Interventional rotational atherectomy instrument and manufacturing method therefor

Abstract

The present invention relates to the technical field of medical instruments, and particularly relates to an interventional rotational atherectomy instrument and a manufacturing method therefor. The rotational atherectomy instrument comprises: an atherectomy head; a transmission shaft which is connected to one end of the atherectomy head and configured to drive the atherectomy head to rotate around the axis of the transmission shaft so as to remove vascular blockages; a guidewire which passes through the atherectomy head and the transmission shaft and points to and is inserted into the vascular blockages; and a sleeve which is sleeved on the transmission shaft, the transmission shaft rotating in the sleeve, and the atherectomy head being limited outside a sleeve opening of the sleeve. The atherectomy head comprises a base body, wherein blind holes are provided in the surface of the base body, and by means of the blind holes, the center of mass of the base body is adjusted to deviate from the advancing direction of the atherectomy head. When the transmission shaft drives the atherectomy head to rotate, the atherectomy head simultaneously moves with the center-of-mass deviation. The interventional rotational atherectomy instrument can drill a gap in a completely blocked blood vessel by means of the rotation of the atherectomy head, and can also remove blockages in a large range by means of the revolution of the atherectomy head. The interventional rotational atherectomy instrument has the advantage of high removal efficiency.

Description

Interventional atherectomy instrument and manufacturing method thereof Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an interventional atherectomy device and a manufacturing method thereof. Background Art

[0002] Minimally invasive interventional therapy is currently the preferred treatment for vascular stenosis and blockage, including coronary heart disease, cerebral infarction, intractable hypertension, and lower limb artery stenosis caused by organ ischemia due to atherosclerosis. The cause is abnormal lipid metabolism in the blood vessels. The accumulation of lipids, necrotic cells, and calcified substances on the vessel walls narrows or even completely blocks the vessel lumen, impairing normal blood flow and leading to a range of vascular diseases that seriously impact human health.

[0003] Endovascular interventional therapies include balloon angioplasty, stent implantation, laser angioplasty, ultrasonic lithotripsy, and diamond atherectomy. Atherosclerosis, with the continuous deposition of calcium salts, eventually leads to moderate and severe calcification. These calcifications are so hard that conventional methods cannot unbend and unclog them. Therefore, diamond atherectomy remains the preferred interventional treatment for moderate and severe vascular calcification.

[0004] There are two types of commercially available atherectomy systems for vascular calcification: a self-rotating system (Figure 1) and an orbital system (Figure 2). Self-rotating systems remove vascular blockages solely through their own rotation, lacking oscillation amplitude and resulting in a limited clearance range. Orbital systems, on the other hand, incorporate an eccentric mass with a larger diameter at the center of the drive shaft. The rotation of the drive shaft drives the eccentric mass to swing, expanding the clearance range. However, the eccentric mass can only remove blockages through impact force, failing to effectively break up blockages and failing to remove clots from completely occluded vessels.

[0005] Furthermore, both self-rotating and orbital atherectomy systems currently utilize diamond particles embedded in the surface of a high-speed rotating grinding head to grind vascular calcification into tiny particles. Because the nickel matrix and diamond particles on the grinding head surface are bonded to the grinding head through electroplating, the diamond particles are 20 to 30 μm in size. A single grinding head typically contains 2,000 to 3,000 diamonds. With such a large number of diamond particles, when atherectomizing calcification at speeds of tens of thousands or even hundreds of thousands of rpm, there is an inevitable risk of diamond particle shedding, which can severely damage blood vessels.

[0006] One of the purposes of the present invention is to avoid the deficiencies in the prior art and provide an interventional atherectomy instrument that can not only drill a gap in a completely occluded blood vessel by utilizing the self-rotation of the grinding head, but also enable the grinding head to revolve to remove blockages over a large area, thereby having the advantage of high removal efficiency.

[0007] The second object of the present application is to provide a manufacturing method of the interventional rotary grinding device.

[0008] To achieve the above-mentioned one of the objects, the present application provides the following technical solutions:

[0009] The present application provides an interventional rotary grinding device, comprising

[0010] a grinding head,

[0011] a transmission shaft connected with one end of the grinding head, used to drive the grinding head to rotate around the axis of the transmission shaft to remove the blood vessel blockage;

[0012] a guide wire, which passes through the grinding head and the transmission shaft, points to and inserts into the blood vessel blockage;

[0013] a sleeve, which sleeves the transmission shaft, the transmission shaft rotates in the sleeve, and the grinding head is limited outside the pipe opening of the sleeve;

[0014] wherein the grinding head comprises a base body, a blind hole is opened on the surface of the base body, the blind hole adjusts the mass center of the base body to deviate from the advancing direction of the grinding head, and when the transmission shaft drives the grinding head to rotate, the mass center of the grinding head deviates and moves at the same time.

[0015] In some embodiments, a plurality of chip removal grooves are opened on the surface of the base body, each chip removal groove extends from the head end of the base body to the tail end of the base body, each chip removal groove is arranged on the peripheral surface of the base body at the same helix angle, and the base body surface between adjacent chip removal grooves forms a rotary cutting edge.

[0016] In some embodiments, the base body is divided into a front end portion and a rear end portion, the chip removal grooves are opened in the front end portion, and the rear end portion is uniformly distributed with grooves, and the grooves reduce the mass of the base body.

[0017] In some embodiments, the blind hole is opened in the rear end portion of the base body.

[0018] In some embodiments, three blind holes are provided, the three blind holes are of the same size, two blind holes are symmetrically located on the Y-axis, and one blind hole is located on the X-axis.

[0019] In some embodiments, the shape of the base body is a shuttle shape, a conical shape or a hemispherical shape.

[0020] The interventional rotary grinding device of the present application has the following advantages:

[0021] The intervention type rotary grinding instrument of the present application, by opening a blind hole on the grinding head, makes the center of mass of the grinding head deviate from the advancing direction of the grinding head, when the grinding head rotates, the grinding head also rotates with the revolution, at this time, the grinding head not only can use its own rotation mode to drill the blockage of the blood vessel, but also makes the blockage drill a gap, which provides the basis for removing the blockage when the grinding head revolves, specifically, when the grinding head drills a gap in the blockage, the grinding head can be positioned in the gap, and the grinding head removes the blockage on the side through its own revolution range, at the same time, since the grinding head also rotates, it overcomes the problem that the traditional rotary grinding system can only rely on impact force to remove the blockage with low removal efficiency, when the grinding head combines the rotation and revolution, the grinding head has both the grinding effect of the rotation and the large impact effect of the revolution, realizes the purpose of expanding the different pipe diameters with a smaller diameter grinding head, and can efficiently remove the blockage of the blood vessel.

[0022] To achieve the second purpose, the present application provides the following technical solutions:

[0023] The manufacturing method of the above intervention type rotary grinding instrument is provided, comprising the following steps:

[0024] S1: obtaining a first model of the grinding head according to the three-dimensional modeling software of the inner diameter size of the blood vessel;

[0025] S2: selecting a bar material matched with the first model, and using laser turning to process a three-dimensional contour of the grinding head base on the bar material;

[0026] S3: obtaining a second model of laser processing removal by Boolean operation of the first model, importing the second model into a multi-axis linkage laser processing machine computer, and processing a chip removal groove on the base by laser milling, so that the base surface between adjacent chip removal grooves constitutes a rotary cutting edge, at the same time, the laser milling laser induces a serrated micro-edge structure on the inner wall surface of the chip removal groove, so that the rotary cutting edge and the chip removal groove both generate micro-edges;

[0027] In the laser processing engineering, the blind hole is also processed on the base.

[0028] In some embodiments, the material of the selected bar material includes polycrystalline diamond or hard alloy.

[0029] In some embodiments, when processing the three-dimensional contour of the grinding head, nanosecond laser is used for rough machining first, and then picosecond or femtosecond laser is used for fine machining;

[0030] The laser power range is 0-30W, the repetition frequency is 5-4000kHz, the scanning speed is 100-2000mm / s, and the single radial cutting depth is 0.01-0.5mm.

[0031] In some embodiments, the laser processing machine tool layers and sets the scanning spacing of the second model using its own software to obtain an actual scanning path of the laser beam, with a layer height of 0.001 to 0.1 mm and a filling spacing of 0.005 to 0.5 mm;

[0032] Set the laser processing parameters: laser power of 5 to 30 W, repetition frequency of 100 to 4000 kHz, and scanning speed of 100 to 2000 mm / s.

[0033] The manufacturing method of the interventional atherectomy device of the present invention has the following beneficial effects:

[0034] The manufacturing method of the interventional atherectomy instrument of the present invention uses a multi-axis linkage laser machine tool to process a chip groove on the grinding head base. The chip groove uses its own spiral extensibility to better introduce debris into the chip groove during the rotation of the grinding head, avoiding clogging of debris and preventing the grinding head from getting stuck when rotating at high speed; and since the present application uses laser processing, the laser processing path not only quickly processes the chip groove, but the cutting action in the laser processing can induce a serrated micro-blade structure on the inner wall surface of the chip groove, so that both the rotary cutting edge and the chip groove produce micro-blades. The rotary cutting edge with micro-blades can replace the grinding action of traditional diamonds, making it unnecessary to use diamonds, avoiding the risk of diamond particles falling off on the surface of traditional atherectomy grinding heads, and the micro-blade structure has both excision and grinding effects on calcified tissue, so that the instrument has both rotary cutting and atherectomy effects, which can improve the cleaning efficiency of the instrument. In addition, the laser-cut micro-edge lines have a regular inclination direction, so that the chips in the chip groove can not only be discharged along the chip groove, but also be transmitted along the micro-edge lines in the chip groove, avoiding the centrifugal effect when the grinding head rotates and throwing out the chips.

[0035] The manufacturing method of the interventional atherectomy instrument of the present invention has the advantage of high processing efficiency by integrally processing the contour, the chip removal groove and the blind hole for adjusting the center of mass through laser. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] FIG1 is a schematic diagram of a prior art self-transforming rotational atherectomy system.

[0037] FIG2 is a schematic diagram of a prior art orbital atherectomy system.

[0038] FIG3 is a schematic diagram of machining the outer contour of a grinding head by a laser turning method according to a specific embodiment of the present invention;

[0039] FIG4 is a schematic diagram of a laser milling method for machining a rotary cutting edge and inducing a micro-edge structure on the rotary cutting edge according to a specific embodiment of the present invention.

[0040] FIG5 is a schematic structural diagram of a grinding head according to a specific embodiment of the present invention.

[0041] Fig. 6 is a schematic diagram of a method of processing a groove by laser processing according to the embodiment of the present application;

[0042] Fig. 7 is a schematic diagram of a method of processing a blind hole by laser processing according to the embodiment of the present application;

[0043] Fig. 8 is a sectional view of Fig. 7 along A-A;

[0044] Fig. 9 is a schematic diagram of cutting off and removing excess rod material according to the embodiment of the present application;

[0045] Fig. 10 is a schematic diagram of removing calcified tissue from a blood vessel by using an interventional rotational atherectomy device according to the embodiment of the present application;

[0046] Fig. 11 is a working state diagram of a flute, a microblade structure and a rotational cutting blade according to the embodiment of the present application;

[0047] Fig. 12 is a schematic diagram of a grinding head with a mass center offset according to the embodiment of the present application;

[0048] Fig. 13 is a schematic diagram of three different three-dimensional profile grinding heads according to the embodiment of the present application;

[0049] Reference Signs:

[0050] 1, grinding head; 101, base body; 2, transmission shaft; 3, blood vessel; 4, occlusion; 5, guide wire; 6, sheath; 7, blind hole; 8, flute; 9, rotational cutting blade; 10, rod material; 11, microblade structure; 12, laser; 13, front end portion; 14, rear end portion; 15, mass center; 16, debris; 17, groove; 18, debris; 19, microblade structure. DETAILED DESCRIPTION

[0051] Preferred embodiments of the present application will be described herein below with reference to the accompanying drawings. While the preferred embodiments of the present application are shown in the drawings, it is understood that the present application can be embodied in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided so that this application will be thorough and complete, and fully convey the scope of the application to those skilled in the art.

[0052] The terminology used in the present application is for the purpose of describing particular embodiments only and is not intended to be limiting of the present application. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and / or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0053] It should be understood that, although the terms "first", "second", "third", etc. can be employed in describing various information according to the present application, such information should not be limited to these terms. These terms are only used to distinguish one category of information from another category of information. For example, a first information can also be termed a second information, and, similarly, a second information can also be termed a first information, without departing from the scope of the present application. Therefore, the features defined with "first", "second" can explicitly or implicitly include one or more of the features. In the description of the present application, the meaning of "a plurality of" is two or more, unless otherwise specifically limited. Embodiment 1

[0054] The present embodiment discloses an interventional rotary grinding instrument, please refer to Figs. 2-13, which comprises

[0055] a grinding head 1 for providing grinding action;

[0056] a transmission shaft 2 connected with one end of the grinding head 1 for driving the grinding head 1 to rotate around the axis of the transmission shaft 2 to remove the blockage 4 in the blood vessel 3;

[0057] The transmission shaft 2 rotates to make the grinding head 1 rotate.

[0058] a guide wire 5 passing through the grinding head and the transmission shaft, pointing to and inserting into the blockage 4 in the blood vessel 3;

[0059] The guide wire 5 plays a guiding role, so that the grinding head 1 can be positioned in the blockage 4, avoiding excessive movement of the grinding head 1 and failure to remove the target blockage 4. At the same time, the slender guide wire passing through the grinding head and the transmission shaft can control the grinding head 1 within a certain range, preventing the grinding head 1 from shaking too much.

[0060] a sleeve 6 sleeving the transmission shaft 2, the transmission shaft 2 rotating in the sleeve 6, and the grinding head 1 being limited outside the pipe opening of the sleeve 6;

[0061] The sleeve 6 can make the transmission shaft 2 rotate smoothly inside the blood vessel 3, avoiding the problem of damaging the blood vessel 3 when rotating at high speed.

[0062] wherein the grinding head 1 comprises a base body 101, a blind hole 7 is opened on the surface of the base body 101, the blind hole 7 adjusts the center of mass 15 of the base body 101 to deviate from the advancing direction of the grinding head 1, and when the transmission shaft 2 drives the grinding head 1 to rotate, the grinding head 1 also deviates from the center of mass 15.

[0063] The blind hole 7 can effectively reduce the local mass of the base body 101, so that the mass center 15 of the originally symmetrical grinding head 1 is offset, thereby causing the grinding head 1 to produce a revolution effect while rotating. Moreover, adjusting the mass center 15 by means of the blind hole 7 can prevent the problem of hindering the chip 1816 from being discharged caused by the traditional protrusion arrangement, while maintaining the appearance shape of the grinding head 1 and ensuring the rotary grinding effect.

[0064] In the embodiment, the surface of the base body 101 is provided with a plurality of chip removal grooves 8, each of which extends from the head end point of the base body 101 to the tail end direction of the base body 101, and each of which is arranged on the peripheral surface of the base body 101 at the same helix angle. The surface of the base body 101 between adjacent chip removal grooves 8 constitutes a rotary cutting edge 9.

[0065] Since each of the chip removal grooves 8 extends from the head end point of the base body 101 to the tail end direction of the base body 101, the chip 1816 is discharged from the head end point of the base body 101, thereby effectively guiding the chip 1816 from the head end to the tail end direction. If each of the chip removal grooves 8 does not extend from the head end to the tail end direction, the chip 1816 will be dispersed in any direction on the peripheral surface of the base body 101, thereby failing to guide each of the chips 1816.

[0066] In the embodiment, the base body 101 is divided into a front end portion 13 and a rear end portion 14, the chip removal grooves 8 are arranged in the front end portion 13, and the rear end portion 14 is uniformly provided with grooves 17. The grooves 17 reduce the mass of the base body 101. The grooves 17 can be uniformly distributed in the rear end portion 14, which is not limited herein.

[0067] The grooves 17 serve to reduce the weight of the entire grinding head 1, so that the grinding head 1 can rotate faster. The grooves 17 arranged in the rear end portion 14 will not affect the chip removal function of the chip removal grooves 8.

[0068] In the embodiment, the blind hole 7 is arranged in the rear end portion 14 of the base body 101.

[0069] Arranging the blind hole 7 in the rear end portion 14 of the base body 101 can effectively prevent the chip 1816 from falling into the blind hole 7, and also prevent the blind hole 7 from affecting the chip removal grooves 8.

[0070] In the embodiment, three blind holes 7 are arranged, the three blind holes 7 are of the same size, two of the blind holes 7 are symmetrically arranged on the Y-axis, and the other blind hole 7 is arranged on the X-axis.

[0071] By arranging the three blind holes 7 in this way, the entire grinding head 1 can produce stable revolution.

[0072] In the embodiment, the base body 101 has a shape of a shuttle, a cone or a hemisphere.

[0073] The manufacturing method of the above-mentioned interventional rotary grinding instrument comprises the following steps:

[0074] S1: according to the inner diameter size of the blood vessel 3, a first model of the grinding head 1 is obtained by using a three-dimensional modeling software;

[0075] The grinding head 1 is initially formed according to the first model.

[0076] Specifically, according to the inner diameter size of the blood vessel 3, the overall size of the instrument is determined, and the model of the instrument is designed by using the three-dimensional modeling software.

[0077] S2: a bar stock 10 matching the first model is selected, and a three-dimensional profile of the grinding head 1 base body 101 is machined on the bar stock 10 by using laser 12 turning.

[0078] The three-dimensional profile of the grinding head 1 base body 101 is formed on the bar stock 10 according to the first model.

[0079] Specifically, according to the model size, a bar stock 10 with a suitable diameter is selected, and the three-dimensional profile of the rotary grinding instrument is machined by using laser 12 turning.

[0080] S3: the first model is subjected to Boolean operation to obtain a second model of the laser 12 machining removal, the second model is imported into a multi-axis linkage laser 12 machining tool computer, and the laser 12 machining tool mills the chip removal groove 8 on the base body 101 by laser 12 milling, so that the base body 101 surface between adjacent chip removal grooves 8 constitutes the rotary cutting edge 9, and at the same time, the laser 12 milling induces the serrated micro-edge structure 11 on the inner wall surface of the chip removal groove 8, so that the rotary cutting edge 9 and the chip removal groove 8 both generate micro-edges.

[0081] According to the removal model obtained by Boolean operation, a suitable tool swing angle is selected to ensure that the scanning path of the laser 12 does not interfere.

[0082] In the laser 12 machining process, the blind hole 7 is machined on the base body 101 by laser 12.

[0083] The chip removal groove 8, the rotary cutting edge 9, the micro-edge structure and the blind hole 7 are machined by laser 12 integrated machining again by using the second model and the laser 12 machining tool, which improves the machining efficiency.

[0084] Specifically, the multi-axis linkage laser 12 machining tool is adopted, the rotary cutting edge 9 is machined by laser 12 milling, and the serrated micro-edge structure 11 is induced on the rotary cutting edge 9; the blind hole 7 is machined by laser 12 machining as needed.

[0085] After step S3, it further includes cutting off and removing the excess bar 10 according to the length size of the model; through post-processing, the defects generated on the surface of the laser 12 processing instrument are removed, the smoothness of the instrument is improved, and the grinding performance of the instrument is improved. The post-processing adopts methods including but not limited to micro-blasting and the like.

[0086] In this embodiment, when machining the three-dimensional profile of the grinding head 1, first, nanosecond laser 12 is used for rough machining, and then picosecond or femtosecond laser 12 is used for fine machining.

[0087] The laser 12 power range is 0-30W, preferably 15W, the repetition frequency is 5-4000kHz, preferably 2000kHz, the scanning speed is 100-2000mm / s, preferably 1000mm / s, and the single radial cutting depth is 0.01-0.5mm, preferably 0.3mm.

[0088] Specifically, the selected bar 10 material includes but is not limited to polycrystalline diamond, cemented carbide and the like, the diameter of the bar 10 is greater than or equal to the diameter of the instrument model, the length of the bar 10 is greater than the length of the instrument model, and when the laser 12 turns the outer contour of the instrument, nanosecond laser 12 is selected for rough machining, and picosecond or femtosecond laser 12 is selected for fine machining. The laser 12 power range is 0-30W, the repetition frequency is 5-4000kHz, the scanning speed is 100-2000mm / s, and the single radial cutting depth is 0.01-0.5mm;

[0089] In this embodiment, the laser 12 processing machine tool sets the second model through the self-provided software to obtain the actual scanning path of the laser 12 beam, the layering height is 0.001-0.1mm, preferably 0.05mm, and the filling interval is 0.005-0.5mm, preferably 0.4mm;

[0090] The laser 12 processing parameters are set as follows: the laser 12 power is 5-30W, preferably 8W, the repetition frequency is 100-4000kHz, preferably 800kHz, the scanning speed is 100-2000mm / s, and the single radial cutting depth is 0.01-0.5mm, preferably 0.3mm.

[0091] Before the laser 12 full-preparation rotary grinding instrument is prepared, the ablation threshold of the bar 10 material needs to be tested, the relationship between the laser 12 processing parameters and the material removal, the machining surface quality and the structure formation of the rotary cutting blade 9 is established, and the laser 12 turning instrument macrostructure and the laser 12 milling processing rotary cutting blade 9 process method are obtained. Embodiment 2

[0092] The embodiment discloses an interventional rotary grinding instrument and a manufacturing method thereof. The instrument is determined by detecting the inner diameter size information of a blood vessel 3 with calcified tissue, and the three-dimensional structure and size of the instrument are determined, the three-dimensional structure includes the outer shape contour such as the shuttle-shaped structure, the conical structure and the semi-spherical structure, and the size includes the length and diameter of the rotary grinding instrument, and the shape, blade width, blade height, blade number and helical angle of the rotary cutting blade 9 on the instrument, and the overall model of the designed instrument is constructed by a three-dimensional drawing software, and the removal model during laser 12 processing is obtained by Boolean operation. According to the three-dimensional size of the instrument, a bar material 10 with a suitable diameter for processing the instrument is selected, the material of the selected bar material 10 includes but is not limited to polycrystalline diamond, hard alloy and the like, the diameter of the bar material 10 is greater than or equal to the diameter of the instrument, and the length of the bar material 10 is greater than the length of the instrument. Before the laser 12 fully prepares the instrument, the laser 12 ablation threshold of the bar material 10 needs to be tested based on the material of the bar material 10, the relationship between the laser 12 processing parameters and the material removal, the processing surface quality and the structure formation of the rotary cutting blade 9 is established, the laser 12 processing parameters and the process for turning the outer contour of the instrument and milling the rotary cutting blade 9 by the laser 12 are obtained. The bar material 10 is fixed on the laser 12 machine tool, the laser 12 focal point is focused on the surface of the bar material 10 through a CCD or a probe, as shown in FIG. 3, the laser 12 turning parameters are adjusted, the laser 12 power range is 0-30W, the repetition frequency is 5-4000kHz, the scanning speed is 100-2000mm / s, the single radial cutting depth is 0.01-0.5mm, the scanning path of the laser 12 beam on the X-axis and the Z-axis is controlled by programming, at the same time, the machine tool clamp clamps the bar material 10 to rotate around the X-axis at a speed of 10-2000r / min. In order to ensure the laser 12 turning efficiency and the turning surface quality, nanosecond laser 12 can be used for rough machining, and picosecond or femtosecond laser 12 can be used for fine machining. After the laser 12 turns the outer contour of the instrument, the laser 12 processing removal model obtained by the Boolean operation of the designed model is imported into the machine tool computer, the removal model is layered and the scanning interval is set by the software of the machine tool, so as to obtain the actual scanning path of the laser 12 beam, the layering height is 0.001-0.1mm, and the filling interval is 0.005-0.5mm. The laser 12 processing parameters are set, the laser 12 power is 5-30W, the repetition frequency is 100-4000kHz, and the scanning speed is 100-2000mm / s. A suitable swing angle is selected, the swing angle range is 5°-90°, and the scanning path of the laser 12 is ensured not to interfere. Since the laser 12 milling forms the rotary cutting blade 9, which is actually the laser 12 milling of the chip groove 8 on the instrument, when the chip groove 8 is processed, the bar material 10 needs to be rotated by an angle around its own axis, and the angle is related to the number of rotary cutting blades 9, which can be controlled by the program to rotate after processing a chip groove 8 for next chip groove 8 processing, and the machining process is shown in FIG. 4.After the machining, the mass groove 17 or the blind hole 7 of the rotary grinding instrument is machined by laser 12 turning or milling according to the need, as shown in FIG. 6 and FIG. 7. Before machining, the structure and distribution of the mass groove 17 and the blind hole 7 need to be designed. The machining of the mass groove 17 needs to ensure that the performance of the entire instrument is not affected. The machining of the blind hole 7 needs to accurately calculate the position of the center of mass 15. As shown in FIG. 12, the position of the center of mass 15 will cause the rotary grinding instrument to move in different forms during rotary grinding. If the center of mass 15 is on the central axis of the instrument, the rotary grinding instrument is more stable during rotary grinding. If the center of mass 15 is not on the central axis, the rotary grinding instrument will rotate around the central axis during rotary grinding, as shown in FIG. 10. The occurrence of the revolution motion can use a rotary grinding instrument with a small diameter to grind a larger lumen. The excess bar stock 10 is cut off by the laser 12 turning method to obtain the rotary grinding instrument, as shown in FIG. 5. Due to the machining defects that are inevitably generated during the laser 12 machining process, in order to remove the defects generated on the surface, improve the smoothness of the instrument, and improve the cutting performance of the instrument, post-processing methods including but not limited to micro-blasting are used. Example 3

[0093] The embodiment provides an interventional rotary abrasive instrument and a manufacturing method thereof. The designed abrasive head 1 is connected with a transmission shaft 2, as shown in Figure 10, the transmission shaft is externally provided with a sleeve 6, and a guide wire 5 passes through the rotary abrasive instrument and the transmission shaft 2. The lesion site of the calcified tissue (obstructive material 4) of the target blood vessel 3 is detected through an ultrasonic (IVUS) or optical coherence tomography (OCT) detection means, the guide wire 5 is pushed to the lesion site, the rotary abrasive instrument and the transmission shaft 2 pass through the guide wire 5 and reach the lesion site under the guidance of the guide wire 5, and the lumen of the sleeve 6 is used to infuse physiological saline outside the body, so that the calcified tissue can be cooled during removal. The power of high-speed rotation outside the body is transmitted to the lesion site through the transmission shaft 2, and the rotary abrasive instrument is driven to rotate at high speed around the guide wire 5, the rotating speed ranges from 2000 to 170000 r / min, the transmission shaft 2 is slowly pushed outside the body, and the instrument gradually approaches the calcified tissue along the guide wire 5 in the axial direction. The rotary cutting blade 9 on the high-speed rotating instrument has a cutting effect on the calcified tissue, and the irregular sawtooth micro-blade structure 11 on the rotary cutting blade 9 has a grinding effect on the calcified tissue, which is similar to the diamond particles on the surface of the traditional rotary abrasive head 1. Since the micro-blade structure 11 is on the rotary cutting blade 9, the rotary cutting and rotary grinding of the calcified tissue occur simultaneously, so the calcified tissue can be cut into smaller debris 1816, avoiding the larger debris 1816 from flowing to other places along the blood flow to cause the occlusion of the blood vessel 3. For the completely occluded blood vessel 3, the traditional rotary abrasive head 1 is similar to drilling when it is rotary ground, and since the abrasive head 1 does not have a chip removal groove 8, the grinding debris is difficult to be discharged as soon as possible, which may cause the rotary abrasive head 1 to be stuck. The new rotary abrasive instrument has a chip removal groove 8 on the surface of the instrument, and the debris 1816 formed after the calcified tissue is removed can be discharged outside in time through the chip removal groove 8, avoiding the instrument from being stuck during high-speed rotation. In addition, if a mass groove 17 is machined on the rotary abrasive instrument, the mass of the entire instrument is reduced, the high-speed rotation during rotary grinding is more stable, that is, the jumping amplitude of the entire instrument is reduced, which is beneficial to avoiding injury to the inside of the blood vessel 3 when rotary grinding in a small-diameter blood vessel 3. Similarly, the blind hole 7 can be machined so that the center of mass 15 is on the axis of the instrument, and the rotation of the instrument during rotary grinding is more stable. On the contrary, if the blind hole 7 is machined so that the center of mass 15 is not on the axis of the instrument, the instrument rotates at high speed, rotates around the axis, and also has a revolution motion, as shown in Figures 8 and 12. At this time, the rotary abrasive instrument with a small diameter can remove a larger lumen than the instrument itself, which reduces the steps of using multiple rotary abrasive instruments with different diameters from small to large to expand the lumen.

[0094] On the basis of laser multi-axis linkage car milling compound processing machine tool manufacturing and laser full preparation micro-blade cutter, a new type of vascular calcification intervention removal instrument is designed and manufactured. The instrument is prepared by laser integrated processing, solves the risk of traditional grinding head diamond particle falling, in addition, the prepared instrument has a rotary cutting blade and a chip removal groove. The rotary cutting blade can cut off the calcified tissue when rotating at high speed, and the chip removal groove can realize the effect of chip removal. And by controlling the laser processing process, irregular serrated micro-blade structure is induced on the rotary cutting blade. The irregular serrated micro-blade structure is similar to the diamond particles on the grinding head, and has the effect of grinding. At the same time, the quality groove can reduce the quality of the whole instrument to ensure the stability of the rotary grinding. On the contrary, the position of the mass center of the rotary grinding instrument can be changed by controlling the arrangement of the blind hole, so that the grinding head can rotate while revolving, and a smaller diameter rotary grinding instrument can be used to expand a larger lumen. The new instrument has rotary cutting and rotary grinding functions, which can ensure the efficiency of calcified vascular dredging and reduce the occurrence of complications.

[0095] It can be seen that the multi-axis linkage laser machine tool fully manufactures the vascular calcified tissue intervention removal instrument, solves the problem that traditional mechanical processing is difficult to process fine cutting blades on difficult-to-machine materials. At the same time, the instrument is prepared by laser integrated processing, which avoids the risk of traditional rotary grinding head surface diamond particle falling. The irregular serrated micro-blade structure is induced on the rotary cutting blade prepared by laser processing. The rotary cutting blade and the micro-blade structure have cutting and grinding effects on calcified tissue respectively, so the instrument has rotary cutting and rotary grinding functions, which can improve the removal efficiency of the instrument, avoid the blockage of the blood vessel caused by the too large size of the grinding chip, and the chip removal groove on the surface of the rotary grinding instrument can timely remove the removed debris, avoiding the jamming of the instrument when rotating at high speed.

[0096] Unless specifically stated otherwise, the relative arrangements of parts and steps, numerical expressions, and numerical values set forth in the examples herein are not intended to limit the scope of the present application. At the same time, it should be understood that the sizes of the various parts shown in the drawings are not drawn in proportion to the actual proportions. The techniques, methods and devices known to those skilled in the relevant art can not be discussed in detail, but under appropriate circumstances, the techniques, methods and devices should be considered as part of the authorized description. In all examples shown and discussed herein, any specific value should be interpreted as merely exemplary, not as a limitation. Therefore, other examples of exemplary embodiments can have different values. It should be noted that similar reference numbers and letters represent similar items in the following drawings, so once an item is defined in one drawing, it does not need to be further discussed in subsequent drawings.

[0097] In the description of the application, it should be understood that the orientation words such as "front, back, up, down, left, right", "transverse, vertical, perpendicular, horizontal" and "top, bottom" and the like indicated orientation or position relationship are generally based on the orientation or position relationship shown in the drawings, only for the convenience of describing the application and simplifying the description, without making the opposite statement, these orientation words do not indicate and imply that the device or element referred to must have a particular orientation or be constructed and operated in a particular orientation, therefore, it cannot be understood as a limitation on the scope of protection of the application; The orientation words "inner, outer" refer to the inner and outer of the contour of each component itself.

[0098] For the convenience of description, spatial relative terms such as "over", "above", "upper surface", "upper" and the like can be used herein to describe the spatial position relationship of one device or feature with other devices or features as shown in the drawings. It should be understood that the spatial relative terms are intended to include different orientations in use or operation in addition to the orientation of the device described in the drawings. For example, if the device in the drawing is inverted, the device described as "above" or "over" other devices or structures will be positioned "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below" orientations. The device can also be positioned in other different ways (rotated 90 degrees or in other orientations), and the spatial relative descriptions used herein are interpreted accordingly.

[0099] In addition, it should be noted that the use of "first", "second" and the like to define parts only facilitates the differentiation of corresponding parts, and the above words have no special meaning unless otherwise stated, and therefore cannot be understood as a limitation on the scope of protection of the application.

[0100] The above only describes the preferred embodiments of the application and is not intended to limit the application. For those skilled in the art, the application can have various modifications and changes. Any modification, equivalent replacement, improvement, etc. made within the spirit and principles of the application shall be included in the protection scope of the application.

Claims

1. An interventional rotational atherectomy device, comprising: Comprising a grinding head (1), a transmission shaft (2) connected with one end of the grinding head (1) for driving the grinding head (1) to rotate around the axis of the transmission shaft (2) to remove the blockage (4) of the blood vessel (3); a guide wire (5) passing through the grinding head (1) and the transmission shaft (2), pointing to and inserting into the blockage (4) of the blood vessel (3); a sleeve (6) sleeving the transmission shaft (2), the transmission shaft (2) rotating in the sleeve (6), and the grinding head (1) being limited outside the nozzle of the sleeve (6); wherein the grinding head (1) comprises a base body (101), the surface of the base body (101) is provided with a blind hole (7), the blind hole (7) adjusts the centroid (15) of the base body (101) to deviate from the advancing direction of the grinding head (1), and when the transmission shaft (2) drives the grinding head (1) to rotate, the grinding head (1) simultaneously occurs the centroid (15) deviated movement.

2. The interventional rotary morcellation device of claim 1, wherein, The surface of the base body (101) is provided with a plurality of chip removal grooves (8), each chip removal groove (8) extends from the head end of the base body (101) to the tail end of the base body (101), and each chip removal groove (8) is arranged on the peripheral surface of the base body (101) at the same helix angle, and the surface of the base body (101) between adjacent chip removal grooves (8) forms a rotary cutting edge (9).

3. The interventional rotary morcellation device of claim 2, wherein, The base body (101) is divided into a front end portion (13) and a rear end portion (14), the chip removal grooves (8) are provided in the front end portion (13), and the rear end portion (14) is uniformly provided with grooves (17), and the grooves (17) reduce the mass of the base body (101).

4. The interventional rotary morcellation device of claim 1, wherein, The blind hole (7) is provided in the rear end portion (14) of the base body (101).

5. The interventional rotary morcellation device of claim 4, wherein, Three blind holes (7) are provided, the three blind holes (7) are of the same size, two of the blind holes (7) are symmetrically located on the Y-axis, and one of the blind holes (7) is located on the X-axis.

6. The interventional rotary morcellation device of claim 3, wherein, The shape of the base body (101) is shuttle-shaped, conical or hemispherical.

7. A method of manufacturing an interventional rotational atherectomy device as in any of claims 2-6, wherein: The method comprises the following steps: S1: according to the inner diameter size of the blood vessel (3), a three-dimensional modeling software is used to obtain a first model of the transmission shaft (2) and the grinding head (1); S2: selecting a bar stock (10) matched with the first model, and using a laser (12) to turn and process the bar stock (10) to form a three-dimensional profile of the base body (101) of the grinding head (1); S3: the first model is subjected to Boolean operation to obtain a second model of the laser (12) processing removal, the second model is imported into a multi-axis linkage laser (12) processing machine computer, and the laser (12) processing machine processes the chip removal grooves (8) on the base body (101) by laser (12) milling, so that the surface of the base body (101) between adjacent chip removal grooves (8) forms a rotary cutting edge (9), and at the same time, the laser (12) moving path induces a serrated micro-edge structure (11) on the inner wall surface of the chip removal groove (8) during laser (12) milling, so that the rotary cutting edge (9) generates micro-edges and the chip removal groove (8) generates micro-edges; In the laser (12) processing project, the blind hole (7) is also processed on the base body (101) by laser (12).

8. The interventional rotary morcellation device of claim 7, wherein, The material of the selected bar (10) includes polycrystalline diamond or cemented carbide.

9. The interventional rotary morcellation device of claim 7, wherein, When processing the three-dimensional profile of the grinding head (1), the nanosecond laser (12) is used for rough machining, and then the picosecond or femtosecond laser (12) is used for fine machining. The laser (12) power ranges from 0 to 30 W, the repetition frequency ranges from 5 to 4000 kHz, the scanning speed ranges from 100 to 2000 mm / s, and the single radial cutting depth ranges from 0.01 to 0.5 mm.

10. The interventional rotary morcellation device of claim 7, wherein, The laser (12) processing machine tool sets the layering and scanning interval of the second model through the self-contained software to obtain the actual scanning path of the laser (12) beam, the layering height is 0.001-0.1 mm, and the filling interval is 0.005-0.5 mm. The laser (12) processing parameters are set as follows: the laser (12) power is 5-30 W, the repetition frequency is 100-4000 kHz, and the scanning speed is 100-2000 mm / s.

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