Body temperature flexible ultrasound probe and preparation method, protective sleeve and preparation method

Abstract

This invention discloses a body-soft ultrasonic probe and its preparation method, as well as a protective sleeve and its preparation method. The ultrasonic probe includes a probe body, a transducer, a matching layer, and a contact layer. The transducer is embedded in the probe body, and a matching layer is provided on one side of the transducer. A contact layer is connected to the outside of the matching layer. The contact layer is made of a body-soft material, which is semi-rigid at 25-30℃ and undergoes a flexible transformation at 32-37℃, with its hardness decreasing to a Shore hardness of 30-50 and an elongation ≥150%. The matching layer is formed by combining the body-soft material and an acoustic functional filler material, with the acoustic impedance of the acoustic functional filler adjustable in the range of 2.0-4.8 Mrayl. The preparation method is used to prepare the ultrasonic probe. The protective sleeve is used to cover the ultrasonic probe, and the preparation method for the protective sleeve is used to prepare the protective sleeve. Its advantages are significantly improved fit and imaging quality. The contact layer is made of a body-soft material, which softens rapidly upon contact with the human body due to body temperature, allowing it to adapt to irregular curved surfaces on the body surface or inside cavities, thus improving work efficiency.

Description

Technical Field

[0001] This invention relates to the field of ultrasound medical device technology, and in particular to a body-soft ultrasonic probe and its preparation method, as well as a protective sleeve and its preparation method. Background Technology

[0002] Ultrasound examination is widely used in clinical diagnosis and health monitoring due to its non-invasive, real-time, and convenient advantages. However, traditional ultrasound probes often use rigid plastics or conventional elastic materials for their contact and encapsulation layers, which presents several technical drawbacks. (1) Poor fit: The human body surface (such as joints and neck) and internal cavities (such as blood vessels and vagina) are mostly irregular curved surfaces. Traditional rigid or low-flexibility materials are difficult to fit completely, which easily forms air gaps, resulting in attenuation of ultrasound signals and decrease in imaging resolution. In addition, a large amount of coupling agent is required to fill the gaps, which is cumbersome and easy to cause pollution. (2) Insufficient comfort: During long-term examination, the hard material continuously compresses human tissue, which can easily cause soreness and pain. It is especially unsuitable for infants, elderly patients and wearable long-term monitoring scenarios. The intelligent display of the contact surface temperature can adjust the temperature at any time to increase comfort as the contact surface becomes softer.

[0003] (3) High safety risks: When a minimally invasive ultrasound probe (such as catheter ultrasound) enters the body, the rigid material is easy to scratch the mucosa of the cavity; and the heat generated by the probe during long-term operation is difficult to dissipate, which may cause local tissue overheating damage. (4) Poor acoustic matching: The acoustic impedance of traditional materials differs greatly from that of human tissue (1.5-2.0 Mt.), resulting in severe loss of ultrasonic energy reflection, which affects imaging quality and detection depth.

[0004] While flexible materials are used in existing ultrasound probes, most are ambient-temperature flexible materials, unable to dynamically adjust their flexibility and fit according to body temperature. Furthermore, they suffer from shortcomings in balancing acoustic performance and biocompatibility. Simultaneously, existing disposable ultrasound probe sleeves are mostly made of ordinary elastic materials or plastics, lacking ambient-temperature flexible materials. This results in poor fit, low sound transmission, inability to adapt to the curved surfaces of flexible probes, and loose adhesion to the probe body, making it easy to slip off. Consequently, it is difficult to simultaneously achieve sterile isolation and imaging quality. Therefore, developing an ultrasound probe that intelligently displays the contact surface temperature while responding to body temperature for flexible self-adaptation, balancing acoustic matching and biosafety, along with a matching disposable probe sleeve made of ambient-temperature flexible materials, has become an urgent technical challenge. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a body-friendly and flexible ultrasound probe and its preparation method, as well as a protective sleeve and its preparation method, in order to address the shortcomings of the prior art.

[0006] To solve the above-mentioned technical problems, the present invention adopts the following technical solution.

[0007] A flexible ultrasound probe made of a flexible material includes a probe body, a transducer, a matching layer, and a contact layer. The probe body is fitted with a transducer, and the matching layer is located on the side of the transducer closest to the human body. A contact layer is compositely connected to the outer side of the matching layer closest to the human body. The contact layer is made of a flexible material composed of polyvinyl acetate and polyurethane. The flexible material is semi-rigid at 25-30°C, undergoes a flexible transformation at 32-37°C, and its hardness decreases to a Shore hardness of 30-50 with an elongation ≥150%. The matching layer is formed by combining the flexible material with an acoustic functional filler material, wherein the acoustic impedance of the acoustic functional filler material is adjustable within the range of 2.0-4.8 MTayl.

[0008] In a preferred embodiment, the probe body further includes a temperature control auxiliary layer, which is attached between the transducer and the matching layer. The matching layer and the temperature control auxiliary layer are fixed by ultrasonic welding. The temperature control auxiliary layer is made of phase change energy storage material with a phase change temperature of 37°C to 40°C. The temperature control auxiliary layer is used to absorb the heat generated by the transducer during operation.

[0009] A preferred embodiment is that the surface of the contact layer is provided with a micro-nano texture structure, the micro-nano texture structure having a depth of 5-20 μm and a width of 10-50 μm, the micro-nano texture structure being used to improve the adhesion to human tissue and reduce the amount of coupling agent used.

[0010] In a preferred embodiment, the acoustic functional filler is one or more combinations of nano-hydroxyapatite, liquid metal microspheres, or piezoelectric ceramic particles, and the acoustic functional filler accounts for 5%-20% of the total mass of the composite material in the matching layer.

[0011] In a preferred embodiment, the body-soft ultrasonic probe made of body-soft material further includes a temperature sensor for detecting human body temperature. The probe body has a processor inside and a display screen on its surface. The temperature sensor is connected to the display screen through the processor. The sensor converts the temperature into an electrical signal, which is then processed by the circuit and displayed on the display screen.

[0012] Another technical solution of the present invention: A protective sleeve for wearing over a body-soft ultrasonic probe made of body-soft material, the protective sleeve being made of body-soft material, the inner wall of the protective sleeve having anti-slip positioning protrusions, the opening of the protective sleeve having an elastic tightening ring, the protective sleeve having a thickness of 0.05-0.12mm, and a sound transmission rate of ≥95%.

[0013] The protective cover contains 0.1%-0.5% silver or zinc ion antibacterial agent in its soft material.

[0014] Another technical solution of the present invention: A method for preparing a micro-flexible ultrasonic probe using the micro-flexible material, comprising: S1. Preparation of body-soft flexible material: Medical-grade polyvinyl acetate and polyurethane are mixed, and 0.5%-2% antioxidant and 0.3%-1% lubricant are added. The mixture is melt-blended at 160-180℃ for 10-20 minutes to obtain a body-soft flexible substrate. The body-soft flexible substrate is taken, and 5%-20% acoustic functional filler is added to it. The mixture is continuously stirred and dispersed for 5-10 minutes. After cooling to room temperature, it is granulated. S2. Contact layer preparation: The flexible substrate is processed into a thin film with a thickness of 0.08-0.15 mm using a blown film process, and a micro-nano textured structure is prepared by laser etching. The film is then sterilized with ethylene oxide and ready for use. S3. Matching layer preparation: The matching layer material prepared in step S1 is injection molded, and the molding temperature is controlled at 170-190℃ and the pressure is 5-10MPa to obtain a matching layer with a thickness of 0.2-0.5mm. Its acoustic impedance is adjusted to 2.0-4.8Mrayl after testing. S4. Assembly: The transducer, temperature control auxiliary layer, matching layer and contact layer are sequentially attached and fixed to the housing of the probe body, and sealed by ultrasonic welding to ensure that there are no air gaps between the layers. Finally, the overall performance is tested.

[0015] Another technical solution of the present invention: A method for preparing a protective case includes: Step 1. Prepare the protective sleeve material by mixing medical-grade polyvinyl acetate and polyurethane, adding 0.5%-2% antioxidant and 0.3%-1% lubricant, and melting and blending at 160-180℃ for 10-20 minutes to obtain a body-friendly flexible substrate. Add an additional 0.1%-0.5% antibacterial agent to the body-friendly flexible substrate and continue mixing for 5-8 minutes. Step 2. Protective sleeve preparation: The protective sleeve material prepared in step S1 is processed into a bag-shaped structure using a blown film heat sealing process. Anti-slip positioning protrusions are molded to form a protective sleeve. An elastic tightening ring is embedded in the sleeve opening. The blown film temperature is 150-170℃ and the heat sealing temperature is 120-140℃.

[0016] This invention provides a body-soft ultrasound probe and its preparation method. The protective sleeve and preparation method have at least the following beneficial effects: Significantly improved fit and imaging quality. The contact layer is made of a body-soft material, which softens rapidly upon contact with the human body due to body temperature, allowing it to adapt to irregular curved surfaces on the body surface or within cavities, effectively eliminating air gaps. The sound transmittance is ≥95%, reducing the amount of coupling agent used by more than 80%, reducing the number of times doctors need to repeatedly add and fill coupling agent, and even achieving coupling agent-free imaging. This improves the ultrasound signal-to-noise ratio and imaging resolution, increasing work efficiency. High acoustic matching accuracy. The matching layer is composed of a body-soft material and acoustic functional filler, allowing for precise adjustment of acoustic impedance to achieve matching between human tissue and the transducer, reducing ultrasound energy reflection loss, and improving detection depth and imaging clarity.

[0017] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, and to make the above and other objects, features and advantages of the present invention more apparent and understandable, preferred embodiments are described in detail below with reference to the accompanying drawings. Attached Figure Description

[0018] Figure 1 This is a three-dimensional view of the micro-flexible ultrasonic probe made of micro-flexible material in this invention; Figure 2 This is an exploded view of the bulk-flexible ultrasonic probe made of bulk-flexible material in this invention; Figure 3 This is a three-dimensional view of the protective sleeve covering the flexible ultrasonic probe made of flexible material in this invention; Figure 4 This is a schematic diagram of the protective sleeve in this invention. Detailed Implementation

[0019] To illustrate the ideas and objectives of this application, the following description will be provided in conjunction with the accompanying drawings and specific embodiments.

[0020] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs; the terminology used herein in the specification of the application is for the purpose of describing particular embodiments only and is not intended to be limiting of the application; the terms "comprising" and "having," and any variations thereof, in the specification, claims, and foregoing drawings of this application are intended to cover non-exclusive inclusion. The terms "first," "second," "left," "right," etc., in the specification, claims, or foregoing drawings of this application are used to distinguish different objects, not to describe a particular order.

[0021] In this document, the term "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this application. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described herein can be combined with other embodiments.

[0022] like Figure 1 and Figure 2 As shown, a body-soft ultrasonic probe made of a body-soft material includes a probe body 1, a transducer 2, a matching layer 3, and a contact layer 4. The transducer 2 is embedded in the probe body 1. The matching layer 3 is provided on the side of the transducer 2 near the human body. The contact layer 4 is compositely connected to the outer side of the matching layer 3 near the human body. The contact layer 4 is made of a body-soft material. The body-soft material is semi-rigid at 25~30℃, undergoes a flexible transformation at 32~37℃, and its hardness decreases to a Shore hardness of 30~50 with an elongation ≥150%. The matching layer 3 is compositely connected to the contact layer 4. The matching layer 3 is formed by a composite of the body-soft material and an acoustic functional filler material. The acoustic impedance of the acoustic functional filler material is adjustable in the range of 2.0~4.8 MTayl.

[0023] like Figure 1 and Figure 2 As shown, the probe body 1 is equipped with a transducer 2, which is arrayed on the end face of the probe body 1. A contact layer 4 is compositely connected to the outer side of the matching layer 3 near the human body. The outer surface of the contact layer 4 is in contact with the human body.

[0024] like Figure 1 and Figure 2 As shown, the contact layer 4 is made of a volumetric flexible material. The volumetric flexible material is in a semi-rigid state at 25-30℃ and undergoes a flexible transformation at 32-37℃, with the hardness decreasing to Shore hardness 30-50 and the elongation ≥150%. The matching layer 3 is formed by a composite of volumetric flexible material and acoustic functional filler, with an acoustic impedance adjustment range of 2.0-4.8Mrayl.

[0025] like Figure 1 and Figure 2 As shown, the present invention significantly improves the fit and imaging quality. The contact layer 4 is made of a body-soft material. After contacting the human body, the contact layer 4 softens rapidly triggered by body temperature, which can adaptively fit irregular curved surfaces on the body surface or inside cavities, effectively eliminating air gaps. The sound transmission rate is ≥95%, which can reduce the amount of coupling agent used by more than 80%, reduce the number of times doctors need to repeatedly add and fill coupling agent, and even achieve coupling agent-free imaging, improve the signal-to-noise ratio and imaging resolution of ultrasound signals, and improve work efficiency.

[0026] like Figure 1 andFigure 2 As shown, the acoustic matching accuracy is high. The matching layer 3 is made of a composite of a body-soft flexible material and an acoustic functional filler, which can precisely adjust the acoustic impedance to achieve the matching between human tissue and transducer 2, reduce ultrasonic energy reflection loss, and improve detection depth and imaging clarity.

[0027] Some embodiments, such as Figure 1 and Figure 2 As shown, the flexible material is a mixture of polyvinyl acetate and polyurethane; wherein, the flexibility softening temperature of the mixture is semi-rigid at 25~30℃, undergoes a flexible transformation at 32~37℃, has an elongation at break of ≥150% at 37℃, and a sound transmission rate of ≥95%.

[0028] In some embodiments, such as Figure 1 and Figure 2 As shown, the probe body 1 also includes a temperature control auxiliary layer 5, which is attached between the transducer 2 and the matching layer 3. The temperature control auxiliary layer 5 is made of phase change energy storage material with a phase change temperature of 37°C to 40°C. The temperature control auxiliary layer 5 is used to absorb the working heat of the transducer 2.

[0029] like Figure 1 and Figure 2 As shown, the transducer 2 has a temperature control auxiliary layer 5 attached to the side closest to the human body, and the two are fully attached to ensure heat conduction; the side of the temperature control auxiliary layer 5 away from the transducer 2 is connected to the matching layer 3, and the matching layer 3 and the temperature control auxiliary layer 5 are fixed without gaps by ultrasonic welding.

[0030] like Figure 1 and Figure 2 As shown, comfort and safety are greatly improved. The softened contact layer 4 can disperse the pressure of human tissue and reduce the discomfort of long-term examination, making it suitable for wearable long-term monitoring scenarios. The temperature control auxiliary layer 5 effectively absorbs heat and avoids local overheating damage.

[0031] In some embodiments, such as Figure 1 and Figure 2 As shown, the surface of the contact layer 4 is provided with a micro-nano texture structure. The micro-nano texture structure has a depth of 5-20μm and a width of 10-50μm. The micro-nano texture structure is used to improve the adhesion to human tissue and reduce the amount of coupling agent used.

[0032] like Figure 1 and Figure 2 As shown, the micro-nano texture structure on the surface of the contact layer 4 is a continuous strip or hemispherical array of protrusions with a depth of 5-20μm and a width of 10-50μm. The spacing between adjacent protrusions is consistent with the width, forming a regular grid-like texture. This texture can be fitted and positioned with the anti-slip positioning protrusions on the inner wall of the protective sleeve 6, and can also enhance the adhesion to the skin or mucous membrane of the cavity when in direct contact with the human body.

[0033] In some embodiments, such as Figure 1 and Figure 2 As shown, the acoustic functional filler is one or more combinations of nano-hydroxyapatite, liquid metal microspheres, or piezoelectric ceramic particles; the acoustic functional filler accounts for 5%-20% of the total mass of the composite material in the matching layer 3.

[0034] In some embodiments, such as Figure 1 and Figure 2 As shown, the body-soft ultrasonic probe also includes a temperature sensor for detecting human body temperature. The probe body 1 is equipped with a processor, and the probe body 1 has a display screen 7 on its surface. The temperature sensor is connected to the display screen 7 through the processor. The sensor converts the temperature into an electrical signal, which is then processed by the circuit and displayed on the display screen 7.

[0035] Another embodiment of the present invention, such as Figures 1 to 4 As shown, a protective sleeve is used to cover a body-soft ultrasonic probe made of a body-soft material. The probe body 1 is covered with a disposable protective sleeve 6, which is made of a body-soft material. The inner wall of the protective sleeve 6 is provided with anti-slip positioning protrusions, and the opening of the protective sleeve 6 is provided with an elastic tightening ring 61. The protective sleeve 6 has a thickness of 0.05-0.12mm and a sound transmission rate of ≥95%.

[0036] like Figures 1 to 4 As shown, the protective sleeve 6 has a bag-like structure, and its body is made of the same body-soft material as the contact layer 4.

[0037] like Figures 1 to 4 As shown, the protective sleeve 6 is disposable, which not only prevents cross-infection but also ensures effective ultrasound transmission. It reduces the frequency of cleaning and disinfecting the probe body 1, avoids corrosion from chemical disinfectants, and extends its service life. The soft, thermally conductive material avoids the cold discomfort of direct skin contact with the metal probe body 1, allowing for quick and easy contact with the body surface and cavities. The protective sleeve 6 can be quickly slipped on and secured to the probe body 1, and is discarded as medical waste after use.

[0038] like Figures 1 to 4 As shown, 0.1%-0.5% silver or zinc ion antibacterial agent is added to the body-soft material of the protective case 6. The additional addition of 0.1%-0.5% silver or zinc ion antibacterial agent to the body-soft material of the protective case 6 ensures sterile protective performance.

[0039] Another embodiment of the present invention, such as Figures 1 to 4 As shown, a method for preparing a volumetrically flexible ultrasonic probe using a volumetrically flexible material includes: S1. Preparation of body-soft flexible material: Medical-grade polyvinyl acetate and polyurethane are mixed, and 0.5%-2% antioxidant and 0.3%-1% lubricant are added. The mixture is melt-blended at 160-180℃ for 10-20 minutes to obtain a body-soft flexible substrate. Matching layer 3 material is prepared. The body-soft flexible substrate is taken, and 5%-20% acoustic functional filler is added to it. The mixture is continuously stirred and dispersed for 5-10 minutes. After cooling to room temperature, it is granulated. S2. Preparation of contact layer 4: The flexible substrate is processed into a thin film with a thickness of 0.08-0.15 mm using a blown film process, and a micro-nano textured structure is prepared by laser etching. After sterilization with ethylene oxide, it is ready for use. S3. Preparation of matching layer 3: The matching layer 3 material prepared in step S1 is injection molded, and the molding temperature is controlled at 170-190℃ and the pressure is 5-10MPa to obtain a matching layer 3 with a thickness of 0.2-0.5mm. Its acoustic impedance is adjusted to 2.0-4.8Mrayl after testing. S4. Assembly: The transducer 2, temperature control auxiliary layer 5, matching layer 3 and contact layer 4 are sequentially attached and fixed to the housing of the probe body 1, and sealed by ultrasonic welding to ensure that there are no air gaps between the layers. Finally, the overall performance is tested. The polyvinyl acetate and polyurethane are mixed in the following proportions: 82%-94% polyvinyl acetate and 6%-18% polyurethane.

[0040] like Figures 1 to 4 As shown, specifically: The body-softening material was prepared by mixing medical-grade polyurethane and polyvinyl acetate in a 6:1 ratio, adding 1% antioxidant and 0.5% calcium stearate, and melting and blending at 170℃ for 15 min to obtain a body-softening substrate. Its flexibility softening temperature was 32℃, its Shore hardness at 37℃ was 40, and its elongation at break was 180%. The body-softening substrate was then blown into a 0.1 mm thick film, and laser etching was used to prepare micro-nano textures with a depth of 10 μm and a width of 30 μm. After sterilization with ethylene oxide, it was ready for use. Matching layer 3 was prepared by taking a bulk flexible substrate, adding 10% liquid metal microspheres with a diameter of 500 nm to the bulk flexible substrate, stirring and dispersing at 175 °C for 8 min, and injection molding to form a 0.3 mm thick matching layer 3. The acoustic impedance was tested to be 3.2 MTayl. Assembly: Transducer 2, temperature control auxiliary layer 5, matching layer 3 and contact layer 4 are sequentially attached and fixed to probe body 1, and then sealed by ultrasonic welding. like Figures 1 to 4 As shown, the test results are as follows: the probe fits the human neck 98% well, the signal-to-noise ratio of the image without coupling agent after the matching protective sleeve 6 is ≥33dB, the local temperature is ≤39℃ after 2 hours of continuous operation, the protective sleeve 6 does not slip off, the antibacterial rate is ≥99%, and the time for the protective sleeve 6 to complete the flexible transformation with body temperature is ≤30s.

[0041] A method for preparing a protective case includes: Step 1. Prepare the protective sleeve material by mixing medical-grade polyvinyl acetate and polyurethane, adding 0.5%-2% antioxidant and 0.3%-1% lubricant, and melting and blending at 160-180℃ for 10-20 minutes to obtain a body-friendly flexible substrate. Add an additional 0.1%-0.5% antibacterial agent to the body-friendly flexible substrate and continue mixing for 5-8 minutes. Step 2. Protective sleeve preparation: The protective sleeve material prepared in step S1 is processed into a bag-shaped structure using a blown film heat sealing process. Anti-slip positioning protrusions are molded to form a protective sleeve. An elastic tightening ring 61 is embedded in the sleeve opening. The blown film temperature is 150-170℃ and the heat sealing temperature is 120-140℃.

[0042] The protective sleeve 6 is made of a bag-shaped material through a blown film heat-sealing process. Anti-slip positioning protrusions are molded to form the protective sleeve 6. An elastic tightening ring 61 is embedded in the sleeve opening. The blown film temperature is 160℃ and the heat-sealing temperature is 130℃. The protective sleeve 6 is then placed on the body-soft ultrasonic probe and tightened and fixed by the elastic tightening ring 61. The anti-slip positioning protrusions are aligned and positioned with the micro-nano texture of the contact layer 4.

[0043] The above are specific embodiments of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.

Claims

1. A flexible ultrasound probe, characterized in that, The device includes a probe body, a transducer, a matching layer, and a contact layer. The probe body is fitted with a transducer, and the transducer has a matching layer on the side closest to the human body. The outer side of the matching layer, near the human body, is compositely connected to the contact layer. The contact layer is made of a body-soft material, which is a mixture of polyvinyl acetate and polyurethane. The body-soft material is semi-rigid at 25~30℃, undergoes a flexible transformation at 32~37℃, and its hardness decreases to a Shore hardness of 30~50 with an elongation ≥150%. The matching layer is formed by combining the body-soft material with an acoustic functional filler material, and the acoustic impedance of the acoustic functional filler material is adjustable in the range of 2.0~4.8 MTayl.

2. The body-soft flexible ultrasound probe according to claim 1, characterized in that, The probe body also includes a temperature control auxiliary layer, which is attached between the transducer and the matching layer. The matching layer and the temperature control auxiliary layer are fixed by ultrasonic welding. The temperature control auxiliary layer is made of phase change energy storage material with a phase change temperature of 37℃~40℃. The temperature control auxiliary layer is used to absorb the working heat of the transducer.

3. The body-soft flexible ultrasound probe according to claim 1, characterized in that, The surface of the contact layer is provided with a micro-nano texture structure, the micro-nano texture structure having a depth of 5-20μm and a width of 10-50μm. The micro-nano texture structure is used to improve the adhesion to human tissue and reduce the amount of coupling agent used.

4. The body-soft flexible ultrasound probe according to claim 1, characterized in that, The acoustic functional filler is one or more of nano-hydroxyapatite, liquid metal microspheres or piezoelectric ceramic particles, and the acoustic functional filler accounts for 5%-20% of the total mass of the composite material in the matching layer.

5. The body-soft flexible ultrasound probe according to claim 1, characterized in that, The body-temperature-sensitive ultrasound probe also includes a temperature sensor for detecting human body temperature. The probe body has a processor and a display screen on its surface. The temperature sensor is connected to the display screen through the processor. The sensor converts temperature into an electrical signal, which is then processed by the circuit and displayed on the display screen.

6. A protective sleeve for covering the body-soft ultrasonic probe according to any one of claims 1 to 5, characterized in that, The protective cover is made of a soft and flexible material. The inner wall of the protective cover is provided with anti-slip positioning protrusions, and the opening of the protective cover is provided with an elastic tightening ring. The thickness of the protective cover is 0.05-0.12mm, and the sound transmission rate is ≥95%.

7. The protective sleeve according to claim 6, characterized in that, The protective cover contains 0.1%-0.5% silver or zinc ion antibacterial agent in its soft material.

8. A method for preparing the body-soft ultrasonic probe of claim 2, characterized in that, include: S1. Preparation of body-soft flexible material: Medical-grade polyvinyl acetate and polyurethane are mixed, and 0.5%-2% antioxidant and 0.3%-1% lubricant are added. The mixture is melt-blended at 160-180℃ for 10-20 minutes to obtain a body-soft flexible substrate. The body-soft flexible substrate is taken, and 5%-20% acoustic functional filler is added to it. The mixture is continuously stirred and dispersed for 5-10 minutes. After cooling to room temperature, it is granulated. S2. Contact layer preparation: The flexible substrate is processed into a thin film with a thickness of 0.08-0.15 mm using a blown film process, and a micro-nano textured structure is prepared by laser etching. The film is then sterilized with ethylene oxide and ready for use. S3. Matching layer preparation: The matching layer material prepared in step S1 is injection molded, and the molding temperature is controlled at 170-190℃ and the pressure is 5-10MPa to obtain a matching layer with a thickness of 0.2-0.5mm. Its acoustic impedance is adjusted to 2.0-4.8 MTayl after testing. S4. Assembly: The transducer, temperature control auxiliary layer, matching layer and contact layer are sequentially attached and fixed to the housing of the probe body, and sealed by ultrasonic welding to ensure that there are no air gaps between the layers. Finally, the overall performance is tested.

9. A method for preparing a protective sleeve according to any one of claims 6 or 7, characterized in that, include: Step 1. Prepare the protective sleeve material by mixing medical-grade polyvinyl acetate and polyurethane, adding 0.5%-2% antioxidant and 0.3%-1% lubricant, and melting and blending at 160-180℃ for 10-20 minutes to obtain a body-friendly flexible substrate. Add an additional 0.1%-0.5% antibacterial agent to the body-friendly flexible substrate and continue mixing for 5-8 minutes. Step 2. Protective sleeve preparation: The protective sleeve material prepared in step S1 is processed into a bag-shaped structure using a blown film heat sealing process. Anti-slip positioning protrusions are molded to form a protective sleeve. An elastic tightening ring is embedded in the sleeve opening. The blown film temperature is 150-170℃ and the heat sealing temperature is 120-140℃.

Images