WO2016037357A1

WO2016037357A1 - Postpartum rehabilitation device

Info

Publication number: WO2016037357A1
Application number: PCT/CN2014/086417
Authority: WO
Inventors: 敬李; 谭普; 毛爱华; 杨征; 张懿; 何伟
Original assignee: 重庆海扶医疗科技股份有限公司
Priority date: 2014-09-12
Filing date: 2014-09-12
Publication date: 2016-03-17

Abstract

Disclosed is a postpartum rehabilitation device, comprising a handle (17) and an ultrasonic treatment head located at the end region of the handle (17), wherein the ultrasonic treatment head comprises a housing (12), wherein an ultrasonic transducer (26) used for sending ultrasound waves to the uterus of a puerpera is provided in the housing (12), and a first anti-ultrasonic radiation structure (13) used for preventing ultrasound waves from penetrating from the housing (12) is also provided in the housing (12), wherein the first anti-ultrasonic radiation construction (13) comprises a plurality of acoustic resistance layers successively located at the side region of the ultrasonic transducer (26), and two adjacent acoustic resistance layers are respectively made of two kinds of material with a natural impedance Z ratio being greater than 1, wherein Z=ρv, ρ being the density of the materials, and v being the spreading velocity of the ultrasonic in the material; the focal plane distance of the ultrasonic transducer (26) is 5 mm - 100 mm, the working frequency is 0.1 MHz - 5 MHz, and the output power density is greater than 0 W/cm² but less than or equal to 5 W/cm². Using the postpartum rehabilitation device for women's postpartum rehabilitation achieves a non-invasive and good rehabilitation efficacy.

Description

Postpartum rehabilitation equipment

Technical field

The invention belongs to the technical field of medical equipment, and particularly relates to a post-natal rehabilitation equipment.

Background technique

After the production of women of childbearing age, there are generally some requirements for assisted rehabilitation, such as uterine involution, relief of postpartum pain. In the prior art, uterine involution is usually carried out by injecting oxytocin, orally or using proprietary Chinese medicine, massage massage, and low frequency electrical stimulation. Among them, injection of oxytocin is the most commonly used way to promote uterine contraction in the clinic, but when the oxytocin receptor site is saturated, excessive doses of oxytocin will not have a corresponding effect, but may cause vasodilation, blood pressure. Decreased, etc., may even have antidiuretic effects, serious water intoxication; oral or use of proprietary Chinese medicines can also help to reduce contractions, overall conditioning, but due to individual differences in different maternal, resulting in slow-acting Chinese patent medicine; Massage and massage is a traditional and simple method to promote postpartum uterine contraction, but because artificial massage can not be unified and standardized in terms of massage time, speed, strength, technique, etc., it is often difficult to ensure the desired effect, and the maternal postpartum rest and rest can be restored. Affected; low-frequency electrical stimulation can be applied to the maternal ankle by low-frequency electrical impulses, thereby promoting pelvic muscle contraction, increased fascial tension, driving uterine ligament movement, eliminating pelvic congestion, promoting lochia discharge, but due to low-frequency electrical stimulation of tissue wear Poor permeability, can only act on superficial muscles, so it is difficult to reach the uterus Period effect.

Since the existing post-natal rehabilitation techniques are not satisfactory, it is urgent to find a safer and more effective post-natal rehabilitation method.

Summary of the invention

The technical problem to be solved by the present invention is to provide a post-natal rehabilitation device with no trauma and good rehabilitation effect in view of the above-mentioned deficiencies existing in the existing post-natal rehabilitation technology.

The technical solution adopted to solve the technical problem of the present invention is that the post-natal rehabilitation device comprises a handle and an ultrasonic treatment head disposed at an end of the handle, the ultrasonic treatment head comprising an outer casing having an ultrasonic transducer for transmitting ultrasonic waves to the maternal uterus Wherein the first anti-ultrasonic radiation structure for preventing the ultrasonic wave from escaping from the outer casing is further disposed in the outer casing, the first anti-ultrasonic radiation structure includes a plurality of sound-insulating layers, and the plurality of sound-insulating layers are in the ultrasonic layer The sides of the transducer are sequentially arranged, and the adjacent two sound-insulating layers are respectively made of two materials having a characteristic impedance Z ratio greater than 1, wherein Z=ρv, ρ is the density of the material, and v is the ultrasonic wave in the material. The speed of internal propagation; the focal plane distance of the ultrasonic transducer is 5 mm to 100 mm, the operating frequency is 0.1 MHz to 5 MHz, and the output power density is greater than 0 W/cm ^{2 and} less than or equal to 5 W/cm ² .

Wherein, the focal plane distance refers to the distance between the end face of the ultrasonic emission window of the ultrasonic treatment head (such as the outer surface of the sound-permeable membrane) and the focal plane of the ultrasonic treatment head.

Preferably, the ultrasonic transducer has an operating frequency of 0.7 MHz to 1 MHz, and the ultrasonic transducer has a focal plane distance of 20 mm to 60 mm.

Further preferably, the ultrasonic transducer is configured to emit a pulsed ultrasonic wave to the maternal uterus; the ultrasonic transducer has an output power density of between 1 W/cm ² and 5 W/cm ² , and the duration of the pulsed ultrasonic wave is greater than 0ms is less than or equal to 400ms, and the on-off time ratio of ultrasonic waves is between 1:20 and 1:2.

It is further preferred that the ultrasonic transducer is configured to emit continuous ultrasonic waves to the maternal uterus; the ultrasonic transducer has an output power density greater than 0 W/cm ^{2 and} less than or equal to 1 W/cm ² .

Preferably, in the plurality of sound-blocking layers of the first anti-ultrasonic radiation structure, two adjacent sound-blocking layers are respectively made of any two materials having a characteristic impedance Z ratio greater than or equal to 5 and less than or equal to 20. to make.

The reason why the adjacent two sound-blocking layer materials are selected as described above is that if the characteristic impedance Z between the adjacent two sound-insulating layers has a large difference, the ultrasonic waves emitted by the ultrasonic transducer sequentially pass through the When two adjacent sound-blocking layers made of a material having a large difference in characteristic impedance Z are used, the sound intensity of the ultrasonic wave is greatly attenuated.

More preferably, in the plurality of sound-blocking layers of the first anti-ultrasonic radiation structure, the wall thickness of each of the sound-insulating layers is respectively a product of a wavelength of ultrasonic waves propagating in the sound-blocking layer and 0.25n, wherein n is an odd number.

The reason for setting the wall thickness of each sound barrier layer is as follows:

In physics, the sound transmission coefficient of sound waves from the first material into the second material adjacent to it and then back to the first material

Where D is the thickness of the second material, R ₁₂ = Z ₁ / Z ₂ , R ₂₁ = Z ₂ / Z ₁ (Z is the characteristic impedance, and Z ₁ is the characteristic impedance of the first material, Z ₂ is the first Characteristic impedance of the two materials),

ω=2πf, where C is the speed of sound of the sound wave in the second material, and f is the frequency of the sound wave,

λ is the wavelength at which the acoustic wave propagates in the second material, ie

When Z ₁ <<Z ₂ (a difference of more than 5 times), and which is

Time (where N is a natural number), the transmission coefficient t1≈0, that is, the sound wave cannot be transmitted, and the sound wave cannot enter the second material from the first material, and

When the transmission coefficient t1≈1, that is, the sound wave is totally transmitted, the sound wave can completely enter the second material from the first material, so in the design, avoiding

The thickness and its close size make it difficult for sound waves to propagate from the first material to the second material.

Combining the above theory into the ultrasonic treatment head of the post-natal rehabilitation device of the present invention, if the wall thickness of each of the sound-insulating layers in the ultrasonic treatment head is to satisfy the product of the wavelength of the ultrasonic wave propagating in the sound-blocking layer and 0.25n, wherein When n is an odd number (ie, an odd multiple of a quarter wavelength), the ultrasonic wave is transmitted in any two adjacent sound-blocking layers of the above size, and a transmission coefficient t1≈0 occurs, thereby effectively preventing ultrasonic radiation. (The sound intensity of the ultrasonic waves) is transmitted from the ultrasonic treatment head.

Preferably, the housing has a transducer support for supporting the ultrasonic transducer, and the sound-proof layer of the first anti-ultrasonic radiation structure is two, and the two sound-insulating layers are set on the transducer. a first damper ring on the support member and a second damper ring disposed on the first damper ring, the outer casing being sleeved on the second damper ring.

Preferably, in the transducer support member, the first sound-blocking ring, the second sound-blocking ring and the outer casing, each of the two adjacent components is respectively made of a metal material, a non-metal material, a liquid material, and a gas material. Any two materials having a ratio of impedance Z greater than or equal to 5 and less than or equal to 20 are made.

It is further preferred that the wall thickness of each of the sound-insulating layer/housing in the first anti-ultrasonic radiation structure is set to a wavelength at which the ultrasonic wave propagates within the sound-insulating layer/housing and 0.25n*{1±[0-20%] The product of }, where n is an odd number.

More preferably, the second anti-ultrasonic radiation structure is further included in the outer casing, and the second anti-ultrasonic radiation structure comprises one or more sub-resistive sound layers disposed at a position where the outer casing is connected with the handle, and the axis of the ultrasonic treatment head can be vertical Passing through the plane of the secondary acoustic shielding layer; when the second anti-ultrasonic radiation structure comprises a plurality of secondary acoustic impedance layers, each adjacent two secondary acoustic impedance layers are respectively made of two materials having a characteristic impedance Z ratio greater than one. to make.

Preferably, the second anti-sonic radiation structure comprises two sub-resistance sound layers arranged in sequence, and the two sub-resistance sound layers are respectively a fourth sound-blocking ring in contact with the end of the first anti-ultrasonic radiation structure, and a third sound-blocking ring of the fourth sound-blocking ring, the handle is fixedly connected with the third sound-blocking ring, and each of the fourth sound-blocking ring, the third sound-blocking ring and the handle They are respectively made of any two materials having a characteristic impedance Z ratio greater than or equal to 5 and less than or equal to 20.

It is further preferred that the wall thickness of each of the sound-insulating layers in the second anti-ultrasonic radiation structure is respectively the product of the wavelength of the ultrasonic wave propagating in the sound-blocking layer and 0.25n*{1±[0-20%]}. Where n is an odd number.

Preferably, the post-natal rehabilitation device further comprises a uterine contraction measuring unit for measuring a uterine contraction condition of the mother; and a uterine contraction signal processing circuit connected to the uterine contraction measuring unit, the uterine contraction signal processing circuit including An amplification circuit connected to the contraction measurement unit, a filter circuit connected to the amplification circuit, and an analog-to-digital conversion circuit connected to the filter circuit.

Preferably, the uterine contraction measuring unit is a pressure sensor for measuring the pressure generated by uterine contractions.

Wherein, the contraction measuring unit and the contraction signal processing circuit are connected by a shielding wire.

The post-natal rehabilitation device also includes an electrical stimulation unit for electrically stimulating uterine involution of the mother; and/or a pneumatic massage unit for massaging the mother.

The post-natal rehabilitation device of the present invention has an ultrasonic transducer capable of emitting ultrasonic waves at a specific frequency, power density (i.e., ultrasonic sound intensity), and focal plane distance. When the ultrasound treatment is placed on the projection surface of the uterine fundus surface of the human body surface, the distance of the focal plane can ensure that the focus of most of the maternal ultrasound can be located at the uterus to improve the healing effect; and the frequency and power density Ultrasound can directly stimulate the maternal uterus, causing rhythmic contraction of uterine smooth muscle, thereby promoting uterine involution; at the same time, the above frequency and power density of ultrasound also has the effect of relieving pain in the human body, thereby reducing postpartum pain and accelerating postpartum rehabilitation; In addition, the ultrasonic wave emitted by the post-natal rehabilitation device of the present invention can be introduced into the body from outside the body without damaging the skin, and is a non-invasive rehabilitation technique, which does not bring pain to the mother.

The post-natal rehabilitation device of the present invention has an anti-ultrasonic radiation structure, and utilizes ultrasonic waves to have a large difference in characteristic impedance Z, that is, a sound-transmitting property transmitted between completely mismatched materials (for example, ultrasonic waves enter a characteristic impedance from a material having a large characteristic impedance. When a small material enters a material with a large characteristic impedance and the thickness of the intermediate layer is an odd multiple of an ultrasonic wave at a quarter of the wavelength of the layer, the ultrasonic wave will have a large attenuation, which can effectively prevent the ultrasonic wave. Propagation between materials having a large difference in characteristic impedance, thereby being able to effectively prevent unwanted or excessive ultrasonic radiation from escaping from the sidewall of the ultrasonic treatment head, and effectively preventing ultrasonic radiation from being applied along the handle of the ultrasonic treatment head Conducted to the operator to ensure the safety of the operator.

By making the wall thickness of each of the sound-insulating layers in the anti-ultrasonic radiation structure a characteristic size of a wavelength of ultrasonic waves propagating in the sound-blocking layer and a product of 0.25 n (n is an odd number), ultrasonic radiation can be further prevented from being The side wall and handle of the ultrasonic treatment head are exposed.

The ultrasonic treatment head in the post-natal rehabilitation device of the present invention can substantially block the ultrasonic radiation emitted by the ultrasonic transducer of any power range, because when the ultrasonic radiation emitted by the ultrasonic transducer is transmitted from the ultrasonic treatment head, The number of layers of the sound-damping layer on the side of the transducer (ie, increasing the number of layers of the sound-damping layer in the first anti-ultrasonic radiation structure), and the resistance between the sound-blocking layer disposed on the outermost side of the ultrasonic transducer and the handle The number of layers of the layer (ie, increasing the number of layers of the secondary impedance layer in the second anti-ultrasonic radiation structure) until ultrasound Radiation cannot pass through the side walls of the ultrasound treatment head and the handle.

The post-natal rehabilitation device of the present invention is particularly suitable for postpartum rehabilitation of women, such as uterine involution and reducing postpartum pain.

DRAWINGS

1 is a schematic block diagram showing the composition of a post-natal rehabilitation device according to Embodiment 2 of the present invention;

2 is a cross-sectional structural view showing an ultrasonic treatment head of a postpartum rehabilitation apparatus according to Embodiment 2 of the present invention;

Figure 3 is an enlarged schematic view of the ultrasonic treatment head of Figure 2.

Wherein: 1-first sound-blocking ring; 2-second sound-blocking ring; 3-third sound-blocking ring; 4-fourth sound-blocking ring; 5--transducer support; 12-shell; 13-first Anti-ultrasonic radiation structure; 14-fan; 15--block; 16-second anti-ultrasonic radiation structure; 17-handle; 18-switch; 19-switch control panel; 20-back cover; 21-connection line; ; 26 - ultrasonic transducer; 27 - ultrasonic medium; 28 - sound-permeable membrane.

detailed description

The post-natal rehabilitation device of the present invention is an ultrasonic treatment device having an ultrasonic transducer, and the ultrasonic wave emitted by the ultrasonic transducer can be introduced into the body from outside the body without damaging the skin, and thus belongs to non-invasive rehabilitation. Will not bring pain to the mother. Moreover, by transmitting ultrasonic waves at a specific frequency, power density (ie, ultrasonic sound intensity), and focal plane distance, ultrasonic waves of the frequency and power density can directly stimulate the maternal uterus, causing rhythmic contraction of the uterine smooth muscle, thereby promoting the uterus rejuvenation. When the ultrasound treatment is placed on the surface of the uterus of the human body, the focal plane distance range is set, so that the focal plane distance range can ensure that the focus of the ultrasound can be located at the uterus for most women. , which can improve the healing effect.

At present, with the further development of ultrasonic medical technology, the use range of ultrasonic therapeutic equipment is more and more extensive, and the national anti-radiation requirements for ultrasonic therapeutic equipment are becoming more and more strict. Due to the safety of the operator, high-intensity ultrasound treatment equipment will be banned from listing if it fails to meet the national standard radiation protection requirements, but Existing hand-held therapeutic devices generally do not have a radiation-proof function, thereby posing a safety hazard to the operator. The post-natal rehabilitation device of the present invention can effectively reduce the ultrasonic radiation by providing an anti-ultrasonic radiation structure in the ultrasonic treatment head to ensure the safety of the treatment.

The present invention will be further described in detail below in conjunction with the accompanying drawings and specific embodiments.

Example 1:

In this embodiment, the post-natal rehabilitation device includes a handle and an ultrasonic treatment head disposed at the end of the handle, the ultrasonic treatment head including a housing having an ultrasonic transducer for emitting ultrasonic waves to the maternal uterus, the ultrasonic transducer The ultrasonic waves emitted are focused ultrasound waves.

Wherein, a first anti-ultrasonic radiation structure for preventing the ultrasonic wave from escaping from the outer casing is further disposed in the outer casing, the first anti-ultrasonic radiation structure includes a plurality of sound-insulating layers, and the plurality of sound-insulating layers are ultrasonically exchanged The side portions of the energy device are sequentially arranged, and the adjacent two sound blocking layers are respectively made of two materials having a characteristic impedance Z ratio greater than 1, wherein Z=ρv, ρ is the density of the material, and v is the ultrasonic wave in the material. The speed of internal propagation; the focal plane distance of the ultrasonic transducer is 5 mm to 100 mm, the operating frequency is 0.1 MHz to 5 MHz, and the output power density is greater than 0 W/cm ^{2 and} less than or equal to 5 W/cm ² .

Among them, the focal plane distance range can ensure that the focus of the ultrasound can be located in the uterus for most women, and the ultrasound of the frequency and power density can directly stimulate the maternal uterus, causing the rhythmic contraction of the uterine smooth muscle, thereby promoting the uterus. At the same time, the above-mentioned frequency and power density of ultrasound also has the effect of relieving pain in the human body, thereby reducing post-natal pain and accelerating postpartum rehabilitation.

Example 2:

As shown in FIG. 2, the present embodiment provides a post-natal rehabilitation device including a main body (not shown) and a treatment gun connected to the main unit. The treatment gun includes a handle 17 and an ultrasonic treatment head disposed at one end of the handle.

The ultrasonic treatment head includes a housing 12 having a housing for delivering to a maternal uterus An ultrasonic transducer 26 of ultrasonic waves, and a first anti-ultrasonic radiation structure for preventing the ultrasonic waves from escaping from the outer casing 12.

In the present embodiment, the ultrasonic waves emitted by the ultrasonic transducer 26 are focused ultrasonic waves. The relevant parameters of the ultrasonic transducer 26 are: a focal plane distance of 5 mm to 100 mm, an operating frequency of 0.1 MHz to 5 MHz, and an output power density of more than 0 W/cm ^{2 and} less than or equal to 5 W/cm ² . In the present embodiment, the ultrasonic transducer 26 can employ a conventional piezoelectric ceramic wafer.

It has been found that the above-mentioned focal plane distance can ensure that for most women, the ultrasound can accurately focus on the uterus area during use, thereby improving the healing effect; while the ultrasound with the above frequency and power density can directly stimulate the maternal uterus. Causes rhythmic contraction of uterine smooth muscle, promotes uterine involution, and also relieves pain.

Preferably, the ultrasonic transducer 26 has an operating frequency between 0.7 MHz and 1 MHz and the ultrasonic transducer 26 has a focal plane distance between 20 mm and 60 mm. It has been found through research that the above preferred working frequency and focal plane distance can achieve better postpartum rehabilitation effects.

Preferably, the ultrasound transducer 26 can emit pulsed ultrasound or continuous ultrasound to the maternal uterus (ie, the ultrasound transducer 26 can have two different modes of operation).

Further preferably, when the ultrasonic wave emitted by the ultrasonic transducer 26 is a pulsed ultrasonic wave, the output power density of the ultrasonic transducer 26 is between 1 W/cm ² and 5 W/cm ² , and the duration of the pulse ultrasonic wave is greater than 0 ms and less than or equal to 400 ms. The ultrasonic on-off time ratio is between 1:20 and 1:2. When the pulsed ultrasound is intermittent, the stimulation to the human body is small, so a larger output power density can be used. When the ultrasonic wave emitted from the ultrasonic transducer 26 is continuous ultrasonic wave, the output power output density of the ultrasonic transducer 26 should be greater than 0 W/cm ² and less than or equal to 5 W/cm ² . The above parameters of the pulsed ultrasonic wave and the continuous ultrasonic wave are the preferred parameters which are most suitable for the two ultrasonic modes after the test, and within the range of the parameter, a better healing effect can be achieved, and the impact on the human body is small.

Preferably, the ultrasonic transducer 26 has a circular arc shape, and the circular arc surface is a part of a spherical surface. That is, the ultrasonic transducer 26 is in the form of a sheet, and its surface is a curved surface, and the curved surface is a part of the spherical surface, and the focus of the ultrasonic transducer 26 is located at the center of the spherical surface corresponding to the circular arc surface thereof. . This form of ultrasonic transducer 26 is a known technique.

The ultrasonic transducer 26 is disposed in the outer casing 12 of the ultrasonic treatment head, and the front end thereof is sequentially provided with an ultrasonic medium 27 (such as deaerated water) and a sound-permeable membrane 28, and the ultrasonic wave emitted by the ultrasonic transducer 26 can pass through the ultrasonic medium 27 It is then ejected from the sound permeable membrane 28. The handle 17 is attached to the end of the outer casing 12 for gripping by a user, and the handle 17 and the outer casing 12 are connected by bolts 24, and a connecting wire 21 for supplying power to the ultrasonic transducer 26 or the like (which is connected to the main body) ) can be introduced through the back cover 20 at the end of the handle.

In this embodiment, the housing 12 may further have a transducer support 5 for supporting the ultrasonic transducer, a fan 14 for cooling the ultrasonic transducer 26, and a compact for fixing the ultrasonic transducer 26. 15. Known structures such as the switch 18 and the switch control board 19 for opening or closing the ultrasonic transducer 26 are not described in detail herein.

The first anti-ultrasonic radiation structure 13 is made of a material that blocks the passage of ultrasonic waves, which prevents ultrasonic waves emitted from the ultrasonic transducer from propagating toward the side walls of the casing 12 and the handle 17, to reduce the influence of ultrasonic waves on the operator. The first anti-ultrasonic radiation structure 13 may include a plurality of sound-blocking layers (including two or more sound-insulating layers), the plurality of sound-blocking layers are sequentially disposed on the side of the ultrasonic transducer, and two adjacent sound-blocking layers The layers are respectively made of two materials having a characteristic impedance Z ratio greater than one.

Of course, when the first anti-ultrasonic radiation structure can also include only one sound-insulating layer, the sound-insulating layer and the outer casing 12 are required to be made of two materials having a characteristic impedance Z ratio greater than one. In this case, the outer casing is actually considered as part of the first anti-ultrasonic radiation structure, that is, the outer casing is regarded as another sound-blocking layer in the first anti-ultrasonic radiation structure. Alternatively, the transducer support 5, the sound-damping layer, and the outer casing 12 are sequentially disposed on the side of the ultrasonic transducer, and the ratio of the characteristic impedance Z of the transducer support 5, the sound-damping layer, and the outer casing 12 is greater than 1 respectively. Made of two materials. In this case, the transducer support and the outer casing are simultaneously part of the first anti-ultrasonic radiation structure, that is, the transducer support and the outer casing are respectively regarded as one sound-insulating layer in the first anti-ultrasonic radiation structure. .

Therefore, in the case where the first anti-ultrasonic radiation structure includes only one sound-blocking layer, the selection of the material for which the outer casing and/or the transducer support is made has the above requirements. When the first anti-ultrasonic radiation structure comprises a plurality of sound-insulating layers, the material of the outer casing and/or the transducer support may be made of a common material or a material required as described above.

Preferably, in the plurality of sound-insulating layers of the first anti-ultrasonic radiation structure, two adjacent sound-insulating layers are respectively made of any two materials having a characteristic impedance Z ratio of more than 5 and less than or equal to 20.

Specifically, the sound absorbing layer in the first anti-ultrasonic radiation structure 13 is two, and the two sound absorbing layers are the first sound absorbing ring 1 which is set on the transducer support member 5, and is set in the first resistance. The second damper ring 2 on the sound ring, the outer casing 12 is fitted on the second damper ring 2.

In this embodiment, for the transducer support 5, the first damper ring 1, the second damper ring 2, and the outer casing 12, each of the two adjacent components is made of a metal material, a non-metal material, or a liquid. The material and the gas material are made of any two materials having a characteristic impedance Z ratio greater than or equal to 5 and less than or equal to 20.

Preferably, for the transducer support 5, the first damper ring 1, the second damper ring 2 and the outer casing 12, two adjacent sound-blocking layers may be made of a metal material and a non-metal material, respectively. The metal material may specifically be stainless steel, copper or the like; the non-metal material may be specifically ABS (Acrylonitrile-Butadiene-Styrene, acrylonitrile-butadiene-styrene copolymer, which is a general-purpose engineering plastic), TPU (Thermo Plastic Polyurethanes, thermoplastic polyurethane elastomer plastics), etc.

Taking the transducer support member, the first sound-blocking ring and the second sound-blocking ring respectively made of ABS, stainless steel and ABS, the ultrasonic waves sequentially pass through the above three adjacent components during the propagation, that is, sequentially pass through the ABS, the stainless steel. And ABS. The density of ABS is 1050 kg/m3, the speed of sound propagation by ultrasonic waves in ABS is 2340 m/s, and the characteristic impedance Z ₁ =ρv=1050×2340=2457000 rayleigh; the density of stainless steel is 7950 kg/m3. The ultrasonic wave propagated in stainless steel at a speed of 5610 m/s, Z ₂ = ρv = 7950 x 5610 = 44599500 ray. Due >> Z ₁ Z _2, in accordance with the matching characteristics of the ultrasonic conductive, passes through the ultrasonic ABS, stainless steel and ABS, i.e. from the ultrasonic characteristic impedance Z ₁ of the medium into the medium a characteristic impedance Z _2, and then into the characteristic impedance In the process of Z ₁ medium, most of the reflection occurs when the ultrasonic wave enters a material interface, so that the ultrasonic wave propagating through the material will greatly attenuate, thereby effectively reducing the ultrasonic wave. Radiant energy.

Preferably, in the plurality of sound-blocking layers of the first anti-ultrasonic radiation structure, the wall thickness of each of the sound-insulating layers is respectively a product of the wavelength of the ultrasonic wave propagating in the sound-blocking layer and 0.25n. Where n is an odd number.

More preferably, the outer casing 12 further includes a second anti-ultrasonic radiation structure 16 including one or more secondary impedance layers disposed at a position where the outer casing is connected to the handle, and the axis of the ultrasonic treatment head can be vertical Pass through the plane where the secondary acoustic barrier layer is located. When the second anti-ultrasonic radiation structure includes a plurality of sub-resistance acoustic layers, each adjacent two sub-resistance acoustic layers are respectively made of two materials having a characteristic impedance Z ratio greater than one.

Of course, the second anti-ultrasonic radiation structure may also include only one sub-resistance layer. In this case, the sub-resistive layer and the handle 17 are required to be made of two materials having a characteristic impedance Z ratio greater than one. In this case, the handle is actually considered as part of the second anti-ultrasonic radiation structure, that is, the handle is considered as another sound-blocking layer in the first anti-ultrasonic radiation structure. Therefore, in the case where the second anti-ultrasonic radiation structure includes only one sub-resistance layer, the selection of the material for the handle has the above requirement, that is, the ratio of the characteristic impedance Z of the sub-resistive layer and the handle 17 is required to be greater than 1 respectively. Made of two materials. When the first anti-ultrasonic radiation structure includes a plurality of sub-resistance sound layers (including two or more sub-resistance sound layers), the handle material may be made of a common material or a material required as described above.

In this embodiment, the second anti-ultrasonic radiation structure includes two sub-resistance sound layers disposed in sequence, and the two sub-resistance sound layers are respectively a fourth sound-blocking ring 4 in contact with the end portion of the first anti-ultrasonic radiation structure. And the third damper ring 3 of the fourth damper ring 4, the handle 17 is fixedly connected with the third damper ring 3, the fourth damper ring 4, the third damper ring 3 and the handle 17 Each of the two adjacent components is made of any two materials having a characteristic impedance Z ratio greater than or equal to 5 and less than or equal to 20.

For the ultrasonic treatment head adopting the above structure and material, the ultrasonic waves emitted by the ultrasonic transducer 26 sequentially pass through the transducer support 5, the first anti-ultrasonic radiation structure 13 and the second anti-ultrasonic radiation structure 16 and the handle 17, Ultrasonic radiation is greatly attenuated, so it can effectively prevent ultrasonic radiation from penetrating from the side wall of the ultrasonic treatment head and the handle 17, and the spatial peak time average sound intensity of the transmitted ultrasonic radiation is less than 100mW/cm ² , in line with national standards. Relevant regulations.

Hereinafter, in the transducer support 5, the first anti-ultrasonic radiation structure 13, the second anti-ultrasonic radiation structure 16, and the handle 7, each of two adjacent components is respectively made of stainless steel The material selection method of each component in the treatment gun of this embodiment is described in detail with ABS as an example:

Specifically, the transducer support 5 is made of stainless steel, the first acoustic ring 1 is made of ABS, the second acoustic ring 2 is made of stainless steel, the outer casing 12 is made of ABS, and the third acoustic ring 4 is used. Made of stainless steel, the third sound-blocking ring 3 is made of ABS, the handle 17 is made of stainless steel; or the transducer support 5 is made of stainless steel, and the first sound-blocking ring 1 is made of ABS, the second resistance The sound ring 2 is made of stainless steel, the outer casing 12 is made of ABS, the third sound-damping ring 4 is made of ABS, the third sound-damping ring 3 is made of stainless steel, and the handle 17 is made of ABS; or, the transducer supports The piece 5 is made of ABS, the first sound-blocking ring 1 is made of stainless steel, the second sound-blocking ring 2 is made of ABS, the outer casing 12 is made of stainless steel, and the third sound-blocking ring 4 is made of stainless steel, the third resistance The sound ring 3 is made of ABS, the handle 17 is made of stainless steel, or the transducer support 5 is made of ABS, the first sound block 1 is made of stainless steel, and the second sound block 2 is made of ABS. The outer casing 12 is made of stainless steel, the third acoustic ring 4 is made of ABS, and the third acoustic ring 3 is made of stainless steel. The handle 7 is made of ABS.

In this embodiment, the two sound blocking layers, the outer casing 12, and the two secondary sound blocking layers, that is, the first sound blocking ring 1, the second sound blocking ring 2, the outer casing 12, the third sound blocking ring 4, and the In the three-resistance sound ring 3, the wall thickness of each component is required to conform to the product of the wavelength of the ultrasonic wave transmitted in the component and 0.25n, where n is an odd number, that is, the wall thickness of each component should satisfy one quarter. An odd multiple of the wavelength.

If the two sound-insulating layers, the outer casing 12, and the two secondary-resistance layers are made of a solid material (that is, metal and non-metal), in practice, the density of the solid material tends to be uneven. The phenomenon, and the uneven phenomenon not only changes the propagation speed of the sound wave in the solid material, but also affects the characteristic impedance of the material, so the error should be considered in the specific design. If the uniformity of the solid material is poor, the range of the error may be appropriately relaxed. Preferably, the error range is within ±20%, that is, the first sound absorbing ring 1, the second damper ring 2, the outer casing 12, and the fourth In the damper ring 4 and the third damper ring 3, the wall thickness of each component is respectively the product of the wavelength of the ultrasonic wave propagating within the component and 0.25n*{1±[0-20%]}, where n is Odd number; if the uniformity of the solid material is general, the error is preferably within ±10%, that is, In the first sound absorbing ring 1, the second damper ring 2, the outer casing 12, the fourth damper ring 4, and the third damper ring 3, the wall thickness of each component is respectively the wavelength at which the ultrasonic wave propagates within the component. The product of 0.25n*{1±[0~10%]}, where n is an odd number.

Taking the first sound-blocking ring 1 as an example, the calculation method of the wall thickness of the sound-blocking layer is explained:

If the first sound-blocking ring 1 is made of stainless steel, and the frequency f of the ultrasonic wave is 830,000 Hz, the sound velocity of the ultrasonic wave propagating in the stainless steel is 5610 m/sec, and the wavelength of the ultrasonic wave propagating in the stainless steel can be calculated according to the formula λ=V/f =0.006759036 meters, the wall thickness of the first sound-blocking ring 1 is 0.25λn*(1±10%), where n is an odd number. If n=1, the wall thickness of the first damper ring 1 is 0.25×0.006759036×(1±10%), that is, 1.521 mm to 1.859 mm. The algorithm for the wall thickness of the transducer support 5, the second damper ring 2, the outer casing 10, the fourth damper ring 4, and the third damper ring 3 is similar.

In summary, the use of the above-mentioned wall thickness of the sound-blocking layer or the secondary-resistance sound layer, whether the ultrasonic transducer used in the ultrasonic treatment head is large or small, can effectively prevent the ultrasonic radiation from seeping through the ultrasonic treatment head. .

Preferably, the postpartum rehabilitation device may further include a uterine contraction measuring unit and a contraction signal processing circuit for measuring a uterine contraction condition of the mother.

The uterine contraction measurement unit measures the uterine contractions of the mother, so that the rehabilitation status can be fed back in real time so that the user can understand the rehabilitation status and adjust the rehabilitation plan in time.

Preferably, the contraction measuring unit may be a pressure sensor for measuring the pressure generated by uterine contractions. By placing the pressure sensor at the bottom of the uterus, the pressure generated by the uterine contractions can be measured to determine the contraction. Specifically, the pressure sensor can be a piezoelectric sensor, although it can also be other types of pressure sensors. Alternatively, the contraction measurement unit may be other types of sensors that measure other signals such as bioelectricity, as long as they are capable of measuring the parameters of the reaction contraction.

Wherein, the pressure sensor (ie, the contraction measurement unit) is further connected to the contraction signal processing circuit (located in the host), the contraction signal processing circuit includes: an amplification circuit connected to the pressure sensor, a filter circuit connected to the amplification circuit, and An analog-to-digital conversion circuit connected to the filter circuit. Wherein, the amplifying circuit can amplify the pressure signal measured by the pressure sensor (because the pressure generated by the contraction is small, the corresponding pressure signal is also inevitable Small), the filter circuit filters out the clutter in the amplified signal, and the analog-to-digital conversion circuit converts the measured analog signal into a digital signal that can be recognized by the processing unit. Of course, the specific circuit structures of the amplifying circuit, the filtering circuit, and the analog-to-digital conversion circuit have many different forms, and all of them are known technologies, and thus will not be described in detail herein.

Further preferably, the pressure sensor (ie, the contraction measurement unit) is connected to the contraction signal processing circuit by a shielded wire. Obviously, the pressure sensor is closely attached to the projection site of the human uterus, so the contraction signal processing circuit should be set separately (such as in the main machine), and since the pressure signal generated by the pressure sensor is usually weak, it is preferable to use the shielded wire (ie, The wire with the shield is connected to the contraction signal processing circuit to prevent the signal in the transmission from being disturbed.

As shown in FIG. 1 , in this embodiment, a power management unit, an ultrasonic driving unit, a display unit, a control unit, an input unit, and the like may be included in the host.

The power management unit can be connected to an external power plug or a battery unit inside the host to supply power to the entire device.

The ultrasonic driving unit, the display unit, the control unit, the input unit and the above-mentioned contraction measuring unit are all connected with the control unit, and the control unit can have data processing capability for a central processing unit (CPU), a single chip microcomputer, a programmable logic controller, and the like. Device for receiving signals from each unit and controlling them.

The ultrasonic driving unit may include a control circuit, a signal generating circuit, a frequency selecting circuit, a power driving amplifying circuit, and a resonant impedance matching circuit. Wherein, the control circuit is connected to the control unit for selecting an output power, an operating frequency, a pulse/continuous ultrasonic mode, etc. according to a signal from the control unit; the signal generating circuit and the frequency selective circuit together constitute an oscillation driving circuit, and the signal generated by the oscillation driving circuit After being controlled by the circuit, it is amplified by the power amplifying circuit, and then the ultrasonic transducer 26 is driven to emit ultrasonic waves through the resonant impedance matching circuit. Since the ultrasonic drive unit can adopt a known structure, it will not be described in detail herein; however, it is obvious that the specific structure of each circuit in the ultrasonic drive unit should ensure that the ultrasonic transducer can operate within the above-mentioned parameters.

The input unit can be a device with a human-computer interaction function such as a keyboard, a mouse, a button, a knob, a touch screen, etc., and is used for the user to select an ultrasonic parameter (output power, operating frequency, pulse/continuous ultrasonic mode, etc.) and a control device.

The display unit can be a display device such as a display screen (such as a liquid crystal display) for displaying ultrasonic parameters, device status, contraction status, etc., so that the user can understand the condition of the device and the rehabilitation condition.

The contraction measurement unit is also connected to the control unit through the contraction signal processing circuit (where the contraction signal processing circuit can be set in the host), so that the signal indicating the contraction condition is displayed on the display unit through the control unit for the user reference.

Of course, the main unit may also include components such as a casing, a fan, a switch, etc. Since the specific shape, structure, and the like of the main body can adopt known technologies, and it is not the focus of the present invention, it will not be described in detail herein.

Preferably, the post-natal rehabilitation device of the embodiment may further comprise: an electrical stimulation unit for electrically stimulating the uterus in the maternal; and/or a pneumatic massage unit for massaging the mother. The electric stimulation unit and the pneumatic massage unit can adopt the existing structure and can be connected to the host and controlled by the control unit. The electric stimulation unit and the air pressure massage unit can respectively assist the mother to perform postpartum rehabilitation through electric stimulation and massage, so that different rehabilitation means can be comprehensively utilized to further improve the rehabilitation effect of the postpartum rehabilitation equipment in the embodiment.

When using the post-natal rehabilitation device of the embodiment, the host switch is first turned on, and the control unit starts initializing the device, after which the user inputs required parameters (including the operating frequency, output power density, and operation of the transducer) through the input device. Mode, etc.), the control unit controls the ultrasound to treat the hair out of the ultrasound according to the input parameters, the user determines the position of the uterus of the mother, and marks the projection area of the body surface, and then applies the ultrasonic coupling agent after spraying the alcohol in the projection area, and the ultrasonic treatment head is applied. The sound-transmitting membrane at the front end is fixed in the projection area, and is pressed down slightly to ensure that it is tightly coupled with the skin, and sends ultrasonic waves to the uterine region; in use, the pressure sensor continuously feeds back the uterus contraction condition in real time and displays it on the display unit, according to the user Uterine contraction status adjusts parameters and rehabilitation programs in real time. Once the use is complete, the ultrasound therapy head can be turned off and the next time the current parameters are used for further use.

Rehabilitation test data:

A total of 120 women were randomly selected as the test subjects. The maternal age ranged from 21 to 40 years old, all of whom were primiparas, 37 to 42 weeks of gestation, no pregnancy complications and complications. Postpartum maternal and child in the same room, breastfeeding, according to hospitalization number were randomly divided into ultrasound group (81 cases) and control group (39 cases). The control group did not undergo assisted rehabilitation and recovered completely. The ultrasound group used the post-natal rehabilitation equipment of the above Example 2 for ultrasound rehabilitation, once a day, 30 minutes each time, a total of 3 times (ie 3 days), of which 41 cases used continuous ultrasound, 40 cases used pulsed ultrasound, in use according to the uterus The contraction condition and the maternal feeling adjust the parameters in real time within the above ranges. The data obtained from the test are shown in Table 1.

Table 1 Comparison of rehabilitation effects of postpartum rehabilitation equipment of the present invention

In Table 1, the height of the palace is also called the height of the fundus, and the unit is centimeter. It is the distance from the upper edge of the phalanges to the bottom of the palace. Before each measurement, the mother emptyes the bladder and massages the uterus to make it contract, and then measures with a tape measure. The mean uterine height change refers to the average uterus height on the first day minus the average uterus height on the third day. The greater the value, the greater the degree of uterine contraction and the better the uterus rejuvenation.

The VAS value is the VAS pain score made by the mother, with 0 points indicating no pain, 3 points below indicating mild pain, 4 to 6 points indicating that the pain is severe but still tolerable, and 7 to 10 points indicating that the pain is unbearable. The average VAS value change refers to the value of the average VAS value on the first day minus the average VAS value on the third day. The larger the value, the more obvious the pain relief, and the better the postpartum rehabilitation effect.

If the postpartum vaginal bleeding time is greater than 42 days, it is considered that the uterus is relapsed. The proportion of uterine involuntary patients indicates the percentage of maternal women who have lost the old age.

It can be seen that the change of the uterus height of the ultrasound group in Table 1 is significantly greater than that of the control group, and the proportion of uterine involution is significantly lower than that of the control group, which indicates that the postnatal rehabilitation equipment of this embodiment has a significant effect on uterine involution.

At the same time, the VAS value of the ultrasound group in Table 1 also changed more than the control group, which indicates that the postpartum rehabilitation equipment of this embodiment also has a certain effect on slowing postpartum pain.

At the same time, a t-test was performed on the mean uterine height changes of the ultrasound group and the control group. As a result, the statistical data correlation degree P was 0.001, which indicates that the data has a strong statistical significance (usually P<0.05 as having The statistically significant criteria), the difference was indeed caused by the postpartum rehabilitation equipment of this example; and the chi-square test was performed on the proportion of uterine involution in the ultrasound group and the control group, and the results showed statistical data correlation degree P It is 0.034, which indicates that the data is statistically significant. The difference is indeed caused by the postpartum rehabilitation equipment of this embodiment; among them, the above two statistics are compared with the ultrasound group and the control group, and the continuous ultrasound and pulse are not distinguished. Ultrasound.

In summary, the post-natal rehabilitation equipment of this embodiment has a significant effect on postpartum rehabilitation of women.

It is to be understood that the above embodiments are merely exemplary embodiments employed to explain the principles of the invention, but the invention is not limited thereto. Various modifications and improvements can be made by those skilled in the art without departing from the spirit and scope of the invention. These modifications and improvements are also considered to be within the scope of the invention.

Claims

A post-natal rehabilitation device includes a handle and an ultrasonic treatment head disposed at an end of the handle, the ultrasonic treatment head including an outer casing having an ultrasonic transducer for transmitting ultrasonic waves to the maternal uterus, wherein the outer casing is further provided a first anti-ultrasonic radiation structure for preventing the ultrasonic wave from escaping from the outer casing, the first anti-ultrasonic radiation structure comprising a plurality of sound-insulating layers, the plurality of sound-blocking layers being sequentially on the side of the ultrasonic transducer The two adjacent sound-blocking layers are respectively made of two materials having a characteristic impedance Z ratio greater than 1, wherein Z=ρv, ρ is the density of the material, and v is the speed at which the ultrasonic wave propagates within the material; The ultrasonic transducer has a focal plane distance of 5 mm to 100 mm, an operating frequency of 0.1 MHz to 5 MHz, and an output power density of more than 0 W/cm 2 and less than or equal to 5 W/cm 2 .
The post-natal rehabilitation device according to claim 1, wherein the ultrasonic transducer has an operating frequency of 0.7 MHz to 1 MHz, and the ultrasonic transducer has a focal plane distance of 20 mm to 60 mm.
The post-natal rehabilitation apparatus according to claim 1, wherein said ultrasonic transducer is configured to emit pulsed ultrasonic waves to a maternal uterus; said ultrasonic transducer has an output power density of from 1 W/cm 2 to 5 W/cm 2 The duration of the pulsed ultrasonic wave is greater than 0 ms and less than or equal to 400 ms, and the on-off time ratio of the ultrasonic wave is between 1:20 and 1:2.
The post-natal rehabilitation device according to claim 1, wherein said ultrasonic transducer is configured to emit continuous ultrasonic waves to a maternal uterus; said ultrasonic transducer has an output power density greater than 0 W/cm 2 and less than or equal to 1 W/cm 2 .
The post-natal rehabilitation device according to any one of claims 1 to 4, wherein in the plurality of sound-blocking layers of the first anti-ultrasonic radiation structure, two adjacent sound-insulating layers respectively adopt a characteristic impedance Z Any ratio greater than or equal to 5 and less than or equal to 20 Made of two materials.
The post-natal rehabilitation device according to claim 5, wherein in the plurality of sound-blocking layers of the first anti-ultrasonic radiation structure, a wall thickness of each of the sound-insulating layers is respectively propagated by the ultrasonic waves in the sound-blocking layer The product of the wavelength and 0.25n, where n is an odd number.
The post-natal rehabilitation device according to claim 5, wherein the housing has a transducer support for supporting the ultrasonic transducer, and the sound-proof layer of the first anti-ultrasonic radiation structure is two. The two sound blocking layers are a first sound blocking ring that is sleeved on the transducer support member, and a second sound blocking ring that is sleeved on the first sound blocker. The outer casing is set on the second sound blocker. .
The post-natal rehabilitation device according to claim 7, wherein in the transducer support member, the first sound-blocking ring, the second sound-blocking ring, and the outer casing, each adjacent two components are respectively made of a metal material or a non-metal material. The metal material, the liquid material, and the gas material are made of any two materials having a characteristic impedance Z ratio greater than or equal to 5 and less than or equal to 20.
The post-natal rehabilitation device according to claim 7, wherein the wall thickness of each of the first sound-proof layer/housing in the first anti-ultrasonic radiation structure is set to a wavelength at which the ultrasonic wave propagates in the inner/shell of the sound-blocking layer and 0.25 The product of n*{1±[0~20%]}, where n is an odd number.
The post-natal rehabilitation device according to claim 7, wherein the outer casing further comprises a second anti-ultrasonic radiation structure, and the second anti-ultrasonic radiation structure comprises one or more secondary impedance layers disposed at a position where the outer casing is connected to the handle. The axis of the ultrasonic treatment head can vertically pass through the plane of the secondary sound-damping layer; when the second anti-ultrasonic radiation structure includes a plurality of secondary-resistance layers, each adjacent two-resistance acoustic layer respectively adopts a characteristic impedance Made of two materials with a Z ratio greater than one.
The post-natal rehabilitation device according to claim 10, wherein the second anti-ultrasonic radiation structure comprises two sub-resistance acoustic layers in sequence, and the two sub-resistance acoustic layers are respectively, and the first anti-ultrasonic radiation structure end a fourth damper ring that is in contact with the third damper ring, and a third damper ring that is in close proximity to the fourth damper ring, the handle is fixedly connected to the third damper ring, the fourth damper ring and the third damper ring Among the handles, each of the two adjacent components is made of any two materials having a characteristic impedance Z ratio greater than or equal to 5 and less than or equal to 20.
The post-natal rehabilitation device according to claim 11, wherein the wall thickness of each of the sound-insulating layers in the second anti-ultrasonic radiation structure is respectively a wavelength at which the ultrasonic wave propagates in the sound-blocking layer and 0.25 n*{1± The product of [0 to 20%]}, where n is an odd number.
The post-natal rehabilitation device according to any one of claims 1 to 4, further comprising: a uterine contraction measuring unit for measuring a uterine contraction condition of the mother; and a palace connected to the uterine contraction measuring unit The contraction signal processing circuit includes an amplification circuit connected to the contraction measurement unit, a filter circuit connected to the amplification circuit, and an analog to digital conversion circuit connected to the filter circuit.
The postpartum rehabilitation device according to claim 13, wherein the contraction measuring unit is a pressure sensor for measuring a pressure generated by uterine contractions.
The postpartum rehabilitation device according to claim 13, wherein the contraction measuring unit and the contraction signal processing circuit are connected by a shield wire.
The post-natal rehabilitation device according to any one of claims 1 to 4, further comprising: an electrical stimulation unit for electrically stimulating uterine involution of the mother; and/or a pressure for massaging the mother Massage unit.