Evaluation system

Abstract

To enhance inspection efficiency of diabetic neuropathy.SOLUTION: A first inspection device 21 acquires a stimulation perception threshold of a subject S being at a predetermined place by stimulating the peripheral nerves of the subject S. A second inspection device 22 stimulates dorsoventral nerves and tibial nerves of the subject S by flowing current to a stimulation electrode 212 worn on the subject S and thereby acquires induction electromyogram from the subject S being at the predetermined place. An evaluation device 23 evaluates the seriousness of a diabetic neuropathy based on a seriousness reference proposed by Dr. Baba of the subject S on the basis of the stimulation perception threshold and the induction electromyogram. An output device 24 outputs a result of the evaluation by the evaluation device 23.SELECTED DRAWING: Figure 3

Description

[Technical Field]

[0001] The present invention relates to an evaluation device for evaluating the severity of diabetic neuropathy in a subject, and also to an evaluation system including a plurality of testing devices for evaluating the severity. [Background technology]

[0002] Patent Document 1 discloses an apparatus for assessing diabetic neuropathy based on the pain threshold measured by stimulating the peripheral nerves of a subject. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] International Publication No. 2014 / 045339 Summary of the Invention [Problem to be solved by the invention]

[0004] An object of the present invention is to improve the efficiency of testing for diabetic neuropathy. [Means for solving the problem]

[0005] In one aspect of the present invention, there is provided an evaluation device for evaluating the severity of diabetic neuropathy in a subject, the evaluation device comprising: a first testing unit that acquires a stimulus perception threshold of the subject by stimulating a peripheral nerve of the subject; a notification unit that notifies the patient to perform a nerve conduction test based on the severity Baba criteria when the stimulus perception threshold exceeds a predetermined value; It is equipped with:

[0006] According to the above configuration, when the onset of diabetic neuropathy is suspected through a simpler test to obtain a stimulus perception threshold, the transition to the more time-consuming nerve conduction test is encouraged, thereby improving the efficiency of the diabetic neuropathy testing process. In addition, since the nerve conduction test is performed based on the Baba severity criteria, which are based solely on objective judgment, subjective evaluation can be eliminated from the entire testing process. Therefore, it is possible to support the objective evaluation of the severity of diabetic neuropathy.

[0007] In one embodiment to achieve the above object, there is provided an evaluation system for evaluating the severity of diabetic neuropathy in a subject, comprising: a first testing device that acquires a stimulus perception threshold of the subject by stimulating a peripheral nerve of the subject; an alarm device that issues an alarm to prompt a nerve conduction test based on the severity of the condition when the stimulus perception threshold exceeds a predetermined value; a second testing device that applies a current to stimulation electrodes attached to the subject to stimulate the sural nerve and the tibial nerve of the subject, thereby acquiring an evoked electromyogram of the subject; an output device that outputs information indicating a classification score based on the severity of the track criteria, which is assigned based on the evoked electromyogram; It is equipped with:

[0008] According to the above configuration, when the onset of diabetic neuropathy is suspected through a simpler test to obtain a stimulus perception threshold, the transition to the more time-consuming nerve conduction test is encouraged, thereby improving the efficiency of diabetic neuropathy testing. In addition, since the nerve conduction test is performed based on the severity criteria based solely on objective judgment, subjective evaluation can be eliminated from the tests performed using the first and second testing devices. Therefore, objective evaluation of the severity of diabetic neuropathy can be supported.

[0009] In one embodiment to achieve the above object, there is provided an evaluation system for evaluating the severity of diabetic neuropathy in a subject, comprising: a first testing device that acquires a stimulus perception threshold of a subject by stimulating a peripheral nerve of the subject; a second testing device that applies a current to stimulation electrodes attached to the subject to stimulate the sural nerve and the tibial nerve of the subject, thereby acquiring an evoked electromyogram of the subject; an evaluation device that evaluates the severity of diabetic neuropathy of the subject based on the stimulus perception threshold and the evoked electromyogram; an output device that outputs an evaluation result by the evaluation device; It is equipped with:

[0010] According to the above-described configuration, the stimulus perception threshold and evoked electromyogram can be obtained without moving the subject, and the severity of diabetic neuropathy can be evaluated, thereby improving the efficiency of diabetic neuropathy testing. [Brief explanation of the drawings]

[0011] [Figure 1] 1 illustrates an example of the configuration of an evaluation system according to a first embodiment. [Figure 2] 1 illustrates a process for assigning classification scores based on severity track criteria. [Figure 3] 1 illustrates a configuration of an evaluation system according to a second embodiment. [Figure 4] 10 illustrates the configuration of an evaluation device according to a third embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0012] Examples of embodiments are described in detail below with reference to the accompanying drawings.

[0013] The expression "at least one of A and B" used in this specification with respect to two entities A and B includes cases where only A is specified, where only B is specified, and where both A and B are specified. Each entity A and B may be singular or plural unless otherwise specified.

[0014] The expression "at least one of A, B, and C" used in this specification with respect to three entities A, B, and C includes cases where only A is specified, where only B is specified, where only C is specified, where A and B are specified, where B and C are specified, where A and C are specified, and where all of A, B, and C are specified. Each of the entities A, B, and C may be singular or plural unless otherwise specified. The same applies when there are four or more entities being described.

[0015] 1 illustrates the configuration of an evaluation system 10 according to the first embodiment. The evaluation system 10 is configured to evaluate the severity of diabetic neuropathy in a subject S.

[0016] The evaluation system 10 includes a first testing device 11. The first testing device 11 is configured to perform a pain threshold of intraepidermal nerve terminal (PINT) test. Specifically, the first testing device 11 is configured to obtain the current perception threshold of the subject S by passing a minute current through a first stimulation electrode 111 attached to the subject S. The value of the minute current is adjustable in increments of 0.01 mA. The current perception threshold is an example of a stimulation perception threshold.

[0017] A microneedle electrode is formed on the surface of the first stimulation electrode 111. The length of the microneedle electrode is approximately 0.1 mm. For example, when the first stimulation electrode 111 is attached to the skin above the extensor digitorum brevis muscle of a subject S, the microneedle electrode penetrates into the epidermis. When a current is passed through it, the A-delta fiber endings of the subject S are stimulated. The A-delta fiber endings are an example of peripheral nerves. The specific techniques and procedures of the PINT test are well known, so a description thereof will be omitted here.

[0018] The evaluation system 10 includes a second testing device 12. The second testing device 12 is configured to perform a nerve conduction test. Specifically, the second testing device 12 is configured to obtain an evoked electromyogram of the subject S by passing a current through a second stimulation electrode 121 attached to the lower leg of the subject S to stimulate the sural nerve and the tibial nerve. Specific techniques and procedures for nerve conduction tests are well known, and therefore will not be described here.

[0019] The second testing device 12 is configured to obtain a classification score based on the Baba Criteria for Diabetic Neuropathy severity, based on the evoked electromyogram. The Baba Criteria for Diabetic Neuropathy severity is an algorithm proposed by Masayuki Baba for diagnosing the severity of diabetic neuropathy. The classification score includes the following five items: 0 degree: No nerve damage Grade 1: Mild disability Grade 2: Moderate disability Grade 3: Severe disability Grade 4: Abolition disorder

[0020] Figure 2 illustrates the specific procedure for obtaining a classification score based on the severity of the condition.

[0021] First, it is determined whether the SNAP (sensory nerve action potential) amplitude of the sural nerve is normal (STEP 1). Specifically, it is determined whether the SNAP amplitude value is less than 5 μV.

[0022] If the SNAP amplitude of the sural nerve is determined to be normal (YES in STEP 1), the presence or absence of nerve conduction delay is then determined (STEP 2). For example, the presence or absence of nerve conduction delay is determined based on whether the conduction velocity of the sural nerve is less than 42 m / s, whether the conduction velocity of the tibial nerve is less than 42 m / s, whether the latency of the F wave in the tibial nerve is prolonged, and whether or not the A wave is present.

[0023] If it is determined that there is no nerve conduction delay (NO in STEP 2), a classification score of 0 is assigned (STEP 3). If it is determined that there is nerve conduction delay (YES in STEP 2), a classification score of 1 is assigned (STEP 4).

[0024] If the SNAP amplitude of the sural nerve is determined to be abnormal (NO in STEP 1), the CMAP (compound muscle action potential) amplitude of the tibial nerve plantaris muscle is then determined to be normal (STEP 5). Specifically, it is determined whether the CMAP amplitude is 5 mV or greater.

[0025] If the CMAP amplitude of the tibial nerve plantaris muscle is determined to be normal (YES in STEP 5), a classification score of grade 2 is assigned (STEP 6).

[0026] If the CMAP amplitude of the tibial nerve plantaris muscle is determined to be abnormal (NO in STEP 5), it is determined whether the CMAP amplitude is severely decreased (STEP 7). Specifically, it is determined whether the CMAP amplitude value is less than 2 mV.

[0027] If it is determined that the CMAP amplitude is not severely decreased (NO in STEP 7), a classification score of 3 is assigned (STEP 8).

[0028] If the CMAP amplitude is determined to be severely decreased (YES in STEP 7), a classification score of 4 is assigned (STEP 9).

[0029] As mentioned above, classification based on the severity criteria is performed using only objective numerical judgments based on evoked electromyograms obtained through nerve conduction studies.

[0030] The processes related to the acquisition of evoked electromyograms and the assignment of classification scores by the second testing device 12 may be realized by a general-purpose microprocessor operating in cooperation with a general-purpose memory. Examples of the general-purpose microprocessor include a CPU, an MPU, and a GPU. Examples of the general-purpose memory include a ROM and a RAM. In this case, a computer program that executes the above-described processes may be stored in the ROM. The general-purpose microprocessor specifies at least a portion of the computer program stored in the ROM, expands it on the RAM, and executes the above-described processes in cooperation with the RAM.

[0031] The above processing may be implemented by a dedicated integrated circuit capable of executing the computer program, such as a microcontroller, an ASIC, or an FPGA. In this case, the computer program is pre-installed in a memory element included in the dedicated integrated circuit. The above processing may also be implemented by a combination of a general-purpose microprocessor and a dedicated integrated circuit.

[0032] 1, the evaluation system 10 includes an output device 13. The output device 13 is configured to output information indicating a classification score based on the severity of the track criteria assigned based on the evoked electromyogram acquired by the second testing device 12.

[0033] The output device 13 may be provided as a part of the second inspection device 12, or may be provided as an independent device capable of wired or wireless communication with the second inspection device 12.

[0034] The information may be presented visually using text, a label, and / or a color corresponding to the classification score. The visual presentation of the information may be provided as an image displayed on a display or as printed material. Additionally or alternatively, the information may be presented audibly through a speaker.

[0035] The evaluation system 10 includes a notification device 14. The notification device 14 is configured to issue a notification to prompt a nerve conduction test based on the severity of the condition when the current perception threshold of the subject S acquired by the first testing device 11 exceeds a predetermined threshold. The notification can be issued through at least one of a visual notification, an auditory notification, and a tactile notification.

[0036] The notification device 14 may be provided as a part of the first inspection device 11, or may be provided as an independent device capable of wired or wireless communication with the first inspection device 11.

[0037] If the current perception threshold of the subject S exceeds a predetermined threshold, the onset of diabetic neuropathy is suspected. On the other hand, if no notification is made by the notification device 14, i.e., if the current perception threshold of the subject S does not exceed the threshold, the subject S is determined to be healthy, and the test can be terminated.

[0038] According to the configuration of this embodiment, if the onset of diabetic neuropathy is suspected through the simpler PINT test, the transition to the more time-consuming nerve conduction test is encouraged, thereby improving the efficiency of diabetic neuropathy testing. In addition, since the nerve conduction test is performed based on the severity criteria based solely on objective judgment as described above, subjective evaluation can be eliminated from the tests performed using the first and second testing devices. Therefore, objective evaluation of the severity of diabetic neuropathy can be supported.

[0039] If the test result from the first testing device is determined to be normal, a classification score such as "-1 degree" can be assigned, providing a common index that can be applied to both the test results from the first testing device and the test results from the second testing device, further increasing the objectivity of the assessment of the severity of diabetic neuropathy.

[0040] 1, the first testing device 11 can be configured to be able to receive subject information SI. The subject information SI is information associated with the subject S. Examples of the information include the name, height, weight, sex, age, medical history, etc. of the subject S.

[0041] In this case, the first test device 11 and the second test device 12 may be connected to enable wired or wireless communication. The first test device 11 may be configured to transmit the subject information SI to the second test device 12 when the current perception threshold of the subject S exceeds a predetermined value as a result of the PINT test.

[0042] The subject information SI transmitted to the second testing device 12 preferably includes at least the height of the subject S. This is because height information is necessary for evaluation of the latency of the F wave in the tibial nerve.

[0043] When a nerve conduction test is prompted as a result of the PINT test, the subject information SI is transmitted to the second testing device 12, thereby avoiding repetitive information input and improving the efficiency of the entire testing process. This configuration is particularly useful when the first testing device 11 and the second testing device 12 are remote from each other.

[0044] 3 illustrates the configuration of an evaluation system 20 according to the second embodiment. The evaluation system 20 includes a first inspection device 21 and a second inspection device 22.

[0045] The first testing device 21 is configured to obtain the current perception threshold of the subject S by passing a minute current through the first stimulation electrode 211. The operation related to obtaining the current perception threshold is the same as that of the first testing device 11 in the evaluation system 10 described with reference to Fig. 1, and therefore a repeated description will be omitted.

[0046] The second testing device 22 is configured to obtain an evoked electromyogram of the subject S by passing a current through a second stimulation electrode 121 attached to the lower leg of the subject S to stimulate the sural nerve and the tibial nerve. The operation related to obtaining the evoked electromyogram is the same as that of the second testing device 12 in the evaluation system 10 described with reference to Fig. 1, and therefore a repeated description will be omitted.

[0047] The evaluation system 20 includes an evaluation device 23. The evaluation device 23 is communicatively connected to a first examination device 21 and a second examination device 22. The first examination device 21 is configured to transmit first data D1 corresponding to the current perception threshold of the subject S obtained through a PINT test to the evaluation device 23. The second examination device 22 is configured to transmit second data D2 corresponding to the evoked electromyogram of the subject S obtained through a nerve conduction test to the evaluation device 23.

[0048] The evaluation device 23 is configured to evaluate the severity of diabetic neuropathy of the subject S based on the first data D1 received from the first testing device 21 and the second data D2 received from the second testing device 22, and to assign a classification score based on the severity Baba criteria.

[0049] Specifically, as illustrated in Figure 2, prior to the process of assigning a classification score based on the evoked electromyogram (STEP 1 to STEP 9), it is determined based on the first data D1 whether the current perception threshold of the subject S exceeds a predetermined value (STEP 10).

[0050] If it is determined that the current perception threshold of the subject S does not exceed the predetermined value (NO in STEP 10), the subject S is evaluated as healthy (STEP 11). In this case, a classification score such as "minus 1 degree" which is an extension of the severity Baba criteria may be assigned.

[0051] When it is determined that the current perception threshold of the subject S exceeds a predetermined value (YES in STEP 10), a process of assigning a classification score based on the evoked electromyogram is started (STEP 1). A repeated explanation of this process will be omitted.

[0052] The evaluation device 23 may be provided as part of either the first inspection device 21 or the second inspection device 22, or may be provided as an independent device capable of wired or wireless communication with the first inspection device 21 and the second inspection device 22.

[0053] The processing performed by the evaluation device 23 may be realized by a general-purpose microprocessor operating in cooperation with a general-purpose memory. Examples of the general-purpose microprocessor include a CPU, an MPU, and a GPU. Examples of the general-purpose memory include a ROM and a RAM. In this case, a computer program that executes the above-described processing may be stored in the ROM. The general-purpose microprocessor specifies at least a portion of the computer program stored in the ROM, expands it on the RAM, and executes the above-described processing in cooperation with the RAM.

[0054] The above processing may be implemented by a dedicated integrated circuit capable of executing the computer program, such as a microcontroller, an ASIC, or an FPGA. In this case, the computer program is pre-installed in a memory element included in the dedicated integrated circuit. The above processing may also be implemented by a combination of a general-purpose microprocessor and a dedicated integrated circuit.

[0055] 3, the evaluation system 20 includes an output device 24. The output device 24 is configured to output information indicative of the classification score assigned by the evaluation device 23.

[0056] The output device 24 may be provided as a part of the evaluation device 23 or may be provided as an independent device capable of wired or wireless communication with the evaluation device 23 .

[0057] The information may be presented visually using text, a label, and / or a color corresponding to the classification score. The visual presentation of the information may be provided as an image displayed on a display or as printed material. Additionally or alternatively, the information may be presented audibly through a speaker.

[0058] According to the configuration of this embodiment, the stimulus perception threshold and evoked electromyogram can be acquired without moving the subject S, and the severity of diabetic neuropathy can be evaluated, thereby improving the efficiency of diabetic neuropathy testing. In addition, since the classification score based on the evoked electromyogram is assigned based on the severity criteria, which are based solely on objective judgment, subjective evaluation can be eliminated from the testing performed using the first and second testing devices. Therefore, objective evaluation of the severity of diabetic neuropathy can be supported.

[0059] 4 illustrates the configuration of an evaluation device 30 according to the third embodiment. The evaluation device 30 includes a first inspection unit 31, a processing unit 32, and a notification unit 33.

[0060] The first testing unit 31 is configured to acquire the current perception threshold of the subject S by passing a minute current through the first stimulation electrode 311. The operation related to acquiring the current perception threshold is the same as that of the first testing device 11 in the evaluation system 10 described with reference to Fig. 1, so repeated explanation will be omitted. The first testing unit 31 is configured to output first data D1 corresponding to the acquired current perception threshold of the subject S.

[0061] The processing unit 32 is configured to receive the first data D1 from the first testing unit 31. The processing unit 32 is configured to determine whether the current perception threshold corresponding to the first data D1 exceeds a predetermined threshold.

[0062] The notification unit 33 is configured to provide a notification to prompt a nerve conduction test based on the severity of the track criteria. The notification can be provided through at least one of a visual notification, an auditory notification, and a tactile notification.

[0063] The processing unit 32 is configured to output a notification control signal NC that causes the notification unit 33 to perform the notification when it determines that the current perception threshold corresponding to the first data D1 exceeds a predetermined threshold.

[0064] According to the configuration of this embodiment, if the onset of diabetic neuropathy is suspected through the simpler PINT test, the transition to the more time-consuming nerve conduction test is encouraged, thereby improving the efficiency of diabetic neuropathy testing. In addition, since the nerve conduction test is performed based on the severity criteria based solely on objective judgment as described with reference to Figure 2, subjective evaluation can be eliminated from the entire testing process. Therefore, objective evaluation of the severity of diabetic neuropathy can be supported.

[0065] The evaluation device 30 having the above-described configuration can be considered to perform substantially the same operations as the first inspection device 11 and the notification device 14 in the evaluation system 10 exemplified in FIG.

[0066] As illustrated in Fig. 4, the evaluation device 30 may include a second testing unit 34. The second testing unit 34 is configured to obtain an evoked electromyogram of the subject S by passing a current through a second stimulation electrode 341 attached to the lower leg of the subject S to stimulate the sural nerve and the tibial nerve. The operation related to obtaining the evoked electromyogram is the same as that of the second testing device 12 in the evaluation system 10 described with reference to Fig. 1, and therefore, repeated description will be omitted. The second testing unit 34 is configured to output second data D2 corresponding to the obtained evoked electromyogram of the subject S.

[0067] In this case, the processing unit 32 is configured to receive second data D2 from the second testing unit 34. The processing unit 32 is configured to evaluate the severity of diabetic neuropathy of the subject S based on the evoked electromyogram corresponding to the second data D2, and to assign a classification score based on the severity Baba criteria. The process for assigning the classification score has been described with reference to Fig. 2, so a repeated description will be omitted.

[0068] The evaluation device 30 may include an output unit 35. The output unit 35 is configured to output information indicating the classification score based on the severity track criteria assigned by the processing unit 32. The information may be provided visually using at least one of text, a mark, and a color corresponding to the classification score. The visual presentation of the information may be provided as an image displayed on a display or as printed matter. Additionally or alternatively, the information may be provided audibly through a speaker.

[0069] In this case, the processing unit 32 is configured to output an output control signal OC that causes the output unit 35 to output information indicating the classification score.

[0070] According to the above configuration, the severity of diabetic neuropathy can be evaluated without the subject S having to move.

[0071] Each function of the processing unit 32 may be realized by a general-purpose microprocessor operating in cooperation with a general-purpose memory. Examples of the general-purpose microprocessor include a CPU, an MPU, and a GPU. Examples of the general-purpose memory include a ROM and a RAM. In this case, the ROM may store a computer program that executes the above-described processing. The general-purpose microprocessor specifies at least a portion of the computer program stored in the ROM, expands it on the RAM, and executes the above-described processing in cooperation with the RAM.

[0072] Each function of the processing unit 32 may be realized by a dedicated integrated circuit capable of executing the computer program, such as a microcontroller, an ASIC, or an FPGA. In this case, the computer program is pre-installed in a memory element included in the dedicated integrated circuit. Each function of the processing unit 32 may be realized by a combination of a general-purpose microprocessor and a dedicated integrated circuit.

[0073] The evaluation device 30 may include a general-purpose connector 360. The general-purpose connector 360 may be configured to selectively connect to either a connector 312 electrically connected to the first stimulation electrode 311 or a connector 342 electrically connected to the second stimulation electrode 341.

[0074] In this case, first, connector 312 is connected to general-purpose connector 360, and a PINT test is performed by first testing unit 31. When notification unit 33 issues a notification urging the user to perform a nerve conduction test, the user connects connector 342 to general-purpose connector 360 instead of connector 312, and the second testing unit 34 performs a nerve conduction test.

[0075] Alternatively, the evaluation device 30 may include a first connector 361 and a second connector 362. In this case, the first connector 361 is configured as a dedicated connector to which a connector 312 electrically connected to the first stimulation electrode 311 is connected. The second connector 362 is configured as a dedicated connector to which a connector 342 electrically connected to the second stimulation electrode 341 is connected.

[0076] The configuration including the general-purpose connector 360 can prevent the size of the evaluation device 30 from increasing. The configuration including the first connector 361 and the second connector 362 can eliminate the need for replacing the stimulation electrodes.

[0077] When the first connector 361 and the second connector 362 are provided, the processing unit 32 may be configured to assign a classification score based on the severity track criteria based on the first data D1 and the second data D2, similar to the evaluation system 20 described with reference to Fig. 3. In this case, the notification operation by the notification unit 33 may be omitted.

[0078] The above-described embodiments are merely examples for facilitating understanding of the present invention, and the configurations according to the above-described embodiments may be appropriately modified or improved without departing from the spirit and scope of the present invention.

[0079] In each of the above embodiments, the stimulus perception threshold of the subject S is obtained through a PINT test in which a minute current is passed through electrodes attached to the subject S. However, the stimulus perception threshold may also be obtained through a stimulus applied by pressing a mechanically displacing probe against the skin of the subject S. [Explanation of symbols]

[0080] 10: evaluation system, 11: first inspection device, 12: second inspection device, 121: second stimulation electrode, 13: output device, 14: notification device, 20: evaluation system, 21: first inspection device, 22: second inspection device, 221: second stimulation electrode, 23: evaluation device, 24: output device, 30: evaluation device, 31: first inspection unit, 311: first stimulation electrode, 312: connector, 33: notification unit, 34: second inspection unit, 341: second stimulation electrode, 342: connector, 35: output unit, 360: general-purpose connector, 361: first connector, 362: second connector, S: subject, SI: subject information

Claims

1. a first testing device that acquires a stimulus perception threshold from a subject at a predetermined location by stimulating a peripheral nerve of the subject; a second testing device that applies a current to stimulation electrodes attached to the subject to stimulate the sural nerve and the tibial nerve of the subject, thereby acquiring an evoked electromyogram from the subject at the predetermined location; an evaluation device for evaluating the severity of diabetic neuropathy of the subject based on the stimulus perception threshold and the evoked electromyogram, the evaluation device being based on the Baba criteria for severity; an output device that outputs an evaluation result by the evaluation device; Equipped with Rating system.

2. the first testing device applies an electric current to a stimulation electrode attached to a skin surface of the subject to stimulate the peripheral nerve, thereby obtaining a current perception threshold of the subject as the stimulation perception threshold; The evaluation system of claim 1 .

3. The output device outputs a classification score based on the severity of the track criteria, which is assigned based on the evoked electromyogram, as the evaluation result. The evaluation system according to claim 1 or 2.

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