JP7387553B2 - Ankle joint instability assessment device - Google Patents

Description

The present invention relates to a device for use in assessing ankle instability.

Evaluation of ankle joint instability caused by damage to ankle ligaments, etc. is performed manually by an examiner such as a doctor, and the diagnosis and evaluation are often left to the examiner's subjective evaluation.
On the other hand, methods for objectively evaluating the state of ligament damage have also been proposed. For example, Patent Document 1 proposes a medical device that evaluates the degree of damage to ligaments in a knee joint. This ligament damage degree measuring device is configured to allow a subject to sit on a seat and evaluate the degree of ligament damage in the knee joint of the subject (FIG. 1 of Patent Document 1).

Japanese Patent Application Publication No. 9-276252

The device proposed in Patent Document 1 has a complicated configuration and is large, so it requires a large space for installation. Furthermore, this device was designed to evaluate the instability of the knee joint, but not the instability of the ankle joint.
The present inventors conducted extensive studies to easily and objectively and accurately evaluate the instability of the ankle joint, and completed the present invention based on a new technical idea.

(1) A device used for an evaluation test of ankle joint instability,
a support member fixed to the ankle joint of the subject;
a sensor element attached to the support member and configured to detect the amount of movement of the ankle joint moved by the examiner;
a measurement unit that measures the amount of deformation of the detection unit of the sensor element;
a display section that displays the amount of movement of the ankle joint based on the measurement results of the measurement section;
The above support member is
a reference index placed at a predetermined position on at least one of the lower leg and foot of the subject;
a fixation index that is an index of the fixation state of the support member fixed to the ankle joint;
and an evaluation test index as an index of the angle of the ankle joint when carrying out the above evaluation test,
The fixation index is an index for confirming the fixation state of the support member fixed to the ankle joint based on the reference index,
The evaluation test index is an index for checking the angle of the ankle joint when carrying out the evaluation test based on the reference index,
Device for assessing ankle instability.

By conducting an evaluation test for ankle joint instability using the ankle joint instability evaluation device described in (1) above (hereinafter also simply referred to as the evaluation device), it is possible to The amount of movement of the ankle joint in the evaluation test can be objectively evaluated based on the detected value by the sensor element.
Further, since the support member has the reference index and the fixed index, it is possible to appropriately attach the support member to the ankle joint to be evaluated. Furthermore, since the support member has the evaluation test index, it is possible to appropriately evaluate ankle joint instability. Therefore, according to the evaluation device described in (1) above, it is possible to accurately evaluate instability of the ankle joint.

Further, according to the evaluation device described in ( 1 ) above, the fixation state of the support member is confirmed by a combination of the reference index and the fixation index, so that the support member is not attached to the subject. More appropriate fixation becomes possible. Further, since the angle of the ankle joint when performing the evaluation test is confirmed by a combination of the reference index and the evaluation test index, more appropriate evaluation of ankle joint instability becomes possible. Therefore, according to the evaluation device described in ( 1 ) above, it is possible to more accurately evaluate instability of the ankle joint.

( 2 ) The ankle joint instability evaluation device according to (1) , wherein the fixation index is an index of the fixation state of the support member when the anatomical limb position of the ankle joint is 0°.

In the evaluation device described in ( 2 ) above, since the angle of the ankle joint is clear when fixing the support member, it is possible to more appropriately fix the support member to the subject. . Therefore, according to the evaluation device described in ( 2 ) above, it is possible to more accurately evaluate instability of the ankle joint.

( 3 ) The ankle joint instability evaluation device according to (1) or (2) , wherein the ankle joint instability evaluation test is a forward drawer test for evaluating the presence or absence of damage to the anterior talofibular ligament.

The evaluation device described in (1) or (2) above can be suitably used in a forward draw test for evaluating the presence or absence of damage to the anterior talofibular ligament.

( 4 ) The ankle joint instability according to ( 3 ), wherein the evaluation test index is an index of at least one angle selected from 15 to 35 degrees of plantar flexion of the ankle joint on which the forward drawer test is performed. Evaluation equipment.

According to the evaluation device described in ( 4 ) above, the examiner can confirm the mild plantar flexion position suitable for the above-mentioned forward drawer test, thereby enabling a more accurate evaluation of instability of the ankle joint.

( 5 ) The ankle joint instability evaluation device according to any one of (1) to ( 4 ), wherein the display section displays the maximum amount of movement of the amount of movement.

Since the evaluation device described in ( 5 ) above displays the maximum amount of movement of the subject's ankle joint on the display section, the examiner can check the current amount of movement of the ankle joint during the evaluation test procedure. There is no need to check the ankle joint stability, and ankle instability can be easily evaluated.

( 6 ) The sensor element is a sensor element whose capacitance changes depending on the amount of movement,
It has a dielectric layer made of an elastomer, a first electrode layer formed on the upper surface of the dielectric layer, and a second electrode layer formed on the lower surface of the dielectric layer, the first electrode layer and the second electrode layer being formed on the lower surface of the dielectric layer. comprising a stretchable sensor member in which opposing portions of the layers serve as the detection portion;
The device for evaluating ankle joint instability according to any one of (1) to ( 5 ).

According to the evaluation device described in ( 6 ) above, the sensor element whose capacitance changes depending on the amount of movement can detect the amount of movement with high accuracy. Further, since the sensor member is suitable for elongation and deformation in the plane direction, it is particularly suitable as a capacitance type sensor member constituting the ankle joint instability evaluation device.

( 7 ) The ankle joint instability evaluation device according to ( 6 ), wherein the sensor element includes a mounting member for adjusting the extension state of the sensor member and attaching the sensor element to the support member.

The sensor element of the evaluation device described in ( 7 ) above can be attached to the support member after adjusting the extension state (hereinafter also referred to as pretension) of the sensor member before conducting the evaluation test. . This can prevent the sensor member from loosening and stretching to the detection limit during the evaluation test. Therefore, according to the evaluation device described in ( 7 ) above, it is possible to more accurately evaluate instability of the ankle joint.

According to the present invention, objective and accurate evaluation of ankle joint instability can be easily performed.

FIG. 2 is a schematic diagram showing the ankle joint instability evaluation device according to the first embodiment attached to the ankle joint of the right foot of a subject. FIG. 2 is a diagram showing the front side of a support member constituting the evaluation device of FIG. 1. FIG. 2 is a diagram showing the back side of a support member that constitutes the evaluation device of FIG. 1. FIG. FIG. 2 is an exploded view of a support member constituting the evaluation device of FIG. 1. FIG. FIG. 2 is a schematic diagram of a subject's left foot viewed from an anatomically outer side in a state where the support member according to the first embodiment is attached to the ankle joint of the subject's left foot. FIG. 6 is a schematic diagram of the subject's left foot in FIG. 5, viewed from the anatomical front side. FIG. 2 is a schematic diagram showing sensor elements constituting the evaluation device of FIG. 1. FIG. FIG. 8 is a perspective view showing the sensor member of FIG. 7; 9 is a sectional view taken along line AA of the sensor member in FIG. 8. FIG. It is a schematic diagram of the connector concerning a first embodiment. FIG. 1 is a schematic diagram showing an apparatus for evaluating ankle joint instability according to a first embodiment. FIG. 2 is a schematic diagram of a display unit according to an embodiment. It is a flowchart of the mode switching process by the arithmetic circuit of the display of the display unit which concerns on 1st embodiment. It is a flowchart of real mode processing by the arithmetic circuit of the display of the display unit concerning the first embodiment. It is a flowchart of hold mode processing by the arithmetic circuit of the indicator of the display unit concerning a first embodiment. FIG. 3 is a diagram illustrating a method of performing a forward pull-out test on the ankle joint of the right foot using the evaluation device according to the first embodiment. It is a perspective view which shows the sensor member which comprises the instrument for joint instability evaluation based on 2nd embodiment. 18 is a sectional view taken along line BB of the sensor member in FIG. 17. FIG.

Embodiments of the present invention will be described below with reference to the drawings.

(First embodiment)
Hereinafter, this embodiment will be described using as an example a case where an anterior talofibular ligament injury of an ankle joint is evaluated by a forward draw test.
<Ankle joint instability evaluation device>
FIG. 1 is a diagram schematically showing a state in which the ankle joint instability evaluation device 100 according to the present embodiment is attached to the ankle joint of the right foot of a subject 51. FIG. 2 is a diagram showing the front side (the side opposite to the subject's body surface side) of the support member 110 that constitutes the evaluation device 100 of FIG. 1. FIG. 3 is a diagram showing the back side (body surface side of the subject) of the support member 110 that constitutes the evaluation device 100 of FIG. 1. FIG. 4 is an exploded view of the support member 110 that constitutes the evaluation device 100 of FIG. 1. In addition, in FIG. 4, the surfaces of the support member pieces 110A and 110B that correspond to the front side of the support member 110 are shown.

As shown in FIG. 1, the evaluation device 100 according to this embodiment is a device that is used by being attached to the ankle joint of a subject. The evaluation device 100 includes a support member 110, a sensor element 120, a display unit 5, and a connector 31.
The evaluation device 100 according to this embodiment can be attached to the ankle joints of both feet. In FIG. 1, a first reference index 130A, a first fixed index 140A, and an evaluation are arranged on the anatomically outer side (hereinafter also simply referred to as outer side) of the right foot of the subject 51 on the support member 110. A test indicator 150A is shown. The first reference indicator 130A, the first fixed indicator 140A, and the evaluation test indicator 150A are indicators used when the evaluation device 100 is used with the right foot. Although not shown in FIG. 1, on the anatomically medial (hereinafter simply referred to as medial) side of the right leg of the subject 51, there are a first reference index 130B, a first fixed index 140B, and a first fixed index 140B, which will be described later. Evaluation test indicators 150B are arranged. The first reference indicator 130B, the first fixed indicator 140B, and the evaluation test indicator 150B are indicators used when the evaluation device 100 is used with the left foot. The second reference indicator 131 and the second fixed indicator 141 shown in FIG. 1 are indicators used for both the right foot and the left foot when using the evaluation device 100.

As shown in FIG. 2, the support member 110 includes a first reference indicator 130A, a first reference indicator 130B, a first fixed indicator 140A, a first fixed indicator 140B, an evaluation test indicator 150A, an evaluation test indicator 150B, and a second reference indicator. It has an indicator 131 and a second fixed indicator 141 line.
The support member 110 is fixed to the ankle joint of the right foot of the subject 51 using the first reference indicator 130A, the first fixed indicator 140A, the second reference indicator 131, and the second fixed indicator 141 as indicators. Further, the support member 110 is fixed to the ankle joint of the left foot of the subject 51 using the first reference indicator 130B, the first fixed indicator 140B, the second reference indicator 131, and the second fixed indicator 141 as indicators.
In the anterior talofibular ligament injury test using the evaluation device 100, the examiner uses the first reference index 130A and the evaluation test index 150A as indexes to check the angle of the ankle joint of the right foot of the subject 51. do. Further, the examiner confirms the angle of the ankle joint of the subject's 51 left foot using the first reference index 130B and the evaluation test index 150B as indexes.

The support member 110 shown in FIGS. 2 and 3 is composed of two support member pieces 110A and 110B shown in FIG. 4. The outer edge shapes of the two support member pieces 110A and 110B are plane symmetrical. When the support member 110 is fixed to the right leg of the subject 51, the support member piece 110A is placed on the outside of the right leg of the subject 51. When the support member 110 is fixed to the left leg of the subject 51, the support member piece 110B is placed on the outside of the left leg of the subject 51.
The support member 110 is a member in which a support member piece 110A and a support member piece 110B are sewn together at predetermined locations. Specifically, the support member 110 includes a part of the outer edge of the support member piece 110A from _P1 to _P2 , and a part of the outer edge of the support member piece 110B from _Q1 to _Q2. Furthermore, a part of the outer edge of the support member piece 110A from P ₃ to P ₄ and a part of the outer edge of the support member piece 110B from Q ₃ to Q ₄ are sewn together. It is a member that is sewn together.

On the front side of the support member 110, the part where the part from P ₁ to P ₂ and the part from Q ₁ to Q ₂ are sewn together becomes the line of the second reference indicator 131. Further, on the front side of the support member 110, the part where the part from P ₃ to P ₄ and the part from Q ₃ to Q ₄ are sewn together becomes the line of the second fixed indicator 141.

The support member piece 110A is made of a nylon material on the front side and a polyurethane material on the back side, and the base fabric 111A is a bonded fabric having elasticity.
A stretchable sheet 112A having elasticity is pasted on the front side of the base fabric 111A, leaving a part of the outer edge of the base fabric. Further, nylon raised fabrics 113A and 114A are pasted on the stretchable sheet 112A except for the part indicated by X and a part of the outer edge of the stretchable sheet 112A. Note that a non-stretchable material having a multilayer structure (not shown) of a plurality of stretchable films (polyurethane films) is pasted on the back surfaces of the raised fabrics 113A and 114A. The raised fabrics 113A and 114A are cut out at portions corresponding to the lines of the first reference indicator 130A, the first fixed indicator 140A, and the evaluation test indicator 150A of the support member piece 110A. Furthermore, in the line of the first reference indicator 130A, the raised fabric 113A is arranged so that the lateral malleolus indicator RLM located at the lateral malleolus of the subject's right foot is larger than the width of the line of the other first reference indicator 130A. , cut out into a roughly circular shape. Therefore, when the raised fabrics 113A, 114A are attached to the elastic sheet 112A, the underlying elastic sheet 112A becomes visible in the cutout portions of the raised fabrics 113A, 114A. Since the raised fabrics 113A, 114A and the elastic sheet 112A have different appearances, the first reference index 130A, the first fixed index 140A, the evaluation test index 150A, and the lateral malleolus index RLM can be visually recognized from the front side of the support member 110. It becomes possible.

In the vicinity of the lateral malleolus index RLM of the support member piece 110A, two male snap buttons 160A are arranged on the raised fabric 113A so as to sandwich the lateral malleolus index RLM. On the raised fabric 114A between the part from P ₃ to P ₄ of the support member piece 110A, which becomes the second fixed index 141, and the line of the evaluation test index 150A, one male snap button 161A is placed. It is located.

The support member piece 110B includes a base fabric 111B, an elastic sheet 112B, a raised fabric 113B, a raised fabric 114B, a male snap button 160B, and a male snap button 161B, which are configured similarly to the support member piece 110A.
The evaluation device 100 according to this embodiment can be attached to the ankle joints of both feet. Therefore, like the support member piece 110A, the support member piece 110B has lines of a first reference indicator 130B, a first fixed indicator 140B, and an evaluation test indicator 150B. Further, the first reference indicator 130B of the support member piece 110B has a lateral malleolus indicator LLM located at the lateral malleolus of the subject's left foot. In addition, in the evaluation device 100 according to the present embodiment, by cutting out the raised fabric 113A, the raised fabric 113B, the raised fabric 114A, and the raised fabric 114B, the first reference index 130A, the first reference index 130B, and the first fixed index are 140A, a first fixed index 140B, an evaluation test index 150A, an evaluation test index 150B, a lateral malleolus index RLM, and a lateral malleolus index LLM, but the above-mentioned indicators are not necessarily configured by cutouts of the raised fabric. There's no need. For example, the above-mentioned index may be configured by forming the front sides of the elastic sheets 112A and 112B so that they are thick and convex. In addition, the indicator may be formed by printing, embroidering, or the like on the indicator portion of the raised fabric. Furthermore, although a line is used as an indicator in this embodiment, it does not necessarily have to be a line. For example, instead of a line, a dot or the like can be used as an index.
In addition, in the evaluation device 100 according to the present embodiment, a difficult-to-stretch material having a multilayer structure of stretch film is pasted on the back surfaces of the raised fabric 113A, the raised fabric 113B, the raised fabric 114A, and the raised fabric 114B. However, a non-stretchable film may be attached to the back surfaces of the raised fabric 113A, the raised fabric 113B, the raised fabric 114A, and the raised fabric 114B.
Note that an adhesive (not shown) is used to prepare the bonded fabric and to attach the elastic sheet, the raised fabric, and the hook-and-loop fastener.

In the support member 110 (support member pieces 110A, 110B), raised fabrics 113A, 113B, 114A, and 114B are provided for bonding with hook-and-loop fasteners 115, 116, and 117. In addition, as shown in FIG. 3, in this embodiment, hook-and-loop fasteners 115, 116, and 117 are provided on the back side (the side that contacts the subject) of the base fabric 111B, which corresponds to the support member piece 110A of the support member 110. However, it is pasted.
The male snap buttons 160A and 161A are provided for attaching the sensor element 120 to the support member 110 when the support member 110 is fixed to the right leg of the subject 51. Moreover, the male snap buttons 160B and 161B are provided for attaching the sensor element 120 to the support member 110 when fixing the support member 110 to the left leg of the subject 51.
The nylon brushed fabrics 113A, 113B, 114A, and 114B suppress the elongation of the base fabric and suppress the occurrence of displacement of the sensor element 120 when measuring the amount of movement of the ankle joint of the subject 51. It also has In order to fulfill this role, a non-stretchable material is pasted on the back surfaces of the raised fabrics 113A, 114A, 113B, and 114B. The portion of the support member 110 on which the raised fabric is not laminated stretches during measurement. Specifically, in FIG. 1, a portion of the support member 110 that is fixed to the lower leg of the subject 51 and a portion that is fixed to the foot of the subject 51 are connected. The part marked with an X is mainly expanded.
In this way, the support member 110 includes a combination of a stretchable material and a hardly stretchable material. Therefore, the support member 110 is suitable for closely contacting the body surface of the ankle joint, which has large irregularities, and for suppressing the occurrence of displacement of the sensor element during measurement.

An example of how the examiner fixes the support member 110 to the ankle joint will be described below.
FIG. 5 is a schematic diagram of the left foot of the subject 51 viewed from an anatomically outer side in a state where the support member 110 is fixed to the ankle joint of the left foot of the subject 51. FIG. 6 is a schematic diagram of the left foot of the subject 51 in FIG. 5, viewed from the anatomical front (hereinafter simply referred to as the front) side.

The examiner places the support member 110 so that the lateral malleolus index LLM of the support member 110 is above the lateral malleolus of the left foot of the subject 51, and then attaches the hook-and-loop fastener 115 to the raised fabric 113B. Then, the support member 110 is attached to the lower leg of the subject 51. Next, the examiner determines that with the lateral malleolus index LLM above the lateral malleolus of the left foot of the subject 51, the line of the first reference index 130B overlaps the line FL of the fibula of the subject 51, The attachment position of the hook-and-loop fastener 115 to the raised fabric 113A is adjusted so that the line of the second reference indicator 131 overlaps with the lower leg axis CA of the subject 51. After that, the examiner brings the ankle joint of the left foot of the examinee 51 to the 0° anatomical position and attaches the hook-and-loop fasteners 116 and 117 to the raised fabric 114B. The support member 110 is attached to. More specifically, the examiner determines that the fifth metatarsal of the subject 51 is on the perpendicular line FV to the fibula, and that the line CL centered on the second metatarsal of the subject 51 is The support member 110 is attached to the left leg of the subject 51 so that the leg of the subject 51 is on the straight line of the crus axis CA when viewed from the front side. Next, the examiner determines that when the ankle joint of the left foot of the subject 51 is in an anatomical limb position of 0°, the line of the first fixed index 140B overlaps the line of the first reference index 130B, and the second The fixed index 141 is placed on the line CL centered on the second metatarsal bone of the left foot of the subject 51, and when the left foot of the subject 51 is viewed from the front side, the second reference index 131 is Adjust the attachment positions of the hook-and-loop fasteners 116 and 117 to the raised fabric 114B so that they are on the straight line. Finally, the examiner confirms that the first reference indicator 130B, first fixed indicator 140B, second reference indicator 131, and second fixed indicator 141 are arranged in the above predetermined state, and 110 to the subject 51 is completed.
Note that the method for fixing the support member 110 to the ankle joint of the left foot is not limited to the above fixing method, as long as the support member 110 can be fixed to the left foot of the subject 51 in the state shown in FIGS. 5 and 6. For example, after attaching the support member 110 to the approximate position of the lower leg and left foot of the test subject 51, the examiner places the ankle joint of the test subject 51 in the anatomical limb position at 0°. , the lateral malleolus index LLM, the first reference index 130B, the second reference index 131, the first fixed index 140B, and the second fixed index 141 are placed in the above-mentioned predetermined positions, so that the hook-and-loop fastener is attached to the raised fabric at the position. may be adjusted.

When fixing the support member 110 to the ankle joint of the right foot of the subject 51, the lateral malleolus index RLM is used as the first fixation index 140B instead of the lateral malleolus index LLM used for fixing the left foot to the ankle joint described above. Instead, the examiner fixes the support member 110 to the ankle joint of the right foot of the subject 51 using the first fixation indicator 140A and the first reference indicator 130A instead of the first reference indicator 130B.
Note that in the support member 110, the indicators placed at predetermined positions on the subject do not necessarily need to be the first reference indicator 130A, the first reference indicator 130B, and the second reference indicator 131 described above. That is, the index placed at a predetermined position of the subject can be another index based on other parts or axes of the lower leg and foot to which the support member 110 is fixed. For example, the line of the tibia and medial malleolus when viewed from the medial side of the foot, the axis of the lower leg when viewed from the anatomically posterior side of the foot, the calcaneus prominence on the sole of the foot, etc. are used as references. , standard indicators can be considered. Further, the indicators of the fixation state of the support member 110 to the ankle joint do not necessarily need to be the first fixation indicator 140A, the first fixation indicator 140B, and the second fixation indicator 141. For example, a fixation index may be used as an index of the state of fixation of the support member 110 to the ankle joint based on the line of the tibia of the foot and the reference index of the medial malleolus. Note that the other reference indicators and other fixed indicators described above may be additionally provided on the support member 110.

The examiner attaches the sensor element 120 to the support member 110 fixed to the ankle joint of the left foot of the subject 51, and completes wearing the evaluation device 100. Specifically, when fixing the support member 110 to the right foot, two female snap buttons 170 arranged on the sensor element 120 shown in FIG. 7 (described later) are attached to the male snap button 160A. It will be done. Similarly, when fixing the support member 110 to the left foot, the two female snap buttons 170 of the sensor element 120 are attached to the male snap button 160B. In addition, when fixing the support member 110 to the right foot, the male snap button 161A is replaced with one of the two female snap buttons 171A and 171B arranged on the sensor element 120 shown in FIG. 7, which will be described later. One side is attached. Similarly, when fixing the support member 110 to the left foot, one of the female snap buttons 171A and 171B of the sensor element 120 is attached to the male snap button 161B.

As shown in FIG. 7, the sensor element 120 includes the sensor member 10, the covering member 21 provided around the sensor member 10, and the female connecting terminal 29A of the connector 31 (see FIG. 10). It includes a male connection terminal 30A for electrical connection, and female snap buttons 170, 171A, and 171B for attaching the sensor element 120 to the support member 110. The sensor element 120 is a member that constitutes a capacitance type sensor.

As shown in FIGS. 8 and 9, the sensor member 10 is a laminate including a dielectric layer, an electrode layer, an electrode connection portion, and the like.
The sensor member 10 has a band shape and is configured to be expandable and contractible in the longitudinal direction (in the horizontal direction in the figure).
The sensor member 10 includes a sheet-like dielectric layer 11 having elasticity, a front electrode layer (first electrode layer) 12A formed on the front surface of the dielectric layer 11, and a front electrode layer (first electrode layer) 12A formed on the back surface of the dielectric layer 11. It includes a back side electrode layer (second electrode layer) 12B, the front side wiring 13A connected to the front side electrode layer 12A and extending in the longitudinal direction, and the back side wiring 13B connected to the back side electrode layer 12B and extending in the longitudinal direction.
The dielectric layer 11 is made of an elastomer composition containing an elastomer such as urethane rubber. The front electrode layer 12A, the back electrode layer 12B, the front wiring 13A, and the back wiring 13B are all made of a conductive composition containing a conductive material such as carbon nanotubes.

The sensor member 10 includes a sheet-like connection member 18 in which two electrode connection parts 16A and 16B made of copper foil are formed on the upper surface of a non-stretchable resin sheet 17. In the sensor member 10, the front side wiring 13A and the electrode connection part 16A, and the back side wiring 13B and the electrode connection part 16B are electrically connected via conductive adhesives 14A and 14B, respectively.
A front side protective layer 15A and a back side protective layer 15B are formed on the front side and the back side of the dielectric layer 11, respectively, so as to cover the front side electrode layer 12A and the back side electrode layer 12B. A connecting member (lead wire) 22 for connecting to the male connecting terminal 30A is soldered to each of the electrode connecting portions 16A and 16B. Further, the connecting member (lead wire) 22 is connected to the connecting pin 24 of the male connecting terminal 30A.

The front electrode layer 12A and the back electrode layer 12B have the same shape in plan view, and the front electrode layer 12A and the back electrode layer 12B are entirely opposed to each other with the dielectric layer 11 in between. In the sensor member 10, a detection portion 19 is a portion where the front electrode layer 12A and the back electrode layer 12B face each other.
In the above-mentioned sensor member, the front side electrode layer and the back side electrode layer do not necessarily need to be entirely opposed to each other with the dielectric layer in between, but it is sufficient that at least a portion thereof is opposed to each other.

In the sensor member 10, the dielectric layer 11 is expandable and contractible in the longitudinal direction. Therefore, the dielectric layer 11 can be deformed so that the areas of the front and back surfaces change. Further, when the dielectric layer 11 is deformed, the front electrode layer 12A, the back electrode layer 12B, the front side protective layer 15A, and the back side protective layer 15B (hereinafter, both may be simply referred to as protective layers) follow the deformation. ) can also be transformed.
Therefore, in the sensor member 10, the capacitance of the detection unit 19 changes in correlation with the amount of deformation of the dielectric layer 11 (change in area of the electrode layer). Therefore, the amount of deformation of the sensor member 10 can be detected by detecting the change in the capacitance of the detection section.
Further, in the sensor member 10, the portion that overlaps with the resin sheet 17 when viewed in plan cannot substantially expand or contract in the longitudinal direction (the surface direction of the sensor member).

Note that the sensor member 10 includes a non-stretchable member only on the back side and on one end side in the longitudinal direction (the right side in the left-right direction in FIG. 8), but the sensor member according to the embodiment of the present invention may also include a non-stretchable member (for example, a resin sheet) on the back side of the sensor member and on the other end side in the longitudinal direction (left side in the left-right direction in FIG. 8).

Returning to FIG. 7, covering members 21 made of stretchable cloth are provided on both sides of the sensor element 120. The covering member 21 is made of two sheets of stretchable cloth whose longitudinal length is longer than the longitudinal length of the sensor member 10 . The sensor member 10 is sandwiched between these two pieces of cloth. By providing the covering member 21, the sensor member 10 can be protected.

The sensor element 120 has a female snap button for attaching the sensor element 120 to the support member 110. The female snap button 170 is arranged on the male connection terminal 30A side of the sensor element 120. The female snap buttons 171A and 171B are arranged on the opposite side of the sensor element 120 from the male connection terminal 30A side with the sensor member 10 interposed therebetween.
The two snap button knives 170 are arranged near the lateral malleolus index RLM of the support member 110 when the support member 110 is fixed to the right foot of the subject 51 as shown in FIG. Attached to two male snap buttons 160A. Further, the two snap button knives 170 are arranged near the lateral malleolus index LLM of the support member 110 when the support member 110 is fixed to the left foot of the subject 51 as shown in FIG. It is attached to two male snap buttons 160B.
When the support member 110 is fixed to the right leg of the subject 51, one of the snap button females 171A and 171B is connected to the line of the second fixed index 141 of the support member 110 and the line of the evaluation test index 150A. It is attached to the male snap button 161A located between. Further, when the support member 110 is fixed to the left leg of the subject 51, either one of the snap button females 171A and 171B is connected to the line of the second fixed index 141 of the support member 110 and the evaluation test index 150B. It is attached to the male snap button 161B located between the line.

The two male snap buttons 160A are arranged to sandwich the lateral malleolus index RLM. Further, the two male snap buttons 160B are arranged to sandwich the lateral malleolus index LLM. As shown in FIG. 1, when the support member 110 is fixed to the right leg of the subject 51, when the female snap button 170 of the sensor element 120 is attached to the male snap button 160A of the support member 110, the connection terminal 30A becomes It is fixed at a position substantially above the lateral malleolus index RLM. Similarly, as shown in FIG. 5, when the support member 110 is fixed to the left leg of the subject 51, when the female snap button 170 of the sensor element 120 is attached to the male snap button 160B of the support member 110, 30A is fixed at a position substantially above the lateral malleolus index LLM. Since the connecting terminal 30A is fixed at a position substantially above the lateral malleolus index RLM or the lateral malleolus index LLM by the two snap buttons, the connecting terminal 30A is restrained from moving during ankle joint instability evaluation. can. As a result, the connection cord 26 of the connector 31 shown in FIG. 10, which will be described later, can be prevented from moving during ankle joint instability evaluation and interfering with the examiner's technique.

When starting the ankle joint forward pull test, the sensor member 10 shown in FIG. 16, which will be described later, preferably has an appropriate pretension. If the sensor member 10 is in a relaxed state at the start of the forward draw test, the amount of movement of the ankle joint will be absorbed by the slackness of the sensor member 10, making it impossible to accurately measure the amount of movement of the ankle joint. Further, if the sensor member 10 is in a non-extended state or a relaxed state at the start of the forward draw test, it becomes difficult to accurately measure the negative movement amount (ankle thrust amount) in the forward draw test. On the other hand, if the sensor member 10 is extended close to the detection limit (pretension is extremely excessive) at the start of the forward pull test, the amount of movement of the ankle joint that exceeds the detection limit of the sensor member 10 is It becomes impossible to measure.
The evaluation device 100 according to the present embodiment can adjust the pretension of the sensor member 10 by selecting the snap button knives 171A and 171B used to attach the sensor element 120 to the support member 110. For example, when attaching the sensor element 120 to the support member 110 using the snap button knife 171A, if the pretension of the sensor member 10 is excessive, use the snap button knife 171B to attach the sensor element 120 to the support member 110. By attaching 120, the pretension of the sensor member 10 can be weakened. Conversely, when the sensor element 120 is attached to the support member 110 using the snap button knife 171B, if the pretension of the sensor member 10 is insufficient, use the snap button knife 171A to attach the sensor element 120 to the support member 110. By attaching the sensor element 120, the pretension of the sensor member 10 can be increased.
Note that in the evaluation device 100 according to the present embodiment, the pretension of the sensor member 10 can be adjusted in two stages using the snap button knives 171A and 171B, but the adjustment is not necessarily limited to two stages. . For example, if a snap button female is further arranged in addition to the snap button females 171A and 171B, the pretension can be adjusted in three or more stages. Further, in this embodiment, the snap button females 171A and 171B are provided on the sensor element 120 side for adjusting the pretension, but the sensor element 120 does not necessarily have a plurality of snap button females 171A and 171B for adjusting the pretension. There is no need to provide a female snap button. For example, the pretension can be adjusted by providing the support member 110 with a plurality of male snap buttons for adjusting the pretension.

In this embodiment, a snap button is used to attach the sensor element 120 to the support member 110, but a magnet, a hook-and-loop fastener, or the like may be used, for example. In addition, in this embodiment, the male snap buttons 160A, 160B, 161A, and 161B of the support member 110 are such that when the evaluation device 100 is attached to the subject, the detection unit 19 of the sensor element 120 It is arranged on the support member 110 so as to substantially follow the anterior talofibular ligament of the patient. Note that the relationship between the male and female parts, which is the combination of snap button attachments, can of course be reversed.

FIG. 10 is a schematic diagram of the connector 31 according to this embodiment. The connector 31 has a connection cord 26, a female connection terminal 29A connected to an end of the connection cord 26, and a female connection terminal 29B connected to the other end of the connection cord 26. The female connection terminal 29A is a terminal connected to a male connection terminal 30A of the sensor element 120 or a male connection terminal 57 described below. The female connection terminal 29B is a terminal connected to a male connection terminal 30B of the display unit 5, which will be described later. The female connection terminals 29A and 29B have connection holes 25 into which the connection pins of the male connection terminals are inserted. By connecting the female connection terminals 29A and 29B of the connector 31 to the male connection terminals 30A (57) and 30B, the sensor element 120 and the display unit 5 are electrically connected via the connector 31. connected to.
The connector 31 of this embodiment can be attached to and detached from the sensor element 120 and the display unit 5, but does not necessarily have to be detachable. For example, the connector 31 may be fixed to at least one of the sensor element 120 and the display unit 5 in a non-removable manner. Further, the sensor element 120 and the display unit 5 can be connected wirelessly instead of being connected by wire through the connection cord 26. In this case, for example, the connector 31 can be configured to include a transmitter connected to the sensor element 120 and a receiver connected to the display unit 5.

FIG. 11 is a schematic diagram showing the ankle joint instability evaluation device 100 of this embodiment.
As shown in FIG. 11, the evaluation device 100 includes a support member 110, an evaluation capacitance type sensor element 120, and a display unit 5 electrically connected to the sensor element 120. The display unit 5 includes a measuring device 3 that measures changes in the capacitance of the sensor element 120, and a display 4 that displays the measurement results obtained by the measuring device 3. The display unit 5 has two modes for displaying measurement results on the display 4: a real mode in which the display 4 displays the amount of movement of the ankle joint, and a hold mode in which the display 4 displays the maximum amount of movement of the ankle joint. It has two modes.

The measuring instrument 3 includes a Schmitt trigger oscillation circuit 3a for converting capacitance C into a frequency signal F, an F/V conversion circuit 3b for converting the frequency signal F into a voltage signal V, and a power supply circuit (not shown). Be prepared. The measuring device 3 converts the capacitance C of the detecting section 19 of the sensor member 10 into a frequency signal F, and then further converts it into a voltage signal V, and transmits it to the display 4.

The display 4 includes a monitor 4a, an arithmetic circuit 4b, and a storage section 4c. The storage unit 4c stores a data table for converting the voltage signal V received from the measuring device 3 into a movement amount (mm) of the ankle joint. Since the output of capacitance with respect to the amount of deformation of the sensor member differs depending on the sensor element used, it is preferable that the data table is set for each sensor element used. The data table suppresses conversion errors from voltage signals between the evaluation devices to the amount of movement of the ankle joint. The storage unit 4c also stores the mode settings of the display unit 5 and the processing flow of the arithmetic circuit 4b. The calculation circuit 4b calculates the amount of movement (mm) of the ankle joint based on the data table stored in the storage unit 4c and the voltage signal V received from the measuring device 3. In the case of real mode, the arithmetic circuit 4b displays the calculated movement amount on the monitor 4a. Further, in the case of the hold mode, the calculation circuit 4b calculates the maximum movement amount of the ankle joint from the calculated movement amount, and displays it on the monitor 4a. Note that the arithmetic circuit 4b may store the maximum movement amount at the end of the measurement in the storage section 4c.

FIG. 12 is a schematic diagram of the display unit 5 according to this embodiment. The display unit 5 includes a male connection terminal 30B, a monitor 4a, an input button 27, and a hook-and-loop fastener (not shown). The connection terminal 30B is a terminal for connecting the female connection terminal 29B of the connector 31 described above.
The input button 27 is used to turn on/off the power of the display unit 5, switch the mode of the display unit 5, and end the measurement. When the input button 27 is pressed for less than 1 second while the power of the display unit 5 is OFF, the power of the display unit 5 is turned ON and measurement in the mode stored in the storage section 4c is started. Further, when the input button 27 is pressed for one second or more while the display unit 5 is powered on, the display unit 5 is powered off. If the input button 27 is pressed for 5 seconds or more while the display unit 5 is powered off, the display unit 5 is powered on and mode switching becomes possible. When the input button 27 is pressed for less than 1 second in a state where mode switching is possible, switching between real mode and hold mode is performed. If the input button 27 is pressed for 1 second or more in a state where mode switching is possible, the mode switching is completed and the power of the display unit 5 is turned off.
Note that the current mode is displayed on the monitor 4a of the display unit 5 when the display unit 5 is powered on before the start of measurement. In the real mode, the characters "REAL" are displayed on the monitor 4a. In the hold mode, the words "HOLD" are displayed on the monitor 4a. Furthermore, if an error occurs after the start of measurement, information indicating the error is displayed on the monitor 4a. Examples of information indicating an error include figures and characters such as an error code. For example, when the battery level is low, a graphic representing the battery is displayed on the monitor 4a. Note that if the error is an error that cannot be recovered, such as a low battery level, the information indicating the error displayed on the monitor 4a flashes three times. After the information indicating the error flashes three times, the power to the display unit 5 is turned off.

Flowcharts in FIGS. 13, 14, and 15 show processing flows of the arithmetic circuit 4b. FIG. 13 is a flowchart of mode switching processing by the arithmetic circuit 4b. FIG. 14 is a flowchart of real mode processing by the arithmetic circuit 4b. FIG. 15 is a flowchart of hold mode processing by the arithmetic circuit 4b.

The flowchart of the mode switching process shown in FIG. 13 will be explained. As described above, when the power of the display unit 5 is OFF and the input button 27 is pressed for 5 seconds or more, mode switching becomes possible (start in FIG. 13). In S1, the arithmetic circuit 4b acquires the current mode of the display unit 5 stored in the storage section 4c. In this embodiment, the mode in which the evaluation device 100 was last used is stored in the storage unit 4c. Note that the initial setting mode is the hold mode. In S2, the arithmetic circuit 4b determines whether there is an input for mode switching. If it is determined in S2 that there is no mode switching input, the process skips to S4. If it is determined in S2 that there is a mode switching input, then in S3 the arithmetic circuit 4b stores the switched mode in the storage unit 4c. In S4, the arithmetic circuit 4b determines whether there is an instruction to turn off the power. If it is determined in S4 that there is no instruction to turn off the power, the process returns to S2. In S4, if it is determined that there is an instruction to turn off the power, the arithmetic circuit 4b turns off the power to the display unit 5, and completes the process. Note that in the flowchart of the mode switching process in this embodiment, the power to the display unit 5 is turned off and the process is completed, but it is not necessarily necessary to turn off the power and complete the process. For example, after it is determined in S4 that there is no instruction to turn off the power, a step may be further provided in which the arithmetic circuit 4b determines whether there is an instruction to start measurement. In this case, if it is determined that there is an instruction to start measurement, the arithmetic circuit 4b shifts to the processing flow of the current mode of the display unit 5, which is stored in the storage section 4c.

When the power of the display unit 5 is OFF and the input button 27 is pressed for less than 1 second and the power is turned ON (start in FIG. 14), if the real mode is stored in the storage unit 4c (S101), The real mode processing is shown in the flowchart of FIG. 14. If the real mode is stored in the storage unit 4c in S101, the arithmetic circuit 4b stores 0 mm in the storage unit 4c as the initial value of the amount of movement of the ankle joint in S102. That is, the pretension state of the sensor member 10 of the sensor element 120 in S102 becomes 0 mm, which is the initial value of the amount of movement of the ankle joint. Next, in S103, the arithmetic circuit 4b determines whether or not the voltage signal V from the measuring device 3 is received. In S103, if the voltage signal V from the measuring instrument 3 is not received, the processing of the arithmetic circuit 4b skips to S105. In S103, when the voltage signal V from the measuring instrument 3 is received, the arithmetic circuit 4b converts the received voltage signal V into a movement amount (mm) based on the above-mentioned data table stored in the storage section 4c. , obtain the amount of movement of the ankle joint (S104). Here, the amount of movement of the ankle joint converted by the arithmetic circuit 4b is based on the above-mentioned initial value 0 mm, and when the sensor member 10 contracts, it becomes a negative amount of movement, and when the sensor member 10 extends, it becomes a negative amount of movement. The amount of movement is positive. For example, if the sensor member 10 is shrunk by 10 mm from its pretensioned state, the amount of movement will be -10 mm. Conversely, when the sensor member 10 is extended by 10 mm from the pretensioned state, the amount of movement is +10 mm. In S105, the arithmetic circuit 4b displays the amount of movement of the ankle joint on the monitor 4a. After the amount of movement of the ankle joint is displayed on the monitor 4a in S105, in S106 the arithmetic circuit 4b determines whether or not a zero reset instruction is given. Zero reset is an instruction to return the amount of movement of the ankle joint to its initial value during measurement. The zero reset instruction is given by pressing the input button 27 for less than 1 second during measurement. If it is determined in S106 that there is a zero reset instruction, the process returns to S102. If it is determined in S106 that there is no instruction to reset to zero, then in S107 the arithmetic circuit 4b determines whether or not there is an instruction to turn off the power. If it is determined in S107 that there is an instruction to turn off the power, the arithmetic circuit 4b turns off the power to the display unit 5, and completes the process. If it is determined in S107 that there is no instruction to turn off the power, the process returns to S103.

When the power of the display unit 5 is OFF and the input button 27 is pressed for less than 1 second and the power is turned ON (start in FIG. 15), if the hold mode is stored in the storage unit 4c (S201), Hold mode processing is performed as shown in the flowchart of FIG. 15. In S201, when the hold mode is stored in the storage unit 4c, in S202, the arithmetic circuit 4b stores the initial movement amount of the ankle joint, the negative maximum movement amount, and the positive maximum movement amount in the storage unit 4c. Store 0mm as the value. In S203, the arithmetic circuit 4b determines whether or not the voltage signal V from the measuring instrument 3 is received. In S203, if the voltage signal V is not received from the measuring instrument 3, the processing of the arithmetic circuit 4b skips to S212. In S203, when the voltage signal V from the measuring instrument 3 is received, the arithmetic circuit 4b converts the received voltage signal V into a movement amount (mm) based on the above-mentioned data table stored in the storage section 4c. , obtain the amount of movement of the ankle joint (S204). After acquiring the amount of movement of the ankle joint in S204, the arithmetic circuit 4b determines whether the amount of movement of the ankle joint is a negative amount of movement (S205). When it is determined in S205 that the amount of movement of the ankle joint is a negative amount of movement, in S206 the arithmetic circuit 4b acquires the maximum amount of movement on the negative side stored in the storage unit 4c. After acquiring the maximum movement amount on the negative side, in S207, the arithmetic circuit 4b determines whether the current movement amount is smaller than the maximum movement amount on the negative side. If the current movement amount is equal to or greater than the maximum movement amount on the negative side, the processing of the arithmetic circuit 4b skips to S212. If the current movement amount is smaller than the maximum movement amount on the negative side, in S208, the arithmetic circuit 4b rewrites the maximum movement amount on the negative side stored in the storage unit 4c to the current movement amount, and proceeds to step S212. Move. When it is determined in S205 that the amount of movement of the ankle joint is a positive amount of movement or 0, in S209 the arithmetic circuit 4b acquires the maximum amount of movement on the plus side stored in the storage unit 4c. After acquiring the maximum positive movement amount, in S210, the arithmetic circuit 4b determines whether the current movement amount is larger than the maximum positive movement amount. If the current movement amount is less than or equal to the maximum movement amount on the plus side, the processing of the arithmetic circuit 4b skips to S212. If the current amount of movement is larger than the maximum amount of movement on the plus side, in S211, the arithmetic circuit 4b rewrites the maximum amount of movement on the plus side stored in the storage unit 4c to the current amount of movement, and proceeds to step S212. Move. In S212, the calculation circuit 4b calculates the maximum amount of movement of the ankle joint from the maximum amount of movement on the negative side and the maximum amount of movement on the plus side stored in the storage unit 4c, and displays the calculated maximum amount of movement on the monitor 4a. Display. Here, the maximum amount of movement is a value obtained by adding the absolute value of the maximum amount of movement on the negative side and the maximum amount of movement on the plus side. Since the maximum movement amount is a positive value, when the display unit 5 is in the hold mode, a positive value is displayed on the monitor 4a. In S212, the maximum movement amount of the ankle joint is displayed on the monitor 4a, and then in S213, the arithmetic circuit 4b determines whether there is an instruction to reset to zero. If it is determined in S213 that there is a zero reset instruction, the process returns to S202. If it is determined in S213 that there is no instruction to reset to zero, then in S214 the arithmetic circuit 4b determines whether or not there is an instruction to turn off the power. If it is determined in S214 that there is an instruction to turn off the power, the arithmetic circuit 4b turns off the power to the display unit 5, and completes the process. If it is determined in S214 that there is no instruction to turn off the power, the process returns to S203.

<Evaluation of ankle instability>
The evaluation device 100 of this embodiment is used to evaluate damage to the anterior talofibular ligament of the ankle joint using a forward pull test.
The anterior drawer test described above for evaluating damage to the anterior talofibular ligament is a well-known evaluation method known in the field of orthopedics. FIG. 16 is a diagram for explaining a method of performing a forward pull test on the ankle joint of the right foot using the evaluation device 100 according to the present embodiment.
In the above-mentioned front drawer test, first, the examiner has the subject 51 wearing the evaluation device 100 on his right leg take a sitting position on the bed, and has his lower leg 53 extend from the edge of the bed 52. Then, the examiner's one hand 55 presses and fixes the distal part of the lower leg from above downward, and the examiner's other hand 56 holds the examinee's 51 so as to wrap around his heel.
Next, the examiner confirms that the line of the first standard index 130A and the line of the evaluation test index 150A overlap on a substantially straight line when viewed from the outside of the right foot of the subject 51, and that the line of the second standard index 131 The right leg of the subject 51 is adjusted so that the lines of the second fixed index 141 and the second fixed index 141 overlap substantially on a straight line when viewed from the front side of the subject's 51 right leg. As a result, the ankle joint of the right foot of the subject 51 is placed in a slight plantar flexion position suitable for the evaluation of the forward drawer test by the evaluation device 100. Here, the mild plantar flexion position suitable for the evaluation of the forward drawer test is 15 to 35 degrees of plantar flexion. Note that the line of the evaluation test index 150A of this embodiment is arranged on the support member 110 so that the ankle joint of the right foot of the subject 51 has a plantar flexion of 30°.

The examiner holds the heel of the examinee 51 with the hand 56, with the ankle joint of the right foot of the examinee 51 in a slight plantar flexion position suitable for the evaluation of the forward pull test using the evaluation device 100. By pulling the heel forward and pushing it backward, the evaluation device 100 measures the amount of movement of the ankle joint. When the display unit 5 of the evaluation device 100 is in the real mode, the amount of movement of the ankle joint (the amount of withdrawal) when the heel is pulled forward is displayed on the monitor 4a of the display unit 5 as a positive amount of movement. Ru. Further, the amount of movement (push-out amount) of the ankle joint when the heel is pushed backward is displayed on the monitor 4a of the display unit 5 as a negative amount of movement. When the display unit 5 of the evaluation device 100 is in the hold mode, the maximum value of the positive movement when the heel is pulled forward and the maximum value of the negative movement when the heel is pushed backwards. The sum of the absolute values is displayed on the monitor 4a of the display unit 5 as the maximum movement amount of the ankle joint. Note that when the power of the display unit 5 is OFF and the input button 27 is pressed for less than 1 second, the power of the display unit 5 is turned ON and measurement is started in the mode stored in the storage section 4c. The pretension state of the sensor member 10 of the sensor element 120 at the start of measurement is 0 mm, which is the initial value of the amount of movement of the ankle joint. Further, during measurement, if the input button 27 is pressed for less than 1 second and zero reset is performed, the pretension state of the sensor member 10 of the sensor element 120 at the time of zero reset is the initial value of the amount of movement of the ankle joint. It becomes 0 mm.
The real mode is preferable for examiners who slowly perform the ankle anterior pull test procedure. In the real mode, the examiner can perform the procedure while checking the current amount of pull-out and push-out of the ankle joint on the monitor 4a. On the other hand, the hold mode is preferable for examiners who perform procedures quickly in order to minimize pain to the examinee during the evaluation test. In the hold mode, the maximum amount of movement of the ankle joint is monitored 4a instead of the current amount of movement of the ankle joint. Therefore, the examiner does not need to check the monitor 4a and can concentrate on the procedure.
Here, the presence or absence of damage to the anterior talofibular ligament can be evaluated as, for example, if the maximum movement amount exceeds 5 mm, the anterior talofibular ligament is damaged. In the above-mentioned anterior drawer test, the maximum amount of movement correlates with the change in the distance between the fibula and talus, and the maximum amount of movement increases when the anterior talofibular ligament is injured and the joint becomes loose.

When the evaluation device 100 is attached to the left foot of the subject 51, the examiner selects the line of the first reference index 130B and the line of the first reference index 130B instead of the line of the first reference index 130A and the line of the evaluation test index 150A. Using the line of evaluation test index 150B, a front pull test is performed to detect damage to the anterior talofibular ligament of the ankle joint of the left foot. That is, the examiner determines that the line of the first reference index 130B of the evaluation device 100 and the line of the evaluation test index 150B overlap on a substantially straight line when viewed from the outside of the left foot of the subject 51, and The right foot of the subject 51 is adjusted so that the line of the index 131 and the line of the second fixed index 141 overlap on a substantially straight line when viewed from the front side of the right leg of the subject 51. As a result, the ankle joint of the left foot of the subject 51 is placed in a slight plantar flexion position suitable for evaluation in the forward draw test using the evaluation device 100.
The angle index of the ankle joint may be any index that can confirm the above-mentioned mild plantar flexion position, and does not necessarily need to be the evaluation test indexes 150A and 150B. For example, an evaluation test index may be used as an index of the angle of the ankle joint based on the reference index of the line of the medial malleolus of the foot and the tibia.

In this embodiment, the above-mentioned forward pull test is performed with the evaluation device 100 attached to the ankle joint of the subject 51. Therefore, based on the change in capacitance of the detection unit 19 of the sensor element 120, the amount of withdrawal in the above-mentioned forward withdrawal test can be measured.
Therefore, according to the present embodiment, evaluation of joint instability, which was conventionally performed subjectively by the examiner, can be performed based on objective data.
In addition, in this embodiment, the first reference index 130A, the first reference index 130B, the second reference index 131, the first fixed index 140A, the first fixed index 140B, the second fixed index 141, the evaluation test index 150A, and the evaluation Using the test index 150B, the evaluation device 100 is attached to the ankle joint of the subject 51, and the ankle joint instability of the subject 51 is evaluated by the evaluation device 100.
Therefore, according to this embodiment, deficiencies in attaching the evaluation device 100 to the subject 51 and in evaluating ankle joint instability are suppressed. As a result, the examiner can accurately assess ankle instability.

In the present embodiment, the ankle joint instability evaluation device 100 for performing a forward pull test for anterior talofibular ligament injury in the ankle joint has been described as an example; , the evaluation test for ankle ligament injuries does not necessarily have to be the anterior drawer test for anterior talofibular ligament injuries. The ankle joint instability evaluation device of the present invention includes an evaluation device for evaluating ligament damage in other ankle joints. In this case, the above-mentioned sensor element 120 is arranged such that the detection unit 19 of the sensor element 120 is arranged so that the detection unit 19 of the sensor element 120 almost follows the ligament targeted for the evaluation test of the subject 51 when the evaluation device 100 is attached to the subject. It is attached to the support member 110. Therefore, the arrangement of the above-described snap button on the male support member 110 is changed or added depending on the attachment position of the support member 110 of the sensor element 120.
Table 1 below shows an evaluation test for ankle ligament damage, which is a target of the ankle instability evaluation device of the present invention.

(Second embodiment)
This embodiment differs from the first embodiment in the sensor member.
Specifically, the sensor member 40 shown in FIGS. 17 and 18 is used instead of the sensor member 10 in the first embodiment. The sensor member 40 includes a dielectric layer (first dielectric layer) and a first electrode layer and a second electrode layer formed on both surfaces thereof, as well as a second dielectric layer and a third electrode layer.
FIG. 17 is a perspective view showing a sensor member used in this embodiment. FIG. 18 is a sectional view taken along line BB in FIG. 17.

The sensor member 40 shown in FIGS. 17 and 18 includes a stretchable sheet-like first dielectric layer 41A, a first electrode layer 42A formed on the front surface of the first dielectric layer 41A, and a first electrode layer 42A formed on the front surface of the first dielectric layer 41A. A second electrode layer 42B formed on the back surface of the dielectric layer 41A, a second dielectric layer 41B laminated on the front side of the first dielectric layer 41A so as to cover the first electrode layer 42A, and a second dielectric layer 41B formed on the back surface of the dielectric layer 41A. and a third electrode layer 42C formed on the front surface.
The sensor member 40 also includes a first wiring 43A connected to the first electrode layer 42A, a second wiring 43B connected to the second electrode layer 42B, and a third wiring 43C connected to the third electrode layer 42C. Equipped with.
Here, a part of the third wiring 43C is stacked on the second wiring 43B and is integrated with the second wiring 43B.

Further, the sensor member 40 includes a connecting member 48 having two electrode connecting parts 46A and 46B made of copper foil formed on a non-stretchable resin sheet 47 on the upper surface, and the first wiring 43A and the electrode connecting part 46A, Further, the integrated second wiring 43B and third wiring 43C and the electrode connection portion 46B are electrically connected via conductive adhesives 44A and 44B, respectively.
Further, in the sensor member 40, a back side protective layer 45B and a front side protective layer 45A are formed on the back side of the first dielectric layer 41A and the front side of the second dielectric layer 41B, respectively. A connecting member (lead wire) 32 for connecting to a male connecting terminal 57 is soldered to each of the electrode connecting portions 46A and 46B. Further, the connecting member (lead wire) 32 is connected to a connecting pin 58 of a male connecting terminal 57. The male connection terminal 57 is a terminal that is connected to the female connection terminal 29A of the connection cord 26 described above.

In the sensor member 40, the first to third electrode layers 42A to 42C have the same shape in plan view. The first electrode layer 42A and the second electrode layer 42B face each other across the first dielectric layer 41A, and the first electrode layer 42A and the third electrode layer 42C face each other across the second dielectric layer 41B. are facing each other.
In the sensor member 40, a portion where the first electrode layer 42A and the second electrode layer 42B face each other, and a portion where the first electrode layer 42A and the third electrode layer 42C face each other serve as the detection portion 49, and the first electrode layer 42A The capacitance of the detection unit 49 is the sum of the capacitance of the opposing portions of the second electrode layer 42B and the capacitance of the opposing portions of the first electrode layer 42A and the third electrode layer 42C.

When performing measurement using the sensor member 40 having such a configuration, the second electrode layer 42B and the third electrode layer 42C are electrically connected, so that noise generated by the living body, which is a conductor, is generated. It is possible to reduce measurement errors caused by
Therefore, by using the sensor member 40, the amount of movement of the joint can be detected with higher accuracy when evaluating the instability of the joint.

The sensor element employed in the embodiment of the present invention is not limited to a capacitance type sensor element, but may be, for example, a resistance type sensor element in which the electrical resistance of the detection part changes depending on the amount of deformation. That's fine, and it could be a laser Doppler displacement meter.

Hereinafter, the constituent members of the ankle joint instability evaluation device 100 will be explained, taking as an example a case where a capacitance type sensor element 120 is employed.
[Capacitance type sensor element]
<Sensor member>
<<Dielectric layer>>
The dielectric layer is a sheet-like material made of an elastomer composition. The dielectric layer can be reversibly deformed so that the areas of its front and back surfaces change. In the present invention, the front and back surfaces of a sheet-like dielectric layer refer to the front and back surfaces of the dielectric layer.
Examples of the elastomer composition include those containing an elastomer and, if necessary, other optional components.
Examples of the elastomer include natural rubber, isoprene rubber, nitrile rubber (NBR), ethylene propylene rubber (EPDM), styrene-butadiene rubber (SBR), butadiene rubber (BR), chloroprene rubber (CR), silicone rubber, and fluorine rubber. Examples include rubber, acrylic rubber, hydrogenated nitrile rubber, and urethane rubber. These may be used alone or in combination of two or more.
The elastomer is preferably urethane rubber or silicone rubber. This is because permanent distortion (or permanent elongation) is small.
In addition to the elastomer, the elastomer composition may also contain additives such as plasticizers, antioxidants, antiaging agents, and colorants, dielectric fillers, and the like.

The average thickness of the dielectric layer is preferably 10 to 1000 μm. In this case, the dielectric layer is suitable for elongation so that the area in plan view becomes large. The above average thickness is more preferably 30 to 200 μm.
The dielectric layer is preferably deformable so that the area of its front and back surfaces increases by 30% or more from the unstretched state.
Here, being deformable so as to increase by 30% or more means that it will not break even if the area is increased by 30% by applying a load, and will return to its original state when the load is released (i.e. (within the elastic deformation range).
Note that the range in which the dielectric layer can be deformed in the plane direction can be controlled by the design (material, shape, etc.) of the dielectric layer.

<<Electrode layer (front side electrode layer and back side electrode layer)>>
The electrode layer is made of a conductive composition containing a conductive material.
The front side electrode layer and the back side electrode layer are usually formed using the same material, but do not necessarily need to use the same material.
Examples of the conductive material include carbon nanotubes, conductive carbon black, graphite, metal nanowires, metal nanoparticles, and conductive polymers. These may be used alone or in combination of two or more.
The conductive material is preferably one with a large aspect ratio, such as carbon nanotubes or metal nanowires. This is because it is suitable for forming an electrode layer that deforms following the deformation of the dielectric layer.

In addition to the conductive material, the conductive composition may contain, for example, a binder component that functions as a binding material for the conductive material and various additives.
Examples of the above additives include dispersants for conductive materials, crosslinking agents for binder components, vulcanization accelerators, vulcanization aids, anti-aging agents, plasticizers, softeners, and colorants. Can be mentioned.

<<Protective layer>>
The sensor member may include the protective layer (a front side protective layer and a back side protective layer). By providing the above protective layer, the electrode layer and the like can be electrically insulated from the outside. Further, by providing the above protective layer, the strength and durability of the sensor member can be increased.
Examples of the material for the protective layer include the same elastomer composition as the material for the dielectric layer.

<<Connection member>>
The connection member includes a sheet-like base material and a plurality of electrode connection parts formed on the upper surface of the base material.
As the sheet-like base material, for example, a resin film, a resin plate, a cloth such as a nonwoven fabric, etc. can be used. The sheet-like base material is preferably one that does not substantially expand/contract (deform) even if the stretchable base material expands/contracts. This is because if the base material is easily deformed, inconveniences such as breakage of electrode connection portions and the like are likely to occur.
The resin material for the resin film or resin plate is not particularly limited, and examples thereof include polyester such as PET, hard polyvinyl chloride, polyethylene (PE), polypropylene (PP), polycarbonate (PC), polyimide (PI), etc. It will be done.

Examples of the electrode connection portion include those made of metal foil such as copper foil. Furthermore, the electrode connection portion may be, for example, a printed layer or a plating layer made of a metal material other than copper foil.
The electrode connection portion is fixed to the base material using an adhesive, for example.

The electrode connection portion is electrically connected to the wiring (front wiring, back wiring, first to third wiring) connected to the electrode layer via a conductive adhesive. The above-mentioned conductive adhesive is not particularly limited, and conventionally known conductive adhesives can be used, and commercially available products can also be used.
Note that the wiring connected to the electrode layer may be made of the same conductive composition as the electrode layer, for example.

A sensor member with such a configuration is manufactured by forming an electrode layer and a protective layer on the front and back surfaces of the dielectric layer using a method similar to the method for manufacturing a sensor sheet described in JP-A No. 2016-90487, for example. After producing a laminated member, the above-mentioned connecting member is attached, and then the electrode layer (wiring) and the electrode connection portion are electrically connected to each other.

<Coated member>
The covering member is an insulating member provided around the sensor member.
Examples of the covering member include a stretchable cloth and a member made of an elastomer composition. The covering member is preferably a member having stretch anisotropy.
The stretchable cloth is not particularly limited, and may be a woven fabric, a knitted fabric, or even a nonwoven fabric.
The cloth material is integrated with the sensor member using an adhesive such as an acrylic adhesive, a urethane adhesive, a rubber adhesive, or a silicone adhesive. Here, the adhesive needs to have flexibility so as not to inhibit the expansion and contraction of the dielectric layer.

[Support members]
Examples of the support member include members made using materials such as nylon, polyurethane, and polyester.
The support member is required to be in close contact with the body surface of the joint portion, which has large irregularities, but not to cause displacement of the sensor element during measurement. In order to meet such requirements, the support member is preferably made by combining a stretchable material and a hardly stretchable material or a non-stretchable material, for example. In this case, by forming the part of the support member to which the sensor element is attached, for example, with a film made of a non-stretchable material, the support member can be brought into close contact with the subject's joint to be measured, and at the time of measurement. The attachment position of the sensor element to the joint becomes less likely to shift.

In the first embodiment, the support member is composed of one member, but in the evaluation device according to the embodiment of the present invention, the support member does not necessarily have to be composed of one member, but is composed of a plurality of members. It may be configured.
For example, the part fixed to the leg of the subject and the part fixed to the lower leg may be composed of two members. A specific example of this case is, for example, in the support member 110 shown in FIGS. 2 and 3, the support member is divided into two members near the X portion in the figures.

[Display unit]
<Measuring instrument>
The measuring device is electrically connected to the sensor member. The measuring device measures the capacitance of the detecting section included in the sensor member. A conventionally known method can be used to measure the capacitance. Therefore, the measuring instrument described above includes a necessary capacitance measuring circuit, arithmetic circuit, amplifier circuit, power supply circuit, and the like.
As a method (circuit) for measuring the capacitance, for example, a CV conversion circuit (LCR meter, etc.) using an automatic balancing bridge circuit, a CV conversion circuit using an inverting amplifier circuit, or a half-wave voltage doubler rectifier circuit is used. Examples include a CV conversion circuit using a Schmitt trigger oscillation circuit, a CF oscillation circuit using a Schmitt trigger oscillation circuit, and a method using a combination of a Schmitt trigger oscillation circuit and an F/V conversion circuit.

<Display>
The display allows the examiner to check information regarding the movement amount of the joint and the measurement mode of the evaluation device.
The display device includes a monitor, an arithmetic circuit, an amplifier circuit, a storage section, a power supply circuit, and the like.
The storage unit may be of any type as long as it can store digital data such as the data table described above and information regarding the amount of movement of the ankle joint. Examples of the storage unit include RAM, ROM, HDD, and the like. Note that the storage unit may be included in the measuring instrument. Further, both the display device and the measuring device may include the storage unit.

When both the display device and the measuring device include the storage unit, for example, a data table for converting the voltage signal V into the amount of movement (mm) of the ankle joint is stored in the measuring device. be able to. In this case, the measuring device can also transmit the converted movement amount (mm) of the ankle joint to the display device.
Further, the display unit stores a data table for converting the voltage signal V into capacitance C in the storage section of the display, and stores the capacitance C of the ankle joint in the storage section of the measuring instrument. A data table for converting the amount of movement (mm) can also be stored. In this case, the voltage signal V received from the measuring device is converted to capacitance C on the display side, and the converted capacitance C is calculated as the amount of movement of the ankle joint (mm) on the measuring device side. ) is converted to As described above, the capacitance output relative to the amount of deformation of the sensor member differs depending on the sensor element used. Furthermore, the length and width of the sensor element used differs depending on the evaluation test for ankle ligament damage that is targeted by the ankle joint instability evaluation device. Therefore, the storage unit on the measuring instrument side to which the sensor member is connected stores a data table for converting the capacitance C into the amount of movement (mm) of the ankle joint, so that the sensor member can be switched easily. However, it becomes possible to respond flexibly.

In the first embodiment described above, the measuring instrument and the display device are integrated as the display unit 5, but each may be configured separately. In this case, the measuring device and the display device may be connected by wire or wirelessly.
Further, when the measuring instrument and the display device are configured separately, a terminal device such as a personal computer, a smartphone, or a tablet may be used as the display device.

3 Measuring instrument 3a Schmitt trigger oscillation circuit 3b F/V conversion circuit 4 Display 4a Monitor 4b Arithmetic circuit 4c Storage section 5 Display unit 10, 40 Sensor member 11 Dielectric layer 12A Front side electrode layer 12B Back side electrode layer 13A Front side wiring 13B Back side wiring 14A, 14B, 44A, 44B Conductive adhesive 15A, 45A Front side protective layer 15B, 45B Back side protective layer 16A, 16B, 46A, 46B Electrode connection section 17, 47 Resin sheet 18, 48 Connection member 19, 49 Detection section 21 Coating Components 22, 32 Connection members 24, 58 Connection pins 25 Connection holes 26 Connection cords 27 Input buttons 29A, 29B Female connection terminals 30A, 30B, 57 Male connection terminals 31 Connector 41A First dielectric layer 41B Second dielectric layer 42A First electrode layer 42B Second electrode layer 42C Third electrode layer 43A First wiring 43B Second wiring 43C Third wiring 51 Subject 52 Bed 53 Lower legs 55, 56 Hands 100 Ankle joint instability evaluation device 110 Support member 110A , 110B Support member pieces 111A, 111B Base fabric 112A, 112B Elastic sheet 113A, 113B, 114A, 114B Raised fabric 115, 116, 117 Hook and loop fastener 120 Sensor element 130A, 130B First reference index 131 Second reference index 140A, 140B One fixed index 141 Second fixed index 150A, 150B Evaluation test index 160A, 160B, 161A, 161B Male snap button 170, 171A, 171B Female snap button CA Lower leg axis CL Line centered on the second metatarsal FL Fibula Line FV Vertical line FV to the fibula
RLM, LLM Lateral malleolus index

Claims (7)

A device used for an evaluation test of ankle joint instability, the device comprising:
a support member fixed to the ankle joint of the subject;
a sensor element attached to the support member and configured to detect the amount of movement of the ankle joint moved by the examiner;
a measurement unit that measures the amount of deformation of the detection unit of the sensor element;
a display unit that displays the amount of movement of the ankle joint based on the measurement result of the measurement unit,
The support member is
a reference index placed at a predetermined position on at least one of the lower leg and foot of the subject;
a fixation index that is an index of the fixation state of the support member fixed to the ankle joint;
and an evaluation test index that is an index of the angle of the ankle joint when carrying out the evaluation test,
The fixation index is an index for confirming the fixation state of the support member fixed to the ankle joint based on the reference index,
The evaluation test index is an index for checking the angle of the ankle joint when carrying out the evaluation test based on the reference index,
Device for assessing ankle instability. The device for evaluating ankle joint instability according to claim 1 , wherein the fixation index is an index of the fixation state of the support member when the anatomical limb position of the ankle joint is 0°. The ankle joint instability evaluation device according to claim 1 or 2 , wherein the ankle joint instability evaluation test is a forward draw test for evaluating the presence or absence of damage to the anterior talofibular ligament. The apparatus for evaluating ankle joint instability according to claim 3 , wherein the evaluation test index is an index of at least one angle selected from 15 to 35 degrees of plantar flexion of the ankle joint at which the anterior drawer test is performed. . The ankle joint instability evaluation device according to any one of claims 1 to 4 , wherein the display section displays the maximum amount of movement of the amount of movement. The sensor element is a sensor element in which the capacitance of the detection part changes depending on the amount of movement,
It has a dielectric layer made of an elastomer, a first electrode layer formed on an upper surface of the dielectric layer, and a second electrode layer formed on a lower surface of the dielectric layer, and the first electrode layer and the second electrode comprising a stretchable sensor member in which opposing portions of the layers serve as the detection portion;
The device for evaluating ankle joint instability according to any one of claims 1 to 5 . The ankle joint instability evaluation device according to claim 6 , wherein the sensor element includes a mounting member for adjusting the extension state of the sensor member and attaching the sensor element to the support member.

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