JP6719743B2 - Ultrasonic fracture treatment device - Google Patents

Description

The present invention relates to an ultrasonic fracture treatment device and an ultrasonic fracture treatment method for performing fracture treatment using ultrasonic waves.

It is known that stimulation such as electric or magnetic influences proliferation of bone cells (for example, see Non-Patent Document 1). Therefore, in recent years, attention has been paid to fracture treatment using ultrasonic waves. For example, Patent Document 1 describes a device that irradiates a fracture site with ultrasonic waves in order to observe the condition of fracture treatment. In addition, Patent Document 2 describes a device that irradiates ultrasonic waves to a fracture site by controlling the directivity of an ultrasonic beam.

Fukada Eiichi, "Research and Prospects of Bone Electrodynamic Stimulation", Journal of Bioelectric and Physical Stimulation Research Society of Japan 24, pp.1-10, 2010 Patent Publication No. 2796179 Patent Publication No. 4567649

However, in the conventional method and the devices described in each patent document, ultrasonic waves are only applied to the fracture site. Therefore, the establishment of a more effective ultrasonic wave irradiation mode becomes an issue.

Therefore, an object of the present invention is to provide an ultrasonic fracture treatment device and an ultrasonic fracture treatment method that realize an ultrasonic wave irradiation mode effective for fracture treatment.

The ultrasonic fracture treatment device of the present invention is a probe that irradiates an ultrasonic wave toward a cortical bone including a fracture site, and the minimum value of the evoked potential in the cortical bone that has the direction dependence of the evoked potential generated by the ultrasonic wave. An irradiation direction setting unit configured to set the ultrasonic wave irradiation direction of the probe, in which the ultrasonic wave is irradiated to the fractured part from a direction in which a larger evoked potential is generated.

For example, in the cross section of cortical bone, the direction from the center (long axis) of the cortical bone to the outside (the direction orthogonal to the long axis) is the radial direction (Radial), and the direction of the long axis of the cortical bone is the long axis direction (Axial). When the direction along the circumference of the cortical bone with the long axis direction as the central axis is taken as the circumferential direction (Tangential), the cortical bone has the direction dependence of the evoked potential generated by ultrasonic waves, and therefore it is shown in FIG. Thus, it is found that when the ultrasonic wave is propagated in a direction other than Axial and Tangential (that is, in a direction in which an evoked potential larger than the minimum value of the evoked potential is generated) in the axial-tangential plane, the evoked potential increases. .. Further, as shown in FIG. 5, even in the Axial-Radial plane, when ultrasonic waves are propagated from a direction other than Axial and Radial (that is, a direction in which an evoked potential larger than the minimum value of the evoked potential is generated), evoked It can be seen that the potential increases.

Therefore, the ultrasonic fracture treatment device of the present invention can realize a more effective ultrasonic irradiation mode for fracture treatment.

According to the present invention, it is possible to realize a more effective ultrasonic wave irradiation mode for bone fracture treatment.

FIG. 1 is a block diagram showing the main configuration of the ultrasonic fracture treatment device. FIG. 2A is a perspective view (partially transparent view) at the time of irradiation, FIG. 2B is a side view partially transparent view, and FIG. 2C is a front view. It is a figure which shows the magnitude|size of the evoked potential at the time of irradiating an ultrasonic wave from each direction in an Axial-Tangential plane. FIG. 4A is a perspective view (partially transparent view) at the time of irradiation, FIG. 4B is a side view partially transparent view, and FIG. 4C is a front view. 5A is a diagram showing a perspective view (partially transparent view) during irradiation, FIG. 5B is a side view partially transparent view, and FIG. 5C is a front view. is there. It is a figure which shows the magnitude|size of the evoked potential at the time of irradiating an ultrasonic wave from each direction in an Axial-Radial plane. 7A is a diagram showing a perspective view (partially transparent view) during irradiation, FIG. 7B is a side view partially transparent view, and FIG. 7C is a front view. is there. FIG. 8A is a partially transparent view of the side view, and FIG. 8B is a top view. FIG. 6 is a perspective view (partially transparent view) at the time of irradiation when a probe including a plurality of ultrasonic elements is used. FIG. 10(A) is a block diagram showing the main configuration of an ultrasonic fracture treatment device equipped with an array element, and FIG. 10(B) is a perspective view (partially transparent view) during irradiation. ..

FIG. 1 is a block diagram showing the main configuration of the ultrasonic fracture treatment device. FIG. 2A is a perspective view (partially transparent view) at the time of irradiation, FIG. 2B is a side view partially transparent view, and FIG. 2C is a front view.

In the present embodiment, the long axis direction (the direction from the extremities to the toes) of the cortical bone 71 is Axial, and in the plane orthogonal to the length direction, the radial direction from the central axis (long axis) of the cortical bone 71 to the outside. The (direction orthogonal to the long axis) is the radial direction (Radial), and the direction along the circumference of the cortical bone 71 whose center axis is the long axis direction (the circumferential direction of the surface of the cortical bone 71) is the circumferential direction (Tangential). To call.

The ultrasonic fracture treatment device 1 includes a probe 2, an irradiation instrument 21, a transmission/reception unit 3, a control unit 4, an operation unit 5, and a display unit 6.

The operation unit 5 includes a mouse, a keyboard, or the like, and receives an operation from a user. The operation unit 5 receives, for example, an operation related to transmission settings or an operation for starting irradiation (starting treatment). The control unit 4 sets the transmission frequency, the pulse width, the input voltage, or the like according to the operation related to the transmission setting received by the operation unit 5. The control unit 4 inputs the set contents to the transmission/reception unit 3. The transmitter/receiver 3 generates an ultrasonic signal under the input setting conditions. The transmitting/receiving unit 3 outputs the generated ultrasonic signal to the probe 2 and causes the probe 2 to transmit the ultrasonic wave. The transmitter/receiver 3 also converts the echo signal received by the probe 2 into a digital signal and outputs the digital signal to the controller 4.

The probe 2 is fixed to the irradiation device 21. The irradiation device 21 is an example of an irradiation direction setting unit, and is a device for bringing the probe 2 into contact with the user's limbs or the like at a predetermined angle, as shown in FIG. The irradiation direction setting unit irradiates the fracture site with ultrasonic waves in a direction that causes an evoked potential larger than the minimum value of the evoked potential in the cortical bone having the direction dependence of the evoked potential generated by the ultrasonic waves. The ultrasonic wave irradiation direction is set, which will be described in detail later.

The irradiation device 21 has a cylindrical shape, and the bottom surface has a shape along the side surfaces of the extremities. However, the irradiation instrument 21 may have any shape.

As shown in FIG. 2B, when the bottom surface of the irradiation instrument 21 is brought into contact with the side surfaces of the extremities, ultrasonic waves are incident on the surface of the cortical bone 71 at an incident angle θ1 with respect to Radial in the axial-radial plane. It is irradiated. Further, as shown in FIG. 2C, when the bottom surface of the irradiation instrument 21 is brought into contact with the side surfaces of the extremities, the ultrasonic waves of the cortical bone 71 at a predetermined angle φ1 with respect to Axial within the axial-tangential plane. It propagates on the surface and reaches the fracture site 70 of the cortical bone 71.

Here, the incident angle θ1 corresponds to the critical angle from the soft tissue to the cortical bone 71. As an example, when the speed of sound in soft tissue is 1500 m/s and the speed of sound in cortical bone is 4000 m/s, the critical angle is about 22°. In practice, the critical angle is determined by the speed of sound in soft tissue and the speed of sound in cortical bone, and is not limited to one angle value, but is within a predetermined angle range. Therefore, when the bottom surface of the irradiation device 21 is brought into contact with the side surfaces of the extremities, the irradiation device 21 irradiates ultrasonic waves to the surface of the cortical bone 71 at about 22° with respect to Radial within the axial-radial plane. The ultrasonic waves applied to the cortical bone 71 in this way propagate along the surface of the cortical bone 71 and reach the fracture site 70 of the cortical bone 71. However, in the axial-tangential plane, it is not essential that the ultrasonic wave is applied to the surface of the cortical bone 71 at a critical angle with respect to the axial.

Therefore, as shown in FIG. 2(C), the ultrasonic waves of the cortical bone 71 at a predetermined angle φ1 with respect to the axial in the axial-tangential plane along the surface of the cortical bone 71 with respect to the fracture site 70. It propagates on the surface and reaches the fracture site 70 of the cortical bone 71.

FIG. 3 is a diagram showing the magnitude of an evoked potential when positive pressure ultrasonic waves are applied from each direction in the axial-tangential plane. Black circles in the figure represent positive potentials, and white circles represent negative potentials. In the graph shown in FIG. 3, the direction that coincides with Axial is 0°, and the direction that coincides with Tangental is 270°. Further, at the center position of the graph shown in FIG. 3, the potential is 0, and the potential is higher toward the outer periphery.

As shown in FIG. 3, in the Axial-Tangential plane, ultrasonic waves are transmitted from the direction of 45° (45°, 135°, 225° and 315°) with respect to Axial or Tangential toward the intersection of Axial and Tangential. When propagated, the evoked potential becomes the largest (maximum value). Further, when ultrasonic waves are propagated from a direction that coincides with Axial or Tangential, the evoked potential becomes the smallest (becomes the minimum value).

Therefore, when the irradiation instrument 21 abuts the bottom surface of the irradiation instrument 21 on the side surface of the extremity, in the axial-tangential plane, a direction other than the direction in which the ultrasonic waves match the axial and tangential (that is, the cortical bone 71 Ultrasonic waves are propagated from a direction in which an evoked potential larger than the minimum value of the evoked potential is generated (in other words, propagated in the cortical bone 71 around the fractured site 70 and irradiated to the fractured site 70). Is set. In addition, the irradiation instrument 21, when the bottom surface of the irradiation instrument 21 is brought into contact with the side surface of the extremity, in the Axial-Tangential plane, the ultrasonic wave is in the range of 45°±30° with respect to Axial or Tangential (see FIG. 3). It is preferable to set so as to propagate in the direction within the hatched portion). Further, it is most preferred that the ultrasonic waves be propagated in a direction of 45° with respect to the axial or tangential.

FIG. 4A is a perspective view (partially transparent view) at the time of irradiation, FIG. 4B is a side view partially transparent view, and FIG. 4C is a front view.

In FIG. 2, the ultrasonic fracture treatment device 1 (irradiation instrument 21) has a cortex around the fracture site 70 from directions other than the long axis direction and the circumferential direction of the cortical bone 71 which are orthogonal to the radial direction of the cortical bone 71. The bone 71 was set to irradiate ultrasonic waves to propagate through the cortical bone around the bone 71 and indirectly irradiate ultrasonic waves to the fractured site, but it is shown in FIGS. 4(A) to 4(C). As described above, the setting may be made to directly irradiate the bone fracture site 70 with ultrasonic waves. It goes without saying that the same effect as described above can be obtained in this case as well.

As described above, the ultrasonic fracture treatment device can realize a more effective ultrasonic irradiation mode for fracture treatment. However, a person who performs the treatment may manually hold the probe 2 so that the ultrasonic wave propagates from a direction other than the direction in which the ultrasonic wave coincides with the axial and tangential in the axial-tangential plane.

In addition, in FIGS. 2A to 2C, 4A to 4C, and 3, the long axis direction (Axial) of the cortical bone 71 orthogonal to the radial direction (Radial) of the cortical bone 71. Also, an example in which ultrasonic waves are applied to the fracture site 70 from directions other than the circumferential direction (Tangential) has been described, but as will be described later, the cortical bone 71 orthogonal to the circumferential direction (Tangential). The bone fracture site 70 may be irradiated with ultrasonic waves from directions other than the long axis direction (Axial) and the radial direction (Radial).

FIG. 5A is a perspective view (partially transparent view) at the time of irradiation when ultrasonic waves are applied to the fracture site 70 from directions other than Axial and Radial in the Axial-Radial plane. 5(B) is a partially transparent view of a side view, and FIG. 5(C) is a front view.

As shown in FIG. 5(B), when the bottom surface of the irradiation instrument 21A is brought into contact with the side surfaces of the extremities, ultrasonic waves are incident on the surface of the cortical bone 71 at an incident angle θ2 with respect to Radial in the axial-radial plane. It is irradiated. Further, as shown in FIG. 5C, when the bottom surface of the irradiation instrument 21A is brought into contact with the side surfaces of the extremities, ultrasonic waves propagate in the cortical bone 71 along the axial line in the axial-tangential plane.

Here, the incident angle θ2 is set to an angle smaller than the critical angle from the soft tissue to the cortical bone 71. As an example, when the sound velocity in the soft tissue is 1500 m/s and the sound velocity in the cortical bone is 4000 m/s, the incident angle θ2 is set to 15°.

Therefore, when the bottom surface of the irradiation device 21A is brought into contact with the side surfaces of the extremities, the irradiation device 21A irradiates ultrasonic waves to the surface of the cortical bone 71 at 15° with respect to the radial within the axial-radial plane. In this way, the ultrasonic waves applied to the cortical bone 71 travel into the cortical bone, are reflected at the interface with the cancellous bone or bone marrow, propagate in the axial direction while being reflected in the cortical bone 71, and reach the fracture site 70. It is irradiated against.

Therefore, as shown in FIG. 5C, the ultrasonic wave propagates to the fracture site 70 at a predetermined angle φ2 with respect to the radial within the axial-radial plane and is applied to the fracture site 70. ..

FIG. 6 is a diagram showing the magnitude of an evoked potential when a positive pressure ultrasonic wave is propagated from each direction in the Axial-Radial plane. Black circles in the figure represent positive potentials, and white circles represent negative potentials. In the graph shown in FIG. 3, the direction that coincides with Axial is 0°, and the direction that coincides with Radial is 90°. Further, at the center position of the graph shown in FIG. 5, the potential is 0, and the potential becomes higher toward the outer periphery.

As shown in FIG. 6, even in the Axial-Radial plane, ultrasonic waves were applied from the direction of 45° (45°, 135°, 225°, and 315°) with respect to Axial or Radial toward the intersection of Axial and Radial. Is propagated, the evoked potential becomes maximum (maximum value). Further, when ultrasonic waves are propagated from the direction that coincides with Axial or Radial, the evoked potential becomes the smallest (it becomes the minimum value).

Therefore, when the irradiation device 21A abuts the bottom surface of the irradiation device 21A against the side surface of the extremity, in the Axial-Radial plane, a direction other than the direction in which the ultrasonic waves match the axial and radial directions (that is, the cortical bone 71 The ultrasonic waves are set to propagate from a direction in which an evoked potential larger than the minimum evoked potential is generated). When the bottom surface of the irradiation device 21A is brought into contact with the side surfaces of the extremities, the irradiation device 21A causes ultrasonic waves to fall within a range of 45°±30° with respect to Axial or Radial in the axial-radial plane ( It is preferably set so as to be propagated by (see the hatched portion in FIG. 6). Further, it is most preferable that the ultrasonic waves are propagated in a direction of 45° with respect to the axial or radial.

FIG. 7(A) is a perspective view (partially transparent view) at the time of irradiation, FIG. 7(B) is a side view partially transparent view, and FIG. 4(C) is a front view.

In FIG. 7, the ultrasonic fracture treatment device 1 (irradiation instrument 21) is arranged around the fracture site 70 from a direction other than the long axis direction and the radial direction of the cortical bone 71 orthogonal to the circumferential direction of the cortical bone 71. Although ultrasonic waves are radiated in the cortical bone 71 and propagated through the cortical bone 71 around the cortical bone 71, the ultrasonic waves are indirectly radiated to the fracture site 70, but FIGS. As shown in C), the bone fracture site 70 may be directly irradiated with ultrasonic waves. It goes without saying that the same effect as described above can be obtained in this case as well.

Next, FIG. 8(A) is a side view partially transparent view of the irradiation instrument 21B according to the application example, and FIG. 8(B) is a top view. The irradiation device 21B is different from the irradiation device 21 of FIGS. 2A to 2C in that it further includes a position confirmation unit 201. Other configurations are the same as those of the irradiation device 21 of FIGS. 2(A) to 2(C).

The position confirmation unit 201 is formed of a flat plate-shaped member extending from the side surface of the irradiation instrument 21B on the bottom surface side. A plurality of holes 215 having a predetermined shape (X shape in this example) are provided on the upper surface of the position confirmation unit 201. The person who performs the treatment marks the fractured part of the user with a predetermined shape (X shape in this example), and brings the irradiation instrument 21B into contact with the user's limbs or the like. The person who performs the treatment moves the irradiation device 21B to a position where the mark can be seen through the holes 215.

Since the thickness of the soft tissue varies from person to person, the position at which the irradiation tool 21B abuts varies from person to person. However, the position confirmation unit 201 is provided with a plurality of holes 215. Each hole 215 corresponds to the thickness of the soft tissue (for example, 3 mm, 5 mm, 7 mm, etc.). The person performing the treatment adjusts the position of the irradiation instrument 21B so that the ultrasonic wave is appropriately irradiated to the fractured part by aligning a mark with any of the holes 215 according to the thickness of the soft tissue. You can

In addition, FIG. 8C is a side view partially transparent view of the irradiation instrument 21C according to the application example, and FIG. 8D is a top view. The irradiation device 21C is different from the irradiation device 21A in FIGS. 5A to 5C in that the irradiation device 21C further includes a position confirmation unit 201. Other configurations are the same as those of the irradiation device 21A in FIGS. 5(A) to 5(C). Also in this case, the position of the irradiation instrument 21C can be adjusted so that the ultrasonic wave is appropriately irradiated to the fractured part.

Next, FIG. 9 is a perspective view (partially transparent view) at the time of irradiation when the probe 2A including a plurality of ultrasonic elements is used. The probe 2A is different from the probe 2 in that it includes a plurality of ultrasonic elements, and the other configurations are similar to those of the probe 2. In this case, the ultrasonic waves propagating in the cortical bone 71 are multiply reflected and propagate to the fracture site 70. Therefore, fracture treatment can be performed more effectively.

Next, FIG. 10(A) is a block diagram showing a main configuration of an ultrasonic fracture treatment device 1A including an array element, and FIG. 10(A) shows a perspective view (partially transparent view) at the time of irradiation. FIG. The ultrasonic fracture treatment device 1A includes a probe 2B instead of the probe 2 of the ultrasonic fracture treatment device 1. The probe 2B includes an array element including a plurality of ultrasonic elements (in this example, eight ultrasonic elements 21-1, ultrasonic elements 21-2,..., Ultrasonic elements 21-8). Other configurations are similar to those of the ultrasonic fracture treatment device 1.

The control unit 4 of the ultrasonic fracture treatment device 1A adjusts the output timing of ultrasonic waves in each ultrasonic element. As a result, the control unit 4 controls the directivity of the ultrasonic waves output from the probe 2B.

In this case, the irradiation direction setting unit is realized by the plurality of ultrasonic elements controlled by the control unit 4. That is, as shown in FIG. 10(B), the directivity of the ultrasonic wave output from the probe 2B is controlled in a predetermined direction, and therefore, as in the example shown in FIG. 5(A), FIG. 9 or the like. , Propagates at a predetermined angle (for example, 45°) in the axial-radial plane with respect to the fracture site 70. Further, as in the example shown in FIG. 2A and the like, it is possible to adopt a mode in which the bone is propagated at a predetermined angle (for example, 45°) in the axial-tangential plane with respect to the fracture site 70.

Furthermore, the control unit 4 may estimate the inclination angle of the surface of the cortical bone 71 with respect to the surface on which the plurality of ultrasonic elements are arranged, and control the directivity of the ultrasonic waves. The control unit 4 can measure the distance between each ultrasonic element and the cortical bone 71 from the time difference between the timing when the ultrasonic wave is output from each ultrasonic element and the timing when the echo signal is received. Thereby, the control unit 4 estimates the inclination angle of the surface of the cortical bone 71 with respect to the surface on which the plurality of ultrasonic elements are arranged. The control unit 4 adjusts the output timing of each ultrasonic element so that the estimated surface of the cortical bone 71 is irradiated with ultrasonic waves at a predetermined angle.

1, 1A... Ultrasonic fracture treatment device 2, 2A, 2B... Probe 3... Transmitting/receiving section 4... Control section 5... Operation section 6... Indicators 21, 21A, 21B, 21C... Irradiation instrument 70... Fracture site 71... Cortical bone 201... Position confirmation part 21-1, 21-2, 21-8... Ultrasonic element 215... Hole part

Claims (11)

A probe that irradiates ultrasonic waves toward cortical bone including a fracture site,
In the cortical bone having the direction dependence of the evoked potential generated by the ultrasonic waves, a range of an angle of 45°±30° with respect to the long axis direction or the circumferential direction of the cortical bone orthogonal to the radial direction of the cortical bone. From a direction inside, irradiate the ultrasonic waves to the fracture site, an irradiation direction setting unit that sets the ultrasonic irradiation direction of the probe,
An ultrasonic fracture treatment device comprising: The ultrasonic fracture treatment device according to claim 1, wherein
The irradiation direction setting unit, directly to to irradiate the ultrasonic wave relative to the fracture site, or propagated in the cortical bone of the surrounding by irradiating the ultrasonic waves to the cortical bone around the fracture site An ultrasonic fracture treatment device characterized in that the ultrasonic wave is indirectly applied to the fracture site. The ultrasonic fracture treatment device according to claim 2,
The irradiation direction setting unit,
When irradiating the fracture site with the ultrasonic wave indirectly, the probe is located on the surface of the soft tissue around the cortical bone, and the ultrasonic wave is incident from the soft tissue to the surface of the cortical bone. An ultrasonic fracture treatment device that sets the angle to a critical angle. In ultrasound fracture treatment device according to any one of claims 1 to 3,
The irradiation direction setting unit,
An ultrasonic fracture treatment device for irradiating the fracture site with the ultrasonic waves from a direction at an angle of 45° with respect to the long axis direction or the circumferential direction. A probe that irradiates ultrasonic waves toward cortical bone including a fracture site,
In the cortical bone having the direction dependence of the evoked potential generated by the ultrasonic waves, a range of an angle of 45°±30° with respect to the long axis direction or the radial direction of the cortical bone orthogonal to the circumferential direction of the cortical bone. From a direction inside, irradiate the ultrasonic waves to the fracture site, an irradiation direction setting unit that sets the ultrasonic irradiation direction of the probe,
An ultrasonic fracture treatment device comprising: The ultrasonic fracture treatment device according to claim 5 ,
The irradiation direction setting unit, directly to to irradiate the ultrasonic wave relative to the fracture site, or propagated in the cortical bone of the surrounding by irradiating the ultrasonic waves to the cortical bone around the fracture site The ultrasonic fracture treatment device characterized by indirectly irradiating the ultrasonic wave to the fracture site. The ultrasonic fracture treatment device according to claim 6,
The irradiation direction setting unit,
When irradiating the fracture site with the ultrasonic wave indirectly, the probe is located on the surface of the soft tissue around the cortical bone, and the ultrasonic wave is incident from the soft tissue to the surface of the cortical bone. An ultrasonic fracture treatment device that sets the angle to a lower angle than the critical angle. The ultrasonic fracture treatment device according to any one of claims 5 to 7 ,
The irradiation direction setting unit is an ultrasonic fracture treatment device for applying the ultrasonic waves to the fracture site from a direction of an angle of 45° with respect to the long axis direction or the radial direction. The ultrasonic fracture treatment device according to any one of claims 1 to 8 ,
An ultrasonic fracture treatment device comprising a position confirmation unit for arranging the probe at a position corresponding to the position of the fracture site on the surface of the soft tissue around the cortical bone. The ultrasonic fracture treatment device according to any one of claims 1 to 9 ,
The probe includes a plurality of ultrasonic elements,
The ultrasonic fracture treatment device in which the irradiation direction setting unit controls the output timing of ultrasonic waves from the ultrasonic elements to irradiate the ultrasonic waves to the fracture site. The ultrasonic fracture treatment device according to any one of claims 1 to 10 ,
The irradiation direction setting unit estimates the inclination angle of the surface of the cortical bone with respect to the ultrasonic irradiation surface of the probe, and sets the ultrasonic irradiation direction by the probe.

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