Ultrasonic therapeutic apparatus for diabetic foot

Abstract

The invention relates to the technical field of medical instruments, and particularly discloses an ultrasonic therapeutic instrument for diabetic foot, which comprises a bandage and a plurality of ultrasonic therapeutic heads mounted on the bandage, each ultrasonic therapeutic head can move along each direction relative to the bandage, the plurality of ultrasonic therapeutic heads form two rows on the bandage, each row comprises a plurality of ultrasonic therapeutic heads, and the ultrasonic therapeutic heads are arranged on the bandage. The distance between the corresponding ultrasonic treatment heads in the same row in the two columns gradually changes in the length direction of the columns, and the binding band is provided with a tying band used for binding the binding band to the shank or is provided with a male hook-and-loop fastener and a female hook-and-loop fastener. The scheme is used for treating diabetic foot vascular injury, relieving vascular occlusion and improving microcirculation.

Description

Technical Field

[0001] The invention relates to the technical field of medical devices, and in particular to an ultrasonic therapeutic device for diabetic foot. Background Art

[0002] Diabetic foot is a serious complication of diabetes and is extremely harmful, including causing difficulty in movement and decreased quality of life for patients, and increasing the risk of infection. If diabetic foot is not treated promptly, the infection will worsen, forming gangrene, aggravating systemic infection, and even endangering life.

[0003] In the prior art, the treatment of diabetic foot is mainly based on the treatment of diabetes itself, mainly including drug therapy, insulin therapy and advice to patients to adjust their lifestyle. However, diabetic foot disease is often accompanied by poor blood circulation in the lower limbs. Therefore, improving the blood supply of diabetic patients' lower limb blood vessels is of great clinical significance for delaying the progression of the disease.

[0004] As a safe and non-invasive method, low-frequency and low-intensity ultrasound has great potential in promoting fracture healing, repairing injuries and ultrasound-mediated drug delivery. It has been widely used in the field of ultrasound therapy. The biological effects of low-frequency and low-intensity ultrasound in treating diseases include thermal effects, mechanical effects and cavitation effects. The above effects interact with each other. On the one hand, it promotes blood circulation: specifically, low-frequency and low-intensity ultrasound can dilate blood vessels, promote blood circulation and nutrient supply, and improve blood supply and hypoxia of tissues. On the other hand, it promotes vascular repair and regeneration: low-frequency and low-intensity ultrasound can stimulate the proliferation and migration of vascular endothelial cells and smooth muscle cells, and promote the repair and regeneration of damaged blood vessels. However, there is still a lack of ultrasonic therapy devices for diabetic foot on the market. Summary of the invention

[0005] The present invention is intended to provide an ultrasonic therapeutic apparatus for diabetic foot, which is used to treat vascular damage in diabetic foot, relieve vascular occlusion and improve microcirculation.

[0006] In order to achieve the above object, the present invention adopts the following technical scheme:

[0007] An ultrasonic therapeutic device for diabetic foot comprises a strap and a plurality of ultrasonic therapeutic heads mounted on the strap, each of the ultrasonic therapeutic heads being able to move in all directions relative to the strap, the plurality of ultrasonic therapeutic heads forming two rows on the strap, each row having a plurality of ultrasonic therapeutic heads, and the distance between the corresponding ultrasonic therapeutic heads in the same row on the two rows gradually changing along the length direction of the row.

[0008] The principles and advantages of this scheme are: when using this scheme, the ultrasonic treatment head is aligned with the patient's calf blood vessels, and the two rows of ultrasonic treatment heads act on the patient's blood vessels simultaneously. The low-frequency and low-intensity ultrasonic waves emitted by the ultrasonic treatment heads can act on the blood vessel wall through mechanical vibration, causing vasodilation, increasing blood flow, and thus promoting blood circulation; in addition, low-frequency and low-intensity ultrasonic waves can also stimulate the proliferation of cells in the body, promote the synthesis of collagen, and help promote the repair and regeneration of damaged blood vessels.

[0009] In addition, in the present solution, a plurality of ultrasonic treatment heads are provided to achieve a better treatment effect on blood vessels, and the spacing between the ultrasonic treatment heads in the same row of two rows gradually changes along the length of the row, which can make the ultrasonic treatment heads more consistent with the distribution of blood vessels on the calf, thereby helping to improve the use effect of the ultrasonic treatment heads.

[0010] Preferably, as an improvement, the strap is provided with a tie for tightening the strap to the calf or the strap is provided with male and female Velcro to facilitate tying the ultrasonic therapeutic device to the patient's calf via the tie.

[0011] Preferably, as an improvement, a plurality of protrusions are provided on both ends of the strap that are close to each other when in use, and the gaps between adjacent protrusions facilitate intuitive inspection of the contact between the ultrasonic treatment head and the skin.

[0012] Preferably, as an improvement, the ultrasonic treatment head is rotated in the strap in a ball-hinged manner, so that the ultrasonic treatment head can be flexibly rotated to easily and conveniently align with the blood vessels of the patient's calf.

[0013] Preferably, as an improvement, the strap is provided with an elastic spherical cavity for installing the ultrasonic therapy head, and a spherical head is provided at one end of the ultrasonic therapy head close to the strap, and the spherical head is rotatably connected in the spherical cavity. This solution can ensure that the ultrasonic therapy head can be removed from the strap under strong pulling, thereby facilitating the disassembly and assembly of the ultrasonic therapy head.

[0014] Preferably, as an improvement, a wire hole is provided on the spherical head, and the wire hole is used to lead out the wires of the ultrasonic treatment head.

[0015] Preferably, as an improvement, the binding band is made of double-layer material, the wires are sandwiched between the double-layer material, and the wires of multiple ultrasonic treatment heads are combined together and led out of the binding band in the form of a wire harness.

[0016] Preferably, as an improvement, the ultrasonic treatment head is a planar array ultrasonic probe with a composite piezoelectric material. Compared with ordinary probes, the planar array ultrasonic probe can better promote blood circulation and accelerate wound healing, thereby achieving a better therapeutic effect on diabetic foot.

[0017] Preferably, as an improvement, the planar array ultrasonic therapy head comprises an acoustic lens, a matching layer 1, a matching layer 2, a piezoelectric composite layer and a backing layer arranged in sequence, the piezoelectric composite layer is a piezoelectric composite electrode layer arranged in an array, and the acoustic impedance matching design of the ultrasonic therapy head follows the following formula:

[0018]

[0019]

[0020] Z1-the acoustic impedance of the first matching layer, Z2-the acoustic impedance of the second matching layer, Z Y - Acoustic impedance of piezoelectric ceramics, Z F - Load acoustic impedance. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] Figure 1 FIG. 1 is a top view of a binding strap according to Embodiment 1 of the present invention.

[0022] Figure 2 for Figure 1 Front view of.

[0023] Figure 3 for Figure 1 Left view of .

[0024] Figure 4 This is a schematic diagram of the three-dimensional structure of the ultrasonic therapy head used in this embodiment.

[0025] Figure 5 for Figure 4 Top view of the .

[0026] Figure 6 for Figure 4 main view.

[0027] Figure 7 for Figure 4 Front cross-sectional view.

[0028] Figure 8 It is a front cross-sectional view showing a local area of ​​the ultrasonic treatment head in the second embodiment.

[0029] Fig. 9 It is a top view and a partially enlarged schematic diagram of the piezoelectric composite material of the ultrasonic treatment head in Example 3.

[0030] Fig.10 This is a schematic diagram showing the spacing between piezoelectric composite array elements in Example 4. DETAILED DESCRIPTION

[0031] The following is further described in detail through specific implementation methods:

[0032] The figure marks in the drawings of the specification include: strap 1, ultrasonic treatment head 100, wire hole 10, elastic support seat 2, spherical cavity 21, wire harness 3, Velcro fur surface 4, Velcro hook surface 5, acoustic lens 11, upper shell 12, lower shell 13, piezoelectric composite material 16, matching layer one 14, matching layer two 15, backing layer 17, piezoelectric ceramic 161, epoxy resin 162.

[0033] Embodiment 1

[0034] Combination Figures 1 to 7 An ultrasonic therapeutic device for diabetic foot comprises a bandage 1 and a plurality of ultrasonic therapeutic heads 100 installed on the bandage 1. The plurality of ultrasonic therapeutic heads 100 form two rows on the bandage 1, and each row has a plurality of ultrasonic therapeutic heads 100. The distance between the corresponding ultrasonic therapeutic heads 100 in the same row on the two rows gradually changes along the length direction of the row. In this embodiment, the number of ultrasonic therapeutic heads 100 in the same row is 4; each ultrasonic therapeutic head 100 can move in all directions relative to the bandage 1. A specific implementation method is that each ultrasonic therapeutic head 100 is ball-hinged with the bandage 1.

[0035] Velcro is installed on the strap 1 to facilitate the ultrasonic therapy device to be tied to the patient's calf through the hook surface 4 and the fleece surface 5 of the Velcro. Multiple protrusions are set on both ends of the strap 1 that are close to each other when in use. The gaps between adjacent protrusions facilitate intuitive viewing of the contact between the ultrasonic therapy head 100 and the skin. There are three rows of protrusions in this embodiment, and the Velcro is fixed on the protrusions.

[0036] The bandage 1 is integrally formed with elastic support seats 2 having the same number as the ultrasonic therapy heads 100. The elastic support seats 2 can be made of any elastic material such as rubber / latex / silicone. Each elastic support seat 2 is provided with an elastic spherical cavity 21 for installing the ultrasonic therapy head 100. A spherical head is provided at one end of the ultrasonic therapy head 100 close to the bandage 1. The spherical head is rotatably connected in the spherical cavity 21 to form a ball hinge in the spherical cavity 21. Before the ultrasonic therapy head 100 is installed in the elastic spherical cavity 21, the maximum diameter of the elastic spherical cavity 21 is smaller than the diameter of the spherical head, so that after the ultrasonic therapy head 100 is squeezed into the spherical elastic cavity, the ultrasonic therapy head 100 is not easy to fall off, and the angle of the ultrasonic therapy head 100 can be adjusted, and it can be maintained at the corresponding angle after each adjustment.

[0037] A wire hole 10 is provided on the spherical head, and the wire hole 10 is used to lead out the wires of the ultrasonic treatment head 100. A through hole is provided at the bottom of the spherical cavity 21 of the elastic support seat 2 to facilitate the wires of the spherical head to be led out along the wire hole 10 and from the through hole. The wires of each ultrasonic treatment head 100 are arranged together to form a wire harness 3.

[0038] The binding strap 1 is made of double-layer material, and each layer of the double-layer material has a soft material. An elastic support seat 2 is installed on the thick layer of the double-layer material, and the thick layer of material is consistent with the material of the elastic support seat 2; the remaining layer of material in the double-layer material can be set to be thinner to facilitate the binding of the binding strap 1. At the same time, the wires are sandwiched in the double-layer material, and the wiring harness 3 is also located in the middle of the double-layer material and extends out of the binding strap 1 of the double-layer material.

[0039] The ultrasonic treatment head 100 is a planar array ultrasonic probe with composite piezoelectric material.

[0040] The ultrasonic therapeutic device for diabetic foot of this embodiment is used for treatment. During treatment, the ultrasonic therapeutic head 100 is adjusted to align with the blood vessels of the patient's treatment area by rotating the angle. Under the elastic action of the elastic support seat 2, it is ensured that the angle of the therapeutic head 100 does not change easily. When the strap 1 is fixed, the strap 1 encloses the calf, and the Velcro fur surface 4 and the Velcro hook surface 5 are adhered to each other to bind the ultrasonic therapeutic device to the calf. Then, the fit between the ultrasonic therapeutic head 100 and the skin is observed through the gap between the multiple protrusions on both sides of the strap 1. After confirming that the fit is intact, the treatment is then energized, and the therapeutic head 100 produces a piezoelectric reverse effect, emitting therapeutic ultrasound to achieve the treatment purpose.

[0041] Embodiment 2

[0042] Combination Figure 8 In this embodiment, the array ultrasound probe of the ultrasound treatment head 100 is specifically described as follows:

[0043] The ultrasonic treatment head 100 includes an acoustic lens 11, an upper shell 12, a lower shell 13, a gold-plated piezoelectric composite material 16, a matching layer 14, a matching layer 2 15 and a backing layer 17. The acoustic lens 11 is nested inside the upper shell 12, and then pressed and fixed by the matching layer 14. Its purpose is to make the ultrasonic wave more concentrated when it is emitted, thereby improving the propagation efficiency and detection accuracy of the ultrasonic wave. The role of the gold-plated piezoelectric composite material 16 is the reverse piezoelectric effect. When a high-frequency electrical signal is applied to the gold-plated piezoelectric composite material 16, a high-frequency mechanical vibration, that is, an ultrasonic signal, is generated. When the acoustic impedances of the two media are different and their acoustic impedances differ too much, if there is no suitable matching layer, most of the ultrasonic waves emitted from the piezoelectric element will be reflected back at the piezoelectric element-load interface. The purpose of the matching layer 14 and the matching layer 2 15 is that the matching layer increases the coupling of the acoustic impedance, so that the impedance of the therapeutic device matches the acoustic impedance of human blood 1.6 MRayls, ensuring that the ultrasonic waves generated by the gold-plated piezoelectric composite material 16 can be effectively absorbed by human blood. The spherical head is integrally formed with the lower shell 1 .

[0044] In this embodiment, the acoustic impedance matching design of the ultrasonic treatment head follows the following formula:

[0045]

[0046]

[0047] Z1-the acoustic impedance of the first matching layer, Z2-the acoustic impedance of the second matching layer, Z Y - Acoustic impedance of piezoelectric ceramics, Z F -Load acoustic impedance, the unit of acoustic impedance is MRayls.

[0048] The specific design calculations are shown in the following table:

[0049]

[0050] Embodiment 3

[0051] The third embodiment is further improved on the basis of the second embodiment, and the details are as follows:

[0052] Combination Fig. 9 The gold-plated piezoelectric composite material 16 is composed of a piezoelectric ceramic 161, an epoxy resin 162, and a surface gold-plated layer. The piezoelectric ceramic 161 mainly utilizes the piezoelectric reverse effect to generate ultrasonic waves; the epoxy resin 162 is mainly used to reduce the piezoelectric ceramic 161 after filling and cutting, thereby reducing the acoustic impedance of the piezoelectric ceramic; the surface gold-plated layer is equivalent to an electrode for signal transmission.

[0053] The production process of the gold-plated piezoelectric composite material 16 is to first select a piezoelectric ceramic material 161, and cut longitudinal or transverse staggered grooves with equal spacing and depth on the piezoelectric ceramic 161 to achieve the purpose of removing the piezoelectric ceramic 161 material. During the cutting process, in order to ensure the material strength of the piezoelectric ceramic 161, first cut transverse grooves or longitudinal grooves, fill with epoxy resin 162, and after drying, cut the longitudinal grooves or transverse grooves again, and then fill with epoxy resin 162; secondly, grind and fill the excess epoxy resin 162 and the excess piezoelectric ceramic 161 on the other side to ensure that the piezoelectric ceramic 161 is completely filled and separated by the epoxy resin 162; finally, gold is plated on the surface to obtain a surface gold-plated layer, and wires are buried at the positive and negative electrodes to obtain the final gold-plated piezoelectric composite material 16.

[0054] Embodiment 4

[0055] Embodiment 4 is further designed based on Embodiment 3: Fig.10 According to the application of ultrasound treatment for diabetic foot, in order to avoid crosstalk, the spacing between the two array elements needs to be designed. The spacing between the two array elements should be less than or equal to λ / 2, where λ is the wavelength emitted by the ultrasonic transducer, the center frequency of the ultrasonic therapeutic device is 2.5MHz, and the ultrasonic propagation speed is about 3880m / s. The calculation results are:

[0056] λ=3880 / (2.5x1000000)x1000=1.55mm, λ / 2=0.8mm, and the slot width between the two array elements is about 0.25mm.

[0057] The above is only an embodiment of the present invention, and the common knowledge such as the known specific technical solutions and / or characteristics in the solution is not described in detail here. It should be pointed out that for those skilled in the art, without departing from the technical solution of the present invention, several modifications and improvements can be made, which should also be regarded as the protection scope of the present invention, and these will not affect the effect of the implementation of the present invention and the practicality of the patent. The scope of protection required by this application shall be based on the content of its claims, and the specific implementation methods and other records in the specification can be used to interpret the content of the claims.

Claims

1. An ultrasonic therapeutic device for diabetic foot, comprising a bandage and a plurality of ultrasonic therapeutic heads mounted on the bandage, characterized in that: Each ultrasonic therapy head can move in all directions relative to the strap. Multiple ultrasonic therapy heads form two rows on the strap, each row has multiple ultrasonic therapy heads, and the distance between corresponding ultrasonic therapy heads in the same row on the two rows gradually changes along the length of the row.

2. The ultrasonic therapeutic device for diabetic foot according to claim 1, characterized in that: The strap is provided with a lace for fastening the strap to the calf, or the strap is provided with male and female Velcro.

3. The ultrasonic therapeutic device for diabetic foot according to claim 2, characterized in that: The two ends of the strap that are close to each other when in use are both provided with a plurality of protrusions, and the gaps between adjacent protrusions facilitate visual inspection of the contact between the ultrasonic treatment head and the skin.

4. The ultrasonic therapeutic device for diabetic foot according to claim 2, characterized in that: The ultrasonic treatment head is rotated in the binding belt in a ball-jointed manner.

5. The ultrasonic therapeutic device for diabetic foot according to claim 4, characterized in that: The binding band is provided with an elastic spherical cavity for installing an ultrasonic treatment head. An end of the ultrasonic treatment head close to the binding band is provided with a spherical head, and the spherical head is rotatably connected in the spherical cavity.

6. The ultrasonic therapeutic device for diabetic foot according to claim 5, characterized in that: The spherical head is provided with a wire hole, and the wire hole is used for leading out the wire of the ultrasonic treatment head.

7. The ultrasonic therapeutic device for diabetic foot according to claim 6, characterized in that: The binding belt is made of double-layer material, and the electric wire is sandwiched between the double-layer material.

8. An ultrasonic therapeutic device for diabetic foot according to any one of claims 1 to 7, characterized in that: The ultrasonic treatment head is a planar array ultrasonic probe with composite piezoelectric material.

9. The ultrasonic therapeutic apparatus for diabetic foot according to claim 8, characterized in that: The planar array ultrasonic therapy head comprises an acoustic lens, a matching layer 1, a matching layer 2, a piezoelectric composite layer and a backing layer arranged in sequence, wherein the piezoelectric composite layer is a piezoelectric composite electrode layer arranged in an array, and the acoustic impedance matching design of the ultrasonic therapy head follows the following formula: Z1-the acoustic impedance of the first matching layer, Z2-the acoustic impedance of the second matching layer, Z Y - Acoustic impedance of piezoelectric ceramics, Z F - Load acoustic impedance.

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