Vascular probe sensing system and related delivery device

Abstract

A vascular access system includes a catheter assembly having a catheter and a nearby patient access port. A sensor probe delivery device connects to the nearby patient access port, with the delivery device having a sensing probe assembly having a probe member containing one or more sensors and an electrical connector positioned proximal to the probe member. The housing of the delivery device includes a detachable portion that can movably receive the sensing probe assembly and separate from the rest of the housing. A lock connects the housing to the nearby patient access port, and a forward member may move relative to the housing to move the sensing probe assembly between a first position and a second position, with the distal end of the probe member positioned inside or outside the catheter when in the second position, enabling measurement of one or more blood-related parameters.

Description

Technical Field

[0001] The present invention is directed to a vascular access system for measuring and monitoring blood-related parameters using a sensing probe delivery device with an arterial catheter implanted in the body and to a method of using the vascular access system.

Background Art

[0002] Cross-references to related applications This application claims priority to U.S. Provisional Application No. 63 / 459,085, filed on April 13, 2023, with the title "Vascular Probe Sensing System and Associated Delivery Device", and as a result, the entire disclosure is incorporated herein by reference.

[0003] Background technology Vascular access devices (VADs) are used in the medical field to access a patient's peripheral vascular system for the purpose of infusion therapy and / or blood sampling. Common types of VADs include over-the-needle peripheral intravenous catheters (PIVCs), peripherally inserted central venous catheters (PICCs), central venous catheters (CVCs), and midline catheters. VADs may be implanted in the body for short periods (days), medium periods (weeks), or long periods (months to years).

[0004] An exemplary use of a VAD as described above is in arterial catheterization. Arterial catheters and related systems are used to continuously monitor and measure blood pressure, heart rate, and the contour of the pulse wave, enabling the immediate recognition of abnormal hemodynamics and the initiation of appropriate treatment. Additionally, arterial catheters are also used to provide samples of arterial blood for arterial blood gas (ABG) testing and analysis without the morbidity associated with repeated arterial punctures.

[0005] It is acknowledged that the current use of arterial catheters and associated arterial blood gas and blood sampling systems can be complex and have many drawbacks, including blood exposure risks and other performance issues. Furthermore, existing hemodynamic monitoring and ABG collection systems are highly complex and expensive, and can require considerable time and resources to collect ABG samples and maintain arterial lines in order to reduce the risk of complications such as infection, CRBSI, flushing of lines and devices, and arterial blood preservation.

[0006] Therefore, there is a need for improved systems and devices that facilitate arterial blood gas sampling and continuous pressure monitoring, overcoming the aforementioned limitations of existing systems and devices. These systems should provide real-time, continuous, or intermittent measurement and analysis of hemodynamic and blood parameters while eliminating the complexities and complications arising from current systems and approaches. [Overview of the project]

[0007] This specification provides a vascular access system comprising a catheter assembly including a catheter and a patient-near access port, and a sensor probe delivery device connectable to the patient-near access port, enabling access to the catheter via the catheter assembly. The delivery device comprises a sensing probe assembly having a probe member containing one or more sensors configured to measure one or more blood-related parameters, the probe member having a distal end and a proximal end, and an electrical connector positioned proximal to the probe member, the electrical connector being configured to operably connect to an external device. Furthermore, the delivery device comprises a housing configured to movably receive at least a portion of the sensing probe assembly within an internal volume, the housing comprising a detachable portion that can be separated from the remainder of the housing. The delivery device further includes a lock configured to connect the housing to a nearby patient access port, and a forward member configured to move relative to the housing to move the sensing probe assembly between a first position in which the distal end of the probe member is positioned within the housing or lock, and a second position in which the distal end of the probe member is positioned inside the catheter beyond the distal end portions of the housing and lock, or outside beyond the distal tip of the catheter. The sensing probe assembly in the second position positions the probe member to measure one or more blood-related parameters.

[0008] In some embodiments, the housing includes a coupler provided at the distal end portion, the coupler being configured to engage with a lock or formed to constitute the whole by a part of the lock, and the detachable portion of the housing is configured to be detachable from the coupler.

[0009] In some embodiments, the detachable portion of the housing is configured to be detached from the coupler via a twist-type disconnector.

[0010] In some embodiments, the detachable portion includes a separable housing which includes a pair of detachable housing portions that separate from the coupler.

[0011] In some embodiments, the sensing probe assembly includes a connector portion comprising a fitting configured to securely fasten the proximal end of a probe member, and a flange member coupled to the fitting, wherein the connector portion is positioned adjacent to the coupler when the sensing probe assembly is in a second position, having the connector portion held in the coupler.

[0012] In some embodiments, the forward member is connected to the flange of the connector portion such that the movement of the forward member relative to the housing causes a corresponding movement of the sensing probe assembly.

[0013] In some embodiments, the electrical connector is coupled to the connector portion and extends outward from there proximal to it.

[0014] In some embodiments, the electrical connector is accessible when the sensing probe assembly is in the second position, and when the detachable portion is disconnected, it is placed within the housing when the sensing probe assembly is in the first and second positions, respectively.

[0015] In some embodiments, the sensing probe assembly includes a wired extension portion coupled to a connector portion and extending proximal outward from there, and the electrical connector is connected to the wired extension portion at its proximal end.

[0016] In some embodiments, the electrical connector is connected to the proximal end of the wired extension, and the electrical connector is spaced apart from the connector portion and coupler when the sensing probe assembly is in a second position.

[0017] In some embodiments, the wireless module is connected to an electrical connector and is configured to receive one or more blood-related parameters from a sensing probe assembly, analyze and display one or more blood-related parameters, and / or wirelessly transmit one or more blood-related parameters to a processing device.

[0018] In some embodiments, the patient data cable is connected to an electrical connector and configured to transmit one or more blood-related parameters to a processing device.

[0019] In some embodiments, the catheter assembly includes a catheter adapter connected to the proximal end of the catheter, the catheter adapter includes an adapter port and a connector connected to the adapter port via an extension tube, and a nearby patient access port is provided at the proximal end of the connector.

[0020] Furthermore, the method also provides a method relating to using a vascular access system having the following characteristics: connecting a sensor probe delivery device to a patient-near access port of a catheter assembly; advancing the sensor probe assembly from a first position to a second position such that the distal end of the probe member extends into or beyond the distal end of the catheter; detaching a detachable portion of the housing; and connecting an external device to an electrical connector of the sensor probe assembly, wherein the external device includes one of a wireless module and a data cable.

[0021] In some embodiments, the method includes securely fixing the wireless module in place via one or more of a stabilizing platform and a security dressing.

[0022] Furthermore, a sensor probe delivery device is also provided that can be connected to a patient-near access port of a catheter assembly. The delivery device includes a sensing probe assembly, which includes a probe member containing one or more sensors configured to measure one or more blood-related parameters, the probe member having a distal end and a proximal end, and an electrical connector located proximal to the probe member, the electrical connector being configured to operably connect to an external device. Furthermore, the delivery device includes a housing configured to movably receive at least a portion of the sensing probe assembly within an inner volume, the housing including a detachable portion that can be separated from the rest of the housing, a lock configured to connect to a nearby patient access port, and a forward member configured to move relative to the housing to move the sensing probe assembly between a first position in which the distal end of the probe member is positioned within the housing or lock, and a second position in which the distal end of the probe member is positioned beyond the distal end portion of the housing and lock. The sensing probe assembly in the second position positions the probe member to measure one or more blood-related parameters.

[0023] In some embodiments, the housing includes a coupler provided at its distal end, the coupler being configured to engage with a lock or formed to be entirely composed of a portion of the lock, and the detachable portion of the housing is configured to be detachable from the coupler.

[0024] In some embodiments, the sensing probe delivery device includes a connector portion having a fitting configured to securely fix the proximal end of the probe member and a flange member coupled to the fitting, and the connector portion is positioned adjacent to the coupler with the connector portion being held in the coupler and the sensing probe assembly being in the second position.

[0025] In some embodiments, the advancement member is connected to the flange of the connector portion such that movement of the advancement member relative to the housing causes a corresponding movement of the sensing probe assembly.

[0026] In some embodiments, the electrical connector is coupled to and extends proximally outward from the connector portion such that the electrical connector is positioned within the housing when the sensing probe assembly is in each of the first and second positions, and the electrical connector is accessible when the detachable portion is detached and the sensing probe assembly is in the second position. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] [Figure 1] FIG. 1 is a top view of an arterial access system including a sensor probe deliver device according to aspects of the present disclosure. [Figure 2] FIG. 1 is a top view of the sensor probe delivery device of the arterial access system of FIG. 1 according to aspects of the present disclosure. [Figure 3] FIG. 2 is an exploded view of the sensor probe delivery device of FIG. 2. [Figure 4] FIG. 2 is a top view of the sensor probe delivery device of FIG. 2 showing a detachable housing portion according to aspects of the present disclosure. [Figure 5] FIG. 2 is a top view of the sensor probe delivery device of FIG. 2 showing a detachable housing portion according to aspects of the present disclosure. [Figure 6]Figure 2 is a top view of the sensor probe delivery device showing a detachable housing portion according to an embodiment of the present disclosure. [Figure 7] This is a top view of the sensor probe assembly included in the sensor probe delivery device of Figure 2 according to an embodiment of the present disclosure. [Figure 8] This is a side cross-sectional view of the distal portion of the probe member of the sensor probe assembly shown in Figure 7 according to an embodiment of the present disclosure. [Figure 9] This is a side cross-sectional view of the distal portion of the probe member of the sensor probe assembly shown in Figure 7 according to an embodiment of the present disclosure. [Figure 10] Figure 2 is a side cross-sectional view of the sensor probe delivery device showing the sensor probe in the first retracted position. [Figure 11] Figure 2 is a side cross-sectional view of the sensor probe delivery device showing the sensor probe assembly in a second extended position. [Figure 12] This figure shows a processing flow for linking a catheter assembly and a sensor probe delivery device to measure and analyze one or more blood-related parameters and hemodynamic parameters according to an aspect of this disclosure. [Figure 13] This figure shows a processing flow for linking a catheter assembly and a sensor probe delivery device to measure and analyze one or more blood-related parameters and hemodynamic parameters according to an aspect of this disclosure. [Figure 14] This figure shows a processing flow for linking a catheter assembly and a sensor probe delivery device to measure and analyze one or more blood-related parameters and hemodynamic parameters according to an aspect of this disclosure. [Figure 15] This is a schematic diagram of a wireless board unit usable with the sensor probe delivery device shown in Figure 2 according to an embodiment of the present disclosure. [Figure 16] This is a schematic diagram of a communication system that can be used with the wireless board unit shown in Figure 15 according to an aspect of this disclosure. [Figure 17] Figure 1 is a top view of a sensor probe delivery device usable by the arterial access system in a state in which the sensor probe delivery device according to an aspect of this disclosure is in the first configuration. [Figure 18] Figure 17 is a top view of the sensor probe delivery device in the second configuration. [Figure 19] Figure 17 is a top view of the sensor probe delivery device according to an aspect of the present disclosure, connected to a catheter assembly and a wireless board unit in a state in a second configuration. [Figure 20] Figure 17 is a top view of the sensor probe delivery device according to an aspect of this disclosure, connected to a catheter assembly and a patient data cable in a state in a second configuration. [Figure 21] This is a top view of a sensor probe delivery device usable with the arterial access system shown in Figure 1 according to an embodiment of the present disclosure. [Modes for carrying out the invention]

[0028] The following description is provided to enable those skilled in the art to construct and use the described embodiments intended for carrying out the invention. However, various modifications, equivalents, variations, and substitutions will remain readily apparent to those skilled in the art. Any such modifications, variations, equivalents, and substitutions are intended to fall within the spirit and scope of the invention.

[0029] As used in this specification, the words “proximal” and “distal” refer to the directions closer to and away from the user who will install the device that comes into contact with the patient, respectively. Therefore, for example, the end of the device that first touches the patient's body would be the distal end, while the opposite end of the device (e.g., the end of the device being operated by the user) would be the proximal end.

[0030] For example, spatial or directional terms such as "left," "right," "inside," "outside," "up," "down," and similar terms are not considered limiting, as the invention allows for the assumption of various alternative orientations.

[0031] Hereafter in this specification, for illustrative purposes, the terms “top,” “bottom,” “right,” “left,” “vertical,” “horizontal,” “up,” “down,” “sideways,” “vertical,” and their derivatives will be relevant to the invention as they are oriented in the drawings depicted. However, it will be understood that the invention may assume various alternative variations unless explicitly stated otherwise. Furthermore, it will be understood that certain devices illustrated in the accompanying drawings and described in the subsequent specification are merely illustrative embodiments of the invention.

[0032] The terms “first,” “second,” and similar terms are not intended to refer to any specific order or timeline, but rather to different conditions, characteristics, or elements.

[0033] As used herein, “at least one of” is synonymous with “one or more of.” For example, the phrase “at least one of A, B, and C” means any one of A, B, or C, or any combination of two or more of A, B, or C. For example, “at least one of A, B, and C” means one or more A alone, or one or more B alone, or one or more C alone, or one or more A and one or more B, or one or more A and one or more C, or one or more B and one or more C, or one or more of all of A, B, and C.

[0034] Referring to Figure 1, non-limiting embodiments of the vascular access system 10 for facilitating blood-related parameters and hemodynamic analysis and monitoring are shown. While the vascular access system 10 will be described hereafter as an arterial access system for facilitating arterial blood gas (ABG) testing and pressure monitoring, it is acknowledged that the system could also be used to measure and monitor blood flow-based parameters in veins or other parts of the vascular system.

[0035] As shown in Figure 1, the arterial access system 10 may include a catheter assembly that provides access to the patient's vascular system. According to embodiments of the present disclosure, the catheter assembly 12 may have any number of preferred configurations, including being constructed / arranged as an integrated catheter assembly or as an unintegrated catheter assembly including an extension set having an access port near the patient. Thus, although Figure 1 illustrates an integrated catheter assembly 12, it is acknowledged that embodiments of the present disclosure may be directed to other catheter assemblies. In Figure 1, the catheter assembly 12 includes a catheter adapter 14 and an associated catheter 16. The catheter adapter 14 may include a distal end 18 and a proximal end 20. In some embodiments, the catheter adapter 14 may include an additional adapter port 22 located between the distal end 18 and the proximal end 20, or located on the proximal end 20. The catheter adapter 14 may include a first lumen 24 extending through a distal end 18 and a proximal end 20, the first lumen 24 may be sealed at the proximal end 20 of the catheter adapter 14. The catheter 16 may be configured as an arterial catheter extending from the distal end 18 of the catheter adapter 14 and placed in the patient's artery, having a distal end or tip 26 of the catheter 16 positioned appropriately in an artery (or other vein) to allow blood collection from the patient. In some embodiments, the catheter 16 may be inserted into the artery such that its distal tip 26 (the opening therein) is directed upstream into the arterial blood flow. The catheter 16 may be formed from any suitable material as is known to those skilled in the art, and may be a catheter of any useful length.

[0036] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a first fluid conduit 30 extending from the port 22. The first fluid conduit 30 may be formed of any suitable material known to those skilled in the art and may have a distal end 32 and a proximal end 34. The distal end 32 of the first fluid conduit 30 may be connected to the port 22, while the proximal end 34 of the first fluid conduit 30 may be connected to a connector 36. The connector 36 may be a T-connector (e.g., one side port positioned at a 90-degree angle with respect to the longitudinal axis of the connector 36), a Y-connector (e.g., one side port positioned at an angle of 15 to 85 degrees with respect to the longitudinal axis of the connector 36), or any other type of connector known in the art. The connector 36 includes a second lumen 38 through which branches of any number appropriate to the type of connector are provided, such as a branch extending between the distal and proximal ends of the connector 36 and a branch providing to the port 44 of the connector 36.

[0037] In some non-limiting embodiments or aspects, the catheter assembly 12 may include a needleless access connector 46 connected to the proximal end of the connector 36, such that the needleless access connector 46 provides a patient-near access port to the catheter assembly 12. The needleless access connector 46 may be configured, for example, as a split septum connector or a self-healing septum connector.

[0038] In some non-limiting embodiments or aspects, the catheter assembly 12 may further include an extension set 48 connected to a port 44 of a connector 36. The extension set 48 may include a conduit 50 connected to the port 44 at one end 52 of the second fluid conduit 50, and a Luer connector 54 (e.g., a needleless access connector) at the opposite end 56, and a clamp 58 provided on the second fluid conduit 50 to allow occlusion. The extension set 48 may be used to provide a route for fluid to or from the catheter assembly 12 to allow the supply of fluid or drug, blood aspiration, or a route for fluid to an ex vivo hemodynamic monitoring device that monitors pulse wave contours based on the patient's blood pressure, heart rate, and / or arterial blood collected through the catheter assembly 12 (and through the extension set 48).

[0039] According to aspects of the present disclosure, the arterial access system 10 further includes a delivery device 60 which may be operated to introduce a sensing probe into the patient's vascular system, for example, having a state in which the sensing probe enables blood gas analysis. As shown in Figure 1, and as shown in more detail in Figures 2 to 11, according to a non-limiting embodiment, the delivery device 60 includes at least a housing 62, a coupling device or "lock" 64, a sensing probe assembly 66, and an advancing member 68. As will be described in more detail below, the sensing probe assembly 66 is movable within the housing 62 to provide for advancing a portion of the sensing probe assembly 66 (i.e., a probe member) from a first or retracted position within the housing 62 (Figure 10) to a second or advanced position outside the housing 62 (Figure 11), such that its distal end may be delivered into the catheter assembly 12. When a portion of the sensing probe assembly 66 is delivered into the catheter assembly 12, into the catheter 16 that is implanted in the body, or beyond the catheter 16 that is implanted in the body, a portion of the housing 62 may be detached, and the sensing probe assembly 66 may remain in place for a period of time without interference from the housing 62.

[0040] As shown in Figures 2-5, the housing 62 of the delivery device 60 can be an elongated member having a proximal end 72 and a distal end 74, defining an internal volume 76. The housing 62 generally includes a coupler 78 provided at the distal end 74 and a detachable portion 80 positioned proximal to the coupler 78. The coupler 78 is configured to connect the housing 62 to the lock 64, while the detachable portion 80 is configured to be selectively detached from the coupler 78. In some embodiments, the housing 62 may include one or more features or surface finishes on its outer surface that can be arranged to improve the ergonomics of the delivery device 60, which in some embodiments may allow the user to operate the delivery device 60 with one hand (i.e., one-handed use).

[0041] The coupler 78 can be any suitable shape, size, and / or configuration and may be integrated with or configured for connection to the lock 64. In some embodiments, the coupler 78 may include a set of threads 82 that enable a threaded connection with an associated threaded portion 84 of the lock 64. In other embodiments, the coupler 78 may be formed to constitute the whole with at least a portion of the lock 64. The coupler 78 may further include a mating feature 86 at its proximal end that provides engagement between the coupler 78 and the removable portion 80 of the housing 62. According to embodiments, the mating feature 86 may be in the form of a groove provided on the outer circumference / outer circumference of the coupler 78 into which the end of the removable portion 80 engages, or in the form of a threaded connection into which the end of the removable portion 80 may engage.

[0042] According to the embodiments, the detachable portion 80 of the housing 62 is configured to detach from the coupler 78 in response to the operation of the detachable portion 80. Referring to Figures 4-6, various embodiments of the detachable portion 80 that provide detachment of the detachable portion 80 relative to the coupler 78 are shown. In the embodiment shown in Figure 4, the detachable portion 80 is configured to engage / disengage with the coupler 78 via a torsional connection, where a threaded or other torsional connection at the distal end 88 of the detachable portion 80 engages with the mating feature 86 of the coupler 78. In the embodiments shown in Figures 5 and 6, the detachable portion 80 is configured as a divisible housing formed from a pair of selectively detachable detachable housing portions 80a, 80b, which may detach from the mating feature 86 of the coupler 78 when separated. In the embodiment of Figure 5, the detachable housing portions 80a and 80b may remain joined at their proximal ends 90 when separated at their distal ends 88, whereas in the embodiment of Figure 6, the detachable housing portions 80a and 80b are provided as completely separate components that may be completely separated from each other.

[0043] Figures 4–6 illustrate the detachable portion 80 of the housing 62 detached from the coupler 78, but it is acknowledged that other parts of the housing 62 (or delivery device 60) may be detachably connected to any components that remain with the patient (i.e., the sensing probe assembly 66 and other possible components), insofar as at least a portion of the delivery device 60 may be detachable to reduce the size / footprint of components that remain with the patient. As one non-limiting example, the coupler 78 may be configured to be quickly detached / separated from the lock 64.

[0044] Referring again to Figures 1-6, the lock 64 of the delivery device 60 is located at the distal end 74 of the housing 62, and the lock 64 is provided to reversibly connect the delivery device 60 to the catheter assembly 12, for example, via a needleless access connector 46, as shown in Figure 1. In some embodiments, the lock 64 is configured as a male Luer connector that mates with a female Luer connector of the needleless access connector 46, and the male Luer connector of the lock 64 has an elongated member 92 surrounded by a rotating collar 94. The rotating collar 94 may rotate to screw-engage the male Luer connector with the female Luer connector of the needleless access connector 46. According to some embodiments, the lock 64 may be provided as a component entirely separate from the housing 62, with its proximal end configured to engage with a coupler 78 of the housing 62, and in one embodiment, the proximal end of the lock 64 is configured as a threaded projection 84 that selectively engages with a set of threads 82 on the coupler 78. In other embodiments, the elongated member 92 of the lock may be formed to constitute the whole with the housing 62 (i.e., with the coupler 78) and extend distally therefrom, and the rotating collar 94 may be firmly fixed around the elongated member 92 and rotatable with respect to it. Although the lock 64 is structured as a male Luer connector in the illustrated embodiment, it is understood that alternative embodiments of the delivery device 60 may include other types of locks 64 for firmly securing the delivery device 60 to the catheter assembly 12, including clips, blunt plastic cannulas, blunt metal cannulas, hybrid Luer (e.g., with cannula) friction fits, etc.

[0045] As shown above, the sensing probe assembly 66 is received movably within the housing 62 to provide forward movement of the sensing probe assembly 66 relative to the housing 62. According to embodiments, and also best shown in Figure 7, the sensing probe assembly generally includes a sensing probe member 96 ("probe member 96"), a connector portion 98, and an electrical connector 100. The probe member 96 may be connected to the connector portion 98 via a fitting 102 of the connector portion 98, and further, in the illustrated embodiment, the electrical connector 100 is connected to the connector portion 98. The electrical connector 100 is located at the proximal end of the sensing probe assembly 66 and provides an output port of the sensing probe assembly 66 to which external devices / components may be connected. According to embodiments, the electrical connector 100 is configured to allow the attachment of a patient data cable or Wi-Fi enabled wireless board with a processor, communications, power supply, sensor leads, and an optional display, as will be described in more detail below.

[0046] The probe member 96 is sized to be introduced into and advance through the fluid pathway of the catheter assembly 12 (i.e., the lumen of the catheter 16, the lumen 24 of the catheter adapter 14, and the conduit 30 of the first fluid). Therefore, the probe member 96 can have an outer diameter smaller than the minimum lumen of the fluid pathway of the catheter assembly (e.g., between 10 gauge and 30 gauge). The probe member 96 can be long enough to position its distal end 98 at a desired location within the fluid pathway of the arterial access system 10. Thus, in one embodiment, the probe member 96 may be long enough to extend its distal end 98 out of the housing 62 and through the catheter assembly (i.e., through the connector 36, the conduit 30, the catheter adapter 14, and the catheter 16) far beyond the distal tip 26 of the catheter 16.

[0047] Exemplary embodiments of the probe member 96 are provided in Figures 8 and 9 according to a non-limiting embodiment. Referring first to Figure 8, in one embodiment the probe member 96 generally includes a support wire 104 and one or more sensors 106 (i.e., sensors or sensor bundles) connected to (or near) the distal end 108 of the support wire 104. The support wire 104 may be constructed of a metal (e.g., nitinol) or other suitable material and formed to have a thin profile so that the wire has some degree of flexibility. The sensors or sensor bundles 106 may be configured to monitor various vital signs or physiological parameters of a patient, hereafter commonly referred to as “blood-related parameters,” such as blood pressure (venous or arterial), blood gases, pH, electrolytes, temperature, oxygen levels, or other target physiological or procedural parameters, and may be configured to wirelessly transmit measurements of such parameters to a remote receiver.

[0048] According to the embodiment, each of the support wire 104 and sensor(s) 106 may be coated with an antithrombotic coating 110. Antithrombotic materials suitable for use in medical devices that access the vascular system are known to those skilled in the art and may include, but are not limited to, heparin, heparin mimics, heparin, albumin, hydrophobic lubricants, fluorinated lubricants, fluorine-containing functional sites, silicone-containing functional sites, and / or poly(ethylene glycol) (PEG) functional sites, antithrombotic polymers (e.g., those containing one or both of poly(ethylene oxide) (PEO) / sulfate / sulfonate and poly(propylene oxide) (PPO), poly(2-methoxyethyl acrylate)), and combinations thereof, phosphorylcholine, prodrugs, and derivatives thereof. The antithrombotic coating 110 may be applied in the form of a film and / or coating to one or more of the support wire 104 and sensors 106, such that the antithrombotic coating is released when exposed to one or more enzymes in the blood when the probe member 96 is received into the catheter 16 of the catheter assembly 12. The antithrombotic coating 110 works to prevent the formation of thrombi on the surface of the probe member 96, and in particular on the surface of the sensors 106, over time, which would negatively affect the performance of the sensors 106. The application of the antithrombotic coating 110 to the sensors 106 can therefore extend the service life of the probe 96.

[0049] Referring now to Figure 9, in another embodiment, the probe member 96 generally includes a protective outer tube 112, an optical fiber 114 housed within the outer tube 112, and an optical sensor 116 connected to the optical fiber 114 and the distal end 118 of the tube 112. The outer tube 112 and the optical fiber 114 form a flexible member that is bent as the probe member 96 is inserted into the patient's vascular system through the catheter 16. The sensor 116 may be configured to acquire measurements of vital signs or other physiological parameters as part of a diagnostic examination and / or continuously over an extended period, and to wirelessly transmit measurements of such parameters to a remote receiver.

[0050] According to the embodiment, the distal tip 118 of the outer tube 112 and the sensor 116 are coated with an antithrombotic coating 110. As described above with respect to the probe member 96 in Figure 8, the antithrombotic coating 110 may be released by exposure to one or more enzymes in the blood when the probe member 96 is received into the catheter assembly 10. The antithrombotic coating 110 works to prevent the formation of thrombi on the surface of the probe member 96, and in particular on the surface of the sensor 116, over time, which would negatively affect the performance of the sensor 116. The application of the antithrombotic coating to the sensor 116 can therefore improve the diagnostic capability or continuous measurement capability of the sensor 116 (by preventing thrombus adhesion or contamination of the sensor 116) and extend the service life of the probe member 96.

[0051] Referring again to Figures 1 to 11, particularly Figures 2, 3, 10, and 11, according to one aspect of the present disclosure, the forward member 68 of the delivery device 60 includes a first portion 120 and a second portion 122. The first portion 120 is movably positioned along the upper surface 128 of the housing 62, and the second portion 122 is movably positioned within an internal volume 76 of the housing 62. In some embodiments, the arrangement of the forward member 68 and the housing 62 is such that a connecting portion 124 of the forward member 68, which connects the first and second portions 120, 122, seats in a slot 126 formed in the upper surface 128 of the housing 62—the slot 126 generally extends between the proximal end 72 and the distal end 74 of the housing 62 (i.e., the detachable portion 80). When the first and second parts 120 and 122 are joined together, the movement of the first part 120 along the upper surface 128 of the housing 62 results in the corresponding movement of the second part 122 within the inner volume 76.

[0052] As shown in Figures 2 and 3, the first portion 120 of the forward member 68 may be configured as a tab 130 having an upper side that can be occupied by a user and a lower side that is in contact with the upper surface 128 of the housing 62. In such embodiments, the upper surface 128 of the housing 62 may include, for example, a set of tracks such as ribs, ridges, bumps, grooves, and / or such, along which the lower surface of the tab advances when the forward member 68 is engaged by a user. In this way, the user is able to engage the first portion 120 of the forward member 68 and move the forward member 68 relative to the housing 62.

[0053] As shown in Figures 3, 10, and 11, the second portion 122 is configured to engage with the sensing probe assembly 66 to grip or hold a portion of the sensing probe assembly 66. More specifically, the second portion 122 of the forward member 68 may engage with the sensing probe assembly 66 between the fitting 102 and the electrical connector 100, either in the connector portion 98 or adjacent to the connector portion 98, such as by engaging with a flange 132 or projection provided to the connector portion 98. Movement of the forward member 68 relative to the housing 62 causes a corresponding movement of the sensing probe assembly 66 relative to the housing 62, so that a portion of the sensing probe assembly 66 is securely fixed to the second portion 122. In this way, the distal end 98 of the probe member 96 can be selectively moved away from the volume 76 inside the housing 62 as desired, so as to advance the distal end 98 of the sensing probe 66 out of the housing 62 when the delivery device 60 is connected to the catheter assembly 12 and arterial blood monitoring and analysis are performed. As described above, when advancing the distal end 98 of the sensing probe 66 out of the housing 62 into the catheter assembly 12, the delivery device 60 may be configured to extend the distal end 98 of the sensing probe 66 beyond the distal tip 26 of the arterial catheter 16 to be placed in the body.

[0054] Referring next to Figures 10 and 11, the advancement of the sensor probe assembly 66 from a first retracted position to a second extended position is shown. The sensor probe assembly 66 can be in the first position before use and can be moved from the first position (Figure 10) to the second position (Figure 11) by a user (e.g., a physician, doctor, nurse, technician, or phlebotomist) to position at least the distal end 98 of the probe member 96 distal to the housing 62 (e.g., inside or distal to a catheter 16 to be implanted in the body).

[0055] When the sensor probe assembly 66 is positioned in the first location within the housing 62, substantially the entire probe member 96 is located within the housing 62. In other embodiments, when the sensor probe assembly 66 is in the first location, the probe member 96 is located within the housing 62 and the lock 64.

[0056] The forward member 68 is positioned proximal when the sensor probe assembly 66 is in a first position, and the user may engage with the tab 130 of the first portion 120 of the forward member 68, thereby moving the forward member 68 relative to the housing 62, and consequently moving the sensor probe assembly 66 from the first position (for example, the position where the probe member 96 is positioned inside the housing 62) toward a second position. In this way, the probe member 96 is moved outward beyond the lock 64, and consequently, at least the distal end portion 98 of the probe member 96 is positioned outside and distal to the lock 64.

[0057] The second position of the sensor probe assembly 66 is reached when the distal end portion 98 of the probe member 96 is positioned at a desired location relative to the distal end 26 of the catheter 16 (see Figure 1). In one embodiment, for example, when the sensor probe assembly 66 is in the second position, the distal end 98 of the probe member 96 can be substantially at the same height as the distal end 26 of the catheter 16. In other embodiments, the distal end 98 of the probe member 96 can extend a predetermined distance beyond the distal end 26 of the catheter 16 so that the distal end 98 of the probe member 96 is placed in the artery (or other vein) by a predetermined distance beyond the distal end 26 of the catheter 16.

[0058] With the sensor probe assembly 66 in a second position (for example, with the forward member 68 advanced toward the distal end 74 of the housing 62 in Figure 11), the connector portion 98 of the sensor probe assembly 66 is positioned adjacent to the distal end 74 of the housing 62. In some embodiments, at least a portion of the connector portion 98 (such as the fittings 102 and flange 132 of the connector portion 98) is placed within the coupler 78 of the housing 62. The connector portion 98 may be sized and / or configured to be held within the coupler 78, for example, via a press fit or interference fit, so that the sensor probe assembly 66 is securely fixed with respect to the coupler 78 and the lock 64.

[0059] The removable portion 80 of the housing 62 may be removed with the sensor probe assembly 66 in the second position and the connector portion 98 securely fixed within the coupler 78 (and with respect to the lock 64). As described above and shown in Figures 4 to 6, the removable portion 80 of the housing 62 may be operated to detach from the coupler 78, for example, by twisting the removable housing 80 or by separating and removing the removable housing portions 80a and 80b. Thus, when the removable housing 80 is removed, only the sensor probe assembly 66 and coupler 78 of the delivery device 60 remain connected to and adjacent to the catheter assembly 12.

[0060] Referring next to Figures 12-14, a processing flow (method) for linking a sensor probe delivery device 60 with a catheter assembly 12 to measure and analyze one or more blood-related parameters is provided. As shown first in Figure 12, the sensor probe delivery device 60 is connected to a vascular access device (i.e., a catheter assembly 12) that is implanted in the body. In some embodiments, the sensor probe delivery device 60 is connected to the vascular access device that is implanted in the body by engaging a lock 64 with a patient-near access port provided by a needleless access connector 46 of the catheter assembly 12.

[0061] When the sensor probe delivery device 60 is connected to the catheter assembly 12, the sensor probe delivery device 60 is operated to advance the probe member 96 (equipped with, for example, sensors 106, 116) into the fluid pathway of the catheter 16 to be placed in the body or beyond its distal tip 26. When the sensor probe assembly 66 is advanced, the advance member 68 is moved distally relative to the housing 62, so that the sensor probe assembly 66 moves from a first position where the probe member 96 is positioned within the housing 62 to a second position where the distal end 98 of the probe member 96 is positioned within the fluid pathway of the catheter 16 to be placed in the body or beyond its distal tip 26. When the sensor probe assembly 66 is advanced to the second position, the connector portion 98 of the sensor probe assembly 66 is brought to the distal end 74 of the housing 62 (for example, within the coupler 78) and adjacent to the lock 64. With the sensor probe assembly 66 in this position, as shown in Figure 13, the detachable housing 80 is detached from the coupler 78 (and lock 64), and only the sensor probe assembly 66 of the delivery device 60 remains connected to the catheter assembly 12.

[0062] Removal of the detachable housing 80 from the sensor probe assembly 66 provides access to the electrical connector 100 of the sensor probe assembly 66. According to some aspects of this disclosure, a wireless module 134 may be connected to the electrical connector 100 of the sensor probe assembly 66, as shown in Figure 14. In the illustrated embodiment, the wireless module 134 is provided as a wireless board unit 134, which may include a processor, communications, power supply, sensor leads, and a user interface, as will be further described below. The wireless board unit 134 may be connected to the electrical connector 100 of the sensor probe assembly 66 via input connections 136 provided therein. Once connected to the sensor probe assembly 66, the wireless board unit 134 may be installed / secured to the patient's skin via a stabilization platform 138 provided on the unit and / or via a fixation dressing or other fixation method.

[0063] As shown in Figure 15, the wireless board unit 134 may include a processor 140, a power supply 142, a display 144, a user interface 146, and a wireless transceiver 148 configured to wirelessly transmit data from sensors 106, 116 to various external devices via Bluetooth or other means. The processor 140, display 144, user interface 146, and wireless transceiver 148 of the wireless board unit 134 may be provided on an SoC microcontroller, but other suitable configurations may be used. The display 144 of the wireless board unit 134 may be configured to display measured blood-related parameter data and / or any warnings to the user, while the user interface 146 may include buttons or other suitable functions on which the user can provide commands to the unit 134.

[0064] When the wireless board unit 134 is connected to the sensor probe assembly 66, the wireless board unit 134 may receive measurements of one or more blood-related parameters from the sensors (e.g., sensors 106, 116) on the probe member 96, then analyze these measurements, and / or communicate them to another processing device. In one aspect or embodiment, as shown in Figure 16, the wireless board unit 134 transmits data from the second probe assembly 66 to the bedside console 149, and the bedside console 149 transmits the data to the local area network via a Wi-Fi access point 150 or other suitable network connection. The local area network may be connected to the cloud 152 and / or a secure hospital server 154, which can be accessed from the nurse central station 102 or other remote locations. Thus, the wireless board unit 134 may provide a mobile data capture, analysis, and monitoring unit that may be used to provide blood-related parameter assessments at the bedside, the nurse central station 102, or a remote data monitoring and analysis center. Through the wireless communication capabilities provided thereby, the wireless board unit 134 may feed data measurements directly to the cloud for monitoring, processing, analysis, and artificial intelligence (AI) predictive analysis relating to one or more acquired blood-related parameters, and / or for transfer to the patient's electronic medical record or nurse monitoring station system or other patient monitoring displays and systems. In some embodiments, the wireless board unit 134 may also alert a clinician, technician, or patient if it is determined that the measured blood-related parameters are at a critical level (e.g., via analysis by AI algorithms(s) performed by the unit or a remote data monitoring and analysis center)—such alerts may be provided as visual, audible, tactile, and / or digital warnings or indicators on a visual display or system component (wired or wireless connection).In yet another embodiment, data, images, or alerts may be captured or communicated via various other systems and displays, including infusion pumps, patient vital sign monitors, arterial monitors, ultrasound system visual displays, smartphones, tablets, PCs, or other systems, and such outputs may be combined (at a nurse station or remote data monitoring and analysis center) with one or more blood-related parameters acquired by the sensor probe assembly 66 for more comprehensive monitoring and analysis of the patient's physiological data.

[0065] Once data acquisition and analysis of one or more blood-related parameters are complete, the probe member 96 may be removed from the catheter that is placed in the body, and the sensor probe assembly 66 may be detached from the catheter assembly 12, for example, by releasing the lock 64 from the needleless access connector 46.

[0066] According to some aspects of this disclosure, the sensor probe delivery device 60 may be configured to position the electrical connector 100 of the sensor probe assembly 66 further away from the insertion site of the catheter assembly 12. That is, as shown in Figures 17 to 20, the sensor probe delivery device 60 may include a wired extension lead or tether 156 (hereafter, "wired extension portion 156") provided as part of the sensor probe assembly 66, which is provided between the probe member 96 and the electrical connector 100. The wired extension portion 156 may include a first fitting 158 at its distal end for connecting the wired extension portion 156 to the connector portion 98 of the sensor probe assembly 66, and a second fitting 160 at its proximal end for connecting the wired extension portion 156 to the electrical connector 100. In the initial configuration of the sensor probe delivery device 60, the wired extension portion 156 may be located outside (and proximal) of the housing 62 of the delivery device 60 (Figure 17). When the forward member 68 of the delivery device 60 is actuated distally, the sensor probe assembly 66 is also moved distally (for example, based on the coupling of the forward member 68 to the connection portion 98), so that the probe member 96 is moved into the catheter assembly 12 and the wired extension portion 156 is moved into the housing 62 (Figure 18). When the detachable housing 80 is removed, the sensor probe assembly 66 is therefore positioned for subsequent vascular monitoring and analysis, with the electrical connector 100 at the proximal end of the wired extension portion 156 enabling connection of an external device to the sensor probe assembly 66. In the embodiment of Figure 19, the wireless board unit 134 (described above) is connected to the electrical connector 100 at the proximal end of the wired extension portion 156, and the wired extension portion 156 enables remote securement (i.e., remote from the insertion site) of the wireless board unit 134.In the embodiment shown in Figure 20, the patient data cable 162 is connected to an electrical connector 100 at the proximal end of a wired extension portion 156, and the data cable 162 can be connected to a nurse monitoring station system or other patient monitoring display and system which may provide blood-related parameter evaluation of data acquired via a sensor probe assembly 66.

[0067] While exemplary embodiments of the sensor probe delivery device 60 for use in the arterial access system 10 have been described above, it is acknowledged that the device may be modified according to additional aspects of the present disclosure. For example, and as also shown in Figure 21, the sensor probe delivery device 60 may include a lock 164 of a different structure than that shown and described in the embodiments of Figures 1-11. That is, the lock 164 may be provided to the sensor probe delivery device 60 including a blunt cannula 166 and a lock arm 168 for connection to the needleless access connector 46 of the catheter assembly 12, with the blunt cannula 166 and lock arm 168 making three-point contact with it.

[0068] Other variations of the sensor probe delivery device 60 shown and described above may include changes to the type of forward member 68 and / or to the sensor probe assembly 66. For example, the sensor probe assembly 66 may be configured as a hybrid wireless and wired system, where a wireless board unit 134 measures certain parameters and a wired connection measures other parameters that require a higher power connection to monitor.

[0069] Beneficially, embodiments of the present disclosure provide a sensor probe delivery device that enables the positioning of a probe component (having a sensor(s) thereon) within a catheter implanted in the body. The delivery device includes a removable housing portion that can be removed so that the sensor probe assembly may remain in place for an extended period adjacent to the catheter insertion site, while the sensor probe assembly is less bulky and more patient-friendly for long-term sensing requirements. By removing the removable housing, the footprint of the sensor probe assembly is minimized, reducing the risk of detachment or other complications that may occur if a bulky, rigid device remains attached to the patient for an extended period.

[0070] This disclosure has been described in detail for illustrative purposes, based on what is considered to be the most practical and preferred embodiments or aspects at present; however, it will be understood that the above details are for illustrative purposes only and this disclosure is not limited to the embodiments or aspects disclosed, in contrast, intended to cover an array of modifications and equivalents that fall within the spirit and scope of the attached claims. For example, it will be understood that, to the extent possible, one or more features of any embodiment may be combined with one or more features of any other embodiment.

Claims

1. A catheter assembly including a catheter and an access port near the patient, A sensor probe delivery device, connectable to an access port near the patient, which enables access to the catheter via the catheter assembly, wherein the delivery device is A probe member comprising one or more sensors configured to measure one or more blood-related parameters, wherein the probe member has a distal end and a proximal end, and An electrical connector located proximal to the probe member, wherein the electrical connector is configured to operably connect to an external device. A sensing probe assembly, including, A housing configured to movably receive at least a portion of the sensing probe assembly within an internal volume, wherein the housing includes a detachable portion that can be separated from the rest of the housing, A lock configured to connect the housing to the nearby patient's access port, A forward member configured to move relative to the housing in order to move the sensing probe assembly between a first position in which the distal end of the probe member is positioned within the housing or the lock, and a second position in which the distal end of the probe member is positioned inside the catheter beyond the distal end portion of the housing and the lock, or outside beyond the distal tip of the catheter. Including a sensor probe delivery device and Equipped with, The sensing probe assembly at the second position positions the probe member to measure one or more blood-related parameters. A vascular access system characterized by the following features.

2. The vascular access system according to claim 1, wherein the housing includes a coupler provided at its distal end, the coupler is configured to engage with the lock, or is formed such that a part of the lock constitutes the whole, and the detachable portion of the housing is configured to be detached from the coupler.

3. The vascular access system according to claim 2, characterized in that the detachable portion of the housing is configured to be detached from the coupler via a twisting mechanism.

4. The vascular access system according to claim 2, characterized in that the detachable portion includes a divisible housing which includes a pair of detachable housing portions that are separated from the coupler.

5. The sensing probe assembly is A fitting configured to securely fix the proximal end of the probe member, The flange member that is coupled to the fitting and Includes connector portion, The connector portion is positioned adjacent to the coupler when the sensing probe assembly is in the second position, such that the connector portion is held by the coupler. A vascular access system according to any one of claims 2 to 4, characterized by the features described herein.

6. The vascular access system according to claim 5, characterized in that the forward member is connected to the flange of the connector portion such that the movement of the forward member relative to the housing causes a corresponding movement of the sensing probe assembly.

7. The vascular access system according to claim 5 or 6, characterized in that the electrical connector is coupled to the connector portion and extends proximal outward.

8. The vascular access system according to claim 7, wherein the electrical connector is accessible when the sensing probe assembly is in the second position, and when the detachable portion is disconnected, the electrical connector is placed in the housing when the sensing probe assembly is in the first and second positions, respectively.

9. The vascular access system according to claim 5 or 6, wherein the sensing probe assembly includes a wired extension portion coupled to the connector portion and extending proximal outward, and the electrical connector is connected to the wired extension portion at its proximal end.

10. The vascular access system according to claim 9, wherein the electrical connector is connected to the proximal end of the extension portion of the wire, and the electrical connector is spaced apart from the connector portion and the coupler when the sensing probe assembly is in the second position.

11. The wireless module is further connected to the aforementioned electrical connector, and the wireless module is The sensing probe assembly receives one or more blood-related parameters, The system analyzes and displays one or more blood-related parameters, and / or wirelessly transmits the one or more blood-related parameters to a processing device. A vascular access system according to any one of claims 1 to 10, characterized in that it is configured as follows.

12. The vascular access system according to any one of claims 1 to 10, further comprising a patient data cable connected to the electrical connector and configured to transmit one or more blood-related parameters to a processing device.

13. The catheter assembly is A catheter adapter connected to the proximal end of the catheter, wherein the catheter adapter includes an adapter port, A connector connected to the adapter port via an extension tube, wherein the nearby patient access port is provided at the proximal end of the connector and A vascular access system according to any one of claims 1 to 12, characterized by including the following:

14. A method using the vascular access system described in any one of claims 1 to 13, Connecting the sensor probe delivery device to the access port of the catheter assembly near the patient, The sensor probe assembly is advanced from the first position to the second position such that the distal end of the probe member extends into the catheter or beyond the distal end of the catheter. The detachable portion of the housing is separated, Connecting an external device to the electrical connector of the sensor probe assembly, wherein the external device includes one of a wireless module and a data cable. A method characterized by comprising:

15. The method according to 14, further comprising securely fixing the wireless module in place via one or more of a stabilizing platform and a security dressing.

16. A sensor probe delivery device that can be connected to the patient-side access port of a catheter assembly, A probe member comprising one or more sensors configured to measure one or more blood-related parameters, wherein the probe member has a distal end and a proximal end, and An electrical connector located proximal to the probe member, wherein the electrical connector is configured to operably connect to an external device. A sensing probe assembly, including, A housing configured to movably receive at least a portion of the sensing probe assembly within an internal volume, wherein the housing includes a detachable portion that can be separated from the rest of the housing, A lock configured to connect to the access port of the nearby patient, A forward member configured to move relative to the housing in order to move the sensing probe assembly between a first position in which the distal end of the probe member is positioned within the housing or the lock, and a second position in which the distal end of the probe member is positioned beyond the distal end portion of the housing and the lock. Equipped with, The sensing probe assembly at the second position positions the probe member to measure one or more blood-related parameters. A sensor probe delivery device characterized by the following.

17. The sensor probe delivery device according to claim 16, wherein the housing includes a coupler provided at the distal end portion, the coupler is configured to engage with the lock, or is formed such that a part of the lock constitutes the whole, and the detachable portion of the housing is configured to be detached from the coupler.

18. The sensing probe assembly is A fitting configured to securely fix the proximal end of the probe member, The flange member that is coupled to the fitting and Includes connector portion, The connector portion is positioned adjacent to the coupler when the sensing probe assembly is in the second position, such that the connector portion is held by the coupler. The sensor probe delivery device according to feature 17.

19. The sensor probe delivery device according to claim 18, characterized in that the forward member is connected to the flange of the connector portion such that the movement of the forward member relative to the housing causes a corresponding movement of the sensing probe assembly.

20. The sensor probe delivery device according to claim 18 or 19, wherein the electrical connector is coupled to the connector portion and extends proximal outward, such that the electrical connector is located within the housing when the sensing probe assembly is in the first and second positions, and when the detachable portion is detached, the electrical connector is accessible when the sensing probe assembly is in the second position.

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