Patent Application
20190374116
Embodiments of the invention relate to non-invasive blood pressure measurement using a finger cuff and a volume clamp method with a heart reference sensor. In particular, embodiments of the invention relate to a heart reference sensor that utilizes non-plasticized tubing or chemically inert tubing.
There are presently many different types of pressure sensor configurations for measuring blood pressure and blood pressure waveforms. As one example, a finger cuff blood pressure measurement system utilizing a finger cuff with a pressure sensor may be used to measure blood pressure utilizing the volume clamp method.
Volume clamping is a technique for non-invasively measuring blood pressure in which pressure is applied to a subject's finger in such a manner that arterial pressure may be balanced by a time varying pressure to maintain a constant arterial volume. In a properly fitted and calibrated system, the applied time varying pressure is equal to the arterial blood pressure in the finger. The applied time varying pressure may be measured to provide a reading of the patient's arterial blood pressure. This may be accomplished by a finger cuff that is arranged around a finger of a patient. The finger cuff may include an infrared light source, an infrared sensor, and an inflatable bladder. The infrared light may be sent through the finger in which a finger artery is present. The infrared sensor picks up the infrared light and the amount of infrared light registered by the sensor may be inversely proportional to the artery diameter and indicative of the pressure in the artery. In the finger cuff implementation, by inflating the bladder in the finger cuff, a pressure is exerted on the finger artery. If the pressure is high enough, it will compress the artery and the amount of light registered by the sensor will increase. The amount of pressure necessary in the inflatable bladder to compress the artery is dependent on the blood pressure. By controlling the pressure of the inflatable bladder such that the diameter of the finger artery is kept constant, the blood pressure may be monitored in very precise detail as the pressure in the inflatable bladder is directly linked to the blood pressure.
In a typical present-day finger cuff implementation, a volume clamp system is used with the finger cuff. The volume clamp system typically includes a pressure generating system and a regulating system that includes: a pump, a valve, and a pressure sensor in a closed loop feedback system that is used in conjunction with the measurement of the arterial volume. To accurately measure blood pressure, the feedback loop provides sufficient pressure generating and releasing capabilities to match the pressure oscillations of the subject's blood pressure.
Further, a second pressure sensor, a heart reference sensor (HRS), may be utilized with the finger cuff system to compensate for pressures generated by height differences between the patient's finger and heart. The HRS connects a liquid filled bladder located at the patient's heart level to a pressure sensor located at the patient's finger or wrist unit through a liquid filled tube. The gravity generated pressures between the patient's heart level and finger level are measured by the HRS and subtracted from the finger cuff pressure sensor in the system's data processing software/algorithms
In present HRS systems, flexible polyvinyl chloride (PVC) tubing is often filled with bioblend, biodegradable oil formulated from renewable base stocks. This biodegradable oil is used to provide pressure readings at different elevations to enable zeroing at the patient's heart level for non-invasive pressure monitoring systems, such as, for finger cuff blood pressure measurement systems.
Unfortunately, flexible PVC tubing contains a significant amount of plasticizer. Bioblend oil and plasticizer are miscible and over time, plasticizer migrates into oil, causing excess oil-plasticizer mixture inside the tubing. Chemical analysis has shown plasticizer can migrate into oil resulting in fluid mixture having 80% oil and 20% plasticizer. Therefore, within the closed HRS fluid line, up to a 25% fluid volume increase can occur. Excess oil-plasticizer mixture inside the tubing causes bulging of the bladder of the HRS over time resulting in drift and difficulty in the zeroing functions of the HRS. As bulging of the bladder becomes more severe, the bladder reaches stretchability (elastic) limit and in effect becomes a taut rigid member. Such “rigid” member imparts step function like back pressure to the sensor with any slight perturbation such as lowering the height of the bladder relative to the sensor height thus causing out of range issues.
With reference to
The blood pressure measurement system 102 may further be connected to a patient monitoring device 140, and, in some embodiments, a separate pump 133. Further, finger cuff 104 may include a bladder (not shown) and an LED-PD pair (not shown), which are conventional for finger cuffs, as will be described in more detail later.
In one embodiment, the blood pressure measurement system 102 may include a pressure measurement controller 120 that includes: a small internal pump, a small internal valve, a pressure sensor, and control circuitry. In this embodiment, the control circuitry may be configured to: control the pneumatic pressure applied by the internal pump to the bladder of the finger cuff 104 to replicate the patient's blood pressure based upon measuring the pleth signal received from the LED-PD pair of the finger cuff 104. Further, the control circuitry may be configured to: control the opening of the internal valve to release pneumatic pressure from the bladder; or the internal valve may simply be an orifice that is not controlled. Additionally, the control circuitry may be configured to: measure the patient's blood pressure by monitoring the pressure of the bladder based upon the input from a pressure sensor, which should be related to or the same as patient's blood pressure, and may display the patient's blood pressure on the patient monitoring device 140.
In another embodiment, a conventional pressure generating and regulating system may be utilized, in which, a pump 133 is located remotely from the body of the patient. In this embodiment, the blood pressure measurement controller 120 receives pneumatic pressure from remote pump 133 through tube 132 and passes on the pneumatic pressure through tube 123 to the bladder of finger cuff 104. Blood pressure measurement device controller 120 may also control the pneumatic pressure (e.g., utilizing a controllable valve) applied to the finger cuff 104 as well as other functions. In this example, the pneumatic pressure applied by the pump 133 to the bladder of finger cuff 104 to replicate the patient's blood pressure based upon measuring the pleth signal received from the LED-PD pair of the finger cuff 104 (e.g., to keep the pleth signal constant) and measuring the patient's blood pressure by monitoring the pressure of the bladder may be controlled by the blood pressure measurement controller 120 and/or a remote computing device and/or the pump 133 and/or the patient monitoring device 140 to implement the volume clamping method. In some embodiments, a blood pressure measurement controller 120 is not used at all and there is simply a connection from tube 132 from a remote pump 133 including a remote pressure regulatory system to finger cuff 104, and all processing for the pressure generating and regulatory system, data processing, and display is performed by a remote computing device.
Also, a heart reference sensor (HRS) 134 may be utilized with the finger cuff system 102 to compensate for pressures generated by height differences between the patient's finger and heart. The HRS 134 may connect a liquid filled bladder located at the patient's heart level to a pressure sensor located at the patient's finger or at the blood pressure measurement controller 120 at the wrist, or at other locations near the patient's finger, through a liquid filled tube 136. The gravity generated pressures between the patient's heart level and finger level are measured by the HRS 134 and subtracted from the finger cuff pressure sensor in the system's data processing software/algorithms. Continuing with this example, the blood pressure measurement controller 120 utilizing the volume clamp method: controls the pneumatic pressure applied to the bladder of finger cuff 104 to replicate the patient's blood pressure based upon measuring the pleth signal received from the LED-PD pair of the finger cuff 104 (e.g., to keep the pleth signal constant); measures the patient's blood pressure by monitoring the pressure of the bladder; and subtracts out the gravity generated pressure differences between the patient's heart level and finger level as measured by the HRS 134 in calculating the patient's blood pressure. Aspects of this will be described in more detail hereafter.
Continuing with this example, as shown in
As an example, as can be seen in
With additional reference to
Embodiments of the invention may relate to utilizing non-plasticized or chemically inert tubing 136 as the tubing 136 between the HRS 134 at the patient's heart level and a pressure sensor of the HRS coupled to the blood pressure measurement controller 120 of the finger cuff system 102, as will be described in more detail hereafter. A more resilient HRS system used with a finger cuff system may be achieved by utilizing non-plasticized tubing or chemically inert tubing. In particular, an HRS 134 used with a finger cuff system that incorporates non-plasticized tubing 136, chemically inert tubing 136, chemically resistant PVC tubing 136, or PVC tubing having a chemically resistant liner 136, has improved signal stability over long periods of time. By incorporating this type of tubing to contain oil (e.g., bioblend oil), bulging of the bladder of the HRS 134 at the patient's heart level may be prevented, which causes a rise in pressure over time that causes drift and difficulty in the zeroing functions of the HRS 134. As has been described, plasticizer from PVC tubing migrates into bioblend oil, causing excess oil-plasticizer mixture inside the tubing. The use of non-plasticized or chemically inert tubing maintains a constant amount of oil that fills the tubing thus providing a measurable stable signal over extended periods of time for the HRS.
With additional reference to
In particular, the HRS 134 may include first portion 135 that includes a housing that contains a bladder for mounting proximate the patient's heart level, tubing 136, and a pressure sensor 137 that is coupled to the blood pressure measurement controller 120. As an example, the finger cuff 104 may be attached to a patient's finger and the first portion 135 of the HRS 134 may be mounted proximate the patient's heart level, in which, the first portion of the HRS 134 includes a bladder. Further, a second portion 139 of the HRS includes the pressure sensor 137 that is mounted proximate to the finger cuff 104. For example, the pressure sensor 137 may be mounted to the same finger as the finger cuff or a different finger, or may be directly mounted to the blood pressure measurement controller 120. Therefore, the HRS 134 includes a first portion 135 including a bladder mounted proximate the patient's heart level, tubing 136, and a second portion 139 including the pressure sensor 137.
In particular, as has been described, the blood pressure measurement controller 120 is coupled to the HRS 134 and the finger cuff 104 to perform blood pressure measurement functions. The pressure sensor 137 may be located at approximately the same height level of the finger cuff 104. Further, the tubing 136 extends from the top first portion 135 of the HRS 134 including the HRS bladder to the pressure sensor 137. The HRS bladder includes liquid in fluid communication with liquid in the tube 136 connected to pressure sensor 137 at the patient's finger level, such that, gravity generated pressure differences between the patient's heart level and finger level are measured by the pressure sensor 137 of the HRS 134, to be subtracted from the blood pressure measurement processed by the blood pressure measurement controller 120.
As has been described, as one example, the blood pressure measurement controller 120 utilizing the volume clamp method: controls the pneumatic pressure applied to the bladder of finger cuff 104 (e.g., from a pump 133) to replicate the patient's blood pressure based upon measuring the pleth signal received from the LED-PD pair of the finger cuff 104 (e.g., to keep the pleth signal constant); measures the patient's blood pressure by monitoring the pressure of the bladder of the finger cuff; and subtracts out the gravity generated pressure differences between the patient's heart level and finger level as measured by the pressure sensor 137 of the HRS 134 in calculating the patient's blood pressure. Further, the patient monitoring device 140 may display physiological readings/data of a patient including blood pressure, as well as any other suitable physiological patient readings.
As an example, it should be appreciated that in operation, a healthcare provider may: attach the finger cuff 104 to the patient's finger; attach the blood pressure measurement controller 120 to the patient's wrist; mount the top first portion 135 of the HRS 134 proximate the patient's heart level; and attach or mount the pressure sensor 137 of the second portion 139 of the HRS to the blood pressure measurement controller 120 or to the patient's finger. It should be appreciated that this is merely an example of setting up the system and many other operations and ordering of operations are possible.
As an example, the tubing 136 may be non-plasticized tubing or chemically inert tubing. For example, the non-plasticized or chemically inert tubing 136 may include a flexible polymer. This type of chemically inert flexible polymer tubing may include at least one or more of: polyurethane, polyolefin, polyester, co-polyester, polyamide, co-polyamide, or fluoropolymer. As another example, the non-plasticized tube 136 may be flexible PVC tube lined with a flexible polymer. The flexible polymer lining of the PVC tube may include at least one or more of: polyurethane, polyolefin, polyester, co-polyester, polyamide, co-polyamide, or fluoropolymer.
With additional reference to
With additional reference to
It should be appreciated that the examples provided in
In particular, as described above, the blood pressure measurement controller 120 is coupled to the HRS 134 and the finger cuff 104 to perform blood pressure measurement functions. The pressure sensor 137 may be located at approximately the same height level of the finger cuff 104. Further, the tubing 136 extends from the top first portion 135 of the HRS 134 including the HRS bladder 402 to the pressure sensor 137. The HRS bladder 402 includes oil in fluid communication with oil in the tube 136 connected to pressure sensor 137 at the patient's finger level, such that, gravity generated pressure differences between the patient's heart level and finger level are measured by the pressure sensor 137 of the HRS 134, to be subtracted from the blood pressure measurement processed by the blood pressure measurement controller 120.
By incorporating non-plasticized or chemically inert tubing 136 to contain oil between the bladder 402 of the HRS 134 at the patient's heart level and the pressure sensor 137 of the HRS 134, a more resilient HRS system used with a finger cuff system may be achieved. In particular, an HRS 134 used with a finger cuff system that incorporates non-plasticized tubing 136, chemically inert tubing 136, chemically resistant PVC tubing 136, or PVC tubing having a chemically resistant liner 136, has improved signal stability over long periods of time. By incorporating this type of tubing to contain oil (e.g., bioblend oil), bulging of the bladder of the HRS 134 at the patient's heart level may be prevented, which causes a rise in pressure over time that causes drift and difficulty in the zeroing functions of the HRS 134. As has been described, plasticizer from PVC tubing migrates into bioblend oil, causing excess oil-plasticizer mixture inside the tubing. The use of non-plasticized or chemically inert tubing maintains a constant amount of oil that fills the tubing thus providing a measurable stable signal over extended periods of time for the HRS.
It should be appreciated that aspects of the invention previously described may be implemented in conjunction with the execution of instructions or code by processors, circuitry, controllers, control circuitry, etc. (e.g., processor, circuitry, etc., of the blood pressure measurement controller). As an example, control circuitry may operate under the control of a program, algorithm, code, routine, or the execution of instructions to execute methods or processes in accordance with embodiments of the invention previously described. For example, such a program may be implemented in firmware or software (e.g. stored in memory and/or other locations) and may be implemented by processors, control circuitry, and/or other circuitry, these terms being utilized interchangeably. Further, it should be appreciated that the terms processor, microprocessor, circuitry, control circuitry, circuit board, controller, microcontroller, etc., refer to any type of logic or circuitry capable of executing logic, commands, instructions, software, firmware, functionality, etc., which may be utilized to execute embodiments of the invention.
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, non-transitory computer readable medium, 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 the benefit of U.S. Provisional Patent Application No. 62/683,798 filed Jun. 12, 2018, which is incorporated by reference herein in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62683798 | Jun 2018 | US |
