LED light array includes a green LED light that flashes after an acceptable flushing procedure has been performed, a red LED light that flashes after a non-acceptable or incomplete flushing procedure has occurred, and a yellow LED light that flashes to indicate a possible occlusion is present in the catheter tube.

37. The catheter flush sensor assembly as defined in claim 31, wherein the visual indicator moves from a first position that is substantially level with the surface of the flush sensor assembly, to a second position that protrudes from the surface of the flush sensor assembly to indicate an occlusion may be present.