JP2003210546A - Therapeutic apparatus for osteochondrosis - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To accomplish the shortening of the period of preservation therapy and avoid treatment and operation of cases showing no reaction to the preservation therapy by promoting repairs of affected sites of the osteochondrosis. <P>SOLUTION: The therapeutic apparatus for osteochondrosis is provided with an ultrasonic treatment head module which has an ultrasonic transducer built therein and irradiates head parts of joint bones of patients suffering osteochondrosis with ultrasonic waves, a control means for controlling the ultrasonic waves, and a joint fixing means which has functions of fixing joint parts of the osteochondrosis patients at specified angles while fixing the ultrasonic treatment head module at a joint part. <P>COPYRIGHT: (C)2003,JPO

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to an epiphyseal treatment device. More specifically, ultrasonic irradiation accelerates the repair of the damaged parts of Osgood-Schlatter disease and sports elbows (baseball elbow, tennis elbow, etc.), thereby shortening the treatment period or performing invasive surgery. It relates to a device to avoid.

[0002]

2. Description of the Related Art It is empirically believed that mechanical stimuli are effective for healing fractures, and various researchers have experimentally and clinically examined them. Oxford University Kenw
right et al., a method of repeatedly giving axial compression stimulation (0.5 Hz (= 600 times) 1 mm micromotion in the bone longitudinal axis direction for 20 minutes a day) directly to the fracture with an external fixator, with a significant difference. It has been reported that bone union was promoted (J Bone Joint Surg B
r 73 (4): 654-659, 1991).

Duarte believes that it is possible to non-invasively promote bone formation by utilizing mechanical stimulation to bone tissue by ultrasonic waves, and from 1980 to 1985, Duarte used an animal model to develop a super treatment suitable for treatment. The conditions of sound waves were examined. Part of this study was published in 1983 as a result of low-intensity ultrasound pulses applied to a rabbit osteotomy model that promoted the normal bone repair process (Arch Orthop Trauma Surg, 101: 1
53-159, 1983). In addition, Xavier and Duarte reported that in 1983, 27 patients in humans were irradiated with low-intensity ultrasound pulses, which accelerated the normal fracture repair process and could also induce nonunion healing (Rev Brasil Ortop, 18: 73-80, 19
83).

Thereafter, a basic patent from Duarte (US Pat. No. 4,
530,360) licensed by Exogen Inc. of the United States, developed the ultrasonic fracture treatment machine Safes ^TM (SAFHS ^TM ),
In a clinical study, tibial shaft fracture (Heckman et al .: J
Bone and Jiont Surg, 76A: 25-34, 1994) and distal radius fracture (Kristiansen et al .: J Bone and Joint Surg.
g, 79A: 961-973, 1997).

[0005] Incidentally, it was revealed in an experiment using dogs that local blood flow was increased by irradiating the fracture site with Safes ^™ ultrasonic waves (Goldberg et al. Presented at the American Radiological Society, 1997/11). ). In addition, when looking at effective cases for refractory fractures in the United States and Europe, it was introduced that it was effective in cases of pseudoarthrosis due to inadequate blood circulation, and "promotion of blood circulation" was assumed as an important mechanism. Has been done. further
In a series of experiments, Bolander and Ryaby et al. Suggest that Safes ^™ ultrasound has a direct effect on bone formation and resorption, non-collagen protein synthesis, and expression of the collagen phenotype.

[0006] As described above, Safex ^™ promotes the osteogenic reaction of the adult, and thus may be applicable to the treatment of epiphysis.

[0007] Epiphysis is an ischemic osteonecrosis that occurs in the epiphyseal nucleus (secondary bone nucleus) of the long bone, the primary bone nucleus of the short bone, or the bone process during development. The following three groups depending on the type of external force applied to the nucleus and bony processes: 1) Crushing type (Keanbeck disease, Perthes disease, etc.), 2) Shearing type (baseball elbow, sports elbows such as tennis elbow, etc.), 3) Traction type. (Osgood-Schlatter disease, etc.)

[0008]

Conservative therapies such as exercise restriction are mainly used for the treatment of epiphysis, but sometimes the conservative therapies are not effective and surgical treatment is also performed. INDUSTRIAL APPLICABILITY The present invention makes it possible to shorten the period of conservative therapy, treat cases that do not respond to conservative therapy, and avoid surgery by promoting the repair of damaged parts of epiphysis.

[0009]

[Means for Solving the Problems] As a result of intensive studies on the above problems, the present inventors have found that the repair of epiphysis is promoted by applying mechanical / mechanical stimulation to a damaged part of the epiphysis. The heading has arrived at the present invention.

That is, the present invention provides an ultrasonic therapeutic head module which incorporates an ultrasonic transducer and radiates ultrasonic waves to the joint head of a patient with epiphysis, control means for controlling the ultrasonic wave, and epiphysis. The present invention provides an epiphyseal treatment device including a joint fixing means having a function of fixing a joint part of a diseased patient at a predetermined angle and fixing the ultrasonic treatment head module to the joint part.

Further, according to the present invention, the control means is means for controlling the output of the ultrasonic pulse from the ultrasonic transducer, and the ultrasonic frequency is 20 kHz to 10 MH.
z, burst width 10 μsec to 1 msec, repetition period 5 Hz to 10 kHz, ultrasonic output 5 to 75 mW
/ Cm ² range, especially ultrasonic frequency of 1.5
The present invention provides a device for treating epiphysis, which is means for controlling the output of ultrasonic waves in the range of MHz, burst width of 200 μsec, repetition cycle of 1.0 kHz, and ultrasonic wave output of 30 mW / cm ^2. .

The present invention further provides a device for treating epiphysis, which is a device applied to the joint site of a patient with Osgood-Schlatter disease or sports elbow.

[0013]

BEST MODE FOR CARRYING OUT THE INVENTION According to the present invention, by irradiating an injured site of epiphysis with ultrasonic waves, a mechanical / mechanical stimulus (mechanical stress) having a certain pattern is applied to the affected site to repair the injured site. Is an epiphyseal treatment device characterized by promoting the following.

The following is an example of the embodiment of the treatment for epiphysis of the present invention. The epiphyseal treatment device of the present invention has a built-in ultrasonic transducer, an ultrasonic treatment head module for irradiating ultrasonic waves to the joint head of a patient with epiphysis, a control means for controlling the ultrasonic wave, The joint fixing means has a function of fixing the joint part of the epiphyseal patient at a predetermined angle and fixing the ultrasonic treatment head module to the joint part.

Such an ultrasonic transducer is made of piezoelectric ceramic, and by utilizing the property that minute distortion is generated when a voltage is applied, an electric signal produced by an ultrasonic waveform synthesizer is applied to the piezoelectric ceramic of the transducer, Vertical vibration (ultrasonic wave) is created on the transducer surface.

The ultrasonic waves used are low-power ultrasonic pulses, the ultrasonic frequency is 20 kHz to 10 MHz, the burst width is 10 μsec to 1 msec, and the repetition period is 5 Hz.
A therapeutic effect of 10 kHz and an ultrasonic output of 5 to 75 mW / cm ² can be expected. Among them, the ultrasonic frequency is 1.5 MHz, the burst width is 200 μsec, and the repetition cycle is 1.0 kHz. It is preferable that the ultrasonic output is 30 mW / cm ² .

The control means has an ultrasonic waveform synthesizing function for synthesizing the ultrasonic waves emitted from the ultrasonic transducer, output control, storage / calculation means, and power ON / OFF control function. Each function may be integrated in the ultrasonic treatment head module or may be divided into the ultrasonic treatment head module and the main body.

[0018]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS An example in which the epiphyseal treatment device of the present invention is divided into a main body portion and an ultrasonic treatment head module will be described below with reference to the drawings.

[Embodiment 1] The external appearance of the epiphyseal treatment apparatus of the present invention comprises a main body and an ultrasonic treatment head module as shown in FIG. [Main body] The main body is, as shown in FIG.
Consists of input / output devices.

1) Power source: The battery uses a high capacity type lithium battery which cannot be charged. There is no power switch, the power is turned on by operating the front panel, and the power is automatically turned off when 20 minutes of treatment is completed. Further, the ultrasonic wave is not output unless the start button is pressed twice so that the ultrasonic wave is not output due to an erroneous operation. The treatment head is also supplied with power from the same battery.

2) Memory arithmetic unit: CPU on the printed circuit board
It is equipped with a (central control unit) and not only manages the treatment time, but also monitors the operation and mounting state of the treatment head and performs self-diagnosis. In addition, the backup memory stores the patient's treatment record and is designed so that it can be retrieved as needed.

3) Input / output device: In addition to the operation switch, liquid crystal display panel and buzzer, the treatment head module is controlled and power is supplied through the connection cable. As the control signal for the treatment head module, ultrasonic pulse burst width 20
A signal with 0 Hz and a repetition period of 1 KHz is sent. Also, a trouble signal is sent back from the treatment head. [Ultrasonic Treatment Head Module] As shown in FIG. 3, the ultrasonic treatment head module includes an oscillating device, an ultrasonic waveform synthesizing device, an ultrasonic wave generating device, and a detecting device. The connection cable to the main body is an integrated type.

1) Oscillator: Generates an ultrasonic signal of 1.5 MHz.

2) Ultrasonic waveform synthesizer: The control signal from the main body and the 1.5 MHz ultrasonic signal are synthesized to produce therapeutic ultrasonic waves, that is, ultrasonic frequency: 1.5 MHz, ultrasonic output: 30 mW / cm ² ,
An electric signal having a waveform having a burst width of 200 μsec and a repetition frequency of 1 kHz is generated.

3) Ultrasonic wave generator: The piezoelectric ceramic has a property that a minute distortion occurs when a voltage is applied. Utilizing this, an electric signal generated by an ultrasonic waveform synthesizer is applied to the piezoelectric ceramic inside the transducer, and vertical vibrations (ultrasonic waves) are generated on the transducer surface for therapeutic application. An ultrasonic absorber is attached to the back surface of the piezoelectric ceramic to prevent ultrasonic leakage.

4) Abnormality detection device: The treatment head detects the fixation to the fixture and the shortage of the jelly for ultrasonic conduction and transmits it to the main body, and the liquid crystal display and alarm warn the patient. In order to detect improper fixation between the treatment head and the fixture, the physical contact of the fixed portion is judged by the presence or absence of conductivity. The detection of jelly deficiency
The change in the resonance state of the ultrasonic transducer due to the lack of jelly is detected by detecting that the drive current is higher than usual. [Treatment Method] For the arm or knee joint of patients with epiphysis,
The ultrasonic treatment head module is applied to the skin of the joint site once a day for 20 minutes, and ultrasonic waves are emitted. When treating
Usually, a fixture for fixing an arm or a knee is attached with the joint bent substantially at a right angle, and a treatment site is provided by providing an attachment site for the ultrasonic treatment head module on the fixture. As such a fitting, the joint fitting described in WO00 / 47142 can be used.

[Example 2] Using the epiphyseal treatment apparatus described in Example 1 above, the therapeutic effect on a patient with Osgood-Schlatter disease was confirmed.

(Purpose) Osgood-Shratter disease (Osgood-S), which is often treated as a sports disorder during growth
The prognosis of chlatter disease (OSD) is relatively good, but there are some cases in which remission is repeated and treatment is often difficult. Here, we confirmed the therapeutic effect of low-power ultrasound pulses on OSD that resists conservative therapy.

[Target] OSD who visited the hospital from 1999 to 2013
Among patients, after resisting conservative therapy for more than half a year, they were treated using the epiphyseal treatment device of the present invention. Targeting 9 knees and 12 knees, 8 boys have 11 knees, and 1 female has 1 knee.
The average age was 13.1 years. The period from the onset to the start of treatment with the epiphyseal treatment device of the present invention is 6 months to 3.5 years, average
It was 1.4 years, and the treatment period was 2 to 6 months, with an average of 3.6 months.

(Results) Regarding pain, it was possible to return to sports by eliminating or reducing pain in 11 out of 12 knees. Radiographically, 8 of 12 knees showed bridging in the detached part of the tibial rough surface, but 3 of them had epiphys
The expansion of the bone transparent region along is was recognized. X-ray bridging was not observed in the other 3 knees, and the bone clear area along epiphysis was enlarged, and the progression of OSD was suspected on the X-ray. No change on X-ray was observed in one knee.

(Conclusion) The apparatus for treating epiphysis of the present invention is an OS
For the case of D, the therapeutic effect was also confirmed by X-ray. Further, even in the case where the therapeutic effect was not confirmed by X-ray radiology, clinical symptoms such as pain disappearance and alleviation were shown to be improved.

[Embodiment 3] Using the epiphyseal treatment apparatus described in Embodiment 1 above, the therapeutic effect on a patient with microchondral osteochondral disorders of the humerus, which is a baseball elbow, was confirmed.

(Purpose) Microcapillary cartilage disorder of the humerus is an incurable disease that occurs in baseball players in the growing stage. This time, low power ultrasonic pulse irradiation was performed by the epiphysis treatment device of the present invention to a patient after conservative therapy and transfixation of osteochondral fragments, and the effect was observed.

(Method) Patients are 10.8 to 14.3 years old (average 12.4
(10 years of age), the stages of the disorder were 5 in the early stage, 4 in the advanced stage, and 1 in the terminal stage. SAFESU was irradiated with 90-degree flexion of the elbow joint on the central part of the arm joint for 20 minutes every day.

(Results) There were 4 cases of repair, 2 cases of incomplete repair, 1 case without repair, and 3 cases during follow-up. The average time required for the repair of 3 cases excluding 1 case with elbow trauma during the course was 10 months. This was almost the same as the average treatment period of conservative therapy by only discontinuing pitching, and no clear shortening of the treatment period was observed. However, it is significant that SAFEZ was applied to a case that seemed to stop healing after 1 year of conservative therapy and was repaired in 8 months. Incomplete repair 1
The patient had a tendency to repair but gave up the hope of surgery strongly, and the other one was adapted after transfixation of the osteochondral piece, resulting in a partial bone defect. The terminally ill case with educts also did not heal. One of the three follow-up patients showed a tendency to repair 4 months after the procedure.

[0036]

INDUSTRIAL APPLICABILITY As described above, according to the present invention, the period of conservative therapy is shortened by promoting the repair of the damaged site of epiphysis
It is possible to treat cases that do not respond to conservative therapy and avoid surgery.

[Brief description of drawings]

FIG. 1 is an external view of a device for treating epiphysis of the present invention.

FIG. 2 is a block diagram showing a configuration of a main body portion of the epiphyseal treatment device of the present invention.

FIG. 3 is a block diagram showing the configuration of an ultrasonic treatment head module of the epiphyseal treatment device of the present invention.

   ─────────────────────────────────────────────────── ─── Continued front page    (71) Applicant 502021501             Muneshi Uchida             1-1 Ikugaoka, Yawatanishi-ku, Kitakyushu City, Fukuoka Prefecture             Industrial Medical College (71) Applicant 502021512             Masahiro Tanaka             1-1 Ikugaoka, Yawatanishi-ku, Kitakyushu City, Fukuoka Prefecture             Industrial Medical College (71) Applicant 502021523             Maedagawa             3-chome, Asakawa Gakuendai, Hachiman Nishi-ku, Kitakyushu City, Fukuoka Prefecture             10-8 Maekawa Orthopedics (71) Applicant 502021534             Yosuke Kanazawa             632 Kotoku, Fujiwara-cho, Shioya-gun, Tochigi Prefecture             In the hospital (71) Applicant 502021545             Shinji Kashiguchi             2-50-1 Kuramoto, Tokushima City, Tokushima Prefecture Tokushima University               Inside the medical school (72) Inventor Toshitaka Nakamura             1-1 Ikugaoka, Yawatanishi-ku, Kitakyushu City, Fukuoka Prefecture             Industrial Medical College (72) Inventor Takuji Yamaguchi             1-1 Ikugaoka, Yawatanishi-ku, Kitakyushu City, Fukuoka Prefecture             Industrial Medical College (72) Inventor Muneshi Uchida             1-1 Ikugaoka, Yawatanishi-ku, Kitakyushu City, Fukuoka Prefecture             Industrial Medical College (72) Inventor Masahiro Tanaka             1-1 Ikugaoka, Yawatanishi-ku, Kitakyushu City, Fukuoka Prefecture             Industrial Medical College (72) Inventor Kazumi Maekawa             3-chome, Asakawa Gakuendai, Hachiman Nishi-ku, Kitakyushu City, Fukuoka Prefecture             10-8 Maekawa Orthopedics (72) Inventor Yosuke Kanazawa             632 Kotoku, Fujiwara-cho, Shioya-gun, Tochigi Prefecture             In the hospital (72) Inventor Shinji Kashiguchi             2-50-1 Kuramoto, Tokushima City, Tokushima Prefecture Tokushima University               Inside the medical school F-term (reference) 4C074 AA03 AA04 AA05 BB05 CC03                       CC11 CC17 DD05 EE05 HH09                       RR10

Claims (5)

[Claims] 1. An ultrasonic therapy head module, which incorporates an ultrasonic transducer and irradiates ultrasonic waves to a condylar head region of an epiphyseal patient, control means for controlling the ultrasonic wave, and An epiphyseal treatment device comprising a joint fixing means having a function of fixing a joint part at a predetermined angle and fixing the ultrasonic treatment head module to the joint part. 2. The epiphysis treatment device according to claim 1, wherein the control means is means for controlling output of ultrasonic pulses from the ultrasonic transducer. 3. The ultrasonic wave frequency of the control means is 20 kHz.
z-10 MHz, burst width 10 μsec-1 mse
3. The epiphyseal treatment device according to claim 2, which is a means for controlling the output of ultrasonic waves in the range of c, a repetition cycle of 5 Hz to 10 kHz, and an ultrasonic wave output of 5 to 75 mW / cm ² . 4. The control means has an ultrasonic frequency of 1.5M.
4. The epiphyseal treatment device according to claim 3, which is a means for controlling the output of ultrasonic waves in the range of Hz, burst width of 200 μsec, repetition period of 1.0 kHz, and ultrasonic wave output of 30 mW / cm ² . 5. The device comprises Osgood-Schlatter disease,
Alternatively, the epiphyseal treatment device according to any one of claims 1 to 4, wherein the device is applied to a joint site of a sports elbow patient.