Newborn continuous cardiac output monitoring

Abstract

A method for neonatal monitoring includes: catheter insertion into a neonatal patient through an implanted umbilical interface; injecting a signal fluid into the body of the neonatal patient through the neonatal PiCCO venous catheter; monitoring hemodynamic signals of circulating blood through a newborn PiCCO arterial duct; and detecting the hemodynamic signal. Catheter insertion into a neonatal patient through an implanted umbilical interface includes: inserting a neonatal PiCCO arterial catheter into an umbilical artery of the neonatal patient; and inserting the neonatal PiCCO venous catheter into the umbilical vein of the neonatal patient.

Description

[0001] Cross-references to related applications This application claims priority and benefit to U.S. Provisional Patent Application Serial No. 63 / 448,119, filed February 24, 2023, which is incorporated herein by reference in its entirety for all purposes (including priority) and to the extent that it does not conflict with this disclosure. Technical Field

[0002] This disclosure relates to hemodynamic monitoring, and more particularly to neonatal hemodynamic monitoring. Background Technology

[0003] This section of the document introduces information about and / or from the art that provides context or relevance to the subject matter described herein and / or claimed below. It provides background information to facilitate a better understanding of the various aspects of the invention. This is a discussion of “related” techniques. The fact that such techniques are related does not in any way mean that they are also “prior” techniques. Related techniques may or may not be prior art. The discussion in this section of the document is to be read from this perspective and is not intended as an admission of prior art.

[0004] One aspect of patient care comes from a field known as hemodynamics. Hemodynamics is the term used to describe how blood flows through the body's arteries and veins and the forces that affect blood flow. Individual patient hemodynamic factors, or factors affecting blood flow, can include things like vessel diameter, friction from the vessel walls and deposits thereon, vasodilation and vasoconstriction, cardiac output, heart rate, and ventricular function. Note that this list is representative and is neither exclusive nor exhaustive. Each of these factors can exhibit a high degree of variability based on the patient's unique physiology.

[0005] This field encompasses numerous techniques for monitoring hemodynamics in patients. Hemodynamic monitoring has proven useful in clinical settings for a variety of reasons, including its occasional use in monitoring and / or diagnosing complex medical conditions. Hemodynamics is known to be associated with a wide range of conditions, such as atherosclerosis, hypertension, hypotension, valvular heart problems, heart failure, peripheral artery disease, deep vein thrombosis, and cardiac arrest. Again, this list is neither exclusive nor exhaustive. Therefore, knowledge of a patient's hemodynamics can provide insight into one or more of these conditions, as well as other possible ones.

[0006] Hemodynamic monitoring techniques are broadly classified as "invasive" or "non-invasive." Invasive techniques may include measuring various arterial or venous blood pressures using catheters. For example, cardiac catheterization can be used to measure pressure on either side of a heart valve in cases of valvular problems. Non-invasive techniques may include echocardiography, electrocardiography, and / or blood pressure cuffs. Some monitoring techniques may employ both invasive and non-invasive methods. For example, in some cases, both pulmonary artery catheterization and transthoracic echocardiography may be used to measure cardiac output.

[0007] One hemodynamic technique is called "Pulse Profile Cardiac Output" monitoring or "Pulse Index Continuous Cardiac Output" monitoring ("PiCCO"). PiCCO combines transpulmonary thermodilution technology and pulse profile analysis. The former calculates volumetric measurements of preload and cardiac output, while the latter provides continuous cardiac output and stroke volume variability. PiCCO involves inserting a central venous pressure catheter and an arterial thermodilution line. The arterial thermodilution line can typically be placed in any of several arteries, including the axillary, brachial, femoral, or radial arteries. Radial insertion is usually used, which requires a relatively long catheter. The PiCCO arterial catheter is used to sense and quantify various hemodynamic parameters related to different hemodynamic factors, which can then be analyzed to derive other hemodynamic parameters.

[0008] Unfortunately, the situation is different for neonates. The difficulties in neonatal hemodynamic monitoring are documented in "Hemodynamic Monitoring in Neonates," authored by Fister, Petja, and Grosek, Štefan, in *Selected Topics in Neonatal Care* (10.5772 / intechopen.69215), edited by R. Barría and published by IntechOpen in 2017. As explained therein, neonates are often hemodynamically unstable, and this instability is a significant problem, frequently leading to admission to the neonatal intensive care unit (“NICU”). Although some useful data have been obtained from known techniques, most of them have not yet demonstrated effectiveness for neonatal hemodynamic monitoring. Summary of the Invention

[0009] In a first aspect, a method for neonatal monitoring includes: inserting a catheter into a neonatal patient via an implanted umbilical interface; injecting a signal fluid into the neonatal patient via a neonatal PiCCO venous catheter; monitoring hemodynamic signals of circulating blood via a neonatal PiCCO arterial catheter; and detecting the hemodynamic signals. Inserting a catheter into the neonatal patient via the implanted umbilical interface includes: inserting a neonatal pulse contour cardiac output (“PiCCO”) arterial catheter into the neonatal patient's umbilical artery; and inserting a neonatal PiCCO venous catheter into the neonatal patient's umbilical vein.

[0010] In a second aspect, a neonatal hemodynamic monitoring device includes: a data input; a user interface; and a hemodynamic monitoring controller. The hemodynamic monitoring controller includes: processor-based resources; and memory encoded with instructions. When executed by the processor-based resources, the instructions perform a method comprising: receiving a hemodynamic signal from a neonatal pulse profile cardiac output (“PiCCO”) arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signal being in response to the injection of signal fluid through a neonatal PiCCO venous catheter inserted into a vein of the neonatal patient, the insertion of the PiCCO arterial catheter and the PiCCO venous catheter occurring through an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters based on the received hemodynamic signal; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; and displaying one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by one or more hemodynamic factors, or a combination thereof.

[0011] In a third aspect, a computer-implemented method for hemodynamic monitoring includes: receiving a hemodynamic signal from a neonatal pulse profile cardiac output (“PiCCO”) arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signal being in response to the injection of signal fluid through a neonatal PiCCO venous catheter inserted into a vein of the neonatal patient, the insertion of the PiCCO arterial catheter and the PiCCO venous catheter occurring through an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters from the received hemodynamic signal; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; and displaying one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by one or more hemodynamic factors, or a combination thereof.

[0012] In a fourth aspect, a neonatal hemodynamic monitoring kit includes: a signal fluid dispenser; a neonatal catheter insertion kit; and an umbilical interface for catheter insertion into a neonatal patient using the neonatal catheter insertion kit. The neonatal catheter insertion kit includes: a neonatal pulse contour cardiac output (“PiCCO”) arterial catheter through which hemodynamic signals can be detected; and a neonatal PiCCO venous catheter through which signal fluid can be injected.

[0013] In the fifth aspect, a method for newborn monitoring is essentially as shown and described.

[0014] In the sixth aspect, a method for monitoring neonatal hemodynamics is essentially as shown and described.

[0015] In the seventh aspect, a computer-implemented method for hemodynamic monitoring is substantially as shown and described.

[0016] In the eighth aspect, a neonatal hemodynamic monitoring kit is essentially as shown and described.

[0017] In the ninth aspect, a neonatal hemodynamic monitoring device is substantially as shown and described.

[0018] The foregoing provides a simplified overview of the invention to offer a basic understanding of some aspects thereof. This overview is not an exhaustive summary of the invention. It is not intended to identify key or essential elements of the invention or to define its scope. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed descriptions discussed later. Attached Figure Description

[0019] The invention will be understood through the following description taken in conjunction with the accompanying drawings, in which like reference numerals identify like elements, and wherein: Figure 1 A conceptual illustration of the circulatory system of a representative neonatal patient with an implanted umbilical interface.

[0020] Figure 2 A neonatal hemodynamic monitoring kit is conceptually described according to one or more embodiments.

[0021] Figure 3 This is a schematic block diagram of a neonatal monitoring device assembled according to one or more embodiments.

[0022] Figure 4 This schematically illustrates a neonatal monitoring device for hemodynamic monitoring of neonatal patients, deployed according to one or more embodiments.

[0023] Figure 5 A neonatal monitoring device is described according to one or more embodiments.

[0024] While the invention is readily adaptable to various modifications and alternatives, the accompanying drawings illustrate specific embodiments described in detail herein by way of example. However, it should be understood that the description of specific embodiments herein is not intended to limit the invention to the particular forms disclosed, but rather is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims. Detailed Implementation

[0025] Exemplary embodiments of the subject matter claimed below will now be disclosed. For clarity, not all features of actual implementations are described in this specification. It will be appreciated that in the development of any such actual embodiment, many implementation-specific decisions must be made to achieve the developer's specific objectives, such as compliance with system-related and business-related constraints that will vary from one implementation to another. Furthermore, it will be appreciated that such development work, however complex and time-consuming, will be a routine task for those skilled in the art who will benefit from this disclosure.

[0026] Figure 1 A conceptual illustration of the circulatory system 100 of a representative neonatal patient 110 with an implanted umbilical interface 120 is provided. Overlaid on the depiction of the neonatal patient 110 are conceptual diagrams of the internal organs of the neonatal patient 110, including veins and arteries. Although the apparatus and methods of this disclosure are intended for use in hemodynamic monitoring of neonatal patients with adverse conditions, this is not the case in all embodiments.

[0027] The umbilical interface 120 includes multiple ports, including at least an umbilical vein catheter (“UVC”) port 122 and two umbilical artery catheter (“UAC”) ports 124. The umbilical interface 120 is implanted in the umbilicus (not shown separately) of a neonatal patient to provide sanitary catheter insertion access to the umbilical vein 126 and the umbilical artery 128.

[0028] Figure 2A neonatal hemodynamic monitoring kit 200 is conceptually depicted according to one or more embodiments. In this particular embodiment, the neonatal hemodynamic monitoring kit 200 includes a signal fluid dispenser 205, a neonatal catheter insertion kit 210, an umbilical interface 120 as discussed above, and a neonatal hemodynamic monitor 220. In some embodiments, one or more of the signal fluid dispenser 205, the umbilical interface 120, and the neonatal hemodynamic monitor 220 may be omitted. The kit 200 may optionally include suitable packaging for sterilization of the contents and for effective storage and transport. Additional contents may be additionally included in alternative embodiments without departing from the scope and spirit of the invention.

[0029] The signal fluid distributor 205 is an injection-type distributor that includes a body 206 defining an injection well 207 and terminating at a tip 208. The signal fluid distributor 205 also includes a plunger 209. When the plunger 209 is pressed down to discharge signal fluid (not shown) from the signal fluid distributor 205 through the tip 208, the plunger 209 can sealably engage the wall of the injection well 207.

[0030] Note that, by way of example and illustration, the signal fluid dispenser 205 disclosed herein is merely one means for dispensing signal fluid as described below. Other embodiments may use equivalent structures that perform the function of dispensing signal fluid. For example, in some embodiments, the signal fluid dispenser may include more than one injection well.

[0031] The neonatal catheter insertion kit 210 includes a neonatal PiCCO arterial catheter 211 and a neonatal PiCCO venous catheter 212. In use, as will be further discussed below, the PiCCO arterial catheter is used to detect hemodynamic signals upon insertion into a neonatal patient. Similarly, the neonatal PiCCO venous catheter 211, through which signal fluid can be injected, is used to inject signal fluid into the neonatal patient's circulatory system.

[0032] Neonatal PiCCO catheters (whether arterial or venous) are catheters that can be used for PiCCO monitoring, but are sized for neonatal veins and arteries and designed for insertion through an implanted umbilical interface. To some extent, the catheter size will depend on the size of the neonatal patient's arteries and veins. The patient's weight can be used as a proxy for this consideration. For example, at least one guideline recommends a 5 Fr umbilical artery catheter for infants weighing over 1500 grams, a 3.5 Fr umbilical artery catheter for infants weighing less than 1500 grams, and a 2.5 Fr umbilical artery catheter for infants who cannot accommodate a 3.5 Fr catheter.

[0033] like Figure 2As shown, both the neonatal PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212 include an electrical lead 213 terminating in an electrical connector 223, which allows for information exchange with the neonatal hemodynamic monitor 220 when assembled with it. The electrical lead 213 may be implemented as a smart PiCCO cable. In some embodiments, the neonatal PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212 may wirelessly exchange information with the neonatal hemodynamic monitor 220. In such embodiments, the neonatal PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212 may include a wireless transceiver (not shown) or a transmitter (not shown), and the neonatal hemodynamic monitor 220 may also include a wireless transceiver (not shown) or a wireless receiver (not shown).

[0034] Although not shown, both the neonatal PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212 also include adapters for interfacing with existing PiCCO smart cables. As used herein, the term "smart cable" means that the cable includes programmed and / or programmable elements.

[0035] The neonatal PiCCO arterial catheter 211 also includes a fluid lead 214 terminating in a fluid connector 216. The fluid connector 216 mates with a fluid connector 217 of a fluid delivery line 218 through which a signal fluid distributor 205 delivers signal fluid to the neonatal PiCCO arterial catheter 211 during assembly and use.

[0036] The neonatal hemodynamic monitor 220 may be a general medical monitor modified to perform the functions disclosed herein, or it may be specifically constructed for this purpose. The medical monitor 220 will typically have some kind of display 221 and some means for electrical or electromagnetic communication with the PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212. These means may be, for example, one or more ports 230 to provide electrical connection on the leads 213 of the neonatal PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212.

[0037] Note that, by way of example and illustration, the neonatal hemodynamic monitor 220 disclosed herein is merely one device for receiving, processing, and displaying information as described below. Other embodiments may use equivalent structures that perform the functions of receiving, processing, and displaying information. For example, the neonatal hemodynamic monitor 220 disclosed herein incorporates a display 221. However, in other embodiments, the display may be separate from the rest of the neonatal hemodynamic monitor and may exchange information via wired or wireless connections.

[0038] Figure 3 This is a schematic block diagram of a neonatal monitoring device 300 assembled according to one or more embodiments. The assembled neonatal monitoring device 300 includes a signal fluid distributor 205, a neonatal PiCCO arterial catheter 211, a neonatal PiCCO venous catheter 212, and a neonatal hemodynamic monitor 220. In addition... Figure 3 In addition to the components shown, some embodiments may also include an umbilical interface 120. However, the illustrated embodiment assumes that the umbilical interface 120 has already been installed and is awaiting assembly into the neonatal monitoring device 300 via catheter insertion into the neonatal patient.

[0039] Neonatal PiCCO arterial catheter 211 and neonatal PiCCO venous catheter 212 are shown assembled with neonatal hemodynamic monitor 220 via a wired electrical connection formed by mating connector 223 to port 230. Neonatal PiCCO arterial catheter 211 and signal fluid distributor 205 are assembled via mating of fluid connectors 216, 217. Alternative embodiments (not shown) may include other components that can be assembled to various parts of the assembled neonatal monitoring device 300. For example, some embodiments may have a temperature sensor (not shown) or a blood pressure sensor (not shown) that can be electrically connected to neonatal hemodynamic monitor 220. Other variations of this type will be understood by those skilled in the art who benefit from this disclosure.

[0040] Figure 3 Selected aspects of a neonatal hemodynamic monitor 220 are also conceptually illustrated. The neonatal hemodynamic monitor 220 is an electronic device and includes a processor-based resource 305 that executes instructions stored in memory 310. Memory 310 may be on-chip memory on the processor-based resource 305, a separate memory device, or a combination thereof. The neonatal hemodynamic monitor 220 also includes conditioning circuitry 315 for data input and / or command output, and a display 221 as mentioned above. The neonatal hemodynamic monitor 220 also includes a bus system 320 through which various electronic components communicate with each other.

[0041] Processor-based resource 305 may include one or more hardware processors, each of which may have one or more processor cores. Therefore, the processor-based resource may be a processor, such as a microprocessor, controller, microcontroller, central processing unit (“CPU”), application-specific integrated circuit (“ASIC”), field-programmable gate array (“FPGA”), digital signal processor (“DSP”), etc., as known in the art. Alternatively, processor-based resource 305 may be a processor chipset that includes one or more processors including one or more of the processor types just listed above, and may also include one or more of a graphics processing unit (“GPU”) and / or a math coprocessor.

[0042] Processor-based resource 305 may include at least one shared cache storing data (e.g., compute instructions) used by one or more other components of processor-based resource 305, and may include a portion of memory 310. For example, the shared cache may be data stored locally in memory for faster access by components constituting the processing elements of processor-based resource 305. In one or more embodiments, the shared cache may include one or more intermediate caches, such as Level 2 (L2), Level 3 (L3), Level 4 (L4), or other levels of cache, Last Level Cache (LLC), or combinations thereof.

[0043] Memory 310 may also include off-chip memory operatively and communicatively coupled to processor 305 via bus system 320. Memory 310 may be a non-transitory medium configured to store various types of data. For example, memory 310 may include one or more storage devices 1320, including non-volatile storage devices and / or volatile memory. Volatile memory, such as random access memory (“RAM”), may be any suitable non-permanent storage device. Non-volatile storage device 1320 may include one or more disk drives, optical drives, solid-state drives (“SSDs”), tape drives, flash memory, read-only memory (“ROM”), and / or any other type of memory designed to retain data for a period of time after a power-off or shutdown operation. In some cases, if the allocated RAM is not large enough to hold all working data, a non-volatile storage device (not shown separately) may be used to store overflow data. Non-volatile storage devices may also be used to store programs loaded into RAM when such programs are selected for execution.

[0044] Those skilled in the art will recognize that software programs can be developed, coded, and compiled for various software platforms and / or operating systems using various computing languages, and are subsequently loaded and executed by processor-based resource 305. In one embodiment, the compilation process of the software program can translate program code written in a programming language into another computer language, enabling processor-based resource 305 to execute the programming code. For example, the compilation process of the software program can generate an executable program that provides processor-based resource 305 with encoded instructions (e.g., machine code instructions) to implement specific, non-general-purpose, particular computational functions.

[0045] Following the compilation process, the encoded instructions can then be loaded from memory 310 into processor-based resource 305 as computer-executable instructions or process steps. Processor-based resource 305 can be configured to execute the stored instructions or process steps to transform the computing device into a non-general-purpose, specific, specially programmed machine or apparatus. Stored data can be accessed by processor-based resource 305, for example, during the execution of the computer-executable instructions or process steps.

[0046] Still referencing Figure 3 Display 221 may be implemented in various ways, including via a liquid crystal display (“LCD”), a cathode ray tube (“CRT”), or a light-emitting diode (“LED”) display such as an organic light-emitting diode (“OLED”) technology. Display 221 may include a touchscreen (not shown), which may be part of a user interface. Information may be displayed as text, graphics, or a combination thereof.

[0047] As will be known to those skilled in the art, computing device 1300 may include other components known in the art, such as Figure 3 Sensors, power sources, and / or analog-to-digital converters not explicitly shown. For example, the neonatal hemodynamic monitor 220 may include a user interface. The user interface may include not only a display 221, but also one or more of position input devices (such as a mouse, touchpad, touchscreen, etc.), a keyboard, buttons, knobs, or other forms of user input and output devices, none of which are shown. The user interface components may also be communicatively coupled to a processor-based resource 305.

[0048] The neonatal hemodynamic monitor 220 is also programmed / configured with various software. Among the software stored in memory 310 are a PiCCO module 325 and a hemodynamic analysis (“HA”) module 330. The term “module” is used in its conventional meaning in the art to describe hardware or software, or a combination thereof, assigned to or dedicated to a specific function. In the illustrated embodiment, the PiCCO module 325 and the HA module 330 are software executed by a processor-based processor 305 to perform the associated functions described below. As discussed above, other software may be stored and typically stored in memory 310, but is not shown. Such additional software may include, but is not limited to, user interface software, data conditioning software, operating systems, etc.

[0049] The memory 310 may also encode a data storage 335, which may be associated with the procedures described herein or in PiCCO and / or hemodynamic analysis. Data may be manually entered, collected electronically, or retrieved from electronic medical records. The data storage 335 may include one or more data structures containing the data and may be selected to best suit the data. Examples of data structures may include, but are not limited to, databases, linked lists, lookup tables, or trees.

[0050] Figure 4 A neonatal monitoring device 300 for hemodynamic monitoring of a neonatal patient 303 is schematically illustrated according to one or more embodiments. An umbilical interface 120 is shown as implanted in the neonatal patient 110. The umbilical interface 120 may be pre-installed or installed as part of the technology described herein. Implantation of the umbilical interface 120 may be performed in any suitable manner known in the art.

[0051] The weight of the newborn patient 110 is known or measured. For example, the newborn patient 303 may be positioned on a scale that outputs a reading of the newborn patient 110's weight to the neonatal hemodynamic monitor 220 or via a wired or wireless connection. In another example, the newborn patient 110 may be removed from the neonatal monitoring device 300 to a remote location (e.g., another room), weighed, and then manually entered into the neonatal hemodynamic monitor 220 via a user interface. In yet another example, the newborn patient 110 may have recently been weighed, and the neonatal hemodynamic monitor 220 may extract the weight from the newborn patient 110's electronic medical records. Other embodiments may utilize some combination of these methods.

[0052] The weight of the neonatal patient 110 has numerous uses in the disclosed art. As mentioned above, weight can be used to determine the dimensions of the neonatal PiCCO arterial catheter 211 and neonatal PiCCO venous catheter 212 to be used in the procedure. Some embodiments may also use weight as an alternative indicator to determine whether the neonatal patient 110 is an infant, adolescent, or adult. This determination may also take into account other physiological parameters, such as sex and height. This determination can then inform the values ​​to be used in various PiCCO and other hemodynamic analyses. Whether the patient is an infant, adolescent, or adult can also be manually entered or retrieved from electronic medical records.

[0053] Many therapeutic and patient care considerations can be addressed by taking actions not discussed herein. These actions are not discussed because they are not closely related to the currently disclosed technology, for clarity, and to avoid obscuring the content claimed below. For example, it may be desirable to restrain the neonatal patient 110. Alternatively, precautions may be taken to prevent the neonatal patient 110 from becoming hypothermic, such as placing the neonatal patient 110 on a heated mattress or using a radiant warmer. Another example is that it may be desirable to flush the neonatal PiCCO arterial catheter 211, the neonatal PiCCO venous catheter 212, and / or the signal fluid dispenser 205 with a sterile saline solution. Those skilled in the art who benefit from this disclosure will be able to recognize the desirability of these and other tasks associated with the disclosed technology and to perform them.

[0054] Similarly, there may be aspects of the PiCCO monitoring process that have not been discussed for the same or similar reasons. For example, the PiCCO monitoring process may include blood pressure monitoring. Depending on the specific embodiment, there may also be calibration practices or display options, or many other options for the PiCCO monitoring process. These actions are not discussed because they are not closely related to the currently disclosed technology, for clarity, and to avoid obscuring the content claimed below.

[0055] A medical practitioner (not shown) – for example, whether a nursing assistant, nurse, physician assistant, or physician – then inserts a catheter into the neonatal patient 303 using a neonatal PiCCO arterial catheter 211 or a neonatal PiCCO venous catheter 212. Those skilled in the art who benefit from this disclosure will recognize that there are typically two umbilical arteries present, but only a single neonatal PiCCO arterial catheter 211. During the procedures disclosed herein, unused umbilical arteries may be clamped or blood flow may be otherwise terminated.

[0056] Once the neonatal patient 110 is inserted into the catheter, a signal fluid is injected from the signal fluid dispenser 205 into the patient through the neonatal PiCCO arterial catheter 211. The signal fluid may be, for example, a 15 mL volume of sterile saline solution cooled to a predetermined temperature. The predetermined temperature is less than the nominal core temperature of the neonatal patient 110.

[0057] Injection is typically preferred to be completed within a relatively short time period (such as 7 seconds) because shorter injection times tend to produce better signals. The injection time of the signal fluid is recorded by the neonatal hemodynamic monitor 220. The neonatal PiCCO arterial catheter 211 may include a microtemperature probe (not shown) or sensor (not shown) capable of sensing a predetermined temperature of the signal fluid. The procedure may be repeated several times. In one embodiment, the procedure is repeated three times.

[0058] The micro-temperature probe or sensor of the neonatal PiCCO arterial catheter 211 continuously senses the temperature of the blood in the umbilical artery and transmits the sensed temperature to the neonatal hemodynamic monitor 220 via the corresponding PiCCO smart cable 400a. When the signal fluid is injected into the umbilical artery at a predetermined temperature, the sensed temperature of the blood in the umbilical artery will decrease or temporarily decrease because the signal fluid cools the blood. The neonatal hemodynamic monitor 220 transmits the temperature via the PiCCO module 325 (in... Figure 3 (As shown in the diagram) A timer can be started when the sensed temperature is recognized as the start of the injection. Alternatively, the injection time can be manually entered into the neonatal hemodynamic monitor 220.

[0059] Blood cooled by a signal fluid passes through the arterial system of the neonatal patient 110 and eventually reaches the neonatal PiCCO venous catheter 212. The neonatal PiCCO venous catheter 212 may also include a micro-temperature probe (not shown) or a sensor (not shown). As blood circulates through the arterial system of the neonatal patient 110, the neonatal PiCCO venous catheter 212 continuously senses the temperature of the blood in the umbilical vein.

[0060] The sensed temperature of the blood in the umbilical vein will decrease or temporarily drop because the signal fluid cools the blood earlier. Those skilled in the artery who benefit from this disclosure will recognize that the cooled blood will warm up as it passes through the arterial system. Therefore, the predetermined temperature of the signal fluid should be sufficiently lower than the nominal core temperature of the neonatal patient 110 to produce a significantly cooler temperature at the neonatal PiCCO venous catheter 212. In one embodiment, the signal fluid is at least 10°C lower and no higher than 24°C than the blood temperature. Therefore, the signal fluid can be refrigerated or cooled on ice before use.

[0061] The temperature sensed by the neonatal PiCCO intravenous catheter 212 can be transmitted to the neonatal hemodynamic monitor 220 via the corresponding PiCCO smart cable 400b. A decrease in the sensed temperature at the neonatal PiCCO intravenous catheter 212 is transmitted to the PiCCO module 325. Figure 3 (As shown in the diagram) a signal indicating transmission completion is issued. Then, the PiCCO module 325 determines the elapsed time of the cooled blood. The PiCCO module 325 then uses the determined elapsed time and other information such as the weight of the neonatal patient 110 to perform a PiCCO analysis.

[0062] PiCCO analysis generally comprises at least two parts. The first part is arterial pulse profile analysis, and the second part is transpulmonary thermodilution. Arterial pulse profile analysis provides continuous dynamic information. Transpulmonary thermodilution provides static measurements used to calibrate continuous pulse profile parameters. Parameters that can be considered include, for example, but are not limited to, continuous cardiac output and stroke volume. For example, saline fluid infusion (as a first step) or antihypertensive medication (as a second step) can be used to improve stroke volume.

[0063] For example, in PiCCO analysis, some embodiments may determine PiCCO parameters including one or more of pulse profile parameters, transpulmonary thermodilution parameters, and physiological parameters. Pulse profile parameters may include, for example, pulse profile cardiac output, continuous cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, left ventricular contractility index, stroke volume variability, and pulse pressure variability. Example transpulmonary thermodilution parameters may include cardiac output, cardiac index, total end-diastolic volume, total end-diastolic volume index, extravascular lung water, extravascular lung water index, total ejection fraction, pulmonary vascular permeability index, cardiac function index, intrapleural blood volume, and intrapleural blood volume index. Physiological parameters may include body surface area, predicted weight, and predicted body surface area.

[0064] Physiological parameters are calculated physical characteristics used to index various other PiCCO volume parameters. The calculation of some of these physiological parameters depends in part on whether the patient is an adult, adolescent, or infant. (Factors such as height, weight, and sex are sometimes also used.) Therefore, many PiCCO parameters depend directly or indirectly on the patient's status in this regard.

[0065] Therefore, in one particular embodiment, the patient is automatically determined to be an adult, adolescent, or infant. This automatic determination can be performed by the neonatal hemodynamic monitor 220. For example, it can be automatically determined based on physiological parameters through some calculation using a weighted formula or a lookup table indexed by physiological parameters. Alternatively, the information can be extracted from medical records stored in some data structure, such as a database, which is stored on the neonatal hemodynamic monitor 220 or accessed through some distributed computing environment.

[0066] The illustrated embodiment also utilizes the PiCCO monitoring described above to perform additional hemodynamic monitoring. For example... Figure 3 The neonatal hemodynamic monitor 220 shown includes a hemodynamic analysis module 330 for this purpose. Various embodiments can monitor one or more of the following: oxygen delivery, oxygen consumption, central venous oxygen saturation, cardiac output, arterial oxygen content, stroke volume, heart rate, oxygenation, hemoglobin concentration, preload, afterload, contractility, and pulmonary edema.

[0067] Figure 5 The illustration schematically depicts a neonatal monitoring device 500 deployed for hemodynamic monitoring of a newborn patient according to one or more embodiments. The neonatal monitoring device 500 shares common parts with previously disclosed devices, and the same parts have the same numbering.

[0068] However, the neonatal monitoring device also includes a flushing bag 503 containing flushing fluid 506 for rinsing various components after assembly and before use. Additionally, an injection temperature sensor housing 509 senses the temperature of the signal fluid 515 during injection and communicates with the neonatal hemodynamic monitor 220 via an injection sensor cable 512. An arterial pressure transducer 518 senses arterial pressure and transmits the sensed pressure to the neonatal hemodynamic monitor 220 via a cable 521. Finally, a central venous pressure transducer 524 senses pressure and transmits it to the neonatal hemodynamic monitor 220 via a pressure connection cable 527.

[0069] Therefore, in a first embodiment, a method for neonatal monitoring includes: inserting a catheter into a neonatal patient through an implanted umbilical interface; injecting signal fluid into the neonatal patient through a neonatal PiCCO venous catheter; monitoring hemodynamic signals of circulating blood through a neonatal PiCCO arterial catheter; and detecting the hemodynamic signals. Catheter insertion into the neonatal patient includes inserting a neonatal PiCCO arterial catheter into the neonatal patient's umbilical artery; and inserting a neonatal PiCCO venous catheter into the neonatal patient's umbilical vein.

[0070] In a second embodiment, the method of the first embodiment further includes implanting an umbilical interface into the newborn patient.

[0071] In the third embodiment, the method of the first embodiment further includes monitoring hemodynamic parameters.

[0072] In the fourth embodiment, the injection of signal fluid in the first embodiment includes injecting a predetermined amount of signal saline solution at a predetermined temperature.

[0073] In the fifth embodiment, the hemodynamic signal in the fourth embodiment is the temperature fluctuation in the circulating blood.

[0074] In a sixth embodiment, the method of the first embodiment further includes: determining a plurality of neonatal patient hemodynamic parameters based on received hemodynamic signals; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; and displaying one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by one or more hemodynamic factors, or a combination thereof.

[0075] In the seventh embodiment, the method of the first embodiment further includes implanting an umbilical interface into the newborn patient.

[0076] In the eighth embodiment, the method of the first embodiment further includes: determining a plurality of neonatal patient hemodynamic parameters based on the detected hemodynamic signals; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; and displaying one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by one or more hemodynamic factors, or a combination thereof.

[0077] In a ninth embodiment, a neonatal hemodynamic monitoring device includes: a data input; a user interface; and a hemodynamic monitoring controller. The hemodynamic monitoring controller includes processor-based resources and memory. The memory is encoded with instructions that, when executed by the processor-based resources, perform a method comprising: receiving a hemodynamic signal from a neonatal PiCCO arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signal being in response to the injection of signal fluid through a neonatal PiCCO venous catheter inserted into a vein of the neonatal patient, the insertion of the PiCCO arterial catheter and the PiCCO venous catheter occurring through an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters based on the received hemodynamic signal; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; and displaying one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by one or more hemodynamic factors, or a combination thereof.

[0078] In the tenth embodiment, the neonatal hemodynamic monitoring device of the ninth embodiment further includes monitoring hemodynamic parameters.

[0079] In the eleventh embodiment, the injection of the signal fluid in the ninth embodiment includes injecting a predetermined amount of signal saline solution at a predetermined temperature.

[0080] In the twelfth embodiment, the hemodynamic signal in the ninth embodiment is the temperature fluctuation in the circulating blood.

[0081] In the thirteenth embodiment, the hemodynamic status in the ninth embodiment includes monitoring hemodynamic parameters.

[0082] In a fourteenth embodiment, a computer-implemented method for hemodynamic monitoring includes: receiving a hemodynamic signal from a neonatal PiCCO arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signal being in response to the injection of signal fluid through a neonatal PiCCO venous catheter inserted into a vein of the neonatal patient, the insertion of the PiCCO arterial catheter and the PiCCO venous catheter occurring through an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters based on the received hemodynamic signal; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; and displaying one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by one or more hemodynamic factors, or a combination thereof.

[0083] In the fifteenth embodiment, the computer-implemented method of the fourteenth embodiment further includes monitoring hemodynamic parameters.

[0084] In the sixteenth embodiment, the injection of the signal fluid in the fourteenth embodiment includes injecting a predetermined amount of signal saline solution at a predetermined temperature.

[0085] In the seventeenth embodiment, the hemodynamic signal of the fourteenth embodiment is the temperature fluctuation in circulating blood.

[0086] In the eighteenth embodiment, the hemodynamic status in the fourteenth embodiment includes monitoring hemodynamic parameters.

[0087] In a nineteenth embodiment, a neonatal hemodynamic monitoring kit includes: a signal fluid dispenser; a neonatal catheter insertion kit; and an umbilical interface for catheter insertion into a neonatal patient. The neonatal catheter insertion kit includes a neonatal PiCCO arterial catheter through which hemodynamic signals can be detected; and a neonatal PiCCO venous catheter through which signal fluid can be injected.

[0088] In the twentieth embodiment, the neonatal hemodynamic monitoring kit of the nineteenth embodiment further includes a hemodynamic monitor that, in use, receives hemodynamic signals from the neonatal PiCCO arterial catheter and performs hemodynamic analysis on the hemodynamic signals.

[0089] In the twenty-first embodiment, the hemodynamic monitor of the twenty-first embodiment further includes: processor-based resources; and a memory encoded with instructions that perform hemodynamic analysis when executed by a process.

[0090] In the twenty-second embodiment, the hemodynamic monitoring kit of the twenty-first embodiment further includes a user interface. Additionally, the memory is encoded with instructions such that the methods executed when run by processor-based resources further include: receiving user commands via the user interface; and displaying one or more hemodynamic parameters or one or more patient conditions indicated by the one or more hemodynamic parameters, or a combination thereof.

[0091] In the twenty-third embodiment, the neonatal hemodynamic monitoring kit of the twenty-second embodiment further includes: data input; and a user interface through which a display is performed.

[0092] The twenty-fourth embodiment is a method for newborn monitoring that is substantially as shown and described herein.

[0093] The twenty-fifth embodiment is a method for monitoring neonatal hemodynamics, which is essentially as shown and described herein.

[0094] The twenty-sixth embodiment is a computer-implemented method for hemodynamic monitoring, which is essentially as shown and described herein.

[0095] The twenty-seventh embodiment is a neonatal hemodynamic monitoring kit that is substantially as shown and described herein.

[0096] The twenty-eighth embodiment is a neonatal hemodynamic monitoring device that is substantially as shown and described herein.

[0097] This concludes the detailed description. The specific embodiments disclosed above are merely illustrative, as the invention can be modified and practiced in different but equivalent ways, as will be apparent to those skilled in the art who have benefited from the teachings herein. Furthermore, the details of the constructions or designs shown herein are not intended to limit the scope of the invention, except as described in the appended claims. Therefore, it will be apparent that the specific embodiments disclosed above can be altered or modified, and all such variations are considered to be within the scope and spirit of the invention. Consequently, the protection sought herein is as set forth in the appended claims.

Claims

1. A method for newborn monitoring, comprising: Catheter insertion into neonatal patients via an implanted umbilical interface includes: A neonatal pulse contour cardiac output ("PiCCO") arterial catheter was inserted into the umbilical artery of the neonatal patient; and The neonatal PiCCO intravenous catheter was inserted into the umbilical vein of the neonatal patient; The signal fluid was injected into the neonatal patient through the neonatal PiCCO intravenous catheter; Hemodynamic signals of circulating blood were monitored using the neonatal PiCCO arterial catheter; and The hemodynamic signals were detected.

2. The method according to claim 1 further includes implanting the umbilical interface into the newborn patient.

3. The method according to claim 1 further includes monitoring hemodynamic parameters.

4. The method according to claim 1, wherein, Injecting the signal fluid involves injecting a predetermined amount of signal salt aqueous solution at a predetermined temperature.

5. The method according to claim 4, wherein, The hemodynamic signal is the temperature fluctuation in the circulating blood.

6. The method according to claim 1, further comprising: Hemodynamic parameters of multiple neonatal patients were determined based on the received hemodynamic signals; Determine one or more hemodynamic conditions indicated by the hemodynamic parameters of the neonatal patient; as well as This indicates one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by the one or more hemodynamic factors, or a combination thereof.

7. The method according to claim 1 further includes implanting the umbilical interface into the neonatal patient.

8. The method according to claim 1, further comprising: Hemodynamic parameters of multiple neonatal patients were determined based on the detected hemodynamic signals; Determine one or more hemodynamic conditions indicated by the hemodynamic parameters of the neonatal patient; as well as This indicates one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by the one or more hemodynamic factors, or a combination thereof.

9. A neonatal hemodynamic monitoring device, comprising: Data input; User interface; as well as Hemodynamic monitoring controller, the hemodynamic monitoring controller comprising: Processor-based resources; and A memory encoded with instructions that, when executed by the processor-based resources, execute a method comprising: Hemodynamic signals are received from a neonatal pulse profile cardiac output ("PiCCO") arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signals being responded to by the injection of signal fluid through a neonatal PiCCO venous catheter inserted into a vein of the neonatal patient, the insertion of the PiCCO arterial catheter and the PiCCO venous catheter occurring through an implanted umbilical interface; Hemodynamic parameters of multiple neonatal patients were determined based on the received hemodynamic signals; Determine one or more hemodynamic conditions indicated by the hemodynamic parameters of the neonatal patient; and This indicates one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by the one or more hemodynamic factors, or a combination thereof.

10. The neonatal hemodynamic monitoring device according to claim 9 further includes monitoring hemodynamic parameters.

11. The neonatal hemodynamic monitoring device according to claim 9, wherein, Injecting the signal fluid involves injecting a predetermined amount of signal salt aqueous solution at a predetermined temperature.

12. The neonatal hemodynamic monitoring device according to claim 9, wherein, The hemodynamic signal is the temperature fluctuation in circulating blood.

13. The neonatal hemodynamic monitoring device according to claim 9, wherein, The hemodynamic status includes monitoring hemodynamic parameters.

14. A computer-implemented method for hemodynamic monitoring, comprising: Hemodynamic signals are received from a neonatal pulse profile cardiac output ("PiCCO") arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signals being responded to by the injection of signal fluid through a neonatal PiCCO venous catheter inserted into a vein of the neonatal patient, the insertion of the PiCCO arterial catheter and the PiCCO venous catheter occurring through an implanted umbilical interface; Hemodynamic parameters of multiple neonatal patients were determined based on the received hemodynamic signals; Determine one or more hemodynamic conditions indicated by the hemodynamic parameters of the neonatal patient; as well as This indicates one or more of the determined hemodynamic parameters, or one or more hemodynamic conditions indicated by the one or more hemodynamic factors, or a combination thereof.

15. The computer-implemented method of claim 14 further includes monitoring hemodynamic parameters.

16. The computer-implemented method according to claim 14, wherein, Injecting the signal fluid involves injecting a predetermined amount of signal salt aqueous solution at a predetermined temperature.

17. The computer-implemented method according to claim 14, wherein, The hemodynamic signal is the temperature fluctuation in circulating blood.

18. The computer-implemented method according to claim 14, wherein, The hemodynamic status includes monitoring hemodynamic parameters.

19. A neonatal hemodynamic monitoring kit, comprising: Signal fluid distributor ； Neonatal catheter insertion kit, the neonatal catheter insertion kit comprising: Neonatal pulse contour cardiac output ("PiCCO") arterial catheter, through which hemodynamic signals can be detected; and Neonatal PiCCO intravenous catheter, through which signal fluid can be injected; and The umbilical interface is used for catheter insertion in neonatal patients.

20. The neonatal hemodynamic monitoring kit according to claim 19, further comprising a hemodynamic monitor, wherein the hemodynamic monitor, in use: Hemodynamic signals are received from the neonatal PiCCO arterial catheter; and Hemodynamic analysis is performed on the hemodynamic signals.

21. The neonatal hemodynamic monitoring kit according to claim 20, wherein, The hemodynamic monitor also includes: Processor-based resources; and A memory encoded with instructions that, when executed by the process, perform the hemodynamic analysis.

22. The neonatal hemodynamic monitoring kit according to claim 21, wherein: The hemodynamic monitor also includes a user interface; and The memory is encoded with instructions such that, when executed by the processor-based resources, the method of execution further includes: Receive user commands through the user interface; and Display one or more hemodynamic parameters or one or more patient conditions indicated by said one or more hemodynamic parameters, or a combination thereof.

23. The neonatal hemodynamic monitoring kit according to claim 22, further comprising: Data input; as well as The user interface is used to perform the display.

24. A method for newborn monitoring that is substantially as shown and described.

25. A method for monitoring neonatal hemodynamics, substantially as shown and described.

26. A computer-implemented method for hemodynamic monitoring, substantially as shown and described.

27. A neonatal hemodynamic monitoring kit, substantially as shown and described.

28. A neonatal hemodynamic monitoring device substantially as shown and described.

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