Simulation Device, System, and Related Method for Use in Automated Blood Pressure Monitoring
The interactive educational system with a simulated arm part and automated blood pressure monitor simulation capabilities addresses the lack of realism in existing simulators, enhancing training effectiveness and safety by simulating realistic blood pressure and sounds.
Patent Information
- Application Number
- JP2024541603
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2022-01-13
- Filing Date
- 2023-01-12
- Publication Date
- 2026-03-05
- Estimated Expiration
- 2043-01-12
AI Technical Summary
Existing patient care simulators lack realism and additional simulation capabilities for training healthcare professionals, posing risks to actual patients during hands-on practice.
An interactive educational system with a patient simulator that includes a simulated arm part configured for non-invasive blood pressure monitoring, interfacing with an automated blood pressure monitor to simulate blood pressure, pulse, and sounds, using sensors, air chambers, and mechanisms to mimic realistic blood pressure readings and vibrations.
Enhances training realism by simulating accurate blood pressure readings and associated sounds, reducing risks to patients and improving training effectiveness.
Smart Images

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Abstract
Description
[Technical Field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of the filing date and priority of U.S. Provisional Patent Application No. 63 / 266,761, filed January 13, 2022, the entire disclosure of which is incorporated herein by reference. [Background technology]
[0002] The present disclosure generally relates to an interactive educational system for teaching patient care. While it is desirable to train healthcare professionals in patient care protocols before allowing them to interact with actual patients, textbooks and flash cards lack the important benefits students gain from hands-on practice. Meanwhile, having inexperienced students practice performing medical procedures on actual patients is not considered a viable alternative due to the inherent risks to the patients. Due to these factors, patient care education has often taught students to perform patient care activities on simulators, such as manikins, using medical equipment. Examples of such simulators include U.S. Patent Application No. 11 / 952,559 (Publication No. 20080138778), U.S. Patent Application No. 11 / 952,606 (Publication No. 20080131855), U.S. Patent Application No. 11 / 952,636 (Publication No. 20080138779), U.S. Patent Application No. 11 / 952,669 (Publication No. 20090148822), U.S. Patent Application No. 11 / 952 ,698 (Publication No. 20080138780), U.S. Patent No. 7,114,954, U.S. Patent No. 6,758,676, U.S. Patent No. 6,503,087, U.S. Patent No. 6,527,558, U.S. Patent No. 6,443,735, U.S. Patent No. 6,193,519, and U.S. Patent No. 5,853,292, each of which is incorporated herein by reference in its entirety.
[0003] Although these simulators have been adequate in many respects, they have not been adequate in all respects. Therefore, there is a need for interactive educational systems that are more realistic and / or include additional simulation capabilities for use in conducting patient care training sessions. The prior art documents relevant to the invention of this application are as follows (including documents cited in the international phase after the international filing date and documents cited when the application entered the national phase in other countries). (Prior art document) (Patent document) (Patent Document 1) U.S. Patent Application Publication No. 2005 / 0131307 (Patent Document 2) U.S. Patent No. 5,027,641 (Patent Document 3) U.S. Patent Application Publication No. 2019 / 0275223 (Patent Document 4) European Patent Application Publication No. 0300412 (Patent Document 5) Korean Patent Publication No. 2011-0095055 (Patent Document 6) U.S. Patent Application Publication No. 2010 / 0316984 Summary of the Invention [Means for solving the problem]
[0004] The following summarizes some aspects of the present disclosure in order to provide a basic understanding of the described technology. This summary is not an extensive overview of all contemplated features of the present disclosure, nor is it intended to identify key or critical elements of all aspects of the present disclosure or to narrow the scope of some or all aspects of the present disclosure. Its sole purpose is to present some concepts of one or more aspects of the present disclosure in summary form as a prelude to the more detailed description that is presented later.
[0005] The present disclosure provides interactive educational systems, devices, components, and methods for teaching patient care. In some embodiments of the present disclosure, a system for teaching patient care is provided. The system may include a patient simulator having a patient body comprised of one or more simulated body parts. The one or more simulated body parts include at least one simulated arm part. The at least one simulated arm part is configured to provide a brachial artery simulation for non-invasive blood pressure monitoring. In some examples, the at least one simulated arm part is configured to interface with an automated blood pressure monitor to simulate the blood pressure of the patient simulator. In some examples, the at least one simulated arm part includes a sensor for monitoring air pressure generated by the automated blood pressure monitor and a mechanism for generating a simulated pulse in an air line of the automated blood pressure monitor. In this regard, the patient simulator may be configured to generate a simulated pulse in the air line of the automated blood pressure monitor based on a desired blood pressure of the patient simulator. For example, the patient simulator may monitor the air pressure generated by the automated blood pressure monitor and generate oscillations in the pressure in the air line to simulate pulses (e.g., brachial and / or radial artery pulsations) according to the desired simulated blood pressure.
[0006] Typically, automated blood pressure monitors generate an initial air pressure that corresponds to a blood pressure that is often significantly higher than the patient's expected blood pressure, and then slowly reduce the initial air pressure while monitoring the pressure in the air line, including the vibrations caused by the patient's pulse, to determine the patient's blood pressure. More specifically, the automated blood pressure monitor can determine the patient's systolic and diastolic blood pressure using the air pressure in the air line and the strength of the vibrations caused by the pulse.
[0007] According to aspects of the present disclosure, the intensity of the vibrations induced in the air line of the automated blood pressure monitor by the simulated pulse mechanism may be varied as the air pressure generated by the automated blood pressure monitor decreases (e.g., as monitored by a sensor) to simulate a pulse pattern consistent with the desired systolic and diastolic blood pressure. In some examples, the patient simulator is further configured to generate one or more sounds based on the simulated blood pressure. For example, the one or more sounds may include Korotkoff sounds, brachial artery pulsations, radial artery pulsations, and other related blood pressure-related sounds. In that regard, the patient simulator may include one or more speakers that generate the one or more sounds in some examples. The one or more sounds based on the simulated blood pressure may be coordinated with the simulated pulse in the air line of the automated blood pressure monitor according to the desired blood pressure of the patient simulator.
[0008] In some embodiments of the present disclosure, a system includes a patient simulator having a simulated body part, an air pressure sensor disposed within the simulated body part, a first air chamber disposed within the patient simulator, the first air chamber in communication with the air pressure sensor, a mechanism for selectively contacting the first air chamber, and an adapter disposed outside the patient simulator, the adapter in communication with the air pressure sensor and configured to communicate with an air line of an automatic pressure monitoring device.
[0009] In some examples, the mechanism for selectively contacting the first air chamber is configured to contact the first air chamber to provide a simulated pulse. The mechanism for selectively contacting the first air chamber may be configured to contact the first air chamber with varying amounts of force to provide the simulated pulse. The mechanism for selectively contacting the first air chamber may include a second air chamber. The system may further include a housing disposed within the patient simulator, the first air chamber and the second air chamber being disposed within the housing. In some embodiments, the first air chamber includes a first bellow and the second air chamber includes a second bellow.
[0010] The system may also include an air supply and at least one valve in communication with the air supply and the second air chamber. The at least one valve may be configured to connect the air supply to the second air chamber and connect the second air chamber to the atmosphere. The air supply may include a compressor, compressed gas / air canister, or other gas / air source. The at least one valve may include a single valve configured to connect the air supply to the second air chamber in a first position and to connect the second air chamber to the atmosphere in a second position. The at least one valve may include a first valve for connecting the air supply to the second air chamber and a second valve for connecting the second air chamber to the atmosphere.
[0011] The system may also include at least one processor in communication with the air supply and the at least one valve. The at least one processor may be configured to control operation of the at least one valve to selectively contact the second air chamber with the first air chamber to provide the simulated pulse. The at least one processor may be configured to selectively contact the second air chamber with a varying amount of force with the first air chamber to provide the simulated pulse. The at least one processor may be in communication with the air pressure sensor and further configured to selectively contact the second air chamber with a varying amount of force with the first air chamber to provide the simulated pulse based on a simulated blood pressure of the patient simulator. The simulated blood pressure may be set by a user, based on a simulation profile, and / or a combination thereof.
[0012] In some examples, the simulated body part includes a simulated arm. The air pressure sensor may be located within an upper portion of the simulated arm. The first air chamber may be located within the simulated arm or may be located remotely from the simulated arm. Furthermore, the air pressure sensor, the air supply source, the one or more valves, the one or more processors, the housing, the first and / or second air chambers, and the first and / or second bellows may be located within the simulated arm or may be located remotely from the simulated arm. In some examples, at least the air pressure sensor, the air supply source, the one or more valves, the housing, and the first and second air chambers are located within the simulated arm.
[0013] In some embodiments, the adapter is configured to connect the air pressure sensor to the air line of the automatic pressure monitoring device, thereby enabling the air pressure sensor to monitor the air pressure generated by the automatic pressure monitoring device. The adapter may be in communication with the air pressure sensor via tubing, i.e., one or more flexible and / or rigid tubing may connect the air pressure sensor to the adapter.
[0014] The system may further include the automatic pressure monitoring device. The automatic pressure monitoring system may include a cuff, a monitor, and the air line. The adapter may be coupled to the air line such that the cuff and the monitor are in fluid communication through the air line and the adapter. In some examples, the adapter may be coupled to a first portion of the air line extending between the adapter and the monitor and to a second portion of the air line extending between the adapter and the cuff.
[0015] In some embodiments of the present disclosure, a method for teaching patient care is provided. The method may include providing a patient simulator having a simulated body part, an air pressure sensor, a first air chamber, and a mechanism for selectively contacting the first air chamber; connecting an air line of an automatic pressure monitoring device to the air pressure sensor of the patient simulator; and simulating blood pressure of the patient simulator using at least the air pressure sensor, the first air chamber, and the mechanism for selectively contacting the first air chamber. Simulating blood pressure of the patient simulator may include simulating a pulse of the patient simulator by selectively contacting the mechanism for selectively contacting the first air chamber with the first air chamber. In this regard, the mechanism for selectively contacting the first air chamber may include a second air chamber. In some examples, the first air chamber and the second air chamber are disposed within a housing within the patient simulator. The first air chamber may include a first bellow, and the second air chamber may include a second bellow.
[0016] In some examples, the patient simulator further includes an air supply and at least one valve in communication with the air supply and the second air chamber, the at least one valve configured to connect the air supply to the second air chamber and connect the second air chamber to atmosphere. In such examples, simulating blood pressure in the patient simulator may further include simulating the blood pressure using the air supply and the at least one valve. In this regard, simulating blood pressure in the patient simulator may include selectively inflating and deflating the second air chamber using the air supply and the at least one valve. Selectively inflating and deflating the second air chamber using the air supply and the at least one valve may include moving the valve between a first position connecting the air supply to the second air chamber and a second position connecting the second air chamber to atmosphere. Selectively inflating and deflating the second air chamber using the air supply and the at least one valve may include selectively opening and closing a first valve connecting the air supply to the second air chamber and selectively opening and closing a second valve connecting the second air chamber to atmosphere. Simulating a pulse of the patient simulator by selectively contacting the first air chamber with a mechanism that selectively contacts the first air chamber may include controlling actuation of the at least one valve to selectively contact the second air chamber with the first air chamber to provide the simulated pulse. In some examples, the actuation of the at least one valve is controlled to selectively contact the second air chamber with the first air chamber with varying amounts of force to provide the simulated pulse. In this regard, the actuation of the at least one valve may be based on a simulated blood pressure of the patient simulator. The simulated blood pressure may be set by a user, based on a simulation profile, and / or a combination thereof.
[0017] The simulated body part may include a simulated arm, the air pressure sensor being located within an upper portion of the simulated arm, and the method may further include placing a cuff of the automatic pressure monitoring device around the simulated arm. The cuff may be in communication with the air line of the automatic pressure monitoring device. Connecting the air line of the automatic pressure monitoring device to the air pressure sensor of the patient simulator may include connecting an adapter to the air line of the automatic pressure monitoring device, thereby enabling the air pressure sensor to monitor the air pressure generated by the automatic pressure monitoring device. Connecting the air line of the automatic pressure monitoring device to the air pressure sensor of the patient simulator may further include extending a tube between the adapter and the air pressure sensor. Connecting the adapter to the air line of the automatic pressure monitoring device may include connecting a first portion of the air line extending from a monitor of the automatic pressure monitoring device to the adapter, and connecting a second portion of the air line extending from the cuff of the automatic pressure monitoring device to the adapter.
[0018] In other embodiments, the device includes a simulated arm configured to interface with an automated blood pressure monitor such that simulated blood pressure in the simulated arm can be measured by the automated blood pressure monitor. The simulated arm may include functionality similar to that described in the context of the systems and methods above, in addition to further details and examples provided in the detailed description below. In this regard, the simulated arm may be used stand-alone and / or attached to a simulated torso of a patient simulator.
[0019] Other aspects, features, and embodiments of the present invention will become apparent to those skilled in the art upon review of the following description of specific illustrative examples of the invention in conjunction with the accompanying drawings. While features of the present invention may be described with reference to specific examples and figures below, all aspects of the present invention may include one or more of the advantageous features described herein. That is, while one or more configurations may be described as having particular advantageous features, one or more of such features may also be used in accordance with various aspects and embodiments of the invention described herein. Similarly, while exemplary aspects may be described below in the context of a device, system, or method, it will be understood that such exemplary aspects may be implemented in a variety of devices, systems, and methods. [Brief explanation of the drawings]
[0020] Other features and advantages of the present invention will become apparent from the following detailed description of illustrative embodiments which proceeds with reference to the accompanying drawings. [Figure 1] FIG. 1 is a perspective view of a patient simulator incorporating aspects of the present disclosure. [Figure 2] FIG. 2 is a schematic diagram illustrating a portion of the patient simulator of FIG. 1 interfacing with an external automated blood pressure monitor in accordance with an embodiment of the present invention. [Figure 3] FIG. 3 provides a graphical representation of sound, air pressure, air pressure oscillations, and pulse associated with simulating blood pressure in an environment with an external automated blood pressure monitor in accordance with an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[0021] For the purposes of promoting an understanding of the principles of the present disclosure, reference will be made to the embodiments illustrated in the drawings and specific language will be used to describe them, although it will be understood that this is not intended to limit the scope of the disclosure. Any alterations and further modifications of the described devices, apparatus, methods, and further applications of the principles of the present disclosure described herein as would normally occur to one skilled in the art to which the present disclosure pertains are fully contemplated. In particular, it is fully contemplated that features, components, and / or steps described with respect to one embodiment may be combined with features, components, and / or steps described with respect to other embodiments of the present disclosure. However, for the sake of brevity, multiple iterations of these combinations will not be individually described. For the sake of brevity, in some instances, the same reference numbers will be used throughout the drawings to refer to the same or similar parts.
[0022] 1 , a patient simulator 100 in the present disclosure may include a simulated head 105, a simulated neck 110, a simulated torso 115, a simulated right arm 120 (or “limb”), a simulated left arm 125 (or “limb”), a simulated right leg 130 (or “limb”), and a simulated left leg 135 (or “limb”). In some embodiments, the patient simulator is, includes, or is part of a mannequin. The simulated head 105 is coupled to the simulated neck 110; for example, the simulated head 105 may be releasably coupled to and / or integrally formed with the simulated neck 110. The simulated neck 110 may be releasably coupled to and / or integrally formed with the simulated torso 115. The simulated right arm 120 includes a simulated right upper arm 145 (or “limb”) and a simulated right lower arm 150 (or “limb”). The simulated right upper arm 145 may be releasably coupled to and / or integrally formed with the simulated torso 115. The simulated right lower arm 150 may be releasably coupled to and / or integrally formed with the simulated right arm 145. In some examples, the simulated right lower arm 150 is coupled to the simulated right arm 145 via a right arm coupling 155. Similarly, the simulated left arm 125 includes a simulated left upper arm 160 (or “limb”) and a simulated left lower arm 165 (or “limb”). The simulated left upper arm 160 may be releasably coupled to and / or integrally formed with the simulated torso 115. The simulated left lower arm 165 may be releasably coupled to and / or integrally formed with the simulated left upper arm 160. In some examples, the simulated left lower arm 165 is coupled to the simulated left upper arm 160 via a left arm coupling 170.
[0023] The simulated right leg 130 includes a simulated right upper leg 175 (or "limb") and a simulated right lower leg 180 (or "limb"). The simulated right upper leg 175 may be releasably coupled to and / or integrally formed with the simulated torso 115. The simulated right lower leg 180 may be releasably coupled to and / or integrally formed with the simulated right upper leg 175. In some examples, the simulated right lower leg 180 is coupled to the simulated right upper leg 175 via a right leg coupling 185. Similarly, the simulated left leg 135 includes a simulated left upper leg 190 (or "limb") and a simulated left lower leg 195 (or "limb"). The simulated left upper leg 190 may be releasably coupled to and / or integrally formed with the simulated torso 115. The simulated left lower leg 195 may be releasably coupled to and / or integrally formed with the simulated left upper leg 190. In some examples, the simulated left lower leg 195 is coupled to the simulated left upper leg 190 via a left leg coupling 200.
[0024] The patient simulator 100 may include one or more of an automatic blood pressure monitoring module 205, a compressor 210, a control unit 215, and / or a power supply 220. In some examples, the compressor 210, the control unit 215, and / or the power supply 220 may be components of the automatic blood pressure monitoring module 205. As described in more detail below, the automatic blood pressure monitoring module 205 may be configured to interface with an external automatic blood pressure monitor to simulate blood pressure, pulses, and / or sounds associated with the patient simulator 100. For example, in some examples, the automatic blood pressure monitoring module 205 of the patient simulator 100 may be configured to generate a simulated pulse in the air line of the automatic blood pressure monitor based on the desired blood pressure of the patient simulator. For example, the automatic blood pressure monitoring module 205 of the patient simulator 100 may monitor the air pressure generated by the automatic blood pressure monitor and generate oscillations in the pressure in the air line to simulate a pulse (e.g., a brachial artery and / or radial artery pulsation) in accordance with the desired simulated blood pressure of the patient simulator. Additional functionality and aspects of the automatic blood pressure monitoring module 205 and the interaction between the patient simulator 100 and the automatic blood pressure monitor are described below with reference to FIGS.
[0025] The compressor 210 may be adapted to supply air pressure to various functional units / components of the patient simulator 100, including components of the automatic blood pressure monitoring module 205. Such functional units / components supplied with air pressure by the compressor 210 may be housed in the simulated torso 115, the simulated head 105, the simulated right arm 120, the simulated left arm 125, the simulated right leg 130, and / or the simulated left leg 135. In some examples, the compressor 210 is a scroll compressor.
[0026] The control unit 215 may be adapted to control aspects and / or components of the automatic blood pressure monitoring module 205, the compressor 210, and / or various other functionalities / components of the patient simulator 100 that may be housed in the simulated torso 115, the simulated head 105, the simulated right arm 120, the simulated left arm 125, the simulated right leg 130, and / or the simulated left leg 135. In some examples, the control unit 215 is configured to control aspects and / or components of the automatic blood pressure monitoring module 205, the compressor 210, and / or various other functionalities / components of the patient simulator 100 based on input from a controller 225 in communication with the patient simulator 100. The controller 225 may be in wireless (RF, Wi-Fi, Bluetooth, optical, etc.) and / or wired communication with the patient simulator 100. In this regard, the patient simulator 100 may be configured to simulate one or more parameters in response to settings and / or programming of the controller 225. In this regard, one or more parameters may be based on user input, a simulation profile, and / or a combination thereof. For example, in some instances, the simulated blood pressure and / or simulated pulse rate of the patient simulator 100 may be set by a user, by a simulation profile defined by or executed on the controller 225, and / or a combination thereof. In this regard, the controller 225 may include multiple pre-programmed and / or custom simulation profiles, each of which may be configured to set the simulated blood pressure and / or simulated pulse rate (along with other parameters) of the patient simulator 100 over time. The simulation profile may vary the particular values of the simulated blood pressure and / or simulated pulse rate of the patient simulator 100 over time according to the medical scenario being simulated.In some examples, the simulation profile may adjust the simulated blood pressure and / or simulated pulse values of the patient simulator 100 over time based at least in part on actions and / or interventions taken by the user to treat the patient simulator.
[0027] The power supply 220 may be adapted to provide power to the automatic blood pressure monitoring module 205, the compressor 210, the control unit 215, and / or various other functional units / components of the patient simulator 100 that may be housed in the simulated torso 115, the simulated head 105, the simulated right arm 120, the simulated left arm 125, the simulated right leg 130, and / or the simulated left leg 135. The power supply 220 may include one or more batteries, capacitors, and / or other power storage components. The power supply 220 may also include one or more controllers, processors, application specific integrated circuits (ASICs), amplifiers, switches, and / or other components configured to control the distribution of power to the various components of the patient simulator.
[0028] It is understood that the illustrated embodiment of the patient simulator 100 is sized and shaped to represent a patient undergoing treatment. In that regard, the patient simulator can take a variety of forms, including a mannequin sized and shaped to replicate male or female patients of any size, age, and / or health condition, from a premature fetus to an adult. Furthermore, the patient simulator may include only a portion of a simulated patient (e.g., a particular body part or combination of body parts). Accordingly, while aspects of the present disclosure are described with respect to a particular embodiment of a patient simulator, no limitation thereto is intended. It is understood that the features of the present disclosure may be incorporated into or utilized in conjunction with any suitable patient simulator. In some examples, aspects of the present disclosure may be modified in accordance with U.S. Patent Application No. 11 / 952,559 (Publication No. 20080138778), U.S. Patent Application No. 11 / 952,606 (Publication No. 20080131855), U.S. Patent Application No. 11 / 952,636 (Publication No. 20080138779), U.S. Patent Application No. 11 / 952,669 (Publication No. 20090148822), U.S. Patent Application No. 11 / 952,698 ...698 (Publication No. 2 No. 080138780), U.S. Patent No. 7,114,954, U.S. Patent No. 6,758,676, U.S. Patent No. 6,503,087, U.S. Patent No. 6,527,558, U.S. Patent No. 6,443,735, U.S. Patent No. 6,193,519, and U.S. Patent No. 5,853,292, each of which is incorporated herein by reference in its entirety.
[0029] Referring now to FIG. 2, additional aspects of the patient simulator 100 according to embodiments of the present disclosure are illustrated. In this regard, FIG. 2 illustrates a schematic diagram of a portion of the patient simulator 100 interfacing with an external automatic blood pressure monitor 300 according to embodiments of the present disclosure. As shown, the portion of the patient simulator 100 includes components of an automatic blood pressure monitoring module 205. In some examples, one or more components of the automatic blood pressure monitoring module 205 are located within the left arm 125 (e.g., the left upper arm 160 and / or the left lower arm 165) and / or the torso 115 of the patient simulator 100. However, one or more components of the automatic blood pressure monitoring module 205 may be located within other portions of the patient simulator 100 as well. In the illustrated example, the automatic blood pressure monitoring module 205 includes a sensor 230, a housing 235 containing a first bellow 240 and a second bellow 245, and a valve 250. Valve 250 may be in communication with an air source (e.g., a compressor, compressed gas / air canister, or other gas / air source). In the illustrated example, valve 250 is in communication with compressor 210. The automatic blood pressure monitoring module may be configured to provide brachial artery simulation for non-invasive blood pressure monitoring, as described below.
[0030] In some examples, the automatic blood pressure monitoring module 205 may include one or more connectors, adapters, ports, tubing, and / or other couplings to facilitate pneumatic connections between the sensor 230, the first bellow 240, and / or the external automatic blood pressure measurement device 300, and / or between an air source (e.g., compressor 210), the valve 250, and / or the second bellow 245. In the illustrated example, a port 255 provides a pneumatic connection to the external automatic blood pressure monitoring device 300. In some examples, the port 255 is positioned adjacent to and / or flush with the skin surface of the patient simulator 100 to allow connection with an external plug or connector configured to mate with the port 255. In some examples, the port 255 may be integral with and / or coupled to the sensor 230. A tube 260 extends between the sensor 230 and the first bellow 240. In some examples, tube 260 may be coupled to a port in housing 235 coupled to first bellows 240. Tube 265 extends between second bellows 245 and valve 250. In some examples, tube 265 may be coupled to a port in housing 235 coupled to second bellows 240. In some examples, tube 265 may be coupled directly or indirectly to port 270 in valve 250. Tube 275 extends between valve 250 and compressor 210. In some examples, tube 275 may be coupled directly or indirectly to port 280 in valve 250. As described below, valve 250 may also include port 285. Port 285 may be open to the atmosphere to allow air to be released from second bellows 245. In this regard, in some examples, the port 285 may open directly or indirectly (e.g., via one or more tubes, connectors, etc.) to a space within the patient simulator 100. In other examples, the port 285 may open directly or indirectly to a space external to the patient simulator 100.
[0031] As shown, the external automatic blood pressure monitor 300 may include a monitor 305 and a cuff 310. The monitor 305 may be pneumatically connected to the cuff via an air line 315. In this regard, the air line 315 may be defined, at least in part, by a first tubing portion 320 and a second tubing portion 325. In some examples, the first tubing portion 320 and the second tubing portion 325 are made from a single piece of tubing or other material that is cut or separated to form two separate sections. The first tubing portion 320 of the air line 315 may extend between the monitor 305 and an adapter 330. The adapter 330 may be configured to enable the automatic blood pressure monitoring module 205 of the patient simulator 100 to interface with the external automatic blood pressure monitor 300. For example, in the illustrated example, the adapter 330 facilitates connection of tubing 335 to port 255 of the patient simulator 100, thereby enabling the sensor 230 to monitor the air pressure in the air line 315 generated by the monitor 305. In some examples, the adapter 330 may include one or more connectors, such as a T-connector, a Y-connector, and / or other suitable connector, to enable the sensor 230 to monitor air pressure in the air line 315 generated by the external automatic blood pressure monitor 300. In some examples, the first tube portion 320 and the second tube portion 325 are a single piece of tubing or other material, and the adapter 330 is configured to engage the air line 315 through an opening in the sidewall and / or connector of the single piece of tubing or other material. An external plug or connector 340 coupled to the tubing 335 mates with the port 255 to provide an air connection between the automatic blood pressure monitoring module 205 and the external automatic blood pressure monitor 300. The sensor 230 may include a pressure sensor, a load sensor, and / or other suitable sensor for monitoring air pressure in the air line 315 (e.g., via the adapter 330 and tubing 335 and / or other suitable connections).
[0032] In use, the automatic blood pressure monitoring module 205 may be used to simulate the blood pressure (including systolic and diastolic blood pressure) and / or pulse of the patient simulator 100. In this regard, the automatic blood pressure monitoring module 205 may be configured to measure the blood pressure and / or pulse of the patient simulator 100 using an external automatic blood pressure system. In this regard, the sensor 230 may be configured to monitor the air pressure generated by the automatic blood pressure monitoring system 300, and the mechanism of the automatic blood pressure monitoring module 205 may be configured to generate a simulated pulse in the air line 315 of the automatic blood pressure monitoring system 300. In this regard, the automatic blood pressure monitoring module 205 of the patient simulator 100 may be configured to generate a simulated pulse in the air line 315 of the automatic blood pressure monitoring system 300 based on the desired blood pressure and / or pulse of the patient simulator 100. For example, the patient simulator 100 may monitor the air pressure generated by the automatic blood pressure monitoring system 300 and generate oscillations in the pressure in the air line 315 to simulate pulses (e.g., brachial and / or radial artery pulsations) according to the desired simulated blood pressure.
[0033] Typically, the automatic blood pressure monitoring system 300 generates an initial air pressure at a value corresponding to a blood pressure significantly higher than the patient's expected blood pressure (e.g., >200-250 mmHg), and then slowly reduces the initial air pressure while monitoring the pressure in the air line 315, including the vibrations caused by the patient's pulse, to determine the patient's blood pressure. More specifically, the automatic blood pressure monitoring system 300 can determine the patient's systolic and diastolic blood pressures using the air pressure in the air line 315 and the intensity of the vibrations caused by the pulse. According to aspects of the present disclosure, the intensity of the vibrations induced by the simulated pulse mechanism in the air line 315 of the automatic blood pressure monitoring system 300 can be varied (e.g., as monitored by the sensor 230) as the air pressure generated by the automatic blood pressure monitoring system 300 is reduced to simulate a pulse pattern consistent with the desired systolic and diastolic blood pressures.
[0034] 2, the mechanism for creating a simulated pulse in the air line 315 of the automated blood pressure monitoring system 300 includes a second bellow 245 that selectively contacts the first bellow 240. However, in other examples, other mechanisms (e.g., mechanical, pneumatic, and / or combinations thereof) may be used to create a simulated pulse in the air line. For example, in some examples, the second bellow 245 may be replaced with a mechanical component (e.g., a piston) driven pneumatically, by an electric motor, and / or by other suitable motion-generating components that selectively contact the first bellow 240. In some examples, a mechanical component (e.g., a piston) driven pneumatically, by an electric motor, and / or by other suitable motion-generating components selectively contacts a flexible tube (e.g., similar to tube 260) to create vibrations in the air line 315. Additionally, in some examples, first bellows 240 and / or second bellows 245 may be replaced with other types of air chambers, including, but not limited to, balloons, flexible membranes, pistons, and / or combinations thereof.
[0035] 2, first bellows 240 is in pneumatic communication with air line 315 via adapter 330, tubing 335, sensor 230, and tubing 260, and therefore expands as automatic blood pressure monitoring system 300 generates initial air pressure in air line 315. Housing 235 can be sized and shaped to ensure first bellows 240 expands (and contracts) generally in the direction of arrow 290. That is, first bellows 240 expands toward second bellow 245 (downward in FIG. 2) upon expansion and contracts away from second bellow 245 (upward in FIG. 2) upon contraction. In some examples, housing 235 is cylindrical and formed of a rigid plastic and / or metal such that the housing does not deform due to the expansion of first bellow 240 and / or second bellow 245. In other examples, the housing 235 may use other configurations and / or materials, including, but not limited to, a rectangular box, a cube, a rounded rectangular box, a rounded cube, a sphere, etc., and / or flexible plastic, flexible metal, fabric, woven fabric, interlocking connectors forming chambers, etc., and combinations thereof.
[0036] The automatic blood pressure monitoring module 205 can selectively inflate and deflate the second bellow 245 to contact the first bellow 245, thereby imparting vibrations to the air line 315 of the automatic blood pressure monitoring system 300. In this regard, the second bellow 245 can be inflated by an air source (e.g., compressor 210) by having the valve 250 connect the port 270 to the port 280 such that air from the air source enters the second bellow 245. The state in which the valve 250 connects the port 270 to the port 280 can be considered the first position of the valve. The second bellow 245 can be deflated by releasing air from the second bellow 245. For example, in some instances, valve 250 connects port 270 to port 285, thereby venting air from second bellow 245 such that the air from second bellow 245 is associated with the atmosphere (e.g., inside or outside patient simulator 100). The state in which valve 250 connects port 270 to port 285 may be considered the second position of the valve. Housing 235 may be sized and shaped to ensure that second bellow 245 expands (and contracts) generally in the direction of arrow 295. That is, second bellow 245 expands toward first bellow 240 (upward in FIG. 2 ) when inflated and contracts away from first bellow 240 (downward in FIG. 2 ) when deflated.
[0037] The automatic blood pressure monitoring module 205 can control the position of the valve 250 to selectively inflate and deflate the second bellow 245 and impart vibrations to the air line 315 of the automatic blood pressure monitoring system 300. In this regard, the intensity of the vibrations can be controlled by the length of time that the valve 250 is in the first position, with ports 270 and 280 connected. For example, the longer the valve 250 is in the first position, with ports 270 and 280 connected, the greater the amount of air delivered to the second bellow 245. The more compressed air delivered to the second bellow 245, the greater the expansion of the second bellow 245. The greater the expansion of the second bellow 245, the greater the contact between the second bellow 245 and the first bellow 240. The greater the contact between second bellow 245 and first bellow 240, the greater the deformation of bellow 240 and, therefore, the greater the vibrations in air line 315 of automated blood pressure monitoring system 300. Thus, by controlling the time valve 250 remains in the first position (connecting port 270 and port 280) and the second position (connecting port 270 and port 285), automated blood pressure monitoring module 205 can generate vibrations in air line 315 of automated blood pressure monitoring system 300 that correspond to a desired simulated blood pressure and / or simulated pulse rate of a patient simulator. In this regard, FIG. 3 depicts a set of graphical representations 400 illustrating example relationships between sound 405, air pressure 410, air pressure vibrations 415, and pulse rate 420 associated with simulating blood pressure in the environment of an external automated blood pressure monitor according to an embodiment of the present disclosure.
[0038] The automatic blood pressure monitoring module 205 may be calibrated so that blood pressure measurements and / or pulse rates measured by the external automatic blood pressure monitor 300 correspond to desired simulated blood pressures and / or simulated pulse rates for the patient simulator 100. In this regard, the automatic blood pressure monitoring module 205 and / or control unit 215 may, in some examples, be programmable via a user interface. In some embodiments, the user interface is computer-based and may be part of an overall user interface for controlling various aspects of the patient simulator 100. In this regard, in some examples, the controller 225 (FIG. 1) or similar device may be used to perform a calibration process in which multiple different simulated blood pressures and / or simulated pulse rates are simulated by the patient simulator 100. Corresponding blood pressure and / or pulse measurements measured by the external automatic blood pressure monitor 300 may be entered into the controller 225 (or other device) manually or automatically. By comparing the measured blood pressure and / or pulse values with the desired simulated blood pressure and / or simulated pulse values, the controller 225 (or other device) and / or automatic blood pressure monitor module 205 can determine adjustments (e.g., valve activation times, mapping of air pressure measurements measured by a sensor to desired simulated blood pressure values, combinations thereof, etc.) to ensure that the blood pressure and / or pulse simulated by the patient simulator 100 matches the values measured by the external automatic blood pressure monitor 300. The calibration process can be repeated multiple times and / or periodically to ensure that the measurements of the external automatic blood pressure monitor 300 match the desired simulated blood pressure and / or simulated pressure values.
[0039] In some examples, the patient simulator 100 is further configured to generate one or more sounds based on the simulated blood pressure. For example, the one or more sounds may include Korotkoff sounds, brachial artery pulsations, radial artery pulsations, and other related blood pressure-related sounds. In some examples, the patient simulator may include one or more speakers for generating the one or more sounds. The one or more sounds based on the simulated blood pressure may be coordinated with a simulated pulse in the air line 315 of the automatic blood pressure monitoring system 300 according to the desired blood pressure of the patient simulator.
[0040] In some examples, the sensor 230 measurements are used to determine when specific sounds should be generated by the patient simulator 100. For example, in some examples, the sensor 230 measurements are used to determine when to play Korotkoff sounds. Additionally, sounds associated with the brachial and / or radial artery pulses may be blocked per desired systolic and diastolic blood pressure of the patient simulator 100. In this regard, the automatic blood pressure monitoring module 205 and / or the control unit 215 may communicate with other modules or controllers to generate these various sounds. Alternatively, the automatic blood pressure monitoring module 205 and / or the control unit 215 may control one or more speakers to generate these sounds. In this manner, using the sensor 230 and its associated components of the automatic blood pressure monitoring module 205, a user can not only measure the simulated blood pressure of the patient simulator in a realistic manner using an external automatic blood pressure monitoring system, but also monitor typical sounds associated with blood pressure measurements with a stethoscope or other monitoring device.
[0041] In some embodiments of the present disclosure, a system includes a patient simulator having a simulated body part, an air pressure sensor disposed within the simulated body part, a first air chamber disposed within the patient simulator, the first air chamber in communication with the air pressure sensor, a mechanism for selectively contacting the first air chamber, and an adapter disposed outside the patient simulator, the adapter in communication with the air pressure sensor and configured to communicate with an air line of an automatic pressure monitoring device.
[0042] In some examples, the mechanism for selectively contacting the first air chamber is configured to contact the first air chamber to provide a simulated pulse. The mechanism for selectively contacting the first air chamber may be configured to contact the first air chamber with a varying amount of force to provide the simulated pulse. The mechanism for selectively contacting the first air chamber may include a second air chamber. The system may further include a housing disposed within the patient simulator, and the first air chamber and the second air chamber may be disposed within the housing. In some embodiments, the first air chamber includes a first bellow, and the second air chamber includes a second bellow.
[0043] The system may also include an air supply and at least one valve in communication with the air supply and the second air chamber. The at least one valve may be configured to connect the air supply to the second air chamber and connect the second air chamber to the atmosphere. The air supply may include a compressor, compressed gas / air canister, or other gas / air source. The at least one valve may include a single valve configured to connect the air supply to the second air chamber in a first position and to connect the second air chamber to the atmosphere in a second position. The at least one valve may include a first valve for connecting the air supply to the second air chamber and a second valve for connecting the second air chamber to the atmosphere.
[0044] The system may also include at least one processor in communication with the air supply and the at least one valve. The processor may be configured to control operation of the at least one valve to selectively contact the second air chamber with the first air chamber to provide the simulated pulse. The at least one processor may be configured to selectively contact the second air chamber with a varying amount of force with the first air chamber to provide the simulated pulse. The at least one processor may be in communication with the air pressure sensor and further configured to selectively contact the second air chamber with a varying amount of force with the first air chamber to provide the simulated pulse based on a simulated blood pressure of the patient simulator. The simulated blood pressure may be set by a user, based on a simulation profile, and / or a combination thereof.
[0045] In some examples, the simulated body part includes a simulated arm. The air pressure sensor may be located within an upper portion of the simulated arm. The first air chamber may be located within the simulated arm or remotely from the simulated arm. Furthermore, the air pressure sensor, the air supply source, the one or more valves, the one or more processors, the housing, the first and / or second air chambers, and the first and / or second bellows may be located within the simulated arm or remotely from the simulated arm. In some examples, at least the air pressure sensor, the air supply source, the one or more valves, the housing, and the first and second air chambers are located within the simulated arm.
[0046] In some embodiments, the adapter is configured to connect the air pressure sensor to the air line of the automatic pressure monitoring device, thereby enabling the air pressure sensor to monitor the air pressure generated by the automatic pressure monitoring device. The adapter may be in communication with the air pressure sensor via tubing, i.e., one or more flexible and / or rigid tubing may connect the air pressure sensor to the adapter.
[0047] The system may further include the automatic pressure monitoring device. The automatic pressure monitoring system may include a cuff, a monitor, and the air line. The adapter may be coupled to the air line such that the cuff and the monitor are in fluid communication through the air line and the adapter. In some examples, the adapter may be coupled to a first portion of the air line extending between the adapter and the monitor, and to a second portion of the air line extending between the adapter and the cuff.
[0048] In some embodiments of the present disclosure, a method for teaching patient care is provided. The method may include providing a patient simulator having a simulated body part, an air pressure sensor, a first air chamber, and a mechanism for selectively contacting the first air chamber; connecting an air line of an automatic pressure monitoring device to the air pressure sensor of the patient simulator; and simulating blood pressure of the patient simulator using at least the air pressure sensor, the first air chamber, and the mechanism for selectively contacting the first air chamber. Simulating blood pressure of the patient simulator may include simulating a pulse of the patient simulator by selectively contacting the mechanism for selectively contacting the first air chamber with the first air chamber. In this regard, the mechanism for selectively contacting the first air chamber may include a second air chamber. In some examples, the first air chamber and the second air chamber are disposed within a housing within the patient simulator. The first air chamber may include a first bellow, and the second air chamber may include a second bellow.
[0049] In some examples, the patient simulator further includes an air supply and at least one valve in communication with the air supply and the second air chamber, the at least one valve configured to connect the air supply to the second air chamber and connect the second air chamber to atmosphere. In such examples, simulating blood pressure in the patient simulator may further include simulating the blood pressure using the air supply and the at least one valve. In this regard, simulating blood pressure in the patient simulator may include selectively inflating and deflating the second air chamber using the air supply and the at least one valve. Selectively inflating and deflating the second air chamber using the air supply and the at least one valve may include moving the valve between a first position connecting the air supply to the second air chamber and a second position connecting the second air chamber to atmosphere. Selectively inflating and deflating the second air chamber using the air supply and the at least one valve may include selectively opening and closing a first valve connecting the air supply to the second air chamber and selectively opening and closing a second valve connecting the second air chamber to atmosphere. Simulating a pulse of the patient simulator by selectively contacting the first air chamber with a mechanism that selectively contacts the first air chamber may include controlling actuation of the at least one valve to selectively contact the second air chamber with the first air chamber to provide the simulated pulse. In some examples, the actuation of the at least one valve is controlled to selectively contact the second air chamber with the first air chamber with varying amounts of force to provide the simulated pulse. In this regard, the actuation of the at least one valve may be based on a simulated blood pressure of the patient simulator. The simulated blood pressure may be set by a user, based on a simulation profile, and / or a combination thereof.
[0050] The simulated body part may include a simulated arm, the air pressure sensor being located within an upper portion of the simulated arm, and the method may further include placing a cuff of the automatic pressure monitoring device around the simulated arm. The cuff may be in communication with the air line of the automatic pressure monitoring device. Connecting the air line of the automatic pressure monitoring device to the air pressure sensor of the patient simulator may include connecting an adapter to the air line of the automatic pressure monitoring device, thereby enabling the air pressure sensor to monitor the air pressure generated by the automatic pressure monitoring device. Connecting the air line of the automatic pressure monitoring device to the air pressure sensor of the patient simulator may further include extending a tube between the adapter and the air pressure sensor. Connecting the adapter to the air line of the automatic pressure monitoring device may include connecting a first portion of the air line extending from a monitor of the automatic pressure monitoring device to the adapter, and connecting a second portion of the air line extending from the cuff of the automatic pressure monitoring device to the adapter.
[0051] In other embodiments, the device includes a simulated arm configured to interface with an automated blood pressure monitor such that simulated blood pressure in the simulated arm can be measured by the automated blood pressure monitor. The simulated arm may include functionality similar to that described in the context of the systems and methods above, in addition to further details and examples provided in the detailed description below. In this regard, the simulated arm may be used stand-alone and / or attached to a simulated torso of a patient simulator.
[0052] While exemplary embodiments have been shown and described, the foregoing disclosure contemplates a wide range of modifications, changes, and substitutions, and in some instances, some features of the disclosure may be employed without the corresponding use of other features. It is understood that such modifications may be made in the foregoing without departing from the scope of the embodiments. Accordingly, it is appropriate that the appended claims be construed broadly in a manner consistent with the scope of the present disclosure.
Claims
1. 1. A system comprising: a patient simulator having a simulated body part; an air pressure sensor disposed within the simulated body part; a first air chamber disposed within the patient simulator, the first air chamber being in communication with the air pressure sensor; a mechanism for selectively contacting the first air chamber; an adapter located outside the patient simulator, the adapter communicating with the air pressure sensor and configured to communicate with an air line of an automatic pressure monitoring device; and a mechanism for selectively contacting the first air chamber configured to contact the first air chamber to provide a simulated pulse; the mechanism for selectively contacting the first air chamber includes a second air chamber; system.
2. 10. The system of claim 1 further comprising: A system comprising: a housing disposed within the patient simulator, the first air chamber and the second air chamber disposed within the housing.
3. 3. The system of claim 2, wherein the first air chamber has a first bellows and the second air chamber has a second bellows.
4. 10. The system of claim 1 further comprising: an air supply source; at least one valve in communication with the air supply and the second air chamber, the at least one valve configured to connect the air supply to the second air chamber and to connect the second air chamber to the atmosphere; The system has:
5. 5. The system of claim 4, wherein the air supply comprises a compressor.
6. 5. The system of claim 4, wherein the at least one valve comprises a single valve configured to connect the air supply to the second air chamber in a first position and to connect the second air chamber to the atmosphere in a second position.
7. 5. The system of claim 4, wherein the at least one valve comprises a first valve for connecting the air supply to the second air chamber and a second valve for connecting the second air chamber to the atmosphere.
8. The system of claim 4 further comprising: A system comprising at least one processor in communication with the air supply and the at least one valve, the at least one processor configured to control operation of the at least one valve to selectively contact the second air chamber with the first air chamber to provide the simulated pulse.
9. 9. The system of claim 8, wherein the at least one processor is configured to selectively contact the second air chamber with the first air chamber with varying amounts of force to provide the simulated pulse.
10. 10. The system of claim 8, wherein the at least one processor is in communication with the air pressure sensor and is further configured to selectively contact the second air chamber with varying amounts of force against the first air chamber to provide the simulated pulse based on a simulated blood pressure of the patient simulator.
11. 11. The system of claim 10, wherein the simulated blood pressure is set by a user.
12. 11. The system of claim 10, wherein the simulated blood pressure is set by the at least one processor based on a simulation profile.
13. 10. The system of claim 1, wherein the mechanism for selectively contacting the first air chamber is configured to contact the first air chamber with varying amounts of force to provide the simulated pulse.
14. The system of claim 1 , wherein the simulated body part comprises a simulated arm.
15. 15. The system of claim 14, wherein the air pressure sensor is located within an upper portion of the simulated arm.
16. 15. The system of claim 14, wherein the first air chamber is located within the simulated arm.
17. 10. The system of claim 1, wherein the adapter is configured to connect the air pressure sensor to the air line of the automatic pressure monitoring device, thereby enabling the air pressure sensor to monitor air pressure generated by the automatic pressure monitoring device.
18. 18. The system of claim 17, wherein the adapter communicates with the air pressure sensor via a tube.
19. 10. The system of claim 1, further comprising the automatic pressure monitoring device: the automatic pressure monitoring device includes a cuff, a monitor, and the air line; The adapter is connected to the air line, whereby the cuff and the monitor are in fluid communication through the air line and the adapter.
20. 20. The system of claim 19, wherein the adapter is coupled to a first portion of the air line extending between the adapter and the monitor and to a second portion of the air line extending between the adapter and the cuff.
21. 1. A method comprising: providing a patient simulator having a simulated body part, an air pressure sensor, a first air chamber, and a mechanism for selectively contacting the first air chamber; connecting an air line of an automatic pressure monitoring device to the air pressure sensor of the patient simulator; simulating blood pressure in the patient simulator using at least the air pressure sensor, the first air chamber, and a mechanism for selectively contacting the first air chamber; and the step of simulating blood pressure of the patient simulator includes the step of simulating a pulse of the patient simulator by selectively contacting the first air chamber with a mechanism that selectively contacts the first air chamber; the mechanism for selectively contacting the first air chamber includes a second air chamber; method.
22. 22. The method of claim 21, wherein the first air chamber and the second air chamber are disposed within a housing within the patient simulator.
23. 23. The method of claim 22, wherein the first air chamber has a first bellows and the second air chamber has a second bellows.
24. 22. The method of claim 21, wherein the patient simulator further comprises: an air supply source; at least one valve in communication with the air supply and the second air chamber, the at least one valve configured to connect the air supply to the second air chamber and to connect the second air chamber to the atmosphere; and simulating blood pressure in the patient simulator further comprises simulating the blood pressure using the air supply and the at least one valve. method.
25. 25. The method of claim 24, wherein simulating blood pressure in the patient simulator includes selectively inflating and deflating the second air chamber using the air supply and the at least one valve.
26. 26. The method of claim 25, wherein selectively inflating and deflating the second air chamber using the air supply and the at least one valve comprises moving the valve between a first position connecting the air supply to the second air chamber and a second position connecting the second air chamber to atmosphere.
27. 26. The method of claim 25, wherein selectively inflating and deflating the second air chamber using the air source and the at least one valve comprises: selectively opening and closing a first valve connecting the air supply to the second air chamber; selectively opening and closing a second valve connecting the second air chamber to the atmosphere; The method of claim 1,
28. 22. The method of claim 21, wherein the step of simulating a pulse of the patient simulator by selectively contacting the first air chamber with a mechanism for selectively contacting the first air chamber comprises: controlling the operation of at least one valve to selectively contact the second air chamber with the first air chamber to provide a simulated pulse.
29. 29. The method of claim 28, wherein controlling the operation of the at least one valve selectively contacts the second air chamber with the first air chamber with varying amounts of force to provide the simulated pulse.
30. 30. The method of claim 29, wherein controlling the actuation of the at least one valve is based on a simulated blood pressure of the patient simulator.
31. 31. The method of claim 30, wherein the simulated blood pressure is set by a user.
32. 31. The method of claim 30, wherein the simulated blood pressure is based on a simulation profile.
33. 22. The method of claim 21, wherein the simulated body part includes a simulated arm, and the air pressure sensor is located within an upper portion of the simulated arm; The method further comprises: placing a cuff of the automatic pressure monitoring device around the simulated arm, the cuff communicating with the air line of the automatic pressure monitoring device; The method of claim 1,
34. 22. The method of claim 21, wherein connecting the air line of the automatic pressure monitoring device to the air pressure sensor of the patient simulator comprises connecting an adapter to the air line of the automatic pressure monitoring device, thereby enabling the air pressure sensor to monitor the air pressure generated by the automatic pressure monitoring device.
35. 35. The method of claim 34, wherein connecting the air line of the automatic pressure monitoring device to the air pressure sensor of the patient simulator further comprises extending tubing between the adapter and the air pressure sensor.
36. 36. The method of claim 35, wherein the step of connecting the adapter to the air line of the automatic pressure monitoring device comprises: connecting a first portion of the air line extending from the automatic pressure monitoring system monitor to the adapter; connecting a second portion of the air line extending from a cuff of the automatic pressure monitoring device to the adapter; The method of claim 1,
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