An ultra-fine stone probe

Abstract

This invention provides an ultrafine lithotripsy probe, comprising a probe base and a probe body. One end of the probe base has a mounting hole for installing the probe body. The probe body is installed in the mounting hole using an interference fit. The overall length of the ultrafine lithotripsy probe is 550mm–610mm, and the diameter of the probe body is 1.1±0.2mm. This invention can directly reach the stone lesion location through natural body cavities such as the ureter, without requiring minimally invasive perforation of the body surface, resulting in minimal trauma. Simultaneously, its structural dimensions are rationally configured, with high ultrasonic vibration transmission efficiency, excellent overall bending and fracture resistance, and is not easily broken, thus meeting the clinical needs for non-invasive lithotripsy of urinary tract stones.

Description

Technical Field

[0001] This invention relates to the field of ultrasonic lithotripsy, and more specifically, to 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 an ultrafine lithotripsy probe that can directly reach the stone location through natural cavities such as the ureter to perform ultrasonic lithotripsy. It has the outstanding advantages of high lithotripsy efficiency and no thermal damage, effectively solving the shortcomings of traditional treatment methods, reducing the incidence of complications, and improving clinical treatment outcomes. Summary of the Invention

[0005] To address the problems in related technologies, this invention provides an ultrafine lithotripsy probe.

[0006] The present invention provides an ultrafine lithotripsy probe, comprising a probe base and a probe body. One end of the probe base is provided with a mounting hole for mounting the probe body. The probe body is mounted in the hole by an interference fit. The overall length of the ultrafine lithotripsy probe is 550mm to 610mm, and the diameter of the probe body is 1.1±0.2mm.

[0007] Preferably, the probe body surface is covered with an adhesive structure for limiting the lateral amplitude, and the distance between the adhesive structure and the tip of the probe body is n / 4λ±10mm, where n is a positive integer and λ is the ultrasonic length of the ultrafine lithotripsy probe at the rated operating frequency.

[0008] Preferably, it also includes a cooling component, which is sleeved on the connection between the probe base and the probe body.

[0009] Preferably, both the probe base and the probe body are made of TC4 titanium alloy.

[0010] Preferably, the depth of the mounting hole is not less than 8 mm, and the depth to which the probe body is inserted into the mounting hole is 5 mm to 8 mm.

[0011] Preferably, the probe body has a recessed structure on its simple working end face.

[0012] Preferably, the pit structure is a spherical pit with a diameter of 0.2mm to 0.7mm and a depth of 0.1mm to 0.4mm.

[0013] Preferably, the working end face of the probe body tip is provided with a raised area, which is composed of raised parts of different heights.

[0014] Compared with the prior art, the beneficial effects of the present invention are as follows: The ultrafine lithotripsy probe disclosed in this invention can be non-invasively inserted through natural cavities such as the ureter to directly reach the lesion and act on and contact the urinary tract stone. It eliminates the need for minimally invasive puncture and hole creation on the patient's body surface, thereby avoiding the problems of wound damage, postoperative infection and long recovery period caused by invasive surgery. It significantly reduces the risk of surgical trauma and clinical complications, and improves the patient's treatment comfort and postoperative recovery efficiency.

[0015] This invention features a refined and targeted design that matches the overall length, outer diameter, external coating structure, and cooling components of the probe. This allows the probe to be smoothly inserted into the ureter during ureterolithotomy, comprehensively covering clinical treatment scenarios for ureteral stones at common sites. At the same time, the special assembly method ensures low loss and high efficiency in transmitting ultrasonic vibration energy to the working end of the probe, resulting in excellent resonance transmission stability and resistance to breakage.

[0016] 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

[0017] 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.

[0018] in, Figures 1 to 5The 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

[0020] 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.

[0021] 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.

[0022] 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.

[0023] 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.

[0024] 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 2 As 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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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.

[0029] In a preferred embodiment, such as Figure 1 As 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.

[0030] 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.

[0031] In a preferred embodiment, such as Figure 3As 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.

[0032] 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.

[0033] 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.

[0034] 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.

[0035] 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.

[0036] 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.

[0037] 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.

[0038] 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.

[0039] 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.

[0040] The predetermined state of the probe base 1 is as follows: the probe base 1 starts to turn red from the bottom when heated, and the reddening position rises to 2-3 mm away from the end face of the mounting hole 101 of the probe body 2, which is when the predetermined state is reached.

[0041] 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.

[0042] S4. After pressing, remove the ultrafine stone probe and perform cooling treatment.

[0043] 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.

[0044] 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.

[0045] 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.

[0046] 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.

[0047] 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.

[0048] When setting the encapsulation structure 3 on the probe body 2, an adhesive encapsulation method is adopted, that is, after applying adhesive to the inner surface of the encapsulation structure 3, it is put into the probe body 2. When fitting, the encapsulation position needs to be marked on the probe body 2 according to the above-mentioned encapsulation distance. The first encapsulation position is 1 / 4λ ± 10mm away from the tip surface of the probe body, the second encapsulation position is 1 / 4λ away from the first encapsulation position, and the subsequent encapsulation positions are arranged backward in 1 / 4λ increments. After all the encapsulation structures 3 are fitted into the designated positions, they can be placed at room temperature for curing.

[0049] 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. An ultrasonic lithotripsy probe, characterized by: The device includes a probe base and a probe body. One end of the probe base is provided with a mounting hole for mounting the probe body. The probe body is mounted in the mounting hole by an interference fit. The overall length of the ultrafine stone crushing probe is 550mm to 610mm, and the diameter of the probe body is 1.1±0.2mm.

2. The ultrafine lithotripsy probe according to claim 1, characterized in that: The probe body surface is covered with an adhesive structure to limit the lateral amplitude. The distance between the adhesive structure and the tip of the probe body is n / 4λ±10mm, where n is a positive integer and λ is the ultrasonic length of the ultrafine lithotripsy probe at the rated operating frequency.

3. The ultrafine lithotripsy probe according to claim 1, characterized in that: It also includes a cooling component, which is sleeved on the connection between the probe base and the probe body.

4. The ultrafine lithotripsy probe according to any one of claims 1-3, characterized in that: Both the probe base and the probe body are made of TC4 titanium alloy.

5. The ultrafine lithotripsy probe according to claim 1, characterized in that: The depth of the mounting hole is not less than 8mm, and the depth to which the probe body is inserted into the mounting hole is 5mm to 8mm.

6. The ultrafine lithotripsy probe according to claim 1, characterized in that: The probe body has a pitted structure on its tip working surface.

7. The ultrafine lithotripsy probe according to claim 6, characterized in that: The pit structure is a spherical pit with a diameter of 0.2mm to 0.7mm and a depth of 0.1mm to 0.4mm.

8. The ultrafine lithotripsy probe according to claim 1, characterized in that: The working end face of the probe body tip is provided with a raised area, which is composed of raised parts of different heights.

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