Embodiments of the invention relate to blood sampling systems and, in particular, to closed blood sampling systems with a clearing reservoir and blood pressure monitoring.
A blood pressure monitoring system comprising a pressure transducer (e.g., a disposable pressure transducer “DPT”) may be used to continuously measure a patient's blood pressure. This type of system may be composed of a patient tubing connection (which is typically attached to an arterial line or pulmonary artery catheter “PAC”), flexible tubing, and an integral DPT. The tubing is filled with saline and is attached to the patient's artery or vein. The DPT is preferably positioned at the same height as the phlebostatic axis of the patient, and the blood pressure is measured through the tubing system.
A means to sample blood (e.g., a blood sampling system), such as a Venous Arterial blood Management Protection (VAMP) system, is often included in or integrated with the pressure transducer system. A blood sampling system may be composed of a reservoir and a sampling site, allowing the sampling of blood through an access port in the tubing system. The reservoir houses a blood-saline mixture (or “clearing volume”) when opened, allowing blood to be sampled from the integral sampling site. After all samples are taken, the clearing volume is infused back into the patient, preventing the loss of blood in critically ill patients.
The mechanical elements which aid in the usability of the blood sampling system (including long flexible tubing, reservoirs, sampling sites, etc.) fundamentally diminish the accuracy of the blood pressure monitoring system. As the natural frequency of the system decreases, the ability of the system to faithfully reproduce the frequencies included within the patient blood pressure waveform decreases. This can have a significant effect on the reported blood pressure values.
Embodiments of the invention may relate to an integrated blood sampling-pressure monitoring system to sample blood from a patient and to measure the blood pressure of the patient. The integrated blood sampling-pressure monitoring system may include: a pressure transducer to measure the blood pressure of the patient; a blood sampling portion to sample blood from the patient; and a restrictor. The restrictor may be interposed between the pressure transducer and the blood sampling portion, such that, the pressure transducer may be located closer to the patient than the blood sampling portion along a fluid line when the blood sampling-pressure monitoring system is connected to the patient.
Embodiments of the invention are related to an integrated blood sampling-pressure monitoring system in which the blood sampling portion and the blood pressure monitoring portion are isolated with respect to fluid pressure transmission by a restrictor member. Although pressure isolated, the two portions are still hydraulically connected for flushing and patency.
Referring to
In the quiescent state, the stopcock valve 125 is open, allowing solution from the IV assembly to be fed through the fluid line 105 and the IV needle into the patient. To obtain a blood sample, the reservoir 130 is slowly moved to an open position (e.g., by pulling a plunger), allowing blood to flow upstream past the sampling site 120 and into the reservoir 130. The stopcock valve 125, located downstream from the reservoir, is then placed in a closed position preventing IV fluid (or saline) from entering the blood sampling site 120. Then, a syringe is positioned through the blood sampling site 120 to draw blood from the patient. After the sample is drawn from the patient, the syringe is detached from the blood sampling site 120, and the stopcock valve 125 is moved to an open position. The reservoir 130 is slowly returned to a closed position (e.g., by pushing the plunger), infusing the blood-IV fluid (saline) mixture (the clearing volume) in the reservoir 130 back into the patient and reestablishing the connection between the patient's circulatory system and the IV infusion or saline line.
Referring to
The proximal segment 224 extends from the reservoir 230 and terminates in a female luer connector 234 attached to a stopcock valve 236 of a pressure transducer 238. The reservoir 230 and pressure transducer 238 removably mount to a bracket 240 which, in turn, may be secured to a conventional pole support 242 with the reservoir in a vertical orientation.
The blood sampling system 220 forms a portion of the integrated system 200. The fluid pressure transducer 238 may be a DPT. A supply of flush solution 244 connects to a flush port 246 of the transducer 238 via tubing 248. Typically, the flush solution 244 comprises a bag of physiological fluid such as saline surrounded by a pressurized sleeve that squeezes the fluid and forces it through the tubing 248. In addition, an IV infusion fluid supply (not shown) may be provided in communication with an infusion port 250 of the stopcock valve 236. The pressure transducer 238 is thus placed in fluid communication with the arterial or venous system of the patient through the fluid line, and may include a cable and plug 252 to connect to a suitable display monitor (not shown).
Therefore, in an existing, conventional integrated blood sampling-pressure monitoring system, the pressure transducer is typically located upstream from the blood sampling portion of the system and away from the patient. As described above, the mechanical elements of the blood sampling portion of the system which aid in the usability of the system fundamentally diminish the accuracy of the pressure monitoring system. As the natural frequency of the system decreases, the ability of the system to faithfully reproduce the frequencies included within the patient blood pressure waveform decreases. This can have a significant effect on the reported blood pressure values.
Embodiments of the invention are related to an integrated blood sampling-pressure monitoring system in which the blood sampling portion and the blood pressure monitoring portion are isolated with respect to fluid pressure transmission by a restrictor member. Although pressure isolated, the two portions are still hydraulically connected for flushing and patency.
Further, according to embodiments of the invention, the pressure transducer may be located downstream from the blood sampling portion (e.g., in the distal segment of the fluid line) of the system and be closer to the patient. A restrictor may be placed between the pressure transducer and the blood sampling portion of the system, allowing the hydraulic connection between the two portions of the system for flushing and patency, but isolating the two portions from each other with respect to pressure transmission.
Referring to
As an example, the system 300 may connected to the patient 310's vein or artery via a fluid line 320. The fluid line 320 also connects the various components of the system 300. The system 300 includes the pressure transducer 330 (e.g., a DPT) in the distal segment of the fluid line 320 downstream from the blood sampling portion 340 (e.g., a VAMP system) of the system. In other words, the pressure transducer 330 is closer to the patient 310 than the blood sampling portion 340 of the system. Preferably the restrictor 350 is interposed between the pressure transducer 330 and the blood sampling portion 340 of the system, allowing the hydraulic connection between the two portions of the system for flushing and patency, but isolating the two portions from each other with respect to pressure transmission. In one embodiment, the restrictor 350 may be part of the pressure transducer 330 assembly. Upstream from the blood sampling portion 340 are flush solution and restrictor 360 and an IV assembly 370, which may be similar to the same components in an existing system.
In one embodiment, the tubing between the patient 310 and the pressure transducer 330 may be approximately 30 to 40 inches long, and the tubing between the pressure transducer 330 and the blood sampling portion 340 may be approximately 80 to 100 inches long. In other words, because pressure transmission between the two portions of the system 300 is isolated from each other, longer, softer, and/or more flexible tubing may be used for the blood sampling portion 340 of the system 300 without negatively affecting the accuracy of blood pressure measurements by the pressure transducer 330.
Referring to
Therefore, in one embodiment, the pressure monitoring portion of the system 400 (comprising the part of the system downstream from the pressure transducer 430 including the pressure transducer 430) may be shortened to arm-length. Thus, the pressure transducer 430 may be fixed on the patient 410 near the phlebostatic axis. Moreover, utilizing the restrictor allows the hydraulic connection between the pressure transducer 430 and the blood sampling portion 440, but isolates the two portions from each other with respect to pressure transmission, the tubing for the blood sampling portion 440 of the system 400 may be adjustable without negatively impacting the accuracy of blood pressure measurements. In other words, longer, softer, and/or more flexible tubing than used in an existing system may be used in the blood sampling portion 440.
Referring to
In one embodiment, the length of tubing between the male luer connector 510 and the pressure transducer assembly 530 may be fixed, and may be approximately 40 inches. In other words, the pressure transducer 530 may be mounted inline at a fixed distance from the patient for all kits. In one embodiment, the pressure transducer 530 may be fixed on the patient near the phlebostatic axis. Since the length of tubing between the patient and the pressure transducer assembly 530 is constant, a hardware filter 531 may be included in the pressure transducer assembly 530 (e.g., at a cable connector), that may be utilized to remove all distortions. With the assistance of the hardware filter, soft and compliant tubing may be used for connecting the male luer connector 510 to the pressure transducer assembly 530 and the stopcock valve 520.
The check-valve/restrictor assembly 535 may isolate the pressure transducer 530 from distortions due to the blood sampling portion of the system 500. In one embodiment, if needed, the check-valve/restrictor assembly 535 may allow an approximately 3 milliliters/hour (mL/hr) flow through the pressure transducer system. The pressure transducer system can be primed or flushed. To prime or flush the pressure transducer system, the stopcock valve 520 may be adjusted to direct all flow through the check-valve restrictor 535 and pressure transducer assembly 530.
With the assistance of the check-valve/restrictor assembly 535, soft and compliant materials may be used for the tubing in the blood sampling portion of the system 500 without negatively affecting the accuracy of blood pressure measurements. Moreover, the length of the tubing in the blood sampling portion of the system 500 may be completely flexible. In other words, longer tubing may be used in this portion.
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The length of tubing between the male luer connector 710 and the pressure transducer assembly 740 may be fixed, and may be approximately 40 inches. Since the length of tubing between the male luer connector 710 and the pressure transducer assembly 740 is fixed, a hardware filter 741 may be included in the pressure transducer assembly 740 (e.g., at a cable connector) to remove all distortions. With the assistance of the hardware filter 741, soft and compliant material may be used for the tubing between the male luer connector 710 and the pressure transducer assembly 740. Therefore, the pressure transducer assembly 740 may be mounted inline at a fixed distance from the patient. In one embodiment, the pressure transducer 740 may be fixed on the patient near the phlebostatic axis.
The dynamic restrictor 745 may serve two functions: 1) it isolates the pressure transducer from distortions due to the blood sampling portion of the system 700 (upstream from the pressure transducer assembly 740); and 2) it allows liquid flow when the system 700 is flushed, or when the blood sampling portion of the system is in use. Because the dynamic restrictor 745 allows the hydraulic connection between the two portions of the system for flushing and patency, but isolates the two portions from each other with respect to pressure transmission, soft and compliant material may be used for the tubing in the blood sampling portion of the system 700 without negatively affecting the accuracy of blood pressure measurements. Moreover, the length of the tubing in the blood sampling portion of the system 700 is completely flexible. In other words, longer tubing may be used in this portion.
It should be appreciated that the restrictor that allows hydraulic connection but isolates pressure transmission between the pressure monitoring portion and the blood sampling portion of the system (e.g., restrictor 350 of
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When liquid with a sufficient pressure within the through portion 916 of the housing 910 comes into contact with the convex center of the diaphragm 930, the convex center of the diaphragm 930 may deflect inwards under the pressure of the liquid, allowing more liquid to pass through. In one embodiment, when the liquid is pressurized to approximately or above 4 to 5 pounds per square inch (psi), the diaphragm 930 may open further (e.g., deflecting inwards), allowing an approximately 1-3 milliliters/second (mL/s) flow to pass through for pressures on the order of 4-20 psi.
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If there is a sufficient liquid pressure coming from the direction of the second portion 1014 (e.g., during flushing), the T-shaped block 1030 may be pushed in the direction from the second portion 1014 to the first portion 1012. Accordingly, the plate portion 1032 may move into the end portion 1024 of the elastic web 1020 (but the plate portion 1032 cannot move past the end of the cut-out portion 1016 of the first portion 1012, as illustrated), flattening the middle portion 1022. Therefore, a greater flow of the liquid may pass through the restrictor 1000 via the space between the outside of the elastic web 1020 and the inside of the cut-out portion 1016. Conversely, if there is a sufficient liquid pressure coming from the direction of the first portion 1012, the T-shaped block 1030 may be pushed in the direction from the first portion 1012 to the second portion 1014. Accordingly, the T-shaped block 1030 may be pushed tightly against the end of the cut-out portion 1016 closer to the second portion 1014, or against a protruding portion of the second portion 1014 near the end of the cut-out portion 1016, as illustrated, at the underside of the plate portion 1032 (e.g., the side of the plate portion 1032 where the column portion 1034 is located), closing off the channel inside the elastic web 1020 that would allow liquid to flow through. Therefore, if the flow pressure is above a threshold and is coming from the direction of the first portion 1012, the flow may be prevented from passing through the restrictor 1000.
Therefore, embodiments of the invention relate to an integrated blood sampling-pressure monitoring system, comprising: a pressure transducer; a blood sampling portion; and a restrictor interposed between the pressure transducer and the blood sampling portion, wherein the pressure transducer is located closer to a patient than the blood sampling portion along a fluid line when the blood sampling-pressure monitoring system is connected to the patient, and wherein the restrictor allows a fluid connection between the pressure transducer and the blood sampling portion for flushing and patency, but isolates the pressure transducer from the blood sampling portion with respect to pressure transmission. Compared to a known, existing integrated blood sampling-pressure monitoring system, embodiments disclosed herein may help reduce or remove the distortions to the blood pressure waveform caused by the blood sampling portion of the system, thus improving the accuracy of blood pressure measurements. The length of the tubing for the portion of the system downstream from the pressure transducer may be fixed for all kits, potentially enabling manufactures to benefit from economies of scale. The pressure transduce assembly may further comprise a hardware filter that removes all distortions. The restrictor and the hardware filter may further allow longer, softer, and/or more compliant tubing to be used, increasing the flexibility of the system.
The various illustrative logical blocks, processors, modules, and circuitry described in connection with the embodiments disclosed herein may be implemented or performed with a general purpose processor, a specialized processor, circuitry, a microcontroller, a digital signal processor (DSP), an application specific integrated circuit (ASIC), a field programmable gate array (FPGA) or other programmable logic device, discrete gate or transistor logic, discrete hardware components, or any combination thereof designed to perform the functions described herein. A processor may be a microprocessor or any conventional processor, controller, microcontroller, circuitry, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration.
The steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module/firmware executed by a processor, or any combination thereof. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art. An exemplary storage medium is coupled to the processor such the processor can read information from, and write information to, the storage medium. In the alternative, the storage medium may be integral to the processor.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
This application claims priority to U.S. Provisional Application No. 62/583,977, filed Nov. 9, 2017, the contents of which are incorporated herein by reference.
Number | Date | Country | |
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62583977 | Nov 2017 | US |