WO2020112548A1

WO2020112548A1 - Method and device for manual entry of vertical height difference between measurement site and heart level for non-invasive blood pressure monitor

Info

Publication number: WO2020112548A1
Application number: PCT/US2019/062807
Authority: WO
Inventors: Sandarsh Mohan KUMAR; Peter James IFFT; Quintin Man Ip ENG
Original assignee: Edwards Lifesciences Corporation
Priority date: 2018-11-27
Filing date: 2019-11-22
Publication date: 2020-06-04

Abstract

Disclosed is a method for receiving manual entry of a vertical height difference for use in non-invasive continuous blood pressure monitoring, comprising: receiving a clinical environment or patient positioning mode selection; determining whether manual entry of the vertical height difference is acceptable based on tire received clinical environment or patient positioning mode selection; in response to determining that the manual entry of the vertical height difference is acceptable, and in response to a determination that a heart reference sensor (HRS) is not connected: prompting a user to manually enter the vertical height difference between a blood pressure measurement site and a patient heart level; receiving the manually entered vertical height difference from the user; and utilizing the manually entered vertical height difference to compensate for hydrostatic pressure differences in non-invasive continuous blood pressure monitoring.

Description

METHOD AND DEVICE FOR MANUAL ENTRY OF VERTICAL HEIGHT

DIFFERENCE BETWEEN MEASUREMENT SITE AND HEART LEVEL FOR NON¬

INVASIVE BLOOD PRESSURE MONITOR

BACKGROUND

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 62/771,696 filed November 27^th, 2018, which is incorporated by reference herein in its entirety.

Field

[0002] Embodiments of the invention relate to non-invasive blood pressure measurement.

Relevant Background

[0003] Volume clamping is a technique for non-invasively measuring blood pressure whereby pressure is applied to a patient's finger in such a manner that arterial pressure is 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 can be measured thus providing a reading of the patient’s arterial blood pressure.

[0004] Conventionally, a patient is required to keep the measurement site (e.g., die finger) at the heart level throughout the period monitoring. In an alternative conventional system, a Heart Reference Sensor (HRS) is used to compensate for hydrostatic pressure differences due to changes in height of the finger relative to the heart, with one end placed at the level of the patient’s finger and the other at heart level.

[0005] Systems that require patients to maintain the measurement site at the same position throughout the monitoring period limit the use of the non-invasive blood pressure monitors to certain clinical environments or risk inaccurate measurements. On the other hand, systems that require additional measurement devices, such as an HRS, for their normal operation, may lead to delayed monitoring when the additional compensatory systems malfunction or are unavailable in the moment monitoring needs to be initiated. BRIEF DESCRIPTION OF THE DRAWINGS

[0006] FIG. 1 is a diagram of an example of a blood pressure measurement device, according to an optional example.

[0007] FIG. 2 is a flowchart illustrating an example method for receiving manual entry of a vertical height difference for use in non-invasive continuous blood pressure monitoring according to an optional example.

[0008] FIGs. 3A-D are diagrams illustrating example user interface display content according to an optional example.

[0009] FIG. 4 is a block diagram illustrating an optional example device.

DETAILED DESCRIPTION

[0010] Various embodiments, examples, and aspects of the disclosures will be described with reference to details discussed below, and the accompanying drawings will illustrate the various embodiments and examples. The following description and drawings are illustrative of the disclosure and are not to be construed as limiting the disclosure.

Numerous specific details are described to provide a thorough understanding of various embodiments and examples of the present disclosure. However, in certain instances, well- known or conventional details are not described in order to provide a concise discussion of embodiments and examples of the present disclosures.

[0011] Reference in the specification to“one embodiment” or“an embodiment” or “an optional example” means that a particular feature, structure, or characteristic described in conjunction with the embodiment or example can be included in at least one embodiment or example of the disclosure or may not necessarily be utilized as it may be optional. The appearances of the phrase“in one embodiment” or“an optional example” in various places in the specification do not necessarily all refer to the same embodiment or example.

[0012] Examples of the disclosure may relate to a method for receiving manual entry of a vertical height difference for use in non-invasive continuous blood pressure monitoring, comprising: receiving a clinical environment or patient positioning mode selection;

determining whether manual entry of the vertical height difference is acceptable based on tire received clinical environment or patient positioning mode selection; in response to determining that the manual entry of the vertical height difference is acceptable, and in response to a determination that a heart reference sensor (HRS) is not connected: prompting a user to manually enter the vertical height difference between a blood pressure measurement site and a patient heart level; receiving the manually entered vertical height difference from the user; and utilizing the manually entered vertical height difference to compensate for hydrostatic pressure differences in non-invasive continuous blood pressure monitoring.

[0013] Examples of the disclosure may relate to a method, apparatus, and system for receiving a manual entry of the vertical height difference between the blood measurement site (e.g., the finger) and the heart level. In clinical environments where a manually entered vertical height difference between the measurement site (e.g., the finger) and tire heart level is acceptable for use in non-invasive continuous blood pressure monitoring, a user may manually enter the vertical height difference at the monitoring device. The manually entered vertical height difference is then used in the non-invasive continuous blood pressure monitoring to compensate for hydrostatic pressure differences. In one optional example, an indicator may be provided to indicate that such a manually entered vertical height difference is being used. In one optional example, the user may be periodically reminded to re-check the patient’s position to confirm that the manually entered vertical height difference remains accurate.

[0014] With reference to Figure 1, an example of a blood pressure measurement device 102 will be described, according to an optional example. The blood pressure measurement device 102 may make measurements using the volume clamp method. As shown in Figure 1, the blood pressure measurement device 102 may include a finger cuff 104 having a suitable housing and a suitable finger connector (e.g., including a bladder) that may be attached to a patient’s finger and a blood pressure measurement controller 120 that may be attached to the patient’s body (e.g., a patient’s hand). The blood pressure measurement device 102 may further be connected to a patient monitoring device 130 and a heart reference sensor (HRS) 134. The operations of the blood pressure measurement device 102 including the finger cuff 104 and the blood pressure measurement controller 120 will be hereafter described in more detail. The operations of the blood pressure measurement device 102 including the finger cuff 104 and the blood pressure measurement controller 120 will be hereafter described in more detail. It should be appreciated that aspects of the invention may relate to any non-invasive blood pressure measuring device that may utilize a heart level reference, and a finger cuff is just one optional example.

[0015] Continuing with this optional example, as shown in Figure 1, a patient’s hand may be placed on the face 110 of an arm rest 112 for measuring a patient’s blood pressure with the blood pressure measurement device 102. The blood pressure measurement controller 120 of tire blood pressure measurement device 102 may be coupled to a bladder of the finger cuff 104 through a finger cuff connector 122 in order to provide pneumatic pressure to the bladder for use in blood pressure measurement. Blood pressure measurement controller 120 may be coupled to the patient monitoring device 130 through a power/data cable 132 and to the HRS 134 through an HRS connector 136. The patient monitoring device 130 may be any type of medical electronic device that may read, collect, process, display, etc., physiological readings/data of a patient including blood pressure, as well as any other suitable physiological patient readings. Accordingly, power/data cable may transmit data to and from patient monitoring device 130 and also may provide power from the patient monitoring device 130 to the blood pressure measurement controller 120 and finger cuff 104. As to the HRS 134, one end of the HRS 134 may be placed near the patient’s heart level, and the other end may be connected by the HRS connector 136 to the blood pressure

measurement controller 120 of the blood pressure measurement device 102 to allow for the compensation of potential errors due to differences in height between the finger cuff 104 and the heart level in the calculation of blood pressure measurements.

[0016] As can be seen in Figure 1, in one optional example, the finger cuff 104 may be attached to a patient’s finger and the blood pressure measurement controller 120 may be attached on the patient’s hand with an attachment bracelet 123 that wraps around the patient’s wrist. However, it should be appreciated that the placement of various components of the blood pressure measurement device 102 described above is illustrative and does not limit the disclosure. The various components including the blood pressure measurement controller 120 may be rearranged in other locations. Examples of the disclosure may work with any volume clamp method-based non-invasive finger blood pressure measurement system.

[0017] Finger cuff 104 in conjunction with blood pressure measurement controller 120 may include: a pump, a valve, a pressure sensor and control circuitry; and may be utilized to measure the patient’s blood pressure by monitoring the pressure of the bladder with the pressure sensor using the volume clamp method; and may display die patient’s blood pressure on die patient monitoring device 130, for example, via a display 131.

[0018] As an optional example, of the finger cuff 104 utilizing the volume clamp method, die finger cuff 104 may include a bladder (not shown) and an optical source and optical sensor pair (e.g., an LED-PD pair) (not shown), which are conventional for finger cuffs. In one optional example, die blood pressure measurement system 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 optional example, 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 (e.g., to keep the pleth signal constant). 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 correspond to or be the same as patient’s blood pressure, and may display the patient’s blood pressure on the patient monitoring device 130.

[0019] In another optional example, a conventional pressure generating and regulating system may be utilized, in which, a pump is located remotely from the body of the patient. In this optional example, the blood pressure measurement controller 120 receives pneumatic pressure from the remote pump through a tube and passes on the pneumatic pressure through tube 122 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 optional example, the pneumatic pressure applied by the pump 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 die 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 and/or the patient monitoring device 130 to implement the volume clamping method. In some optional examples, a blood pressure measurement controller 120 is not used at all and there is simply a connection from a tube from a remote pump 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. Therefore, it should be appreciated that the finger cuff 104 may be connected to a blood pressure measurement controller described herein, or a pressure generating and regulating system of any other kind, such as a pressure generating and regulating system that is located remotely from the body of the patient. Any kind of pressure generating and regulating system can be used, including but not limited to the previously described blood pressure measurement controller, and may be described simply as a pressure generating and regulating system that may be used with a finger cuff 104 including an LED-PD pair and a bladder to implement die volume clamp method. It should be appreciated that the previously described finger cuff, blood pressure measurement controller, and pressure generating and regulating system are optional examples that may be utilized with the aspects of the invention related to non-invasive continuous blood pressure monitoring with a blood pressure measuring device to be hereafter described, and other optional suitable examples may also be utilized.

[0020] hi one optional example, the use of the HRS 134 may be optional, and a manually entered vertical height difference between the measurement site at which the blood pressure measurement device is located (e.g., the finger) and the heart level may be utilized to compensate for the hydrostatic pressure differences in the continuous monitoring of the patient’s blood pressure utilizing any suitable type of blood pressure measurement device. Using a manually entered vertical height difference may be more suitable in some clinical environments than in others as the manually entered vertical height difference value will not automatically update when the relative position between the measurement site and the heart level changes. In one optional example, manual entry of the vertical height difference may not be suitable for patients in the Emergency Department (ED) because such patients are free to move and tend to move frequently; moreover, the ED is an uncontrolled environment in general. In contrast, there tends to be little or no movement for patients in the Intensive Care Unit (ICU) or Operating Room (OR) setting because, for example, patients in the OR setting are generally under anesthesia. Therefore, the relative height difference between the measurement site (e.g., the finger) and the heart level tends not to change for ICU or patients. Accordingly, in some optional examples, manual entry of the vertical height difference may be more suitable for patients in the ICU or OR.

[0021] Therefore, in one optional example, a clinical environment or patient positioning mode selection may be received from a user (e.g., a clinician), such as, through a user interface of the patient monitoring device 130. If no HRS 134 is connected, and the clinical environment or the patient positioning mode selected by the clinician is one where manual entry of the vertical height difference is acceptable (e.g., in the ICU or OR), the clinician may be provided with the option to manually enter the vertical height difference between the measurement site (e.g., the finger) and the heart level. After receiving the manually entered vertical height difference value from the clinician, the vertical height difference value may be used to compensate for the hydrostatic pressure differences in the continuous blood pressure monitoring. In one optional example, after manually entering die vertical height difference, the clinician may be reminded that blood pressure measurement accuracy may be affected if the patient’s position changes thereafter. On the other hand, in another optional example, if the selected clinical environment is one where manual entry of the vertical height difference is not acceptable (e.g., in the ED), the patient monitoring device 130 may prompt the clinician to connect and calibrate an HRS if one is not already connected.

[0022] In one optional example, after a patient is transferred from a first clinical environment to a second clinical environment, a clinician may update the clinical environment selection. In one optional example, after a patient is transitioned from a first patient positioning mode to a second patient positioning mode, the clinician may update the patient positioning mode selection. In one optional example, if the new clinical environment or the patient positioning mode is one where manual entry of the vertical height difference is acceptable (e.g., in the ICU or OR), and if no HRS 134 is connected, the clinician may be provided with the option to manually enter the vertical height difference between the measurement site (e.g., the finger) and the heart level.

[0023] hi one optional example, an indicator may be provided by the patient monitoring device 130 when a manually entered vertical height difference value is being used. The indicator may be a special icon, an indicator light, or a textual indicator, etc., displayed on the patient monitoring device 130.

[0024] In one optional example, a clinician may be periodically reminded by the patient monitoring device 130 to re-check the patient's position to make sure the manually entered vertical height difference value is still accurate. The reminder may be a popup reminder displayed on the patient monitoring device 130. In one optional example, the reminder period may be user-configurable. For example, the clinician may be reminded every 30 minutes, every 2 hours, every 4 hours, etc.

[0025] In one optional example, during continuous blood pressure monitoring where a manually entered vertical height difference is used, if connection of an HRS 134 is detected, use of the manually entered vertical height difference may be ceased, and the clinician may be prompted to calibrate die HRS. The continuous blood pressure monitoring may then resume using the HRS output to compensate for the hydrostatic pressure differences.

[0026] Referring to Figure 2, a flowchart illustrating an example method 200 for receiving manual entry of a vertical height difference for use in non-invasive continuous blood pressure monitoring according to one optional example is shown. At block 210, a clinical environment or patient positioning mode selection may be received. At block 220, whether manual entry of the vertical height difference is acceptable may be determined based on the received clinical environment or patient positioning mode selection. At block 230, in response to determining that the manual entry of the vertical height difference is acceptable, and in response to a determination that an HRS is not connected, a user may be prompted to manually enter the vertical height difference between a blood pressure measurement site and a patient heart level. At block 240, the manually entered vertical height difference may be received from the user. At block 250, the manually entered vertical height difference may be utilized to compensate for hydrostatic pressure differences in non-invasive continuous blood pressure monitoring. As one optional example, non-invasive continuous blood pressure monitoring may be determined utilizing the finger cuff 104, as previously described.

However, it should be appreciated that any suitable blood pressure monitoring device for non-invasive continuous blood pressure monitoring may be utilized.

[0027] In one optional example, in response to determining that manual entry of die vertical height difference is not acceptable, a user may be prompted to connect and calibrate an HRS. In one optional example, manual entry of the vertical height difference may be determined to be acceptable when the clinical environment or patient positioning mode selection indicates a patient is not free to move (e.g., in an ICU or an OR setting). In one optional example, manual entry of the vertical height difference may be determined to not be acceptable when the clinical environment or patient positioning mode selection indicates a patient is free to move (e.g., in an ED setting).

[0028] In one optional example, an indicator may be provided to indicate that die manually entered vertical height difference is being used in non-invasive continuous blood pressure monitoring. In one optional example, the user may be periodically reminded to check a patient position to confirm the manually entered vertical height difference remains accurate.

[0029] In one optional example, the utilization of the manually entered vertical height difference may be ceased in response to a determination that an HRS has been connected and is to be used to measure the hydrostatic pressure differences.

[0030] Referring to Figures 3A-D, diagrams illustrating example user interface displays 300A-D according to optional examples are shown.

[0031] In particular, referring to Figure 3A1, a diagram illustrating an optional example of a user interface display 300A1, according to one optional example is shown. Figure 3A1 illustrates a clinical environment selection screen. Four options are displayed: Emergency Department, Intensive Care Unit, Operating Room, and Other. Based on the actual clinical environment, a clinician may select the most suitable option. In one optional example, the selection may be used in the determination of whether manual entry of the vertical height difference is acceptable, as previously described.

[0032] Further, referring to Figure 3A2, a diagram illustrating an optional example of a user interface display 300A2, according to one optional example is shown. Figure 3A2 illustrates a patient positioning mode selection screen. A clinician may be prompted to select from a first patient positioning mode indicative of a sedated and stationary patient and a second patient positioning mode indicative of a patient with variable positioning. The selection may be used in the determination of whether manual entry of the vertical height difference is acceptable, as previously described. In particular, manual entry of the vertical height difference is acceptable only when the first patient positioning mode indicative of a sedated and stationary patient is selected. In one optional example, the screen notifies the clinician that an HRS is required if the second patient positioning mode indicative of a patient with variable positioning is selected.

[0033] Referring to Figure 3B, a diagram illustrating an optional example of a user interface display 300B, according to one optional example is shown. Figure 3B illustrates a user interface for entering patient data for a new patient. As shown in the figure, a user may enter a Patient ID, a height, a weight, an age, a gender, and a body surface area (BSA) of the new patient utilizing the user interface. In one optional example, the data may be entered with an onscreen keyboard (not shown) or a regular keyboard or by other suitable means.

[0034] Referring to Figure 3C, a diagram illustrating an optional example of a user interface display 300C, according to one optional example is shown. Figure 3C illustrates a user interface for receiving a manually entered vertical height difference value for use in non- invasive continuous blood pressure monitoring. In one optional example, the clinician may use this interface to designate a relative height difference between the measurement site (e.g., the finger) and the heart level. For example, the height of the measurement site may be within the range of 50 centimeters (cm) below the heart level to 50 cm above die heart level. In one optional example, the clinician may manually enter the height difference based on the patient’s actual position by either using a vertical scroll bar 310 or by directly entering an offset value 320 with an onscreen keyboard (not shown) or a regular keyboard or by other suitable means. It should be appreciated that these are just optional examples of inputting height differences. The user interface further may include an optional example for allowing for a patient posture selection 330, where the clinician may select from three possible patient postures (incline, flat, or decline). [0035] Referring to Figure 3D, a diagram illustrating an optional example of a user interface display 300D, according to one optional example is shown. Figure 3D illustrates a user interface display for continuous patient monitoring. The patient’s current blood pressure and a blood pressure time series plot are shown. In optional example, an indicator 350 is shown to indicate that a manually entered vertical height difference value is used in determining the patient’s blood pressure. In the illustrated optional example, the indicator 350 comprises a textual notification to notify die user that no HRS is connected and the patient positioning should be verified and re-verified from time to time. The user interface 300D may further show: the patient’s stroke volume (SV), systemic vascular resistance (SVR), and systolic blood pressure (SYS) values.

[0036] Referring to Figure 4, a block diagram illustrating an optional example device 400 is shown. It should be appreciated that the device 400 represents a non-limiting optional example of a patient monitoring device 130 implementation. The device 400 may comprise a processor 410, a memory 420, an input/output interface 430, and a storage device 440 connected with a bus 450. Under the control of the processor 410, data may be received from an external source through the input/output interface 430, or from the storage device 440, and stored in the memory 420, and/or may be transmitted from the memory 420 to an external destination through the input/output interface 430, or to the storage device 440. A nonlimiting implementation of the input/output interface 430 may comprise one or more of: a display, a touchscreen, a sensor connector port, a bidirectional communication port, etc. The storage device 440 may be implemented with one or more of: a hard disk drive, a flash drive, etc. The processor 410 may process, add, remove, change, or otherwise manipulate data stored in the memory 420. Further, code may be stored in die memory 420. Alternatively or additionally, code may be stored in the storage device 440, or received through the input/output interface 430, and then transferred to the memory 420. The code, when executed by the processor 410, may cause the processor 410 to perform operations relating to data manipulation and/or transmission and/or any other possible operations.

[0037] Accordingly, one optional example is related to a patient monitoring device 130, comprising: a memory 420; and a processor 410 coupled to the memory 420, the processor to: receive a clinical environment or patient positioning mode selection, determine whether manual entry of a vertical height difference is acceptable based on the received clinical environment or patient positioning mode selection, in response to determining that the manual entry of the vertical height difference is acceptable, and in response to a determination that a heart reference sensor (HRS) 134 is not connected: prompt a user to manually enter the vertical height difference between a blood pressure measurement site and a patient heart level, receive the manually entered vertical height difference from the user, and utilize the manually entered vertical height difference to compensate for hydrostatic pressure differences in non-invasive continuous blood pressure monitoring. Therefore, the functions described herein may be implemented by the patient monitoring device 130, as an optional example, or any other suitable computing device.

[0038] In one optional example, the blood pressure measurement site may be a patient finger. As one optional example, a finger cuff 104 may be a blood pressure measuring device at the blood pressure measurement site. However, as has been described, these are only optional examples of blood pressure measurement devices and blood pressure measurement sites and any suitable blood pressure measurement devices and blood pressure measurement sites may be utilized. In one optional example, the processor 410 of the patient monitoring device 130 is further to: in response to determining that manual entry of the vertical height difference is not acceptable, prompt the user to connect and calibrate an HRS.

[0039] In one optional example, the manual entry of the vertical height difference may be determined to be acceptable when the clinical environment or patient positioning mode selection indicates a patient is not free to move (e.g., in an Intensive Care Unit (ICU) or an Operating Room (OR) setting). In one optional example, the manual entry of the vertical height difference may be determined to be not acceptable when the clinical environment or patient positioning mode selection indicates a patient is free to move (e.g., in an Emergency Department (ED) setting).

[0040] In one optional example, the processor 410 of the patient monitoring device 130 is further to: provide an indicator to indicate that the manually entered vertical height difference is being used in non-invasive continuous blood pressure monitoring. In one optional example, the processor 410 of die patient monitoring device 130 is further to:

periodically remind the user to check a patient position to confirm the manually entered vertical height difference remains accurate. In one optional example, the processor 410 of the patient monitoring device 130 is further to: cease utilization of the manually entered vertical height difference in response to a determination that an HRS has been connected and is to be used to measure the hydrostatic pressure differences. Various optional examples of these implementations have been previously described in detail.

[0041] Therefore, examples of the disclosure are related to receiving a manually entered vertical height difference between a measurement site (e.g., the finger via finger cuff) and the patient heart level for use in non-invasive continuous blood pressure monitoring in clinical environments where such manually entered height difference values are acceptable. Accordingly, an HRS may not be required. The optional examples add to the flexibility of the blood pressure monitoring system in situations where an HRS may not be readily available. Also, as has been described, these are only optional examples of blood pressure measurement devices (e.g., finger cuff) and blood pressure measurement sites (e.g., finger) and any suitable blood pressure measurement devices and blood pressure measurement sites may be utilized.

[0042] 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. (e.g., processor 410 of Figure 4). As an optional example, a processor may operate under the control of a program, algorithm, routine, or the execution of instructions to execute methods or processes (e.g., method 200 of Figure 2) in accordance with examples 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.

[0043] 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.

[0044] 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 ait. 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.

[0045] The previous description of the disclosed optional examples and embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these optional examples and 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.

[0046] The disclosure also includes the following clauses:

1. A method for receiving manual entry of a vertical height difference for use in non-invasive continuous blood pressure monitoring, comprising:

receiving a clinical environment or patient positioning mode selection;

determining whether manual entry of the vertical height difference is acceptable based on the received clinical environment or patient positioning mode selection; and

in response to determining that the manual entry of die vertical height difference is acceptable, and in response to a determination that a heart reference sensor (HRS) is not connected:

prompting a user to manually enter the vertical height difference between a blood pressure measurement site and a patient heart level;

receiving the manually entered vertical height difference from the user; and utilizing the manually entered vertical height difference to compensate for hydrostatic pressure differences in non-invasive continuous blood pressure

monitoring.

2. The method of claim 1, wherein the blood pressure measurement site is a patient finger.

3. The method of any of the claims 1-2, further comprising:

in response to determining that manual entry of the vertical height difference is not acceptable, prompting the user to connect and calibrate an HRS. 4. The method of any of the claims 1-3, wherein manual entry of the vertical height difference is determined to be acceptable when the clinical environment or patient positioning mode selection indicates a patient is not free to move.

5. The method of any of the claims 1-4, wherein manual entry of the vertical height difference is determined to be not acceptable when the clinical environment or patient positioning mode selection indicates a patient is free to move.

6. The method of any of the claims 1-5, further comprising:

providing an indicator to indicate that the manually entered vertical height difference is being used in non-invasive continuous blood pressure monitoring.

7. The method of any of the claims 1-6, further comprising:

periodically reminding the user to check a patient position to confirm the manually entered vertical height difference remains accurate.

8. The method of any of the claims 1-7, further comprising:

ceasing utilization of the manually entered vertical height difference in response to a determination that an HRS has been connected and is to be used to measure the hydrostatic pressure differences.

9. A patient monitoring device, comprising:

a memory; and

a processor coupled to the memory, the processor configured to:

receive a clinical environment or patient positioning mode selection,

determine whether manual entry of a vertical height difference is acceptable based on the received clinical environment or patient positioning mode selection, and

in response to determining that the manual entry of the vertical height difference is acceptable, and in response to a determination that a heart reference sensor (HRS) is not connected: prompt a user to manually enter the vertical height difference between a blood pressure measurement site and a patient heart level,

receive the manually entered vertical height difference from the user, and

utilize the manually entered vertical height difference to

compensate for hydrostatic pressure differences in non-invasive continuous blood pressure monitoring.

10. The patient monitoring device of claim 9, wherein the blood pressure measurement site is a patient finger.

11. The patient monitoring device of any of the claims 9-10, the processor further to:

in response to determining that manual entry of the vertical height difference is not acceptable, prompt the user to connect and calibrate an HRS.

12. The patient monitoring device of any of the claims 9-11, wherein manual entry of the vertical height difference is determined to be acceptable when the clinical environment or patient positioning mode selection indicates a patient is not free to move.

13. The patient monitoring device of any of the claims 9-12, wherein manual entry of the vertical height difference is determined to be not acceptable when the clinical environment or patient positioning mode selection indicates a patient is free to move.

14. The patient monitoring device of any of the claims 9-13, the processor further to:

provide an indicator to indicate that the manually entered vertical height difference is being used in non-invasive continuous blood pressure monitoring.

15. The patient monitoring device of any of the claims 9-14, die processor further to:

periodically remind the user to check a patient position to confirm the manually entered vertical height difference remains accurate. 16. The patient monitoring device of any of the claims 9-15, the processor further configured to:

cease utilization of the manually entered vertical height difference in response to a determination that an HRS has been connected and is to be used to measure the hydrostatic pressure differences.

17. A system to provide for non-invasive continuous blood pressure monitoring, comprising:

a finger cuff attached to a patient’s finger, the finger cuff attached to a patient monitoring device, the patient monitoring device comprising:

a memory; and

a processor coupled to the memory, the processor configured to:

receive a clinical environment or patient

positioning mode selection,

determine whether manual entry of a vertical

height difference is acceptable based on the received

clinical environment or patient positioning mode selection, and

in response to determining that the manual entry

of the vertical height difference is acceptable, and in

response to a determination that a heart reference sensor

(HRS) is not connected:

prompt a user to manually enter the vertical

height difference between die finger cuff and a patient

heart level,

receive die manually entered vertical height

difference from the user, and

utilize the manually entered vertical height

difference to compensate for hydrostatic pressure differences in non-invasive continuous blood pressure

monitoring by the finger cuff. 18. The system of claim 17, the processor of the patient monitoring device further configured to:

19. The system of any of the claims 17-18, wherein manual entry of the vertical height difference is determined to be acceptable when the clinical environment or patient positioning mode selection indicates a patient is not free to move.

20. The system of any of the claims 17-19, wherein manual entry of the vertical height difference is determined to be not acceptable when the clinical environment or patient positioning mode selection indicates a patient is free to move.

21. The system of any of the claims 17-20, the processor of the patient monitoring device further configured to:

22. The system of any of the claims 17-21 , the processor of die patient monitoring device further configured to:

periodically remind the user to check a patient position to confirm the manually entered vertical height difference remains accurate.

23. The system of any of the claims 17-22, the processor of the patient monitoring device further configured to:

Claims

WHAT IS CLAIMED IS:

1. A method for receiving manual entry of a vertical height difference for use in non- invasive continuous blood pressure monitoring, comprising:

receiving a clinical environment or patient positioning mode selection;

in response to determining that the manual entry of the vertical height difference is acceptable, and in response to a determination that a heart reference sensor (HRS) is not connected:

prompting a user to manually enter the vertical height

difference between a blood pressure measurement site and a patient heart level;

receiving the manually entered vertical height difference from tire user; and

utilizing the manually entered vertical height difference to

3. The method of either of the claims 1 or 2, further comprising:

in response to determining that manual entry of the vertical height difference is not acceptable, prompting the user to connect and calibrate an HRS.

4. The method of any of the claims 1-3, wherein manual entry of the vertical height difference is determined to be acceptable when the clinical environment or patient positioning mode selection indicates a patient is not free to move.

5. The method of any of the claims 1-4, wherein manual entry of die vertical height difference is determined to be not acceptable when the clinical environment or patient positioning mode selection indicates a patient is free to move.

6. The method of any of the claims 1-5, further comprising:

7. The method of any of the claims 1-6, further comprising:

8. The method of any of the claims 1-7, further comprising:

9. A patient monitoring device, comprising:

a memory; and

a processor coupled to the memory, the processor configured to:

receive a clinical environment or patient positioning mode selection,

prompt a user to manually enter the vertical

height difference between a blood pressure

measurement site and a patient heart level,

receive the manually entered vertical height

difference from the user, and

utilize the manually entered vertical height

monitoring.

10. The patient monitoring device of claim 9, wherein the blood pressure

measurement site is a patient finger.

11. The patient monitoring device of either of the claims 9 or 10, the processor further configured to:

14. The patient monitoring device of any of the claims 9-13, the processor further configured to provide an indicator to indicate that the manually entered vertical height difference is being used in non-invasive continuous blood pressure monitoring.

15. The patient monitoring device of any of the claims 9-14, the processor further configured to periodically remind the user to check a patient position to confirm the manually entered vertical height difference remains accurate.

16. The patient monitoring device of any of the claims 9-15, the processor further configured to:

17. A system to provide for non-invasive continuous blood pressure monitoring, die system including a finger cuff attached to a patient’s finger, the finger cuff attached to a patient monitoring device, the patient monitoring device comprising:

a memory; and a processor coupled to the memory, the processor configured to:

receive a clinical environment or patient positioning

mode selection,

determine whether manual entry of a vertical height

difference is acceptable based on the received clinical

environment or patient positioning mode selection, and

in response to determining that the manual entry of the

vertical height difference is acceptable, and in response to a

determination that a heart reference sensor (HRS) is not

connected:

prompt a user to manually enter die vertical height difference between the finger cuff and a patient heart level,

receive the manually entered vertical height difference

from the user, and

utilize the manually entered vertical height difference to

compensate for hydrostatic pressure differences in non-invasive continuous blood pressure monitoring by the finger cuff.

18. The system of claim 17, the processor of the patient monitoring device further configured to:

22. The system of any of the claims 17-21, the processor of the patient monitoring device further configured to: