Medical palpation device, system and method for enhanced physical examination

By using handheld medical palpation devices and software analysis, the shortcomings of abdominal pain assessment in telemedicine have been addressed, enabling safe and accurate abdominal pain risk assessment and supporting clinicians' decision-making.

CN121001650APending Publication Date: 2025-11-21MEDAMERICA CONSULTING EMPLOYEES INC DBA INFLECT HEALTH
View PDF 4 Cites 0 Cited by

Patent Information

Application Number
CN202480025523.3
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-02-15
Filing Date
2024-02-14
Publication Date
2025-11-21

AI Technical Summary

Technical Problem

The lack of effective palpation methods in telemedicine makes it impossible to safely and accurately assess acute abdominal conditions such as abdominal pain virtually, making it difficult for clinicians to determine whether advanced imaging examinations or surgery are needed.

Method used

A handheld medical palpation device has been designed, equipped with a digital force sensor and processing circuitry. Patients or caregivers can use this device to press on the abdomen, collect pressure data, and transmit it to software for analysis, providing clinicians with information on abdominal pain risk assessment.

Benefits of technology

It enables patients to safely perform virtual palpation at home, helping clinicians determine whether imaging examinations or hospitalization are needed, thus improving the safety and accuracy of telemedicine.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure CN121001650A_ABST
    Figure CN121001650A_ABST
Patent Text Reader

Abstract

A handheld palpation device for telemedicine examinations includes a handle that applies pressure to a patient's body through a palpation head. The handle includes an interior space and an opening to the interior space. One end of the palpation head is installed in the opening, and the other end of the palpation head comprises a circular soft head part which is configured to be in contact with the body of the patient when pressure is applied. A pressure pad located in the interior space acquires voltage data when applying pressure. A sensor chip located in the interior space receives voltage data from the pressure pad, calculates one or more quantitative pressure measurements, and transmits the quantitative measurements to a communication chip connected to the sensor chip, which transmits the quantitative pressure measurements to an external device for analysis, a clinical assessment is provided based on the pressure measurements using machine learning.
Need to check novelty before this filing date? Find Prior Art

Description

Inventor: Joshua Tamayo-Sarver Samuel Tamayo-Sarver Isaac Tamayo-Sarver Cross-reference to related applications This application claims priority to U.S. Provisional Application No. 63 / 445997, filed February 15, 2023, and to non-provisional application No. 18 / 442057, filed February 14, 2024. The entire contents of these applications are incorporated herein by reference. Technical Field

[0001] This disclosure generally relates to virtual or telemedicine, and more specifically, to the use of medical palpation devices held by the patient and used by the patient under the guidance of a clinician to perform remote or enhanced physical examinations on the patient. Background Technology

[0002] Abdominal pain is the most common cause of out-of-call medical care. According to the American Hospital Association, there are over 130 million emergency room visits annually. (See American Hospital Association, Fact Sheet: Telehealth, February 2019.) The primary cause of 11 million emergency room visits is stomach pain, abdominal pain, cramps, and convulsions. Of these, 6 million are initially diagnosed with abdominal pain-related conditions. (See Reed ME, Parikh R, Huang J, et al., Real-Time Patient-Provider Video Telemedicine Integrated with Clinical Care, N Engl J Med. 2018; 379:1478-1479.)

[0003] The Centers for Medicare & Medicaid Services (CMS) has developed guidelines for on-site physical examination records for 12 organ systems or 7 body parts. See the Centers for Medicare & Medicaid Services, 1995 Documentation Guidelines for Evaluation and Management Services, and 1997 Documentation Guidelines for Evaluation and Management Services.

[0004] There are many types of diagnoses related to abdominal pain. Palpation of the abdomen can help clinicians determine the likelihood of a "surgical acute abdomen," a pathological condition that may require surgical intervention, such as appendicitis, small bowel obstruction, intestinal perforation, or hernia. When a clinician suspects a surgical acute abdomen based on abdominal palpation, the patient will undergo further advanced imaging evaluations: computed tomography (CT), ultrasound (US), or magnetic resonance imaging (MRI). Sometimes, the patient will be admitted to the hospital for a repeat abdominal examination or directly to the operating room for surgery without further advanced imaging.

[0005] The total number of abdominal or pelvic CT scans performed annually reaches 10 million (see study by Reed et al.). Furthermore, although CT scans are widely used in emergency department patients with abdominal pain (approximately 40% in adults and 15% in children), they also carry some significant risks, including an increased incidence of cancer. See Centers for Medicare & Medicaid Services, 1995 and 1997 Documentation Guidelines for Evaluation and Management Services.

[0006] Telemedicine is playing an increasingly important role in healthcare services. The American Hospital Association (AHA) notes that telemedicine has the potential to reduce costs and improve access to healthcare, particularly for populations with limited access to medical resources and rural residents. An AHA fact sheet report indicates that 79% of U.S. hospitals use some form of telemedicine. Despite the rapid development of telemedicine, abdominal pain often cannot be safely and accurately assessed virtually because clinicians cannot palpate the abdomen to determine if a patient requires advanced imaging or surgery.

[0007] To maximize the benefits of telemedicine, patients need to be able to complete as many in-person doctor's consultations as possible in a virtual environment. A complete Virtual Physical Exam (VPE) allows clinicians to conduct physical examinations remotely. For clinicians to effectively conduct examinations during telemedicine consultations, the VPE should provide real-time, high-quality information similar to that of an in-person consultation. In addition to relying on video conferencing applications for telemedicine consultations, occasional sporadic examinations using affordable equipment may also be necessary. Specifically, a virtual physical exam should include the following objective data and support the following tasks: • Observe / examine (whole body, eyes, ears, throat, skin, wounds) • Auscultation (heart, lungs, neck, abdomen) • Palpation (injured area, lymph nodes, abdomen, lower leg, skin) • Obtain vital signs (heart rate, respiratory rate, blood pressure, pulse oxygen saturation, weight, height). While numerous technological solutions exist for remote examination (visual), auscultation (audio), and obtaining vital signs for telemedicine access, palpation methods and information available during telemedicine visits remain lacking. For example, U.S. Patent 9,826,904, "System and Method for Excluding Tissue Surface Properties," provides a system for identifying the shape of a body or body part but does not assess clinical tenderness. Similarly, U.S. Patent 6,192,143, "Apparatus for Detecting Minor Breast Abnormalities," uses mechanical palpation of the breast surface to identify small lumps or other abnormalities but does not provide tenderness information. Furthermore, U.S. Patent 5,351,677, "Medical System with an Objective Information Reproduction Device for Palpation," provides an operator with a method for remotely palpating distant objects through tactile feedback, but patients or caregivers cannot perform self-palpation and provide useful information to clinicians.

[0008] It is noteworthy that there is still a lack of patient-reported and subjective descriptions of abdominal palpation experiences, particularly regarding patient self-examination and palpation. This may be one reason why gastroenterology ranks second lowest in telemedicine integration rates among internal medicine specialties in the AACM Patient Practice Benchmarks Survey. Therefore, while telemedicine does enable clinicians to remotely diagnose and treat many clinical conditions, it does not readily diagnose and treat conditions such as acute abdomens. In these cases, clinicians need to determine if a patient has an “acute abdomen” requiring advanced imaging, or address issues such as lymph node problems, traumatic injuries, or musculoskeletal discomfort—all of which typically require the ability to palpate the abdomen or other sites of pain / injury. Summary of the Invention

[0009] An apparatus, system, and method for performing standardized remote home palpation will enable safe virtual medical care for patients with abdominal pain and provide healthcare professionals with a pathway to increase the scope of safe and accurate assessment of pathology through telemedicine.

[0010] Embodiments of the medical examination devices, systems, and methods disclosed herein enable remote palpation of patients through standardized home palpation, thus making safe virtual healthcare possible for patients with abdominal pain. The device allows a patient or caregiver to palpate (press) the patient's abdomen or areas of interest, providing sensor pressure data to a software product connected to the device during the palpation. Embodiments of the software product disclosed herein analyze this sensor pressure data and provide clinicians with available data regarding the patient's risk of abdominal pain, including information on whether advanced imaging is required. Clinicians can then incorporate the device's findings into their decisions regarding the likelihood of pathological conditions (appendicitis, fractures, etc.).

[0011] In one embodiment, the handheld device is used by a patient during virtual abdominal examinations and other virtual physical examinations requiring palpation. Embodiments of the palpation devices disclosed herein include a non-sterile, reusable medical device that can provide data and information to telemedicine personnel to help them determine whether abdominal imaging or further hospitalization in the emergency department is necessary.

[0012] In some embodiments, the device includes a handle, a palpation head, a digital force sensor and processing circuitry, a pressure-bearing member including a comfort spring or rigid block, a rechargeable battery pack, a Bluetooth module, and a USB port. During use, the patient or caregiver picks up the device and applies maximum force to the sternum, or until the patient feels any discomfort, to establish a baseline. The device measures the maximum applied force and transmits it via Bluetooth to a connected computer or smartphone. The connected computer or smartphone contains software that receives the force data and applies experimentally derived algorithms to the data processing, then informs the clinician of the patient's clinically significant level of tenderness. The clinician can then combine this information with medical history and other physical examination results to arrive at a diagnosis. Attached Figure Description

[0013] Figure 1 A front view of a medical palpation device for remote physical examination according to an embodiment of the present disclosure is shown.

[0014] Figure 2 A cross-sectional view of a medical palpation device for remote physical examination according to an embodiment of the present disclosure is shown, wherein cable connections are illustrated.

[0015] Figure 3 A left-top perspective view of a medical palpation device for remote physical examination according to an embodiment of the present disclosure is shown;

[0016] Figure 4 An exploded perspective view of the upper left corner of a medical palpation device for remote physical examination according to an embodiment of the present disclosure is shown.

[0017] Figure 5 A cross-sectional view of a medical palpation device for remote physical examination according to an embodiment of the present disclosure is shown;

[0018] Figure 6 An exploded perspective view of the upper left corner of a medical palpation device for remote physical examination according to an embodiment of the present disclosure is shown.

[0019] Figures 7A-7F Exemplary screenshots of a patient software application used with a medical palpation device for remote physical examination according to embodiments of the present disclosure are shown.

[0020] Figure 8 An exemplary flowchart of data analysis software process operation according to an embodiment of the present disclosure is shown;

[0021] Figures 9A-9C Exemplary wireframes are shown, depicting screenshots of exemplary user interfaces for clinicians to examine patients using remote physical examination medical palpation devices, consistent with embodiments of this disclosure;

[0022] Figure 10Examples of computer systems are shown, one or more of which can be used to implement one or more apparatuses, systems and methods shown herein.

[0023] Although the present invention has been described in conjunction with the accompanying drawings, the drawings are for illustrative purposes only, and other embodiments are consistent with the spirit of the present invention and are also within the scope of the present invention. Detailed description

[0024] Various embodiments are now described more fully with reference to the accompanying drawings, which form part of this document. These drawings illustrate specific examples of implementing these embodiments by way of example. However, this specification may be embodied in many different forms and should not be construed as limited to the embodiments described herein; rather, these embodiments are provided to make this specification more comprehensive and complete, and to fully convey the scope of protection of the invention to those skilled in the art. Furthermore, this specification may be embodied in the form of methods or apparatus, etc. Therefore, any embodiment described herein may take the form of a purely hardware embodiment, a purely software embodiment, or an embodiment combining software and hardware aspects. Consequently, the following description should not be considered restrictive.

[0025] Figure 1 A front view of a medical palpation device 100 for remote physical examination according to an embodiment of the present disclosure is shown. Figure 1 The illustrated palpation device includes an ergonomic handle 110, one end of which is rounded and designed to be comfortably held in the hand by a patient or caregiver during abdominal palpation. In some embodiments, this ergonomic design is optimized for both comfort and structure. A comfortable handle means patients are more likely to use the device continuously, resulting in accurate results. The structural characteristics of the handle provide sufficient contact area for the user to apply moderate force without compromising the structural integrity of the handle. Furthermore, the handle's structure maintains a substantially constant spacing between the handle, sensors, and massage heads, and provides sufficient internal space to accommodate internal circuitry. In some embodiments, the handle employs an ergonomically designed rigid structure, made of materials including rigid, smooth plastic or polycarbonate, or even other materials such as wood or leather. The handle may have a hollow interior or otherwise form an internal space to accommodate chips, pressure pads, and other components, as described below.

[0026] The second end of the palpation device has an opening leading to the internal space of the handle (e.g., as shown in the image). Figure 2 The numbers 115 and 215 shown, and as shown in the figure, are also included. Figure 4(As shown in 415). The device 100 also includes a palpation head 130, one end of which is configured to fit into an opening in the handle 100, and the other end has a rounded, soft head designed to contact the patient's body when pressure is applied by the user. In some embodiments, the palpation head 130 includes a massage head similar to those used in handheld electronic massage devices or electronic massage kits. In one embodiment, the palpation head 130 includes a massage head with a firm foam ball that achieves an optimal balance between friction with the body part being palpated, conformity to the contours of the body part, and the firmness of the pressure transmission. The palpation head 130 may include a massage head that provides a comfortable, foam-like surface that generates pressure on the contact surface, resulting in better palpation results and operational consistency when the user holds the palpation device and applies it to the patient's body.

[0027] Figure 2 A cross-sectional view 200 of one embodiment of a medical palpation device 100 for remote physical examination is shown, illustrating the cable connection structure and a handle 210 with an internal space 212 and an opening 215. A pressure pad 230 is located within the internal space 212 and acquires pressure applied by the user via resistance. In some embodiments, the pressure pad 230 includes a force sensor. In one embodiment, the force sensor includes a force-sensitive resistor. In some embodiments, the force sensor is calibrated to a specific range of force values ​​known to be applied during self-palpation to achieve the highest force resolution within the relevant force range.

[0028] Figure 2 The locking system 240 is located within the opening 215 and functions to lock the palpation head 220 (e.g., a massage head) in a fixed position within the handle 210 to prevent the palpation head from ejecting from the palpation device during use. In some embodiments, the locking system 240 includes a horizontal bar or horizontal pin 242 that can be inserted into a vertical slot 244 within the opening 215. In one embodiment, the vertical slot allows the horizontal bar 242 to move approximately 4 mm between the massage head and the handle, thereby achieving optimal operability or tactile feedback of the palpation device during palpation.

[0029] like Figure 2As shown, in one embodiment, a sensor-embedded chip 250 is connected to a pressure pad 230. The pressure pad 230 is connected to the sensor-embedded chip 250 via wires. In one embodiment, the sensor-embedded chip 250 includes an internal circuit board chip that converts electrical signals from the pressure pad into quantitative measurement data. This measurement data can be transmitted to a networked device via a voltage divider circuit 260, which can relay the data from the sensor-embedded chip 250 via a cable connection 280, ultimately transmitting it over the Internet to a clinician for appropriate interpretation. In some embodiments, resistance can be measured and recorded using software code and converted into force units. In one embodiment, such software code is provided by Tekscan, Inc. under the name Flexiforce. TM For trademark development.

[0030] In some embodiments, the voltage divider circuit 260 includes an analog circuit module for handling external forces applied by the user. The voltage divider circuit 260 may have a programmable reference voltage for sensitivity adjustment and is connected to the pressure pad 250 (e.g., a force-sensitive resistor). In one embodiment, the pressure pad 250 is a Tekscan, Inc. Flexiforce... TM The force sensor is a trademarked A201-25 model pad. In one embodiment, the voltage divider circuit 260 may be a voltage divider circuit module also manufactured by Texcan Corporation. The voltage divider circuit 260 calibrates the force sensor by setting default sensitivity adjustment parameters via a programmable reference voltage. In other embodiments, an inverting operational amplifier circuit module or a non-inverting operational amplifier circuit module (not shown) may be used instead of the voltage divider circuit module 260. In some embodiments, Figure 2 The internal space 212 of the middle handle 210 is large enough that skin, metal or any other ionized surface may interfere with the open circuit of the voltage divider 260, but such interference will not affect the value reading and will not cause a problem.

[0031] In some embodiments, cable connection 280 includes a cable sheath to protect the internal wires of the handle from damage, and a power cord for connecting the stethoscope device to a power adapter or charger, and / or a user device (such as a mobile phone, tablet, or laptop). In some embodiments, cable connection 280 is connected to power source 270, which may include rechargeable batteries known in the art, such as lithium-ion batteries. In one embodiment, power source 270 may also include a power delivery module containing a small chip capable of enabling power and data transfer from the stethoscope device to the user device (such as a mobile phone, tablet, laptop, or desktop computer). In one embodiment, cable connection 280 may also include a USB-C interface through which the stethoscope device can be charged, powered by an external charger, and connected directly to a computer for data transfer. Furthermore, cable connection 280 may include a power cord connected to one or more connector heads 285, which may include one or more connectors, such as micro-USB connectors, Lightning connectors, or USB-C connectors, for connection to a user's mobile phone, tablet, laptop, or other networked device.

[0032] Finally, Figure 2 In the illustrated embodiment, the sensor deformer 290 is located within the opening 215 and is also connected to the palpation head 220 to provide a contact point for the palpation head to press against the pressure pad 230.

[0033] Figure 3 A left-top perspective view 300 of a medical palpation device for remote physical examination according to an embodiment of the present disclosure is shown. The view shows a handle 310, a palpation head 320, and an opening 315 connecting one end of the handle 310 and the palpation head 320.

[0034] Figure 4 An exploded perspective view 400 of a medical palpation device for remote physical examination according to an embodiment of the present disclosure is shown in the upper left corner. This exploded view shows... Figure 1 , Figure 2 and Figure 3 The relative positions of some components in various embodiments of the medical palpation device shown include the ergonomic handle 410, pressure pad 430, sensor deformer 490, and palpation head 420.

[0035] Figure 5 A cross-sectional view of a medical palpation device 500 for remote physical examination according to an embodiment of the present disclosure is shown. Figure 5 The components shown are the same as those mentioned above. Figure 1-4The components described herein are similar. These similar components include: an ergonomic handle 510, which is a simple, circular, ergonomically shaped handle with internal space to accommodate chips and other components; a palpation head (e.g., a massage head) 520 for pressing on the patient's body; a pressure pad 530 for generating data based on the applied pressure; a locking system 540 for locking the palpation head in place to prevent it from popping out during use; and, in one embodiment, a sensor internal chip 550 connected to the pressure pad 530. The pressure pad 530 is connected to the sensor internal chip 550 via wires. In one embodiment, the sensor internal chip 550 includes an internal circuit board chip that converts electrical signals from the pressure pad 530 into quantitative measurement data, which can be transmitted to a networked device via a Bluetooth internal chip 560, which connects and transmits data from the pressure pad 530 to devices such as Bluetooth-connected computers, tablets, or smartphones.

[0036] In some embodiments, power port 580 is connected to an internal power supply 570 to power pressure pad 530, sensor internal chip 550, and Bluetooth internal chip 560. In one embodiment, power supply 570 may include a rechargeable battery known in the art, such as a lithium-ion battery. In one embodiment, power port 580 may also include a data interface and / or a power cord connection including a USB-C interface, enabling the palpation device to be charged, powered by an external charger, and / or directly connected to a computer for data transfer. Power port 280 may also include a power cord connected to one or more connector heads 285, which may include one or more connectors, such as micro-USB, Lightning connectors, or USB-C connectors, which can be connected to a power source (such as a power outlet or power bank) or a user's mobile phone, tablet, laptop, or other networked device.

[0037] exist Figure 5 In the illustrated embodiment, a spring 590 is located between the ergonomic handle 510 and the palpation head 520 for applying pressure to the palpation head 520 during palpation, causing it to extend and contact a part of the patient's body (e.g., the patient's abdomen). In some embodiments, the use of the spring 590 allows for a softer, more natural tactile sensation during palpation.

[0038] Figure 6 This invention illustrates a method for remote physical examination according to embodiments of the present disclosure. Figure 5 The exploded perspective view 600 of the medical palpation device shown is located at the top left. This exploded view illustrates... Figure 5 The relative positions of certain components in the illustrated medical palpation device embodiment include the ergonomic handle 610, pressure pad 630, spring 690, and palpation head 620.

[0039] Figures 1-6 The illustrated embodiment of the medical palpation device can be configured for use with the interpretation software described below. This interpretation software includes a desktop or mobile application installed on a computer or smartphone connected to the palpation device. It guides the user through palpation movements, receives sensor data, and then applies data processing algorithms to determine the extent to which clinically significant tenderness is present in the patient.

[0040] Figures 7A-7F Exemplary screenshots of a patient software application used in conjunction with a medical palpation device for remote physical examination, according to embodiments of the present disclosure, are shown. Figures 7A-7F The screenshots illustrate a user demonstration flow of a medical palpation device according to some embodiments of this disclosure. In some embodiments, before starting the user demonstration flow, a patient can log in to their networked computing device (e.g., a mobile phone, tablet, or laptop) to conduct a virtual consultation with a telemedicine clinician or healthcare professional. In one example, the patient may have identified abdominal pain as a symptom. The telemedicine professional may issue initial instructions to the patient to retrieve and turn on the medical palpation device. If necessary, the palpation device should be plugged into a power source. Furthermore, the palpation device should be connected to a networked device via a physical cable or Bluetooth connection to transmit pressure sensor data readings to interpretation software to assess the clinical significance of the patient's abdominal or other pain.

[0041] After these initial steps are completed, in some embodiments of this disclosure, a webpage or mobile application launches on a networked device (e.g., a smartphone, tablet, or laptop / desktop computer). After the patient clicks "Accept," a demonstration process guides the patient or caregiver to palpate the patient's body according to the instructions in the user demonstration process. The patient can use the palpation device for self-palpation. Alternatively, a caregiver can apply the palpation device to the patient's body to perform the palpation process. In one embodiment, the demonstration process guides the patient or caregiver to palpate the patient's abdomen. Figure 7A In the screenshot 700A shown, the patient is first instructed to lie flat, and then click the "Ready" button when ready to perform palpation. Figures 7A-7F The screenshots 700A-700F also demonstrate how users hold the palpation device to perform the palpation procedure as instructed.

[0042] First of all, Figure 7B In the screenshot 700B shown, the user is instructed to palpate the patient's sternum. The user is instructed to press the palpation device into the patient's sternum as forcefully as possible until the patient (or the user) feels pain. Simultaneously, the patient is informed that the sternum is located in the center of the chest, between the nipples.

[0043] Next, the patient or user needs to identify the four abdominal quadrants to be palpated: upper left quadrant (LUQ), lower left quadrant (LLQ), lower right quadrant (RLQ), and upper right quadrant (RUQ). Figure 7C In the screenshot 700C shown, the user is instructed to palpate the upper left quadrant (LUQ). The palpation device should be pressed firmly into the upper left quadrant of the patient's abdomen until the patient experiences pain. The upper left quadrant is located directly below the patient's left ribcage. Figure 7D In the screenshot 700D shown, the user is instructed to palpate the lower left quadrant (LLQ), pressing the palpation device firmly into the patient's lower left quadrant of the abdomen until the patient experiences pain. The lower left quadrant is located on the medial side of the patient's left hip. Figure 7E The screenshot shown is from 700E. The user must palpate the lower right quadrant (RLQ) of the patient's abdomen as instructed, pressing firmly as possible until the patient experiences pain. The lower right quadrant is located on the medial side of the patient's right hip.

[0044] Next, as Figure 7F As shown in screenshot 700F, the patient or user needs to palpate the upper right quadrant (RUQ) of the patient's abdomen as instructed, pressing as firmly as possible until the patient feels pain. The upper right quadrant is located directly below the patient's right rib. After completing the palpation in screenshot 700F, the user can click the "Submit" button to transfer the pressure sensor data and run the data analysis software to send it to the clinician.

[0045] Patients are expected to have a mechanism in place to begin and stop measurements when they indicate that they have completed pressing on each designated palpation site. In some embodiments, the medical palpation device generates five data files for the patient, containing pressure sensor data for each of the five palps performed on the patient as instructed by the software. During the palpation, sensor data may be collected multiple times at fixed intervals (e.g., 50 times / second). In one embodiment, for each of the five sensor data files, the average of the first 25 maximum pressure readings is used, as described below. This generates a pressure reading for each of the five palpation sites on the patient's body. In one embodiment, for each of the four abdominal quadrants (upper left quadrant, upper right quadrant, lower left quadrant, lower right quadrant), the difference between the pressure reading in that quadrant and the baseline sternal pressure reading is used as the maximum reliable pressure in that quadrant. This data is then transferred from the palpation device to the patient's mobile device, tablet, and / or laptop or desktop computer for further analysis.

[0046] In one example use case of the medical palpation device and data interpretation software embodiments discussed herein, a 27-year-old woman is experiencing abdominal pain and wishes to undergo a medical evaluation. She contacts her doctor's office, and the doctor schedules a virtual consultation. Prior to the virtual consultation, the woman uses other devices to assess her vital signs (temperature, heart rate, respiratory rate, blood pressure, and pulse oxygen saturation) and provides records of her heart, lungs, and abdomen for the doctor to review. She then uses the medical palpation device discussed in the embodiments herein to press on four quadrants of her abdomen, which provides the data to the doctor for use during the consultation. The doctor begins the virtual consultation with the woman. Based on the woman's medical history and the clinically significant tenderness in her right lower quadrant as shown by the device, the doctor schedules an appendiceal ultrasound for the woman that day to assess for appendicitis.

[0047] In another example use case of the medical palpation device and data interpretation software discussed in this article, a 30-year-old man experienced nausea and vomiting and sought medical evaluation. He logged into a virtual emergency room service. Before the virtual consultation, the man used other devices to assess his vital signs (temperature, heart rate, respiratory rate, blood pressure, and pulse oxygen saturation) and provided records of his heart, lungs, and abdomen for the doctor to review. He then used the medical palpation device of this invention to press on four quadrants of his abdomen, which provided the data to the doctor for use during the consultation. The doctor began a virtual consultation with the man. Based on the man's medical history and the device's finding of no clinically significant tenderness in his abdomen, the doctor suspected he might have gastroenteritis and recommended antiemetics, as well as drinking water and Gatorade.

[0048] Figure 8 An exemplary flowchart 800 illustrating the operation of data analysis software according to an embodiment of this disclosure is shown. First, in step 810, the system sends a touch command to be displayed to the user on a user device (e.g., a smartphone, tablet, desktop computer, or laptop). Its exemplary interface has been described above. Figures 7A-7F The content will be presented and discussed in the document.

[0049] In operation 820, a set of pressure readings for each of multiple body parts is received from the handheld palpation device, and the maximum reliable pressure for each abdominal quadrant is determined as follows. In some embodiments of the invention, operation 820 may be performed with reference to step 1. Operation 830 may be performed with reference to step 2. Operation 840 may be performed with reference to step 3. Operation 850 may be performed with reference to step 4. Next, operation 860 may be performed with reference to step 5.

[0050] Step 1: Collect sensor readings for the following five locations: i. sternum ii. Upper left quadrant iii. Upper right quadrant iv. Lower left quadrant v. Lower right quadrant

[0051] Step 2: For the sensor readings at each location, determine the maximum pressure using the following methods: i. Filter the pressure sensor data readings, retaining only the 25 highest readings. ii. Take the average of these 25 highest readings.

[0052] Step 3: For each maximum pressure in the abdomen, construct the maximum reliable pressure as follows: i. Standardize the maximum abdominal pressure based on the maximum pressure on the sternum. Specifically: subtract the maximum sternal pressure from the maximum pressure in the lower left quadrant, and so on for the other abdominal quadrants.

[0053] Step 4: Multiply the maximum reliable pressure for each feature by the corresponding weighting factor: i. Coefficient × Top Left Quadrant (LUQ) ii. Coefficient × Lower Left Quadrant (LLQ) iii. Coefficient × Upper Right Quadrant (RUQ) iv. Coefficient × Lower Right Quadrant (RLQ) v. Coefficient × Top Left Quadrant (LUQ) × Bottom Left Quadrant (LLQ) vi. Coefficient × Top Left Quadrant (LUQ) × Top Right Quadrant (RUQ) vii. Coefficient × Upper Left Quadrant (LUQ) × Lower Right Quadrant (RLQ) viii. Coefficient × Lower Left Quadrant (LLQ) × Upper Right Quadrant (RUQ) ix. Coefficient × Lower Left Quadrant (LLQ) × Lower Right Quadrant (RLQ) x. Coefficient × Upper Right Quadrant (RUQ) × Lower Right Quadrant (RLQ) xi. Coefficient × Top Left Quadrant (LUQ) × Bottom Left Quadrant (LLQ) × Top Right Quadrant (RUQ) xii. Coefficient × Top Left Quadrant (LUQ) × Bottom Left Quadrant (LLQ) × Bottom Right Quadrant (RLQ) xiii. Coefficient × Top Left Quadrant (LUQ) × Top Right Quadrant (RUQ) × Bottom Right Quadrant (RLQ) xiv. Coefficient × Lower Left Quadrant (LLQ) × Upper Right Quadrant (RUQ) × Lower Right Quadrant (RLQ) xv. Coefficient × Top Left Quadrant (LUQ) × Bottom Left Quadrant (LLQ) × Top Right Quadrant (RUQ) × Bottom Right Quadrant (RLQ)

[0054] Step 5: Combine the above results into a predicted score and calculate the probability of needing advanced imaging or hospitalization.

[0055] In some embodiments of the invention, the probability of needing advanced imaging or hospitalization is calculated using machine learning techniques. In one embodiment, an algorithm is developed using statistical methods based on data from approximately 76 patients who visited the emergency department of a regional medical center (Arrow Regional Medical Center (ARMC)) with primary symptoms of abdominal pain, nausea, vomiting, and / or diarrhea. Additional and / or other data may be collected for the training set or feasibility set used in embodiments of the invention. In some embodiments, a linear regression model is used. In other embodiments, other machine learning models known in the art may also be considered. In one embodiment, a multivariate logistic regression analysis is performed, with the outcome variable being whether the patient needs advanced imaging or hospitalization, and the predictor variables being the maximum reliable stress in each quadrant and all interaction effects. This generates a predicted probability of hospitalization or advanced imaging, categorized into three probabilities: low, uncertain, and high.

[0056] The following provides some example implementations in the embodiments, which involve a representative training dataset containing patient samples from the emergency department of a county hospital as described above.

[0057] analyze

[0058] In one embodiment, for each patient in the study, basic data indicating their consent to participate were entered into an Excel spreadsheet. This data included: age, sex at birth, race, ethnicity, height, weight, emergency department diagnosis, duration of symptoms, treatment received, location of abdominal pain, final diagnosis, whether emergency surgical intervention was required, whether a CT scan was performed, and whether an ultrasound examination was performed. Additionally, the palpation device generated five files containing sensor data for each patient. For each of these five sensor data files, the average of the top 25 maximum pressure readings was used. This generated a pressure reading for each of the five patient locations, and for the four abdominal quadrants, the difference between the pressure reading in that quadrant and the baseline sternal pressure reading was used as the maximum reliable pressure for that quadrant. A multivariate logistic regression was then performed, with the patient's need for advanced imaging or hospitalization as the outcome variable, and the maximum reliable pressure in each quadrant and all interaction effects as predictors. This generated a predicted probability of hospitalization or advanced imaging, categorized into three probabilities: low, moderate, and high. In one embodiment, linear regression analysis was performed using a Stata 16.1MP (StataCorp, College City, Texas).

[0059] result

[0060] In one embodiment of the training set, among the 83 patients who consented to participate in the study, our study sample included complete sensor data, imaging data, and treatment data for 76 patients. In this patient sample that ultimately returned to the busy county emergency room beds, data showed extremely high rates of imaging examinations (86%), hospital admissions (42%), and surgical interventions (15%) (Table 1). The multivariate logistic regression model incorporated the maximum reliable pressure data for each quadrant of the patients and standardized it to the maximum reliable pressure data of the sternum, demonstrating good modeling properties in this derivation study. Based on prior assumptions, all interaction terms were included in the model and therefore also included in the final model to reduce data overfitting. However, some individual interaction terms were not statistically significant (Table 2). The model showed a likelihood ratio chi-square of 28.83 with 15 degrees of freedom, a p-value of 0.017, and a pseudo-determination coefficient (pseudo R-squared value). 2 The value is 0.49. Therefore, the area under the curve (AUC) is 0.95.

[0061] The purpose of this device is to allow healthcare providers, without physical contact with the patient, to determine whether a patient's abdominal pain symptoms can be safely managed remotely. To maximize its clinical value, we created three risk categories for patients requiring advanced imaging or hospitalization: low-risk, intermediate-risk, and high-risk. Based on informal feedback from clinicians, we categorized patients with a predicted probability below 10% into the low-risk group, those with a predicted probability above 90% into the high-risk group, and those between the two thresholds into the intermediate or uncertain-risk group. This approach assesses the device's performance and its intended clinical use, although in this case, the assessment was based solely on the derived set (data). In this derived sample, the device performed excellently, with no misclassifications observed in either the low-risk or high-risk groups (Table 3).

[0062] Table 1: Demographic characteristics and results of the study sample

[0063] Table 2: Multiple logistic regression model with "patient admission and / or advanced imaging examinations" as the dependent variable

[0064] Table 3: Derivation of Equipment Performance in the Sample Fisher's exact test p-value < 0.001

[0065] In the preliminary feasibility study described above, researchers collected complete data from 76 patients who visited the emergency department of a large county hospital. These patients primarily presented with abdominal symptoms, including abdominal pain, nausea, vomiting, and / or diarrhea. If patients with abdominal pain could receive treatment virtually, those requiring appointment-free services might opt ​​for telemedicine. Currently, these patients must choose between an emergency care center and the emergency department; therefore, selecting a sample of emergency department patients with abdominal pain reasonably represents those who could benefit from virtual treatment alternatives, and embodiments of the palpation device disclosed herein can be applied to this virtual treatment scenario. In this sample, patients were instructed to use the device themselves. Furthermore, an unsuspecting physician assessed the patient according to standard procedures, including abdominal palpation. Results showed that in this sample, the device correctly categorized patients into low-risk, uncertain (medium-risk), and high-risk groups to assist physicians in determining whether patients required advanced imaging or hospitalization. Of the patients predicted to be at high risk by the device, 100% (53 / 53) required imaging and / or hospitalization, indicating that the device is highly effective in detecting highly sensitive lesions. Of the 21 patients in the uncertain risk (intermediate risk) group, 13 (61.9%) underwent imaging and / or hospitalization. Therefore, the determination of uncertain risk level cannot reliably predict the need for imaging / hospitalization. All patients considered low risk (0 / 2) did not require imaging and / or hospitalization.

[0066] In some embodiments, the device can serve as an auxiliary tool to assess whether abdominal pain patients receiving virtual consultations via telemedicine require in-person imaging examinations or hospitalization. Therefore, two types of errors may occur when using this device: one is incorrectly recommending in-person consultation when it is not necessary (i.e., false positives), or incorrectly recommending telemedicine when an in-person consultation is required (i.e., false negatives).

[0067] If the equipment unnecessarily recommends an in-person consultation, the patient will still receive the current standard of care without facing potential health risks. Patients may experience some time and / or temporary anxiety before receiving an in-person consultation. After the in-person examination, the doctor will palpate the patient's abdomen and, if necessary, arrange imaging studies or hospitalization. Therefore, false positive results do not increase health risks compared to the current standard treatment process.

[0068] On the other hand, if a patient has a surgical emergency but the device determines it to be of low or uncertain risk, it could lead to treatment delays. However, the device's instruction manual mitigates this risk, explicitly stating that device results must be comprehensively assessed in conjunction with the patient's clinical signs and symptoms. If the patient's signs and symptoms indicate the need for in-person imaging or hospitalization, the device's results should never replace clinical judgment. Furthermore, there are already procedures for assessing abdominal pain patients virtually. This assessment relies entirely on the patient's qualitative self-report. In some embodiments, the device proposed in this invention can provide additional information beyond the current information available to telemedicine personnel. Therefore, the potential risk of false negatives is no greater than the risk of potentially unreliable patient self-reports obtained through current telemedicine. By conducting additional laboratory, usability, and clinical studies, the risks of false positives and false negatives that may arise from using the various embodiments of this invention can be reasonably controlled.

[0069] From a technical perspective, using the various embodiments of the palpation device disclosed herein does not inherently pose a health risk. Just as a doctor presses on a patient's abdomen, as long as the patient and / or user use the palpation device according to the instructions, the pressure applied will only reach the level at which the patient begins to feel pain. Therefore, from a technical standpoint, the health risk of this device is low, and these risks can be managed through appropriate verification and validation testing (including software testing, electrical safety testing, and electromagnetic compatibility testing).

[0070] The various embodiments of this invention disclose multiple usage methods, supporting diverse application scenarios, including fully remote scenarios where patients use the palpation device and telemedicine personnel provide services via telemedicine. If no upgrades to treatment measures are required (e.g., no emergency room admission or advanced imaging examinations), the patient's treatment process can also be completely self-service. In some embodiments discussed herein, other treatment locations can also be considered, including pharmacies, clinics, hospitals, and even schools and workplaces. Potential users may be students, customers, or employees performing self-palpation, or performing palpation with the assistance of healthcare professionals such as physicians (MDs), registered nurses, registered nurses, pharmacy technicians, or school nurses, but the scope of users is by no means limited to the examples described above.

[0071] The benefits that the various embodiments of this disclosure bring to patients include avoiding unnecessary visits to the emergency department and reducing medical costs by obtaining the appropriate level of medical care.

[0072] The various embodiments of this disclosure bring value to insurance companies including faster and more accurate triage, savings in imaging and unnecessary surgical costs, and improved patient outcomes, including a reduction in the number of hospital and emergency room admissions, readmissions, and emergency surgeries.

[0073] The value that the various embodiments of this disclosure can bring to employers may include reducing employee absenteeism days and lowering healthcare costs (which is particularly significant for self-insured employers).

[0074] Finally, the various embodiments of this disclosure bring value to doctors and healthcare professionals including increased workflow throughput, optimized medical indicators and treatment outcomes, and reduced legal liability risks to patients.

[0075] Figures 9A-9C Exemplary wireframes 900A, 900B, and 900C are shown, depicting screenshots illustrating an exemplary user interface of a clinician performing a remote physical examination of a patient using a medical palpation device, a scenario consistent with one embodiment of this disclosure. In screenshot 900A, an example screen of a clinician's or physician's smartphone or other mobile device is shown, displaying the palpation results of a 45-year-old male patient, John Smith, who has just completed a self-palpation procedure. The software analysis process has been completed, giving a "high" risk of acute abdomen, meaning the clinician recommends the patient visit the emergency room and / or schedule advanced imaging studies.

[0076] Screenshot 900B shows an example screen on a clinician's or physician's smartphone or other mobile device, displaying the palpation results of a 34-year-old female patient, Jane Doe, who has just completed a self-palpation procedure. The software analysis is complete, and the risk of acute abdomen is shown as "low," meaning that based on the patient's history, the clinician does not need to recommend the patient to the emergency room and / or schedule advanced imaging. Screenshot 900C shows an example screen on a clinician's or physician's smartphone or other mobile device, displaying the palpation results of a 49-year-old female patient, Sally Jones, who has just completed a self-palpation procedure. The software analysis is complete, and the risk of acute abdomen is shown as "uncertain," further noting tenderness in the right lower quadrant. At this point, the clinician may review the patient's history more thoroughly or conduct further examinations via telemedicine, and then, depending on whether any new concerns are found, the clinician can decide whether to recommend the patient to the emergency department and / or schedule advanced imaging.

[0077] Figure 10An example of computer system 1000 is shown, wherein one or more of the computer systems may be used to implement one or more apparatuses, systems, and methods shown herein, such as devices 100-600 and method 800 described herein, as well as user interfaces 700A-700F and 900A-900C. Computer system 1000 executes instruction code contained in computer program product 1060. Computer program product 1060 includes executable code in an electronically readable medium that may instruct one or more computers (e.g., computer system 1000) to perform processing operations to complete the exemplary method steps performed by the embodiments referenced herein.

[0078] An electronically readable medium can be any non-transitory medium that stores information electronically and is accessible locally or remotely, such as via a network connection. In other alternative embodiments, the medium can also be a transient medium. The medium may include multiple geographically dispersed sub-media, each configured to store different portions of executable code at different locations and / or at different times. Executable instruction code in the electronically readable medium instructs the computer system 1000 to perform the various exemplary tasks described herein. Typically, the executable code used to instruct the performance of the tasks described herein is implemented in software. However, those skilled in the art will understand that computers or other electronic devices may also utilize code implemented in hardware to perform one or more of the specified tasks described above without departing from the scope of the invention. Those skilled in the art will also recognize that various variations of the executable code that implements the exemplary methods exist within the spirit and scope of the invention.

[0079] The code or a copy of code contained in the computer program product 1060 may be stored in one or more persistent storage media (not shown separately) that are communicatively coupled to the system 1000 for loading and storage in persistent storage device 1070 and / or memory 1010 for execution by processor 1020. The computer system 1000 also includes an input / output subsystem 1030 and peripheral devices 1040. The input / output subsystem 1030, peripheral devices 1040, processor 1020, memory 1010, and persistent storage device 1070 are coupled to each other via bus 1050. Like persistent storage device 1070 and any other persistent storage media that may contain computer program product 1060, memory 1010 is a non-transitory medium, even though it is implemented as a typical volatile computer storage device. Furthermore, those skilled in the art will understand that, in addition to storing the computer program product 1060 for performing the processing described herein, the memory 1010 and / or persistent storage device 1070 may also be configured to store various data elements referenced and described herein.

[0080] Those skilled in the art should understand that computer system 1000 is merely one example of a system that can implement the computer program product described in the embodiments of the present invention. As an alternative embodiment, the instructions included in the computer program product described in the embodiments of the present invention can be executed on multiple computers, for example, on computers distributed across a distributed computing network.

[0081] According to the disclosed embodiments, instructions for implementing a machine learning-based propensity score model, a logistic regression model, a probabilistic unit model, and / or an artificial neural network implementing any of the above models can be stored in the computer program product 1060. When the processor 1020 executes the instructions of the computer program product 1060, these instructions, or portions thereof, are typically loaded into the working memory 1010, from which the processor 1020 can conveniently retrieve these instructions.

[0082] In one embodiment, processor 1020 actually includes multiple processors, which may be equipped with additional working memory (the additional processors and memory are not shown separately), including one or more graphics processing units (GPUs), each containing at least several thousand arithmetic logic units to support massively parallel computing. Graphics processing units (GPUs) are commonly used in deep learning applications because they can perform related processing tasks more efficiently than typical general-purpose processors (CPUs). In other embodiments, one or more dedicated processing units are included, which contain systolic arrays and / or other hardware configurations that support efficient parallel processing. In some embodiments, such dedicated hardware works in conjunction with a CPU and / or GPU to perform the various processing operations described herein. In some embodiments, such dedicated hardware includes application-specific integrated circuits (ASICs, which may refer to the portion of an integrated circuit with application-specific functionality), field-programmable gate arrays, or combinations thereof. However, in some embodiments, processors such as processor 1020 may be implemented as one or more general-purpose processors (preferably multi-core processors) without departing from the spirit and scope of the invention. Exemplary Touch Device Embodiment

[0083] 1. A handheld palpation device for medical examination, comprising: a. A handle, designed in an arc shape to facilitate the user holding the handheld palpation device to apply pressure to the user's body, wherein the handle includes an internal space and an opening leading to the internal space; b. A palpation head having a first end and a second end, wherein the first end is configured to be mounted within the opening, and the second end includes an arcuate, flexible head configured to contact the user's body when pressure is applied by the user; c. A pressure pad located in the internal space of the handle, having a first surface configured to contact a first end of the palpation head, wherein the pressure pad captures electrical force data when the user applies pressure; d. A sensor chip located in the internal space of the handle and connected to the pressure pad, wherein the sensor chip is configured to receive electrical force data from the pressure pad and calculate one or more quantitative pressure measurements; e. A communication chip located inside the handle and connected to the sensor chip, wherein the communication chip is configured to receive quantitative pressure measurements from the sensor chip and transmit the quantitative pressure measurements to an external device; f. Power supplies connected to the sensor chip and communication chip; and g. A locking system is configured to hold the first end of the palpation head within the internal space of the handle.

[0084] 2. The palpation device according to Embodiment 1, wherein the communication chip includes Bluetooth connectivity.

[0085] 3. The palpation device according to Embodiment 1, wherein the sensor chip includes a voltage divider circuit.

[0086] 4. The palpation device according to Embodiment 1, wherein the pressure pad includes a force-sensitive resistor.

[0087] 5. The palpation device according to embodiment 1, wherein the locking system includes one or more pins located on the surface of the palpation head between the first end and the second end, wherein the one or more pins are configured to be located within the inner surface of the handle;

[0088] 6. The palpation device according to Embodiment 1, wherein a first end of the palpation head includes a pressure-bearing member that supports pressure applied by a user holding the palpation device.

[0089] 7. The palpation device according to Embodiment 6, wherein the pressure-bearing component comprises a rigid three-dimensional object.

[0090] 8. The palpation device according to embodiment 6, wherein the pressure-bearing component includes a spring.

[0091] 9. The palpation device according to Embodiment 1, wherein the power source includes a battery located within the handle.

[0092] 10. The palpation device according to Embodiment 1 further includes a cable connection to a power source.

[0093] 11. The palpation device according to Embodiment 1 further includes a power cord, the first end of which is connected to the cable connection.

[0094] 12. The palpation device according to embodiment 11, wherein the power cord includes a second end having one or more adapters configured for connection to a user device.

[0095] 13. The palpation device according to embodiment 12, wherein one or more adapters include a USB-C connector.

[0096] 14. The palpation device according to Embodiment 1, wherein the palpation head includes a massage head.

[0097] 15. The palpation device according to Embodiment 1, wherein the handle comprises rigid plastic. Exemplary Touch Device Software Implementation

[0098] 16. A method for conducting a telemedicine examination on a patient with abdominal pain, the method comprising: a. displaying a set of palpation instructions to the patient on a user device, wherein the set of palpation instructions instructs the patient to palpate multiple locations on the patient's body using a handheld palpation device, wherein the multiple locations include a baseline location; b. receiving a set of pressure readings from the handheld palpation device for each of the multiple locations on the patient's body. c. Calculate the average pressure reading for the set of pressure readings at each of multiple locations on the patient's body (including the baseline location); d. Calculate the maximum reliable pressure reading for at least a subset of the plurality of locations on the patient's body, wherein the maximum reliable pressure reading is the difference between the average pressure reading at that location and the average pressure reading at the baseline location; and e. To provide further medical advice to the patient or the patient's healthcare provider, wherein the advice is based on a calculated maximum reliable pressure reading and includes one or more of imaging studies, admission to the emergency department, or virtual medical procedures.

[0099] 17. The method according to embodiment 16, wherein the plurality of locations include the upper right quadrant of the abdomen, the lower right quadrant of the abdomen, the upper left quadrant of the abdomen, the lower left quadrant of the abdomen, and the sternum.

[0100] 18. The method according to Example 16, wherein the baseline location includes the sternum.

[0101] 19. The method according to Example 16, wherein the recommendation is derived using multivariate logistic regression, wherein the outcome variables include whether the patient requires imaging or admission to the emergency department.

[0102] 20. The method according to Example 19, wherein multiple predictor variables include the maximum reliable pressure in the upper right quadrant, lower right quadrant, upper left quadrant, and lower right quadrant.

[0103] 21. The method according to Example 19, wherein the recommendation further includes classifying patients requiring imaging examinations or admission to the emergency department into low, medium, or high-risk categories.

[0104] 22. The method according to Example 16, wherein the handheld palpation device includes any one of Examples 1-15.

[0105] 23. The method according to embodiment 16, wherein the user equipment includes a mobile phone, tablet computer, laptop computer, or desktop computer.

[0106] 24. A non-transitory computer-readable medium storing one or more software instructions, which, when executed by a processor, perform the following operations: a. Displaying a set of palpation instructions to the patient on an external device, wherein the set of palpation instructions instructs the patient to palpate multiple locations on the patient's body using a handheld palpation device, wherein the multiple locations include a baseline location; b. Receiving a set of pressure readings from the handheld palpation device for each of the multiple locations on the patient's body; c. Calculate the average pressure reading of the set of pressure readings for each of the plurality of locations on the patient’s body (including the baseline location); d. Calculate the maximum reliable pressure reading for at least a subset of the plurality of locations on the patient's body, wherein the maximum reliable pressure reading is the difference between the average pressure reading at that location and the average pressure reading at the baseline location; and e. To recommend further treatment to the patient or the patient's healthcare provider, wherein the recommendation is based on a calculated maximum reliable pressure reading and includes one or more of imaging studies, admission to the emergency department, or virtual medical procedures.

[0107] 25. The palpation device according to Embodiment 1, wherein the external device includes a mobile phone, tablet computer, laptop computer, or desktop computer.

[0108] While the present invention has been described in detail with reference to the illustrated embodiments, it should be understood that various changes, modifications, and adaptations can be made based on this disclosure, and all such changes, modifications, and adaptations are intended to fall within the protection scope of the present invention. Although the present invention has been described in conjunction with embodiments currently considered to be most practical and preferred, it should be clear that the present invention is not limited to the disclosed embodiments. Rather, the present invention is intended to cover various modifications and equivalent configurations, all of which are included within the protection scope of the basic principles of the present invention set forth in the embodiments cited above and below.

Claims

1. Handheld palpation devices for medical examinations, including: The handle, which is arc-shaped, is for gripping when applying pressure to the user's body using the handheld palpation device, wherein the handle includes an internal space and an opening leading to the internal space; The palpation head has a first end and a second end, wherein the first end is configured to be mounted within the opening, and the second end includes an arc-shaped flexible head configured to contact the user's body when pressure is applied. A pressure pad located in the internal space of the handle has a first surface configured to contact a first end of the palpation head, wherein the pressure pad captures electrical force data when pressure is applied. A sensor chip located inside the handle and connected to the pressure pad is configured to receive electrical force data from the pressure pad and calculate one or more quantitative pressure measurements. A communication chip located inside the handle and connected to the sensor chip is configured to receive quantitative pressure measurements from the sensor chip and transmit the quantitative pressure measurements to an external device. Power supply connected to the sensor chip and communication chip; A locking system is configured to hold the first end of the palpation head within the internal space of the handle.

2. The palpation device according to claim 1, wherein the communication chip includes Bluetooth connectivity.

3. The palpation device according to claim 1, wherein the sensor chip includes a voltage divider circuit.

4. The palpation device according to claim 1, wherein the pressure pad comprises a force-sensitive resistor.

5. The palpation device of claim 1, wherein the locking system comprises one or more pins located on the surface of the palpation head between the first end and the second end, wherein, One or more pins are configured to be located within the inner surface of the handle.

6. The palpation device of claim 1, wherein a first end of the palpation head includes a pressure-bearing member for supporting the pressure applied by a user when holding the palpation device.

7. The palpation device according to claim 6, wherein the pressure-bearing component comprises a rigid three-dimensional object.

8. The palpation device according to claim 6, wherein the pressure-bearing component comprises a spring.

9. The palpation device of claim 1, wherein the power source comprises a battery located within the handle.

10. The palpation device of claim 1, further comprising a wire connection to a power source.

11. The palpation device according to claim 1, further comprising a power cord, the first end of which is connected to the wire connection.

12. The palpation device of claim 11, wherein the power cord includes a second end having one or more adapters configured for connection to a user device.

13. The palpation device of claim 12, wherein one or more adapters include a USB-C connector.

14. The palpation device according to claim 1, wherein the palpation head includes a massage head.

15. The palpation device of claim 1, wherein the handle is made of rigid plastic.

16. A method for conducting remote medical examinations on patients with abdominal pain, the method comprising: A set of palpation instructions is displayed to the patient on a user device, wherein the set of palpation instructions instructs the patient to palpate multiple locations on the patient's body using a handheld palpation device, wherein the multiple locations include a baseline location; Receive a set of pressure readings for each of multiple locations on the patient's body from the handheld palpation device; Calculate the average pressure reading for the set of pressure readings at each of the plurality of locations on the patient's body (including the baseline location); Calculate the maximum reliable pressure reading for at least a subset of the plurality of locations on the patient's body, wherein the maximum reliable pressure reading is the difference between the average pressure reading at that location and the average pressure reading at the baseline location, and To provide recommendations for further treatment to a patient or the patient’s healthcare provider, wherein the recommendations are based on a calculated maximum reliable pressure reading and include one or more of imaging studies, admission to the emergency department, or virtual medical procedures.

17. The method of claim 16, wherein the plurality of locations includes the upper right abdomen, the lower right abdomen, the upper left abdomen, the lower left abdomen, and the sternum.

18. The method of claim 16, wherein the baseline location includes the sternum.

19. The method of claim 16, wherein the recommendation is derived by multivariate logistic regression, wherein the outcome variables include whether the patient requires imaging or admission to the emergency department.

20. The method of claim 19, wherein the plurality of predictor variables includes the maximum reliable pressure in the upper right quadrant, the lower right quadrant, the upper left quadrant, and the lower right quadrant.

21. The method of claim 19, wherein the recommendation further includes assigning patients to low-risk, uncertain, or high-risk categories.

22. The method of claim 16, wherein the handheld palpation device comprises any one of claims 1-15.

23. The method of claim 16, wherein the user equipment includes a mobile phone, tablet computer, laptop computer, or desktop computer.

24. A non-transitory computer-readable medium storing one or more software instructions, which, when executed by a processor, perform the following operations: A set of palpation instructions is displayed to the patient on an external device, wherein the set of palpation instructions instructs the patient to palpate multiple locations on the patient's body using a handheld palpation device, wherein the multiple locations include a baseline location; Receive a set of pressure readings for each of the plurality of locations on the patient's body from the handheld palpation device; Calculate the average pressure reading for the set of pressure readings at each of the plurality of locations on the patient's body (including the baseline location); Calculate the maximum reliable pressure reading for at least a subset of the plurality of locations on the patient's body, wherein the maximum reliable pressure reading is the difference between the average pressure reading at that location and the average pressure reading at the baseline location; as well as To provide recommendations for further treatment to a patient or the patient’s healthcare provider, wherein the recommendations are based on a calculated maximum reliable pressure reading and include one or more of imaging studies, admission to the emergency department, or virtual medical procedures.

25. The palpation device according to claim 1, wherein the external device includes a mobile phone, tablet computer, laptop computer, or desktop computer.

Citation Information

Patent Citations

  • Medical palpation device, system and method for augmented physical examination

    US20240268671A1

  • Medical system having object information reproduction means for palpation

    US5351677A

  • Apparatus for detecting very small breast anomalies

    US6192143B1

  • System and method for detecting tissue surface properties

    US9826904B2