Catheter system having a fluid chamber adjacent to a pressure transducer

Abstract

A catheter system may include a catheter assembly, which may include a catheter hub and a catheter extending distally from the catheter hub. A catheter system may include a fluid chamber proximal to the catheter. A catheter system may include a fluid pathway within the catheter system, which may extend through the catheter and the fluid chamber. A catheter system may include a pressure transducer in fluid communication with the fluid chamber to monitor the patient's hemodynamic characteristics.

Description

Technical Field

[0001] The present disclosure generally relates to catheter systems used to detect a patient's hemodynamic characteristics, as well as related devices and methods.

Background Art

[0002] Arterial catheters and systems provide healthcare providers with a way to monitor a patient's arterial hemodynamic parameters and to collect data related to the patient's hemodynamic characteristics and properties, including, for example, blood pressure, pulse contour, and arterial blood gases. All of these hemodynamic characteristics can be used to determine the immediate recognition of abnormal hemodynamic events and the initiation of appropriate treatment. Arterial catheters can also be used to provide specimens for blood gas analysis without the specific complications and risks associated with repeated arterial punctures.

[0003] However, current arterial catheter devices, systems, and methods have other performance issues such as significant blood exposure risks and accurate placement of the arterial catheter. Additionally, current hemodynamic monitoring and ABG collection systems can be complex and expensive, and may require a significant amount of time and resources to collect the necessary samples. Further, maintaining an arterial line may require a significant amount of time and resources to minimize the risk of complications such as infections and catheter-related bloodstream infections (CRBSI). Additionally, among other processes associated with currently implemented arterial catheters, a significant amount of time and resources may be required to ensure proper line and device cleaning, as well as to preserve arterial blood.

[0004] The subject matter claimed in the present disclosure is not limited to embodiments that solve any disadvantages or to embodiments that operate only in the environments as described in the present disclosure. Rather, this background art is provided to explain the environment in which the embodiments described herein may operate.

Summary of the Invention

[0005] In some embodiments, the catheter system may be configured for blood pressure monitoring and blood sampling, which may be performed simultaneously. In some embodiments, the catheter system may be configured to simultaneously monitor the patient's blood pressure and sample or collect blood. In some embodiments, the catheter system may include a catheter assembly, which may include a catheter hub and a catheter extending distally from the catheter hub.

[0006] In some embodiments, the catheter system may include a fluid chamber proximal to the catheter. In some embodiments, the catheter system may include a fluid pathway within the catheter system, extending through the catheter and the fluid chamber. In some embodiments, the catheter system may include a pressure transducer that is in fluid communication with the fluid chamber to monitor the patient's hemodynamic characteristics.

[0007] In some embodiments, the pressure transducer may be located close to the fluid chamber and the fluid path through it. In some embodiments, the pressure transducer may be aligned with the fluid chamber such that the pressure transducer is at the same distance from the catheter system and / or other components of the catheter. In some embodiments, the catheter hub may include a distal end and a proximal end. In some embodiments, the fluid chamber may be coupled to the proximal end of the catheter adapter. In some embodiments, the vascular instrument access device is operationally coupled to the port access to provide vascular instrument access via the port access.

[0008] In some embodiments, the catheter system may include an extension tube positioned immediately between the fluid chamber and the port access. In some embodiments, the port access may be aligned with the longitudinal axis of the catheter hub. In some embodiments, the catheter system may include a secondary pressure transducer that communicates fluidly with the extension tube. In some embodiments, the secondary pressure transducer may be configured to be positioned at the level of the patient's heart when the catheter is inserted into the patient's vascular system.

[0009] In some embodiments, the pressure transducer may be operationally coupled to a hardware processing device. In some embodiments, the hardware processing device may receive pressure sensor data from the pressure transducer and convert the pressure sensor data into pressure sensor values ​​associated with hemodynamic characteristics. The catheter system further comprises a wireless transmitter operationally coupled to the hardware processing device for wirelessly transmitting the patient's hemodynamic characteristics.

[0010] In some embodiments, the catheter system may include an extension tube extending from the tube inlet port. In some embodiments, the catheter system may include another extension tube extending between the side port and the fluid chamber. In some embodiments, the other extension tube may be shorter than the extension tube. In some embodiments, the tube inlet port may be located proximal to the pressure transducer and distal to the port access. In some embodiments, the tube inlet port may be located proximal to the other extension tube and distal to the pressure transducer and port access.

[0011] In some embodiments, the catheter may be a peripheral venous catheter. In some embodiments, the catheter may be an arterial catheter. In some embodiments, the catheter may be another suitable type of catheter.

[0012] It should be understood that both the above-mentioned general description and the following detailed description are illustrative and for illustrative purposes only, and do not limit the claimed invention. It should be understood that various embodiments are not limited to the arrangements and instrumentations shown in the drawings. Furthermore, it should be understood that embodiments may be combined, or other embodiments may be used, and structural modifications may be made without departing from the scope of the various embodiments of the invention, unless otherwise claimed. Therefore, the following detailed description should not be interpreted as restrictive.

[0013] Exemplary embodiments are described and explained in more specific and detail with reference to the accompanying drawings. [Brief explanation of the drawing]

[0014] [Figure 1] Figure 1 is a top view of a catheter system according to several embodiments of the present disclosure. [Figure 2] Figure 2 is a top view of a catheter system operationally coupled to a vascular instrument access device and a blood sampling device, according to several embodiments of the present disclosure. [Figure 3] Schematic diagrams of catheter systems and monitoring systems according to some embodiments of the present disclosure. [Figure 4] Figure 4 is a top view of a catheter system according to some embodiments of the present disclosure. [Figure 5] Figure 5 is a top view of a catheter system according to some embodiments of the present disclosure. [Figure 6] Figure 6 is a top view of a catheter system according to some embodiments of the present disclosure. [Figure 7] Figure 7 is a top view of a catheter system according to some embodiments of the present disclosure. [Figure 8] Figure 8 is a top view of a catheter system according to several embodiments of the present disclosure. [Figure 9] Figure 9 is a top view of a catheter system comprising a vascular instrument access device and a blood sampling device according to some embodiments of the present disclosure. [Figure 10] Figure 10 is a schematic diagram of a catheter system and monitoring system according to some embodiments of the present disclosure. [Figure 11] Figure 11 is a top view of a catheter system according to some embodiments of the present disclosure. [Figure 12] Figure 12 is a top view of a catheter system according to some embodiments of the present disclosure. [Figure 13] Figure 13 is a top view of a catheter system according to some embodiments of the present disclosure. [Figure 14] Figure 14 is a top view of a catheter system according to some embodiments of the present disclosure. [Figure 15] Figure 15 is a cross-sectional view of a catheter system according to several embodiments of the present disclosure. [Modes for carrying out the invention]

[0015] Figure 1 is a top view of a catheter system 100 according to several embodiments of the present disclosure. The catheter system 100 described herein may provide predictive and / or indicative data related to patient hemodynamic events through the use of a pressure transducer 106 formed in a fluid chamber 104 adjacent to a catheter 102. This hemodynamic event data may be acquired by the pressure transducer 106 and transmitted wirelessly or via a wired connection to a monitoring system for review and use by healthcare professionals during patient treatment.

[0016] The catheter system 100 may include a port access 108 proximal to the fluid chamber 104 and the pressure transducer 106 of the catheter system 100. Since the pressure transducer 106 is offset from the axis of the catheter 102 within the fluid chamber 104, the port access 108 enables a healthcare provider to engage in intravascular sensing probe blood sampling and / or instrument delivery via the port access 108, thereby simultaneously monitoring the patient's hemodynamic characteristics and eliminating the need to use a relatively complex system to provide blood sampling / instrument delivery.

[0017] In some embodiments, the catheter 102, fluid chamber 104, pressure transducer 106, and port access 108 may be formed as a monolithic piece by the use of the catheter 102 associated with the use of the pressure transducer 106. In another embodiment, the catheter 102 may include a catheter hub 110 that operatively couples the catheter 102 to the fluid chamber 104, pressure transducer 106, and port access 108. In some embodiments, the threads of the catheter hub may engage other threads 112 formed on the fluid chamber 104. Thereby, the healthcare provider can selectively couple and separate the fluid chamber 104 from the catheter 102 as needed. In some embodiments, the catheter may be used to provide the ability to continue measuring hemodynamic pressure while the port access 108 is being used for blood collection or introducing a sensor into the patient's vascular anatomy through the fluid chamber 104 and the catheter 102, and may include one or more perforations formed through the wall of the catheter 102.

[0018] In some embodiments, catheter 102 can be any type of device that provides access to a patient's vascular anatomy, such as a vein or artery. In some embodiments, catheter 102 can include, for example, a tubular cannula that is inserted into the patient's anatomy to access the vascular structure. In some embodiments, catheter 102 can be rigid to access an artery. In some embodiments, catheter 102 may be similar to that of the ACCUCATH ACETM or BD INSYTETM AUTOGUARDTM IV catheter manufactured by Becton, Dickinson and Company of Franklin Lakes, New Jersey. In some embodiments, other types of catheters 102 may be used and may be operatively coupled to fluid chamber 104 and / or pressure transducer 106 described in the present disclosure, and it is understood that the present disclosure contemplates the use of these other types of catheters 102.

[0019] In some embodiments, fluid chamber 104 may be operatively coupled to stabilization platform 122. Stabilization platform 122 can be used to position fluid chamber 104 and its pressure transducer 106 on the patient's external anatomical structure to stabilize catheter system 100 relative to the patient. In some embodiments, stabilization platform 122 can include an adhesive and / or a friction generating surface formed on the surface of stabilization platform 122 that contacts the patient's external anatomical structure. This adhesive and / or friction generating surface can be used to adhere stabilization platform 122, and thus catheter system 100, to the patient's external anatomical structure while catheter system 100 is placed in the patient's vascular anatomy.

[0020] In some embodiments, the pressure transducer 106 may be any type of pressure sensor capable of detecting hemodynamic characteristics of the patient's blood. These hemodynamic characteristics may include, for example, the patient's blood pressure. Therefore, in some embodiments, the fluid chamber 104 and the pressure transducer 106 may be in fluid communication with the catheter 102, such that the fluid chamber 104 is also in fluid communication with the patient's vascular anatomy when the catheter 102 is inserted into the patient's vascular anatomy. This allows the pressure transducer 106 to detect the patient's blood pressure in real time.

[0021] In some embodiments, the pressure transducer 106 may be operationally coupled to a microcontroller or another hardware processing device capable of receiving and processing the data acquired by the pressure transducer 106. Processing of the data from the pressure transducer 106 may, for example, determine the patient's real-time blood pressure or provide other data indicating the patient's hemodynamic characteristics. Furthermore, the data acquired by the microcontroller may also be used to determine whether there are any complications associated with the use of the catheter system 100.

[0022] For example, when the catheter 102 is inserted into the patient's vascular anatomical structure, blood may begin to flow in the fluid chamber 104. However, if the catheter 102 is not properly inserted, or if a blood flow problem occurs in one or more of the catheter 102, the fluid chamber 104, or the port access 108 during use, these complications can be detected using data acquired by the pressure transducer 106 and provided to the microcontroller. To notify healthcare workers of such complications, the microcontroller may be operationally coupled to one or more lights (e.g., light-emitting diodes or LEDs) formed in or on the fluid chamber 104 that indicate to healthcare workers when the catheter system 100 is experiencing these complications. In some embodiments, the fluid chamber 104 or monitoring system described herein may include both visual indicators (e.g., LEDs) or audible indicators to warn healthcare workers of these complications.

[0023] In some embodiments, the port access 108 may include any type of access device that allows a healthcare professional to selectively insert a needle, sensor, or any other type of device into the fluid chamber 104 and the catheter 102. In some embodiments, the port access 108 may facilitate the collection of blood samples from the patient's vascular anatomical structure and / or the introduction of a sensor into the patient's vascular anatomical structure. In some embodiments, the port access 108 may include a split septum needleless connector (NFC) used for direct line draw or sensing instrument delivery. In some embodiments, the port access 108 may be color-coded for use with either arterial (e.g., red) or venous (e.g., blue) vascular access to indicate the type of vascular anatomical structure into which the catheter 102 of the catheter system 100 has been inserted.

[0024] In some embodiments, the port access 108 may provide a washable feature to the catheter system 100 proximal to the pressure transducer 106, for example, to wash the catheter system 100 with saline solution. In some embodiments, the pressure transducer 106 is offset from the fluid path in the fluid chamber 104 and catheter 102, so that healthcare workers can wash the catheter system 100 more easily without the pressure transducer 106 blocking or interfering with this process.

[0025] In some embodiments, the port access 108 may include an interface that allows an instrument delivery device (e.g., a PIVO® needleless blood collection device available from Becton, Dickinson and Company) to be coupled to the port access 108. In some embodiments, the port access 108 may include a female Luer connector. In some embodiments, the port access 108 may include a tube inlet that includes a cleaning function used to clean the catheter system 100. In some embodiments, the tube inlet may include a cleaning angle (e.g., 15 to 165 degrees with respect to the longitudinal axis of the port access 108) to allow for proper cleaning.

[0026] In some embodiments, the catheter system 100 may include an extension tube 114. In some embodiments, for example as shown in Figure 1, the extension tube 114 is formed midway between the fluid chamber 104 / pressure transducer 106 and the port access 108. This extension tube 114 may also be in fluid communication with the fluid chamber 104, the catheter 102, and the patient's vascular anatomy when the catheter 102 is inserted into the patient's vascular anatomy. In some embodiments, the extension tube 114 may include any type of low-compliance tubing that does not expand or stretch under internal pressure placed over it, for example, via the patient's blood pressure. In some embodiments, the extension tube 114 may include any type of tube clamp 116 that selectively allows or prevents the flow of the patient's blood through the extension tube 114. The tube clamp 116 may be moved along the length of the extension tube 114 by a healthcare professional when their need arises. In some embodiments, the tube clamp 116 may be a roller clamp.

[0027] In some embodiments, the extension tube 114 may operatively couple the catheter 102, fluid chamber 104, and port access 108 to the extension tube proximal port 118. In some embodiments, the extension tube proximal port 118 may be used to operatively couple the catheter system 100 to a monitoring system, for example, via a port connection 120. As described in this disclosure, in some embodiments, the pressure transducer 106 formed in the catheter system 100 may be a primary pressure transducer to which the catheter system 100 shown in Figure 1 is operatively coupled to a secondary pressure transducer, which may be located in a monitoring system or in another or secondary fluid chamber formed proximal to the extension tube proximal port 118. In some embodiments, the secondary pressure transducer may be operatively coupled to the extension tube proximal port 118 via a proximal port connection 120.

[0028] In some embodiments where the secondary pressure transducer is located in the monitoring system, the secondary pressure transducer may be used to compare hemodynamic measurements with the primary pressure transducer to obtain a more comprehensive analysis of the patient's hemodynamic state and the overall function of the patient's cardiovascular system. This can further help in detecting the presence of hemodynamic abnormalities in the patient's body, potentially predicting future hemodynamic events, and treating such events before or during their occurrence. Similarly, the extension tube proximal port 118 may be used to operatively couple the secondary fluid chamber and secondary pressure transducer to the catheter system 100 so that the secondary fluid chamber / secondary pressure transducer can be positioned at the height of the patient's heart (e.g., while the patient is seated). This can provide additional data showing the relative blood pressure at the height of the patient's heart with respect to the insertion site of the catheter 102 in the catheter system 100. By doing so, healthcare professionals can be alerted to blood pressure events or conditions in the limbs of the patient's body (e.g., arms, legs, etc.) that may be relatively lower than the patient's heart, in order to help diagnose certain vascular conditions.

[0029] In some embodiments, the extension tube proximal port 118 may include a single port used by a healthcare professional to access the patient's vascular anatomical structure. The extension tube proximal port 118 may include, or be coupled to, a removable connector, a three-way stopcock, an end cap, or a vent plug. In some embodiments where the extension tube proximal port 118 is a single port, a conventional arterial line system may be connected to the extension tube proximal port 118 for temporary blood sampling, fluid delivery, and / or blood collection. In some embodiments, the extension tube proximal port 118 may include a female Luer connector.

[0030] In some embodiments, the proximal port 118 of the extension tube may include a dual port used by a healthcare professional to access the patient's vascular anatomical structure. The dual port may include, or be coupled to, a removable connector, a three-way stopcock, an end cap, or a vent plug. In some embodiments, the dual port may include a Y-adapter or a T-adapter. In some embodiments, the dual-port extension tube proximal port 118 may include one or more washable features to facilitate blood collection using a blood collection port corresponding to one of the dual ports.

[0031] In some embodiments, the catheter system 100, devices, and methods described herein can reduce blood clearance, blood collection, and blood return problems that may be associated with other vascular access devices. The systems, devices, and methods described herein can also reduce problems associated with system cleaning procedures. The systems, devices, and methods described herein can provide line draw sampling (e.g., venous or arterial blood collection) directly from within the patient's vascular anatomical structure, thereby simplifying the procedure, particularly when the catheter 102 is positioned within the patient's arterial anatomical structure. In some embodiments, the systems, devices, and methods described herein provide continuous pressure monitoring for predictive identification or detection of complications and / or procedural steps that may occur during use of the catheter system 100.

[0032] Figure 2 is a top view of a catheter system 100 operatively coupled to a vascular instrument access device 201 and a blood sampling device 203, according to some embodiments of the present disclosure. The catheter system 100 shown in Figure 2 may include similar devices shown and described in Figure 1, including a catheter 102, a fluid chamber 104, a pressure transducer 106, a port access 108, a catheter hub 110, a thread 112, an extension tube 114, a tube clamp 116, an extension tube proximal port 118, a proximal port connection (not shown), and a stabilization platform 122. These devices may be used in conjunction with the vascular instrument access device 201 and / or the blood sampling device 203 to take blood samples from a patient's vascular anatomical structure and / or to introduce a vascular sensor into the catheter system 100, via the catheter 102, and into the patient's vascular anatomical structure.

[0033] In some embodiments, the vascular instrument access device 201 and / or the blood sampling device 203 may be operatively coupled to the port access 108. In some embodiments, the port access 108 may include any connection features that allow the vascular instrument access device 201 or the blood sampling device 203 to be operatively coupled to the catheter system 100, thereby preventing them from being detached unless a healthcare professional interacts with the connection. In the example shown in Figure 2, the vascular instrument access device 201 is directly coupled to the port access 108 via a clamp or other connection system that secures the distal end of the vascular instrument access device 201 to the proximal end of the port access 108. The vascular instrument access device 201 may include, for example, a needleless collection device (e.g., the PIVO® needleless blood collection device available from Becton, Dickinson and Company), which may be used to advance an internal flexible fluid tube through a fluid chamber 104 and catheter 102 into the patient's vascular anatomy to reach blood flow within the patient's vascular anatomy to an optimal location for aspiration. In some embodiments, the vascular instrument access device 201 may be discarded after use.

[0034]

[0049] In some embodiments, the distal end of the blood sampling device 203 may be operatively coupled to the proximal end of the vascular instrument access device 201. The blood sampling device may be an arterial blood gas (ABG) syringe (e.g., see Figure 2), a Luer-Lok® access device (LLAD) and vacuum tubing, a diagnostic cartridge, a diagnostic container, or a point-of-care (POC) dispensing device, among other devices capable of receiving a certain amount of blood from a patient.

[0035] As described in this disclosure, the vascular instrument access device 201 and the blood sampling device 203 may be used by a healthcare professional to selectively access the patient's vascular anatomical structure, deliver the instrument / sensor device to the vascular system, better access the patient's blood flow, and collect a blood sample for ABG diagnosis while the catheter system 100 remains in place within the patient's vascular system. In some embodiments, the vascular instrument access device 201 and the blood sampling device 203 are selectively coupled to the catheter system 100 via a port access 108, so that a healthcare professional can complete their tasks associated with the vascular instrument access device 201 and the blood sampling device 203 by attaching these devices to the catheter system 100 via the port access 108. The healthcare professional can then detach the vascular instrument access device 201 and the blood sampling device 203 from the catheter system 100, leaving the catheter system 100 with the patient's vascular anatomical structure, for example, to monitor the patient's hemodynamic characteristics.

[0036] Figure 3 is a schematic diagram of a catheter system 100 and a monitoring system 307 according to some embodiments of the present disclosure. In some embodiments, a primary pressure transducer 106-1 may be formed in a first fluid chamber in the catheter system 100. The primary pressure transducer 106-1 can monitor the patient's hemodynamic characteristics at the location where the catheter 102 is inserted into the patient's vascular anatomical structure (e.g., the patient's arm). In some embodiments, for example as shown in Figure 3, the catheter system 100 may be fluidly coupled to a secondary pressure transducer 106-2 formed in a second fluid chamber.

[0037] In some embodiments, the secondary pressure transducer 106-2 and the second fluid chamber may be fluidically coupled to the catheter system 100 via one or more of the extension tube 114, the extension tube proximal port 118, and the proximal port connection 120. In some embodiments, the secondary pressure transducer 106-2 may be located or coupled to another location on the patient's body, such as near the heart in the patient's chest. This may be done so that each of the primary pressure transducer 106-1 and the secondary pressure transducer 106-2 can detect the patient's hemodynamic characteristics at different altitudes, for example. In some embodiments, the primary pressure transducer 106-1 and the secondary pressure transducer 106-2 may provide additional data indicating relative blood pressure at the height of the patient's heart relative to the location of the insertion site of the catheter 102 in the catheter system 100. By doing so, healthcare professionals may be alerted to blood pressure events or conditions in the limbs of the patient's body (e.g., arms, legs, etc.) that may be relatively lower than the patient's heart, in order to help diagnose a particular vascular condition.

[0038] In some embodiments, the proximal port 118 of the extension tube may include a tertiary or third pressure transducer (not shown) that can also detect the hemodynamic characteristics of the patient's vascular system. In some embodiments, the primary pressure transducer 106-1, the secondary pressure transducer 106-2, and this tertiary pressure transducer may be fluidly coupled to the patient's vascular anatomical structure via the catheter system 100, so that their relatively detected hemodynamic data can be used to detect and diagnose specific blood pressure problems present in the patient's vascular system.

[0039] Figure 3 also shows another hemodynamic monitoring system sensor 305 operatively coupled to a structural support of the monitoring system 307, according to several embodiments. In some embodiments, the hemodynamic monitoring system sensor 305 may replace the secondary pressure transducer 106-2 and may similarly be coupled to the structural support of the monitoring system 307 at a height similar to that of the patient's heart. In some embodiments, this may be done to detect relative hemodynamic characteristics of the patient's vascular system (e.g., relative blood pressure at different altitudes) in order to detect, diagnose, or predict cardiovascular events.

[0040] In some embodiments, the monitoring system 307 may include any computing device capable of calculating, classifying, processing, transmitting, receiving, acquiring, transmitting, switching, storing, displaying, manifesting, detecting, recording, playing back, processing, or using any form of data received by any pressure transducers 106-1, 106-2, etc., in the system shown in Figure 3. In some embodiments, during operation, the monitoring system 307 may receive hemodynamic data received wirelessly or via a wired connection at each of the pressure transducers for display to a healthcare professional. In some embodiments, the monitoring system 307 may include a specific artificial intelligence (AI) algorithm capable of evaluating pressure waveforms to detect pressure signals that may indicate complications within the patient's vascular anatomical structure. In some embodiments, these complications, which may be detected via the execution of the AI ​​algorithm by a hardware processor in the monitoring system 307, may include, for example, loss of patency, infiltration within the catheter system 100 or other fluid channels, and thrombus formation. Other detectable complications may include complications during specific procedures, such as line and device flushing, line and device aspiration, and connection / disconnection of certain devices, among other hardware complications.

[0041] In some embodiments, the execution of the AI ​​algorithm can be completed by a hardware processing device located within the monitoring system 307. This hardware processing device may have relatively higher processing resources than the microcontrollers located within each pressure transducer shown in Figure 3. In some embodiments, the hardware processing device of the monitoring system 307 may also be operationally coupled to a wireless radio that receives data from the pressure transducers and each of their respective wireless radios. Furthermore, the hardware processing device may receive data from each of the pressure transducers via a wired connection operationally coupled to an input port formed on the monitoring system 307. This allows the monitoring system 307 to receive data from each of the pressure transducers via either a wired or wireless connection.

[0042] Figure 4 is a partial top view of a catheter system 100 according to some embodiments of the present disclosure. Furthermore, Figure 5 is also a top view of a catheter system 100 according to some embodiments of the present disclosure. Figures 4 and 5 show embodiments in which the catheter 102 and catheter hub 110 are not integrated into the rest of the catheter system 100 so that they are removable from the fluid chamber 104. For example, Figure 4 shows the catheter assembly, including the catheter 102 and catheter hub 110, removed, and Figure 5 shows the catheter 102 in place and operatively and fluidly coupled to the fluid chamber 104 and pressure transducer 106.

[0043] In some embodiments, the catheter hub 110 may include a set of screws that interface with or mate with a screw 112. These screws of the catheter hub 110 may be used by a healthcare professional to screw the catheter hub 110 into the body of the fluid chamber 104 in order to assemble the catheter system 100. In some embodiments, the catheter system 100 may be provided to the healthcare professional in an assembled state. However, in some embodiments, as described in this disclosure, if a monitoring system or microcontroller operatively coupled to the pressure transducer 106 detects a hardware complication (e.g., aspiration of lines and devices, connection / disconnection of a particular device among other hardware complications), the healthcare professional may separate the catheter 102 from the rest of the catheter system 100, discard the rest of the catheter system 100, and then couple a new fluid chamber 104, pressure transducer 106, and port access 108 to the catheter 102. This allows the healthcare professional to hold the catheter 102 in place, thereby reducing trauma to the patient while also reducing the possibility of infection, such as sepsis.

[0044] In some embodiments, the catheter system 100 may include a proximal Y-adapter 409 or another suitable connector, as shown, for example, in Figures 4 and 5. In some embodiments, the proximal Y-adapter 409 may be operatively coupled to the catheter system 100 via an extension tube 114, as described in this disclosure. In some embodiments, the proximal Y-adapter 409 may provide another access point to the patient's vascular system to allow the incorporation of another pressure transducer 106 and / or to provide another port for introducing a drug or other fluid into the patient's blood flow (e.g., IV infusion). This allows for the use of multiple ports to access the patient's vascular system and provides a single location for the catheter 102 to access the patient's vascular system for the healthcare professional.

[0045] Figure 6 is a top view of a catheter system 100 according to some embodiments of the present disclosure. Figure 7 is also a top view of a catheter system 100 according to some embodiments of the present disclosure. Again, Figures 6 and 7 show embodiments in which the catheter 102 and catheter hub 110 are not integrated with the rest of the catheter system 100. For example, Figure 6 shows the catheter removed, and Figure 7 shows the catheter 102 in place and operatively and fluidly coupled to the fluid chamber 104 and pressure transducer 106 via the catheter hub 110.

[0046] In some embodiments, the catheter system 100 may include a proximal Y-adapter 409, as shown, for example, in Figures 6 and 7. The proximal Y-adapter 409 may be operatively coupled to the catheter system 100 via an extension tube 114, as described in this disclosure. In some embodiments, the proximal Y-adapter 409 may provide another access point to the patient's vascular system to allow the incorporation of another pressure transducer 106 and / or to provide another port for introducing a drug or other fluid into the patient's blood flow (e.g., IV infusion). This makes it possible to access the patient's vascular system using multiple ports and provide a single location for the catheter 102, which a healthcare professional can do so.

[0047] In some embodiments, the catheter system 100 shown in Figures 6 and 7 may include a wired connection 611 used to electrically and communicatively couple a pressure transducer 106 in a fluid chamber 104 to a monitoring system (not shown in Figures 6 and 7). In some embodiments, the wired connection 611 may be operationally coupled to the pressure transducer 106 and / or a microcontroller (if present) to transmit hemodynamic data detected by the pressure transducer 106 to the monitoring system. In some embodiments, the wired connection 611 may include an electrical connector 613, which allows the wired connection 611 to be coupled to the monitoring system via a port formed in the monitoring system.

[0048] In some embodiments, it is understood that any pressure transducer 106 (e.g., primary, secondary, and tertiary pressure transducers) may also be operationally and electrically coupled to a monitoring system to facilitate the transmission of this data from each pressure transducer. Furthermore, in some embodiments, it is understood that any pressure transducer in the system described herein may be wirelessly connected to a monitoring system or coupled to the monitoring system via a wired connection 611 and an electrical connector 613. In some embodiments, the electrical connector 613 may be specific to the type of monitoring system used and the ports formed within the monitoring system, such that the electrical connector 613 is electrically coupled only to the correct ports in the monitoring system.

[0049] Figure 8 is a top view of a catheter system 100 according to several embodiments of the present disclosure. The catheter system 100 described herein may provide predictive and / or indicative data related to patient hemodynamic events through the use of a pressure transducer 106 formed in a fluid chamber 104 adjacent to a catheter 102. This hemodynamic event data may be acquired by the pressure transducer 106 and transmitted wirelessly or via a wired connection to a monitoring system for review and use by healthcare professionals during patient treatment. The catheter system 100 shown in Figure 8 may be similar to the catheter system 100 shown in Figures 1 to 7 in one or more features and / or operation.

[0050] In some embodiments, the catheter system 100 shown in Figure 8 may include a port access 108 located proximal to the fluid chamber 104 and pressure transducer 106 of the catheter system 100. Since the pressure transducer 106 is offset from the axis of the catheter 102 in the fluid chamber 104, the port access 108 allows a healthcare professional to engage in blood sampling and / or instrument delivery of an intravascular sensing probe via the port access 108, thereby reducing or eliminating the need to use a relatively complex system to simultaneously monitor the patient's hemodynamic characteristics and provide blood sampling / instrument delivery.

[0051] In some embodiments, the catheter 102 may include a catheter port access 815 aligned with the axis of the catheter 102. Thus, the catheter port access 815 may enable an inline vascular access system for arterial or vein access, monitoring, and blood sampling, as well as drug delivery in the catheter 102, separate from those features provided to the port access 108.

[0052] In some embodiments, the fluid chamber 104, pressure transducer 106, and port access 108 may be formed into a monolithic piece by the use of a catheter 102 associated with the use of the pressure transducer 106. In some embodiments, for example as shown in Figure 8, the distal end of the fluid chamber 104 may be fluidically coupled to the catheter 102 via a side port 819, which may be angled with respect to the longitudinal axis of the catheter hub. The side port 819 may be formed between the catheter 102 and the catheter port access 815 and may be used to fluidly couple the distal end of the fluid chamber 104 to the catheter 102. In some embodiments, the side port 819 may include any type of low-compliance tubing that does not expand or stretch under internal pressure placed over it, for example, via the patient's blood pressure. In some embodiments, any type of interface between the side port 819 and the distal end of the fluid chamber 104 may include their coupling devices that allow selective detachment of the fluid chamber 104 from the side port 819, as contemplated and described herein.

[0053] In some embodiments, the catheter 102 may be any type of device that provides access to the patient's vascular anatomical structure. In some embodiments, the catheter 102 may include, for example, a cannula that is inserted into the patient's anatomical structure to access the vascular structure. In some embodiments, a fluid chamber 104 coupled to the catheter 102 may be operatively coupled to a stabilization platform 122. In some embodiments, the stabilization platform 122 may be used to position the fluid chamber 104 and its pressure transducer 106 on the patient's extracorporeal anatomical structure in order to stabilize the catheter system 100 relative to the patient. In some embodiments, the stabilization platform 122 may include an adhesive and / or friction-generating surface formed on the surface of the stabilization platform 122 that is in contact with the patient's external anatomical structure. This adhesive and / or friction-generating surface may be used to bond the stabilization platform 122 and thus the catheter system 100 to the patient's external anatomical structure while the catheter system 100 is being placed in the patient's vascular anatomical structure.

[0054] In some embodiments, the catheter 102 may include a catheter stabilization wing 817 or a plurality of catheter stabilization wings. The catheter stabilization wing 817 may be used to position the catheter 102 in the patient's extracorporeal anatomical structure in order to stabilize the catheter system 100 relative to the patient. In some embodiments, the catheter stabilization wing 817 may include an adhesive or friction-generating surface formed on the surface of the catheter stabilization wing 817 that contacts the patient's extracorporeal anatomical structure. This adhesive or friction-generating surface may be used to adhere the catheter stabilization wing 817, and by extension, the catheter system 100, to the patient's external anatomical structure while the catheter system 100 is implanted in the patient's vascular anatomical structure.

[0055] In some embodiments, the pressure transducer 106 may be any type of pressure sensor capable of detecting hemodynamic characteristics of the patient's blood. These hemodynamic characteristics may include, for example, the patient's blood pressure and pulse rate. Thus, in some embodiments, the fluid chamber 104 and the pressure transducer 106 are fluidly connected to the catheter 102, so that when the catheter 102 is inserted into the patient's vascular anatomy, the fluid chamber 104 is also fluidly connected to the patient's vascular anatomy. This allows the pressure transducer 106 to detect the patient's blood pressure in real time.

[0056] In some embodiments, the pressure transducer 106 may be operationally coupled to a microcontroller or another hardware processing device capable of receiving and processing the data acquired by the pressure transducer 106. Processing of the data from the pressure transducer 106 may, for example, determine the patient's real-time blood pressure or provide other data indicating the patient's hemodynamic characteristics, as described in this disclosure. In some embodiments, the data acquired by the microcontroller may also be used to determine whether there are any complications associated with the use of the catheter system 100.

[0057] In some embodiments, when the catheter 102 is inserted into the patient's vascular anatomical structure, blood may begin to flow in the fluid chamber 104 via the side port 819. However, if the catheter 102 is not properly inserted, or if a blood flow problem occurs in one or more of the catheter 102, fluid chamber 104, or port access 108 during use, these complications can be detected using data acquired by the pressure transducer 106 and provided to the microcontroller. To notify healthcare workers of such complications, the microcontroller may be operationally coupled to one or more lights (e.g., light-emitting diodes or LEDs) formed in or on the fluid chamber 104 to indicate to healthcare workers whether and when the catheter system 100 is experiencing these complications. In another embodiment, the fluid chamber 104 or monitoring system described herein may include, for example, both visual indicators (e.g., LEDs) or audible indicators to warn healthcare workers of these complications.

[0058] In some embodiments, the port access 108 may include any type of access device that allows a healthcare professional to selectively insert a needle, sensor, or any other type of device into the fluid chamber 104 and into the catheter 102 via the side port 819 to take a blood sample from the patient's vascular anatomy or to introduce a sensor into the patient's vascular anatomy. In some embodiments, the port access 108 may include a split-partition needleless connector (NFC) used for direct drawing or instrument delivery sensing.

[0059] In some embodiments, the port access 108 may be color-coded for use with either arterial (e.g., red) or venous (e.g., blue) vascular access to indicate the type of vascular anatomical structure into which the catheter 102 of the catheter system 100 is inserted. In some embodiments, the port access 108 may provide a washable feature to the catheter system 100 proximal to the pressure transducer 106 for, for example, washing the catheter system 100 with saline solution. In some embodiments, the pressure transducer 106 is offset from the fluid path in the fluid chamber 104 so that healthcare professionals can more easily wash the catheter system 100 without the pressure transducer 106 blocking or interfering with this process.

[0060] In some embodiments, the port access 108 may include an interface that allows an instrument delivery device (e.g., the PIVO® needleless blood collection device available from Becton, Dickinson and Company in Franklin Lakes, New Jersey) to be coupled to the port access 108. In some embodiments, the catheter system 100 may include an extension tube 114. In some embodiments, for example, as shown in Figure 8, the extension tube 114 may be formed between the fluid chamber 104 / pressure transducer 106 and the port access 108. In some embodiments, the extension tube 114 may also be in fluid communication with the fluid chamber 104, the catheter 102, and the patient's vascular anatomy when the catheter 102 is inserted into the patient's vascular anatomy. In some embodiments, the extension tube 114 may include any type of low-compliance tubing that does not expand or stretch under internal pressure placed over it, for example, via the patient's blood pressure.

[0061] In some embodiments, the catheter system 100 may include another extension tube 115, which may be shorter than the extension tube 114, to facilitate the insertion of a probe, secondary catheter, or another suitable instrument from the catheter 102 into the patient's vascular system through the catheter system 100. In some embodiments, the other extension tube 115 may be integrated with the side port 819 and / or fluid chamber 104.

[0062] In some embodiments, the extension tube 114 and / or another extension tube 115 may include any type of tube clamp 116 that selectively allows or prevents the flow of patient blood through the extension tube 114. Depending on the needs of the healthcare professional, the tube clamp 116 can be moved along the length of the extension tube 114. In some embodiments, the tube clamp 116 may be a roller clamp.

[0063] In some embodiments, the extension tube 114 is in fluid communication with the catheter 102, and the fluid chamber 104 and port access 108 may be fluidly and operatively coupled to the extension tube proximal port 118. In some embodiments, the extension tube proximal port 118 may be used to operatively couple the catheter system 100 to a monitoring system, for example, via a proximal port connection 120. As described in this disclosure, the pressure transducer 106 formed in the catheter system 100 may be a secondary pressure transducer in which the catheter system 100 shown in Figure 8 is located in a monitoring system, or a secondary pressure transducer that is operatively coupled to another fluid chamber or secondary fluid chamber formed proximal to the extension tube proximal port 118 and operatively coupled to it via the proximal port connection 120. In some embodiments in which the secondary pressure transducer is located in a monitoring system, the secondary pressure transducer may be used to compare the respective hemodynamic measurements to obtain a relatively comprehensive analysis of the patient's hemodynamic state and the overall function of the patient's cardiovascular system. This could further help in detecting the presence of hemodynamic abnormalities in a patient's body, potentially predicting future hemodynamic events, and treating such events before or during their occurrence.

[0064] In some embodiments, the extension tube proximal port 118 may be used to operatively couple the secondary fluid chamber and secondary pressure transducer to the catheter system 100 so that the secondary fluid chamber / pressure transducer can be positioned at the height of the patient's heart (e.g., while the patient is seated). This may provide additional data indicating the relative blood pressure at the height of the patient's heart with respect to the insertion site of the catheter 102 in the catheter system 100. By doing so, healthcare professionals may be alerted to blood pressure events or conditions in the limbs of the patient's body (e.g., arms, legs, etc.) that may be relatively lower than the patient's heart, in order to help diagnose a particular vascular condition.

[0065] The catheter system 100, system, device, and method described in the disclosure may reduce blood clearance problems, blood collection problems, and / or blood return problems that may be associated with other vascular access devices. The system and method described in the disclosure may also eliminate problems associated with system cleaning procedures that may occur. In some embodiments, the system, device, and method described in the disclosure may also provide line draw sampling (e.g., venous or arterial blood collection) directly from within the patient's vascular anatomical structure, thereby simplifying the procedure, particularly when the catheter 102 is positioned within the patient's arterial anatomical structure. In some embodiments, the system, device, and method described in the disclosure may provide continuous pressure monitoring for predictive identification or detection of complications and / or procedural steps that may occur during the use of the catheter system 100.

[0066] Figure 9 is a top view of a catheter system 100 operatively coupled to a vascular instrument access device 201 and a blood sampling device 203, according to some embodiments of the present disclosure. The catheter system 100 may include similar devices shown and described in Figure 8, including a catheter 102, a fluid chamber 104, a pressure transducer 106, a port access 108, a catheter port access 815, a catheter stabilizing wing 817, a side port 819, an extension tube 114, a tube clamp 116, an extension tube proximal port 118, a proximal port connection (not shown), and a stabilizing platform 122. These devices may be used in conjunction with the vascular instrument access device 201 and / or the blood sampling device 203 to take blood samples from the patient's vascular anatomical structure and / or to introduce vascular sensors into the catheter system 100, via the catheter 102, and into the patient's vascular anatomical structure.

[0067] In some embodiments, the vascular instrument access device 201 and / or the blood sampling device 203 may be operatively coupled to the port access 108. The port access 108 may include any connection features that allow the vascular instrument access device 201 or the blood sampling device 203 to be operatively coupled to the catheter system 100, thereby preventing them from being detached unless a healthcare professional interacts with the connection. For example, as shown in Figure 9, the vascular instrument access device 201 may be directly coupled to the port access 108 via a clamp or other connection system that secures the distal end of the vascular instrument access device 201 to the proximal end of the port access 108. In some embodiments, the vascular instrument access device 201 may include, for example, a needleless collection device (such as the PIVO® needleless blood collection device available from Becton, Dickinson and Company in Franklin Lakes, New Jersey), which may be used to advance an internal flexible fluid tube through a fluid chamber 104 and catheter 102 into the patient's vascular anatomy to reach blood flow within the patient's vascular anatomy to an optimal location for aspiration. In some embodiments, the vascular instrument access device 201 may be discarded after use.

[0068] In some embodiments, the distal end of the blood sampling device 203 may be operatively coupled to the proximal end of the vascular instrument access device 201. In some embodiments, the blood sampling device 203 shown in Figure 9 may be an arterial blood gas (ABG) syringe (e.g., see Figure 2), a Luer-Lok® access device (LLAD) and vacuum tubing, a diagnostic cartridge, a diagnostic container, or a point-of-care (POC) dispensing device, among other devices capable of receiving a certain amount of blood from the patient.

[0069] As described in this disclosure, the vascular instrument access device 201 and the blood sampling device 203 may be used by a healthcare professional to selectively access the patient's vascular anatomical structure, deliver the instrument / sensor device to the vascular system, better access the patient's blood flow, and collect blood samples for ABG diagnosis or clinical testing while the catheter system 100 remains in place within the patient's vascular system. In some embodiments, the vascular instrument access device 201 and the blood sampling device 203 are selectively coupled to the catheter system 100 via a port access 108, so that a healthcare professional can complete their tasks associated with the vascular instrument access device 201 and the blood sampling device 203 by attaching these devices to the catheter system 100 via the port access 108. The healthcare professional can then detach the vascular instrument access device 201 and the blood sampling device 203 from the catheter system 100, leaving the catheter system 100 in place to continue, for example, monitoring the patient's hemodynamic characteristics.

[0070] Figure 10 is a schematic diagram of a catheter system 100 and a monitoring system 307 according to some embodiments of the present disclosure. As described in the present disclosure, in some embodiments, a primary pressure transducer 106-1 may be formed in the first fluid chamber of the catheter system 100. In some embodiments, the primary pressure transducer 106-1 may monitor the patient's hemodynamic characteristics at the location where the catheter 102 is inserted into the patient's vascular anatomical structure (e.g., the patient's arm).

[0071] As shown in Figure 10, for example, the catheter system 100 may be fluidically coupled to a secondary pressure transducer 106-2 formed in a second fluid chamber. In some embodiments, the secondary pressure transducer 106-2 and the second fluid chamber may be fluidly coupled to the catheter system 100 via one or more of an extension tube 114, an extension tube proximal port 118, and a proximal port connection 120, and may be located or connected to another location on the patient's body, such as near the heart in the patient's chest. This may be done so that each of the primary pressure transducer 106-1 and the secondary pressure transducer 106-2 can detect the patient's hemodynamic characteristics at different altitudes, for example. This may provide additional data showing the relative blood pressure at the height of the patient's heart relative to the location of the insertion site of the catheter 102 of the catheter system 100. By doing so, healthcare professionals may be alerted to blood pressure events or conditions in the limbs of the patient's body (e.g., arms, legs, etc.) that may be relatively lower than the patient's heart, in order to help diagnose a particular vascular condition.

[0072] In some embodiments, the proximal port 118 of the extension tube may include a tertiary or third pressure transducer (not shown) that can also detect the hemodynamic characteristics of the patient's vascular system. In some embodiments, the primary pressure transducer 106-1, the secondary pressure transducer 106-2, and this tertiary pressure transducer may be fluidly coupled to the patient's vascular anatomical structure via the catheter system 100 so that their relatively detected hemodynamic data can be used to detect and diagnose specific blood pressure problems present in the patient's vascular system.

[0073] Figure 10 also shows another hemodynamic monitoring system sensor 305 operatively coupled to a structural support of the monitoring system 307, according to several embodiments. In some embodiments, the hemodynamic monitoring system sensor 305 may replace the secondary pressure transducer 106-2 and may similarly be coupled to the structural support of the monitoring system 307 at a height similar to that of the patient's heart. Again, this may be done to detect relative hemodynamic characteristics of the patient's vascular system (e.g., relative blood pressure at different altitudes) in order to detect, diagnose, or predict cardiovascular events.

[0074] In some embodiments, the monitoring system 307 may include any computing device capable of calculating, classifying, processing, transmitting, receiving, acquiring, transmitting, switching, storing, displaying, manifesting, detecting, recording, playing back, processing, or using any form of data received by any pressure transducers 106-1, 106-2, etc., in the system shown in Figure 10. During operation, the monitoring system 307 may receive hemodynamic data received via wireless or wired connections at each of the pressure transducers for display to healthcare professionals. In some embodiments, the monitoring system 307 may include a specific artificial intelligence (AI) algorithm that evaluates pressure waveforms to detect pressure signals that may indicate complications within the patient's vascular anatomical structure. These complications, which can be detected via the execution of the AI ​​algorithm by a hardware processor in the monitoring system 307, may include, for example, loss of patency, infiltration or thrombus formation in the catheter system 100 or other fluid channels. Other detectable complications may include complications during specific procedures, such as line and device flushing, line and device aspiration, and connection / disconnection of certain devices, among other hardware complications.

[0075] As described in this disclosure, in some embodiments, the execution of the AI ​​algorithm may be completed by a hardware processing device located within the monitoring system 307. This hardware processing device may have relatively higher processing resources than the microcontrollers located within each pressure transducer shown in Figure 10. In some embodiments, the hardware processing device of the monitoring system 307 may also be operationally coupled to a wireless radio that receives data from the pressure transducers and each of their respective wireless radios. In some embodiments, the hardware processing device may receive data from each of the pressure transducers via a wired connection operationally coupled to an input port formed on the monitoring system 307. This allows the monitoring system 307 to receive data from each of the pressure transducers via either a wired or wireless connection.

[0076] Figure 11 is a top view of a catheter system 100 according to some embodiments of the present disclosure. Figure 12 is a top view of a catheter system 100 according to some embodiments of the present disclosure. Figures 11 and 12 show embodiments in which the tube inlet 1121 is in fluid communication with and / or adjacent to the fluid chamber 104 of the catheter system 100. For example, Figure 11 shows that the tube inlet 1121 may be formed midway between the fluid chamber 104 and the port access 108, and Figure 12 shows that the tube inlet 1121 may be formed distal to the fluid chamber 104.

[0077] In some embodiments, the catheter system 100 shown in Figures 11 and 12 may include, for example, one or more of the following: a catheter 102, a fluid chamber 104, a pressure transducer 106, a port access 108, an extension tube 114, a tube clamp 116, and an extension tube proximal port 118, as described in relation to Figure 8. In some embodiments, a tube inlet 1121 may be located between the fluid chamber 104 and the port access 108 to allow fluid flushing of both the fluid chamber 104 and the catheter 102.

[0078] In some embodiments, as shown, for example in Figure 11, the tube inlet 1121 may include a cleaning angle (e.g., 15 to 165 degrees with respect to the longitudinal axis of the port access 108) to allow for proper cleaning. In Figure 12, the tube inlet 1121 is located distal to the fluid chamber 104. Again, in this exemplary embodiment, the tube inlet 1121 may include a cleaning angle (e.g., 15 to 165 degrees with respect to the longitudinal axis of the port access 108) to allow for proper cleaning. In some embodiments, by positioning the tube inlet 1121 upstream or downstream of the fluid chamber 104, vortices generated in the fluid introduced into the tube inlet 1121 due to the cleaning angle can clean the tube inlet 1121 and / or any obstructions in the fluid chamber 104. In some embodiments, blood may accumulate and coagulate at specific locations in the fluid chamber 104, catheter 102, or any other fluid channels within the catheter system 100. In some embodiments, the placement of the tube inlet 1121 may be selected based on the location where thrombi or other occlusions may form during use of the catheter system 100.

[0079] Figure 13 is a top view of a catheter system 100 according to some embodiments of the present disclosure. Furthermore, Figure 14 is a top view of a catheter system 100 according to some embodiments of the present disclosure. Figures 13 and 14 show embodiments in which the tube inlet 1121 is formed to be in fluid communication with and / or adjacent to the fluid chamber 104 of the catheter system 100. For example, Figure 13 shows that the tube inlet 1121 is formed midway between the fluid chamber 104 and the port access 108, while Figure 12 shows that the tube inlet 1121 is formed proximal to the fluid chamber 104.

[0080] In some embodiments, as shown, for example, in Figures 13 and 14, the catheter system 100 may also include a tube inlet 1121 located distal to the fluid chamber 104 or intermediate between the fluid chamber 104 and the port access 108. For example, in Figure 13, the tube inlet 1121 may be located between the fluid chamber 104 and the port access 108 to allow fluid flushing for both the fluid chamber 104 housing the pressure transducer 106 and for both the catheter 102 and the catheter housing. In this exemplary embodiment, the tube inlet 1121 may include a flushing angle (e.g., 15 to 165 degrees with respect to the longitudinal axis of the port access 108) to allow for proper flushing. In Figure 12, the tube inlet 1121 may be located distal to the fluid chamber 104. Again, in this exemplary embodiment, the tube inlet 1121 may include a flushing angle (e.g., 15 to 165 degrees with respect to the longitudinal axis of the port access 108) to allow for proper flushing. In some embodiments, by positioning the tube inlet 1121 upstream or downstream of the fluid chamber 104, vortices generated in the fluid introduced into the tube inlet 1121 due to the cleaning angle can clean away any obstructions specifically contained in their junctions. In some embodiments, blood may accumulate and coagulate at specific locations in the fluid chamber 104, catheter 102, or any other fluid channel within the catheter system 100. In some embodiments, the positioning of the tube inlet 1121 may be selected based on where thrombi or other blockages may form during use of the catheter system 100.

[0081] In some embodiments, for example, the catheter system 100 shown in Figures 13 and 14 may include a wired connection 611 used to electrically and communicatively couple a pressure transducer 106 in a fluid chamber 104 to a monitoring system (not shown in Figures 13 and 14). The wired connection 611 is operationally coupled to the pressure transducer 106 and / or a microcontroller (if present) and can transmit hemodynamic data detected by the pressure transducer 106 to the monitoring system. In some embodiments, the wired connection 611 may include an electrical connector 613, which allows the wired connection 611 to be coupled to the monitoring system via a port formed in the monitoring system. In some embodiments, it is understood that any pressure transducer 106 (e.g., primary, secondary, and tertiary pressure transducers) may also be operationally and electrically coupled to the monitoring system as needed to facilitate the transmission of this data from each pressure transducer.

[0082] Furthermore, in some embodiments, it is understood that any pressure transducer in the system described herein may be wirelessly connected to a monitoring system or coupled to the monitoring system via a wired connection 611 and an electrical connector 613. In some embodiments, the electrical connector 613 may be specific to the type of monitoring system used and the ports formed within the monitoring system, such that the electrical connector 613 is electrically coupled only to the correct ports in the monitoring system.

[0083] Figure 15 is a partial cross-sectional view of a catheter system 100 according to some embodiments of the present disclosure. In some embodiments, the tube inlet 1121 may be located between the fluid chamber 104 and the port access 108. In some embodiments, the catheter hub 110 may be operatively and fluidly coupled to a side port (see side port 819, for example, as shown in Figure 8). In some embodiments, the interface at the distal end of the fluid chamber 104 may include a catheter hub 110 having a thread used to operatively couple a catheter (not shown in Figure 15) to the fluid chamber 104 (for example, as shown in Figure 1).

[0084] Figure 15 shows that the tube inlet 1121 may be angled with respect to the fluid axis formed within the fluid chamber 104 and the port access 108. In this disclosure, this angle, referred to as the cleaning angle 1523, may be set between 15 and 165 degrees with respect to the longitudinal axis of the port access 108 to allow proper cleaning of the fluid chamber 104, the catheter, or any other fluid channel within a particular catheter system.

[0085] In some embodiments, the fluid chamber 104 may be operatively coupled to a stabilization platform 122. Again, in some embodiments, the stabilization platform 122 may be used to position the fluid chamber 104 and its pressure transducer 106 on the patient's extracorporeal anatomical structure in order to stabilize the catheter system 100 relative to the patient. In some embodiments, the stabilization platform 122 may house a hardware processing device such as a microcontroller and a pressure transducer circuit 1525 associated with the pressure transducer 106. In some embodiments, the pressure transducer circuit 1525 may also include a circuit associated with a wireless transmitter. As described in this disclosure, in some embodiments, a wireless transmitter operatively coupled to a hardware processing device may be used to wirelessly transmit the patient's hemodynamic characteristics in some embodiments of this disclosure.

[0086] All illustrative and conditional statements contained herein are intended for educational purposes to facilitate the Art and to help the reader understand the Invention and the concepts provided by the Inventors, and should be construed as not being limited to the specifically listed examples and conditions. Although embodiments of this disclosure are described in detail, it should be understood that various modifications, substitutions, and alternatives can be made to this specification without departing from the spirit and scope of the disclosed embodiments.

Claims

1. It is a catheter system, A catheter assembly comprising a catheter hub and a catheter extending distally from the catheter hub, A fluid chamber located proximal to the catheter, Extending through the catheter and the fluid chamber, and a fluid path within the catheter system, A pressure transducer is fluid-communicated with the fluid chamber to monitor the hemodynamic characteristics of the patient, A catheter system comprising a port access located near the pressure transducer.

2. The catheter system according to claim 1, wherein the pressure transducer is located in close proximity to the fluid chamber.

3. The catheter system according to claim 1, wherein the catheter hub includes a distal end and a proximal end, and the fluid chamber is coupled to the proximal end of the catheter adapter.

4. The catheter system according to claim 3, further comprising a vascular instrument access device operatively coupled to the port access in order to provide vascular instrument access through the port access.

5. The catheter system according to claim 3, further comprising an extension tube immediately positioned between the fluid chamber and the port access, wherein the port access is aligned with the longitudinal axis of the catheter hub.

6. The catheter system according to claim 4, comprising a secondary pressure transducer having fluid communication with the extension tube, the secondary pressure transducer being configured to be positioned at the level of the patient's heart when the catheter is inserted into the patient's vascular system.

7. The catheter system according to claim 1, wherein the pressure transducer is operationally coupled to a hardware processing device, the hardware processing device receives pressure sensor data from the pressure transducer and converts the pressure sensor data into pressure sensor values ​​associated with hemodynamic characteristics, and the catheter system further comprises a wireless transmitter operationally coupled to the hardware processing device for wirelessly transmitting the hemodynamic characteristics of the patient.

8. The catheter system according to claim 1, further comprising a wired connection operatively coupled to the pressure transducer for operatively coupling the pressure transducer to the monitoring system in order to transmit pressure sensor values ​​from the pressure transducer to the monitoring system.

9. The catheter system according to claim 8, wherein the wired connection is operationally coupled to the port access.

10. The catheter hub includes a distal end, a proximal end, and a side port located between the distal end and the proximal end. A tube inlet port positioned offset from the axis of the pressure transducer and the port access, wherein the tube inlet port generates a fluid vortex to prevent fluid stagnation within the catheter system, An extension tube extending from the tube inlet port, The catheter system according to claim 1, further comprising another extension tube extending between the side port and the fluid chamber.

11. The catheter system according to claim 10, wherein the other extension tube is shorter than the extension tube.

12. The catheter system according to claim 10, wherein the tube inlet port is located proximal to the pressure transducer and distal to the port access.

13. The catheter system according to claim 10, wherein the tube inlet port is located proximal to the other extension tube and distal to the pressure transducer and the port access.

14. The catheter system according to claim 10, further comprising a vascular instrument access device operatively coupled to the port access in order to provide vascular instrument access through the port access.

15. The catheter system according to claim 10, further comprising: a secondary pressure transducer having fluid communication with the extension tube, configured to be positioned at the level of the patient's heart when the catheter is inserted into the patient's vascular system.

16. The catheter system according to claim 10, wherein the pressure transducer is operationally coupled to a hardware processing device, the hardware processing device receives pressure sensor data from the pressure transducer and converts the pressure sensor data into pressure sensor values ​​associated with hemodynamic characteristics, and the catheter system further comprises a wireless transmitter operationally coupled to the hardware processing device for wirelessly transmitting the hemodynamic characteristics of the patient.

17. The catheter system according to claim 10, further comprising a wired connection operatively coupled to the pressure transducer for operatively coupling the pressure transducer to the monitoring system in order to transmit pressure sensor values ​​from the pressure transducer to the monitoring system.

18. The catheter system according to claim 17, wherein the wired connection is operationally coupled to the port access.

19. The catheter system according to claim 1, wherein the catheter is a peripheral intravenous catheter.

20. The catheter system according to claim 1, wherein the catheter is an arterial catheter.

Images