Inflatable ultrasound sheath

Abstract

The present application belongs to the technical field of medical devices, and discloses an inflatable ultrasonic sheath. The inflatable ultrasonic sheath comprises a sheath body, the sheath body is sleeved on an ultrasonic probe and is tightly connected with the ultrasonic probe, the sheath body has an imaging functional area and a non-imaging functional area, and the material of at least the imaging functional area is a soft material and forms a main conforming capsule; an inflation annular capsule and a bubble capturing capsule are both located in the non-imaging functional area of the sheath body, the inflation annular capsule is connected with the sheath body, a control channel is formed around the inner wall surface of the inner circle of the inflation annular capsule, one end of the control channel is communicated with the main conforming capsule, the control channel can be opened after the inflation annular capsule is inflated, and the control channel can be closed after the inflation annular capsule is contracted; the bubble capturing capsule is connected with the inflation annular capsule, the other end of the control channel is communicated with the bubble capturing capsule, and the inflation annular capsule can lift the bubble capturing capsule after being inflated. The present application can not only be closely conformed to the tissue, but also eliminate the influence of bubbles and improve the quality of acquired images.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to an expandable ultrasonic sheath. Background Technology

[0002] In modern interventional medicine, ultrasound imaging is usually performed by inserting auxiliary equipment into the body cavity for examination. The ultrasound probe acquires tomographic images of human tissue, thereby detecting early cancerous changes and small tumors within the tissue, achieving early tumor screening. It is currently a common method for diagnosing lesions in tissues within the body cavity.

[0003] Currently, when performing ultrasound probe examinations through natural cavities (such as the rectum and vagina), several issues often arise that affect image quality. On one hand, poor adhesion to the tissue and air bubbles in the coupling gel lead to decreased image quality. On the other hand, if the lesion site lacks bodily fluids, saline solution must be injected as the ultrasound transmission medium before ultrasound imaging can be performed. However, directly injecting saline solution lacks an effective air bubble removal mechanism, which also affects image quality. Summary of the Invention

[0004] The purpose of this invention is to provide an expandable ultrasonic sheath to assist the ultrasonic probe in detection. It can not only fit tightly to the tissue, but also eliminate the influence of air bubbles and improve the quality of acquired images.

[0005] To achieve this objective, the present invention adopts the following technical solution:

[0006] Expandable ultrasonic sheath, comprising:

[0007] The outer sleeve body has a accommodating chamber, is fitted onto the ultrasound probe and is tightly secured to the ultrasound probe, the outer sleeve body has an imaging functional area and a non-imaging functional area, at least the imaging functional area is made of a soft material and forms a main fitting capsule;

[0008] An inflatable annular bladder is located in the non-imaging functional area of ​​the outer casing. The inflatable annular bladder is connected to the outer casing. The inner wall of the inner ring of the inflatable annular bladder forms a control channel. One end of the control channel is connected to the main fitting bladder. The control channel can be opened when the inflatable annular bladder expands and can be closed when the inflatable annular bladder contracts.

[0009] A bubble trapping bladder is located in the non-imaging functional area of ​​the outer casing. The bubble trapping bladder is connected to the inflatable annular bladder. The other end of the control channel is connected to the bubble trapping bladder. After the inflatable annular bladder expands, it can raise the bubble trapping bladder. The bubble trapping bladder is connected to the outer casing through the control channel.

[0010] As an optional solution for the expandable ultrasonic sheath, the front end of the expandable annular bladder is provided with an annular control cavity, the longitudinal section of which is crescent-shaped and curved toward the outer sheath body, and the rear end of the expandable annular bladder is provided with an elevation cavity, which extends away from the main apposition bladder, and the bubble trapping bladder is located at the top of the elevation cavity.

[0011] As an optional solution for the expandable ultrasonic sheath, the inner wall of the annular control cavity forms the control channel, and the longitudinal section of the control channel is crescent-shaped when closed, and the control channel is bent toward the outer sheath body.

[0012] As an optional solution for the expandable ultrasonic sheath, the upper wall of the control channel is provided with several sets of first serrated structures, and the lower wall of the control channel is provided with several sets of second serrated structures, wherein the first serrated structures and the corresponding second serrated structures mesh with each other.

[0013] As an alternative to the expandable ultrasonic sheath, both the first serrated structure and the second serrated structure are trapezoidal or triangular.

[0014] As an optional solution for the expandable ultrasonic sheath, the control channel is provided with a plurality of elastic reset connectors. One end of the elastic reset connector is connected to the upper wall of the control channel, and the other end of the elastic reset connector is connected to the lower wall of the control channel. The elastic reset connector always has a tendency to close the control channel. When the control channel is opened, the elastic reset connector is in a stretched state.

[0015] As an optional solution for the expandable ultrasonic sheath, the soft material is made of rubber or silicone, and / or the outer sheath body, the expandable annular bladder, and the bubble trapping bladder are integrally molded structures.

[0016] As an alternative to the expandable ultrasonic sheath, the expandable ultrasonic sheath further includes:

[0017] The first injection channel tube is located in the non-imaging functional area of ​​the outer shell body, and one end of the first injection channel tube is connected to the outer shell body and communicates with the main fitting bag.

[0018] The second injection channel tube is located in the non-imaging functional area of ​​the outer casing body. One end of the second injection channel tube is connected to the outer casing body and communicates with the inflatable annular bladder.

[0019] As an alternative to the expandable ultrasonic sheath, a first switching valve is provided on the first injection channel tube; and / or a second switching valve is provided on the second injection channel tube.

[0020] As an alternative to an expandable ultrasonic sheath, the soft material includes an ultrasonic imaging material.

[0021] The beneficial effects of this invention are:

[0022] The expandable ultrasonic sheath provided by this invention comprises an expandable annular bladder and a bubble-catching bladder, all located in the non-imaging functional area of ​​the outer sheath body. The expandable annular bladder is connected to the outer sheath body, and the bubble-catching bladder is connected to the expandable annular bladder. The imaging functional area of ​​the outer sheath body forms a main fitting bladder. After the outer sheath body is placed over the ultrasonic probe and liquid is added, the main fitting bladder expands under liquid pressure and adheres tightly to the tissue, improving the image quality acquired by the ultrasonic probe. However, air bubbles may exist during liquid injection, potentially affecting imaging performance. A control channel is formed on the inner wall of the expandable annular bladder; one end of the control channel communicates with the main fitting bladder, and the other end communicates with the bubble-catching bladder. When pressure is applied to the expandable annular bladder, the control channel opens after the bladder expands, raising the height of the bubble-capturing bladder. Therefore, bubbles in the liquid within the main bladder, under buoyancy, will pass through the control channel into the bubble-capturing bladder, thus expelling the bubbles from the main bladder into the bubble-capturing bladder. Conversely, reducing the pressure within the expandable annular bladder causes it to contract, closing the control channel and preventing bubbles from flowing back from the bubble-capturing bladder into the main bladder, further improving image quality. This expandable ultrasonic sheath is a disposable product; it can be discarded after each use without requiring cleaning or disinfection of the ultrasonic probe, ensuring its lifespan and avoiding the risk of cross-infection. Attached Figure Description

[0023] To more clearly illustrate the technical solutions in the embodiments of the present invention, the accompanying drawings used in the description of the embodiments of the present invention will be briefly introduced below. Obviously, the accompanying drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on the content of the embodiments of the present invention and these drawings without creative effort.

[0024] Figure 1 This is a schematic diagram of the assembly of the expandable ultrasonic sheath installed on the ultrasonic probe in Embodiment 1 of the present invention;

[0025] Figure 2 This is a left-side schematic diagram of the inflatable annular bladder in a contracted state in Embodiment 1 of the present invention;

[0026] Figure 3 This is a left-side schematic diagram of the inflatable annular bladder in an inflated state according to Embodiment 1 of the present invention;

[0027] Figure 4 This is a side view of the inflatable annular bladder in a contracted state in Embodiment 1 of the present invention;

[0028] Figure 5 This is a side view of the inflatable annular bladder in an inflated state according to Embodiment 1 of the present invention;

[0029] Figure 6 This is a schematic diagram of the main fitting bag in a semi-inflated state in Embodiment 1 of the present invention;

[0030] Figure 7 This is a schematic diagram showing the main fitting bladder in a semi-inflated state and the expanding annular bladder in an expanded state in Embodiment 1 of the present invention.

[0031] Figure 8 This is a schematic diagram showing the main fitting bladder in a fully inflated state and the inflatable annular bladder in a contracted state in Embodiment 1 of the present invention.

[0032] Figure 9 This is a schematic diagram of an expandable ultrasonic sheath with an exhaust channel pipe in Embodiment 1 of the present invention;

[0033] Figure 10 This is a side view schematic diagram of the inflatable annular bladder in a contracted state in Embodiment 2 of the present invention;

[0034] Figure 11 This is a side view of the inflatable annular bladder in an inflated state in Embodiment 2 of the present invention.

[0035] Figure label:

[0036] 100. Ultrasonic probe;

[0037] 1. Outer casing; 2. Inflatable annular bladder; 3. Bubble trapping bladder; 4. First injection channel tube; 5. Second injection channel tube; 6. First switching valve; 7. Second switching valve; 8. Cable tie; 9. Exhaust channel tube;

[0038] 11. Main fitting bag;

[0039] 21. Control channel; 211. First sawtooth structure; 212. Second sawtooth structure; 22. Annular control cavity; 23. Elevating cavity; 24. Elastic reset connector. Detailed Implementation

[0040] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0041] In the description of this invention, unless otherwise explicitly specified and limited, the terms "connected," "linked," and "fixed" should be interpreted broadly. For example, they can refer to a fixed connection or a detachable connection; a mechanical connection or an electrical connection; a direct connection or an indirect connection through an intermediate medium; or the internal communication of two components or the interaction between two components. Those skilled in the art can understand the specific meaning of the above terms in this invention according to the specific circumstances.

[0042] In the description of this invention, unless otherwise expressly specified and limited, "above" or "below" the second feature can include direct contact between the first and second features, or contact between the first and second features through another feature between them. Furthermore, "above," "over," and "on top" of the second feature includes the first feature being directly above or diagonally above the second feature, or simply indicates that the first feature is at a higher horizontal level than the second feature. "Below," "below," and "under" the second feature includes the first feature being directly below or diagonally below the second feature, or simply indicates that the first feature is at a lower horizontal level than the second feature.

[0043] Embodiments of the present invention are described in detail below. Examples of these embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals denote the same or similar components or components having the same or similar functions throughout. The embodiments described below with reference to the accompanying drawings are exemplary and intended to explain the present invention, and should not be construed as limiting the present invention.

[0044] In the vast field of modern interventional medicine, ultrasound imaging technology has become an indispensable tool due to its unique advantages. Typically, an ultrasound probe needs specialized auxiliary equipment to carefully enter the body cavity for examination. Once successfully inserted, the probe begins to function powerfully, precisely emitting and receiving ultrasound waves to acquire tomographic images of the tissue. These images allow doctors to clearly observe the subtle structures and changes within the tissue. This capability enables ultrasound to detect early-stage cancers and small tumors hidden within tissues. Early-stage cancers and small tumors often present with no obvious symptoms in their early stages, making them difficult to detect. However, ultrasound imaging technology can identify them in their nascent stages, enabling early tumor screening. This is crucial for improving cancer cure rates, reducing patient mortality, and improving patients' quality of life. Therefore, it has become a commonly used method for diagnosing lesions in tissue cavities and is widely applied in clinical practice.

[0045] However, in practical applications, ultrasound imaging technology also faces some pressing problems. Currently, when performing ultrasound examinations through natural cavities (such as the rectum and vagina), several issues often arise that affect image quality. Firstly, due to the irregular shapes of the body's natural cavities, it is difficult to achieve a completely seamless fit between the ultrasound probe and the tissue. Secondly, the coupling gel used during the examination inevitably contains some tiny air bubbles. These bubbles interfere with the propagation path of ultrasound waves, causing scattering and attenuation of the ultrasound signal during transmission, thus reducing the quality of the acquired images and resulting in blurriness and unclear images, affecting the doctor's accurate assessment of the lesion.

[0046] On the other hand, when there is insufficient bodily fluid at the lesion site to serve as an ultrasound transmission medium, saline solution needs to be injected into the lesion site to enable ultrasound imaging. Saline solution, as a commonly used ultrasound transmission medium, can improve ultrasound imaging conditions to some extent. However, the current method of directly injecting saline solution has a significant drawback: the lack of an effective air bubble removal mechanism. During injection, air can easily mix into the saline solution, forming bubbles. Once these bubbles enter the lesion site, they interfere with the propagation of ultrasound waves, similar to bubbles in natural cavity coupling agents, thus affecting image quality. This decline in image quality may cause doctors to miss subtle lesion information, thereby delaying diagnosis and treatment, and posing potential risks to the patient's health.

[0047] To assist ultrasound probes in detection, ensure close contact with tissue, eliminate air bubble interference, and improve image quality, this embodiment provides an expandable ultrasound sheath, which is described below. Figures 1 to 11 The specific content of this embodiment will be described in detail. It should be noted that, in this embodiment, "vertical" refers to... Figure 2 The Z direction in the equation.

[0048] Example 1

[0049] like Figures 1 to 5As shown, the expandable ultrasonic sheath in this embodiment includes an outer sheath body 1, an expandable annular bladder 2, and a bubble trapping bladder 3. Each part cooperates with the others to achieve the goal of high-quality ultrasonic imaging. The outer sheath body 1 serves as the basic structure of the entire expandable ultrasonic sheath. The outer sheath body 1 has an internal accommodating chamber, a design that provides the necessary space for inserting the ultrasonic probe 100, subsequent liquid injection, and bubble removal. The outer sheath body 1 is fitted onto and secured to the ultrasonic probe 100 (e.g., using a cable tie 8 to ensure it does not loosen or fall off during use, providing a solid guarantee for the stability of ultrasonic imaging. Liquid leakage is prevented when adding liquid to the outer sheath body 1). The outer sheath body 1 is also divided into an imaging functional area and a non-imaging functional area according to functional requirements. At least the imaging functional area is made of a soft material with excellent flexibility and conformability. When liquid is injected, the imaging functional area expands naturally under liquid pressure, forming the main conforming bladder 11. The main fitting bag 11 can closely conform to human tissue, effectively reducing the scattering and reflection of ultrasound waves during propagation. This allows more ultrasound waves to accurately reach the tissue and be reflected back, significantly improving the clarity and accuracy of the images acquired by the ultrasound probe 100. The expandable annular bag 2 is located in the non-imaging functional area of ​​the outer casing 1 and is connected to the outer casing 1. The unique feature of the expandable annular bag 2 is that its inner wall forms a control channel 21. One end of the control channel 21 is connected to the main fitting bag 11, and the other end is connected to the bubble trapping bag 3, playing a crucial regulatory role in the entire bubble removal system. The control channel 21 can be opened when the expandable annular bag 2 expands and closed when the expandable annular bag 2 contracts. The bubble trapping bag 3 is located in the non-imaging functional area of ​​the outer casing 1 and is connected to the expandable annular bag 2. The expansion of the expandable annular bag 2 raises the bubble trapping bag 3, which is connected to the outer casing 1 via the control channel 21. When an air bubble in the main fitting capsule 11 enters the air bubble trapping capsule 3 through the control channel 21, the air bubble is stably trapped within it and cannot return to the main fitting capsule 11 to interfere with ultrasound imaging. The design of the air bubble trapping capsule 3 not only solves the problem of air bubble interference with ultrasound imaging, but also ensures the stability and reliability of the entire system.

[0050] When pressure is applied to the annular bladder 2, it expands rapidly. As the expansion increases, the previously closed control channel 21 gradually opens, forming a clear passage. Simultaneously, the expansion of the annular bladder 2 generates an upward lifting force, elevating the connected bubble-capturing bladder 3. This synergistic effect provides a clear path for the air bubbles in the liquid within the main fitting bladder 11 to escape. Under buoyancy, the bubbles move upwards with the liquid, pass through the opened control channel 21, and smoothly enter the bubble-capturing bladder 3, thus effectively venting the air bubbles from the main fitting bladder 11. When the pressure inside the annular bladder 2 is reduced, it gradually contracts. As the contraction progresses, the opening of the control channel 21 gradually narrows, eventually closing completely. This closing process effectively prevents air bubbles from flowing back from the bubble-capturing bladder 3 into the main fitting bladder 11, ensuring that the main fitting bladder 11 always maintains a relatively bubble-free environment, further improving the quality of ultrasound imaging.

[0051] In summary, the expandable ultrasonic sheath provided in this embodiment effectively solves the problem of air bubbles interfering with ultrasound imaging through its ingenious structural design. After liquid injection, the main adhering bladder 11 adheres tightly to the tissue under liquid pressure, providing a stable foundation for ultrasound imaging. The coordinated work of the expanding annular bladder 2 and the air bubble trapping bladder 3 effectively and promptly removes air bubbles from the main adhering bladder 11, avoiding interference with ultrasound wave propagation and enabling the ultrasound probe 100 to acquire clearer and more accurate images. This is crucial for doctors to accurately diagnose conditions and formulate appropriate treatment plans. For example, in the diagnosis of cardiovascular diseases, clear ultrasound images help doctors accurately observe the structure and function of the heart, promptly identify potential problems, and gain valuable time for patient treatment. Traditional ultrasound probes 100 are easily contaminated and damaged during use due to frequent contact with human tissue and various liquids. To ensure safety and effectiveness for subsequent use, the ultrasound probe 100 requires rigorous cleaning and disinfection after each use. However, frequent cleaning and disinfection not only consume significant time and labor costs but may also damage the surface of the ultrasound probe 100, shortening its lifespan. The expandable ultrasonic sheath provided in this embodiment is a disposable product, which can be discarded after each use without the need for cleaning and disinfection of the ultrasonic probe 100. This not only greatly saves time and labor costs but also avoids damage to the ultrasonic probe 100 caused by improper cleaning and disinfection, effectively ensuring the service life of the ultrasonic probe 100 and reducing the cost of using medical equipment. In the medical environment, cross-infection is a serious problem that cannot be ignored. As a medical device that comes into direct contact with the patient's body, the ultrasonic probe 100 can easily become a medium for the spread of pathogens if it is not effectively protected and disinfected during use, leading to cross-infection between patients. The disposable nature of this expandable ultrasonic sheath fundamentally avoids the risk of cross-infection caused by the reuse of the ultrasonic probe 100. Each use of a new expandable ultrasonic sheath is equivalent to providing a brand new, clean protective layer for the ultrasonic probe 100, ensuring the safety of each patient when using the ultrasonic probe 100 and providing strong protection for the patient's health. It effectively avoids the risk of cross-infection.

[0052] Furthermore, the front end of the expandable annular bladder 2 is provided with an annular control cavity 22. The longitudinal cross-section of the annular control cavity 22 is crescent-shaped and curved towards the outer sheath body 1. The rear end of the expandable annular bladder 2 is provided with an elevation cavity 23, which extends away from the main fitting bladder 11. The bubble trapping bladder 3 is located at the top of the elevation cavity 23. As the core control component of the expandable ultrasonic sheath, the expandable annular bladder 2 has an annular control cavity 22 at its front end and an elevation cavity 23 at its rear end. This unique multi-cavity design provides key support for achieving precise bubble discharge. When pressure is applied to the expandable annular bladder 2, the annular control cavity 22 expands and deforms like an inflated annular balloon. The control channel 21 formed by the inner wall of its inner ring is like the inner hole of the annular balloon. As the annular control cavity 22 expands, the control channel 21 gradually opens, and the originally closed channel opening slowly expands, providing a channel for bubble discharge. This process can be compared to the inflation and deformation of a lifebuoy. When air is inflated into a lifebuoy, the inner hole of the inner ring increases as the lifebuoy expands; when air is deflated, the inner hole gradually decreases until it closes. The working principle of the annular control cavity 22 is similar. By inflating and deflating, it precisely controls the opening and closing of the control channel 21, thereby regulating the expulsion of air bubbles. The lifting cavity 23 extends away from the main fitting bladder 11, and the air bubble trapping bladder 3 is cleverly located at the top of the lifting cavity 23. When pressure is applied to the expanding annular bladder 2, the lifting cavity 23 also expands accordingly. As the lifting cavity 23 expands, the height of its top continuously increases, thereby raising the air bubble trapping bladder 3 so that its height is higher than that of the main fitting bladder 11. This height difference design is a key factor in enabling air bubbles to move quickly and smoothly from the main fitting bladder 11 to the air bubble trapping bladder 3.

[0053] Furthermore, the inner wall of the annular control cavity 22 forms a control channel 21. When closed, the longitudinal section of the control channel 21 is crescent-shaped, and the control channel 21 bends towards the outer body 1. First, the crescent shape allows the control channel 21 to fit tightly when closed, effectively preventing leakage of liquid and bubbles when unpressurized, ensuring the system's sealing and stability. Second, when pressurization is applied to the expansion annular bladder 2, the annular control cavity 22 expands, allowing the crescent-shaped control channel 21 to open more smoothly without jamming, ensuring smooth bubble discharge. When pressurization is applied to the expansion annular bladder 2, the annular control cavity 22 expands, opening the control channel 21 and raising the height of the bubble-capturing bladder 3. Under the action of buoyancy, bubbles in the liquid in the main fitting bladder 11 will quickly move along the control channel 21 into the bubble-capturing bladder 3. Since the height of the bubble-capturing bladder 3 is higher than that of the main fitting bladder 11, bubbles can enter it more smoothly and will not easily flow back. In this way, a large number of air bubbles are expelled from the main adhering capsule 11, reducing the interference of air bubbles on the propagation of ultrasound waves and enabling the ultrasound probe 100 to acquire clearer and more accurate images. For example, in liver ultrasound examinations, clear images help doctors accurately observe the shape, size, and internal structure of the liver, and detect liver lesions such as fatty liver, cirrhosis, and tumors in a timely manner, providing a strong basis for the early diagnosis and treatment of diseases. In traditional ultrasound examinations, in order to eliminate the interference of air bubbles on the imaging, doctors may need to adjust the position of the ultrasound probe 100 multiple times, or try to expel air bubbles by shaking or squeezing. These operations are not only cumbersome, but also often ineffective. However, the operation of this expandable ultrasound sheath is very simple. Simply pressurizing the expandable annular capsule 2 can automatically expel air bubbles. After pressurization, the annular control cavity 22 and the elevation cavity 23 work together to open the control channel 21 and raise the air bubble capture capsule 3. The entire process does not require complicated operations by the doctor, greatly saving examination time and improving work efficiency. At the same time, this automated air bubble expulsion method also reduces the influence of human factors on the examination results, improving the accuracy and reliability of the examination.

[0054] Furthermore, the upper wall of the control channel 21 is provided with several sets of first sawtooth structures 211, and the lower wall of the control channel 21 is provided with several sets of second sawtooth structures 212. The first sawtooth structures 211 and their corresponding second sawtooth structures 212 mesh with each other. The second sawtooth structures 212 and the first sawtooth structures 211 are matched in shape and size, like a pair of perfectly fitting puzzle pieces. When the control channel 21 is in the closed state, the first sawtooth structures 211 and their corresponding second sawtooth structures 212 mesh with each other, like the tight meshing of gears, forming a perfectly fitted whole. This meshing method is not a simple surface contact, but achieves a multi-layered sealing effect through the interlocking of the sawtooths. After the control channel 21 is closed, the meshing of the first sawtooth structures 211 and the second sawtooth structures 212 greatly improves the airtightness of the control channel 21. When the control channel 21 is closed, sealing may only rely on the contact of two planes. This method is easily affected by factors such as surface flatness and uneven pressure distribution, leading to poor sealing and leakage of liquid or air bubbles. In this embodiment, the serrated structure, through interlocking, increases the contact area and sealing layers. Even if one serration has minor unevenness or defects, the other serrations can still mesh tightly, forming an effective sealing barrier. This multi-layered sealing mechanism effectively prevents liquid and air bubbles from leaking when the control channel 21 is closed, ensuring a stable liquid environment within the main sealing bladder 11 and providing a fundamental guarantee for high-quality ultrasound imaging. The interlocking of the serrated structure not only improves the airtightness but also enhances the overall structural stability of the control channel 21. During ultrasound examinations, the ultrasound sheath may be subjected to various external pressures, such as patient movement and medical staff operations. These pressures may cause deformation of the control channel 21, affecting its sealing performance and normal function. However, the interlocking of the first sawtooth structure 211 and the second sawtooth structure 212 forms a connection similar to a mortise and tenon joint, allowing the upper and lower walls to support and constrain each other. When subjected to external pressure, the meshing force between the sawtooths can disperse the pressure, preventing excessive deformation of the control channel 21. This structural stability ensures that the control channel 21 maintains a good sealing state under various complex operating environments, accurately controlling the discharge of air bubbles and providing strong support for the stability and reliability of ultrasonic imaging. During the frequent opening and closing of the control channel 21, friction and wear between components are unavoidable. Long-term wear may lead to a decrease in sealing performance and even affect the service life of the entire device. The sawtooth structure design reduces this wear and fatigue to a certain extent. Because the contact between the sawtooth structures is multi-point contact, the pressure distribution per unit area is more uniform compared to traditional planar contact, reducing local stress concentration.This means that during opening and closing, the wear between the saw teeth is more uniform, preventing localized excessive wear. Simultaneously, the uniform pressure distribution helps reduce material fatigue damage, extending the service life of the control channel 21 and related components. For disposable, expandable ultrasonic sheaths, while long-term wear is not a concern, this design improves product quality stability, reduces defect rates, and lowers production costs. For reusable devices (if future improvements and applications occur), this design can significantly extend their service life and reduce the cost of using medical equipment.

[0055] For example, both the first serrated structure 211 and the second serrated structure 212 are trapezoidal or triangular. When the first serrated structure 211 and the second serrated structure 212 are trapezoidal, the difference in length between the upper and lower bases and the inclination angle of the hypotenuse have unique performance advantages. During the closing process of the control channel 21, the hypotenuse of the trapezoidal serrations can play a good guiding role, allowing the serrations on the upper and lower walls to interlock more smoothly, reducing the problem of loose meshing caused by positional deviation. This smooth interlocking process can ensure a tight seal under relatively low pressure, improving the efficiency and reliability of the seal. At the same time, the trapezoidal shape design results in a large contact area between the serrations and a relatively uniform pressure distribution. When subjected to external pressure or internal liquid pressure, the large contact area can disperse the pressure and enhance the stability of the seal. Even if one or several serrations have minor defects or wear, the other serrations can still provide sufficient sealing force to ensure the airtightness of the control channel 21. If the first sawtooth structure 211 and the second sawtooth structure 212 are triangular, the sharp angles and characteristics of the three sides of the triangular sawtooth offer unique sealing advantages. The sharp vertices of the triangles can quickly embed into the grooves of the opposing sawtooths upon closure, forming a tight point-contact seal. This point-contact sealing method can quickly and effectively prevent leakage of liquids and air bubbles in the initial sealing stage, especially under low pressure, rapidly establishing a sealing barrier. Furthermore, the triangular sawtooth structure has good flexibility, adapting to pressure changes in different directions. During ultrasonic testing, the control channel 21 may be subjected to complex pressures from multiple directions. The three sides of the triangular sawtooth can automatically adjust their engagement state according to the direction of the pressure, maintaining a tight seal at all times. For example, when the device is subjected to lateral pressure, the hypotenuses of the triangular sawtooth can readjust their engagement position through mutual compression and sliding, ensuring that the sealing performance is not affected. This flexible adaptability allows the triangular sawtooth structure to be used reliably in various complex operating environments.

[0056] Furthermore, the soft material is made of rubber or silicone. Rubber has excellent elasticity, allowing it to deform under external force and quickly return to its original shape after the force is removed. In the expandable ultrasonic sheath, the rubber-made expandable annular bladder 2 can easily expand under pressure, opening the control channel 21 and raising the bubble capture bladder 3; it can also quickly contract back to its original shape under decompression, restoring the device to its initial state. This good elasticity allows the device to be used repeatedly without significant performance degradation during repeated expansion and contraction. Simultaneously, rubber also has good abrasion resistance. During ultrasound examinations, the ultrasonic sheath may rub against the patient's skin, clothing, and other objects; the abrasion resistance of rubber ensures that the device is not easily worn during long-term use, extending its service life. In addition, rubber also has a certain degree of flexibility, allowing it to better conform to the human body surface, reducing patient discomfort and improving the patient's examination experience. Silicone, with its excellent biocompatibility, is widely used in the medical field. In the expandable ultrasonic sheath, silicone comes into direct contact with the patient's skin and bodily fluids without causing allergic reactions or other adverse reactions, ensuring patient safety. This is especially important for patients with sensitive skin or those requiring prolonged ultrasound examinations. Furthermore, silicone material boasts excellent chemical stability, resisting the corrosive effects of various chemicals. Simultaneously, its smooth surface does not easily attract bacteria and dirt, facilitating cleaning and disinfection, further reducing the risk of cross-infection.

[0057] Furthermore, the outer casing 1, the expanding annular bladder 2, and the bubble trapping bladder 3 are integrally molded structures. This integral molding structure eliminates any noticeable seams between the outer casing 1, the expanding annular bladder 2, and the bubble trapping bladder 3, preventing leakage problems caused by weak connections. During pressurization and expansion, the integral structure can evenly distribute pressure, reducing local stress concentration and thus enhancing the overall structural strength of the device. Even under high pressure, the device will not rupture or deform, ensuring the normal operation of the control channel 21 and the bubble trapping bladder 3. For example, during some ultrasound examinations requiring high pressure, the integral molding structure can withstand greater pressure, ensuring the sealing of the control channel 21 and the stability of the bubble trapping bladder 3, providing reliable support for ultrasound imaging. Simultaneously, the absence of seams reduces the hiding places for bacteria and dirt, improving the device's hygiene performance and reducing the risk of cross-infection.

[0058] Furthermore, the expandable ultrasonic sheath also includes a first injection channel tube 4 and a second injection channel tube 5. The first injection channel tube 4 is located in the non-imaging functional area of ​​the outer sheath body 1, and one end of the first injection channel tube 4 is connected to the outer sheath body 1 and communicates with the main fitting sac 11. The second injection channel tube 5 is located in the non-imaging functional area of ​​the outer sheath body 1, and one end of the second injection channel tube 5 is connected to the outer sheath body 1 and communicates with the expandable annular sac 2. The core of ultrasound examination is to obtain clear and accurate images. The imaging functional area needs to be kept as simple and stable as possible, avoiding any factors that may interfere with the ultrasound signal. Placing the first injection channel tube 4 and the second injection channel tube 5 in the non-imaging functional area of ​​the outer sheath body 1 ensures that they will not interfere with ultrasound imaging, guaranteeing the quality and accuracy of the imaging. At the same time, the non-imaging functional area usually has a relatively spacious layout, providing convenient conditions for the installation and connection of the injection channel tubes. This layout allows the injection channel tubes to be firmly connected to the outer sheath body 1, reducing the risk of leakage due to weak connections and improving the overall reliability of the device. For example, in complex ultrasound examinations, medical staff can operate the device more freely without worrying that the injection channel tube might affect imaging function due to collisions or pulling. The main fitting capsule 11 and the expandable annular capsule 2 serve different functions within the expandable ultrasound sheath. The main fitting capsule 11 is primarily used to adhere to human tissue, providing a stable ultrasound imaging environment; the expandable annular capsule 2 controls the opening and closing of the control channel 21, as well as the elevation and lowering of the air bubble trapping capsule 3, through expansion and contraction. Through the first injection channel tube 4 and the second injection channel tube 5, medical staff can inject appropriate amounts of liquid into the main fitting capsule 11 and the expandable annular capsule 2 according to actual examination needs. For example, before an ultrasound examination, an appropriate amount of coupling agent or saline solution can be injected into the main fitting capsule 11 through the first injection channel tube 4, allowing it to better adhere to the human body surface, reducing air gaps, improving the transmission efficiency of ultrasound signals, and thus obtaining clearer images. Simultaneously, liquid is injected into the expansion annular bladder 2 through the second injection channel tube 5, causing it to expand, opening the control channel 21 and raising the bubble-capturing bladder 3, preparing for the expulsion and capture of bubbles. This precise fluid delivery control can meet the needs of different examination scenarios and examination sites, improving the flexibility and adaptability of ultrasound examinations.

[0059] Furthermore, a first switching valve 6 is installed on the first injection channel tube 4, and a second switching valve 7 is installed on the second injection channel tube 5. These two switching valves provide a flexible control method for fluid delivery. During ultrasound examination, medical staff can open or close the switching valves at any time as needed to control the injection and cessation of fluid. For example, when injecting fluid into the main apposition bladder 11 or the inflatable annular bladder 2, the corresponding switching valve is opened, allowing the fluid to flow smoothly into the bladder; when the required pressure or volume is reached, the switching valve is closed to prevent further fluid inflow and avoid over-inflation or excessive pressure in the bladder. In addition, the switching valves can also be used to regulate the fluid flow rate. By partially opening or closing the switching valves, the injection speed of the fluid can be controlled, making the expansion or contraction process of the bladder more stable and controllable. This flexible opening and closing and flow regulation function allows medical staff to more accurately control the working status of the device, improving the accuracy and stability of ultrasound examination.

[0060] For example, in this embodiment, the working process of the expandable ultrasonic sheath is as follows:

[0061] 1. Main Adhesion Bag 11 in Semi-Inflated State: A portion of fluid is injected into the main adhesion bag 11 through the first injection channel tube 4. At this time, the main adhesion bag 11 is filled with liquid and is in a semi-inflated state, with the internal air bubbles floating on the top, such as... Figure 6 As shown.

[0062] II. Opening state of the expansion annular bladder 2: Liquid or air is injected into the expansion annular bladder 2 through the second injection channel tube 5, causing the expansion annular bladder 2 to inflate. The cross-sections of the expansion annular bladder 2 before and after opening are shown below. Figure 2 and Figure 3 As shown, after the annular bladder 2 is inflated, the channel between the main bonding bladder 11 and the bubble trapping bladder 3 becomes open. Simultaneously, the inflation of the annular bladder 2 raises the bubble trapping bladder 3 to a position higher than the main bonding bladder 11. At this time, the bubbles in the main bonding bladder 11 are transferred to the bubble trapping bladder 3 under the action of buoyancy. Figure 7 As shown.

[0063] III. Retracted State of the Expanding Annular Bag 2: When the fluid inside the expanding annular bag 2 is extracted, the bag collapses, and the control channel 21 is blocked by the collapsed pipe wall, causing the two bags to disconnect. The bubble trapping bag 3 falls back to its initial position under the action of gravity. At this time, the expanding annular bag 2 returns to the same state as the semi-inflated state of the main fitting bag 11, but the bubbles in the main fitting bag 11 are transferred to the bubble trapping bag 3. (If necessary, an exhaust channel pipe 9 can be added to connect the bubble trapping bag 3 to the outside to discharge the bubbles in the bubble trapping bag 3, such as...) Figure 9 (As shown).

[0064] IV. In working condition, continue to inject liquid into the main adhesion capsule 11 through the first injection channel tube 4, causing the main adhesion capsule 11 to expand until it adheres well to the tissue, such as... Figure 8 As shown.

[0065] V. Withdrawal State: Inflate the annular bladder 2 again, and at the same time drain the liquid inside the two bladders (main fitting bladder 11 and bubble trapping bladder 3) through the first injection channel tube 4. Then, extract the fluid from the annular bladder 2, and the whole thing returns to the state before insertion.

[0066] Furthermore, the soft material includes an ultrasound-detecting material. These materials include micron-sized zirconium dioxide, titanium dioxide, or polymer microbubbles. This allows the water sac boundaries or specific marked areas formed by the material to appear as clear hyperechoic contours or markers on ultrasound images, aiding in the identification of tissue and instrument boundaries.

[0067] Example 2

[0068] This embodiment provides an expandable ultrasonic sheath. Compared with Embodiment 1, the basic structure of the expandable ultrasonic sheath provided in this embodiment is the same as that in Embodiment 1, except that the internal settings of the control channel 21 are different. This embodiment will not describe the structure that is the same as that in Embodiment 1 again.

[0069] Furthermore, such as Figure 10 and Figure 11As shown, a plurality of elastic reset connectors 24 are provided within the control channel 21. One end of each elastic reset connector 24 is connected to the upper wall of the control channel 21, and the other end is connected to the lower wall of the control channel 21. Each elastic reset connector 24 always has a tendency to close the control channel 21. When the control channel 21 is opened, the elastic reset connector 24 is in a stretched state. For example, the elastic reset connector 24 is made of rubber. When not subjected to external force, the molecular structure of the elastic reset connector 24 is in a relatively balanced state. At this time, it generates an inward contraction force, attempting to pull the upper and lower walls of the control channel 21 together, thereby keeping the control channel 21 closed. This closing tendency is an inherent property of the elastic reset connector 24, providing an automatic reset function for the entire device without the need for an additional power source or complex control mechanism. When the control channel 21 needs to be operated to open, a sufficiently large external force (adding liquid or gas into the expansion annular bladder 2) is required to overcome the contractile force of the elastic reset connector 24. Under this external force, the upper and lower walls of the control channel 21 gradually separate, and the elastic reset connector 24 is stretched, its internal molecular structure deforms, and it stores a certain amount of elastic potential energy. At this time, the control channel 21 opens, and fluids or other substances can flow or be transported through the control channel 21.

[0070] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the implementation of the present invention. Those skilled in the art can make other variations or modifications based on the above description. It is neither necessary nor possible to exhaustively describe all embodiments here. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the scope of protection of the claims of the present invention.

Claims

1. An expandable ultrasonic sheath, characterized in that, include: The outer body (1) has a accommodating chamber, is fitted onto the ultrasound probe (100) and is tightly fastened to the ultrasound probe (100). The outer body (1) has an imaging functional area and a non-imaging functional area. At least the material of the imaging functional area is a soft material and forms a main fitting bag (11). An inflatable annular bladder (2) is located in the non-imaging functional area of ​​the outer casing (1). The inflatable annular bladder (2) is connected to the outer casing (1). The inner wall of the inner ring of the inflatable annular bladder (2) forms a control channel (21). One end of the control channel (21) is connected to the main fitting bladder (11). The control channel (21) can be opened after the inflatable annular bladder (2) expands, and the control channel (21) can be closed after the inflatable annular bladder (2) contracts. The bubble trapping bladder (3) is located in the non-imaging functional area of ​​the outer casing (1). The bubble trapping bladder (3) is connected to the inflatable annular bladder (2). The other end of the control channel (21) is connected to the bubble trapping bladder (3). After the inflatable annular bladder (2) expands, it can raise the bubble trapping bladder (3). The bubble trapping bladder (3) is connected to the outer casing (1) through the control channel (21).

2. The expandable ultrasonic sheath according to claim 1, characterized in that, The front end of the expansion annular bladder (2) is provided with an annular control cavity (22), the longitudinal section of the annular control cavity (22) is crescent-shaped and curved toward the outer body (1), the rear end of the expansion annular bladder (2) is provided with an elevation cavity (23), the elevation cavity (23) extends away from the main fitting bladder (11), and the bubble capturing bladder (3) is located at the top of the elevation cavity (23).

3. The expandable ultrasonic sheath according to claim 2, characterized in that, The inner wall of the inner ring of the annular control cavity (22) forms the control channel (21). When the control channel (21) is closed, its longitudinal section is crescent-shaped, and the control channel (21) bends toward the outer body (1).

4. The expandable ultrasonic sheath according to claim 1, characterized in that, The upper wall of the control channel (21) is provided with a plurality of first sawtooth structures (211), and the lower wall of the control channel (21) is provided with a plurality of second sawtooth structures (212). The first sawtooth structures (211) and the corresponding second sawtooth structures (212) mesh with each other.

5. The expandable ultrasonic sheath according to claim 4, characterized in that, Both the first sawtooth structure (211) and the second sawtooth structure (212) are trapezoidal or triangular.

6. The expandable ultrasonic sheath according to claim 1, characterized in that, The control channel (21) is provided with a plurality of elastic reset connectors (24). One end of the elastic reset connector (24) is connected to the upper wall of the control channel (21), and the other end of the elastic reset connector (24) is connected to the lower wall of the control channel (21). The elastic reset connector (24) always has a tendency to close the control channel (21). When the control channel (21) is opened, the elastic reset connector (24) is in a stretched state.

7. The expandable ultrasonic sheath according to claim 1, characterized in that, The soft material is made of rubber or silicone, and / or the outer shell body (1), the expansion annular bladder (2) and the bubble trapping bladder (3) are integrally molded structures.

8. The expandable ultrasonic sheath according to claim 1, characterized in that, The expandable ultrasonic sheath also includes: The first injection channel tube (4) is located in the non-imaging functional area of ​​the outer body (1). One end of the first injection channel tube (4) is connected to the outer body (1) and communicates with the main fitting bag (11). The second injection channel tube (5) is located in the non-imaging functional area of ​​the outer casing (1). One end of the second injection channel tube (5) is connected to the outer casing (1) and communicates with the inflatable annular bladder (2).

9. The expandable ultrasonic sheath according to claim 8, characterized in that, A first switching valve (6) is provided on the first injection channel pipe (4); and / or a second switching valve (7) is provided on the second injection channel pipe (5).

10. The expandable ultrasonic sheath according to any one of claims 1-9, characterized in that, The soft material includes an ultrasonic imaging material.

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