Medical Palpation Device, System, and Method for Augmented Physical Examination

Abstract

The handheld palpation device for remote medical examinations includes a handle for applying pressure to a patient's body using a palpation head. The handle includes an interior space and an opening to the interior space. The palpation head fits inside the opening at one end, and the other end includes a round, flexible head configured to contact the patient's body when pressure is applied. Pressure pads disposed in the interior space derive electrical pressure data when pressure is applied. A sensor chip within the interior space receives the electrical pressure data from the pressure pads, calculates one or more quantitative pressure measurements, and transmits the quantitative measurements to a communication chip connected to the sensor chip. The sensor chip uses machine learning to communicate the quantitative pressure measurements to an external device for analysis and provides a clinical assessment using the pressure measurements.

Description

[Technical Field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of U.S. Provisional Application No. 63 / 445,997, filed February 15, 2023, and claims priority to U.S. Non-Provisional Application No. 18 / 442,057, filed February 14, 2024, the entire contents of which are incorporated herein by reference. The present disclosure relates generally to virtual or remote care in medicine, and more particularly to remote or augmented physical examination of a patient using a medical palpation device that is held in the patient's hand during a virtual physical examination and used by the patient at the direction of a clinician to palpate the patient's body. [Background technology]

[0002] Abdominal pain is the most common reason for unscheduled medical visits. According to the American Hospital Association, there are over 130 million emergency department (ED) visits annually. See: American Hospital Association, Fact Sheet: Telehealth, February 2019. Eleven million ED visits have a principal reason of stomach and abdominal pain, cramps, and spasms. Of these, 6 million have a principal diagnosis in the abdominal pain group. 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 have developed guidelines for documenting physical examination guidelines by 12 organ systems or 7 body regions. See: Centers for Medicare & Medicaid Services, 1995 Documentation Guidelines for Evaluation and Management Services, and 1997 Documentation Guidelines for Evaluation and Management Services.

[0004] Numerous diagnoses exist that are associated with abdominal pain. By palpating the abdomen, clinicians can determine whether a patient may have an "acute abdomen," a condition that requires surgical intervention, such as appendicitis, small bowel obstruction, intestinal perforation, or hernia. If a clinician palpates a patient's abdomen and, based on that palpation, suspects that the patient may have an acute abdomen, the patient is then further evaluated with advanced imaging, such as computed tomography (CT), ultrasound (US), or magnetic resonance imaging (MRI). In some cases, the patient is admitted as an inpatient for a repeat abdominal examination or taken directly to the operating room for surgical management without advanced imaging.

[0005] Ten million CT scans are performed annually on the abdomen or pelvis. See Reed et al. Furthermore, although CT use is common in ED patients with abdominal pain (approximately 40% in adults and 15% in children), CT use is associated with several significant risks, including a high rate of cancer. See Centers for Medicare & Medicaid Services, 1995 and 1997 Documentation Guidelines for Evaluation and Management Services.

[0006] Telemedicine is an increasingly important aspect of healthcare delivery. According to the American Hospital Association, telemedicine has the potential to reduce costs and improve access to care, especially for underserved populations and residents of rural areas. According to an American Hospital Association fact sheet, 79% of U.S. hospitals utilize some form of telemedicine. Despite the rise of telemedicine, abdominal pain generally cannot be safely and accurately assessed because clinicians cannot palpate the abdomen to determine whether the patient requires advanced imaging or surgery.

[0007] For telehealth to be maximally beneficial, patients must virtually perform many of the tasks performed during a visit with a human physician. A complete virtual physical examination (VPE) allows clinicians to perform the examination remotely. For clinicians to effectively perform a physical examination during a telehealth visit, the VPE should provide real-time, high-quality information similar to that of an in-person visit. In addition to relying on videoconferencing applications for telehealth visits, temporary use from inexpensive devices may be necessary. Specifically, the virtual physical examination must include objective data and enable the following tasks: ·Observation / examination (whole body, eyes, ears, throat, skin, trauma) Auscultation (heart, lungs, neck, abdomen) Palpation (injured area, lymph nodes, abdomen, calves, skin) - Obtaining vital signs (heart rate, respiratory rate, blood pressure, pulse oxygen saturation, weight, height) While many technological options are available for remote examination (visual), auscultation (audio), and obtaining vital signs for telehealth visits, there remains a lack of available methods and information regarding palpation during telehealth visits. For example, U.S. Patent No. 9,826,904, entitled "System and Method Rejecting Tissue Surface Properties," provides a system for identifying the shape of a body part or part, but does not evaluate clinical tenderness. As another example, U.S. Patent No. 6,192,143, entitled "Apparatus for Detecting Very Small Breast Anomalies," mechanically palpates the breast surface to identify small lumps or other abnormalities, but does not provide information regarding tenderness. Additionally, U.S. Patent No. 5,351,677, entitled "Medical System Having Objective Information Reproduction Means for Palpation," provides a means for an operator to remotely palpate distant objects using tactile feedback, but does not allow patients or caregivers to self-palpate and provide useful information to the clinician.

[0008] When it comes to palpation during abdominal examination, there remains a lack of alternatives to patient self-examination and patient-reported and subjective descriptions of their experience with palpation. This may be one of the reasons why gastroenterology ranks second lowest among internal medicine specialties in adopting telemedicine, according to the American Medical Association's Patient Care Benchmark Survey. Thus, while telemedicine allows clinicians to care for many clinical conditions remotely, the diagnosis and management of conditions such as acute abdominal pain are not readily available. With acute abdominal pain, clinicians must determine whether the patient has an "acute abdomen" and whether advanced imaging, lymph node problems, trauma, or musculoskeletal complaints are warranted, all of which typically require the ability to palpate the abdomen and other areas of injury / pain. Summary of the Invention

[0009] Devices, systems, and methods for performing standardized remote home palpation enable safe virtual care of patients with abdominal pain and provide a means to expand the range of medical conditions that healthcare providers can safely and accurately assess via telemedicine.

[0010]

[0003] Embodiments of the physical examination device, system, and method disclosed herein enable remote patient palpation by standardizing at-home palpation to enable safe virtual care for patients with abdominal pain. The device allows the patient or caregiver to palpate (press) the patient's abdomen or area of ​​interest and provide sensor pressure data to a software product connected to the device during abdominal palpation. Embodiments of the software product disclosed herein analyze the sensor pressure data and provide actionable data to the clinician regarding the patient's risk of abdominal pain, including information regarding whether advanced imaging is likely to be required. The clinician can then incorporate the device's findings regarding possible pathologies (such as appendicitis or fractures) into their decision-making.

[0011] In one embodiment, the handheld device is intended for use by patients during virtual abdominal exams and other virtual physical exams where palpation is required. Embodiments of the disclosed palpation device include a non-sterile, reusable medical device that can provide data and information to a remote healthcare provider to help determine whether abdominal imaging or further inpatient treatment in the ED is necessary.

[0012] In some embodiments, the device is disclosed as comprising a handle, a palpation head, a digital force sensor and processing circuitry, a compression member with a comfort spring or rigid block, a rechargeable battery pack, a Bluetooth module, and a USB port. In use, the patient or caregiver takes the device and presses on the sternum as hard as possible or until some discomfort is experienced to establish a baseline. The device measures the maximum force applied and transmits it via Bluetooth to a connected computer or smartphone. The connected computer or smartphone has a software application that receives the force data, applies an empirically derived algorithm to the data, and then informs the clinician of the degree to which the patient has clinically significant tenderness. The clinician can then integrate this information with the medical history and other physical examination findings to arrive at a diagnosis. [Brief explanation of the drawings]

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

[0014] [Figure 2] 1 illustrates a cross-sectional view of a medical palpation device for remote physical examination showing cord connections according to an embodiment of the present disclosure;

[0015] [Figure 3] 1 illustrates a top left perspective view of a medical palpation device for remote physical examination, according to an embodiment of the present disclosure;

[0016] [Figure 4] 1 illustrates an upper left perspective exploded view of a medical palpation device for remote physical examination, according to an embodiment of the present disclosure;

[0017] [Figure 5] 1 illustrates a cross-sectional view of a medical palpation device for remote physical examination, according to an embodiment of the present disclosure;

[0018] [Figure 6] 1 illustrates an upper left perspective exploded view of a medical palpation device for remote physical examination, according to an embodiment of the present disclosure;

[0019] [Figure 7A] 10A-10C illustrate exemplary screenshots of a patient software application for use with a medical palpation device for remote physical examination, according to an embodiment of the present disclosure. [Figure 7B] 10A-10C illustrate exemplary screenshots of a patient software application for use with a medical palpation device for remote physical examination, according to an embodiment of the present disclosure. [Figure 7C] 10A-10C illustrate exemplary screenshots of a patient software application for use with a medical palpation device for remote physical examination, according to an embodiment of the present disclosure. [Figure 7D] 10A-10C illustrate exemplary screenshots of a patient software application for use with a medical palpation device for remote physical examination, according to an embodiment of the present disclosure. [Figure 7E] 10A-10C illustrate exemplary screenshots of a patient software application for use with a medical palpation device for remote physical examination, according to an embodiment of the present disclosure. [Figure 7F] 10A-10C illustrate exemplary screenshots of a patient software application for use with a medical palpation device for remote physical examination, according to an embodiment of the present disclosure.

[0020] [Figure 8] 1 illustrates an exemplary flowchart showing operations for a data analysis software process according to an embodiment of the present disclosure.

[0021] [Figure 9A]1 illustrates an exemplary wireframe diagram showing a screenshot illustrating an exemplary user interface for a clinician treating a patient using a medical palpation device for remote physical examination, according to one embodiment of the present disclosure. [Figure 9B] 1 illustrates an exemplary wireframe diagram showing a screenshot illustrating an exemplary user interface for a clinician treating a patient using a medical palpation device for remote physical examination, according to one embodiment of the present disclosure. [Figure 9C] 1 illustrates an exemplary wireframe diagram showing a screenshot illustrating an exemplary user interface for a clinician treating a patient using a medical palpation device for remote physical examination, according to one embodiment of the present disclosure.

[0022] [Figure 10] Illustrative examples of computer systems are provided, one or more of which may be used to implement one or more of the devices, systems, and methods described herein.

[0023] Although the invention is described with reference to the above-mentioned drawings, the drawings are intended to be exemplary and other embodiments are consistent with the spirit and scope of the invention. DETAILED DESCRIPTION OF THE INVENTION

[0024] Various embodiments will now be described more fully hereinafter with reference to the accompanying drawings, which form a part hereof, and which show, by way of illustration, specific examples in which the embodiments may be practiced. This specification may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this specification will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. Among other things, the specification may be embodied as methods or devices. Accordingly, any of the various embodiments herein may take the form of an entirely hardware embodiment, an entirely software embodiment, or an embodiment combining software and hardware aspects. Therefore, the following specification is not to be construed in a limiting sense.

[0025] FIG. 1 illustrates a front exterior view of a medical palpation device 100 for remote physical examination, according to an embodiment of the present disclosure. The palpation device shown in FIG. 1 includes an ergonomic handle 110 with one end rounded and shaped to be held comfortably in a patient's or caregiver's hand during the pushing or pressing action of abdominal palpation. In some embodiments, the ergonomic design is optimized for both comfort and structure. A comfortable handle means that the patient is likely to use it consistently to achieve accurate results. The structural aspects of the handle allow the device to support a sufficient surface area for a moderate amount of force to be applied by the user without compromising the handle's structural integrity. The handle's structure also keeps the spacing between the handle, sensor, and massage head substantially constant with sufficient space inside the handle for internal circuitry. In some embodiments, the handle is an ergonomically designed, rigid structure and may be constructed from materials such as a rigid, smooth plastic or polyvinyl carbonate material. Other materials, such as wood or leather, may also be used. The interior of the handle may be hollow or may have interior spaces to house or allow for housing of tips, pressure pads, and other components, as described below.

[0026] The second end of the palpation device comprises an opening to the interior space of the handle (e.g., 115, 215 as shown in FIG. 2 and 415 as shown in FIG. 4). The device 100 further comprises a palpation head 130, one end of which is configured to fit inside the opening in the handle 100 and the other end of which comprises a round, flexible head configured to contact the patient's body when pressure is applied by the user's hand. In some embodiments, the palpation head 130 comprises a massage head similar to those used in handheld electronic massage devices or electronic massage kits. In one embodiment, the palpation head 130 comprises a massage head having a firm foam ball that provides an optimal balance of friction with the body part being palpated, contouring characteristics of the body part, and firmness for pressure transmission. The palpation head 130 may also comprise a massage head that provides a comfortable foam-like surface that provides compression over the surface area for better palpation and consistency when the user holds the palpation device and applies it to the patient's body.

[0027] 2 shows a cross-sectional view 200 of an embodiment of a medical palpation device 100 for remote physical examination, showing a cord connection, illustrating a handle 210 having an interior space 212 and an opening 215. A pressure pad 230 resides within the interior space 212 and uses electrical resistance to capture pressure applied by a user. In some embodiments, the pressure pad 230 comprises a force sensor. In one embodiment, the force sensor comprises a force-sensing resistor. In some embodiments, the force sensor is calibrated to a range of forces known to be applied by people during self-palpation to provide identification of maximum force in the relevant force range.

[0028] 2 resides within opening 215 and functions to lock palpation head 220 (e.g., massage head) in place within handle 210 to prevent ejection of the palpation head from the palpation device during use. Locking system 240, in some embodiments, comprises a horizontal bar or pin 242 that fits into a vertical slot 244 within opening 215. In one embodiment, the vertical slot allows for approximately 4 mm of movement of horizontal bar 242 between the massage head and handle, allowing for optimal handling of the palpation device during the palpation process.

[0029] The sensor internal chip 250, shown in FIG. 2, is connected to pressure pads 230 in one embodiment. The pressure pads 230 are connected to the sensor internal chip 250 by wires. In one embodiment, the sensor internal chip 250 includes an internal circuit board chip that converts the electrical signal from the pressure pads into a quantitative measurement that can be transmitted to a network device via a voltage divider circuit 260. The voltage divider circuit 260 relays data from the sensor internal chip 250 via a cord connection 280 and ultimately transmitted over the internet to a clinician for interpretation as needed. In some embodiments, software code can be used to measure and record electrical resistance and convert it to pounds of force. In one embodiment, such software code is manufactured by Tekscan, Inc. under the trade name Flexiforce™.

[0030] In some embodiments, the voltage divider circuit 260 includes an analog circuit module that processes the external force applied by a user. The voltage divider circuit 260 can have a programmable reference voltage for sensitivity adjustment and a connection to the pressure pad 250 (e.g., a force-sensing resistor). In one embodiment, the pressure pad 250 includes a force-sensing resistor A201-25 pad manufactured by Tekscan, Inc. under the trade name Flexiforce™. In one embodiment, the voltage divider circuit 260 can include a voltage divider module manufactured by Tekscan, Inc. The voltage divider circuit 260 can have a programmable reference voltage to set a default sensitivity adjustment for calibrating the force sensor. In other embodiments, an inverting or non-inverting op-amp circuit module (not shown) can be used instead of the voltage divider circuit module 260. In some embodiments, the interior space 212 of the handle 210 of FIG. 2 is of sufficient size that any interference with the voltage divider circuit 260, which may be caused by skin, metal, or any other ionizing surface interfering with an open circuit in the voltage divider 260, does not cause issues by affecting the force readings.

[0031] In some embodiments, the cord connection 280 includes a cord sheath that protects the wires from damage inside the handle and a power cord for connecting the palpation device to a power adapter or charger and / or a user device such as a cell phone, tablet, or laptop. In some embodiments, the cord connection 280 connects to a power source 270 that includes a rechargeable battery known in the art, such as a lithium-ion battery. In one embodiment, the power source 270 can also include a power transfer module that includes a small chip that allows for the transfer of power and data from the palpation device to a user device such as a cell phone, tablet, or laptop or desktop computer. In one embodiment, the cord connection 280 can also include a USB-C port that allows for recharging the palpation device, powering the device from an external charger, and connecting directly to a computer for data transfer. The cord connection 280 can also include a power cord that connects to one or more connector heads 285 that include one or more connectors, such as a micro USB, Lightning port connector, or USB-C port connector, that can connect to a user's cell phone, tablet, laptop computer, or other networked device.

[0032] Finally, in the embodiment shown in FIG. 2, the sensor deformation 290 is positioned inside the opening 215 and is also connected to the palpation head 220 to provide a contact point against which the palpation head presses against the pressure pad 230 .

[0033] 3 illustrates a top left perspective view 300 of a medical palpation device for remote physical examination, according to an embodiment of the present disclosure. This external view shows a handle 310, a palpation head 320, and an area where an opening 315 connects the handle 310 to one end of the palpation head 320.

[0034] 4 illustrates an upper left perspective exploded view 400 of a medical palpation device for remote physical examination according to an embodiment of the present disclosure. The exploded view shows the relative positions of certain components of the embodiment of the medical palpation device shown in FIGS. 1, 2, and 3, including an ergonomic handle 410, a pressure pad 430, a sensor deformer 490, and a palpation head 420.

[0035] FIG. 5 illustrates a cross-sectional view of a medical palpation device 500 for remote physical examination, according to an embodiment of the present disclosure. FIG. 5 shows similar components to those described above in FIGS. 1-4, including an ergonomic handle 510, which is a simple circular, ergonomically shaped handle with an internal space for a tip and other components; a palpation head (e.g., a massage head) 520 for pressing against the patient's body; a pressure pad 530 for generating data from the amount of pressure applied; a locking system 540 for locking the palpation head in place to prevent ejection of the palpation head during use; and a sensor internal chip 550, which in one embodiment is connected to the pressure pad 530. The pressure pad 530 is connected to the sensor internal chip 550 by wires. In one embodiment, sensor internal chip 550 includes an internal circuit board chip that converts electrical signals from pressure pads 530 into quantitative measurement data that can be transmitted to a network device via Bluetooth internal chip 560, which connects and transmits data from pressure pads 530 to a device such as a Bluetooth connected computer, tablet, or smartphone.

[0036] In some embodiments, power port 580 is connected to an internal power source 570 for powering pressure pads 530, sensor internal chip 550, and Bluetooth internal chip 560. Power source 570, in one embodiment, can include a rechargeable battery known in the art, such as a lithium-ion battery. Power port 580, in one embodiment, further includes a power cord connection including a data port and / or a USB-C port, which allows for recharging the palpation device, powering the device from an external charger, and / or connecting directly to a computer for data transfer. Power port 280 can also include a power cord that connects to one or more connector heads 285, including one or more connectors, such as a micro USB, Lightning port connector, or USB-C port connector, which can connect to a power source, such as an electrical outlet or power bank, or a user's mobile phone, tablet, laptop computer, or other network device.

[0037] 5, a spring 590 positioned between the ergonomic handle 510 and the palpation head 520 applies pressure to the palpation head 520 during palpation, causing the palpation head 520 to extend to a portion 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 feel to the palpation.

[0038] Figure 6 illustrates an upper left perspective exploded view 600 of the medical palpation device for remote physical examination shown in Figure 5, according to an embodiment of the present disclosure. The exploded view illustrates the relative positions of certain components of the embodiment of the medical palpation device shown in Figure 5, including an ergonomic handle 610, a pressure pad 630, a spring 690, and a palpation head 620.

[0039] The embodiments of the medical palpation device shown in Figures 1-6 may be configured for use with interpretation software, as described below. The interpretation software consists of a desktop or mobile application that connects to the palpation device, includes software resident on a computer or smartphone that guides a user through the palpation motion, receives the sensor data, and applies data processing algorithms to determine the extent to which the sensor data indicates that the patient has clinically significant tenderness.

[0040] 7A-7F show exemplary screenshots of a patient software application for use with a medical palpation device for remote physical examination, according to embodiments of the present disclosure. The screenshots in FIGS. 7A-7F illustrate a user demonstration sequence for a medical palpation device according to some embodiments of the present disclosure. In some embodiments, before starting the user demonstration sequence, the patient can log in to their networked computing device, e.g., a mobile phone, tablet, or laptop, for a virtual visit with their telehealth clinician or care provider. In one example, the patient identifies abdominal pain as a symptom. The telehealth care provider can issue preliminary instructions to the patient to go to the medical palpation device and turn it on. If necessary, connect the palpation device to a power source. The palpation device also needs to connect to a network device via a physical cord or Bluetooth connection to transmit pressure sensor data readings to an interpretation software program for assessing the clinical significance of the patient's abdominal or other pain.

[0041] Once these preliminary steps are completed, in some embodiments of the present disclosure, a web or mobile application launches on the network device (e.g., a smartphone, tablet, or laptop / desktop computer). After the patient clicks "Accept," the demonstration sequence guides the patient or caregiver to follow the instructions in the user demonstration sequence for palpating the patient's body. The patient can perform the sequence on their own body using the palpation device for self-palpation. Alternatively, a caregiver may perform the palpation sequence by applying the palpation device to the patient's body. In one embodiment, the demonstration sequence guides the patient or caregiver to palpate the patient's abdomen. In screenshot 700A shown in FIG. 7A, the patient is first instructed to lie flat and click the "Ready" button when ready to proceed with palpation. The screenshots in FIGS. 7A-7F also show how a user may hold or grasp the palpation device to perform the palpation sequence as instructed.

[0042] First, in screenshot 700B shown in FIG. 7B, 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 hard as the patient (or user) can until it hurts. The patient is instructed to position the sternum in the center of the chest between the patient's nipples.

[0043] Next, the patient or user is asked to identify the four abdominal quadrants to be palpated: the left upper quadrant (LUQ), the left lower quadrant (LLQ), the right lower quadrant (RLQ), and the right upper quadrant (RUQ). In screenshot 700C shown in FIG. 7C, the user is instructed to palpate the left upper quadrant (LUQ) by pressing the palpation device against the patient's left upper quadrant as hard as possible or until it hurts. The LUQ is located just below the patient's left ribs. In screenshot 700D shown in FIG. 7D, the user is instructed to palpate the left lower quadrant (LLQ) by pressing the palpation device against the patient's left lower quadrant as hard as possible or until it hurts. The LLQ is located just inside the patient's left hip joint. In screenshot 700E shown in FIG. 7E, the user is instructed to palpate the patient's right lower quadrant (RLQ) as hard as possible or until it hurts. The RLQ is located just inside the patient's right hip joint.

[0044] Next, as shown in screenshot 700F of FIG. 7F, the patient or user is instructed to palpate the patient's right upper quadrant (RUQ) until it feels as firm or painful as possible. The RUQ is located just below the patient's right ribs. Once the palpation in screenshot 700F is complete, the user can press "Submit" to submit the pressure sensor data and run the data analysis software for transmission to the clinician.

[0045] The patient is expected to have a mechanism for initiating a measurement with each palpation and stopping it when the patient indicates they have finished pushing to the designated location. In some embodiments, the medical palpation device, under software direction, generates five patient data files containing pressure sensor data from each of the five palps performed on the patient. The sensor data is collected multiple times at regular intervals (e.g., 50 times per second) during the palpation. In one embodiment, for each of the five sensor data files, an average of the top 25 maximum pressure readings is used, as described below. This generates one pressure reading for each of the five palpation locations on the patient's body. For each of the four abdominal quadrants (LUQ, RUQ, LLQ, RLQ), in one embodiment, the difference between the pressure reading and the baseline chest pressure reading is used as the maximum reliable pressure for that quadrant. This data is then transmitted from the palpation device to the patient's mobile device, tablet, and / or laptop or desktop computer for further analysis.

[0046] In one exemplary use case of the medical palpation device and data interpretation software embodiments discussed herein, a 27-year-old woman has abdominal pain and wishes to receive a medical evaluation. She contacts her doctor's office, which arranges a virtual visit. Prior to the virtual visit, the woman uses other devices to assess her vital signs (temperature, heart rate, respiratory rate, blood pressure, and pulse oxygen saturation) and provide a record of her heart, lungs, and abdomen for physician review. She then uses the medical palpation device discussed herein with respect to various embodiments to press on the four quadrants of her abdomen, which provides the physician with data for use during the encounter. The physician initiates the virtual visit with the woman. Based on the woman's medical history and the device's indication that she has clinically significant tenderness in the right lower quadrant, the physician orders a same-day ultrasound of the woman's appendix to evaluate for appendicitis.

[0047] In another exemplary use case of the medical palpation device and data interpretation software embodiments discussed herein, a 30-year-old man has nausea and vomiting and wishes to seek medical attention. He logs into Virtual Urgent Care. Prior to the virtual visit, the man uses other devices to assess his vital signs (temperature, heart rate, respiratory rate, blood pressure, and pulse oxygen saturation) and provide a record of his heart, lungs, and abdomen for physician review. He then uses the invention to press four quadrants of his abdomen, which provides the physician with data to use during the encounter. The physician begins the virtual visit with the man. Based on the man's medical history and the device's indication that there is no clinically significant tenderness in the abdomen, the physician recommends an antiemetic, water, and Gatorade for the possibility of gastroenteritis.

[0048] 8 shows an exemplary flowchart 800 illustrating the operation of a data analysis software process according to one embodiment of the present disclosure. First, in step 810, the system transmits palpation instructions for display to a user on a user device, such as a smartphone, tablet, or desktop or laptop computer. Exemplary interfaces for this are presented and discussed in FIGS. 7A-7F.

[0049] In operation 820, a set of pressure readings is received from a handheld palpation device for each of a plurality of locations on the user's body, and the most reliable pressure for each abdominal quadrant is identified, as follows: In some embodiments of the invention, operation 820 is performed according to step 1 below. Operation 830 may be performed according to step 2 below. Operation 840 may be performed according to step 3 listed below. Operation 850 may be performed according to step 4 listed below. Operation 860 may then be performed according to step 5 listed below.

[0050] Step 1: Take sensor readings at each of the five locations: i. Sternum ii.Left upper abdomen iii. Right upper abdomen iv.Left lower abdomen v. Right lower abdomen

[0051] Step 2: For each location sensor reading, create a maximum pressure as follows: i. Trim the number of pressure sensor data readings to include only the 25 highest readings ii. Take the average of the 25 highest readings

[0052] Step 3: For each maximum abdominal pressure, create the most reliable pressure as follows: i. Normalize abdominal maximum pressure using sternal maximum pressure. This is the form of maximum pressure left lower quadrant (minus maximum pressure sternal).

[0053] Step 4: Multiply the maximum reliability pressure of each part by the appropriate weighting factor: i. Coefficient X LUQ ii. Factor x LLQ iii. Coefficient X RUQ iv. Coefficient X RLQ v.Coefficient X LUQ X LLQ vi. Coefficient X LUQ X RUQ vii. Coefficient X LUQ X RLQ viii. Coefficient X LLQ X RUQ ix. Coefficient X LLQ X RLQ x. Coefficient X RUQ X RLQ xi. Coefficient X LUQ X LLQ X RUQ xii. Coefficients X LUQ X LLQ X RLQ xiii. Coefficients X LUQ X RUQ X RLQ xiv. Coefficients X LLQ X RUQ X RLQ xv.Coefficient X LUQ X LLQ X RUQ X RLQ

[0054] Step 5: The above is combined into a predictive score to calculate the probability of needing advanced imaging or hospitalization.

[0055] In some embodiments of the present invention, the probability of requiring advanced imaging or hospitalization is calculated using machine learning techniques. In one embodiment, the algorithm was statistically developed from approximately 76 patients presenting to the emergency department of a regional medical center (Arrowhead Regional Medical Center (ARMC)) primarily complaining of abdominal pain, nausea, vomiting, and / or diarrhea. Additional and / or other data may be collected for training or running sets for use in embodiments of the present invention. In some embodiments, a linear regression model is used. Other machine learning models known in the art may also be used in other embodiments. In one embodiment, a multiple logistic regression is performed using whether the patient requires advanced imaging or hospitalization as the patient outcome variable and the maximum confidence interval for each quadrant, including all interaction effects, as the predictor variable. This generates a predicted probability of hospitalization or advanced imaging, which is placed into three categories of likelihood: low, intermediate, and high.

[0056] An exemplary implementation in some embodiments is provided below for a representative training dataset including a patient sample from a county hospital emergency department as described above.

[0057] analysis

[0058] In one embodiment, basic data for each patient in the derivation study who consented to participate in the study were entered into an Excel spreadsheet: age, birth sex, race / ethnicity, height, weight, ED diagnosis, symptom duration, cause, location of abdominal pain, final diagnosis, whether immediate surgical intervention was required, whether a CT scan was performed, and whether an ultrasound was performed. Additionally, the palpation device generated five files for each patient containing sensor data. For each of the five sensor data files, the average of the top 25 maximum pressure readings was used. This resulted in one pressure measurement for each of the patient's five locations. For the abdominal quadrant, the difference between that pressure measurement and the baseline sternal pressure measurement was used as the most reliable pressure for that quadrant. Multiple logistic regression was then performed using the outcome variable of patients requiring advanced imaging or hospitalization and the most reliable pressure for each quadrant, including all interaction effects, as predictors. This generated a predicted probability of hospitalization or advanced imaging, which was categorized into three probability categories: low, medium, and high. In one embodiment, linear regression analysis was performed using Stata 16.1 MP (StataCorp, College Station, TX).

[0059] result

[0060] In one embodiment of the training set, of 83 patients who consented to participate in the study, 76 patients had complete sensor, image, and etiological data for the present study sample. This sample of patients admitted to bed in a busy county emergency department had a high rate of imaging (86%), hospitalization (42%), and surgical intervention (15%) (Table 1). Multivariate logistic regression including maximum confidence pressure data for each patient quadrant normalized by maximum confidence pressure data for the sternum demonstrated strong modeling properties in this derivation study. All interaction terms were included in the model based on a priori hypotheses; therefore, although some individual interaction terms were not statistically significant, they were included in the final model to reduce overfitting of the data (Table 2). This model demonstrated a chi-square likelihood ratio of 28.83 with 15 degrees of freedom, a P value of 0.017, and a pseudo-R-squared of 0.49. This resulted in an area under the curve of 0.95.

[0061] The purpose of the device is to determine whether a provider who is not physically present with the patient can safely treat a patient's abdominal pain virtually. To make this most clinically useful, three risk categories were created: low, medium, and high, for patients requiring advanced imaging or hospitalization. Based on informal clinician feedback, a low-risk group was created for those with a predicted probability of less than 10%, a high-risk group for those with a predicted probability of greater than 90%, and a moderate or uncertain-risk group for those falling between the two cutoffs. This allows for evaluation of device performance and its intended clinical use, albeit in this case using a derivation set. Device performance in this derivation sample was very good, with no misclassification in either the low-risk or high-risk groups (Table 3).

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

[0063] Table 2: Multiple logistic regression model with dependent variable = patient was hospitalized and / or underwent advanced imaging [Table 2]

[0064] Table 3: Device performance in derived samples [Table 3] Fisher's exact test P value < 0.001

[0065] In the initial feasibility study described above, complete data were collected on 76 patients who visited the Great County Hospital Emergency Department with primarily abdominal-related complaints: pain, nausea, vomiting, and / or diarrhea. Patients with abdominal pain who required unscheduled care may opt for telemedicine if their abdominal pain could be treated virtually. Because these patients currently must choose between the emergency room and the emergency department for treatment, this sample of emergency room patients with abdominal pain may adequately represent patients who could benefit from a virtual treatment alternative using embodiments of the disclosed palpation device. In this sample, patients were asked to use the device themselves. Separately, blinded physicians assessed patients according to a standard of care that included abdominal palpation. In this sample, the device accurately classified patients into low, uncertain (intermediate), and high-risk groups for physicians to prescribe advanced imaging or hospitalization. One hundred percent (53 / 53) of patients predicted as high risk by the device required imaging and / or hospitalization, suggesting that the device is highly effective in detecting serious medical conditions. Thirteen of 21 patients (61.9%) in the uncertain-risk group underwent imaging and / or hospitalization. Therefore, uncertain risk measures could not reliably predict the need for imaging / hospitalization. None of the patients considered low risk (0 / 2) required imaging and / or hospitalization.

[0066] In some embodiments, the device helps assess the likelihood that a patient with abdominal pain who is being evaluated virtually through telehealth will require in-person imaging or hospitalization. Thus, two types of errors can occur with the use of the device: incorrectly recommending an in-person visit when one is not necessary (false positive), or incorrectly recommending a virtual visit when an in-person visit is necessary (false negative).

[0067] If the device unnecessarily recommends an in-person visit, the patient receives the current standard of care and is not exposed to potential risks to their health. The patient may experience lost time and / or temporary anxiety until they are seen in person by a healthcare provider. During the in-person visit, the physician palpates the patient's abdomen and, if necessary, orders diagnostic imaging or admits the patient to the hospital. Therefore, a false-positive result does not indicate an increased risk to health above the current standard of care.

[0068] On the other hand, if a patient has an acute abdominal condition and the device indicates that the patient is at low or uncertain risk, treatment may be delayed. This risk is mitigated by the device's labeling, which indicates that device results must be evaluated alongside the patient's clinical signs and symptoms. If the patient's signs and symptoms suggest the need for in-person consultation for imaging or hospitalization, device results should not be used to override clinical judgment. Furthermore, patients are currently evaluated virtually for abdominal pain. This evaluation relies entirely on qualitative self-reporting from the patient. In some embodiments, the proposed device can provide additional information beyond what virtual providers have today. Therefore, the risk of potential false negatives is less than the potentially unreliable self-reporting from patients provided today via telemedicine. The risk of potential false positive and false negative results from the use of embodiments of the present invention can be appropriately mitigated through additional bench, usability, and clinical research.

[0069] From a technical standpoint, the act of using embodiments of the disclosed palpation device itself does not pose any potential health risks. As long as the patient and / or user performs palpation using the palpation device as instructed, much like a doctor pressing on a patient's abdomen, the pressure will only be so strong that the patient feels pain. Therefore, from a technical standpoint, the health risks are low and can be addressed through appropriate verification and validation testing, including software, electrical safety, and electromagnetic compatibility testing.

[0070] Embodiments of the present invention disclose methods that enable a variety of uses, including completely remote use cases with patients using the palpation device and remote care providers via telemedicine. Patient care can be completely self-service if there is no escalation to required care (e.g., ER admission or advanced imaging). Other care locations, including pharmacies, clinics, hospitals, or schools, work sites, etc., are also contemplated in some embodiments discussed herein. Potential users include, but are not limited to, students performing self-palpation, customers, employees, or care providers such as physicians (MDs), registered nurses (RNs), registered nurse practitioners (NPs), pharmacy technicians, and school nurses.

[0071] The patient value proposition of embodiments of the present disclosure includes eliminating unnecessary visits to the emergency room (ED) and reducing costs by receiving the appropriate level of care.

[0072] The value proposition of embodiments of the present disclosure to insurance companies includes faster and more accurate triage that avoids diagnostic imaging and unnecessary surgical costs while improving patient outcomes, including reduced hospital and ED admissions, readmissions, and emergency surgeries.

[0073] The value proposition to the inventors of embodiments of the present disclosure includes reduced employee days of absence and reduced care costs (especially for self-insured employers).

[0074] Finally, the value proposition of embodiments of the present disclosure to physicians and care providers includes increased workflow throughput, better care metrics and outcomes, and reduced burden on patients.

[0075] 9A-9C show exemplary wireframe diagrams 900A, 900B, and 900C, each showing a screenshot illustrating an exemplary user interface for a clinician treating a patient using a medical palpation device for remote physical examination, according to one embodiment of the present disclosure. In screenshot diagram 900A, an exemplary screen of a clinician's or doctor's smartphone or other mobile device is shown depicting the palpation results of a 45-year-old male patient, John Smith, who has just completed a self-palpation method. The software analysis method is complete, and the risk of acute abdomen is given as "high," meaning the clinician should advise the patient to go to the ED and / or prescribe advanced imaging tests.

[0076] In screenshot 900B, an exemplary screen of a clinician's or physician's smartphone or other mobile device is shown depicting the results of the self-examination of Jane Doe, a 34-year-old female patient. The software analysis method is completed and the risk of acute abdomen is given as "low," meaning that, depending on the patient's medical history, the clinician does not need to advise the patient to go to the ED and / or order further imaging. In screenshot 900C, an exemplary screen of a clinician's or physician's smartphone or other mobile device is shown depicting the results of the self-examination of Sally Jones, a 49-year-old female patient, who has just completed the self-examination. The software analysis method is completed and the risk of acute abdomen is given as "indeterminate," further including the notation that there was some tenderness in the right lower quadrant. At this point, the clinician can review the patient's medical history more closely or conduct further examinations via telemedicine. Depending on whether further concerns are raised, the clinician can then advise the patient to go to the ED and / or order further imaging.

[0077] 10 illustrates an example computer system 1000, one or more of which may be used to implement one or more of the apparatuses, systems, and methods described herein, such as devices 100-600 and method 800, and user interfaces 700A-700F and 900A-900C, described herein. Computer system 1000 executes instruction code included in computer program product 1060. Computer program product 1060 comprises executable code in an electronically readable medium that can instruct one or more computers, such as computer system 1000, to perform steps to effectuate example method steps performed by the embodiments referenced herein.

[0078] The electronically readable medium may be any non-transitory medium that stores information electronically and may be accessed locally or remotely, for example, via a network connection. In alternative embodiments, the medium may be transitory. The medium may include multiple geographically distributed media, each configured to store different portions of executable code at different locations and / or different times. Executable instruction code in the electronically readable medium directs the illustrated computer system 1000 to perform the various exemplary tasks described herein. Executable code for directing the performance of the tasks described herein is typically implemented in software. However, those skilled in the art will understand that a computer or other electronic device may utilize code implemented in hardware to perform many or all of the identified tasks without departing from the invention. Those skilled in the art will appreciate that many variations of executable code may be found that implement the exemplary methods within the spirit and scope of the invention.

[0079] Code or copies of code included in computer program product 1060 may reside on one or more storage persistent media (not separately shown) communicatively coupled to system 1000 for loading and storing into persistent storage 1070 and / or memory 1010 for execution by processor 1020. Computer system 1000 also includes an I / O subsystem 1030 and peripherals 1040. The I / O subsystem 1030, peripherals 1040, processor 1020, memory 1010, and persistent storage 1070 are coupled via a bus 1050. Like persistent storage 1070 and any other persistent storage that may comprise computer program product 1060, memory 1010 is a non-transitory medium (even if implemented as a typical volatile computer memory device). Further, those skilled in the art will understand that in addition to storing the computer program product 1060 for performing the processes described herein, the memory 1010 and / or persistent storage device 1070 may be configured to store various data elements referenced and illustrated herein.

[0080] Those skilled in the art will appreciate that computer system 1000 represents only one example of a system in which a computer program product according to an embodiment of the present invention may be implemented. To cite one example of an alternative embodiment, execution of instructions included in a computer program product according to an embodiment of the present invention may be distributed over multiple computers, such as, for example, over computers in a distributed computing network.

[0081] Instructions for implementing a machine learning-based propensity score model, a logistic regression model, a probit model, and / or an artificial neural network implementing any of the above according to disclosed embodiments may be present in a computer program product 1060. When the processor 1020 is executing the instructions of the computer program product 1060, the instructions, or portions thereof, are typically loaded into the working memory 1010 from which the instructions are easily accessed by the processor 1020.

[0082] In one embodiment, processor 1020 includes multiple processors, which may include additional working memory (additional processors and memory not separately shown), including one or more graphics processing units (GPUs) with at least thousands of arithmetic logic units to support massively parallel computations. GPUs are often utilized in deep learning applications because they can perform associated processing tasks more efficiently than typical general-purpose processors (CPUs). Other embodiments include one or more specialized processing units, including 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 various processes described herein. In some embodiments, such dedicated hardware includes an application-specific integrated circuit (referring to a portion of an application-specific integrated circuit), a field-programmable gate array, or the like, or a combination thereof. However, in some embodiments, a processor such as processor 1020 may be implemented as one or more general-purpose processors (preferably having multiple cores) without necessarily departing from the spirit and scope of the present invention.

[0083] Exemplary Haptic Device Embodiments 1. A handheld palpation device for medical examination, comprising: a. a handle having a rounded shape configured to be held by a user's hand while using the handheld palpation device to apply pressure to the user's body, the handle including an interior space and an opening to the interior space; b. a palpation head having a first end and a second end, the first end configured to fit inside the opening and the second end comprising a rounded, flexible head configured to contact the user's body when pressure is applied by the user; c. a pressure pad disposed in the interior space of the handle, the pressure pad having a first surface configured to contact the first end of the palpation head, the pressure pad capturing electrical pressure data when pressure is applied by a user; d. a sensor chip disposed within the interior space of the handle and connected to the pressure pads, the sensor chip configured to receive electrical pressure data from the pressure pads and calculate one or more quantitative pressure measurements; e. a communications chip disposed within the interior space of the handle and connected to the sensor chip, the communications chip configured to receive quantitative pressure measurements from the sensor chip and communicate the quantitative pressure measurements to an external device; f. A power supply connected to the sensor chip and the communication chip; g. a locking system configured to retain the first end of the palpation head within the interior space of the handle; A palpation device comprising:

[0084] 2. The palpation device of embodiment 1, wherein the communication chip comprises a Bluetooth® connection.

[0085] 3. A palpation device as described in embodiment 1, wherein the sensor chip comprises a voltage divider circuit.

[0086] 4. The palpation device of embodiment 1, wherein the pressure pad comprises a force-sensing resistor.

[0087] 5. The palpation device of embodiment 1, wherein the locking system comprises one or more pins on a surface of the palpation head between the first end and the second end, the one or more pins being configured to reside within the interior surface of the handle;

[0088] 6. A palpation device as described in embodiment 1, wherein the first end of the palpation head comprises a compression member that supports pressure applied by the user holding the palpation device.

[0089] 7. The palpation device of embodiment 6, wherein the compression member comprises a rigid three-dimensional object.

[0090] 8. The palpation device of embodiment 6, wherein the compression member comprises a spring.

[0091] 9. The palpation device of embodiment 1, wherein the power source includes a battery located inside the handle.

[0092] 10. The palpation device of embodiment 1, further comprising a cord connection connected to the power source.

[0093] 11. The palpation device of embodiment 1, further comprising a power cord having a first end connected to the cord connection portion.

[0094] 12. A palpation device as described in embodiment 11, wherein the power cord has a second end having one or more adapters configured to connect to a user device.

[0095] 13. A palpation device as described in embodiment 12, wherein the one or more adapters include a USB-C connector.

[0096] 14. The palpation device of embodiment 1, wherein the palpation head comprises a massage head.

[0097] 15. The palpation device of embodiment 1, wherein the handle comprises a rigid plastic.

[0098] Exemplary Haptic Device Software Embodiments 16. A method for conducting a remote medical examination of a patient for abdominal pain, comprising: a. displaying a set of palpation instructions to a patient on a user device, the set of palpation instructions guiding the patient to palpate a plurality of locations on the patient's body using a handheld palpation device, the plurality of locations including a baseline location; b. receiving a set of pressure readings from a handheld palpation device for each of a plurality of locations on the patient's body; c. calculating an average pressure reading of the set of pressure readings for each of a plurality of locations on the patient's body, including the baseline location; d. calculating a maximum reliable pressure reading for at least a subset of the plurality of locations on the patient's body, the maximum reliable pressure reading being the difference between the average pressure reading for the location and the average pressure reading for the baseline location; e. providing a recommendation to the patient or the patient's healthcare provider for further medical treatment, the recommendation being derived based on the calculated maximum confidence pressure reading, the recommendation including one or more of diagnostic imaging, admission to an emergency department, or a virtual medical treatment; A method having the following.

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

[0100] 18. The method of embodiment 16, wherein the baseline location comprises the sternum.

[0101] 19. The method of embodiment 16, wherein the recommendations are derived using multiple logistic regression and the outcome variables include whether the patient requires diagnostic imaging or admission to the emergency department.

[0102] 20. The method of embodiment 19, wherein the plurality of predictor variables comprises maximum confidence pressure for the upper right quadrant, the lower right quadrant, the upper left quadrant, and the lower right quadrant.

[0103] 21. The method of embodiment 19, wherein said recommendation further comprises assigning patients requiring diagnostic imaging or hospitalization to a low-risk, medium-risk, or high-risk category.

[0104] 22. The method of embodiment 16, wherein the handheld palpation device comprises any one of embodiments 1 to 15.

[0105] 23. The method of embodiment 16, wherein the user device comprises a mobile phone, a tablet, a laptop computer, or a desktop computer.

[0106] 24. A non-transitory computer-readable medium storing one or more software instructions that, when executed by a processor: a. displaying a set of palpation instructions to a patient on an external device, the set of palpation instructions guiding the patient to palpate a plurality of locations on the patient's body using a handheld palpation device, the plurality of locations including a baseline location; b. receiving a set of pressure readings from a handheld palpation device for each of a plurality of locations on the patient's body; c. calculating an average pressure reading of the set of pressure readings for each of a plurality of locations on the patient's body, including the baseline location; d. calculating a maximum reliable pressure reading for at least a subset of a plurality of locations on the patient's body, the maximum reliable pressure reading being the difference between the average pressure reading for said locations and the average pressure reading for a baseline location; e. providing a recommendation to the patient or the patient's healthcare provider for further medical treatment, the recommendation being derived based on the calculated maximum confidence pressure reading, the recommendation including one or more of diagnostic imaging, admission to an emergency department, or a virtual medical treatment; A non-transitory computer-readable medium implementing the above.

[0107] 25. The palpation device of embodiment 1, wherein the external device comprises a mobile phone, a tablet, a laptop computer, or a desktop computer.

[0108] While the present invention has been particularly described with reference to the illustrated embodiments, it will be understood that various changes, modifications, and adaptations can be made based on this disclosure and are intended to be within the scope of the present invention. While the present invention has been described in connection with what are presently considered to be the most practical and preferred embodiments, it will be understood that the invention is not limited to the disclosed embodiments, but on the contrary, is intended to encompass various modifications and equivalent arrangements that are included within the scope of the principles underlying the invention, as illustrated by the various embodiments referenced above and below.

Claims

1. 1. A handheld palpation device for medical examination, comprising: a handle having a rounded shape for holding and applying pressure to a user's body while using the handheld palpation device, the handle having an interior space and an opening to the interior space; a palpation head having a first end and a second end, the first end configured to fit inside the opening and the second end comprising a rounded, flexible head configured to contact the user's body when pressure is applied; a pressure pad disposed within the interior space of the handle, the pressure pad having a first surface configured to contact the first end of the palpation head, the pressure pad acquiring electrical pressure data when pressure is applied; a sensor chip disposed within the interior space of the handle and connected to the pressure pads, the sensor chip configured to receive electrical pressure data from the pressure pads and calculate one or more quantitative pressure measurements; a communications chip disposed within the interior space of the handle and connected to the sensor chip, the communications chip configured to receive the quantitative pressure measurements from the sensor chip and to transmit the quantitative pressure measurements to an external device; a power supply connected to the sensor chip and the communication chip; a locking system configured to retain the first end of the palpation head within an interior space of the handle; A palpation device comprising:

2. The palpation device of claim 1 , wherein the communication chip has a Bluetooth connection.

3. The palpation device of claim 1 , wherein the sensor chip comprises a voltage divider circuit.

4. The palpation device of claim 1 , wherein the pressure pad comprises a force-sensing resistor.

5. 2. The palpation device of claim 1, wherein the locking system comprises one or more pins on a surface of the palpation head between the first end and the second end, the one or more pins being configured to be positioned inside an inner surface of the handle.

6. The palpation device of claim 1 , wherein the first end of the palpation head comprises a compression member that supports pressure applied by the user holding the palpation device.

7. The palpation device of claim 6 , wherein the compression member comprises a rigid three-dimensional object.

8. The palpation device of claim 6 , wherein the compression member comprises a spring.

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

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

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

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

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

14. The palpation device of claim 1 , wherein the palpation head comprises a massage head.

15. The palpation device of claim 1 , wherein the handle is constructed from a rigid plastic.

16. 1. A method for conducting a remote medical examination of a patient with abdominal pain, comprising: displaying a set of palpation instructions to a patient on a user device, the set of palpation instructions guiding the patient to palpate a plurality of locations on the patient's body using a handheld palpation device, the plurality of locations including a baseline location; receiving a set of pressure readings from the handheld palpation device for each of the plurality of locations on the patient's body; calculating an 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; calculating a maximum reliable pressure reading for at least a subset of the plurality of locations on the patient's body, the maximum reliable pressure reading being the difference between the average pressure reading for the location and the average pressure reading for the baseline location; providing a recommendation to the patient or the patient's healthcare provider for further medical treatment, the recommendation being derived based on the calculated maximum reliable pressure reading, the recommendation including one or more of diagnostic imaging, admission to an emergency department, or a virtual medical treatment; A method having the following.

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

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

19. 17. The method of claim 16, wherein the recommendation is derived using multiple logistic regression and outcome variables include whether the patient requires diagnostic imaging or admission to the emergency department.

20. 20. The method of claim 19, wherein a plurality of predictor variables comprises the maximum reliable pressure readings for the right upper quadrant, the right lower quadrant, the left upper quadrant, and the right lower quadrant.

21. 20. The method of claim 19, wherein the recommendation further comprises assigning the patient to a low-risk, uncertain-risk, or high-risk category.

22. 17. The method of claim 16, wherein the handheld palpation device comprises a palpation device according to any one of claims 1 to 15.

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

24. A non-transitory computer-readable medium storing one or more software instructions that, when executed by a processor, displaying a set of palpation instructions to a patient on an external device, the set of palpation instructions guiding the patient to palpate a plurality of locations on the patient's body using a handheld palpation device, the plurality of locations including a baseline location; receiving a set of pressure readings from the handheld palpation device for each of the plurality of locations on the patient's body; calculating an 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; calculating a maximum reliable pressure reading for at least a subset of the plurality of locations on the patient's body, the maximum reliable pressure reading being the difference between the average pressure reading for the location and the average pressure reading for the baseline location; providing a recommendation to the patient or the patient's healthcare provider for further medical treatment, the recommendation being derived based on the calculated maximum reliable pressure reading, the recommendation including one or more of diagnostic imaging, admission to an emergency department, or a virtual medical treatment; A non-transitory computer-readable medium for executing the method.

25. The palpation device of claim 1 , wherein the external device comprises a mobile phone, a tablet, a laptop computer, or a desktop computer.

Images