Catheter system with fluid chamber proximate to pressure transducer
By designing a fluid chamber and pressure transducer in the catheter system, a simplified process for simultaneously monitoring blood pressure and collecting blood was achieved, solving the problems of high blood exposure risk and resource consumption in existing technologies, and improving the efficiency and accuracy of monitoring and collection.
Patent Information
- Application Number
- CN202480046547.7
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Priority Date
- 2023-07-13
- Filing Date
- 2024-05-30
- Publication Date
- 2026-02-06
AI Technical Summary
Existing arterial catheter devices and systems have problems such as blood exposure risk, difficulty in accurate placement, complex and resource-intensive monitoring and data collection, and high risk of infection. They also require a lot of time and resources for tubing maintenance and flushing.
A catheter system was designed, including a catheter, a fluid chamber, a pressure transducer, and a port inlet, which allows for simultaneous monitoring of blood pressure and blood collection. It enables real-time monitoring and data transmission of hemodynamic characteristics through a fluid path and a wireless transmitter, and simplifies blood sampling and device delivery through a port inlet that is off-axis of the catheter.
It reduces the risk of blood exposure, simplifies the hemodynamic monitoring and collection process, lowers the risk of infection, improves the accuracy and efficiency of monitoring, and reduces resource consumption.
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Figure CN121487684A_ABST
Abstract
Description
Background Technology
[0001] Arterial catheters and systems provide healthcare professionals with a method to monitor patients' arterial hemodynamic parameters and a means to collect data related to patients' hemodynamic characteristics and features, including, for example, blood pressure, pulse contour, and arterial blood gases. These hemodynamic characteristics can be used to determine the immediate identification of abnormal hemodynamic events and the initiation of appropriate treatment. Arterial catheters can also be used to provide blood gas analysis samples without bringing certain symptoms and pathologies associated with repeated arterial punctures.
[0002] However, current arterial catheter devices, systems, and methods present significant risks of blood exposure and other performance issues, such as accurate catheter placement. Furthermore, current hemodynamic monitoring and ABG collection systems can be complex, expensive, and require substantial time and resources to collect the necessary samples. Additionally, significant time and resources may be needed to maintain the arterial line in order to minimize the risk of symptoms such as infection and catheter-related bloodstream infection (CRBSI). Moreover, other procedures associated with currently implemented arterial catheters may require substantial time and resources to ensure proper flushing of the tubing and devices and preservation of arterial blood.
[0003] The subject matter claimed in this disclosure is not limited to embodiments that address any drawbacks or operate only in environments such as those described herein. Rather, this background is provided to describe the environments in which the embodiments currently described can operate. Summary of the Invention
[0004] This disclosure generally relates to a catheter system for detecting hemodynamic characteristics of a patient, and related apparatus and methods. 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 a 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.
[0005] 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 path within the catheter system, and the fluid path extends through the catheter and the fluid chamber. In some embodiments, the catheter system may include a pressure transducer in fluid communication with the fluid chamber to monitor the patient's hemodynamic characteristics.
[0006] In some embodiments, a pressure transducer may be located near the fluid chamber and the fluid path through the fluid chamber. In some embodiments, the pressure transducer may be aligned with the fluid chamber such that the pressure transducer and the fluid chamber are at the same distance from the catheter system and / or another component of the catheter. In some embodiments, the catheter hub may include a distal and a proximal end. In some embodiments, the fluid chamber may be coupled to the proximal end of the catheter hub. In some embodiments, a vascular device access device is operatively coupled to a port access port to provide vascular device access through the port access port.
[0007] In some embodiments, the catheter system may include an extension tube disposed directly between the fluid chamber and the port inlet. In some embodiments, the port inlet may be aligned with the longitudinal axis of the catheter hub. In some embodiments, the catheter system may include a second pressure transducer in fluid communication with the extension tube. In some embodiments, the second 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.
[0008] In some embodiments, a pressure transducer is operatively 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 pressure sensor values associated with hemodynamic characteristics. The catheter system also includes a wireless transmitter operatively coupled to the hardware processing device to wirelessly transmit the patient's hemodynamic characteristics.
[0009] In some embodiments, the conduit system may include a wired connection operatively coupled to a pressure transducer to operatively connect the pressure transducer to a monitoring system, thereby transmitting pressure sensor values from the pressure transducer to the monitoring system. In some embodiments, the wired connection may be operatively coupled to a port inlet.
[0010] In some embodiments, the conduit hub may include a distal end, a proximal end, and a side port disposed between the distal end and the proximal end. In some embodiments, the conduit system may include a fitting inlet port positioned off-axis from the longitudinal axis of the pressure transducer and port inlet, such that fluid eddies are generated at the fitting inlet port to prevent fluid stagnation within the conduit system.
[0011] In some embodiments, the conduit system may include an extension tube extending from the fitting inlet port. In some embodiments, the conduit 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 original extension tube. In some embodiments, the fitting inlet port may be proximal to the pressure transducer and distal to the port inlet. In some embodiments, the fitting inlet port may be proximal to the other extension tube and distal to the pressure transducer and the port inlet.
[0012] 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.
[0013] It should be understood that the above overview and the following detailed description are merely illustrative and explanatory, and do not limit the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description should not be considered limiting. Attached Figure Description
[0014] Exemplary embodiments will be described and explained using additional features and details in the accompanying drawings, in which:
[0015] Figure 1 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0016] Figure 2 This is a top view of a catheter system according to some embodiments of the present disclosure, the catheter system being operatively connected to a vascular device access device and a blood sampling device;
[0017] Figure 3 These are schematic diagrams of catheter systems and monitoring systems according to some embodiments of this disclosure;
[0018] Figure 4 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0019] Figure 5 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0020] Figure 6 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0021] Figure 7 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0022] Figure 8 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0023] Figure 9 This 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;
[0024] Figure 10 These are schematic diagrams of catheter systems and monitoring systems according to some embodiments of this disclosure;
[0025] Figure 11 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0026] Figure 12 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0027] Figure 13 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0028] Figure 14 This is a top view of a catheter system according to some embodiments of the present disclosure;
[0029] Figure 15 This is a cross-sectional view of a catheter system according to some embodiments of the present disclosure. Detailed Implementation
[0030] Figure 1 This is a top view of a 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 hemodynamic events in a patient by using a pressure transducer 106 formed within a fluid chamber 104 proximal to the catheter 102. This 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.
[0031] The catheter system 100 may include a port inlet 108 located proximal to the fluid chamber 104 and 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 inlet 108 allows healthcare professionals to perform blood sampling and / or device delivery of intravascular sensing probes via the port inlet 108, thereby eliminating the need for a relatively more complex system for simultaneously monitoring a patient's hemodynamic characteristics and providing blood sampling / device delivery.
[0032] In some embodiments, the catheter 102, fluid chamber 104, pressure transducer 106, and port inlet 108 may be integrally formed, wherein the use of the catheter 102 is associated with the use of the pressure transducer 106. In another embodiment, the catheter 102 may include a catheter seat 110 that operatively connects the catheter 102 to the fluid chamber 104, pressure transducer 106, and port inlet 108. In some embodiments, the catheter seat threads may engage additional threads 112 formed on the fluid chamber 104. This may allow healthcare professionals to selectively connect and disconnect the fluid chamber 104 from the catheter 102 if desired. In some embodiments, the catheter may include one or more openings formed through the wall of the catheter 102, which may be used to provide the ability to continuously measure hemodynamic pressure while the port inlet 108 is used to draw blood or to introduce sensors through the fluid chamber 104 and the catheter 102 into the patient's vascular anatomy.
[0033] 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 may include, for example, a tubular cannula that is inserted into the patient's anatomy to provide access to the vascular anatomy. In some embodiments, catheter 102 may be rigid to provide access to an artery. In some embodiments, catheter 102 may be similar to the ACCUCATH ACE manufactured by Becton, Dickinson and Company of Franklin Lakes, New Jersey. TM Or BD INSYTE TM AUTOGUARD TM Shield IV conduit. It should be understood that in some embodiments, other types of conduits 102 may be used and are operatively coupled to the fluid chamber 104 and / or pressure transducer 106 described in this disclosure, and the use of these other types of conduits 102 is contemplated in this disclosure.
[0034] In some embodiments, the fluid chamber 104 may be operatively coupled to a stabilizing platform 122. The stabilizing platform 122 may be used to position 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 stabilizing platform 122 may include an adhesive and / or friction-generating surface formed on the surface of the stabilizing platform 122 that contacts the patient's external anatomy. This adhesive and / or friction-generating surface may be used to adhere the stabilizing platform 122 to the patient's external anatomy, and thus to the catheter system 100, during placement of the catheter system 100 into the patient's vascular anatomy.
[0035] In some embodiments, the pressure transducer 106 can be any type of pressure sensor capable of detecting the hemodynamic properties of a patient's blood. These hemodynamic properties may include, for example, the patient's blood pressure. Therefore, 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 patient's vascular anatomy, the fluid chamber 104 is also in fluid communication with the patient's vascular anatomy. This allows the pressure transducer 106 to detect the patient's blood pressure in real time.
[0036] 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 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 indicative of the patient's hemodynamic characteristics. Furthermore, the data acquired by the microcontroller may also be used to determine the presence of symptoms associated with the use of the catheter system 100.
[0037] For example, when catheter 102 is inserted into a patient's vascular anatomy, blood may begin to flow within fluid chamber 104. However, if catheter 102 is not properly inserted, or if any blood flow problems occur during use within one or more of catheter 102, fluid chamber 104, or port access 108, data acquired by pressure transducer 106 and provided to the microcontroller can be used to detect these symptoms. To notify healthcare professionals 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 fluid chamber 104, which would alert the healthcare professional when catheter system 100 is experiencing these symptoms. In some embodiments, fluid chamber 104 or monitoring system described in this disclosure may include visual indicators (e.g., LEDs) or auditory indicators that alert healthcare professionals to these symptoms.
[0038] In some embodiments, port access 108 may include any type of access device that allows healthcare professionals to selectively insert needles, sensors, or any other type of device into fluid chamber 104 and catheter 102. In some embodiments, port access 108 may facilitate the extraction of blood samples from a patient's vascular anatomy and / or the introduction of sensors into a patient's vascular anatomy. In some embodiments, port access 108 may include a diaphragm needleless connector (NFC) for direct tubing extraction or sensing device delivery. In some embodiments, 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 anatomy into which catheter 102 of catheter system 100 has been inserted.
[0039] In some embodiments, port inlet 108 may provide flushing capability features to the catheter system 100 proximal to pressure transducer 106 to flush the catheter system 100 with, for example, a saline solution. In some embodiments, because pressure transducer 106 is offset from the fluid path within fluid chamber 104 and catheter 102, healthcare professionals can more easily flush the catheter system 100 without the pressure transducer 106 obstructing or hindering the process.
[0040] In some embodiments, port access 108 may include an interface that allows instrument delivery devices (such as PIVO, available from Becton, Dickinson and Company) to deliver instruments. TM A needle-free blood collection device is coupled to port inlet 108. In some embodiments, port inlet 108 may include a female lug. In some embodiments, port inlet 108 may include a tubular inlet that includes flushing features for flushing the catheter system 100. In some embodiments, the tubular inlet may include a flushing angle (e.g., 15 to 165 degrees relative to the longitudinal axis of port inlet 108) to allow for proper flushing.
[0041] In some embodiments, the conduit system 100 may include an extension tube 114. In some embodiments, such as... Figure 1As shown, an extension tube 114 is formed between the fluid chamber 104 / pressure transducer 106 and the port inlet 108. The extension tube 114 is also 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 fitting that does not expand or stretch under internal pressure applied thereto, such as the patient's blood pressure. In some embodiments, the extension tube 114 may include any type of clamp 116 that selectively allows or prevents the flow of blood from the patient through the extension tube 114. When needed, a healthcare professional may allow the clamp 116 to move along the length of the extension tube 114. In some embodiments, the clamp 116 may be a roller clamp.
[0042] In some embodiments, the extension tube 114 can operatively connect the conduit 102, the fluid chamber 104, and the port inlet 108 to the proximal port 118 of the extension tube. In some embodiments, the proximal port 118 of the extension tube can be used to operatively connect the conduit system 100 to, for example, a monitoring system via a proximal port connector 120. As described in this disclosure, in some embodiments, the pressure transducer 106 formed in the conduit system 100 can be a first pressure transducer, wherein... Figure 1 The illustrated conduit system 100 is operatively coupled to a second pressure transducer, which may be located at the monitoring system or formed in another or a second fluid chamber proximal to the proximal port 118 of the extension tube. In some embodiments, the second pressure transducer may be operatively coupled to the proximal port 118 of the extension tube via a proximal port connector 120.
[0043] In some embodiments where the second pressure transducer is located at the monitoring system, the second pressure transducer can be used to compare hemodynamic measurements with those of the first pressure transducer for a more comprehensive analysis of the patient's hemodynamic status and overall cardiovascular function. This can also help detect the presence of hemodynamic abnormalities in the patient, aid in predicting potential impending hemodynamic events, and allow for treatment before or during any such events. Similarly, the proximal port 118 of the extension tube can be used to operatively connect the second fluid chamber and the second pressure transducer to the catheter system 100, allowing the second fluid chamber / second pressure transducer to be positioned at the height of the patient's heart (e.g., when the patient is sitting up). This can provide additional data indicating 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 alerted to blood pressure events or conditions in the patient's extremities (e.g., arms, legs, etc.) that may be relatively lower than the blood pressure at the patient's heart, thus aiding in the diagnosis of certain vascular conditions.
[0044] In some embodiments, the proximal port 118 of the extension tube may include a single port used by healthcare professionals to access a patient's vascular anatomy. The 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 proximal port 118 is a single port, conventional arterial tubing systems may be connected to the proximal port 118 for temporary blood aspiration, fluid delivery, and / or blood sampling. In some embodiments, the proximal port 118 may include a female Luer element.
[0045] In some embodiments, the proximal port 118 of the extension tube may include a dual-port connection used by healthcare professionals to access a 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-adapter or a T-adapter. In some embodiments, the proximal port 118 of the dual-port extension tube may include one or more flushing capability features to facilitate blood aspiration using a blood aspiration port corresponding to one of the dual ports.
[0046] In some embodiments, the catheter system 100, apparatus, and methods described herein can reduce blood clearance problems, blood aspiration problems, and blood backflow problems that may be associated with other vascular access devices. The systems, apparatus, and methods described herein can also reduce problems associated with system flushing procedures. The systems, apparatus, and methods described herein can provide direct tubing aspiration sampling (e.g., venous or arterial blood aspiration) from within the patient's vascular anatomy, thereby simplifying procedures, especially when the catheter 102 has already been placed within the patient's arterial anatomy. In some embodiments, the systems, apparatus, and methods described herein provide continuous pressure monitoring for the predictive identification or detection of symptoms and / or procedural steps that may occur during use of the catheter system 100.
[0047] Figure 2 This is a top view of a catheter system 100 according to some embodiments of the present disclosure, which is operatively connected to a vascular device access device 201 and a blood sampling device 203. Figure 2 The catheter system 100 shown may include Figure 1The illustrated and described similar devices include a catheter 102, a fluid chamber 104, a pressure transducer 106, a port inlet 108, a catheter seat 110, a thread 112, an extension tube 114, a tube clamp 116, a proximal port 118 of the extension tube, a proximal port connector (not shown), and a stabilizing platform 122. These devices can be used in conjunction with a vascular device access device 201 and / or a blood sampling device 203 to retrieve blood samples from a patient's vascular anatomy and / or to introduce vascular sensors into the catheter system 100, through the catheter 102, and into the patient's vascular anatomy.
[0048] In some embodiments, the vascular device access device 201 and / or the blood sampling device 203 may be operatively coupled to the port access point 108. In some embodiments, the port access point 108 may include any connection features that allow the vascular device access device 201 or the blood sampling device 203 to be operatively coupled to the catheter system 100, such that they are non-removable unless a healthcare professional interacts with the connection. Figure 2 In the example shown, the vascular device access device 201 is directly coupled to the port inlet 108 via a clamp or other connection system that secures the distal end of the vascular device access device 201 to the proximal end of the port inlet 108. The vascular device access device 201 may include, for example, a needleless acquisition device (such as a PIVO, available from Becton, Dickinson and Company). TM A needleless blood aspiration device is provided, which can be used to advance an internal flexible flow tube through a fluid chamber 104 and a catheter 102 into the patient's vascular anatomy to achieve optimal blood flow for aspiration within the patient's vascular anatomy. In some embodiments, the vascular device access device 201 can be discarded after use.
[0049] In some embodiments, the distal end of the blood sampling device 203 may be operatively coupled to the proximal end of the vascular device access device 201. The blood sampling device may be an arterial blood gas (ABG) injector (e.g., in... Figure 2 (as shown in the image) Luer-Lok TM Access devices (LLADs) and vacuum tubes, diagnostic kits, diagnostic containers, or point-of-care (POC) dispensing devices, as well as other devices that can receive a certain amount of blood from a patient.
[0050] As described in this disclosure, healthcare professionals can use the vascular device access device 201 and blood sampling device 203 to selectively access a patient's vascular anatomy, deliver device / sensor devices to the vascular system, better access the patient's blood flow, and extract blood samples for ABG diagnostics, wherein the catheter system 100 remains in place within the patient's vascular system. In some embodiments, because the vascular device access device 201 and blood sampling device 203 are selectively coupled to the catheter system 100 via port access 108, healthcare professionals can perform those tasks associated with the vascular device access device 201 and blood sampling device 203 by attaching these devices to the catheter system 100 at port access 108. Healthcare professionals can then disconnect the vascular device access device 201 and 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.
[0051] Figure 3 This 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 may be formed in 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, such as... Figure 3 As shown, the conduit system 100 can be fluidly connected to the second pressure transducer 106-2 formed in the second fluid chamber.
[0052] In some embodiments, the second pressure transducer 106-2 and the second fluid chamber may be fluidly coupled to the catheter system 100 via one or more of the extension tube 114, the proximal port 118 of the extension tube, and the proximal port connector 120. In some embodiments, the second pressure transducer 106-2 may be placed or connected to another location on the patient's body, such as on the patient's chest near the patient's heart. 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 indicating relative blood pressure at the patient's heart height relative to the insertion site of the catheter 102 of the catheter system 100. By doing so, healthcare professionals can be alerted to blood pressure events or conditions in the patient's limbs (e.g., arms, legs, etc.) that may be relatively lower than the blood pressure at the patient's heart, in order to aid in the diagnosis of certain vascular conditions.
[0053] In some embodiments, the proximal port 118 of the extension tube may include a third or tertiary 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 can be fluidly coupled to the patient's vascular anatomy via the catheter system 100, the relative detection of their hemodynamic data can be used to detect and diagnose certain blood pressure problems within the patient's vascular system.
[0054] According to some embodiments, Figure 3 Another hemodynamic monitoring system sensor 305 is also shown, operatively coupled to the structural support of monitoring system 307. In some embodiments, hemodynamic monitoring system sensor 305 may replace the second pressure transducer 106-2 and may similarly be coupled to the structural support of 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 heights) to detect, diagnose, or even predict cardiovascular events.
[0055] In some embodiments, the monitoring system 307 may include any computing device capable of calculating, classifying, processing, transmitting, receiving, retrieving, generating, switching, storing, displaying, exhibiting, detecting, recording, reproducing, disposing of, or using data generated by the system. Figure 3 Data of any form received by any pressure transducer 106-1, 106-2, etc., within the system shown. In some embodiments, during operation, monitoring system 307 may wirelessly or via a wired connection receive hemodynamic data received at each pressure transducer for display to healthcare professionals. In some embodiments, monitoring system 307 may include certain artificial intelligence (AI) algorithms that can evaluate pressure waveforms to detect pressure signals that may indicate symptoms within a patient's vascular anatomy. In some embodiments, these symptoms that may be detected by the hardware processor in monitoring system 307 by executing AI algorithms may include, for example, loss of patency, permeation within catheter system 100 or other fluid channels, thrombosis, etc. Other detectable symptoms may include symptoms during certain procedural steps, such as flushing of tubing and devices, aspiration of tubing and devices, connection / disconnection of certain devices, and other hardware symptoms.
[0056] In some embodiments, the execution of the AI algorithm can be performed by a hardware processing device present within the monitoring system 307. This hardware processing device may include... Figure 3The microcontrollers present within each pressure transducer illustrate relatively high processing resources. In some embodiments, the hardware processing unit of the monitoring system 307 may also be operatively coupled to a wireless device that receives data from each pressure transducer and their respective wireless devices. Furthermore, the hardware processing unit may receive data from each pressure transducer via a wired connection operatively coupled to an input port formed on the monitoring system 307. This allows the monitoring system 307 to receive data from each pressure transducer via either a wired or wireless connection.
[0057] Figure 4 This is a top view of a portion of a catheter system 100 according to some embodiments of the present disclosure. Furthermore, Figure 5 This is also a top view of a catheter system 100 according to some embodiments of the present disclosure. Figure 4 and Figure 5 An embodiment is shown in which catheter 102 and catheter seat 110 are not integrated into the rest of the catheter system 100 so that they can be removed from the fluid chamber 104. For example, Figure 4 The catheter assembly, including catheter 102 and catheter hub 110, has been removed, while Figure 5 The conduit 102 is shown in place and operatively and fluidly connected to the fluid chamber 104 and the pressure transducer 106.
[0058] In some embodiments, the catheter hub 110 may include a series of threads that abut or mate with thread 112. Healthcare professionals can use these threads to screw the catheter hub 110 onto the body of the fluid chamber 104 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 herein detects hardware symptoms (e.g., tubing and device aspiration, connection / disconnection of certain devices, and other hardware symptoms), the healthcare professional may detach the catheter 102 from the rest of the catheter system 100, discard the rest of the catheter system 100, and attach a new fluid chamber 104, pressure transducer 106, and port inlet 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 infections such as sepsis.
[0059] In some embodiments, such as Figure 4 and Figure 5As shown, the catheter system 100 may include a proximal Y-adaptor 409 or other suitable connector. In some embodiments, as described in this disclosure, the proximal Y-adaptor 409 may be operatively coupled to the catheter system 100 via an extension tube 114. In some embodiments, the proximal Y-adaptor 409 may provide another access point to the patient's vascular system to allow for the inclusion of another pressure transducer 106 and / or to provide another port for introducing medications or other fluids into the patient's bloodstream (e.g., IV drips, etc.). This allows for the use of multiple ports to access the patient's vascular system and provides a single location at catheter 102 where a healthcare professional accesses the patient's vascular system.
[0060] Figure 6 This is a top view of a catheter system 100 according to some embodiments of the present disclosure. Figure 7 This is also a top view of a catheter system 100 according to some embodiments of this disclosure. Similarly, Figure 6 and Figure 7 Examples are shown in which catheter 102 and catheter hub 110 are not integrated into the rest of the catheter system 100. For example, Figure 6 It shows that the catheter has been removed, and Figure 7 The diagram shows the conduit 102 in place and operatively and fluidly connected to the fluid chamber 104 and the pressure transducer 106 via the conduit seat 110.
[0061] In some embodiments, such as Figure 6 and Figure 7 As shown, the catheter system 100 may include a proximal Y-adaptor 409. The proximal Y-adaptor 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-adaptor 409 may provide another access point to the patient's vascular system to allow for the inclusion of another pressure transducer 106 and / or to provide another port for introducing medications or other fluids into the patient's bloodstream (e.g., IV drips, etc.). This allows for the use of multiple ports to access the patient's vascular system, and provides a single location at catheter 102 where a healthcare professional can do so.
[0062] In some embodiments, Figure 6 and Figure 7 The illustrated conduit system 100 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 7Electrical and communication connections are established between the wired connection 611 and a pressure transducer 106 (not shown). In some embodiments, the wired connection 611 may be operatively 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 that allows the wired connection 611 to be coupled to the monitoring system via a port formed in the monitoring system.
[0063] It should be understood that, in some embodiments, any pressure transducer 106 (e.g., first, second, and third pressure transducers) can be similarly operatively and electrically coupled to the monitoring system to facilitate the transmission of the data from each pressure transducer. Furthermore, it should be understood that, in some embodiments, any pressure transducer within the system described in this disclosure can be wirelessly connected to the monitoring system or connected to the monitoring system via a wired connection 611 and an 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 electrically coupled only to the correct ports in the monitoring system.
[0064] Figure 8 This is a top view of a 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 hemodynamic events in a patient by using a pressure transducer 106 formed within a fluid chamber 104 proximal to the catheter 102. This 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. Figure 8 The catheter system 100 shown may be similar in one or more features and / or operations to Figures 1 to 7 The catheter system 100 shown.
[0065] In some embodiments, Figure 8 The catheter system 100 may include a port inlet 108 located proximal to the fluid chamber 104 and 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 inlet 108 allows healthcare professionals to perform blood sampling and / or device delivery of intravascular sensing probes via the port inlet 108, thereby reducing or eliminating the need for the relatively more complex systems required for simultaneously monitoring a patient's hemodynamic characteristics and providing blood sampling / device delivery.
[0066] In some embodiments, catheter 102 may include catheter port inlet 815, which is collinear with the axis of catheter 102. Thus, catheter port inlet 815 may allow for an inline vascular access system at catheter 102 for arterial or venous access, monitoring and blood sampling, and drug delivery, which is separate from those features provided at port inlet 108.
[0067] In some embodiments, the fluid chamber 104, pressure transducer 106, and port inlet 108 can be formed as a single unit, wherein the use of conduit 102 is associated with the use of pressure transducer 106. In some embodiments, such as... Figure 8 As shown, the distal end of the fluid chamber 104 can be fluidly coupled to the catheter 102 via a side port 819, which may be angled relative to the longitudinal axis of the catheter hub. The side port 819 may be formed between the catheter 102 and the catheter port inlet 815 and can 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 fitting that will not expand or stretch under internal pressure applied thereto, such as by a 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 this disclosure, and the interface includes those coupling means that allow the fluid chamber 104 to be selectively removed from the side port 819, as described in this disclosure.
[0068] In some embodiments, catheter 102 can be any type of device providing access to a patient's vascular anatomy. In some embodiments, catheter 102 may include, for example, a cannula inserted into the patient's anatomy for access to the vascular anatomy. In some embodiments, a fluid chamber 104 coupled to catheter 102 may be operatively coupled to stabilizing platform 122. In some embodiments, stabilizing platform 122 may be used to position fluid chamber 104 and its pressure transducer 106 onto the patient's external anatomy to stabilize catheter system 100 relative to the patient. In some embodiments, stabilizing platform 122 may include an adhesive and / or friction-generating surface formed on the surface of stabilizing platform 122 that contacts the patient's external anatomy. During placement of catheter system 100 into the patient's vascular anatomy, the adhesive and / or friction-generating surface may be used to adhere stabilizing platform 122 to the patient's external anatomy, and thus to catheter system 100.
[0069] In some embodiments, catheter 102 may include catheter stabilizing wings 817 or more. Catheter stabilizing wings 817 may be used to place catheter 102 onto a patient's external anatomy to stabilize catheter system 100 relative to the patient. In some embodiments, catheter stabilizing wings 817 may include an adhesive or friction-generating surface formed on the surface of catheter stabilizing wings 817 that contacts the patient's external anatomy. During placement of catheter system 100 into the patient's vascular anatomy, this adhesive or friction-generating surface may be used to adhere catheter stabilizing wings 817 to the patient's external anatomy, and thus to catheter system 100.
[0070] In some embodiments, the pressure transducer 106 can be any type of pressure sensor capable of detecting the hemodynamic properties of a patient's blood. These hemodynamic properties may include, for example, the patient's blood pressure and pulse rate. Therefore, 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 patient's vascular anatomy, the fluid chamber 104 is also in fluid communication with the patient's vascular anatomy via a side port 819. This allows the pressure transducer 106 to detect the patient's blood pressure in real time.
[0071] 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 acquired by the pressure transducer 106. Processing of the data from the pressure transducer 106 may, for example, determine a patient's real-time blood pressure or provide other data indicative of 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 the presence of symptoms associated with the use of the catheter system 100.
[0072] In some embodiments, when catheter 102 is inserted into a patient's vascular anatomy, blood may begin to flow within fluid chamber 104 via side port 819. However, if catheter 102 is not properly inserted, or if any blood flow problems occur during use within one or more of catheter 102, fluid chamber 104, or port inlet 108, data acquired by pressure transducer 106 and provided to the microcontroller can be used to detect these symptoms. To notify healthcare professionals 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 fluid chamber 104, indicating to healthcare professionals whether and when the catheter system 100 is experiencing these symptoms. In another embodiment, for example, fluid chamber 104 or monitoring system described in this disclosure may include visual indicators (e.g., LEDs) or auditory indicators that alert healthcare professionals to these symptoms.
[0073] In some embodiments, port access 108 may include any type of access device that allows healthcare professionals to selectively insert needles, sensors, or any other type of device into fluid chamber 104 and catheter 102 via side port 819 to draw blood samples from a patient's vascular anatomy or introduce sensors into a patient's vascular anatomy. In some embodiments, port access 108 may include a diaphragm needleless connector (NFC) for direct tubing aspiration or sensing device delivery.
[0074] In some embodiments, 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 catheter 102 of catheter system 100 has been inserted. In some embodiments, port access 108 may provide a flushing capability feature to catheter system 100 proximal to pressure transducer 106 to flush catheter system 100 with, for example, a saline solution. In some embodiments, because pressure transducer 106 is offset from the fluid path within fluid chamber 104, healthcare professionals can more easily flush catheter system 100 without the pressure transducer 106 obstructing or hindering the process.
[0075] In some embodiments, port access 108 may include an interface that allows the delivery of medical devices (such as PIVO, available from Becton Dickinson and Company of Franklin Lakes, New Jersey). TM A needle-free blood collection device is connected to port inlet 108. In some embodiments, catheter system 100 may include extension tube 114. In some embodiments, such as... Figure 8 As shown, extension tube 114 may be formed between fluid chamber 104, pressure transducer 106, and port inlet 108. In some embodiments, extension tube 114 may also be in fluid communication with fluid chamber 104, catheter 102, and patient's vascular anatomy when catheter 102 is inserted into the patient's vascular anatomy. In some embodiments, extension tube 114 may include any type of low-compliance fitting that does not expand or stretch under internal pressure applied thereto, such as by the patient's blood pressure.
[0076] 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 probes, second catheters, or other suitable instruments, through the catheter system 10 and out of the catheter 102 into the patient's vascular system. In some embodiments, the other extension tube 115 may be integrated with the side port 819 and / or the fluid chamber 104.
[0077] In some embodiments, extension tube 114 and / or another extension tube 115 may include any type of clamp 116 that selectively allows or prevents blood flow from the patient through extension tube 114. When needed, a healthcare professional may allow the clamp 116 to move along the length of extension tube 114. In some embodiments, the clamp 116 may be a roller clamp.
[0078] In some embodiments, extension tube 114 can fluidly connect conduit 102 to and fluidly and operatively connect fluid chamber 104 and port inlet 108 to proximal port 118 of extension tube. In some embodiments, proximal port 118 of extension tube can be used to operatively connect conduit system 100 to, for example, a monitoring system via proximal port connector 120. As described in this disclosure, pressure transducer 106 formed in conduit system 100 may be a first pressure transducer, wherein Figure 8 The catheter system 100 shown is operatively coupled to a second pressure transducer, which is located at the monitoring system or formed proximally to the proximal port 118 of the extension tube and operatively coupled thereto via a proximal port connector 120 to another or second fluid chamber. In some embodiments where the second pressure transducer is located at the monitoring system, the second pressure transducer can be used to compare corresponding hemodynamic measurements to obtain a relatively more comprehensive analysis of the patient's hemodynamic status and overall cardiovascular function. This can also help detect the presence of hemodynamic abnormalities in the patient, aid in predicting potential impending hemodynamic events, and allow for treatment before or during any such events.
[0079] In some embodiments, the proximal port 118 of the extension tube can be used to operatively connect a second fluid chamber and a second pressure transducer to the catheter system 100, such that the second fluid chamber / pressure transducer can be positioned at the height of the patient's heart (e.g., when the patient is sitting up). This can provide additional data on relative blood pressure at the height of the patient's heart, indicating the location of the insertion site of the catheter 102 relative to the catheter system 100. By doing so, healthcare professionals can be alerted to blood pressure events or conditions in the patient's limbs (e.g., arms, legs, etc.) that may be relatively lower than the blood pressure at the patient's heart, in order to aid in the diagnosis of certain vascular conditions.
[0080] The catheter system 100, systems, devices, and methods described in this disclosure can reduce blood clearance problems, blood aspiration problems, and / or blood backflow problems associated with other vascular access devices. The systems and methods described in this disclosure can also eliminate problems that may arise associated with system flushing procedures. In some embodiments, the systems, devices, and methods described in this disclosure can also provide direct tubing aspiration sampling (e.g., venous or arterial blood aspiration) from within the patient's vascular anatomy, 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 this disclosure can provide continuous pressure monitoring for the predictive identification or detection of symptoms and / or procedural steps that may occur during use of the catheter system 100.
[0081] Figure 9 This 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. The catheter system 100 may include... Figure 8 The illustrated and described similar devices include catheter 102, fluid chamber 104, pressure transducer 106, port inlet 108, catheter port inlet 815, catheter stabilizing wing 817, side port 819, extension tube 114, tube clamp 116, proximal port 118 of the extension tube, proximal port connector (not shown), and stabilizing platform 122. These devices can be used in conjunction with vascular device access device 201 and / or blood sampling device 203 to retrieve blood samples from a patient's vascular anatomy and / or to introduce vascular sensors into catheter system 100, through catheter 102, and into the patient's vascular anatomy.
[0082] In some embodiments, the vascular device access device 201 and / or the blood sampling device 203 may be operatively coupled to the port access point 108. The port access point 108 may include any connection features that allow the vascular device access device 201 or the blood sampling device 203 to be operatively coupled to the catheter system 100, such that they are non-removable unless a healthcare professional interacts with the connection. For example, such as... Figure 9 As shown, the vascular device access device 201 can be directly coupled to the port inlet 108 via a clamp or other connection system, which secures the distal end of the vascular device access device 201 to the proximal end of the port inlet 108. In some embodiments, the vascular device access device 201 may include, for example, a needleless acquisition device (such as a PIVO, available from Becton Dickinson and Company of Franklin Lakes, New Jersey). TMA needleless blood aspiration device is provided, which can be used to advance an internal flexible flow tube through a fluid chamber 104 and a catheter 102 into the patient's vascular anatomy to achieve optimal blood flow for aspiration within the patient's vascular anatomy. In some embodiments, the vascular device access device 201 can be discarded after use.
[0083] In some embodiments, the distal end of the blood sampling device 203 may be operatively coupled to the proximal end of the vascular device access device 201. In some embodiments, Figure 9 The blood sampling device 203 shown can be an arterial blood gas (ABG) injector (e.g., in... Figure 2 (as shown in the image) Luer-Lok TM Access devices (LLADs) and vacuum tubes, diagnostic kits, diagnostic containers, or point-of-care (POC) dispensing devices, as well as other devices that can receive a certain amount of blood from a patient.
[0084] As described in this 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 device / sensor devices to the vascular system, better access the patient's blood flow, and draw blood samples for ABG diagnostics or laboratory testing, wherein the catheter system 100 remains in place within the patient's vascular system. In some embodiments, because the vascular device access device 201 and the blood sampling device 203 are selectively coupled to the catheter system 100 via port access 108, healthcare professionals 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 port access 108. Healthcare professionals 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.
[0085] Figure 10 This 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 first pressure transducer 106-1 may be formed in a first fluid chamber at the catheter system 100. In some embodiments, the first pressure transducer 106-1 may 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).
[0086] For example, such 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 to another location on the patient's body, such as on the patient's chest near the patient's heart. 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. This can provide additional data indicating the relative blood pressure at the patient's heart height relative to the insertion site of the catheter 102 of the catheter system 100. By doing so, healthcare professionals can be alerted to blood pressure events or conditions in the patient's limbs (e.g., arms, legs, etc.) that may be relatively lower than the blood pressure at the patient's heart, in order to aid in the diagnosis of certain vascular conditions.
[0087] In some embodiments, the proximal port 118 of the extension tube may include a third or tertiary pressure transducer (not shown), which may 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 the third pressure transducer may be fluidly coupled to the patient's vascular anatomy via the catheter system 100, the relative detection of their hemodynamic data may be used to detect and diagnose certain blood pressure problems in the patient's vascular system.
[0088] According to some embodiments, Figure 10 Another hemodynamic monitoring system sensor 305 is also shown, operatively coupled to the structural support of monitoring system 307. In some embodiments, hemodynamic monitoring system sensor 305 may replace the second pressure transducer 106-2 and may similarly be coupled to the structural support of monitoring system 307 at a height similar to that of the patient's heart. This can also be done to detect relative hemodynamic characteristics of the patient's vascular system (e.g., relative blood pressure at different heights), thereby detecting, diagnosing, or even predicting cardiovascular events.
[0089] In some embodiments, the monitoring system 307 may include any computing device capable of calculating, classifying, processing, transmitting, receiving, retrieving, generating, switching, storing, displaying, exhibiting, detecting, recording, reproducing, disposing of, or using data generated by the system. Figure 10Data of any form received by any pressure transducer 106-1, 106-2, etc., within the system shown. During operation, monitoring system 307 can receive hemodynamic data received at each pressure transducer wirelessly or via a wired connection for display to healthcare professionals. In some embodiments, monitoring system 307 may include artificial intelligence (AI) algorithms that evaluate pressure waveforms to detect pressure signals that may indicate symptoms within a patient's vascular anatomy. These symptoms, which may be detected by the hardware processor in monitoring system 307 by executing AI algorithms, may include, for example, loss of patency, permeation or thrombosis within catheter system 100 or other fluid channels. Other detectable symptoms may include those occurring during certain procedural steps, such as flushing of tubing and devices, aspiration of tubing and devices, connection / disconnection of certain devices, and other hardware symptoms.
[0090] As described in this disclosure, in some embodiments, the execution of the AI algorithm may be performed by a hardware processing device present within the monitoring system 307. This hardware processing device may include... Figure 10 The microcontrollers present within each pressure transducer illustrate relatively high processing resources. In some embodiments, the hardware processing unit of monitoring system 307 may also be operatively coupled to a wireless device that receives data from each pressure transducer and their respective wireless devices. In some embodiments, the hardware processing unit may receive data from each pressure transducer via a wired connection operatively coupled to an input port formed on monitoring system 307. This allows monitoring system 307 to receive data from each pressure transducer via wired or wireless connections.
[0091] Figure 11 This is a top view of a catheter system 100 according to some embodiments of the present disclosure. Figure 12 This is a top view of a catheter system 100 according to some embodiments of the present disclosure. Figure 11 and Figure 12 An embodiment is shown in which the fitting inlet 1121 is formed in fluid communication with and / or near the fluid chamber 104 of the conduit system 100. For example, Figure 11 It is shown that the pipe inlet 1121 can be formed between the fluid chamber 104 and the port inlet 108, while Figure 12 It is shown that the pipe inlet 1121 can be formed on the distal side of the fluid chamber 104.
[0092] In some embodiments, Figure 11 and Figure 12The illustrated conduit system 100 may include one or more of the following: conduit 102, fluid chamber 104, pressure transducer 106, port inlet 108, extension tube 114, tube clamp 116, and proximal port 118 of the extension tube, for example, as combined Figure 8 In some embodiments, the fitting inlet 1121 may be positioned between the fluid chamber 104 and the port inlet 108 to allow fluid flushing of both the fluid chamber 104 and the conduit 102.
[0093] In some embodiments, such as Figure 11 As shown, for example, the pipe inlet 1121 may include a flushing angle (e.g., 15 to 165 degrees relative to the longitudinal axis of the port inlet 108) to allow for proper flushing. Figure 12 In this embodiment, the fitting inlet 1121 is positioned 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 facilitate proper flushing. In some embodiments, by positioning the fitting inlet 1121 upstream or downstream of the fluid chamber 104, eddies generated in the fluid introduced at the fitting inlet 1121 due to the flushing angle can flush any obstructions 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 such blood clots or other obstructions may form during use of the catheter system 100.
[0094] Figure 13 This is a top view of a catheter system 100 according to some embodiments of the present disclosure. Additionally, Figure 14 This is a top view of a catheter system 100 according to some embodiments of the present disclosure. Figure 13 and Figure 14 An embodiment is shown in which the fitting inlet 1121 is formed in fluid communication with and / or near the fluid chamber 104 of the conduit system 100. For example, Figure 13 The diagram shows a pipe inlet 1121 formed between the fluid chamber 104 and the port inlet 108, while Figure 12 The pipe inlet 1121 is shown to be formed on the proximal side of the fluid chamber 104.
[0095] In some embodiments, such as Figure 13 and Figure 14 As shown, the conduit system 100 may further include a fitting inlet 1121 located distal to the fluid chamber 104, or intermediate between the fluid chamber 104 and the port inlet 108. For example, in Figure 13In this embodiment, the fitting inlet 1121 may be positioned between the fluid chamber 104 and the port inlet 108 to allow fluid flushing of the fluid chamber 104 housing the pressure transducer 106, as well as the conduit 102 and conduit 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 facilitate proper flushing. Figure 14 In this embodiment, the fitting inlet 1121 may be located 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 facilitate proper flushing. In some embodiments, by placing the fitting inlet 1121 upstream or downstream of the fluid chamber 104, eddies generated in the fluid introduced at the fitting inlet 1121 due to the flushing angle can flush away any blockages, particularly at those junctions. 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 use of the catheter system 100.
[0096] In some embodiments, for example Figure 13 and Figure 14 The illustrated conduit system 100 may include a wired connection 611 for connecting the pressure transducer 106 within the fluid chamber 104 to a monitoring system. Figure 13 and Figure 14 Electrical and communication connections are established between the pressure transducer 106 (not shown) and a microcontroller (if present) for transmitting 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 connected 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, and third pressure transducers) may similarly be operatively and electrically connected to the monitoring system as needed to facilitate the transmission of the data from each pressure transducer.
[0097] Furthermore, it should be understood that in some embodiments, any pressure transducer within the system described in this disclosure may be wirelessly connected to the monitoring system, or connected 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 in the monitoring system, such that the electrical connector 613 is electrically coupled only to the correct ports in the monitoring system.
[0098] Figure 15 This is a cross-sectional view of a portion of a conduit system 100 according to some embodiments of the present disclosure. In some embodiments, the fitting inlet 1121 may be located between the fluid chamber 104 and the port inlet 108. In some embodiments, the conduit seat 110 may be operatively and fluidly coupled to a side port (e.g., see...). Figure 8 (Side port 819 shown). In some embodiments, the interface at the distal end of the fluid chamber 104 may include a catheter seat 110 having a design for receiving a catheter ( Figure 15 (not shown) can be operatively connected to fluid chamber 104 (e.g., like, such as) Figure 1 The thread shown.
[0099] Figure 15 The diagram shows that the fitting inlet 1121 can be angled relative to the fluid axis formed within the fluid chamber 104 and the port inlet 108. This angle, as used in this disclosure, refers to a flushing angle 1523, which can be positioned between 15 and 165 degrees relative to the longitudinal axis of the port inlet 108 to allow proper flushing of the fluid chamber 104, the conduit, or any other fluid passage within a particular conduit system.
[0100] 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 position the fluid chamber 104 and its pressure transducer 106 onto an external anatomical structure of the patient to stabilize the catheter system 100 relative to the patient. In some embodiments, the stabilization platform 122 may house pressure transducer circuitry 1525 associated with the pressure transducer 106 and, if present, hardware processing devices (such as a microcontroller). In some embodiments, the pressure transducer circuitry 1525 may also include circuitry associated with a wireless transmitter. As described in this disclosure, in some embodiments, the wireless transmitter is operatively coupled to the hardware processing device, which, in some embodiments of this disclosure, may be used to wirelessly transmit the patient's hemodynamic characteristics.
[0101] All examples and conditional language described in this disclosure are intended for educational purposes to help the reader understand the inventions and concepts contributed by the inventors to the field, and are to be construed as not being limited to such specific examples and conditions. Although embodiments of this disclosure have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the embodiments of this disclosure.
Claims
1. A catheter system, the catheter system comprising: A catheter assembly, the catheter assembly including a catheter seat and a catheter extending distally from the catheter seat; A fluid chamber, the fluid chamber being proximal to the conduit; A fluid path, which is located within the conduit system and extends through the conduit and the fluid chamber; A pressure transducer, which is in fluid communication with the fluid chamber, is used to monitor the patient's hemodynamic characteristics; A port inlet is located near the pressure transducer.
2. The conduit system of claim 1, wherein the pressure transducer is located near the fluid chamber.
3. The catheter system of 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 of claim 3, further comprising a vascular device access device operatively coupled to the port access point to provide vascular device access through the port access point.
5. The catheter system according to claim 3, further comprising an extension tube disposed directly between the fluid chamber and the port inlet, wherein the port inlet is aligned with the longitudinal axis of the catheter seat.
6. The catheter system according to claim 4, further comprising: A second pressure transducer, which is in fluid communication with the extension tube, is 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 of claim 1, wherein the pressure transducer is operatively coupled to a hardware processing device that receives pressure sensor data from the pressure transducer and converts the pressure sensor data into pressure sensor values associated with hemodynamic characteristics, the catheter system further comprising a wireless transmitter operatively coupled to the hardware processing device for wirelessly transmitting the patient's hemodynamic characteristics.
8. The catheter system according to claim 1, further comprising: A wired connection is provided, which is operatively connected to the pressure transducer to operatively connect the pressure transducer to a monitoring system, thereby transmitting pressure sensor values from the pressure transducer to the monitoring system.
9. The catheter system of claim 8, wherein the wired connection is operatively coupled to the port inlet.
10. The catheter system of 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 comprising: The fitting inlet port is positioned off-axis from the pressure transducer and the port inlet, such that a fluid vortex is generated at the fitting inlet port to prevent fluid stagnation within the conduit system. An extension tube extends from the inlet port of the fitting; as well as Another extension tube extends between the side port and the fluid chamber.
11. The catheter system of claim 10, wherein the other extension tube is shorter than the extension tube.
12. The conduit system of claim 10, wherein the fitting inlet port is proximal to the pressure transducer and distal to the port inlet.
13. The conduit system of claim 10, wherein the fitting inlet port is proximal to the other extension tube and distal to the pressure transducer and the port inlet.
14. The catheter system of claim 10, further comprising a vascular device access device operatively coupled to the port access point to provide vascular device access through the port access point.
15. The catheter system of claim 10, further comprising: A second pressure transducer, which is in fluid communication with the extension tube, is 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 of claim 10, wherein the pressure transducer is operatively coupled to a hardware processing device that receives pressure sensor data from the pressure transducer and converts the pressure sensor data into pressure sensor values associated with hemodynamic characteristics, the catheter system further comprising a wireless transmitter operatively coupled to the hardware processing device for wirelessly transmitting the patient's hemodynamic characteristics.
17. The catheter system of claim 10, further comprising: A wired connection is provided, which is operatively connected to the pressure transducer to operatively connect the pressure transducer to a monitoring system, thereby transmitting pressure sensor values from the pressure transducer to the monitoring system.
18. The catheter system of claim 17, wherein the wired connection is operatively coupled to the port inlet.
19. The catheter system of claim 1, wherein the catheter is a peripheral venous catheter.
20. The catheter system of claim 1, wherein the catheter is an arterial catheter.