Processing method of ultra-fine stone probe

Abstract

This invention provides a method for processing an ultrafine lithotripsy probe, comprising the following steps: S1. Inserting one end of the probe body into the mounting hole of the probe base to complete the initial assembly; S2. Placing the initially assembled ultrafine lithotripsy probe into a pressing device and fastening the probe body to the column of the pressing device, so that the probe base is located inside the heating coil of the heating machine; S3. Starting the heating machine to heat the probe base, and when the probe base reaches a predetermined state, using the pressing device to press the probe body into the mounting hole to a predetermined depth; S4. After pressing, removing the ultrafine lithotripsy probe and performing a cooling treatment. The ultrafine lithotripsy probe produced by this processing method has the advantages of tight assembly between the probe body and the probe base, low ultrasonic transmission loss, and the connection between the probe body and the probe base is not easily broken under high-frequency ultrasonic vibration, resulting in high lithotripsy efficiency.

Description

Technical Field

[0001] This invention relates to the field of ultrasonic lithotripsy, and more specifically, to a method for processing an ultrafine lithotripsy probe. Background Technology

[0002] Ureteral stones are a common and frequently occurring disease in urology. Currently, the main equipment used in clinical practice for the treatment of ureteral stones includes extracorporeal shock wave lithotripsy (ESWL), transurethral pneumatic lithotripsy (TURP), and ureteral laser lithotripsy (LASIK). However, these traditional treatment methods all have significant limitations, resulting in poor stone fragmentation effects. The complications they cause, such as ureteral stricture, have become serious problems that urgently need to be addressed in clinical treatment.

[0003] Percutaneous nephrolithotomy (PCNL) with ultrasound is a commonly used clinical treatment for kidney stones. This technique involves inserting a lithotripsy probe into the location of the kidney stone through a minimally invasive perforation. The high-frequency vibration of the ultrasound transducer then breaks up and simultaneously removes the stone. However, this technique has clear limitations. It can only be used for PCNL procedures, requires punctures on the patient's skin, and cannot be performed through natural cavities such as the ureter, making it unsuitable for treating ureteral stones.

[0004] To address the aforementioned technical challenges, this invention provides a method for processing an ultrafine lithotripsy probe. The ultrafine lithotripsy probe manufactured using this method can directly reach the stone location through natural cavities such as the ureter to perform ultrasonic lithotripsy. It has outstanding advantages such as being less prone to breakage, having high lithotripsy efficiency, and being free from thermal damage. It can effectively solve the shortcomings of traditional treatment methods, reduce the incidence of complications, and improve clinical treatment outcomes. Summary of the Invention

[0005] To address the problems in related technologies, this invention provides a method for processing ultrafine stone crushing probes.

[0006] This invention provides a method for processing an ultrafine lithotripsy probe, comprising the following steps: S1. Insert one end of the probe body into the mounting hole of the probe base to complete the initial installation; S2. Place the initially assembled ultrafine stone crushing probe into the pressing device, and fasten the probe body to the column of the pressing device, so that the probe base is located inside the heating coil of the heating machine; S3. Start the heating machine to heat the probe base. When the probe base reaches the predetermined state, use the pressing device to press the probe body into the mounting hole to the predetermined depth. S4. After pressing, remove the ultrafine stone crushing probe and perform cooling treatment.

[0007] Preferably, the process parameters of the high-frequency induction heating machine in step S3 are set as follows: heating time 10s to 15s, holding time 1s to 3s, cooling time 1s to 3s, and output current 400A to 550A.

[0008] Preferably, the predetermined depth in step S3 is 5mm to 8mm.

[0009] In a preferred embodiment, the predetermined depth is set to 7 mm.

[0010] Preferably, the predetermined state in step S3 refers to the position where the probe base turns red from heat rising from the bottom to a distance of 2mm to 3mm from the end face of the mounting hole.

[0011] Preferably, the processing method further includes the following steps: S4. Applying an adhesive to the inner surface of the coated structure, and then fitting the coated structure onto the outside of the probe body and completing the bonding and fixing.

[0012] Preferably, step S4 further includes positioning and marking the coating positions, wherein the distance between the first coating position and the tip face of the probe body is 1 / 4λ±10mm, and the distance between each of the remaining coating positions and the adjacent previous coating position is n / 4λ, where λ is the ultrasonic length of the ultrafine lithotripsy probe at the rated working frequency.

[0013] Compared with the prior art, the beneficial effects of the present invention are as follows: The processing method of the ultrafine lithotripsy probe provided by the present invention has the advantages of tight assembly of the probe body and the probe base, low ultrasonic transmission loss, and the connection between the probe body and the probe base is not easily broken under high frequency ultrasonic vibration, resulting in high lithotripsy efficiency.

[0014] This invention discloses a method for processing ultrafine lithotripsy probes, which uses a combination of thermal expansion and mechanical pressing to fix the probe base and probe body together. First, heating expands the mounting hole of the probe base, increasing the internal clearance and reducing the insertion resistance when the probe body is pressed in. This avoids defects such as bending, deformation, and surface scratches caused by rigid interference fits, ensuring the straightness and structural integrity of the ultrafine probe body. Simultaneously, the base expands under heat before pressing, and after cooling and shrinking, a high-strength interference fit is formed, significantly improving the connection strength between the probe base and probe body. This prevents problems such as loosening, detachment, and energy attenuation during high-frequency ultrasonic vibration. Furthermore, this processing method is simple, highly controllable, and suitable for the industrial mass production of ultrafine diameter probes. It has low processing costs, high yield, and effectively ensures long-term stable vibration of the ultrafine lithotripsy probe in clinical lithotripsy surgery, improving ultrasonic transmission stability and overall reliability.

[0015] It should be understood that the above general description and the following detailed description are exemplary and explanatory only, and are not intended to limit this disclosure. Attached Figure Description

[0016] Figure 1 This is a structural diagram of an ultrafine lithotripsy probe; Figure 2 This is a structural diagram of the base of an ultrafine lithotripsy probe. Figure 3 A partial structural diagram of an ultrafine lithotripsy probe with a cooling component; Figure 4 This is a structural diagram of the probe body end face of an ultrafine lithotripsy probe. Figure 5 This is a flowchart of the processing method for ultrafine stone crushing probes.

[0017] in, Figures 1 to 5 The correspondence between the reference numerals and component names in the attached drawings is as follows: 1. Probe base; 101. Mounting hole; 102. Base body; 103. Connecting part; 2. Probe body; 201. Recessed structure; 202. First protrusion; 203. Second protrusion; 204. Third protrusion; 3. Coated structure; 4. Cooling component. Detailed Implementation

[0018] In the following, exemplary embodiments of the present disclosure will be described in detail with reference to the accompanying drawings to enable those skilled in the art to readily implement them. Furthermore, for clarity, portions unrelated to the description of exemplary embodiments have been omitted from the drawings.

[0019] In this invention, it should be understood that terms such as “comprising” or “having” are intended to indicate the presence of features, figures, steps, behaviors, components, portions or combinations thereof disclosed in this specification, and do not preclude the possibility that one or more other features, figures, steps, behaviors, components, portions or combinations thereof are present or added.

[0020] It should also be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other. The present disclosure will now be described in detail with reference to the accompanying drawings and embodiments.

[0021] It should be noted that the acquisition or display of data in this invention is authorized or confirmed by the user, or is actively selected by the user.

[0022] Embodiments of the present invention provide an ultrafine lithotripsy probe, such as Figure 1 As shown, it includes a probe base 1 and a probe body 2, as... Figure 2As shown, the probe base 1 comprises a base body 102 and a connecting part 103. The base body 102 is a cylinder used to connect an ultrasonic transducer. The top diameter of the connecting part 103 is smaller than the diameter of the base body 102, and a mounting hole 101 for connecting with the probe body 2 is provided at the top. The diameter of the probe body 2 is 1.1±0.2mm, and the diameter of the mounting hole 101 is slightly smaller than the diameter of the probe body 2. The probe body 2 and the mounting hole 101 are connected by an interference fit.

[0023] The overall length of the lithotripsy probe body 2 and probe base 1 after installation is determined by the coupling of the longitudinal and transverse wavelengths of the ultrasound. When the tip of the ultrafine lithotripsy probe is exactly at the antinode of the superposition of the longitudinal and transverse waves, the ultrasonic energy focusing effect is optimal, resulting in the best lithotripsy effect.

[0024] However, since the rated operating frequency of the ultrasonic lithotripsy unit paired with the ultrafine lithotripsy probe is 60kHz, the actual resonant frequency of different individual ultrafine lithotripsy probes fluctuates due to the influence of probe structure assembly, processing tolerances, and resonance characteristics. The actual operating frequency range is 58kHz~62kHz. This difference in operating frequency directly causes deviations in the wavelength parameters of the longitudinal and transverse waves within each probe, resulting in the optimal fitting length of a single probe being a dynamic variable that cannot be uniformly defined.

[0025] To meet the requirements of industrialized mass production and standardized design, a fixed benchmark value needs to be set for the overall length of the ultrafine lithotripsy probe. Through multiple batches of prototype manufacturing, physical installation testing, and performance verification, it has been found that for most specifications of ultrafine lithotripsy probes, with an overall length of 580mm-590mm, the tip can be stably positioned within the composite antinode range, achieving optimal levels of ultrasonic energy transmission and overall lithotripsy performance. Based on this benchmark, when the overall length deviates by 20mm in either the positive or negative direction, the probe antinode matching degree remains within the acceptable range, with no significant attenuation in lithotripsy effect and performance meeting clinical requirements. Therefore, this solution sets the benchmark overall length of the ultrafine lithotripsy probe at 550mm-610mm.

[0026] In a preferred embodiment, the interference fit is achieved by heating the probe base 1, causing the mounting hole 101 at the top of the probe base 1 to expand to a diameter greater than that of the probe body 2, then pressing the probe body 2 into the mounting hole 101, and finally cooling the probe base 1, thereby achieving a tight fit between the probe body 2 and the probe base 1. Similarly, other temperature difference methods can also be used, such as freezing the probe body 2, or heating the probe base 1 while simultaneously freezing the probe body 2, to achieve the interference fit installation.

[0027] In a preferred embodiment, such as Figure 1As shown, the surface of the probe body 2 is covered with multiple adhesive structures 3 to limit the lateral amplitude of the probe. The distance between the adhesive structure 3 and the tip of the probe body 2 is n / 4λ±10mm, where n is a positive integer and λ is the ultrasonic wave length of the ultrafine lithotripsy probe at its rated operating frequency. Specifically, there are a total of 4 adhesive structures 3. The first one is located 1 / 4λ±10mm behind the tip of the probe body 2, and the following 3 are arranged sequentially with distances of λ, 2λ, and 3λ.

[0028] The encapsulation structure 3 is made of spherical or annular silicone material with a diameter of 3mm. When the probe body 2 is placed into the instrument channel of the rigid ureteroscope, the encapsulation structure 3 can enter the instrument channel and contact the inner wall of the instrument channel, thereby limiting the lateral vibration of the probe body 2 and preventing the probe body 2 from rubbing against the instrument channel and causing damage.

[0029] In a preferred embodiment, such as Figure 3 As shown, a cooling component 4 is fitted at the connection between the probe body 2 and the probe base 1. The cooling component 4 is made of silicone and filled with liquid. It is used to cool the connection when the ultrafine stone crushing probe is working, so as to reduce the breakage rate of the probe body 2.

[0030] In a preferred embodiment, both the probe base 1 and the probe body 2 are made of TC4 titanium alloy. TC4 titanium alloy has the advantages of high strength, high toughness, fatigue resistance and extreme corrosion resistance. As the main material of the ultrafine stone crushing probe, it can ensure that the probe still has excellent strength and toughness under ultrafine diameter and is not easy to break.

[0031] In a preferred embodiment, the depth of the mounting hole 101 is not less than 8 mm, and the depth to which the probe body 2 is inserted into the mounting hole 101 is 5 mm to 8 mm. Specifically, the depth of the mounting hole 101 is 8 mm. When the probe body 2 is inserted into the mounting hole 101, its insertion depth is preferably 7 mm, so that it does not contact the bottom of the mounting hole 101. The gap left is the shrinkage space after the mounting hole 101 cools down, so as to avoid the probe body 101 being squeezed against the bottom of the mounting hole 101 when the assembly is completed and cooled, which would make the probe body 101 easy to break.

[0032] In a preferred embodiment, such as Figure 4 As shown, a recessed structure 201 is provided on the working end face of the tip of the probe body 2. Specifically, the recessed structure 201 is a spherical recess with a diameter of 0.2 mm to 0.7 mm and a depth of 0.1 mm to 0.4 mm. The recessed structure on the working end face of the tip of the probe body 2 forms a cavity. When the probe body 2 vibrates at a high frequency of 60 kHz, local eddies and cavitation bubbles easily form within the cavity, generating micro-jets and secondary impacts on the stone surface, thereby enhancing the stone fragmentation effect.

[0033] like Figure 4 As shown, a raised area is provided along the edge of the pit on the working surface of the probe body 2. Its function is to reduce slippage of the probe body 2 on the stone surface, thereby improving the accuracy and efficiency of the lithotripsy probe during operation. Specifically, the raised area consists of three sets of raised parts arranged in a ring array. The first raised part 202 is located on the outermost side, the second raised part 203 is located in the middle, and the third raised part 204 is located on the innermost side. Among them, the third raised part 204 has the highest height, and the heights of the second raised part 203 and the first raised part 202 decrease sequentially.

[0034] A second aspect of the present invention also provides a method for processing an ultrafine lithotripsy probe, such as... Figures 1-5 As shown, the processing method includes the following steps: S1. Insert one end of the probe body 2 into the mounting hole 101 of the probe base 1 to complete the initial installation; Since the diameter of the probe body 2 is larger than the inner diameter of the mounting hole 101, pre-treatment is required during initial assembly. A grinding device is used to grind the mounting end of the probe body 2 to create a chamfer, facilitating insertion into the mounting hole. The grinding length of the probe body 2 is controlled to approximately 2mm. This ensures good stability after the probe body 2 is initially inserted into the mounting hole 101, and also guarantees a large contact area between the probe body 2 and the probe base 1 after final assembly, reducing the breakage rate.

[0035] S2. Place the initially assembled ultrafine stone crushing probe vertically into the pressing device, and fasten the probe body 2 to the column of the pressing device, so that the probe base 1 is located inside the heating coil of the high-frequency induction heating machine.

[0036] The pressing device includes a tooling base and a pressing part. The pressing part includes a pressure wrench and a fixing tool. The initially assembled ultrafine stone crushing probe is placed into the pressing part so that the probe body 2 fits into the groove set in the pressing part, and the probe base 1 is placed in the heating coil of the high frequency heating machine. At the same time, the base of the pressing device abuts against each other. At this time, the ultrafine stone crushing probe is placed vertically. Then, the fixing tool is used to fix the probe body 2.

[0037] S3. Start the high-frequency induction heating machine to heat the probe base 1. When the probe base 1 reaches the predetermined state, use the pressing device to press the probe body 2 into the mounting hole 101 to the predetermined depth. When placing the probe base 1 inside the heating coil, it is necessary to ensure that the probe base 1 is centered in the heating coil so that the probe base 1 can be heated and expanded evenly. When starting the high-frequency induction heater, the circulating water pump should be turned on first to ensure sufficient water volume and smooth circulation. Then, the power switch of the high-frequency induction heater should be turned on, and the following parameters should be adjusted: heating time 10s~15s, holding time 1s~3s, cooling time 1s~3s, output current 400A-550A.

[0038] The predetermined state of the probe base 1 is as follows: the probe base 1 starts to turn red from the bottom when heated, until the reddened position rises to 2-3mm from the end face of the mounting hole 101 of the probe body 2, which is when the predetermined state is reached.

[0039] When the probe base 1 reaches the predetermined state within the heating coil of the high-frequency induction heater, the operator presses down the pressure wrench to complete the pressing action, causing the probe body 2 to be pressed into the mounting hole 101. During the pressing process, the change in the height gauge of the pressing device should be observed simultaneously to ensure that the insertion depth of the probe body 2 reaches 5-8mm, with an optimal depth of 7mm. Since the probe body 2 is already inserted into the mounting hole 101 at a depth of about 2mm during initial installation, the height gauge of the pressing device only needs to be observed to drop by 3mm-5mm during the pressing process. It is important to note that the pressure wrench should be pressed down slowly, and the changes in the probe base 1 should be observed at all times to prevent deformation of the probe base due to excessive pressing pressure.

[0040] S4. After pressing, remove the ultrafine stone probe and perform cooling treatment.

[0041] After the ultrafine crushing probe is pressed together, the heat-fitted ultrafine crushing probe is lifted using a pressure wrench, the fixing fixture is removed, and the probe is then cooled. The cooling process includes natural cooling and forced cooling. In this method, it is preferable to immerse the ultrafine crushing probe in a coolant for forced cooling.

[0042] The ultrafine lithotripsy probe needs to be used in conjunction with a rigid ureteroscope. During use, the probe body 2 of the ultrafine lithotripsy probe needs to be inserted through the instrument channel of the rigid ureteroscope. During operation, the ultrafine lithotripsy probe vibrates at a high frequency of 60kHz. If it comes into rigid contact with the rigid ureteroscope, friction will occur, causing abnormal temperature increases and potentially leading to breakage of the probe body 2 and damage to the rigid ureteroscope. To address these issues, the ultrafine lithotripsy probe also requires a silicone coating 3 to be applied to the surface of the probe body 2. The diameter of the silicone coating 3 is smaller than the diameter of the instrument channel.

[0043] Multiple coating structures 3 are provided, and the spacing between each coating structure 3 is λ, which is the wavelength of the 60kHz ultrasound in the probe body 2. Since the probe body 2 is made of TC4 titanium alloy, the length of λ is between 95mm and 105mm (due to the error of wave velocity and the resonant frequency fluctuating within a certain range of 60kHz, the value of wavelength λ will keep changing). 100mm is preferred as the standard value of wavelength λ.

[0044] The first encapsulation structure 3 is located at the tip of the probe body 2, at a distance of 1 / 4λ±10mm, preferably 2.5mm, from the tip surface. This position is at the node of the ultrasonic longitudinal wave. The encapsulation structure will not cause loss to the transmission of the ultrasonic longitudinal wave, and can ensure that the amplitude of the ultrasonic longitudinal wave is not reduced due to the encapsulation to the greatest extent. At the same time, it can limit the lateral vibration of the probe body 2 caused by the ultrasonic transverse wave and avoid the probe body 2 from making hard contact with the inner wall of the instrument channel.

[0045] The second coating structure 3 is moved backward by one wavelength λ from the first, and the third is moved backward by another wavelength λ. Subsequent coatings are arranged sequentially at intervals of λ. The coating structures 3 arranged in this way are all located at nodes of the longitudinal wave of the ultrasound, thus minimizing interference with the longitudinal wave amplitude. Simultaneously, they limit lateral vibration, preventing rigid contact with the inner wall of the instrument channel. It should be noted that to enhance lateral limiting capability, the spacing between multiple coating structures 3 can be reduced from λ to 1 / 2λ, in which case the coating remains at a node. Alternatively, it can be reduced to 1 / 4λ, which provides even stronger limiting capability, but the denser the coating, the greater the impact on the longitudinal amplitude, reducing the lithotripsy capability of the ultrafine lithotripsy probe.

[0046] When setting the overlay structure 3 on the probe body 2, an adhesive overlay method is used. This involves applying adhesive to the inner surface of the overlay structure 3 and then fitting it onto the probe body 2. During fitting, marking the overlay positions on the probe body 2 according to the aforementioned overlay distances is necessary. The first overlay position is 1 / 4λ ± 10mm from the tip surface of the probe body, the second overlay position is 1 / 4λ from the first overlay position, and subsequent overlay positions are arranged in 1 / 4λ increments. After all the overlay structures 3 are fitted into their designated positions, they can be left to cure at room temperature. It should be noted that the distance between the second and first overlay positions can also be 1 / 2λ or λ, while the remaining overlay positions maintain the same distance from the adjacent preceding overlay position.

[0047] The above description is merely a preferred embodiment of the present invention and an explanation of the technical principles employed. Those skilled in the art should understand that the scope of the invention is not limited to the specific combination of the above-described technical features, but also includes other technical solutions formed by arbitrary combinations of the above-described technical features or their equivalents without departing from the inventive concept. For example, technical solutions formed by substituting the above-described features with (but not limited to) technical features with similar functions disclosed in this invention.

Claims

1. A method for processing an ultrafine lithotripsy probe, characterized in that, Includes the following steps: S1. Insert one end of the probe body into the mounting hole of the probe base to complete the initial installation; S2. Place the initially assembled ultrafine stone crushing probe into the pressing device, and fasten the probe body to the column of the pressing device, so that the probe base is located inside the heating coil of the heating machine; S3. Start the heating machine to heat the probe base. When the probe base reaches the predetermined state, use the pressing device to press the probe body into the mounting hole to the predetermined depth. S4. After pressing, remove the ultrafine stone crushing probe and perform cooling treatment.

2. The processing method of the ultrafine lithotripsy probe according to claim 1, characterized in that, The process parameters of the high-frequency induction heating machine in step S3 are set as follows: heating time 10s~15s, holding time 1s~3s, cooling time 1s~3s, and output current 400A-550A.

3. The processing method of the ultrafine lithotripsy probe according to claim 1, characterized in that, The predetermined depth mentioned in step S3 is 5mm to 8mm.

4. The processing method of the ultrafine lithotripsy probe according to claim 3, characterized in that, The predetermined depth is 7mm.

5. The processing method of the ultrafine lithotripsy probe according to claim 1, characterized in that, The predetermined state mentioned in step S3 refers to the position where the probe base turns red from the heat rising from the bottom to a distance of 2mm to 3mm from the end face of the mounting hole.

6. The processing method of the ultrafine lithotripsy probe according to claim 1, characterized in that, It also includes the following steps: S4. Apply adhesive to the inner surface of the coated structure, then fit the coated structure onto the outside of the probe body and fix it in place.

7. The processing method of the ultrafine lithotripsy probe according to claim 6, characterized in that, Step S4 also includes positioning and marking the coating positions, wherein the distance between the first coating position and the tip face of the probe body is 1 / 4λ±10mm, and the distance between each of the remaining coating positions and the adjacent previous coating position is n / 4λ, where λ is the ultrasonic length of the ultrafine lithotripsy probe at the rated working frequency.

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