Catheter system

Abstract

The present disclosure relates to a catheter system that may include a catheter assembly that may include a catheter hub and a catheter extending distally from the catheter hub. The catheter system may include a fluid chamber proximal to the catheter. The conduit system may include a fluid path located within the conduit system and extending through the conduit and the fluid chamber. The catheter system may include a pressure transducer in fluid communication with the fluid chamber to monitor hemodynamic characteristics of a patient.

Description

Technical Field

[0001] The present disclosure relates to a catheter system. Background Art

[0002] Arterial catheters and systems provide healthcare professionals with a method for monitoring a patient's arterial hemodynamic parameters and provide a means for collecting data related to the patient's hemodynamic characteristics and features, which characteristics and features include, for example, blood pressure, pulse contour, and arterial blood gases. These hemodynamic characteristics can all be used to determine the immediate recognition of an abnormal hemodynamic event and the initiation of appropriate treatment. Arterial catheters can also be used to provide samples for blood gas analysis without the certain symptoms and morbidities associated with repeated arterial punctures.

[0003] However, current arterial catheter devices, systems, and methods present significant risks of blood exposure and other performance issues, such as the accurate placement of the arterial catheter. In addition, current hemodynamic monitoring and ABG collection systems can be complex, expensive, and may require a significant amount of time and resources to collect the necessary samples. In addition, a significant amount of time and resources may be required to maintain the arterial line in order to minimize the risk of developing symptoms such as infections and catheter-related bloodstream infections (CRBSI). In addition, in other processes associated with currently implemented arterial catheters, a significant amount of time and resources may be required to ensure proper flushing and preservation of the arterial line and the device with arterial blood.

[0004] The subject matter claimed in the present disclosure is not limited to embodiments that solve any disadvantages or operate only in environments such as those described in the present disclosure. Rather, this background is provided to describe the environment in which the presently described embodiments can operate. Summary of the Utility Model

[0005] The present disclosure generally relates to a catheter system for detecting a patient's hemodynamic characteristics, as well as related devices and methods. In some embodiments, the catheter system can be configured for blood pressure monitoring and blood sampling, which can be performed simultaneously. In some embodiments, the catheter system can be configured to simultaneously monitor a patient's blood pressure and sample or collect blood. In some embodiments, the catheter system can include a catheter assembly, which can include a catheter hub and a catheter extending distally from the catheter hub.

[0006] In some embodiments, the catheter system can include a fluid chamber proximal to the catheter. In some embodiments, the catheter system can include a fluid path within the catheter system, and the fluid path extends through the catheter and the fluid chamber. In some embodiments, the catheter system can include a pressure transducer in fluid communication with the fluid chamber to monitor the patient's hemodynamic characteristics.

[0007] In some embodiments, the pressure transducer can be close to the fluid chamber and the fluid path passing through the fluid chamber. In some embodiments, the pressure transducer can be aligned with the fluid chamber such that the pressure transducer is at the same distance from the catheter system and / or another component of the catheter as the fluid chamber. In some embodiments, the catheter hub can include a distal end and a proximal end. In some embodiments, the fluid chamber can be coupled to the proximal end of the catheter hub. In some embodiments, the vascular device access device can be operably coupled to the port access opening to provide access to a vascular device through the port access opening.

[0008] In some embodiments, the catheter system can include an extension tube disposed directly between the fluid chamber and the port access opening. In some embodiments, the port access opening can be aligned with the longitudinal axis of the catheter hub. In some embodiments, the catheter system can include a second pressure transducer in fluid communication with the extension tube. In some embodiments, the second pressure transducer can be configured to be positioned at the level of the patient's heart when the catheter is inserted into the patient's vasculature.

[0009] In some embodiments, the pressure transducer is operably coupled to a hardware processing device. In some embodiments, the hardware processing device can receive pressure sensor data from the pressure transducer and convert the pressure sensor data into a pressure sensor value associated with hemodynamic characteristics. The catheter system further includes a wireless transmitter operably coupled to the hardware processing device to wirelessly transmit the patient's hemodynamic characteristics.

[0010] In some embodiments, the catheter system can include a wired connection operably coupled to the pressure transducer to operably connect the pressure transducer to a monitoring system for transmitting the pressure sensor value from the pressure transducer to the monitoring system. In some embodiments, the wired connection can be operably coupled to the port access opening.

[0011] In some embodiments, the catheter hub can include a distal end, a proximal end, and a side port disposed between the distal end and the proximal end. In some embodiments, the catheter system can include a fitting inlet port positioned off the longitudinal axis of the pressure transducer and the port access opening such that the fitting inlet port creates a fluid vortex at the fitting inlet port to prevent fluid stagnation within the catheter system.

[0012] In some embodiments, the catheter system can include an extension tube extending from the fitting inlet port. In some embodiments, the catheter system can include another extension tube extending between the side port and the fluid chamber. In some embodiments, the other extension tube can be shorter than the extension tube. In some embodiments, the fitting inlet port can be proximal to the pressure transducer and distal to the port access opening. In some embodiments, the fitting inlet port can be proximal to the other extension tube and distal to the pressure transducer and the port access opening.

[0013] In some embodiments, the catheter can be a peripheral venous catheter. In some embodiments, the catheter can be an arterial catheter. In some embodiments, the catheter can be another suitable type of catheter.

[0014] It should be understood that the above summary and the following detailed description are only exemplary and explanatory, and do not limit the claimed utility model. It should be understood that the various embodiments are not limited to the arrangements and means shown in the drawings. It should also be understood that embodiments can be combined, or other embodiments can be utilized, and structural changes can be made without departing from the scope of the various embodiments of the present utility model, unless so claimed. Therefore, the following detailed description should not be considered restrictive. BRIEF DESCRIPTION OF THE DRAWINGS

[0015] Exemplary embodiments will be described and explained with additional features and details by using the drawings, in which:

[0016] Figure 1 is a top view of a catheter system according to some embodiments of the present disclosure;

[0017] Figure 2 is a top view of a catheter system according to some embodiments of the present disclosure, the catheter system being operatively coupled to a vascular device access device and a blood sampling device;

[0018] Figure 3 is a schematic diagram of a catheter system and a monitoring system according to some embodiments of the present disclosure;

[0019] Figure 4 is a top view of a catheter system according to some embodiments of the present disclosure;

[0020] Figure 5 is a top view of a catheter system according to some embodiments of the present disclosure;

[0021] Figure 6 is a top view of a catheter system according to some embodiments of the present disclosure;

[0022] Figure 7 is a top view of a catheter system according to some embodiments of the present disclosure;

[0023] Figure 8 is a top view of a catheter system according to some embodiments of the present disclosure;

[0024] Figure 9 is a top view of a catheter system according to some embodiments of the present disclosure, the catheter system having a vascular device access device and a blood sampling device;

[0025] Figure 10 is a schematic diagram of a catheter system and a monitoring system according to some embodiments of the present disclosure;

[0026] Figure 11 is a top view of a catheter system according to some embodiments of the present disclosure;

[0027] Figure 12 is a top view of a catheter system according to some embodiments of the present disclosure;

[0028] Figure 13 is a top view of a catheter system according to some embodiments of the present disclosure;

[0029] Figure 14 is a top view of a catheter system according to some embodiments of the present disclosure;

[0030] Figure 15 is a cross-sectional view of a catheter system according to some embodiments of the present disclosure. Detailed Description

[0031] Figure 1 is a top view of a catheter system 100 according to some embodiments of the present disclosure. The catheter system 100 described in the present disclosure can provide prediction and / or indication data related to a patient's hemodynamic events by using a pressure transducer 106 formed within a fluid chamber 104 proximal to a catheter 102. The hemodynamic event data can be obtained by the pressure transducer 106 and transmitted to a monitoring system via a wireless or wired connection for viewing and use by healthcare professionals during patient treatment.

[0032] The catheter system 100 can include a port access 108 that is proximal to the fluid chamber 104 and the pressure transducer 106 of the catheter system 100. Because the pressure transducer 106 is offset from the axis of the catheter 102 within the fluid chamber 104, the port access 108 allows healthcare professionals to perform blood sampling and / or instrument delivery of an intravascular sensing probe via the port access 108, eliminating the need for a relatively more complex system for simultaneously monitoring a patient's hemodynamic characteristics and providing blood sampling / instrument delivery.

[0033] In some embodiments, the catheter 102, fluid chamber 104, pressure transducer 106, and port access 108 can form an integral unit, where the use of the catheter 102 is associated with the use of the pressure transducer 106. In another embodiment, the catheter 102 can 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 catheter hub threads can engage other threads 112 formed on the fluid chamber 104. This can allow a healthcare professional to selectively couple and decouple the fluid chamber 104 from the catheter 102, if desired. In some embodiments, the catheter can include one or more fenestrations formed through the wall of the catheter 102, which can be used to provide the ability to continuously measure hemodynamic pressure while the port access 108 is used to draw blood or introduce a sensor through the fluid chamber 104 and catheter 102 into the patient's vascular anatomy.

[0034] In some embodiments, the 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, the catheter 102 can include, for example, a tubular cannula that is inserted into the patient's anatomy to access the vascular anatomy. In some embodiments, the catheter 102 can be rigid to access an artery. In some embodiments, the catheter 102 can be similar to the ACCUCATH ACE TM or BD INSYTE TM AUTOGUARD TM Shield IV catheter manufactured by Becton, Dickinson and Company of Franklin Lakes, New Jersey. It should be understood that in some embodiments, other types of catheters 102 can be used and are operatively coupled to the fluid chamber 104 and / or pressure transducer 106 described in the present disclosure, and the present disclosure contemplates the use of these other types of catheters 102.

[0035] In some embodiments, the fluid chamber 104 can be operatively coupled to a stabilization platform 122. The stabilization platform 122 can be used to place the fluid chamber 104 and its pressure transducer 106 onto an external anatomy of a patient so as to stabilize the catheter system 100 relative to the patient. In some embodiments, the stabilization platform 122 can include an adhesive and / or a friction generating surface formed on a face of the stabilization platform 122 that contacts the external anatomy of the patient. During placement of the catheter system 100 into the vascular anatomy of the patient, the adhesive and / or the friction generating surface can be used to adhere the stabilization platform 122 to the external anatomy of the patient and, thus, adhere the catheter system 100 to the external anatomy of the patient.

[0036] In some embodiments, the pressure transducer 106 can be any type of pressure sensor that can detect hemodynamic characteristics of a patient's blood. These hemodynamic characteristics can include, for example, the patient's blood pressure. Thus, in some embodiments, the fluid chamber 104 and the pressure transducer 106 can be in fluid communication with the catheter 102 such that when the catheter 102 is inserted into the vascular anatomy of the patient, the fluid chamber 104 is also in fluid communication with the vascular anatomy of the patient. This allows the pressure transducer 106 to detect the patient's blood pressure in real time.

[0037] In some embodiments, the pressure transducer 106 can be operatively coupled to a microcontroller or other hardware processing device that can receive data obtained by the pressure transducer 106 and process the data. Processing of the data from the pressure transducer 106 can, for example, determine the patient's real-time blood pressure or provide other data indicative of the patient's hemodynamic characteristics. Additionally, the data obtained by the microcontroller can also be used to determine whether there are any symptoms associated with the use of the catheter system 100.

[0038] For example, when the catheter 102 is inserted into the vascular anatomy of the patient, blood can begin to flow within the fluid chamber 104. However, if the catheter 102 is not properly inserted, or if any blood flow problems occur within one or more of the catheter 102, the fluid chamber 104, or the port access 108 during use, the data obtained by the pressure transducer 106 and provided to the microcontroller can be used to detect these symptoms. To notify a healthcare professional of such symptoms, the microcontroller can be operatively coupled to one or more lights (e.g., light-emitting diodes or LEDs) formed within or on the fluid chamber 104 that will indicate to the healthcare professional when the catheter system 100 is experiencing these symptoms. In some embodiments, the fluid chamber 104 or the monitoring system described in the present disclosure can include a visual indicator (e.g., an LED) or an auditory indicator that warns the healthcare professional of these symptoms.

[0039] 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 drawing a blood sample from a patient's vascular anatomy and / or introducing a sensor into the patient's vascular anatomy. In some embodiments, the port access 108 may include a septumless needleless connector (NFC) for direct line draw or sensing device delivery. In some embodiments, the port access 108 may be color-coded for use with either an arterial (e.g., red) or venous (e.g., blue) vascular access to indicate the type of vascular anatomy into which the catheter 102 of the catheter system 100 has been inserted.

[0040] In some embodiments, the port access 108 may provide a flushing capability feature for the catheter system 100 proximal to the pressure transducer 106 to flush the catheter system 100 with, for example, a saline solution. In some embodiments, because the pressure transducer 106 is offset from the fluid path within the fluid chamber 104 and the catheter 102, a healthcare professional may more easily flush the catheter system 100 without the pressure transducer 106 blocking or impeding the process.

[0041] In some embodiments, the port access 108 may include an interface that allows an instrument delivery device (such as, for example, a PIVO TM needleless blood draw 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. In some embodiments, the port access 108 may include a tubing inlet that includes a flushing feature for flushing the catheter system 100. In some embodiments, the tubing inlet may include a flushing angle (e.g., 15 to 165 degrees relative to the longitudinal axis of the port access 108) to allow for proper flushing.

[0042] In some embodiments, the catheter system 100 may include an extension tube 114. In some embodiments, for example, as Figure 1As shown, an extension tube 114 is formed intermediate the fluid chamber 104 / pressure transducer 106 and the port access 108. When the catheter 102 is inserted into a patient's vascular anatomy, the extension tube 114 can also be in fluid communication with the fluid chamber 104, the catheter 102, and the patient's vascular anatomy. In some embodiments, the extension tube 114 can comprise any type of low-compliance tubing that does not expand or stretch under internal pressure applied thereto, such as by the patient's blood pressure. In some embodiments, the extension tube 114 can comprise any type of tubing clamp 116 that selectively permits or blocks the flow of the patient's blood through the extension tube 114. When desired, a healthcare professional can move the tubing clamp 116 along the length of the extension tube 114. In some embodiments, the tubing clamp 116 can be a roller clamp.

[0043] In some embodiments, the extension tube 114 can operably couple the catheter 102, the fluid chamber 104, and the port access 108 to an extension tube proximal port 118. In some embodiments, the extension tube proximal port 118 can be used to operably couple the catheter system 100 to, for example, a monitoring system via a proximal port connector 120. As described in the present disclosure, in some embodiments, the pressure transducer 106 formed in the catheter system 100 can be a first pressure transducer, wherein Figure 1 the illustrated catheter system 100 is operably coupled to a second pressure transducer that can be located at the monitoring system or at another or second fluid chamber proximal to the extension tube proximal port 118. In some embodiments, the second pressure transducer can be operably coupled to the extension tube proximal port 118 via the proximal port connector 120.

[0044] In some embodiments in which the second pressure transducer is located at the monitoring system, the second pressure transducer can be used to compare hemodynamic measurements with the first pressure transducer in order to provide a more comprehensive analysis of the patient's hemodynamic status and the overall function of the patient's cardiovascular system. This can also help to detect the presence of hemodynamic abnormalities in the patient, help to predict potential upcoming hemodynamic events, and treat any such events before or during their occurrence. Similarly, the extension tube proximal port 118 can be used to operably couple the second fluid chamber and the second pressure transducer to the catheter system 100 such that the second fluid chamber / second pressure transducer can be placed at the height of the patient's heart (e.g., when the patient is sitting up). This can provide additional data of the relative blood pressure at the height of the patient's heart indicative of the position of the insertion site of the catheter 102 relative to the catheter system 100. By doing so, a healthcare professional can be warned of blood pressure events or conditions within the patient's body extremities (e.g., arms, legs, etc.) that may be relatively lower than the blood pressure at the patient's heart in order to assist in the diagnosis of certain vascular conditions.

[0045] In some embodiments, the proximal port 118 of the extension tube may include a single port through which a healthcare professional accesses the patient's vascular anatomy. The proximal port 118 of the extension tube may include or be coupled to a removable connector, a three-way stopcock, an end cap, or a vent plug. In some embodiments in which the proximal port 118 of the extension tube is a single port, a conventional arterial tubing system may be connected to the proximal port 118 of the extension tube for temporary blood withdrawal, fluid delivery, and / or blood sampling. In some embodiments, the proximal port 118 of the extension tube may include a female Luer fitting.

[0046] In some embodiments, the proximal port 118 of the extension tube may include a dual port through which a healthcare professional accesses the patient's vascular anatomy. 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-shaped adapter or a T-shaped adapter. In some embodiments, the dual-port proximal port 118 of the extension tube may include one or more flushing capabilities features to facilitate blood withdrawal using the blood withdrawal port corresponding to one of the dual ports.

[0047] In some embodiments, the catheter system 100, devices, and methods described in the present disclosure may reduce blood clearance problems, blood withdrawal problems, and blood reflux problems that may be associated with other vascular access devices. The systems, devices, and methods described in the present disclosure may also reduce problems associated with system flushing procedures. The systems, devices, and methods described in the present disclosure may provide direct tubing sampling from within the patient's vascular anatomy (e.g., venous or arterial blood withdrawal), thereby simplifying procedures, especially in cases where the catheter 102 has already been placed within the patient's arterial anatomy. In some embodiments, the systems, devices, and methods described in the present disclosure provide continuous pressure monitoring for predictive identification or detection of symptoms and / or procedural steps that may occur during use of the catheter system 100.

[0048] Figure 2 is a top view of a catheter system 100 according to some embodiments of the present disclosure, which is operatively coupled to a vascular device access device 201 and a blood sampling device 203. Figure 2 The illustrated catheter system 100 may include Figure 1The similar devices shown and described include catheter 102, fluid chamber 104, pressure transducer 106, port access 108, catheter hub 110, threads 112, extension tube 114, tube clamp 116, proximal port of extension tube 118, proximal port connector (not shown), and stable platform 122. These devices can be used in combination with vascular access device 201 and / or blood sampling device 203 to retrieve a blood sample from a patient's vascular anatomy and / or introduce a vascular sensor into catheter system 100, through catheter 102, and into the patient's vascular anatomy.

[0049] In some embodiments, vascular access device 201 and / or blood sampling device 203 can be operatively coupled to port access 108. In some embodiments, port access 108 can include any connection feature that allows vascular access device 201 or blood sampling device 203 to be operatively coupled to catheter system 100 such that they are non-removable unless a healthcare professional interacts with the connector. In Figure 2 the example shown, vascular access device 201 is directly coupled to port access 108 via a clamp or other connection system that secures the distal end of vascular access device 201 to the proximal end of port access 108. Vascular access device 201 can include, for example, a needleless collection device (such as a PIVO TM needleless blood draw device) available from Becton, Dickinson and Company, which can be used to advance an internal flexible flow tube through fluid chamber 104 and catheter 102 and into the patient's vascular anatomy to achieve a blood flow most suitable for aspiration within the patient's vascular anatomy. In some embodiments, vascular access device 201 can be discarded after use.

[0050] In some embodiments, the distal end of blood sampling device 203 can be operatively coupled to the proximal end of vascular access device 201. The blood sampling device can be an arterial blood gas (ABG) syringe (such as shown in Figure 2 ), a Luer-Lok TM access device (LLAD) and vacuum tube, diagnostic cassette, diagnostic container, or point-of-care (POC) dispensing device, and other devices that can receive a quantity of blood from a patient.

[0051] As described in the present disclosure, healthcare professionals can use the vascular device access device 201 and the blood sampling device 203 to selectively access a patient's vascular anatomy, deliver an instrument / sensor device to the vascular system, better access the patient's blood flow, and draw a blood sample for ABG diagnostics, where the catheter system 100 remains in place within the patient's vascular system. In some embodiments, since the vascular device access device 201 and the blood sampling device 203 are selectively coupled to the catheter system 100 via the port access 108, the healthcare professional can perform those tasks associated with the vascular device access device 201 and the blood sampling device 203 by attaching these devices to the catheter system 100 at the port access 108. The healthcare professional can then disconnect the vascular device access device 201 and the blood sampling device 203 from the catheter system 100, leaving the catheter system 100 in the patient's vascular anatomy to continue monitoring, for example, the patient's hemodynamic characteristics.

[0052] 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 first pressure transducer 106-1 can be formed into a first fluid chamber of the catheter system 100. The first pressure transducer 106-1 can monitor the patient's hemodynamic characteristics at a location where the catheter 102 has been inserted into the patient's vascular anatomy (e.g., the patient's arm). In some embodiments, for example, as Figure 3 shown, the catheter system 100 can be fluidly coupled to a second pressure transducer 106-2 formed in a second fluid chamber.

[0053] In some embodiments, the second pressure transducer 106-2 and the second fluid chamber can 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 connector 120. In some embodiments, the second pressure transducer 106-2 can be placed or connected at another location on the patient's body, such as near the patient's heart on the patient's chest. This can be done such that, for example, each of the first pressure transducer 106-1 and the second pressure transducer 106-2 can detect the patient's hemodynamic characteristics at different heights. In some embodiments, the first pressure transducer 106-1 and the second pressure transducer 106-2 can provide additional data indicative of the relative blood pressure at the patient's heart height that indicates the position of the insertion site of the catheter 102 relative to the catheter system 100. By doing so, the healthcare professional can be warned of blood pressure events or conditions within the patient's body extremities (e.g., arms, legs, etc.) that may be relatively lower than the blood pressure at the patient's heart to assist in diagnosing certain vascular conditions.

[0054] In some embodiments, the proximal port 118 of the extension tube may include a tertiary or third pressure transducer (not shown), which may also detect hemodynamic characteristics of the patient's vascular system. Similarly, in some embodiments, because the first pressure transducer 106-1, the second pressure transducer 106-2, and the third pressure transducer may be fluidly coupled to the patient's vascular anatomy via the catheter system 100, their relatively detected hemodynamic data may be used to detect and diagnose certain blood pressure problems present within the patient's vascular system.

[0055] According to some embodiments, Figure 3 Another hemodynamic monitoring system sensor 305 is also shown, which is operably coupled to the structural support of the monitoring system 307. In some embodiments, the hemodynamic monitoring system sensor 305 may replace the second pressure transducer 106-2 and may be similarly coupled to the structural support of the monitoring system 307 at a height similar to the height of the patient's heart. In some embodiments, this may be done to detect relative hemodynamic characteristics (e.g., relative blood pressure at different heights) of the patient's vascular system, thereby detecting, diagnosing, or even predicting cardiovascular events.

[0056] In some embodiments, the monitoring system 307 may include any computing device that may compute, classify, process, transmit, receive, retrieve, generate, switch, store, display, manifest, detect, record, reproduce, dispose of, or use any form of data received by any pressure transducer 106-1, 106-2, etc. within the Figure 3 system shown. In some embodiments, during operation, the monitoring system 307 may receive hemodynamic data received at each of the pressure transducers wirelessly or via a wired connection in order to display the data to a healthcare professional. In some embodiments, the monitoring system 307 may include certain artificial intelligence (AI) algorithms that may evaluate the pressure waveform to detect pressure signals that may indicate symptoms within the patient's vascular anatomy. In some embodiments, these symptoms that may be detected by a hardware processor within the monitoring system 307 via the execution of the AI algorithm may include, for example, loss of patency, the presence of leaks within the catheter system 100 or other fluid channels, the formation of blood clots, etc. Other detectable symptoms may include symptoms during certain procedural steps, such as tubing and device flushing, tubing and device aspiration, connection / disconnection of certain devices, and other hardware symptoms.

[0057] In some embodiments, the execution of the AI algorithm may be accomplished by a hardware processing device present within the monitoring system 307. This hardware processing device may include more than Figure 3Those relatively higher processing resources present within each of the pressure transducers shown. In some embodiments, the hardware processing means of the monitoring system 307 may also be operatively coupled to a radio device that receives data from each of the pressure transducers and their respective radio devices. Additionally, the hardware processing means may receive data from each of the pressure transducers via a wired connection that is operatively 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 a wired or wireless connection.

[0058] Figure 4 is a top view of a portion of a catheter system 100 in accordance with some embodiments of the present disclosure. Additionally, Figure 5 is also a top view of a catheter system 100 in accordance with some embodiments of the present disclosure. Figure 4 and Figure 5 illustrate embodiments in which the catheter 102 and the catheter hub 110 are not integrated into the remainder of the catheter system 100 such that they can be removed from the fluid chamber 104. For example, Figure 4 illustrates that the catheter assembly including the catheter 102 and the catheter hub 110 has been removed, while Figure 5 illustrates that the catheter 102 is in place and operatively and fluidly coupled to the fluid chamber 104 and the pressure transducer 106.

[0059] In some embodiments, the catheter hub 110 may include a series of threads that mate or cooperate with the threads 112. A healthcare professional may use these threads of the catheter hub 110 to screw the catheter hub 110 onto 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 a healthcare professional in an assembled state. However, in some embodiments, if and when a monitoring system or microcontroller operatively coupled to the pressure transducer 106 as described in the present disclosure detects hardware symptoms (e.g., tubing and device aspiration, connection / disconnection of certain devices, and other hardware symptoms), the healthcare professional may separate the catheter 102 from the remainder of the catheter system 100, discard the remainder of the catheter system 100, and couple a new fluid chamber 104, pressure transducer 106, and port access 108 to the catheter 102. This allows the healthcare professional to keep the catheter 102 in place, thereby reducing trauma to the patient and also reducing the likelihood of infection such as sepsis.

[0060] In some embodiments, such as Figure 4 and Figure 5As shown, the catheter system 100 may include a proximal Y adapter 409 or other suitable connector. In some embodiments, as described in the present disclosure, the proximal Y adapter 409 may be operably coupled to the catheter system 100 via an extension tube 114. In some embodiments, the proximal Y adapter 409 may provide another access point to the patient's vascular system to allow for inclusion of another pressure transducer 106 and / or provide another port for introducing a drug or other fluid into the patient's bloodstream (e.g., IV drip, etc.). This allows for the use of multiple ports to access the patient's vascular system and provides a single location at the catheter 102 where a healthcare professional can do so.

[0061] 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. Similarly, Figure 6 and Figure 7 illustrate those embodiments in which the catheter 102 and the catheter hub 110 are not integrated into the remainder of the catheter system 100. For example, Figure 6 illustrates that the catheter has been removed, while Figure 7 illustrates the catheter 102 in place and operably and fluidly coupled to the fluid chamber 104 and the pressure transducer 106 via the catheter hub 110.

[0062] In some embodiments, such as as Figure 6 and Figure 7 shown, the catheter system 100 may include a proximal Y adapter 409. The proximal Y adapter 409 may be operably coupled to the catheter system 100 via an extension tube 114, as described in the present disclosure. In some embodiments, the proximal Y adapter 409 may, in some embodiments, provide another access point to the patient's vascular system to allow for inclusion of another pressure transducer 106 and / or provide another port for introducing a drug or other fluid into the patient's bloodstream (e.g., IV drip, etc.). This allows for the use of multiple ports to access the patient's vascular system and provides a single location at the catheter 102 where a healthcare professional can do so.

[0063] In some embodiments, Figure 6 and Figure 7 the catheter system 100 shown may include a wired connection 611 for connecting the pressure transducer 106 within the fluid chamber 104 to a monitoring system ( Figure 6 and Figure 7(not shown in the figure) for electrical and communication connections. In some embodiments, the wired connection 611 can be operatively coupled to the pressure transducer 106 and / or the microcontroller (when present) to transmit the hemodynamic data detected by the pressure transducer 106 to the monitoring system. In some embodiments, the wired connection 611 can 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.

[0064] It should be understood that in some embodiments, any pressure transducer 106 (e.g., the first, second, and third pressure transducers) can be similarly operatively and electrically coupled to the monitoring system to facilitate the transmission of this data from each pressure transducer. Additionally, it should be understood that in some embodiments, any pressure transducer within the systems described in this disclosure can be wirelessly connected to the monitoring system or connected to the monitoring system via the wired connection 611 and the electrical connector 613. In some embodiments, the electrical connector 613 can be specific to the type of monitoring system used and the ports formed in the monitoring system, such that the electrical connector 613 is only electrically coupled to the correct port in the monitoring system.

[0065] Figure 8 is a top view of the catheter system 100 according to some embodiments of the present disclosure. The catheter system 100 described in this disclosure can provide predictive and / or indicative data related to the hemodynamic events of a patient by using a pressure transducer 106 formed within a fluid chamber 104 proximal to the catheter 102. The hemodynamic event data can be obtained by the pressure transducer 106 and transmitted to the monitoring system via a wireless or wired connection for viewing and use by healthcare professionals during patient treatment. Figure 8 The illustrated catheter system 100 can be similar in one or more features and / or operational aspects to Figures 1 to 7 the illustrated catheter system 100.

[0066] In some embodiments, Figure 8 the catheter system 100 in

[0067] In some embodiments, the catheter 102 may include a catheter port access 815 that is collinear with the axis of the catheter 102. Accordingly, the catheter port access 815 may permit an in-line vascular access system for arterial or venous access, monitoring, and blood sampling, as well as drug delivery, at the catheter 102 that is separate from those features provided at the port access 108.

[0068] In some embodiments, the fluid chamber 104, the pressure transducer 106, and the port access 108 may be formed as an integral unit, where the use of the catheter 102 is associated with the use of the pressure transducer 106. In some embodiments, for example, as Figure 8 shown, the distal end of the fluid chamber 104 may be fluidly coupled to the catheter 102 via a side port 819, which may be angled relative to the longitudinal axis of the catheter seat. 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 the internal pressure exerted thereon, such as by 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 is contemplated in the present disclosure, and the interfaces include those coupling means that permit selective removal of the fluid chamber 104 from the side port 819, as described in the present disclosure.

[0069] In some embodiments, the catheter 102 may be any type of device that provides access to a patient's vascular anatomy. In some embodiments, the catheter 102 may include, for example, a cannula that is inserted into the patient's anatomy to access the vascular anatomy. In some embodiments, the fluid chamber 104 coupled to the catheter 102 may be operably coupled to a stabilization platform 122. In some embodiments, the stabilization platform 122 may be used to place the fluid chamber 104 and its pressure transducer 106 onto the patient's external anatomy to stabilize the catheter system 100 relative to the patient. In some embodiments, the stabilization platform 122 may include an adhesive and / or a friction-generating surface formed on the face of the stabilization platform 122 that contacts the patient's external anatomy. During placement of the catheter system 100 into the patient's vascular anatomy, the adhesive and / or the friction-generating surface may be used to adhere the stabilization platform 122 to the patient's external anatomy and, thus, to adhere the catheter system 100 to the patient's external anatomy.

[0070] In some embodiments, the catheter 102 may include a catheter stabilizing fin 817 or a plurality of catheter stabilizing fins. The catheter stabilizing fin 817 may be used to place the catheter 102 onto an external anatomy of a patient to stabilize the catheter system 100 relative to the patient. In some embodiments, the catheter stabilizing fin 817 may include an adhesive or a friction generating surface formed on a face of the catheter stabilizing fin 817 that contacts the external anatomy of the patient. During placement of the catheter system 100 into a vascular anatomy of a patient, the adhesive or the friction generating surface may be used to adhere the catheter stabilizing fin 817 to the external anatomy of the patient and thus adhere the catheter system 100 to the external anatomy of the patient.

[0071] In some embodiments, the pressure transducer 106 may be any type of pressure sensor that can detect hemodynamic characteristics of a 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 in fluid communication with the catheter 102 such that when the catheter 102 is inserted into the vascular anatomy of the patient, the fluid chamber 104 is also in fluid communication with the vascular anatomy of the patient via the side port 819. This allows the pressure transducer 106 to detect the patient's blood pressure in real time.

[0072] In some embodiments, the pressure transducer 106 may be operatively coupled to a microcontroller or other hardware processing device that can receive and process data obtained 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 indicative of the patient's hemodynamic characteristics, as described in the present disclosure. In some embodiments, the data obtained by the microcontroller may also be used to determine whether there are any symptoms associated with the use of the catheter system 100.

[0073] In some embodiments, when the catheter 102 is inserted into the vascular anatomy of a patient, blood may begin to flow within the fluid chamber 104 via the side port 819. However, if the catheter 102 is not properly inserted, or if any blood flow problems occur within one or more of the catheter 102, the fluid chamber 104, or the port access 108 during use, the data obtained by the pressure transducer 106 and provided to the microcontroller may be used to detect these symptoms. To notify a healthcare professional of such symptoms, the microcontroller may be operatively coupled to one or more lights (e.g., light emitting diodes or LEDs) formed within or on the fluid chamber 104 that indicate to the healthcare professional whether and when the catheter system 100 is experiencing these symptoms. In another embodiment, for example, the fluid chamber 104 or the monitoring system described in the present disclosure may include a visual indicator (e.g., an LED) or an auditory indicator that warns the healthcare professional of these symptoms.

[0074] In some embodiments, the port access 108 can 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 draw a blood sample from the patient's vascular anatomy or introduce a sensor into the patient's vascular anatomy. In some embodiments, the port access 108 can include a septumless needleless connector (NFC) for direct tubing draw or sensing device delivery.

[0075] In some embodiments, the port access 108 can be color-coded for use with either an arterial (e.g., red) or venous (e.g., blue) vascular access to indicate the type of vascular anatomy into which the catheter 102 of the catheter system 100 has been inserted. In some embodiments, the port access 108 can provide a flush capability feature for the catheter system 100 proximal to the pressure transducer 106 to flush the catheter system 100 with, for example, a saline solution. In some embodiments, because the pressure transducer 106 is offset from the fluid path within the fluid chamber 104, a healthcare professional can more easily flush the catheter system 100 without the pressure transducer 106 blocking or impeding the process.

[0076] In some embodiments, the port access 108 can include an interface that allows an instrument delivery device (such as, for example, a PIVO TM needleless blood sampling device) available from Becton, Dickinson and Company of Franklin Lakes, New Jersey to be coupled to the port access 108. In some embodiments, the catheter system 100 can include an extension tube 114. In some embodiments, as shown, for example, Figure 8 the extension tube 114 can be formed intermediate the fluid chamber 104, the pressure transducer 106, and the port access 108. In some embodiments, when the catheter 102 is inserted into the patient's vascular anatomy, the extension tube 114 can also be in fluid communication with the fluid chamber 104, the catheter 102, and the patient's vascular anatomy. In some embodiments, the extension tube 114 can include any type of low-compliance tubing that does not expand or stretch under internal pressure applied thereto, such as, for example, by the patient's blood pressure.

[0077] 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 instruments, such as a probe, a second catheter, or another suitable instrument, through the catheter system 10 and out of the catheter 102 into the patient's vascular system. In some embodiments, the another extension tube 115 may be integrated with the side port 819 and / or the fluid chamber 104.

[0078] In some embodiments, the extension tube 114 and / or the another extension tube 115 may include any type of tube clamp 116 that selectively allows or blocks the flow of the patient's blood through the extension tube 114. When needed, a healthcare professional may move the tube clamp 116 along the length of the extension tube 114. In some embodiments, the tube clamp 116 may be a roller clamp.

[0079] In some embodiments, the extension tube 114 may fluidly couple the catheter 102 and fluidly and operably couple the fluid chamber 104 and the port access 108 to the extension tube proximal port 118. In some embodiments, the extension tube proximal port 118 may be used to operably couple the catheter system 100 to, for example, a monitoring system via a proximal port connector 120. As described in the present disclosure, the pressure transducer 106 formed in the catheter system 100 may be a first pressure transducer, where Figure 8 the illustrated catheter system 100 is operably coupled to a second pressure transducer that is located at the monitoring system or proximal to the extension tube proximal port 118 and is operably coupled to another or second fluid chamber formed thereon via the proximal port connector 120. In some embodiments in which the second pressure transducer is located at the monitoring system, the second pressure transducer may be used to compare corresponding hemodynamic measurements in order to obtain a relatively more comprehensive analysis of the patient's hemodynamic status and the overall function of the patient's cardiovascular system. This may also help detect the presence of hemodynamic abnormalities in the patient, help predict potential upcoming hemodynamic events, and treat any such events before or during their occurrence.

[0080] In some embodiments, the extension tube proximal port 118 may be used to operably couple the second fluid chamber and the second pressure transducer to the catheter system 100 such that the second fluid chamber / pressure transducer may be placed at the height of the patient's heart (e.g., when the patient is sitting up). This may provide additional data on the relative blood pressure at the height of the patient's heart that indicates the position relative to the insertion site of the catheter 102 of the catheter system 100. By doing so, a healthcare professional may be warned of blood pressure events or conditions within the patient's body extremities (e.g., arms, legs, etc.), which may be relatively lower than the blood pressure at the patient's heart, in order to assist in diagnosing certain vascular conditions.

[0081] The catheter system 100, system, device, and method described in the present disclosure can reduce blood clearance problems, blood withdrawal problems, and / or blood reflux problems associated with other vascular access devices. The systems and methods described in the present disclosure can also eliminate problems associated with system flushing procedures that may occur. In some embodiments, the systems, devices, and methods described in the present disclosure can also provide direct line sampling from within the patient's vascular anatomy (e.g., venous or arterial blood withdrawal), thereby simplifying procedures, especially when the catheter 102 has already been placed within the patient's arterial anatomy. In some embodiments, the systems, devices, and methods described in the present disclosure can provide continuous pressure monitoring for predictive identification or detection of symptoms and / or procedural steps that may occur during use of the catheter system 100.

[0082] Figure 9 is a top view of a catheter system 100 according to some embodiments of the present disclosure, which is operably coupled to a vascular instrument access device 201 and a blood sampling device 203. The catheter system 100 can include Figure 8 the devices shown and described, including a catheter 102, a fluid chamber 104, a pressure transducer 106, a port inlet 108, a catheter port inlet 815, catheter stabilizing wings 817, a side port 819, an extension tube 114, a tube clamp 116, an extension tube proximal port 118, a proximal port connector (not shown), and a stabilizing platform 122. These devices can be used in combination with the vascular instrument access device 201 and / or the blood sampling device 203 to retrieve a blood sample from the patient's vascular anatomy and / or introduce a vascular sensor into the catheter system 100, through the catheter 102, and into the patient's vascular anatomy.

[0083] In some embodiments, the vascular instrument access device 201 and / or the blood sampling device 203 can be operably coupled to the port inlet 108. The port inlet 108 can include any connection feature that allows the vascular instrument access device 201 or the blood sampling device 203 to be operably coupled to the catheter system 100 such that they are non-removable unless a healthcare professional interacts with the connector. For example, as Figure 9 shown, the vascular instrument access device 201 can be directly coupled to the port inlet 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 inlet 108. In some embodiments, the vascular instrument access device 201 can include, for example, a needleless collection device (such as, the PIVO available from Becton, Dickinson and Company of Franklin Lakes, New Jersey) TMNeedleless blood drawing device), which can be used to advance an internal flexible flow tube through the fluid chamber 104 and the catheter 102 and into the patient's vascular anatomy to achieve the blood flow most suitable for aspiration within the patient's vascular anatomy. In some embodiments, the vascular device access device 201 can be discarded after use.

[0084] In some embodiments, the distal end of the blood sampling device 203 can be operably coupled to the proximal end of the vascular device access device 201. In some embodiments, Figure 9 The illustrated blood sampling device 203 can be an arterial blood gas (ABG) syringe (such as shown in Figure 2 ), a Luer-Lok TM access device (LLAD) and vacuum tube, a diagnostic cassette, a diagnostic container, or a point-of-care (POC) dispensing device, and other devices that can receive a certain amount of blood from the patient.

[0085] As described in the present disclosure, a healthcare professional can use the vascular device access device 201 and the blood sampling device 203 to selectively access the patient's vascular anatomy, deliver the instrument / sensor device to the vascular system, better access the patient's blood flow, and draw a blood sample for ABG diagnosis or laboratory testing, where the catheter system 100 remains in place within the patient's vascular system. In some embodiments, since the vascular device access device 201 and the blood sampling device 203 are selectively coupled to the catheter system 100 via the port access 108, the healthcare professional can perform those tasks associated with the vascular device access device 201 and the blood sampling device 203 by attaching these devices to the catheter system 100 at the port access 108. The healthcare professional can then disconnect the vascular device access device 201 and the blood sampling device 203 from the catheter system 100, leaving the catheter system 100 to continue monitoring, for example, the patient's hemodynamic characteristics.

[0086] Figure 10 is a schematic diagram of the catheter system 100 and the monitoring system 307 according to some embodiments of the present disclosure. As described in the present disclosure, in some embodiments, the first pressure transducer 106-1 can be formed in the first fluid chamber at the catheter system 100. In some embodiments, the first pressure transducer 106-1 can monitor the patient's hemodynamic characteristics at the location where the catheter 102 has been inserted into the patient's vascular anatomy (e.g., the patient's arm).

[0087] For example, as Figure 10As shown, the catheter system 100 can be fluidly coupled to a second pressure transducer 106-2 formed in a second fluid chamber. In some embodiments, the second pressure transducer 106-2 and the second fluid chamber can 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 connector 120, and can be placed or connected at another location on the patient's body, such as near the patient's heart on the patient's chest. This can be done such that, for example, each of the first pressure transducer 106-1 and the second pressure transducer 106-2 can detect hemodynamic characteristics of the patient at different heights. This can provide additional data indicative of the relative blood pressure at the height of the patient's heart relative to the insertion site of the catheter 102 of the catheter system 100. By doing so, healthcare professionals can be warned of blood pressure events or conditions within the limbs (e.g., arms, legs, etc.) of the patient's body, which may be relatively lower than the blood pressure at the patient's heart, in order to assist in diagnosing certain vascular conditions.

[0088] In some embodiments, the extension tube proximal port 118 can include a tertiary or third pressure transducer (not shown), which can also detect hemodynamic characteristics of the patient's vascular system. In some embodiments, because the first pressure transducer 106-1, the second pressure transducer 106-2, and this third pressure transducer can be fluidly coupled to the patient's vascular anatomy via the catheter system 100, their relatively detected hemodynamic data can be used to detect and diagnose certain blood pressure problems present within the patient's vascular system.

[0089] According to some embodiments, Figure 10 Another hemodynamic monitoring system sensor 305 is also shown, which is operably coupled to the structural support of the monitoring system 307. In some embodiments, the hemodynamic monitoring system sensor 305 can replace the second pressure transducer 106-2 and can be similarly coupled to the structural support of the monitoring system 307 at a height similar to the height of the patient's heart. Again, this can be done in order to detect relative hemodynamic characteristics (e.g., relative blood pressure at different heights) of the patient's vascular system, thereby detecting, diagnosing, or even predicting cardiovascular events.

[0090] In some embodiments, the monitoring system 307 can include any computing device that can calculate, classify, process, transmit, receive, retrieve, generate, switch, store, display, manifest, detect, record, reproduce, dispose of, or use the data obtained from Figure 10Any form of data received by any of the pressure transducers 106-1, 106-2, etc. within the system shown. During operation, the monitoring system 307 can receive hemodynamic data received at each of the pressure transducers either wirelessly or via a wired connection in order to display the data to a healthcare professional. In some embodiments, the monitoring system 307 can include certain artificial intelligence (AI) algorithms that evaluate the pressure waveforms to detect pressure signals that can indicate a condition within the patient's vascular anatomy. These conditions that can be detected by a hardware processor within the monitoring system 307 via execution of the AI algorithms can include, for example, loss of patency, the presence of leaks or thrombus formation within the catheter system 100 or other fluid conduits, etc. Other detectable conditions can include conditions during certain procedural steps, such as tubing and device flushing, tubing and device aspiration, connection / disconnection of certain devices, and other hardware conditions.

[0091] As described in the present disclosure, in some embodiments, the execution of the AI algorithms can be accomplished by a hardware processing device present within the monitoring system 307. This hardware processing device can include relatively higher processing resources than those present within each of the microcontrollers present within each of the pressure transducers shown. In some embodiments, the hardware processing device of the monitoring system 307 can also be operably coupled to a radio device that receives data from each of the pressure transducers and their respective radio devices. In some embodiments, the hardware processing device can receive data from each of the pressure transducers via a wired connection that is operably 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 a wired or wireless connection. Figure 10 is a top view of a catheter system 100 according to some embodiments of the present disclosure.

[0092] 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. Figure 11 and Figure 12 illustrate embodiments in which the fitting inlet 1121 is formed in fluid communication with and / or proximate to the fluid chamber 104 of the catheter system 100. For example, Figure 11 illustrates that the fitting inlet 1121 can be formed intermediate the fluid chamber 104 and the port access 108, while Figure 12 illustrates that the fitting inlet 1121 can be formed distal to the fluid chamber 104.

[0093] In some embodiments, Figure 11 and Figure 12The catheter system 100 shown may include one or more of 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, such as as described in connection with Figure 8 described. In some embodiments, a fitting inlet 1121 may be positioned between the fluid chamber 104 and the port access 108 to allow fluid flushing of both the fluid chamber 104 and the catheter 102.

[0094] In some embodiments, as Figure 11 shown, for example, the fitting inlet 1121 may include a flushing angle (e.g., 15 to 165 degrees relative to the longitudinal axis of the port access 108) for proper flushing. In Figure 12 it, the fitting inlet 1121 is placed distal to the fluid chamber 104. Similarly, in this exemplary embodiment, the fitting inlet 1121 may include a flushing angle (e.g., 15 to 165 degrees relative to the longitudinal axis of the port access 108) for proper flushing. In some embodiments, by placing the fitting inlet 1121 upstream or downstream of the fluid chamber 104, the vortices generated in the fluid introduced at the fitting inlet 1121 due to the flushing angle may flush any blockages within the fitting inlet 1121 and / or the fluid chamber 104. In some embodiments, blood may accumulate and clot at certain locations within the fluid chamber 104, the catheter 102, or any other fluid passage within the catheter system 100. In some embodiments, the placement of the fitting inlet 1121 may be selected based on the locations where these blood clots or other blockages may form during the use of the catheter system 100.

[0095] Figure 13 is a top view of a catheter system 100 according to some embodiments of the present disclosure. Additionally, Figure 14 is a top view of a catheter system 100 according to some embodiments of the present disclosure. Figure 13 and Figure 14 illustrate embodiments in which the fitting inlet 1121 is formed in fluid communication with and / or proximal to the fluid chamber 104 of the catheter system 100. For example, Figure 13 illustrates the fitting inlet 1121 formed intermediate the fluid chamber 104 and the port access 108, while Figure 12 illustrates the fitting inlet 1121 formed proximal to the fluid chamber 104.

[0096] In some embodiments, such as as Figure 13 and Figure 14 shown, the catheter system 100 may further include a fitting inlet 1121 that is positioned distal to the fluid chamber 104 or intermediate between the fluid chamber 104 and the port access 108. For example, in Figure 13In [the description], the fitting inlet 1121 may be positioned between the fluid chamber 104 and the port inlet 108 to allow for fluid flushing of the fluid chamber 104 housing the pressure transducer 106 as well as the catheter 102 and the catheter housing. In this exemplary embodiment, the fitting inlet 1121 may include a flushing angle (e.g., 15 to 165 degrees relative to the longitudinal axis of the port inlet 108) to effect proper flushing. In Figure 14 [the description], the fitting inlet 1121 may be placed distal to the fluid chamber 104. Similarly, in this exemplary embodiment, the fitting inlet 1121 may include a flushing angle (e.g., 15 to 165 degrees relative to the longitudinal axis of the port inlet 108) to effect proper flushing. In some embodiments, by placing the fitting inlet 1121 upstream or downstream of the fluid chamber 104, the vortices generated in the fluid introduced at the fitting inlet 1121 due to the flushing angle may flush any blockages, particularly those included at the junctions. In some embodiments, blood may accumulate and coagulate at certain locations within the fluid chamber 104, the catheter 102, or any other fluid channels within the catheter system 100. In some embodiments, the placement of the fitting inlet 1121 may be selected based on the locations where these blood clots or other blockages may form during the use of the catheter system 100.

[0097] In some embodiments, for example Figure 13 and Figure 14 the catheter system 100 as shown may include a wired connection 611 for electrically and communicatively coupling the pressure transducer 106 within the fluid chamber 104 to a monitoring system ( Figure 13 and Figure 14 not shown in [the description]). The wired connection 611 may be operatively coupled to the pressure transducer 106 and / or a microcontroller (when 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 that allows the wired connection 611 to be coupled to the monitoring system via a port formed in the monitoring system. It should be understood that in some embodiments, any pressure transducer 106 (e.g., first, second, third pressure transducers) may similarly be operatively and electrically coupled to the monitoring system as necessary to facilitate transmission of this data from each pressure transducer.

[0098] Furthermore, it should be understood that in some embodiments, any pressure transducer within the systems described in the present disclosure may be wirelessly connected to the monitoring system, or connected to the monitoring system via the wired connection 611 and the electrical connector 613. In some embodiments, the electrical connector 613 may be specific to the type of monitoring system used and the port formed in the monitoring system such that the electrical connector 613 is only electrically coupled to the correct port in the monitoring system.

[0099] Figure 15 is a cross-sectional view of a part of a catheter system 100 according to some embodiments of the present disclosure. In some embodiments, the fitting inlet 1121 may be located midway between the fluid chamber 104 and the port inlet 108. In some embodiments, the catheter seat 110 may be operatively and fluidly coupled to a side port (e.g., see the side port 819 shown in Figure 8 ). In some embodiments, the interface at the distal end of the fluid chamber 104 may include a catheter seat 110 having a thread for operatively coupling a catheter ( Figure 15 not shown) to the fluid chamber 104 (e.g., as shown in Figure 1 ).

[0100] Figure 15 shows that the fitting inlet 1121 may be at an angle relative to the fluid axis formed within the fluid chamber 104 and the port inlet 108. This angle is referred to in the present disclosure as the flushing angle 1523, which may be set between 15 and 165 degrees relative to the longitudinal axis of the port inlet 108 to allow for proper flushing of the fluid chamber 104, the catheter, or any other fluid passage within a particular catheter system.

[0101] In some embodiments, the fluid chamber 104 is operatively coupled to a stabilization platform 122. Similarly, in some embodiments, the stabilization platform 122 may be used to place the fluid chamber 104 and its pressure transducer 106 onto an external anatomy of a patient to stabilize the catheter system 100 relative to the patient. In some embodiments, the stabilization platform 122 may house a pressure transducer circuit 1525 associated with the pressure transducer 106 and a hardware processing device (if present), such as a microcontroller. In some embodiments, the pressure transducer circuit 1525 may also include a circuit associated with a wireless transmitter. As described in the present disclosure, in some embodiments, the wireless transmitter is operatively coupled to the hardware processing device, which may be used in some embodiments of the present disclosure to wirelessly transmit hemodynamic characteristics of a patient.

[0102] All of the example and conditional language recited in the present disclosure are intended for pedagogical purposes to aid the reader in understanding the utility model and concepts contributed by the inventor to the art, and are to be construed as not being limited to such specifically recited examples and conditions. Although the embodiments of the present disclosure have been described in detail, it should be understood that various changes, substitutions, and alterations can be made without departing from the spirit and scope of the embodiments of the present disclosure.

Claims

1. A catheter system, characterized in that, The catheter system includes: A catheter assembly, the catheter assembly including a catheter hub and a catheter extending distally from the catheter hub; A fluid chamber, the fluid chamber being proximal to the catheter; A fluid path, the fluid path being located within the catheter system and extending through the catheter and the fluid chamber; A pressure transducer, the pressure transducer being in fluid communication with the fluid chamber to monitor hemodynamic characteristics of a patient; A port access inlet, the port access inlet being proximal to the pressure transducer.

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

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

4. The catheter system according to claim 3, wherein, The catheter system further includes a vascular instrument access device, the vascular instrument access device being operatively coupled to the port access inlet to provide access to a vascular instrument through the port access inlet.

5. The catheter system according to claim 3, wherein, The catheter system further includes an extension tube, the extension tube being disposed directly between the fluid chamber and the port access inlet, wherein the port access inlet is aligned with the longitudinal axis of the catheter hub.

6. The catheter system according to claim 5, characterized in that, The catheter system further includes: A second pressure transducer, the second pressure transducer being in fluid communication with the extension tube, the second pressure transducer being configured to be positioned at the height level of the patient's heart when the catheter is inserted into the patient's vasculature.

7. The catheter system according to claim 1, wherein The pressure transducer is operatively coupled to a hardware processing device, the hardware processing device receiving pressure sensor data from the pressure transducer and converting the pressure sensor data into a pressure sensor value associated with hemodynamic characteristics, the catheter system further including a wireless transmitter, the wireless transmitter being operatively coupled to the hardware processing device to wirelessly transmit the hemodynamic characteristics of the patient.

8. The catheter system according to claim 1, characterized in that, The catheter system further includes: A wired connection, the wired connection being operatively coupled to the pressure transducer to operatively couple the pressure transducer to a monitoring system to transmit the pressure sensor value from the pressure transducer to the monitoring system.

9. The catheter system according to claim 8, characterized in that, The wired connection is operatively coupled to the port access inlet.

10. The catheter system according to claim 1, wherein The catheter hub includes a distal end, a proximal end, and a side port disposed between the distal end and the proximal end, the catheter system further including: A fitting inlet port, the fitting inlet port being positioned off the axis of the pressure transducer and the port access inlet such that the fitting inlet port creates a fluid vortex at the fitting inlet port to prevent fluid stagnation within the catheter system; An extension tube, the extension tube extending from the fitting inlet port; and Another extension tube, the another extension tube extending between the side port and the fluid chamber.

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

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

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

14. The catheter system according to claim 10, wherein The catheter system further includes a vascular instrument access device, the vascular instrument access device being operatively coupled to the port access inlet to provide access to a vascular instrument through the port access inlet.

15. The catheter system according to claim 10, wherein, The catheter system further comprises: A second pressure transducer, which is in fluid communication with the extension tube and is configured to be positioned at the height level of the patient's heart when the catheter is inserted into the patient's vasculature.

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

17. The catheter system according to claim 10, wherein, The catheter system further comprises: A wired connection, which is operatively coupled to the pressure transducer to operatively couple the pressure transducer to a monitoring system, thereby transmitting the pressure sensor value from the pressure transducer to the monitoring system.

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

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

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

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