Patent Application
20250127409
The present teachings relate generally to blood pressure monitoring and, more particularly, to blood pressure monitoring with the use of ultrasound and methods thereof.
Automated non-invasive blood pressure monitoring is an essential component of modern medical management and measures an important vital sign. Current oscillometric automated blood pressure cuffs have several limitations. Oscillometric blood pressure cuffs perform poorly in obese patients, patients with severe vascular disease, and during episodes of low blood pressure. Furthermore, they do not directly measure systolic blood pressure, but rather estimate it from the mean arterial pressure (MAP). Accurate non-invasive blood pressure monitoring in subjects with non-pulsatile flow, such as those with left ventricular assist devices (LVAD) or on veno-arterial extracorporeal membrane oxygenation (VA-ECMO) can also be challenging.
In patients with non-pulsatile flow, non-invasive blood pressure is usually obtained with multiple devices, such as an audible hand-held vascular Doppler with a manual sphygmometer. The hand-held vascular Doppler is placed over the presumed location of an artery and adjusted until arterial flow is audible. The sphygmometer is inflated until the sound goes away, and then slowly deflated. The pressure at which the sound returns (or disappears) is generally referred to as the mean arterial pressure (MAP). In critically ill patients or those undergoing anesthesia, frequent blood pressure measurement can be difficult because any movement of the patient or measurement apparatus can result in loss of the signal, even after the location is marked on the skin. Thus, it may be sometimes unclear if the Doppler simply moved and can be realigned for repeat measurement (a frequent occurrence), or if the patient has lost a perfusing blood pressure and is in fact in a state equivalent to pulseless electrical activity (a rare occurrence). Therefore, one or more invasive arterial lines are often placed even for short elective procedures. However, because patients with LVADs are medically fragile and require frequent procedures such as upper and lower endoscopy, multiple arterial line placements lead to scarring, making monitoring increasingly difficult or impossible in the future and compromising blood flow to extremities. More than 50 million surgeries are performed each year in the United States, and 234 million globally. Furthermore, more than 25,000 LVADs have been implanted in the US with greater than 2,500 new implants per year. In a given year, close to 16% of these patients undergo surgery.
Therefore, it would be beneficial to have a minimally invasive device and methods for continuous automated blood pressure monitoring of patients during various procedures and/or in various stages of care.
The following presents a simplified summary in order to provide a basic understanding of some aspects of one or more embodiments of the present teachings. This summary is not an extensive overview, nor is it intended to identify key or critical elements of the present teachings, nor to delineate the scope of the disclosure. Rather, its primary purpose is merely to present one or more concepts in simplified form as a prelude to the detailed description presented later.
A method of automatically measuring blood pressure is disclosed. The method of automatically measuring blood pressure includes applying a sphygmometer cuff coupled to a transducer capable of detecting an imaging signal to an extremity of a patient. The method of automatically measuring blood pressure also includes contacting the transducer to a location on the extremity adjacent to the applied sphygmometer cuff and corresponding to a location of a vessel of interest. The method of automatically measuring blood pressure also includes inflating the sphygmometer cuff to increase an applied pressure to the extremity until no detectable color flow imaging signal is present in the vessel of interest. The method of automatically measuring blood pressure also includes deflating the sphygmometer cuff to reduce the applied pressure to the extremity until a detectable color flow imaging signal is present in the vessel of interest. The method of automatically measuring blood pressure also includes generating an imaging signal from analyzing a detected image from the vessel of interest. The method of automatically measuring blood pressure also includes analyzing the imaging signal and the applied pressure to determine blood pressure within the vessel of interest. The method of automatically measuring blood pressure may include where the location on the extremity is overlying a presumed location of a brachial artery. The location on the extremity may be overlying a presumed location of a radial artery. A non-pulsatile flow or a pulsatile flow may be measured.
Another method of automatically measuring blood pressure is disclosed. The method of automatically measuring blood pressure may include applying a tonometer coupled to an imaging detector to an extremity of a patient. The method of automatically measuring blood pressure also includes contacting the imaging detector to a location on the extremity adjacent to the applied tonometer and corresponding to a location of a vessel of interest. The method of automatically measuring blood pressure also includes generating an imaging signal from analyzing a detected image from the vessel of interest. The method of automatically measuring blood pressure also includes analyzing the imaging signal and a pressure signal from the applied tonometer to determine blood pressure. The method of automatically measuring blood pressure may include a contact tonometer. The location on the extremity may be overlying a presumed location of a brachial artery or a radial artery. A non-pulsatile flow or a pulsatile flow may be measured.
Another method of automatically measuring blood pressure is disclosed. The method of automatically measuring blood pressure may include applying a photoacoustic imaging apparatus to an extremity of a patient. The method of automatically measuring blood pressure may include contacting the photoacoustic imaging apparatus to a location on the extremity adjacent to a location of a vessel of interest. The method of automatically measuring blood pressure may include delivering energy to the extremity with the photoacoustic imaging apparatus at the location of the vessel of interest. The method of automatically measuring blood pressure may include receiving a detectable imaging signal from analyzing a detected image from the vessel of interest. The method of automatically measuring blood pressure also may include analyzing the imaging signal and the delivered energy to determine blood flow and blood pressure. The method of automatically measuring blood pressure may include where the location on the extremity is overlying a presumed location of a brachial artery or a radial artery. The method of automatically measuring blood pressure may include measuring a pulsatile flow or a non-pulsatile flow with a sphygmometer cuff. The method of automatically measuring blood pressure may include receiving a pulse wave velocity signal. The method of automatically measuring blood pressure may include receiving a continuous wave signal. The method of automatically measuring blood pressure may include transmitting blood pressure information to an external device.
An automated blood pressure monitoring device is disclosed. The automated blood pressure monitoring device may include a sphygmometer having a pressure cuff, and an ultrasound transducer coupled to and in a position adjacent to the pressure cuff. Another automated blood pressure monitoring device is disclosed. The automated blood pressure monitoring device may include a tonometer having a pressure transducer. The automated blood pressure monitoring device may also include an ultrasound transducer coupled to and in a position adjacent to the pressure transducer. Another automated blood pressure monitoring device is disclosed. The automated blood pressure monitoring device may include a photoacoustic element. The automated blood pressure monitoring device may also include an ultrasound transducer coupled to and disposed in a position in adjacent to the photoacoustic element. The automated blood pressure monitoring device may also include a pressure cuff coupled to and adjacent to the photoacoustic element. Another automated blood pressure monitoring device is disclosed. The automated blood pressure monitoring device may also include a sphygmometer having a pressure cuff, and a photoacoustic element coupled to and in a position adjacent to the pressure cuff. Another automated blood pressure monitoring device is disclosed, which may include a tonometer having a pressure transducer and a photoacoustic element coupled to and in a position adjacent to the pressure transducer.
The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the present teachings and together with the description, serve to explain the principles of the disclosure. In the figures:
It should be noted that some details of the figures have been simplified and are drawn to facilitate understanding of the present teachings rather than to maintain strict structural accuracy, detail, and scale.
Reference will now be made in detail to exemplary embodiments of the present teachings, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same, similar, or like parts.
Bedside ultrasound machines that include color flow Doppler for vascular identification are now ubiquitous in the operating room, emergency department, and ICU. Because of the difficulty associated with identifying arterial flow with audible handheld vascular Doppler, color flow Doppler ultrasound is more capable of identifying brachial and/or radial arteries and other vessels in patients, particularly in patients having conditions such as LVAD to facilitate audible handheld Doppler placement for non-invasive blood pressure monitoring. It has also been established that both the handheld vascular Doppler reporting the signal as a sound signal and the color flow Doppler reporting the signal as color on an image measure the same Doppler signal. Furthermore, color flow Doppler ultrasound can be significantly easier in terms of identifying and maintaining the Doppler signal as compared to audible handheld vascular Doppler ultrasound. Due to the ease of obtaining a signal using color flow Doppler with ultrasound this may be used in conjunction with adjunct measurement devices or methods to facilitate blood pressure measurement in patients with LVAD undergoing anesthesia and with other complications or states of care. These automated blood pressure measurements utilizing color flow Doppler measurement methods should correlate with the more invasive yet accurate method of arterial line pressure monitoring.
Embodiments of the devices disclosed herein have the capability of more accurately measuring systolic blood pressure in all patients and offer continuous blood pressure estimates. In embodiments described herein, the blood pressure in patients with low flow states, including LVADS and VA-ECMO may be measured via non-invasive measurement. Devices as described herein may also enable direct visualization of flow in the artery, as well as arterial caliber and other patient vital signs and measurements. In an embodiment described herein, an automated blood pressure measurement device cuff using ultrasound, including measurements of colorflow, pulse wave, continuous Doppler, strain and area change, or combinations thereof. In addition, we plan to utilize 3D ultrasound to enhance function. The device, according to embodiments, may include a pressure inducing element, such as a sphygmometer or sphygmomanometer or sphygmometer cuff, tonometer, or combinations thereof, coupled with an ultrasound or photoacoustic transducer that contacts the skin on the extremity adjacent to the pressure measuring element. The cuff or pressure inducing element and ultrasonic transducer, or light source and detector are positioned such that the transducer is overlying the presumed location of the brachial or radial artery, as well as other target vessels of the lower extremity or in other anatomical locations, such as the neck of a patient (carotid artery). Such a device, according to embodiments automatically measures, recognizes, and analyzes an arterial and blood flow signal by Doppler, including color flow, pulse wave velocity, and continuous measurements. In certain embodiments, a sphygmometer cuff may inflate until there is no longer a measurable flow through the artery, then it will deflate until a color flow signal is once again measurable. Next, the flow patterns may be analyzed to determine mean and diastolic blood pressure, among other patient vital signs. Devices utilizing photoacoustic measurement may measure pulse oximetry, hemoglobin, and temperature. Certain embodiments of devices as described herein can be utilized to estimate arterial flow, cardiac output, and systemic vascular resistance. Certain embodiments may also include continuous wave doppler in order to more accurately determine, and coordinate with known pressure application from the device, the systolic and diastolic pressure of the patient. In a case of non-pulsatile flow in a patient, the pressure at which flow returns could be measured and displayed as the mean arterial pressure (MAP) for either the caregiver or the device user. According to other embodiments, the application of non-occlusive pressure in conjunction with a doppler waveform may be used to estimate a continuous blood pressure waveform, and allows for estimation of cardiac output, systemic vascular resistance (SVR), and other measurements. In certain embodiments, an output ultrasound image and waveform can be displayed visually in a monitor as part of the device, allowing for important confirmation and feedback of hemodynamic status by a clinician or other user of the device. In general, a first embodiment involves inflating a cuff, patch, or other pressure inducing or measuring component to measure blood pressure in a vessel of interest by a detector capable of interpreting, analyzing, and/or calculating blood pressure from a detected image. Another embodiment involves measuring and detecting a partially occlusive flow in a vessel of interest. Certain embodiments may not include a cuff or patch or direct pressure measuring element, instead utilizing photoacoustic or ultrasonic energy mathematically derive a blood pressure signal from flow velocities within a vessel of interest, thereby determining blood flow and related vital patient data from the data and acquired imaging information. In some cases, a blood pressure cuff or other measuring device may be added to improve reliability of the measurement. Transmission of acquired, analyzed or directly measured blood pressure and other vital sign data may be transmitted to a de-localized or remote location to provide blood pressure or patient vital sign information to an internal or external display, physician's office, a nurse's station, home health monitoring hub, other medical data center, and the like, or combinations thereof.
Various sizes and other configurations may be found in certain embodiments. For example, it should be noted that any of the aforementioned components or device elements may be located on the wearable portion of the device itself, i.e., on the cuff or as a wearable watch or wrist strap device. The detector or imaging component may include ultrasound or photoacoustic based imaging devices and/or detectors. The continuous measurement as enabled by such configurations may enhance the fidelity of the blood pressure derivation and/or measurement. Certain embodiments of an apparatus to measure blood pressure may include an inflatable bladder, wrist-worn device including LED, halogen or laser light source. Computer components, power sources, displays, or wireless communications devices may be integrated or external depending on the embodiment. Other pressure inducing or pressure measurement devices may be used in combination with other device elements, such as pressure cuffs, sphygmometers, or other similar devices known to those skilled in the art. Furthermore, the automated devices as described herein may be used in the measurement and evaluation of vasoreactivity, which involves the occlusion of a vessel for a period of time, evaluating, observing, or measuring dynamic parameters of the vessel, such as diameter changes in the vessel as compared to a baseline measurement, to provide an indication of endothelial dysfunction, cardiovascular reserve, or vascular stiffness. Time of inflation during such a measurement, as well as times between baseline measurements and comparative measurements may be important factors in vasoreactivity measurements as described.
In various embodiments, the apparatus and methods described herein may include a computer readable medium comprising instructions which, when executed by at least one electronic processor, configure the at least one electronic processor to execute one or more of the methods or individual steps of methods for automated measurement of blood pressure. Certain embodiments can further include a software or hardware application to allow a user to control the electronic processor. The software application can be, for example, a non-transitory computer readable medium storing instructions, that when executed by a hardware processor, performs a method of providing a graphical user interface on the display to allow a user to control various options for measurements or displayed information. Optionally, the software application can automatically substitute alternate steps, calculations, or output parameters based on attached accessory devices, such as a sphygmometer cuff, tonometer, photoacoustic transducer, or other pressure inducing device element as described previously herein. The method may further includes receiving an input by a user or a request generated by a user. Instructions can then be provided to operate one or more measurement algorithms to be run by the electronic processor, and a display of information intended for a primary care individual or a secondary care individual or a patient may be generated. The software application or the computer readable medium or electronic processor can then provide further instructions, cues, alarms or other information to a user. Next, a primary or alternate output or display may be transmitted to a display device, and an image representing blood pressure data or other vital signs can be displayed on the display device.
In various embodiments, a hardware configuration may include the computer readable medium which can be used to perform one or more of the processes described above. The hardware configuration may include any type of mobile devices, such as smart telephones, laptop computers, tablet computers, cellular telephones, personal digital assistants, wearable devices, etc. Further, the hardware configuration can include one or more processors of varying core configurations and clock frequencies. The hardware configuration may also include one or more memory devices that serve as a main memory during operations, calculations, or simulations as described herein. For example, during operation, a copy of the software that supports the above-described operations can be stored in one or more memory devices. One or more peripheral interfaces, such as keyboards, mice, touchpads, computer screens, touchscreens, etc., for enabling human interaction with and manipulation of the hardware configuration may also be included. Exemplary hardware configurations can also include a data bus, one or more storage devices of varying physical dimensions and storage capacities, such as flash drives, hard drives, random access memory, etc., for storing data, such as images, files, and program instructions for execution by the one or more processors. One or more network interfaces for communicating via one or more networks, such as Ethernet adapters, wireless transceivers, or serial network components, for communicating over wired or wireless media using protocols may further be included.
Additionally, hardware configurations in certain embodiments can include one or more software programs that enable the functionality described herein. The one or more software programs can include instructions that cause the one or more processors to perform the processes, functions, and operations described herein related to calculations, inputs, simulations, pulsed waveform generation, and combinations thereof. Copies of the one or more software programs can be stored in the one or more memory devices and/or on in the one or more storage devices. Likewise, the data utilized by one or more software programs can be stored in the one or more memory devices and/or on in the one or more storage devices.
Embodiments as described herein provide a significantly improved, automated non-invasive blood pressure monitor. This could serve as alternatives to conventional in-hospital blood pressure cuffs, particularly in intensive care units (ICUs), operating rooms, or recovery areas where frequent, accurate blood pressure measurement is of paramount importance. Furthermore, devices and methods embodied herein include automated blood pressure monitoring capable of specific use in measuring blood pressure in patients with low or non-pulsatile flow, including patients in shock and those with a left ventricular assist device (LVAD) or on veno-arterial extracorporeal membrane oxygenation (VA-ECMO). Intraoperative blood pressure monitoring of patients with LVADs or on ECMO is often labor intensive, invasive, and unreliable. Often, a highly trained clinician medical doctor (MD) or certified registered nurse anesthetist (CRNA) is dedicated to this single measurement for the duration of a procedure while others conduct the rest of the anesthetic or associated treatment procedures. An automated blood pressure monitor for these patients as disclosed herein would have further advantages of liberating costly human resources from this duty.
Any of the foregoing embodiments wherein an image is generated, or a vital sign measurement is mathematically derived may require the use of a computer readable medium. A computer readable medium may include instructions which, when executed by at least one electronic processor, configure the at least one electronic processor to execute a method for deriving blood pressure or other vital sign from the automated blood pressure monitoring apparatus as described herein. Certain embodiments can further include a software or hardware application to allow a user to control the electronic processor. The software application can be, for example, a non-transitory computer readable medium storing instructions, that when executed by a hardware processor, performs a calculation or estimate to populate a graphical user interface on a display to allow a user to control various readouts or displays of various vital sign information pertaining to a patient. This data, estimate, or calculation may be received via a wired connection or via a transmitted data stream. The software application or the computer readable medium or electronic processor can then provide instructions to the display or provide user instructions or options for alternate display information. Next, an output of the simulation, calculations, visual representations, or data outputs may be transmitted to an external device or display device.
In various embodiments, a hardware configuration may include the computer readable medium which can be used to perform one or more of the processes described above. The hardware configuration may include any type of mobile devices, such as smart telephones, laptop computers, tablet computers, cellular telephones, personal digital assistants, etc. Further the hardware configuration can include one or more processors of varying core configurations and clock frequencies. The hardware configuration may also include one or more memory devices that serve as a main memory during operations, calculations, or simulations as described herein. For example, during operation, a copy of the software that supports the above-described operations can be stored in one or more memory devices. One or more peripheral interfaces, such as keyboards, mice, touchpads, computer screens, touchscreens, etc., for enabling human interaction with and manipulation of the hardware configuration may also be included. Exemplary hardware configurations can also include a data bus, one or more storage devices of varying physical dimensions and storage capacities, such as flash drives, hard drives, random access memory, etc., for storing data, such as images, files, and program instructions for execution by the one or more processors. One or more network interfaces for communicating via one or more networks, such as Ethernet adapters, wireless transceivers, or serial network components, for communicating over wired or wireless media using protocols may further be included.
Additionally, hardware configurations in certain embodiments can include one or more software programs that enable the functionality described herein. The one or more software programs can include instructions that cause the one or more processors to perform the processes, functions, and operations described herein related to calculations, inputs, simulations, pulsed waveform generation, and combinations thereof. Copies of the one or more software programs can be stored in the one or more memory devices and/or on in the one or more storage devices. Likewise, the data utilized by one or more software programs can be stored in the one or more memory devices and/or on in the one or more storage devices.
If implemented in software, the functions can be stored on or transmitted over a computer-readable medium as one or more instructions or code. Computer-readable media includes both tangible, non-transitory computer storage media and communication media including any medium that facilitates transfer of a computer program from one place to another. A storage media can be any available tangible, non-transitory media that can be accessed by a computer. By way of example, and not limitation, such tangible, non-transitory computer-readable media can comprise RAM, ROM, flash memory, or EEPROM. Also, any connection is properly termed a computer-readable medium. For example, if the software is transmitted from a website, server, or other remote source using a coaxial cable, fiber optic cable, twisted pair, digital subscriber line (DSL), or wireless technologies such as infrared, radio, and microwave, then the coaxial cable, fiber optic cable, twisted pair, DSL, or wireless technologies such as infrared, radio, and microwave are included in the definition of medium. Combinations of the above should also be included within the scope of computer-readable media.
In one or more exemplary embodiments, the functions described can be implemented in hardware, software, firmware, or any combination thereof. For a software implementation, the techniques described herein can be implemented with modules (e.g., procedures, functions, subprograms, programs, routines, subroutines, modules, software packages, classes, and so on) that perform the functions described herein. A module can be coupled to another module or a hardware circuit by passing and/or receiving information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, or the like can be passed, forwarded, or transmitted using any suitable means including memory sharing, message passing, token passing, network transmission, and the like. The software codes can be stored in memory units and executed by processors. The memory unit can be implemented within the processor or external to the processor, in which case it can be communicatively coupled to the processor via various means as is known in the art.
In one or more exemplary embodiments, the functions described can be implemented in hardware, software, firmware, or any combination thereof. For a software implementation, the techniques described herein can be implemented with modules (e.g., procedures, functions, subprograms, programs, routines, subroutines, modules, software packages, classes, and so on) that perform the functions described herein. A module can be coupled to another module or a hardware circuit by passing and/or receiving information, data, arguments, parameters, or memory contents. Information, arguments, parameters, data, or the like can be passed, forwarded, or transmitted using any suitable means including memory sharing, message passing, token passing, network transmission, and the like. The software codes can be stored in memory units and executed by processors. The memory unit can be implemented within the processor or external to the processor, in which case it can be communicatively coupled to the processor via various means as is known in the art.
While the present teachings have been illustrated with respect to one or more implementations, alterations and/or modifications may be made to the illustrated examples without departing from the spirit and scope of the appended claims. For example, it may be appreciated that while the process is described as a series of acts or events, the present teachings are not limited by the ordering of such acts or events. Some acts may occur in different orders and/or concurrently with other acts or events apart from those described herein. Also, not all process stages may be required to implement a methodology in accordance with one or more aspects or embodiments of the present teachings. It may be appreciated that structural objects and/or processing stages may be added, or existing structural objects and/or processing stages may be removed or modified. Further, one or more of the acts depicted herein may be carried out in one or more separate acts and/or phases. Furthermore, to the extent that the terms “including,” “includes,” “having,” “has,” “with,” or variants thereof are used in either the detailed description and the claims, such terms are intended to be inclusive in a manner similar to the term “comprising.” The term “at least one of” is used to mean one or more of the listed items may be selected. Further, in the discussion and claims herein, the term “on” used with respect to two materials, one “on” the other, means at least some contact between the materials, while “over” means the materials are in proximity, but possibly with one or more additional intervening materials such that contact is possible but not required. Neither “on” nor “over” implies any directionality as used herein. The term “conformal” describes a coating material in which angles of the underlying material are preserved by the conformal material. The term “about” indicates that the value listed may be somewhat altered, as long as the alteration does not result in nonconformance of the process or structure to the illustrated embodiment. The terms “couple,” “coupled,” “connect,” “connection,” “connected,” “in connection with,” and “connecting” refer to “in direct connection with” or “in connection with via one or more intermediate elements or members.” Finally, the terms “exemplary” or “illustrative” indicate the description is used as an example, rather than implying that it is an ideal. Other embodiments of the present teachings may be apparent to those skilled in the art from consideration of the specification and practice of the disclosure herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the present teachings being indicated by the following claims.
This application is the national stage entry of International Patent Application No. PCT/US2022/039379, filed on Aug. 4, 2022, and published as WO 2023/033983 A1 on Mar. 9, 2023, which claims the benefit of U.S. Provisional Patent Application Ser. No. 63/240,073, filed Sep. 2, 2021, which are hereby incorporated by reference herein in their entireties.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2022/039379 | 8/4/2022 | WO |
| Number | Date | Country | |
|---|---|---|---|
| 63240073 | Sep 2021 | US |
