Neonatal continuous cardiac output monitoring

Abstract

A method for neonatal monitoring includes catheterizing a neonatal patient via an implanted umbilical interface, infusing a signaling fluid into the neonatal patient via the neonatal PiCCO venous catheter, monitoring circulating blood for a hemodynamic signal via the neonatal PiCCO arterial catheter, and detecting the hemodynamic signal. Catheterizing the neonatal patient via the implanted umbilical interface includes inserting the neonatal PiCCO arterial catheter into an umbilical artery of the neonatal patient and inserting the neonatal PiCCO venous catheter into an umbilical vein of the neonatal patient.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to and benefit of U.S. Provisional Patent Application No. 63 / 448,119, filed February 24, 2023, including priority thereto, for all purposes, the entirety of which is incorporated herein by reference to the extent not inconsistent with the present disclosure.

[0002] The present disclosure relates to hemodynamic monitoring, and more particularly to neonatal hemodynamic monitoring.

[0003] Background technology This section of the specification provides context for or introduces information about and / or from the art that may be relevant to the subject matter described herein and / or claimed below. It provides background information to facilitate a better understanding of various aspects of the present invention. This is a description of "related" art. The fact that such art is related does not in any way mean that it is also "prior" art. Related art may or may not be prior art. The statements in this section of the specification should be read in this light, and not as admissions of prior art.

[0004] One aspect of patient care comes from the field known as "hemodynamics." Hemodynamics is a term used to describe how blood flows through the arteries and veins of the body and the forces that affect blood flow. Hemodynamic factors, or factors that affect blood flow, for an individual patient can include factors such as blood vessel diameter, friction from the blood vessel walls and deposits thereon, vascular dilation and contraction, cardiac output, heart rate, and ventricular effectiveness, among others. It should be noted that this list is representative and not necessarily exclusive or exhaustive. Each of these factors can exhibit a high degree of variability based on the patient's unique physiology.

[0005] The art includes several techniques for monitoring a patient's hemodynamic status. Hemodynamic monitoring has proven useful in clinical settings for several reasons, including its potential use in monitoring and / or diagnosing complex medical conditions. Hemodynamic status is known to be associated with several broad conditions, including atherosclerosis, high blood pressure, low blood pressure, heart valve problems, heart failure, peripheral arterial disease, deep vein thrombosis, and cardiac arrest. Again, this list is not exclusive or comprehensive. Thus, knowledge of a patient's hemodynamic status may provide insight into one or more of these conditions, and possibly others as well.

[0006] Hemodynamic monitoring techniques are generally categorized as "invasive" or "non-invasive." Invasive techniques may involve measuring blood pressure in various arteries or veins using catheters. For example, cardiac catheterization may be used to measure pressure on either side of a heart valve for heart valve problems. Non-invasive techniques may include echocardiograms, electrocardiograms, and / or blood pressure cuffs. Some monitoring techniques may employ both invasive and non-invasive techniques. For example, in some cases, cardiac output may be measured using both a pulmonary artery catheter and a transthoracic echocardiogram.

[0007] One hemodynamic technique is called "pulse contour cardiac output" monitoring or "pulse index continuous cardiac output" monitoring ("PiCCO"). PiCCO combines transpulmonary arterial thermodilution with pulse contour analysis. The former calculates volumetric measurements of preload and cardiac output, while the latter provides continuous cardiac output and stroke volume variation. PiCCO involves inserting a central venous pressure catheter and an arterial thermodilution line. The arterial thermodilution line can generally be placed in any one of several arteries, including the axillary, brachial, femoral, or radial arteries. Radial insertion, which requires a longer catheter, is generally used. The PiCCO arterial catheter is used to sense various hemodynamic parameters that quantify various hemodynamic factors, which can then be analyzed to arrive at further hemodynamic parameters.

[0008] Unfortunately, the situation is different for neonatal patients. A survey of the challenges in neonatal hemodynamic monitoring is described in Fister, Petja, and Grosek, Stefan, "Hemodynamic Monitoring in Neonates," Selected Topics in Neonatal Care, edited by R. Barria, IntechOpen, 2017.10.5772 / intechopen.69215. As described therein, neonatal patients are often hemodynamically unstable, and such instability is a significant concern, often leading to admission to the neonatal intensive care unit ("NICU"). While there is some useful data from known techniques, the majority of them have not been shown to be effective for neonatal hemodynamic monitoring.

[0009] Summary of the Invention In a first aspect, a method for neonatal monitoring includes catheterizing a neonatal patient via an implanted umbilical interface, infusing a signaling fluid into the neonatal patient via a neonatal PiCCO venous catheter, monitoring circulating blood for a hemodynamic signal via a neonatal PiCCO arterial catheter, and detecting the hemodynamic signal. Catheterizing 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 a memory encoded with instructions. When executed by the processor-based resources, the instructions implement a method including receiving hemodynamic signals from a neonatal pulse contour cardiac output ("PiCCO") arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signals being responsive to infusion of a signaling 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 being performed via an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters from the 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 the one or more hemodynamic factors, or a combination thereof.

[0011] In a third aspect, a computer-implemented method for hemodynamic monitoring includes receiving hemodynamic signals from a neonatal pulse contour cardiac output ("PiCCO") arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signals being responsive to infusion of a signaling 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 being performed via an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters from the 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 the one or more hemodynamic conditions indicated by the one or more hemodynamic factors, or a combination thereof.

[0012] In a fourth aspect, a neonatal hemodynamic monitoring kit includes a signal transmission fluid dispenser, a neonatal catheterization kit, and an umbilical interface for use in catheterizing a neonatal patient using the neonatal catheterization kit. The neonatal catheterization 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 transmission fluid can be infused.

[0013] In a fifth aspect, a method for neonatal monitoring is substantially as shown and described.

[0014] In a sixth aspect, a method for neonatal hemodynamic monitoring is substantially as shown and described.

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

[0016] In an eighth aspect, a neonatal hemodynamic monitoring kit substantially as shown and described.

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

[0018] The foregoing presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an exhaustive overview of the invention. It is not intended to identify key or critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concepts in a simplified form as a prelude to the more detailed description that is discussed later.

[0019] The present invention may be understood by reference to the following description in conjunction with the accompanying drawings, in which like reference numerals identify like elements and in which: [Brief explanation of the drawings]

[0020] [Figure 1] FIG. 1 conceptually illustrates the circulatory system of a typical neonatal patient with an implanted umbilical interface. [Figure 2] FIG. 1 conceptually illustrates a neonatal hemodynamic monitoring kit, according to one or more embodiments. [Figure 3] FIG. 1 is a schematic block diagram of an assembled neonatal monitoring device, according to one or more embodiments. [Figure 4] FIG. 1 is a schematic representation of a neonatal monitoring device deployed for hemodynamic monitoring of a neonatal patient, according to one or more embodiments. [Figure 5] FIG. 1 illustrates a neonatal monitoring device, according to one or more embodiments.

[0021] While the invention is susceptible to various modifications and alternative forms, the drawings show, by way of example, specific embodiments described in detail herein. It should be understood, however, that the description herein of specific embodiments is not intended to limit the invention to the particular forms disclosed, but rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

[0022] MODE FOR CARRYING OUT THE INVENTION Next, exemplary embodiments of the claimed subject matter are disclosed. In the interest of clarity, not all features of an actual implementation are described herein. It will be understood that developing such an actual embodiment will involve many implementation-specific decisions that will vary from implementation to implementation in order to achieve the developer's particular goals, including compliance with system- and business-related constraints. Moreover, it will be understood that such a development effort, even if complex and time-consuming, would be a routine undertaking for those of ordinary skill in the art having the benefit of this disclosure.

[0023] 1 conceptually illustrates the blood circulatory system 100 of a representative neonatal patient 110 having an implanted umbilical interface 120. A conceptual diagram of the internal organs of the neonatal patient 110, including veins and arteries, is superimposed on a depiction of the neonatal patient 110. It is anticipated that the devices and methods of the present disclosure will be used for hemodynamic monitoring of unwell neonatal patients, although this may not be the case in all embodiments.

[0024] 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) of a neonatal patient and provides sanitary catheter access to an umbilical vein 126 and an umbilical artery 128.

[0025] FIG. 2 conceptually illustrates a neonatal hemodynamic monitoring kit 200 according to one or more embodiments. In this particular embodiment, the neonatal hemodynamic monitoring kit 200 includes a signal transfer fluid dispenser 205, a neonatal catheter kit 210, an umbilical interface 120 as described above, and a neonatal hemodynamic monitor 220. One or more of the signal transfer fluid dispenser 205, the umbilical interface 120, and the neonatal hemodynamic monitor 220 may be omitted in some embodiments. The kit 200 may optionally include appropriate packaging effective for sterilization and storage and transport of the contents. Additional content may also be included in alternative embodiments without departing from the scope and spirit of the present invention.

[0026] The signal transfer fluid dispenser 205 is a syringe-type dispenser that includes a body 206 that defines an injectate well 207 and terminates in a tip 208. The signal transfer fluid dispenser 205 also includes a plunger 209 that sealably engages the walls of the injectate well 207 when depressed to expel signal transfer fluid (not shown) from the signal transfer fluid dispenser 205 through the tip 208.

[0027] It should be noted that the signal transfer fluid dispenser 205 disclosed herein is by way of example and illustration, but is one means for dispensing signal transfer fluid as described below. Other embodiments may use equivalent structures that perform the function of dispensing signal transfer fluid. For example, in some embodiments, the signal transfer fluid dispenser may include two or more injectate wells.

[0028] The neonatal catheter kit 210 includes a neonatal PiCCO arterial catheter 211 and a neonatal PiCCO venous catheter 212. In use, as described further below, the PiCCO arterial catheter is used to detect hemodynamic signals when inserted into a neonatal patient. The neonatal PiCCO venous catheter 211, into which a signaling fluid may be infused, is similarly used to infuse the signaling fluid into the neonatal patient's blood circulatory system.

[0029] Neonatal PiCCO catheters, whether arterial or venous, can be used in PiCCO monitoring. However, they are sized for the neonatal vein and artery and designed for insertion through an implanted umbilical interface. To some extent, catheter size depends on the size of the neonatal patient's arteries and veins. Patient weight can be used as a surrogate for this consideration. For example, at least one guideline recommends a 5 Fr umbilical artery catheter for infants over 1500 grams, a 3.5 Fr catheter for infants under 1500 grams, and a 2.5 Fr catheter for infants unable to accommodate a 3.5 Fr catheter.

[0030] As shown in FIG. 2 , both the neonatal PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212 include electrical leads 213 terminating in electrical connectors 223, via which information can be exchanged with the neonatal hemodynamic monitor 220 when assembled with the neonatal hemodynamic monitor. The electrical leads 213 can be implemented in a smart PiCCO cable. In some embodiments, the neonatal PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212 can exchange information wirelessly with the neonatal hemodynamic monitor 220. In such embodiments, the neonatal PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212 can include a wireless transceiver (not shown) or transmitter (not shown), and the neonatal hemodynamic monitor 220 can also include a wireless transceiver (not shown) or wireless receiver (not shown).

[0031] 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 elements that are programmed and / or programmable.

[0032] The neonatal PiCCO arterial catheter 211 also includes a fluid lead 214 that terminates in a fluid connector 216. The fluid connector 216 mates with a fluid connector 217 of a fluid delivery line 218 through which the signaling fluid dispenser 205 delivers signaling fluid to the neonatal PiCCO arterial catheter 211 when assembled and in use.

[0033] The neonatal hemodynamic monitor 220 may be a general-purpose medical monitor modified to perform the functions disclosed herein, or may be specially and purpose-built for that purpose. The medical monitor 220 will generally have some type of display 221 and some means for electrically or electromagnetically communicating with the PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212. These means may be, for example, one or more ports 230 for providing electrical connection via the leads 213 of the neonatal PiCCO arterial catheter 211 and the neonatal PiCCO venous catheter 212.

[0034] It should be noted that the neonatal hemodynamic monitor 220 disclosed herein is by way of example and illustration, but is one means 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 remainder of the neonatal hemodynamic monitor, and information may be exchanged via a wired or wireless connection.

[0035] 3 is a schematic block diagram of an assembled neonatal monitoring device 300 according to one or more embodiments. The assembled neonatal monitoring device 300 includes a signal transfer fluid dispenser 205, a neonatal PiCCO arterial catheter 211, a neonatal PiCCO venous catheter 212, and a neonatal hemodynamic monitor 220. Some embodiments may include an umbilical interface 120 in addition to the components shown in FIG. 3. However, the illustrated embodiment assumes that the umbilical interface 120 is already in place and awaits assembly into the neonatal monitoring device 300 with the neonatal patient's catheters.

[0036] Neonatal PiCCO arterial catheter 211, neonatal PiCCO venous catheter 212 are shown assembled with neonatal hemodynamic monitor 220 via a wired electrical connection formed by plugging connector 223 into port 230. Neonatal PiCCO arterial catheter 211 and signaling fluid dispenser 205 are connected via mating fluid connectors 216, 217. Alternative embodiments (not shown) may include other components that may be assembled to various portions 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 may be electrically connected to neonatal hemodynamic monitor 220. Those skilled in the art with the benefit of this disclosure will recognize still other variations of this type.

[0037] 3 also conceptually illustrates selected aspects of a neonatal hemodynamic monitor 220. The neonatal hemodynamic monitor 220 is an electronic device and includes processor-based resources 305 that execute instructions stored in memory 310. Memory 310 may be on-chip memory on the processor-based resources 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 described above. The neonatal hemodynamic monitor 220 further includes a bus system 320 through which the various electronic components communicate with each other.

[0038] The processor-based resources 305 may comprise one or more hardware processors, each of which may have a single or multiple processor cores. Thus, the processor-based resources may be processors such as microprocessors, controllers, microcontrollers, central processing units ("CPUs"), application-specific integrated circuits ("ASICs"), field-programmable gate arrays ("FPGAs"), digital signal processors ("DSPs"), etc., as known in the art. Alternatively, the processor-based resources 305 may be processor chipsets that include multiple processors, including one or more of the immediately preceding processor types, and possibly also include one or more graphics processing units ("GPUs") and / or math coprocessors.

[0039] Processor-based resources 305 may include at least one shared cache that stores data (e.g., computational instructions) utilized by one or more other components of processor-based resources 305, and may include a portion of memory 310. For example, the shared cache may be locally cached data stored in memory for faster access by components of the processing elements that make up processor-based resources 305. In one or more embodiments, the shared cache may include one or more intermediate level caches, such as a level 2 (L2), level 3 (L3), level 4 (L4), or other level cache, a last level cache (LLC), or a combination thereof.

[0040] The memory 310 may also include off-chip memory operatively and communicatively coupled to the processor 305 via the bus system 320. The memory 310 may be a non-transitory medium configured to store various types of data. For example, the 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. The non-volatile storage device 1320 may include one or more disk drives, optical drives, solid-state drives (“SSD”), tap drives, flash memory, read-only memory (“ROM”), and / or any other type of memory designed to retain data for a duration after a power loss 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 separately shown) may be used to store overflow data. The non-volatile storage device may also be used to store programs, which are loaded into RAM when such programs are selected for execution.

[0041] Those skilled in the art will recognize that software programs may be developed, coded, and compiled in a variety of computing languages ​​for a variety of software platforms and / or operating systems, and then loaded and executed by processor-based resources 305. In one embodiment, the software program compilation process may convert program code written in a programming language into another computer language so that processor-based resources 305 can execute the programming code. For example, the software program compilation process may generate an executable program, which provides coded instructions (e.g., machine code instructions) for processor-based resources 305 to accomplish specific, uncommon, and distinct computing functions.

[0042] After the compilation process, the encoded instructions may then be loaded from memory 310 into processor-based resources 305 as computer-executable instructions or process steps. Processor-based resources 305 may be configured to execute the stored instructions or process steps to perform the instructions or process steps to transform the computing device into a non-generic, specific, specially programmed machine or apparatus. Stored data may be accessed by processor-based resources 305, for example, during execution of the computer-executable instructions or process steps.

[0043] 3, display 221, the display may be implemented in various ways, including by a liquid crystal display ("LCD"), or cathode ray tube ("CRT"), or light emitting diode ("LED") display such as organic light emitting diode ("OLED") technology. Display 221 may include a touch screen (not shown) that may be part of the user interface. Information may be displayed as text, graphics, or a combination thereof.

[0044] Those skilled in the art will recognize that computing device 1300 may include other components well known in the art, such as sensors, power sources, and / or analog-to-digital converters, which are not explicitly shown in FIG. 3 . For example, neonatal hemodynamic monitor 220 may include a user interface. The user interface may include not only display 221 but also one or more of a pointing input device (such as a mouse, touchpad, touchscreen), keyboard, buttons, dials, or other forms of user input / output devices, none of which are shown. The user interface components may also be communicatively coupled to processor-based resources 305.

[0045] The neonatal hemodynamic monitor 220 is also programmed / configured with various software. Among the software stored in the memory 310 are a PiCCO module 325 and a hemodynamic analysis (“HA”) module 330. The term “module” is used in its ordinary sense in the art to describe hardware or software, or a combination thereof, assigned to or dedicated to a particular function. In the illustrated embodiment, the PiCCO module 325 and the HA module 330 are software executed by the processor-based processor 305 to perform associated functions as described below. As noted above, other software may be, and typically will be, stored in the memory 310 but is not shown. Such additional software may include, but is not limited to, user interface software, data conditioning software, an operating system, etc.

[0046] The memory 310 may also be encoded with or may be a store 335 of data that may be related to the treatments described herein or in PiCCO and / or hemodynamic analysis. The data may be manually entered, collected electronically, or pulled from an electronic medical record. The data store 335 may include one or more data structures that contain the data and may be selected to best suit the data. Examples of data structures may include, but are not limited to, a database, a linked list, a lookup table, or a tree.

[0047] 4 is a schematic representation of a neonatal monitoring device 300 deployed for hemodynamic monitoring of a neonatal patient 303, according to one or more embodiments. An implantable umbilical interface 120 is shown in the neonatal patient 110. The umbilical interface 120 may be pre-installed or installed as part of the techniques described herein. Implantation of the umbilical interface 120 may be performed in any suitable manner known in the art.

[0048] The weight of the neonatal patient 110 is known or measured. For example, the neonatal patient 303 may be positioned on a scale that outputs a reading for the neonatal patient's 110 weight to the neonatal hemodynamic monitor 220 or a wired or wireless connection. In another example, the neonatal patient 110 may be removed from the neonatal monitoring device 300, moved to a remote location (e.g., another room), and weighed, and the weight is then manually entered into the neonatal hemodynamic monitor 220 via a user interface. In yet another example, the neonatal patient 110 may have been recently weighed, and the neonatal hemodynamic monitor 220 may pull the weight from the electronic medical record for the neonatal patient 110. Still other embodiments may utilize some combination of parts of these approaches.

[0049] The weight of the neonatal patient 110 may have many uses in the disclosed technology. As mentioned above, weight may be used to size the neonatal PiCCO arterial catheter 211 and neonatal PiCCO venous catheter 212 used in the procedure. Some embodiments may also use weight as a proxy for determining whether the neonatal patient 110 is an infant, juvenile, or adult. This determination may also consider other physiological parameters, such as gender and height. This determination may then inform the values ​​used in various PiCCO and other hemodynamic analyses. Whether the patient is an infant, juvenile, or adult may also be entered manually or pulled from the electronic medical record.

[0050] There are several treatment and patient care considerations that may be addressed by measures taken not described herein. Because these measures are not germane to the presently disclosed technology, they are not described for clarity and so as not to obscure what is claimed below. For example, it may be desirable to restrain the neonatal patient 110. Alternatively, precautions may be taken to prevent hypothermia in the neonatal patient 110, such as placing the neonatal patient 110 on a heating mattress or using a radiant warmer. As yet another example, it may be desirable to flush the neonatal PiCCO arterial catheter 211, the neonatal PiCCO venous catheter 212, and / or the signaling fluid dispenser 205 with sterile saline solution. Those skilled in the art, having the benefit of this disclosure, will recognize the desirability of and be able to perform these and other tasks associated with the disclosed technology.

[0051] Similarly, there may be aspects of the PiCCO monitoring process that are not described for the same or similar reasons. For example, the PiCCO monitoring process may include blood pressure monitoring. Depending on the particular embodiment, there may also be calibration or display options for the PiCCO monitoring process, or many other options. Because these measures are not germane to the presently disclosed technology, they will not be described for clarity and to avoid obscuring what is claimed below.

[0052] A medical professional (not shown), whether a nurse's assistant, nurse practitioner, physician's assistant, or physician, catheterizes the neonatal patient 303 using a neonatal PiCCO arterial catheter 211, a neonatal PiCCO venous catheter 212. Those skilled in the art having the benefit of this disclosure will understand that there are typically two umbilical arteries but only a single neonatal PiCCO arterial catheter 211. The unused umbilical artery may be clamped or otherwise closed during the procedures disclosed herein.

[0053] Once the neonatal patient 110 is catheterized, signaling fluid is infused into the patient from the signaling fluid dispenser 205 through the neonatal PiCCO arterial catheter 211. The signaling fluid may be, for example, a 15 mL volume of sterile saline solution cooled to a predetermined temperature that is below the nominal core temperature of the neonatal patient 110.

[0054] It is generally preferable to complete the infusion in a relatively short period of time, such as 7 seconds, as shorter infusion times tend to produce a better signal. The time the signaling fluid is infused is recorded by the neonatal hemodynamic monitor 220. The neonatal PiCCO arterial catheter 211 may include a fine temperature probe (not shown) or sensor (not shown) capable of sensing a predetermined temperature of the signaling fluid. This procedure may be repeated several times. In one embodiment, the process is repeated three times.

[0055] The fine temperature probe or sensor in the neonatal PiCCO arterial catheter 211 may continuously sense the temperature of the blood in the umbilical artery and transmit the sensed temperature to the neonatal hemodynamic monitor 220 via the respective PiCCO smart cable 400a. When a signaling fluid at a predetermined temperature is infused into the umbilical artery, the sensed temperature of the blood in the umbilical artery will drop or temporarily decrease as the signaling fluid cools the blood. The neonatal hemodynamic monitor 220, via the PiCCO module 325 (shown in FIG. 3), may start a timer upon recognizing the sensed temperature as the start of the infusion. Alternatively, the infusion time may be manually entered into the neonatal hemodynamic monitor 220.

[0056] The blood, cooled by the signal transfer fluid, passes through the neonatal patient's 110 arterial system and eventually reaches the neonatal PiCCO venous catheter 212. The neonatal PiCCO venous catheter 212 may also include a fine temperature probe (not shown) or sensor (not shown). The neonatal PiCCO venous catheter 212 continuously senses the temperature of the blood in the umbilical vein as the blood circulates through the neonatal patient's 110 arterial system.

[0057] The sensed temperature of the blood in the umbilical vein drops or temporarily decreases when the signaling fluid has previously cooled the blood. Those skilled in the art with the benefit of this disclosure will understand that the cooled blood warms as it passes through the arterial system. Therefore, the predetermined temperature of the signaling fluid must be sufficiently lower than the nominal core temperature of the neonatal patient 110 to produce a discernibly cool temperature at the neonatal PiCCO venous catheter 212. In one embodiment, the signaling fluid is at least 10° C. lower than blood temperature and no higher than 24° C. Therefore, the signaling fluid may be refrigerated or cooled on ice prior to use.

[0058] The temperature sensed by the neonatal PiCCO venous catheter 212 may be transmitted to the neonatal hemodynamic monitor 220 via the respective PiCCO smart cable 400b. A decrease in the sensed temperature in the neonatal PiCCO venous catheter 212 signals to the PiCCO module 325 (shown in FIG. 3) that transit is complete. The PiCCO module 325 then determines the transit time of the cooled blood. The PiCCO module 325 then performs a PiCCO analysis using the determined transit time and other information, such as the weight of the neonatal patient 110.

[0059] PiCCO analysis generally includes at least two parts: the first is arterial pulse contour analysis and the second is transpulmonary arterial thermodilution. The arterial pulse contour analysis provides continuous, dynamic information. The transpulmonary arterial thermodilution provides static measurements used to calibrate the continuous pulse contour parameters. Parameters that may be considered include, for example, but are not limited to, continuous cardiac output and stroke volume. For example, saline infusion (as a first step) or antihypertensive drugs (as a second step) may be used to improve stroke volume.

[0060] For example, in PiCCO analysis, some embodiments may determine PiCCO parameters including one or more of pulse contour parameters, transpulmonary arterial thermodilution parameters, and physiological parameters. Pulse contour parameters may include, for example, pulse contour cardiac output, continuous cardiac index, stroke volume, stroke volume index, systemic vascular resistance, systemic vascular resistance index, index of left ventricular contractility, stroke volume variation, and pulse pressure variation. Exemplary transpulmonary arterial thermodilution parameters may include cardiac output, cardiac index, global end-diastolic volume, global end-diastolic volume index, extravascular lung water, extravascular lung water index, global ejection fraction, pulmonary vascular permeability index, cardiac performance index, intrathoracic blood volume, and intrathoracic blood volume index. Physiological parameters may include body surface area, predicted body weight, and predicted body surface area.

[0061] Physiological parameters are calculated body characteristics used to index various other PiCCO volumetric parameters. Calculations for some of these physiological parameters depend in part on whether the patient is an adult, juvenile, or infant. (Factors such as height, weight, and gender may also be used.) Thus, many of the PiCCO parameters depend directly or indirectly on the patient's condition in this respect.

[0062] Thus, one particular embodiment automatically determines whether the patient is an adult, a juvenile, or an infant. This automatic determination may be performed by the neonatal hemodynamic monitor 220. The automatic determination may be made from the physiological parameters by some calculation, for example, using a weighted formula or lookup table indexed by the physiological parameters. Alternatively, the information may be drawn from medical records stored in some data structure, such as a database, stored in the neonatal hemodynamic monitor 220, or accessed via some distributed computing environment.

[0063] The illustrated embodiment also performs additional hemodynamic monitoring using the PiCCO monitoring described above. As shown in Figure 3, the neonatal hemodynamic monitor 220 includes a hemodynamic analysis module 330 for this purpose. Various embodiments may monitor one or more of oxygen delivery, oxygen consumption, central venous oxygen saturation, cardiac output, arterial oxygen content, stroke volume, heart rate, oxygenation, hemoglobin, preload, afterload, contractility, and pulmonary edema.

[0064] 5 is a schematic representation of a neonatal monitoring device 500 deployed for hemodynamic monitoring of a neonatal patient, according to one or more embodiments. The neonatal monitoring device 500 shares common parts with previous disclosures, and like parts have like numbers.

[0065] However, the neonatal monitoring device also includes a flush bag 503 that contains flush fluid 506 for flushing the various components after assembly and before use. Additionally, an infusate temperature sensor housing 509 senses the temperature of the signal transfer fluid 515 as it is infused and communicates this with the neonatal hemodynamic monitor 220 via an infusate sensor cable 512. An arterial pressure transducer 518 senses the arterial pressure and communicates the sensed pressure to the neonatal hemodynamic monitor 220 via cable 521. Finally, a central venous pressure transducer 524 senses the pressure and transmits it to the neonatal hemodynamic monitor 220 via a pressure connection cable 527.

[0066] Thus, in a first embodiment, a method for neonatal monitoring includes catheterizing a neonatal patient via an implanted umbilical interface, infusing a signaling fluid into the neonatal patient via a neonatal PiCCO venous catheter, monitoring circulating blood for a hemodynamic signal via a neonatal PiCCO arterial catheter, and detecting the hemodynamic signal. Catheterizing the neonatal patient includes inserting the neonatal PiCCO arterial catheter into the neonatal patient's umbilical artery and inserting the neonatal PiCCO venous catheter into the neonatal patient's umbilical vein.

[0067] In a second embodiment, the method of the first embodiment further comprises implanting an umbilical interface in the neonatal patient.

[0068] In a third embodiment, the method of the first embodiment further comprises monitoring a hemodynamic parameter.

[0069] In a fourth embodiment, injecting the signaling fluid in the first embodiment includes injecting a predetermined amount of signaling saline solution at a predetermined temperature.

[0070] In the fifth embodiment, the hemodynamic signal in the fourth embodiment is temperature fluctuation of circulating blood.

[0071] In a sixth embodiment, the method of the first embodiment further includes determining a plurality of neonatal patient hemodynamic parameters from the 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 the one or more hemodynamic conditions indicated by the one or more hemodynamic factors, or a combination thereof.

[0072] In a seventh embodiment, the method of the first embodiment further comprises implanting an umbilical interface in the neonatal patient.

[0073] In an eighth embodiment, the method of the first embodiment further includes determining a plurality of neonatal patient hemodynamic parameters from 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 the one or more hemodynamic conditions indicated by the one or more hemodynamic factors, or a combination thereof.

[0074] 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 a processor-based resource and a memory. The memory is encoded with instructions that, when executed by the processor-based resource, implement a method including receiving hemodynamic signals from a neonatal PiCCO arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signals responsive to infusion of a signaling 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 via an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters from the 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 the one or more hemodynamic factors, or a combination thereof.

[0075] In a tenth embodiment, the neonatal hemodynamic monitoring device of the ninth embodiment further comprises monitoring a hemodynamic parameter.

[0076] In an eleventh embodiment, injecting the signaling fluid in the ninth embodiment includes injecting a predetermined amount of signaling saline solution at a predetermined temperature.

[0077] In a twelfth embodiment, the hemodynamic signal in the ninth embodiment is temperature fluctuations of circulating blood.

[0078] In a thirteenth embodiment, the hemodynamic status in the ninth embodiment includes monitoring hemodynamic parameters.

[0079] In a fourteenth embodiment, a computer-implemented method for hemodynamic monitoring includes receiving hemodynamic signals from a neonatal PiCCO arterial catheter inserted into an artery of a neonatal patient, the hemodynamic signals being responsive to infusion of a signaling fluid via 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 being performed via an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters from the 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 the one or more hemodynamic conditions indicated by the one or more hemodynamic factors, or a combination thereof.

[0080] In a fifteenth embodiment, the computer-implemented method of the fourteenth embodiment further comprises monitoring hemodynamic parameters.

[0081] In a sixteenth embodiment, injecting the signaling fluid in the fourteenth embodiment includes injecting a predetermined amount of signaling saline solution at a predetermined temperature.

[0082] In a seventeenth embodiment, the hemodynamic signal of the fourteenth embodiment is temperature fluctuations of circulating blood.

[0083] In an eighteenth embodiment, the hemodynamic status in the fourteenth embodiment includes monitoring hemodynamic parameters.

[0084] In a nineteenth embodiment, a neonatal hemodynamic monitoring kit comprises a signal transfer fluid dispenser, a neonatal catheterization kit, and an umbilical interface for use in catheterizing a neonatal patient. The neonatal catheterization kit includes a neonatal PiCCO arterial catheter through which hemodynamic signals can be detected, and a neonatal PiCCO venous catheter through which signal transfer fluid can be infused.

[0085] In a twentieth embodiment, the neonatal hemodynamic monitoring kit of the nineteenth embodiment further comprises a hemodynamic monitor that, in use, receives hemodynamic signals from the neonatal PiCCO arterial catheter and performs hemodynamic analysis on the hemodynamic signals.

[0086] In a twenty-first embodiment, the hemodynamic monitor of the twentieth embodiment further comprises a processor-based resource and a memory encoded with instructions that, when executed by a process, perform hemodynamic analysis.

[0087] In a twenty-second embodiment, in the neonatal hemodynamic monitoring kit of the twenty-first embodiment, the hemodynamic monitor further comprises a user interface, and the memory is encoded with instructions such that a method, when executed by the processor-based resource, further includes receiving a user command via the user interface and displaying one or more hemodynamic parameters, one or more patient conditions indicated by the one or more hemodynamic parameters, or a combination thereof.

[0088] In a twenty-third embodiment, the neonatal hemodynamic monitoring kit of the twenty-second embodiment further comprises a user interface through which data entry and displaying is performed.

[0089] A twenty-fourth embodiment is a method for neonatal monitoring substantially as shown and described herein.

[0090] A twenty-fifth embodiment is a method for neonatal hemodynamic monitoring substantially as shown and described herein.

[0091] A twenty-sixth embodiment is a computer-implemented method for hemodynamic monitoring substantially as shown and described herein.

[0092] A twenty-seventh embodiment is a neonatal hemodynamic monitoring kit substantially as shown and described herein.

[0093] A twenty-eighth embodiment is a neonatal hemodynamic monitoring apparatus substantially as shown and described herein.

[0094] This concludes the detailed description. The particular embodiments disclosed above are illustrative only, as the invention may be modified and practiced in different but equivalent manners apparent to those skilled in the art having the benefit of the teachings herein. Furthermore, no limitations are intended to the details of construction or design herein shown, other than as set forth in the claims below. It will therefore be apparent that the particular embodiments disclosed above may be altered or modified and all such variations are considered within the scope and spirit of the invention. Accordingly, the protection sought herein is as set forth in the following claims.

Claims

1. 1. A method for neonatal monitoring, comprising: Inserting a catheter into a neonatal patient via an implanted umbilical interface, 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 umbilical vein of said neonatal patient. inserting a catheter, infusing a signaling fluid into the neonatal patient via the neonatal PiCCO venous catheter; monitoring circulating blood for hemodynamic signals via said neonatal PiCCO arterial catheter; detecting the hemodynamic signal; A method comprising:

2. 10. The method of claim 1, further comprising implanting the umbilical interface in the neonatal patient.

3. The method of claim 1 , further comprising monitoring a hemodynamic parameter.

4. 10. The method of claim 1, wherein injecting the signaling fluid comprises injecting a predetermined amount of signaling saline solution at a predetermined temperature.

5. The method of claim 4 , wherein the hemodynamic signal is a temperature variation of the circulating blood.

6. determining a plurality of neonatal patient hemodynamic parameters from the received hemodynamic signals; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; 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; The method of claim 1 further comprising:

7. 10. The method of claim 1, further comprising implanting the umbilical interface in the neonatal patient.

8. determining a plurality of neonatal patient hemodynamic parameters from the detected hemodynamic signals; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; 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; The method of claim 1 further comprising:

9. Data entry and A user interface; Hemodynamic monitoring controller and 1. A neonatal hemodynamic monitoring device comprising: processor-based resources; Instruction-encoded memory and wherein the instructions, when executed by the processor-based resource, receiving hemodynamic signals from a neonatal pulse contour cardiac output ("PiCCO") arterial catheter inserted into an artery of the neonatal patient, the hemodynamic signals being responsive to injection of a signaling 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 being performed via an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters from the received hemodynamic signals; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; 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; A neonatal hemodynamic monitoring device that performs a method comprising:

10. 10. The neonatal hemodynamic monitoring device of claim 9, further comprising monitoring hemodynamic parameters.

11. 10. The neonatal hemodynamic monitoring device of claim 9, wherein injecting the signaling fluid comprises injecting a predetermined volume of signaling saline solution at a predetermined temperature.

12. 10. The neonatal hemodynamic monitoring device of claim 9, wherein the hemodynamic signal is temperature fluctuations of circulating blood.

13. 10. The neonatal hemodynamic monitoring device of claim 9, wherein the hemodynamic status comprises monitoring a hemodynamic parameter.

14. 1. A computer-implemented method for hemodynamic monitoring, comprising: receiving hemodynamic signals from a neonatal pulse contour cardiac output ("PiCCO") arterial catheter inserted into an artery of the neonatal patient, the hemodynamic signals being responsive to injection of a signaling 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 being performed via an implanted umbilical interface; determining a plurality of neonatal patient hemodynamic parameters from the received hemodynamic signals; determining one or more hemodynamic conditions indicated by the neonatal patient hemodynamic parameters; 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; 11. A computer-implemented method comprising:

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

16. 15. The computer-implemented method of claim 14, wherein injecting the signaling fluid comprises injecting a predetermined amount of signaling saline solution at a predetermined temperature.

17. The computer-implemented method of claim 14 , wherein the hemodynamic signal is temperature fluctuations of circulating blood.

18. The computer-implemented method of claim 14 , wherein the hemodynamic status comprises monitoring a hemodynamic parameter.

19. a signal transmission fluid dispenser; A neonatal catheter kit, comprising: a neonatal pulse contour cardiac output ("PiCCO") arterial catheter from which hemodynamic signals can be detected; and Neonatal PiCCO venous catheter through which signaling fluid can be infused a neonatal catheter kit including: an umbilical interface for use in inserting a catheter into a neonatal patient; A neonatal hemodynamic monitoring kit comprising:

20. When using, receiving a hemodynamic signal from the neonatal PiCCO arterial catheter; performing a hemodynamic analysis on the hemodynamic signal; 20. The neonatal hemodynamic monitoring kit of claim 19, further comprising a hemodynamic monitor that performs the steps of:

21. the hemodynamic monitor processor-based resources; a memory encoded with instructions that, when executed by said process, perform said hemodynamic analysis; 21. The neonatal hemodynamic monitoring kit of claim 20, further comprising:

22. the hemodynamic monitor further comprising a user interface; The memory is configured to implement a method when executed by the processor-based resource, the method comprising: receiving a user command via the user interface; Displaying one or more hemodynamic parameters, or one or more patient conditions indicated by said one or more hemodynamic parameters, or a combination thereof; and further comprising:

22. The neonatal hemodynamic monitoring kit of claim 21.

23. Data entry and a user interface in which the displaying is performed; 23. The neonatal hemodynamic monitoring kit of claim 22, further comprising:

24. 10. A method for neonatal monitoring substantially as hereinbefore shown and described.

25. 10. A method for neonatal hemodynamic monitoring substantially as hereinbefore depicted and described.

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

27. 10. A neonatal hemodynamic monitoring kit substantially as hereinbefore depicted and described.

28. 10. A neonatal hemodynamic monitoring apparatus substantially as herein shown and described.

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