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WO2025240649A1 - Dispositif de mesure destiné à être utilisé avec un cathéter à demeure - Google Patents

Dispositif de mesure destiné à être utilisé avec un cathéter à demeure

Info

Publication number
WO2025240649A1
WO2025240649A1 PCT/US2025/029411 US2025029411W WO2025240649A1 WO 2025240649 A1 WO2025240649 A1 WO 2025240649A1 US 2025029411 W US2025029411 W US 2025029411W WO 2025240649 A1 WO2025240649 A1 WO 2025240649A1
Authority
WO
WIPO (PCT)
Prior art keywords
measurement device
stylet
sensors
housing
catheter
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2025/029411
Other languages
English (en)
Inventor
Adam J. Boud
Christopher QUACH
Haley ABRAMSON
Daniel Blanchard
Chad Alan TAGGE
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US19/207,101 external-priority patent/US20250352091A1/en
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Publication of WO2025240649A1 publication Critical patent/WO2025240649A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6851—Guide wires
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0022—Monitoring a patient using a global network, e.g. telephone networks, internet
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6846—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive
    • A61B5/6847—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be brought in contact with an internal body part, i.e. invasive mounted on an invasive device
    • A61B5/6852—Catheters

Definitions

  • An arterial catheter may be indwelling to provide ongoing access to a patient’s blood for withdrawal, infusion, measurement, etc.
  • a device such as a stylet may be inserted into the indwelling catheter.
  • the present disclosure relates generally to a measurement device for use with an indwelling catheter.
  • the measurement device can include a housing from which a stylet extends.
  • the housing can include circuitry for receiving measurements from one or more sensors on the stylet.
  • the circuitry may also include a wireless module for wirelessly transmitting the measurements to a patient’s electronic medical record or monitoring device.
  • a measurement device for use with an indwelling catheter may include a housing containing circuitry, a stylet that extends from the housing, and one or more sensors on the stylet.
  • the circuitry may be configured to receive measurements from the one or more sensors.
  • the circuitry may include a wireless module for wirelessly transmitting the measurements to an external system.
  • the stylet may comprise a hollow interior through which one or more cables extend to connect the one or more sensors to the circuitry.
  • the hollow interior may form a fluid pathway.
  • the stylet may extend from the housing via a connector that is configured to connect the housing to a catheter adapter.
  • the connector may be a luer connector.
  • the circuitry may include a replaceable battery.
  • the measurement device may include a medium that isolates the one or more sensors from an environment external to the stylet.
  • the medium may be contained within one or more holes through a sidewall of the stylet and may be configured to allow an analyte to pass through to the one or more sensors.
  • the medium may be positioned overtop the one or more sensors.
  • the housing may be wearable.
  • the circuitry may include storage.
  • the housing may include a display.
  • the circuitry may include a wireless module.
  • the circuitry may form a wired interface.
  • a measurement device for use with an indwelling catheter may include a housing containing a wireless module, a stylet that is coupled to the housing, and one or more sensors positioned on the stylet. The one or more sensors may be configured to provide measurements to the wireless module for transmission to an external system.
  • the housing may include a connector by which the housing is coupled to a catheter adapter.
  • a measurement device for use with an indwelling catheter may include a stylet that is configured to insert into a catheter and to selectively occlude the catheter, one or more sensors on the stylet, and a wireless module that receives measurements from the one or more sensors and transmits the measurements to an external system.
  • the stylet may have a hollow interior through which one or more cables extend to connect the one or more sensors to the wireless module.
  • Figures 1A and IB are side and cross-sectional views respectively of an example measurement device that is configured in accordance with one or more embodiments;
  • Figures 2A and 2B are side and cross-sectional views respectively of another example measurement device that is configured in accordance with one or more embodiments;
  • Figures 3A and 3B are perspective and cross-sectional views respectively of another example measurement device that is configured in accordance with one or more embodiments;
  • Figure 4 provides another example of a measurement device that is configured in accordance with one or more embodiments including how the measure device may facilitate patient mobility;
  • Figure 5 provides an example of how a stylet of a measurement device may be configured to selectively occlude a catheter in accordance with one or more embodiments.
  • FIGS 1 A and IB illustrate an example of a measurement device 100 that is configured in accordance with one or more embodiments.
  • Measurement device 100 includes housing 110 and a stylet 120 that extends distally from housing 110 and that may include one or more sensors 121.
  • Stylet 120 can be configured to selectively occlude a catheter into which it is inserted.
  • Figure 5 provides an example where stylet 120 includes an occluding portion 123 that occludes a distal tip of a catheter 202 that is inserted into a patient’s vasculature 400.
  • stylet 120 may couple to housing 110 via a connector 1 11 (e.g., a luer connector) which can facilitate connecting housing 110 to a catheter into which stylet 120 is inserted (e.g., via a needle free connector on the catheter adapter).
  • a connector 1 11 e.g., a luer connector
  • Stylet 120 could be formed of any suitable material such as polyimide, polyurethane, stainless steel, Nitinol, PEEK, etc.
  • housing 110 may include a removable cover 112 which provides access to circuity 113.
  • circuitry 113 can include one or more sensor base units (which may be in communication with one or more sensors 121 formed on or integrated into stylet 120), one or more wireless modules (e.g., for transmitting measurements), one or more batteries (e.g., for powering other components of circuitry 113), etc.
  • Circuitry 113 can be configured to receive measurements obtained via one or more sensors on stylet 120 and to transmit these measurements to another system (e.g., to the patient’s electronic medical record).
  • Figure IB which is a cross-sectional view taken through stylet 120, provides an example of how stylet 120 may include a hollow interior 120a through which one or more cables 122 may be routed.
  • Cable(s) 122 could be used for communicating with sensor(s) 121 included on stylet 120 at or towards the distal end of stylet 120 (e.g., as shown in Figure 5).
  • Any suitable number and/or type of sensor 121 could be used such as one or more pressure sensors, one or more temperature sensors, one or more optical sensors, one or more electromagnetic sensors, one or more electrochemical sensors, one or more photoelectric sensors, one or more electrodes, etc.
  • one or more of cable(s) 122 could be used to power corresponding sensor(s) 121 .
  • measurement device 100 can be used to obtain measurements while allowing the patient to be mobile. For example, a patient may walk around while measurement device 100 remains connected to a catheter assembly and provides continuous monitoring.
  • the wireless module(s) can receive measurements from one or more sensors included on stylet 120 and can transmit the measurements to an external system (e.g., a nursing station). Any suitable wireless protocol could be used such as Wi-Fi, Bluetooth, NFC, etc.
  • Figures 2A and 2B which are similar to Figures 1A and IB, provide an example of how stylet 120 may isolate one or more sensors 121.
  • a sensor 121 is integrated into a sidewall of stylet 121 such that sensor 121 is not exposed to the external environment outside of stylet 121 (e.g., to blood, medicaments, other fluids, etc. that may be present in the patient’s vasculature and/or within the catheter).
  • one or more holes 120b may be formed in stylet 121 in the vicinity of sensor 121.
  • each hole 120b may be fdled with a medium that is diffusive to the analyte of interest and that is biocompatible.
  • a polyacrylamide gel could be used to fill holes 120b.
  • a polyacrylamide gel (or other suitable medium) could include additives that filter undesired analytes such that only the desired analyte is able to pass through holes 120b to reach sensor 121.
  • sensor 121 could be integrated into stylet 120 so that it forms part of the sidewall of stylet 120 (i.e., so that it is otherwise exposed to the external environment) and the medium can be used to directly cover sensor 121.
  • Figures 3A and 3B provide another example of how measurement device 100 may be configured in one or more embodiments.
  • measurement device 100 includes a connector 11 1 that is connected to a connector 201 of a catheter assembly 200 from which a catheter 202 extends.
  • stylet 120 extends through catheter 202 and may have its distal end positioned at or near a distal tip of catheter 202.
  • an additional connector 114 is formed on (or extends from) connector 111 and provides an access point for fluidly connecting a blood draw device (or another device) to catheter 202.
  • a fluid pathway 115 may be formed through connectors 111 and 114 and into the lumen of catheter 202.
  • stylet 120 may be routed from housing 110, through connector 111, and into catheter 202.
  • Figure 3B also provides an example of circuitry 113 that includes a circuit board to which the proximal end of stylet 120 (or, more specifically, the proximal end of cable(s) 122) are connected and a battery for providing power to the circuit board.
  • the circuit board also includes various electronic components such as a wireless transceiver and one or more base units for sensors 121.
  • stylet 120 could be configured to form a fluid pathway for performing blood draws and/or infusions.
  • the proximal end of stylet 120 could be connected to connector 114 so that fluid pathway 115 continues into hollow interior 120a of stylet 120 rather than into the lumen of catheter 202.
  • cable(s) 122 could be configured to extend through a sidewall of stylet 120 to connect to circuitry 113.
  • the application incorporated by reference above provides examples of how the distal end of stylet 120 could be configured in these embodiments to enable blood draws or infusions through stylet 120. However, any suitable configuration of stylet 120 could be employed.
  • housing 110 (including connector 111) could be configured to provide a separate fluid pathway into the lumen of catheter 202.
  • a separate connector could be provided to form this separate fluid pathway.
  • Figure 4 provides an example where measurement device 100 includes a housing 110 that is in the form of an armband and is therefore wearable.
  • Other types of wearable housings 110 could be employed such as a watch, adhesive patch, necklace, fanny pack, etc.
  • connector 111 could be connected to housing 110 via tubing (e.g., to house cables 122 and/or to form a fluid pathway) to facilitate a desired positioning of housing 110.
  • housing 110 may include a display 116 on which measurements obtained via stylet 120 may be displayed in real-time.
  • circuitry 113 could employ display 116 to output alerts (e.g., similar to a vital signs monitor).
  • circuitry 113 could calculate advanced parameters from measurements obtained via stylet 120 and could output such advanced parameters (e.g., via display 116 or by transmitting the advanced parameters to an external system).
  • circuitry 113 in a wearable housing 110 could include a wireless module for transmitting measurements to another system.
  • circuitry 113 of a wearable housing 110 may not include a wireless module but may include a wired interface for connecting to a nearby system such as a vital signs monitor.
  • circuitry 113 may also include storage for temporarily storing measurements while the wired interface is disconnected and may be configured to transfer stored measurements once the wired interface is again connected. In this way, patient mobility is still facilitated even though a wired interface is employed to transfer measurements from measurement device 100.
  • a measurement device configured in accordance with one or more embodiments can be used to enhance mobility of any patient having an indwelling catheter. This enhancement in mobility may be due to the use of a wireless module to eliminate the need for a wired connection and/or to the use of a stylet that selectively occludes the catheter to eliminate the need for a constant flow of saline through the catheter. This mobility is provided without foregoing the benefits of constant monitoring and data acquisition.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Medical Informatics (AREA)
  • Physics & Mathematics (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Computer Networks & Wireless Communication (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

Un dispositif de mesure peut être utilisé avec un cathéter à demeure. Le dispositif de mesure peut comprendre un boîtier à partir duquel s'étend un stylet. Le boîtier peut comprendre des circuits pour recevoir des mesures provenant d'un ou de plusieurs capteurs sur le stylet. Les circuits peuvent également comprendre un module sans fil pour transmettre sans fil les mesures au dossier médical électronique ou au dispositif de surveillance électronique d'un patient.
PCT/US2025/029411 2024-05-17 2025-05-14 Dispositif de mesure destiné à être utilisé avec un cathéter à demeure Pending WO2025240649A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463648822P 2024-05-17 2024-05-17
US63/648,822 2024-05-17
US19/207,101 2025-05-13
US19/207,101 US20250352091A1 (en) 2024-05-17 2025-05-13 Measurement device for use with an indwelling catheter

Publications (1)

Publication Number Publication Date
WO2025240649A1 true WO2025240649A1 (fr) 2025-11-20

Family

ID=95939389

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/029411 Pending WO2025240649A1 (fr) 2024-05-17 2025-05-14 Dispositif de mesure destiné à être utilisé avec un cathéter à demeure

Country Status (1)

Country Link
WO (1) WO2025240649A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020128546A1 (en) * 2000-05-15 2002-09-12 Silver James H. Implantable sensor
WO2014062728A1 (fr) * 2012-10-18 2014-04-24 C.R. Bard, Inc. Ensembles aiguille équipés d'un élément magnétique
US20160262698A1 (en) * 2013-10-25 2016-09-15 St. Jude Medical Coordination Center Bvba Sensor guide wire device and system including a sensor guide wire device
US9585566B2 (en) * 2006-11-20 2017-03-07 St. Jude Medical Coordination Center Bvba Transceiver unit in a measurement system
US20210275256A1 (en) * 2020-03-03 2021-09-09 Bard Access Systems, Inc. System and Method for Optic Shape Sensing and Electrical Signal Conduction
WO2022036168A2 (fr) * 2020-08-14 2022-02-17 Becton, Dickinson And Company Obturateur pour faciliter la traction d'une ligne de cathéter
US20230285719A1 (en) * 2020-09-08 2023-09-14 Piccolo Medical, Inc. Devices and methods for vascular navigation, assessment, treatment and/or diagnosis

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20020128546A1 (en) * 2000-05-15 2002-09-12 Silver James H. Implantable sensor
US9585566B2 (en) * 2006-11-20 2017-03-07 St. Jude Medical Coordination Center Bvba Transceiver unit in a measurement system
WO2014062728A1 (fr) * 2012-10-18 2014-04-24 C.R. Bard, Inc. Ensembles aiguille équipés d'un élément magnétique
US20160262698A1 (en) * 2013-10-25 2016-09-15 St. Jude Medical Coordination Center Bvba Sensor guide wire device and system including a sensor guide wire device
US20210275256A1 (en) * 2020-03-03 2021-09-09 Bard Access Systems, Inc. System and Method for Optic Shape Sensing and Electrical Signal Conduction
WO2022036168A2 (fr) * 2020-08-14 2022-02-17 Becton, Dickinson And Company Obturateur pour faciliter la traction d'une ligne de cathéter
US20230285719A1 (en) * 2020-09-08 2023-09-14 Piccolo Medical, Inc. Devices and methods for vascular navigation, assessment, treatment and/or diagnosis

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