Closure System Flexible Vascular Access Device Sensor Deployment System

The sensor deployment system for vascular access devices addresses the lack of real-time monitoring by integrating sensors and communications within the vascular access device system, enabling continuous patient parameter monitoring and improving clinical outcomes.

JP2025514012APending Publication Date: 2025-05-02BECTON DICKINSON & CO
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Patent Information

Application Number
JP2024556374
Authority / Receiving Office
JP · JP
Patent Type
Applications
Current Assignee / Owner
Priority Date
2022-03-21
Filing Date
2023-03-15
Publication Date
2025-05-02

AI Technical Summary

Technical Problem

Existing vascular access devices lack integrated sensors for real-time monitoring of patient parameters, which can lead to delayed detection of conditions such as sepsis and inadequate assessment of therapeutic effectiveness.

Method used

A sensor deployment system for vascular access devices that includes a primary lumen, a deployment connector, an instrument with a sensor, and a communications device. The system allows the instrument to be extended beyond the catheter, enabling sensor placement within the patient's vasculature and real-time data transmission.

Benefits of technology

Enables continuous, real-time monitoring of patient parameters, providing early indications of disease states and therapeutic effectiveness, thereby improving patient care and clinical decision-making.

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Abstract

1. A sensor deployment system for a vascular access device comprising: a primary lumen; a deployment connector configured to connect to at least one of a luer connector, a needleless connector, and a catheter adapter, the deployment connector attached to the primary lumen; an instrument at least partially received within the primary lumen, the instrument including a sensor, the instrument having a retracted position in which a distal end of the instrument is disposed within the primary lumen or the deployment connector, and an extended position in which the distal end of the instrument extends beyond the primary lumen and the distal end of the deployment connector; and a communication device configured to transmit data from the sensor.
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Description

[Technical field]

[0001] The present disclosure relates to a vascular access device sensor deployment system. [Background technology]

[0002] This application claims priority to U.S. Provisional Application No. 63 / 321,950, entitled "Closed System Flexible Vascular Access Device Sensor Deployment System," filed March 21, 2022, the entire disclosure of which is incorporated herein by reference in its entirety.

[0003] Catheters are frequently used to administer fluids to and from the body. Patients in a variety of settings, including hospitals and home care, receive fluids, medicines, and blood products via vascular access devices inserted into the patient's vascular system. Catheters of various types and sizes are widely used in a variety of procedures, including, but not limited to, treating infections, providing anesthesia or analgesia, providing nutritional support, treating cancerous growths, maintaining blood pressure and cardiac rhythm, and many other clinical applications. A common vascular access device is a plastic catheter that is inserted into a patient's vein. The length of the catheter can vary from a few centimeters for peripheral access to tens of centimeters for central access. Catheters are commonly incorporated into a catheter adapter to aid in the ease of use, accessibility, and usefulness of the catheter. The catheter adapter can be adapted to accommodate one end of the catheter such that one end of the catheter is supported by the catheter adapter and the body and tip of the catheter extend beyond the first end of the catheter adapter. The catheter adapter generally further includes a second end adapted to receive additional infusion components for use with the catheter. For example, the second end of the catheter adapter may include a series of threads for attaching an intravenous line or for coupling a syringe to the catheter adapter, thereby providing access to the patient's vascular system via the attached catheter.

[0004] The catheter may be inserted percutaneously. When inserted percutaneously, insertion of the catheter is generally assisted by an introducer needle. The introducer needle is generally housed within the lumen of the catheter such that the gauge of the needle approximates the inner diameter of the catheter. The needle is positioned within the catheter such that the needle tip extends beyond the tip of the catheter, whereby the needle is used to pierce the patient's vein and provide an opening for insertion of the catheter.

[0005] To verify proper placement of the introducer needle and / or catheter within the blood vessel, the clinician will typically confirm that there is a "flashback" of blood within the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician may temporarily occlude flow within the vasculature and remove the needle, leaving the catheter in place for subsequent blood draws, infusions or probe access. [Prior art documents] [Patent documents]

[0006] [Patent Document 1] U.S. Patent Application Publication No. 2021 / 0290126 [Patent Document 2] U.S. Patent No. 11,191,939 Summary of the Invention [Means for solving the problem]

[0007] In one aspect or embodiment, a sensor deployment system for a vascular access device includes a primary lumen, a deployment connector configured to connect to at least one of a luer connector, a needleless connector, and a catheter adapter, an instrument at least partially received within the primary lumen with the deployment connector attached to the primary lumen, and a communication device. The instrument includes a sensor. The instrument has a retracted position in which a distal end of the instrument is disposed within the primary lumen or the deployment connector, and an extended position in which the distal end of the instrument extends beyond the primary lumen and the distal end of the deployment connector. The communication device is configured to transmit data from the sensor.

[0008] The system may include an advancement member configured to be grasped by a health care technician, movement of the advancement member moving the instrument between a retracted position and an extended position. The advancement member may be configured to move along an exterior surface of the primary lumen, such that the advancement member is disposed entirely outside of the primary lumen.

[0009] The system may include a catheter adapter including a catheter configured to be inserted into a patient's blood vessel, the deployment connector configured to be connected to the catheter adapter. The catheter adapter may include a side port and a mating connector in fluid communication with the side port, the deployment connector configured to be connected to the mating connector. The mating connector may include a needleless connector, the deployment connector may include a blunt cannula. The deployment connector may include an instrument seal. The instrument may include a Nitinol guidewire having an atraumatic tip. The system may include wiring in communication with the electrical connector and the sensor. The communication device may include a processor and a power source. The communication device may include a wireless transceiver. The sensor may include at least one of a temperature sensor, a pressure sensor, a pH sensor, a flow sensor, and an optical sensor.

[0010] The system may include a stabilizing member configured to contact the patient's skin, wherein the communication device, the processor, and the power source are received by the stabilizing member. The stabilizing member may be disposed at a proximal end of the primary lumen. The communication device may be disposed at a distal end of the primary lumen. The deployment connector may include a threaded luer connector disposed at the distal end of the primary lumen.

[0011] The system may include a catheter adapter having a catheter configured to be inserted into a blood vessel of a patient, an extension set having an access port near the patient, and an extension tube in fluid communication with the access port near the patient, the deployment connector configured to be connected to the access port near the patient. The extension set may include an extension set stabilizing member configured to contact the patient's skin. The system may include a stabilizing member configured to contact the patient's skin, the stabilizing member disposed at a proximal end of the primary lumen, the communication device including a processor and a power source, the communication device received by the stabilizing member. The communication device may include a processor and a power source, the communication device disposed at a proximal end of the primary lumen.

[0012] In a further aspect or embodiment, a method of using the sensor deployment system of any of the above aspects or embodiments includes connecting a deployment connector to a catheter adapter having a catheter, advancing the instrument from a retracted position to an extended position such that a distal end of the instrument extends beyond the distal end of the catheter, collecting data from the sensor, and transmitting the data to an external device using a communication device. [Brief description of the drawings]

[0013] The above and other features and advantages of the present disclosure, as well as the manner in which they are accomplished, will become more apparent, and the disclosure itself will be better understood, by reference to the following description of embodiments of the disclosure taken in conjunction with the accompanying drawings, in which: [Figure 1] FIG. 1 is a top view of a sensor deployment system for a vascular access device according to one aspect or embodiment of the present application, showing the system detached from the vascular access device. [Diagram 2] FIG. 2 is a top view of the sensor deployment system of FIG. 1, showing the system in an advanced position coupled to a vascular access device. [Diagram 3] FIG. 3 is a top view of a sensor deployment system for a vascular access device according to a further aspect or embodiment of the present application, showing the system detached from the vascular access device. [Figure 4] FIG. 4 is a top view of the sensor deployment system of FIG. 3, showing the system coupled to a vascular access device. [Diagram 5] FIG. 5 is a perspective view of the sensor deployment system of FIG. 3, showing the system coupled to a vascular access device. [Figure 6] FIG. 6 is a top view of the sensor deployment system of FIG. [Figure 7] FIG. 7 is a top view of a sensor deployment system according to a further aspect or embodiment of the present application. [Figure 8]FIG. 8 is a partial cross-sectional view of a sensor deployment system according to a further aspect or embodiment of the present application. [Figure 9] FIG. 9 is a perspective view of a sensor deployment system according to a further aspect or embodiment of the present application, showing a stored position of the system. [Figure 10] FIG. 10 is a perspective view of the sensor deployment system of FIG. 9 showing the system in an advanced position. [Figure 11] FIG. 11 is a perspective view of the sensor deployment system of FIG. 1 showing an instrument next to the system. [Figure 12] FIG. 12 is a top view of a sensor deployment system for a vascular access device according to a further aspect or embodiment of the present application showing an advanced position of the system. [Figure 13] FIG. 13 is a partial top view of a sensor deployment system for a vascular access device according to a further aspect or embodiment of the present application. [Figure 14] FIG. 14 is a schematic diagram of a data capture and communication system according to one aspect or embodiment of the present application. [Figure 15] FIG. 15 is a schematic diagram of the data capture system of FIG. [Figure 16] FIG. 16 is a top view of a sensor deployment system for a vascular access device according to a further aspect or embodiment of the present application, showing the system detached from the vascular access device. [Figure 17] FIG. 17 is a top view of the sensor deployment system of FIG. 16 showing the system in an advanced position coupled to a vascular access device. [Figure 18] FIG. 18 is a top view of the sensor deployment system of FIG. 16 showing the system in an advanced position coupled to a vascular access device and with an integrated power supply. [Figure 19] FIG. 19 is a top view of a sensor deployment system for a vascular access device according to a further aspect or embodiment of the present application showing an advanced position of the system. [Figure 20]FIG. 20 is a top view of the sensor deployment system of FIG. 19, showing the system without a stabilization device. [Figure 21] FIG. 21 is a perspective view of the sensor deployment system of FIG. [Figure 22] FIG. 22 is a cross-sectional view of an advancement mechanism according to one aspect or embodiment of the present application. [Figure 23] FIG. 23 is a cross-sectional view of an advancement mechanism according to a further aspect or embodiment of the present application.

[0014] Corresponding reference characters indicate corresponding parts throughout the several views. The illustrations presented herein illustrate exemplary embodiments of the present disclosure, and such illustrations are not to be construed as limiting the scope of the present disclosure in any way. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0015] Spatial or directional terms such as "left," "right," "inner," "outer," "above," "below," etc. should not be considered limiting as the present invention may contemplate various alternative orientations.

[0016] For purposes of explanation hereinafter, the terms "top", "bottom", "right", "left", "vertical", "horizontal", "top", "bottom", "transverse", "length" and their derivatives shall refer to the invention as oriented in the drawings. It will be understood, however, that the invention may be subject to various alternative modifications unless expressly specified to the contrary. It should also be understood that the specific devices illustrated in the accompanying drawings, and described in the following specification, are merely exemplary embodiments of the invention.

[0017] Unless otherwise indicated, all ranges or ratios disclosed herein should be understood to encompass the starting and ending values, and any and all subranges or subratios contained therein. For example, a specified range or ratio of "1 to 10" should be considered to include any and all subranges or subratios between (and including) the minimum value of 1 and the maximum value of 10, i.e., all subranges or subratios begin with a minimum value of 1 or greater and end with a maximum value of 10 or less.

[0018] The terms "first," "second," and the like are not intended to refer to any particular order or chronology, but rather to different conditions, characteristics, or elements.

[0019] As used herein, "at least one" is synonymous with "one or more." For example, the phrase "at least one of A, B, and C" means any one of A, B, or C, or any combination of any two or more of A, B, or C. For example, "at least one of A, B, and C" includes 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 all of A, B, and C.

[0020] 1-6, in one aspect or embodiment, a sensor deployment system 10 for a vascular access device 12 includes a primary lumen 14, a deployment connector 16, an instrument 18 at least partially received within the primary lumen 14, and a communication device 20. The deployment connector 16 is configured to connect to at least one of a luer connector, a needleless connector, and a catheter adapter, and the deployment connector 16 is attached to the primary lumen 14. The instrument 18 includes a sensor 22. The instrument 18 has a retracted position (FIG. 1) in which a distal end 24 of the instrument 18 is disposed within the primary lumen 14 or the deployment connector 16, and an extended position (FIG. 2) in which the distal end 24 of the instrument 18 extends beyond the primary lumen 14 and the distal end 26 of the deployment connector 16. The communication device 20 is configured to transmit data from the sensor 22. The sensor deployment system 10 is configured to provide closed system instrument access to a patient's vascular system for venous, arterial, or fluid pathway data capture throughout the dwell time of the vascular access device 12 for short-term or long-term sensing and data capture. Additionally, the sensor deployment system 10 is configured to provide support, alignment, and sterile delivery of the instrument 18 and sensor 22 to the patient's vascular system via the vascular access device 12. The instrument 18 is flexible to facilitate introduction of the sensor 22 into the patient's vascular system. The sensor deployment system 10 is configured to be compatible with existing and emerging vascular access devices and is configured to be scaled for use with peripheral intravenous catheters, midline, peripherally inserted central catheters, and central venous catheters for intravenous sensing via peripheral, internal jugular, femoral, central venous, and / or arterial access. Continuous real-time intravenous measurement of patient parameters may provide an early indication of an emerging disease state, such as sepsis, or an indication of the effectiveness of a therapeutic treatment.

[0021] In some aspects or embodiments, the primary lumen 14 is flexible and may be formed from an extension tube. The primary lumen 14 may be formed from TPE, TPU, PVC, or other suitable tubing material. Additives may be provided in association with the primary lumen 14 to increase lubricity. The primary lumen 14 may be flexible, semi-rigid, or rigid. The primary lumen 14 may include a marker or other indicator to inform a medical clinician of the position of the instrument 18 relative to the vascular access device 12. The primary lumen 14 may be transparent or opaque. The primary lumen 14 may include a textured surface to reduce contact friction. The primary lumen 14 may be unvented or vented (open air pathway, breathable filter membrane, porous vent material, microchannels, etc.).

[0022] In some aspects or embodiments, the sensor 22 includes at least one of a temperature sensor, a pressure sensor, a pH sensor, a flow sensor, and an optical sensor. In one aspect or embodiment, the sensor 22 is a lactate sensor. In one aspect or embodiment, the sensor 22 monitors core body temperature or pressure via vascular access in the internal jugular vein. The sensor 22 may measure at least one of blood flow velocity, temperature-based cardiac output, fluid pathway system pressure, heart rate, blood gases, and SpO2 levels, and other physiological parameters. An absolute value or trend in body temperature may be used to indicate changes in the patient's condition or response to a treatment or procedure. The sensor 22 may be positioned near the distal end of the instrument 18, along the length of the instrument 18, and / or to facilitate measurement of multiple parameters. For example, a sensor 22 deployed in a vein may measure temperature and flow, while a sensor placed elsewhere may measure pressure. As described in more detail below, the communication device 20 may transmit data via a wired connection or wirelessly to a local hub, a cloud, a nurse monitoring station, and / or an electronic medical record.

[0023] 1-6, 22, and 23, the sensor deployment system 10 includes an advancement member 32 configured to be grasped by a medical technician, and movement of the advancement member 32 moves the instrument 18 between a retracted position and an extended position. The advancement member 32 is configured to be disposed entirely outside of the primary lumen 14 and move along the outer surface of the primary lumen 14 with the advancement member 32. As shown in FIG. 22, the advancement member 32 includes a body 34 having a gripping surface 36 and a ball bearing 38 that engages the outer surface of the primary lumen 14. A coupler 40 is disposed within the primary lumen 14 with the instrument 18 attached to the coupler 40. The coupler 40 is disposed between the ball bearings 38. In one aspect or embodiment, as shown in FIG. 23, rather than providing a ball bearing 38, the advancement member body 34 may include a bump 42, such as a cylindrical or spherical bump, that engages the outer surface of the primary lumen 14. Distal or proximal movement of the advancement member 32 engages the ball bearing 38 with the coupler 40 and depresses the primary lumen 14 to position the ball bearing 38 between the coupler 40, thereby moving the coupler 40 and the instrument 18 with the advancement member 32. The advancement member 32 may be the same as or similar to the translation handle shown and described in U.S. Patent No. 5,399,323, which is incorporated herein by reference in its entirety. The advancement member 32 may include lubrication around the coupler 40 and / or around the bumps 42 or bearings 38. The instrument 18 may also include one or more support features configured to facilitate insertion of the instrument 18 using the advancement member 23 by minimizing flexing of the instrument 18 during insertion.

[0024] 1-6 , in some aspects or embodiments, the vascular access device 12 includes a catheter adapter 50 having a catheter 52 configured to be inserted into the vascular system of a patient, and the deployment connector 16 is configured to be connected to the catheter adapter 50. The catheter adapter 50 includes a side port 54 and a mating connector 56 in fluid communication with the side port 54. The deployment connector 16 is configured to be connected to the mating connector 56. The mating connector 56 may include an access port near the patient or a needleless connector 58 for connecting to the deployment connector 16. Using multiple access points, fluid and drug delivery can continue through additional ports 59 of the mating connector 56, as needed. The deployment connector 16 includes an instrument seal 60 configured to maintain a seal between the primary lumen 14 and the instrument 18 at the distal end 26 of the primary lumen 14. Thus, a portion of the deployment connector 16 is configured to be within the fluid path of the vascular access device 12, and the instrument seal 60 seals the primary lumen 14 from the fluid path of the vascular access device 12. In some aspects or embodiments, the instrument 18 includes a Nitinol guidewire with an atraumatic tip. In some aspects or embodiments, the instrument 18 is an extruded tube including sensor wiring and / or a combined Nitinol wire and tube assembly. In some aspects or embodiments, the sensor deployment system 10 includes an electrical connector 62 and wiring 64 that communicates with the sensor 22. The wiring 64, such as an insulated wire, may be connected to the coupler 40 of the advancement member 32. The communication device 20 includes a processor 66, a power source 68, and a wireless transceiver 70. In some aspects or embodiments, the sensor 22 is connected to a battery-powered data reader, a processor, a signal-conditioning device, a visual indicator, and / or a wireless transceiver that may communicate with an external device, a monitor, and / or the cloud.

[0025] 1-5, the sensor deployment system 10 includes a stabilizing member 80 configured to contact the skin of a patient along with a communication device 20, a processor 66, and a power source 68 received by the stabilizing member 80. In some aspects or embodiments, the communication device 20 is integrated within the stabilizing member 80. The stabilizing member 80 is configured to provide a reliable method of securing the sensor deployment device 10 in a desired position on the patient for long-term sensing. The stabilizing member 80 may be disposed at a proximal end 82 of the primary lumen 14, although other suitable positions and configurations may be utilized. In some aspects or embodiments, such as in FIGS. 3-5 and 7, the sensor deployment system 10 does not include a stabilizing member 80 and the electrical connector 62 provides only a wired connection to the sensor 22.

[0026] 8 and 11 , in some aspects or embodiments, the deployment connector 16 includes a blunt cannula 86 configured to be inserted into the needleless connector. The primary lumen 14 may also include a proximal bushing and grip 88, through which the wire 64 extends.

[0027] With reference to FIGS. 9 and 10 , in some aspects or embodiments, the deployment connector 16 includes a threaded luer connector 90 disposed at the distal end 26 of the primary lumen 14 .

[0028] 12 , in some aspects or embodiments, the communication device 20 is disposed at the proximal end 82 of the primary lumen 14. The communication device 20 may be incorporated into the stabilization apparatus 80, or may be separately attached or integrated into the proximal connector 92 or the electrical connector 62.

[0029] With reference to FIG. 13, in some aspects or embodiments, the communication device 20 is disposed at a distal end 26 of the primary lumen 14 .

[0030] 14 and 15, the communication device 20 is configured to transmit data wirelessly from the sensors 22, such as via a Bluetooth connection or via a wired connection to various external devices. In one aspect or embodiment, the communication device 20 transmits data from the sensors 22 to a bedside console 94, which then transmits the data to a local area network via a WiFi access point 96 or another suitable network connection. The local area network may be connected to a cloud 98 and / or a secure hospital server 100 that may be accessed at a nurse central station 102 or other remote location. The processor 66, wireless transceiver 70, lights or other indicators 104 of the communication device 20 may be provided on a SoC microcontroller, although other suitable configurations may be utilized. The communication device 20 may include a user interface 106 having a display, buttons, or other suitable features.

[0031] 16-21 , in some aspects or embodiments, the sensor deployment system includes or is configured to be utilized with a non-integrated catheter 108. The non-integrated catheter 108 includes a catheter adapter 110 having a catheter 112 configured to be inserted into a patient's vascular system and an extension set 114 having a nearby patient access port 116 and an extension tube 118 in fluid communication with the nearby patient access port 116. The deployment connector 16 is configured to be connected near the patient access port 116. The extension set 114 includes an extension set stabilizing member 120 configured to contact the patient's skin. As shown in FIGS. 17 and 18 , for example, the sensor deployment system 10 can include a stabilizing member 80 disposed at a proximal end 82 of the primary lumen 14, with the communication device 20 being received by the stabilizing member 80 ( FIG. 17 ) or integrated into the electrical connector 62 ( FIG. 18 ). In one aspect or embodiment, the extension set 114 is the same as or similar to one of the extension sets shown and described in U.S. Patent No. 6,399,633, the entirety of which is incorporated herein by reference. As shown in Figures 19-21, in some aspects or embodiments, the primary lumen 14 is flexible, which is configured to improve fixation of the sensor deployment system 10 to the patient for short-term or long-term intravenous sensing.

[0032] In one aspect or embodiment, the sensor deployment system 10 can be used by connecting the deployment connector 16 to a catheter adapter 50, 110 having a catheter 52, 112, advancing the instrument 18 from a retracted position to an extended position such that the distal end 24 of the instrument 18 extends beyond the distal end 122 of the catheter 52, 112, collecting data from the sensor 22, and transmitting the data using the communication device 20 to an external device, such as an electronic medical record, a bedside console 94, an access point 96, a cloud 98, or a server 100.

[0033] While the present invention has been described in detail for purposes of illustration based on what are presently considered to be the most practical and preferred embodiments or aspects, it is to be understood that such detail is for this purpose only, and that the present invention is not limited to the disclosed embodiments or aspects, but on the contrary, is intended to cover modifications and equivalent arrangements within the spirit and scope of the appended claims. For example, it is to be understood that the present invention contemplates 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. 1. A sensor deployment system for a vascular access device, the system comprising: A primary lumen; a deployment connector configured to be connected to at least one of a luer connector, a needleless connector, and a catheter adapter, the deployment connector attached to a primary lumen; an instrument at least partially received within the primary lumen, the instrument including a sensor, the instrument having a retracted position in which a distal end of the instrument is disposed within the primary lumen or the deployment connector, and an extended position in which a distal end of the instrument extends beyond the primary lumen and the distal end of the deployment connector; a communication device configured to transmit data from the sensor; and A sensor deployment system comprising:

2. and further comprising an advancement member configured to be grasped by a health care technician, movement of the advancement member moving the instrument between the retracted position and the extended position. The sensor deployment system of claim 1 .

3. The sensor deployment system of claim 2 , wherein the advancement member is configured to travel along an exterior surface of the primary lumen, the advancement member being disposed entirely outside of the primary lumen.

4. 4. The sensor deployment system of claim 1, further comprising a catheter adapter including a catheter configured to be inserted into a patient's blood vessel, the deployment connector being configured to be connected to the catheter adapter.

5. The sensor deployment system of claim 4 , wherein the catheter adapter includes a side port and a mating connector in fluid communication with the side port, the deployment connector being configured to connect to the mating connector.

6. The sensor deployment system of claim 5 , wherein the mating connector comprises a needleless connector and the deployment connector comprises a blunt cannula.

7. The sensor deployment system of claim 1 , wherein the deployment connector includes an instrument seal.

8. The sensor deployment system of any one of claims 1 to 7, wherein the instrument comprises a Nitinol guidewire having an atraumatic tip.

9. The sensor deployment system of claim 1 , further comprising wiring in communication with the electrical connector and the sensor.

10. The sensor deployment system of claim 1 , wherein the communication device includes a processor and a power source.

11. The communication device includes a wireless transceiver. The sensor deployment system of claim 10.

12. The sensor deployment system of any one of claims 1 to 11, wherein the sensor includes at least one of a temperature sensor, a pressure sensor, a pH sensor, a flow sensor, and an optical sensor.

13. The sensor deployment system of claim 10 , further comprising a stabilizing member configured to contact a patient's skin, the communications device, the processor, and the power source being received by the stabilizing member.

14. The sensor deployment system of claim 13 , wherein the stabilizing member is disposed at a proximal end of the primary lumen.

15. The sensor deployment system of claim 10 , wherein the communication device is disposed at a distal end of the primary lumen.

16. The sensor deployment system of claim 1 , wherein the deployment connector comprises a threaded luer connector disposed at a distal end of the primary lumen.

17. 10. The sensor deployment system of claim 1, further comprising a catheter adapter having a catheter configured to be inserted into a blood vessel of a patient, an extension set having an access port near the patient, and an extension tube in fluid communication with the access port near the patient, wherein the deployment connector is configured to be connected to the access port near the patient.

18. The sensor deployment system of claim 17 , wherein the extension set includes an extension set stabilizing member configured to contact the patient's skin.

19. 20. The sensor deployment system of claim 17, further comprising a stabilizing member configured to contact a patient's skin, the stabilizing member disposed at a proximal end of the primary lumen, the communications device including a processor and a power source, the communications device received by the stabilizing member.

20. The sensor deployment system of claim 17 , wherein the communication device includes a processor and a power source, the communication device being disposed at a proximal end of the primary lumen.

21. A method of using the sensor deployment system according to any one of claims 1 to 20, said method comprising: connecting the deployment connector to a catheter adapter having a catheter; advancing the instrument from the retracted position to the extended position such that a distal end of the instrument extends beyond the distal end of the catheter; collecting data from the sensors; transmitting the data to an external device using the communication device; The method includes:

Citation Information

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