Embodiments of the invention relate generally to non-invasive blood pressure measurement. More particularly, embodiments of the invention relate to the performance of diagnostic procedures for a volume clamp finger cuff.
Volume clamping is a technique for non-invasively measuring blood pressure in which pressure is applied to a patient'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 or wrapped 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 are used in 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 patient's blood pressure.
Today, finger cuff based blood pressure monitoring devices generally use the same technology (e.g., photoplethysmography or similar technologies) to measure blood pressure. Unfortunately, such finger cuff devices may not be easily attachable to a patient's finger and may not be that accurate due to the finger cuff's positioning on the patient's finger. That is, attaching the finger cuff in a suboptimal way may negatively influence the measurement reliability and accuracy of the volume clamp system. For example, a loose finger cuff on the patient's finger may require the bladder to stretch in order to reach the finger. Therefore, this may lead to the additional consumption of energy and a reading of an artificially high blood pressure.
Embodiments of the invention may relate to a system to monitor a finger cuff connectable to a patient's finger to be used in measuring the patient's blood pressure by a blood pressure measurement system utilizing the volume clamp method and to measure the plethysmogram of the finger cuff. The system comprises the finger cuff that includes an enclosing portion that encloses a patient's finger. The enclosing portion includes a bladder and a light emitting diode (LED) and photodiode (PD) pair. The system further comprises a processor to: command applying pneumatic pressure to the bladder of the finger cuff from a low pressure to a high pressure; measure the plethysmogram of the finger cuff as the pressure increases from the low pressure to the high pressure; and determine the fitness of the finger cuff on the patient's finger based on the measured plethysmogram. When the finger cuff is placed around the patient's finger, the bladder and the LED-PD pair aid the processor in measuring the plethysmogram.
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The blood pressure measurement system 102 may further be connected to a patient monitoring device 130, and, in some embodiments, a pump 134. Further, finger cuff 104 may include a bladder (not shown) and an LED-PD pair (not shown), which are conventional for finger cuffs.
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 circuity. 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 the same as patient's blood pressure, and may display the patient's blood pressure on the patient monitoring device 130.
In another embodiment, a conventional pressure generating and regulating system may be utilized, in which, a pump 134 is located remotely from the body of the patient. In this embodiment, the blood pressure measurement controller 120 receives pneumatic pressure from remote pump 134 through tube 136 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 134 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 134 and/or the patient monitoring device 130 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 136 from a remote pump 134 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.
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In one embodiment, pressure generating and regulating system 220 and control circuitry 230 may automatically perform diagnostic procedures (e.g., a series of tests) to assess equipment statuses (e.g., pump performance, valve performance), finger cuff fitness (e.g., tightness, location and fit), and/or patient suitability (e.g., patient's perfusion) for the volume clamp method. In some embodiments, the diagnostic procedures may be performed at system start-up and/or during system run time of the pressure generating and regulating system 220 and/or control circuitry 230 to obtain and assess various metrics associated with the equipment statuses, finger cuff fitness, and patient suitability.
A plethysmogram, or pleth signal, obtained by the bladder 212 and LED-PD pair 214 contains two parts. The finger pulsatility, also known as the AC pleth, is the pulsation due to the subject's heart beats. The pulsatility can be changed by applying pressure to the finger, for example by the bladder 212, that confine the artery's movement within the finger. The finger blood volume, also known as the DC pleth, excludes changes due to the subject's heart beats. Rather, it is the steady background level of light absorbing blood and tissue in the finger. The finger blood volume can be changed by applying pressure to the finger, for example by the bladder 212, which squeezes blood, both arterial and venous, out of the finger. Both pulsatility and blood volume can be characterized as functions of external pressure applied by the bladder 212.
In particular, pressure generating and regulating system 220 in cooperation with control circuitry 230 may apply pneumatic pressure to bladder 212 from a low pressure, e.g., 20-40 millimeter of mercury (mmHg), to a high pressure (e.g., 200 mmHg) and measure the plethysmogram of finger cuff 202 as the pressure increases from the low pressure to the high pressure. That is, in one embodiment, the pressure generating and regulating system 220 and control circuitry 230 (by way of bladder 212 and LED-PD pair 214) may make continuous volumetric measurements (or plethysmogram) of arterial blood flows within the patient's finger as the pressure increases from the low pressure to the high pressure. Thus, pulsatility and blood volume in the finger may be detected based on the plethysmogram, which may be generated based on the pleth signal received from the PD of LED-PD pair 214. Based on the measured pulsatility and/or blood volume of finger cuff 202, the control circuitry 230 may determine the fitness of finger cuff 202 on the patient's finger. For example, the control circuitry 230 may determine whether finger cuff 202 is loose, properly fitted, or too tight on the patient's finger.
In some embodiments, in determining the fitness of finger cuff 202, the pressure generating and regulating system 220 and control circuitry 230 may apply multiple pressure sequences to the finger cuff 202, and the pleth signal received from LED-PD pair 214 may be acquired and analyzed. For example, a low pressure (e.g., 20-40 mmHg) may be applied to bladder 212, and the pleth signal may be measured as the pressure of the bladder increases to the low pressure. A high pressure (200 mmHg) may then be applied to bladder 212 and held for a time period (e.g., 1 second), and during such time period, the pleth signal may again be measured. Subsequently, the pressure from bladder 212 may be released (e.g., by turning off the pump) and the pressure decay may be observed. The pleth signal may be measured throughout the pressure decay, and in some embodiments, for an additional time period (e.g., 3 seconds or any suitable amount of time) after the pump has been turned off. Based on the various measurements of the pleth signal, as previously described, the control circuitry 230 may determine whether finger cuff 202 is loose, properly fitted, or too tight on the patient's finger (as described in more detail with respect to
In some embodiments, with respect to equipment statuses, control circuitry 230 may check pump performance of the pressure generating and regulating system 220. For example, control circuitry 230 may control a designated pneumatic pressure applied by the pump to the bladder 212 of the finger cuff 202. Control circuitry 230 may then determine whether the pump has reached the designated pressure. If the pump does not reach the designated pressure, control circuitry 230 may determine that the pump is inoperable. Otherwise, control circuitry 230 may then determine whether the ratio of the designated pressure to the power of the pump during pressure impulse is within a desired ratio. If the ratio is not within the desired ratio, control circuitry 230 may determine that the pump is inoperable. In this case, an operator (e.g., healthcare provider) may be instructed to replace parts of the pump (e.g., servo unit).
In some embodiments, if a valve is present in pressure generating and regulating system 220, the valve may be utilized to release pneumatic pressure from bladder 212. In this case, control circuitry 230 may determine whether a leakage rate with the pump off and the valve closed is above a leakage threshold. If the leakage rate is not above the leakage threshold, control circuitry 230 may determine that a leakage exists in pressure generating and regulating system 220. In this scenario, the operator may be instructed to check one or more connections between the servo and finger cuff 202. If such condition occurs for a number of times (e.g., three times), the operator may be instructed to replace finger cuff 202. If the condition continues to occur after the replacement of finger cuff 202, control circuitry 230 may determine that the valve is inoperable and instruct the operator to replace, for example a servo unit associated with the valve.
In some embodiments, with respect to patient suitability, control circuitry 230 may check the patient's perfusion, which is the volume of blood flow through the finger. For example, control circuitry 230 may determine whether the blood volume measured at the end of recovery time, for example a DC Pleth magnitude, has returned to an initial value measured at the low pressure, thereby indicating that blood has returned to the finger. If the blood volume measured at the end of the recovery time has not returned to the initial value (i.e., the blood has not fully returned), control circuitry 230 may determine that the patient's perfusion is too low for the volume clamp system to operate properly. In this case, the operator may be instructed to increase the patient's perfusion by warming the hand or to select a different pressure monitoring technology.
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It should be appreciated that aspects of the invention previously described may be implemented in conjunction with the execution of instructions by processors, circuitry, controllers, control circuitry, etc. As an example, control circuity may operate under the control of a program, algorithm, 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, 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. 62/594,111, filed Dec. 4, 2017, the contents of which are incorporated herein by reference in its entirety.
Number | Date | Country | |
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62594111 | Dec 2017 | US |