Rotational atherectomy device and apparatus
By placing the atherectomy head at the distal end of the drive shaft and adjusting the atherectomy diameter in the atherectomy device, the problems of poor atherectomy effect and high surgical risk in narrow blood vessels of existing atherectomy devices are solved, and efficient and safe removal of atherosclerotic plaques is achieved.
Patent Information
- Application Number
- CN202210615844.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2022-05-31
- Publication Date
- 2025-11-04
- Estimated Expiration
- 2042-05-31
AI Technical Summary
When treating atherosclerotic plaques, the diameter of the burr head in existing rotational atherectomy devices is not suitable for narrowed blood vessels, resulting in poor rotational atherectomy effect, high surgical risk, and the need to frequently change burr heads of different sizes, which increases the operation time and difficulty.
Design a rotary grinding device, in which a rotary grinding head is set at the far end of a drive shaft, the center of mass connecting the rotary grinding head and the drive shaft does not coincide with the central axis of the hollow structure, the outer surface of the rotary grinding head is covered with a rotary grinding layer, and the rotary grinding diameter is controlled by adjusting the rotation speed to achieve adaptive rotary grinding.
It improves the effectiveness and accessibility of rotational ablation, reduces surgical risks, shortens surgical time and difficulty, and ensures surgical safety and rotational ablation efficiency.
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Figure CN114916997B_ABST
Abstract
Description
TECHNICAL FIELD
[0001] The present application relates to the technical field of medical devices, in particular to a rotary grinding device and a rotary grinding equipment. BACKGROUND
[0002] Atherosclerotic plaques are generally located in the vasculature of coronary or peripheral arteries, and may have different characteristics according to the texture of the plaques. For severe calcified lesions, an atherectomy device is needed for pretreatment, which works by rotating and grinding the rotary grinding device at high speed at the vascular lesion to remove calcified or fibrotic atherosclerotic plaques, open the blocked blood vessels, and obtain an enlarged and smooth vascular lumen, facilitating the subsequent implantation of a stent.
[0003] The current rotary grinding device mainly includes a flexible drive shaft and a rotary grinding head carried by the flexible drive shaft; the drive shaft drives the rotary grinding head to rotate at high speed, contacts and grinds the lesion for removal; wherein the diameter of the rotary grinding head is not less than the diameter of the drive shaft. The rotary grinding head is mostly arranged at the middle position of the drive shaft, so that the distal end of the rotary grinding head is a section of the drive shaft without rotary grinding effect. At this time, the distal end of the drive shaft needs to be screwed into or squeezed through the narrow lesion before the rotary grinding head at the middle position can contact the lesion, not only the rotary grinding effect and passability are poor, but also the distal end of the drive shaft may be stuck in the narrow lesion when it is screwed into or squeezed through the narrow lesion and the blood vessel, causing risks, and even expanding the blood vessel, causing blood vessel damage, especially for some narrow lesions and completely occluded lesions, the rotary grinding head at the middle position is more difficult to contact the lesion and has no way to grind the lesion. Moreover, the surface of the rotary grinding head is not completely covered with wear-resistant material, which cannot realize bidirectional rotary grinding in the axial direction, resulting in that the rotary grinding head often cannot be reversely ground and withdrawn after striding through the lesion under the action of the forward pushing force, the rotary grinding efficiency is low, and there is a problem that the rotary grinding head is easily stuck in the blood vessel plaque and cannot be removed.
[0004] In addition to the above problems, the conventional rotary grinding head cannot adjust the rotary grinding diameter during the opening of the lesion, and therefore a plurality of rotary grinding heads with different sizes are configured during the operation, a rotary grinding head with a small diameter is used for rotary grinding first, and then a rotary grinding head with a larger diameter is used for rotary grinding, so that different size rotary grinding devices need to be frequently replaced, which increases the operation time and the risk of damaging the blood vessel, and when the diameter of the rotary grinding head is large, it is also difficult to pass through the narrow blood vessel and the catheter to reach the lesion position of the blood vessel, which increases the operation difficulty, and the large-diameter rotary grinding head blocks the blood flow in the narrow lesion blood vessel, and also blocks the flow of the cooling liquid and / or lubricating liquid to the distal end. Further, some existing rotary grinding devices have a plurality of rotary grinding heads arranged axially at the middle position of the driving shaft, and the diameters of the rotary grinding heads increase from the distal end to the proximal end. Although the frequency of replacement is reduced, the axial length of the entire driving shaft is increased, which not only affects the normal blood vessels at the distal end and the proximal end of the lesion during the rotary grinding process, but also causes the large-diameter rotary grinding head at the proximal end to block the flow of blood and the cooling liquid and / or lubricating liquid. In addition, if the plurality of rotary grinding heads are eccentrically arranged, the rotary grinding heads with different static diameters will have different centers of mass and weights, which will cause uncontrollable centrifugal forces to interact with each other due to the change in angular momentum during the rotary grinding process, resulting in uncontrollable motion states and forces of the rotary grinding heads on the blood vessel, increasing the uncontrollable risk of the operation and reducing the safety of the operation. In addition, the plurality of rotary grinding heads increase the overall hardness of the driving shaft, reduce the flexibility of the driving shaft, and make it difficult to pass through the narrow blood vessel and the catheter to reach the lesion position. SUMMARY
[0005] The present application aims to provide a rotary grinding device and a rotary grinding equipment to solve at least one technical problem of the existing rotary grinding device.
[0006] To achieve the above-mentioned purpose, the present application provides a rotary grinding device, comprising a driving shaft and a rotary grinding head; the driving shaft has a connecting portion at the distal end, and the connecting portion is connected with the rotary grinding head; the rotary grinding head and the driving shaft both have a hollow structure extending through in the axial direction, and the hollow structure is used for guiding the passage of a guide body; wherein the center of mass of the structure formed by the connection of the rotary grinding head and the connecting portion does not coincide with the central axis of the hollow structure.
[0007] In an embodiment, the diameter of the distal end portion of the rotary grinding head gradually increases from the distal end to the proximal end in the axial direction, and the outer surface of the distal end portion of the rotary grinding head is covered with a rotary grinding layer.
[0008] In an embodiment, the diameter of the proximal end portion of the rotary grinding head gradually decreases from the distal end to the proximal end in the axial direction, the outer surface of the proximal end portion of the rotary grinding head is covered with a rotary grinding layer, and / or the outer surface of the intermediate portion formed between the distal end portion and the proximal end portion of the rotary grinding head is covered with a rotary grinding layer.
[0009] In one embodiment, the intermediate portion has equal diameter, or the diameter of the intermediate portion gradually increases first and then decreases along the axial direction from the distal end to the proximal end.
[0010] In one embodiment, the rotational atherectomy head comprises a base provided with the hollow structure of the rotational atherectomy head, the outer surface of the base is covered with a rotational atherectomy layer, the rotational atherectomy layer is composed of rotational atherectomy particles made of one or more rotational atherectomy materials.
[0011] In one embodiment, the thickness of the rotational atherectomy layer is 20-120um, such as 20um, 40um, 50um or 100um.
[0012] In one embodiment, the diameter of the rotational atherectomy head gradually decreases along the axial direction towards the distal end, and also gradually decreases along the axial direction towards the proximal end, such as forming a spindle with small ends and large middle, the spindle has a smooth outer surface.
[0013] In one embodiment, the rotational atherectomy head has at least one of the following features:
[0014] The minimum diameter of the distal end portion of the rotational atherectomy head is smaller than the minimum diameter of the proximal end portion of the rotational atherectomy head;
[0015] The maximum diameter of the distal end portion of the rotational atherectomy head is smaller than the maximum diameter of the proximal end portion of the rotational atherectomy head;
[0016] The bending radius of the distal end portion of the rotational atherectomy head is greater than or equal to the bending radius of the proximal end portion of the rotational atherectomy head.
[0017] In one embodiment, the rotational atherectomy head has at least one of the following features:
[0018] The diameter of the distal end portion of the rotational atherectomy head is 0.13-0.66mm, such as the minimum diameter of the distal end portion is 0.13mm, 0.2mm, 0.3mm, and the maximum diameter is 0.66mm;
[0019] The maximum diameter of the intermediate portion formed between the proximal end portion and the distal end portion of the rotational atherectomy head is 0.66-4.0mm, such as the maximum diameter of the intermediate portion is 0.66mm, 1.25mm, 2.0mm or 4.0mm;
[0020] The diameter of the proximal end portion of the rotational atherectomy head is 0.5-1.2mm, such as the minimum diameter of the proximal end portion is 0.5mm, 0.75mm, 1.0mm, and the maximum diameter is 1.2mm.
[0021] In one embodiment, the rotational atherectomy device further comprises the guide body, the rotational atherectomy head and the drive shaft can rotate and axially move relative to the guide body.
[0022] In an embodiment, the hollow structure of the rotary grinding head is composed of a distal hollow structure and a proximal hollow structure which are in communication with each other, the lumen diameter of the distal hollow structure is adapted to the diameter of the guide body, the lumen diameter of the proximal hollow structure is larger than that of the distal hollow structure, and the proximal hollow structure is fixedly connected with the connecting portion.
[0023] In an embodiment, the driving shaft is a hollow tubular structure with a constant diameter, and the central axis of the driving shaft coincides with the central axis of the guide body.
[0024] In an embodiment, the driving shaft is a hollow tubular structure with a variable diameter, the diameter of the connecting portion increases from the proximal end to the distal end in the axial direction, and the driving shaft further has a constant diameter portion connected with the proximal end of the connecting portion, and the central axis of the constant diameter portion coincides with the central axis of the guide body.
[0025] In an embodiment, the connecting portion is inserted into the proximal hollow structure from the proximal opening of the rotary grinding head, and the radial dimension of the proximal opening is less than or equal to the diameter of the proximal end of the connecting portion.
[0026] In an embodiment, the connecting portion is asymmetrically arranged about the central axis of the constant diameter portion, and / or the diameter of the connecting portion gradually increases and then gradually decreases in the axial direction from the proximal end to the distal end.
[0027] In an embodiment, the rotary grinding head is a spindle, and the shape of the proximal hollow structure is adapted to the shape of the spindle, and the shape of the connecting portion is adapted to the shape of the proximal hollow structure. At this time, the rotary grinding head can be arranged as a hollow shell, which can reduce the mass of the rotary grinding head to reduce the influence of centrifugal force on the motion state of the rotary grinding head.
[0028] To achieve the above-mentioned purpose, the application further provides a rotary grinding device, which comprises a driving device and any one of the rotary grinding devices; the driving device is connected with the driving shaft in the rotary grinding device to drive the rotary grinding device to rotate.
[0029] In the rotary grinding device and the rotary grinding equipment provided by the application, the rotary grinding device comprises a driving shaft and a rotary grinding head; the driving shaft has a connecting portion at the distal end, and the connecting portion is connected with the rotary grinding head; the rotary grinding head and the driving shaft both have a hollow structure extending through in the axial direction, and the hollow structure is used for passing the guide body; wherein the center of mass of the structure formed by the rotary grinding head and the connecting portion does not coincide with the central axis of the hollow structure; when configured in this way, the application at least has the following advantages:
[0030] First, since the rotary grinding head is arranged at the distal end of the driving shaft, the distal end of the rotary grinding device is the rotary grinding head with the rotary grinding function, and thus, during the operation, the distal end of the driving shaft does not need to be screwed into or squeezed through the narrow lesion, but only needs to contact the lesion and perform rotary grinding, so that the rotary grinding effect and passability are good, the operation risk is reduced, and the operation success rate is improved.
[0031] Second, due to the offset of the centroid of the structure formed by the connection of the rotary grinding head and the connecting part at the distal end of the driving shaft, the rotary grinding head can self-adjust the rotary grinding diameter during the opening of the lesion during the rotary grinding process, effectively removing the lesion, thereby avoiding the arrangement of multiple rotary grinding heads of different sizes, avoiding the frequent replacement of equipment, reducing the operation time, reducing the operation risk, and especially the static diameter (i.e. the diameter when not rotating) of the rotary grinding head can be set smaller, so that the rotary grinding device is more easily passed through the narrow blood vessels and catheters to reach the lesion blood vessel position, reducing the operation difficulty and improving the operation treatment method.
[0032] Third, since the static diameter of the rotary grinding head can be smaller, the rotary grinding head is not easy to block the blood flow in the narrow lesion blood vessel, nor to block the flow of cooling liquid and / or lubricating liquid to the distal end, further reducing the operation risk and increasing the operation safety.
[0033] Fourth, only one rotary grinding head is arranged, and the rotary grinding head is arranged at the distal end of the driving shaft, thereby reducing the axial length of the entire driving shaft and reducing the influence of the driving shaft on the distal lesion and the normal blood vessel during the rotary grinding process. In particular, the eccentric arrangement of the rotary grinding head makes the centrifugal force controllable during the rotary grinding process, without affecting the motion state of the rotary grinding head and the force acting on the blood vessel, thereby reducing the uncontrollable risk during the operation process and increasing the operation safety. At the same time, the arrangement of one rotary grinding head does not increase the overall hardness of the driving shaft, and the flexibility of the driving shaft can be ensured to improve the ability to pass through the blood vessels and catheters.
[0034] In addition to the above effects, in the rotary grinding device and rotary grinding equipment provided by the application, the diameter of the distal end portion of the rotary grinding head gradually increases from the distal end to the proximal end along the axial direction, and the outer surface of the distal end portion of the rotary grinding head is covered with a rotary grinding layer, so that the lesion can be contacted and rotary ground by the rotary grinding layer at the distal end of the rotary grinding head, improving the rotary grinding efficiency. Further, the diameter of the proximal end portion of the rotary grinding head gradually decreases from the distal end to the proximal end along the axial direction, and the outer surface of the proximal end portion of the rotary grinding head is covered with a rotary grinding layer, so that the rotary grinding head can realize bidirectional rotary grinding. When the rotary grinding head stalls while passing through the narrow lesion, it can still rotary grind the lesion to retreat. Not only is the rotary grinding efficiency higher, but the operation risk is also lower. BRIEF DESCRIPTION OF DRAWINGS
[0035] Those skilled in the art will understand that the drawings provided are for the purpose of better illustrating the present application and do not constitute any limitation to the scope of the present application. In the drawings:
[0036] Figure 1 is a perspective view of the rotational atherectomy device in an embodiment of the present application;
[0037] Figure 2 is a sectional view of the rotational atherectomy device in an embodiment of the present application;
[0038] Figure 3 is an end view of the structure formed by the connection of the rotational atherectomy head and the connecting portion in an embodiment of the present application, in which the center of mass of the structure deviates from the central axis of the hollow structure;
[0039] Figure 4 is an application principle diagram of the rotational atherectomy device in an embodiment of the present application, in which the rotational atherectomy head first contacts and atherectomizes the stenosis;
[0040] Figure 5 is an application scene view of the rotational atherectomy device in an embodiment of the present application, in which the rotational atherectomy head atherectomizes the stenosis along the guide body;
[0041] Figure 6 is a view of the rotational atherectomy device in an embodiment of the present application, in which the distal end of the drive shaft is provided with a connecting portion with increased diameter, and is fixedly connected with the hollow rotational atherectomy head;
[0042] Figure 7 is a curve diagram of the centrifugal force received by the rotational atherectomy head in an embodiment of the present application, which varies with the rotational speed;
[0043] Figure 8 is a curve diagram of the centrifugal force received by the rotational atherectomy head in an embodiment of the present application, which varies with the rotational diameter.
[0044] In the drawings:
[0045] 10-rotational atherectomy device; 11-rotational atherectomy head; 11a-distal end portion; 11b-proximal end portion; 11c-middle portion; 111-rotational atherectomy layer; 112-base; 113-proximal end hollow structure; 114-distal end hollow structure; 12-drive shaft; 121-connecting portion; 122-constant diameter portion; 13-guide body; 14-center of mass; 31-blood vessel; 32-stenosis; 41-catheter. DETAILED DESCRIPTION
[0046] In order to make the objects, advantages and features of the present application clearer, the following further details the present application with reference to the drawings. It should be noted that the drawings are simplified and not drawn to scale, and are only used to facilitate and clarify the purpose of illustrating the embodiments of the present application.
[0047] As used in the description of the application, the singular forms "a", "an" and "the" include plural referents unless the context clearly dictates otherwise. As used in the description of the application, the term "or" is generally employed in its sense of "and / or" unless the content clearly dictates otherwise. In describing the present application, the meaning of "a", "an", and "the" is that one or more unless the context clearly dictates otherwise. Additionally, in the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. However, it will be apparent to one skilled in the art that the present application can be practiced without one or more of these specific details. In other instances, well-known features have not been described in detail so as not to unnecessarily obscure the present application. In the following description, "distal" and "proximal", "axial" and "circumferential" are used for the convenience of description; "distal" is the side away from the operator of the rotational atherectomy device; "proximal" is the side close to the operator of the rotational atherectomy device; "axial" refers to the direction along the central axis of the rotational atherectomy device or the blood vessel; "circumferential" refers to the direction around the central axis of the rotational atherectomy device or the blood vessel; "central axis" refers to the length direction of the rotational atherectomy device or the blood vessel. In this document, "diameter" refers to the outer diameter of the structure; the diameter of the rotational atherectomy head includes the rotational atherectomy layer.
[0048] The technical solutions of the present application are further described below in conjunction with the drawings and preferred embodiments, and the following embodiments and features in the embodiments can be complementary or combined with each other without conflict.
[0049] As shown in Figures 1 to 8 Some embodiments of the present application disclose a rotational atherectomy device and a rotational atherectomy device thereof, which comprises a rotational atherectomy device 10 and a driving device (not shown), the driving device is connected to the proximal end of the driving shaft 12 in the rotational atherectomy device 10 to drive the rotational atherectomy device 10 to rotate. The rotational atherectomy device and the rotational atherectomy device thereof are used for intravascular surgery, such as removing tissue from the body channel, such as removing calcified or fibrotic atherosclerotic plaques in the blood vessels with the rotational atherectomy device, thereby opening the blood vessels (including coronary vessels, peripheral vessels or other vessels) blocked by the plaques and obtaining a smooth intravascular lumen.
[0050] The rotational atherectomy device 10 comprises a rotational atherectomy head 11 and a driving shaft 12; the driving shaft 12 has a connecting portion 121 at the distal end, and the rotational atherectomy head 11 is connected to the connecting portion 121; the rotational atherectomy head 11 and the driving shaft 12 are usually independently manufactured and then assembled together, and the driving shaft 12 is of an integral or one-piece structure; the driving shaft 12 is preferably a flexible driving shaft, which can be constructed by a spiral coiled wire; the driving shaft 12 is driven to rotate by the driving device, and the rotational atherectomy head 11 is driven to rotate by the driving shaft 12.
[0051] Compared with the prior art of arranging the rotary grinding head at the middle position of the driving shaft, the application arranges the rotary grinding head 11 at the distal end of the driving shaft 12, so that the rotary grinding head 11 can first contact the vascular lesion and enter the stenosis for rotary grinding, overcoming the defect that the rotary grinding head at the middle position can only contact the lesion after the distal end of the driving shaft is screwed into or squeezed through the stenosis lesion in the traditional method, so that the application can obtain better rotary grinding effect and passability, reduce the risk of surgery, and at the same time, only one rotary grinding head 11 is arranged, reducing the axial length of the entire driving shaft 12, reducing the influence of the driving shaft 12 on the distal lesion and the normal blood vessel in the rotary grinding process, and further reducing the risk of surgery.
[0052] In addition to the above arrangement, the rotary grinding head 11 and the driving shaft 12 are both arranged to have a hollow structure extending axially through, so that the guide body 13 passes through the hollow structure of the rotary grinding head 11 and the driving shaft 12. The guide body 13, for example, is a guide wire, which is used to guide the rotary grinding device 10 through the lesion blood vessel. The central axis of the hollow structure of the rotary grinding head 11 coincides with the central axis of the hollow structure of the driving shaft 12.
[0053] In addition, the center of mass 14 of the structure formed by the connection of the rotary grinding head 11 and the connecting part 121 does not coincide with the central axis of the hollow structure. At this time, when the rotary grinding head 11 and the driving shaft 12 are driven to rotate around the central axis of the hollow structure, the rotary grinding head 11 will deviate from the central axis of the hollow structure to form revolution under the action of centrifugal force, and on this basis, by increasing the rotational speed n of the rotary grinding head 11, the revolution diameter (i.e. the rotary grinding diameter D) of the rotary grinding head 11 can be increased, so as to realize a rotary grinding diameter D larger than the static diameter of the rotary grinding head 11. When arranged in this way, the rotary grinding head 11 can adjust the rotary grinding diameter D during the opening of the lesion during the rotary grinding process, so as to realize the treatment of lesions of different sizes, effectively eliminate various lesions, thereby avoiding the arrangement of multiple rotary grinding heads of different sizes, avoiding the frequent replacement of equipment, reducing the operation time and reducing the risk of surgery. In addition, the static diameter of the rotary grinding head 11 can be set smaller, so that the rotary grinding device 10 is easier to pass through the stenosis blood vessel and the catheter to reach the lesion blood vessel position, reducing the difficulty of surgery. It should also be understood that, since the static diameter of the rotary grinding head 11 is smaller, the rotary grinding head 11 is not easy to block the blood flow through the stenosis blood vessel, nor to block the flow of cooling liquid and / or lubricating liquid to the distal end, further reducing the risk of surgery and increasing the safety of surgery.
[0054] It should also be understood that, since only one rotary burr 11 is provided, and the rotary burr 11 is provided at the distal end of the drive shaft 12, the overall axial length of the drive shaft 12 is reduced, and the influence of the drive shaft 12 on the distal lesion and the proximal normal blood vessel during the rotary grinding process is reduced. In particular, the eccentric arrangement of the one rotary burr 11 makes the centrifugal force during the rotary grinding process controllable, and does not affect the movement state of the rotary burr and the force on the blood vessel, thereby reducing the uncontrollable risk during the operation and increasing the safety of the operation. At the same time, the provision of one rotary burr 11 does not increase the overall hardness of the drive shaft 12, and can ensure the flexibility of the drive shaft 12 to improve the ability of the drive shaft 12 to pass through the blood vessel and the catheter. It should be understood here that static refers to the state of the rotary burr 11 when it is not rotating, and correspondingly, the static diameter refers to the diameter of the rotary burr 11 when it is not rotating; and the rotary grinding diameter D refers to the revolution diameter of the rotary burr 11 when it is rotating.
[0055] In actual use, the revolution diameter (i.e. the rotary grinding diameter) of the rotary burr 11 can be adjusted by controlling the rotational speed of the rotary burr 11, so that the rotary grinding diameter D of the rotary burr 11 is variable, and the rotary grinding diameter D can be large or small, so that the same rotary burr 11 can be used to grind both small and large lesions.
[0056] In this embodiment, the centrifugal force Fc experienced by the rotary burr 11 can be determined by the following formula:
[0057] F C = m△x(πn / 30) 2
[0058] wherein Fc is the centrifugal force; m is the mass of the structure formed by the connection of the rotary burr 11 and the connecting portion 121;△x is the distance by which the center of mass 14 of the structure formed by the connection of the rotary burr 11 and the connecting portion 121 is offset from the central axis of the hollow structure; and n is the rotational speed of the rotary burr 11. The units of each parameter are not limited here, and those skilled in the art can understand the determination method of the centrifugal force and the factors affecting the centrifugal force from the formula. Therefore, the size of the centrifugal force Fc experienced by the rotary burr 11 is related to the structure mass m, the offset distance of the structure center of mass, and the rotational speed of the rotary burr. C
[0059] It should also be understood that the central axis of the hollow structure serves as the axis of rotation, and the central axis of the lesion blood vessel serves as the axis of revolution. It should also be understood that as the rotational speed n increases, the distance between the axis of revolution and the center of mass 14 will change, and therefore the rotary grinding diameter D will increase as the rotational speed n increases. However, when the rotational speed n is constant, the rotary grinding diameter D will continuously increase during the process of the rotary burr 11 grinding the stenotic lesion 32, but the centrifugal force Fc will continuously decrease, and when the rotary grinding diameter D increases to the maximum value, the centrifugal force Fc will also tend to 0, and therefore will not cause damage to the normal blood vessel. For more details, please refer toFigure 7 and Figure 8 .
[0060] As shown in Figure 7 , with the increase of the rotation speed n, the centrifugal force Fc C experienced by the rotary grinding head 11 also increases, thus the centrifugal force Fc can be increased by adjusting the rotation speed n, and thereby the rotary grinding diameter D is increased to grind larger lesions. As shown in Figure 8 , at the same rotation speed n, with the increase of the rotary grinding diameter D of the rotary grinding head, the centrifugal force Fc experienced by the rotary grinding head 11 gradually decreases until it tends to 0, and finally the rotary grinding diameter D tends to be stable to reach the maximum value, when the centrifugal force Fc tends to 0 or is very small, the rotary grinding head 11 will not damage the normal blood vessels. Therefore, during the entire grinding process, the centrifugal force is within a predictable and controllable range, so that the motion state of the rotary grinding head 11 and the force acting on the blood vessels are also controllable, ensuring the safety of the operation.
[0061] In order to make the center of mass 14 deviate from the central axis of the hollow structure, in an embodiment, as shown in Figures 1 to 3 , the structure of the rotary grinding head 11 is arranged to be asymmetric about the central axis of the hollow structure, for example, from the perspective of Figure 2 , the structural mass of the rotary grinding head 11 at the upper part of the guide body 13 is greater than that at the lower part of the guide body 13, and the driving shaft 12 is a hollow tubular structure with equal diameter, so that the central axis of the driving shaft 12 coincides with the central axis of the guide body 13, at this time, only in view of the asymmetric structure of the rotary grinding head 11 itself, the center of mass 14 is located on the upper side of the central axis of the hollow structure for the guide body 13 to pass through.
[0062] In order to make the center of mass 14 deviate from the central axis of the hollow structure, in another embodiment, as shown in Figure 6 , the structure of the rotary grinding head 11 is arranged to be asymmetric about the central axis of the hollow structure, for example, from the perspective of Figure 6In view of the structure of the rotary burr 11, the structure quality of the rotary burr 11 at the upper part of the guide body 13 is greater than that at the lower part of the guide body 13, and the driving shaft 12 is a variable-diameter hollow tubular structure, the diameter of the connecting portion 121 increases from the proximal end to the distal end along the axial direction, and the driving shaft 12 further has an equal-diameter portion 122 connected to the proximal end of the connecting portion 121. At this time, the central axis of the driving shaft 12 partially coincides with the central axis of the guide body 13, that is, the central axis of the equal-diameter portion 122 always coincides with the central axis of the guide body 13, and the connecting portion 121 is asymmetrically arranged about the central axis of the hollow structure. At this time, due to the asymmetry of the rotary burr 11 itself and the asymmetry of the connecting portion 121 itself, the centroid 14 of the structure formed after the connecting portion 121 is connected to the rotary burr 11 is located on the upper side of the central axis of the hollow structure through which the guide body 13 is arranged. However, in other embodiments of the present application, the connecting portion 121 can be symmetrically arranged about the central axis of the equal-diameter portion 122, that is, symmetrically arranged about the central axis of the hollow structure.
[0063] In order to more effectively remove the lesion, the diameter of the distal end portion 11a of the rotary burr 11 gradually increases from the distal end to the proximal end along the axial direction, so that the distal end portion 11a of the rotary burr 11 is formed as a smooth taper, which can better pass through the lesion, and the outer surface of the distal end portion 11a of the rotary burr 11 is covered with a rotary grinding layer 111 (see Figure 2 and Figure 6 ). When the distal end portion 11a of the rotary burr 11 first contacts the lesion, the lesion can be ground by the rotary grinding layer 111, and the removal efficiency is higher.
[0064] In order to further solve the problem that the existing rotary burr cannot be withdrawn by reverse grinding after passing through the lesion under the action of the forward pushing force, the diameter of the proximal end portion 11b of the rotary burr 11 gradually decreases from the distal end to the proximal end along the axial direction, so that the proximal end portion 11b of the rotary burr 11 is formed as a smooth taper, which can better pass through the lesion when withdrawing, and the outer surface of the proximal end portion 11b of the rotary burr 11 is covered with a rotary grinding layer 111 (see Figure 2 and Figure 6 ), so that the rotary burr 11 can realize bidirectional grinding, that is, grinding when advancing to the distal end and grinding when withdrawing to the proximal end. Therefore, even if the rotary burr 11 is stuck when passing through the lesion under the action of the forward pushing force, the lesion can still be ground by withdrawing, which not only has high grinding efficiency, but also prevents the rotary burr 11 from being stuck in the vascular plaque and being unable to be removed, thereby further reducing the risk of surgery.
[0065] Preferably, the entire outer surface of the rotating burr 11 is covered with the rotating layer 111. In this embodiment, the outer surface of the intermediate portion 11c formed between the distal end portion 11a and the proximal end portion 11b of the rotating burr 11 is also covered with the rotating layer 111, in addition to the outer surface of the distal end portion 11a and the proximal end portion 11b, so as to further improve the rotating efficiency. The intermediate portion 11c can have an equal diameter, so that the intermediate portion 11c forms a cylinder, i.e. a cylinder in the middle and two tapered pyramids at the two ends. In this case, the diameter of the intermediate portion 11c is equal to the maximum diameter of the proximal end portion 11b and the distal end portion 11a. Alternatively, the diameter of the intermediate portion 11c gradually increases and then gradually decreases along the axial direction from the distal end to the proximal end, so that the intermediate portion 11c has an arc-shaped outer surface. In this case, the rotating burr 11 as a whole is similar to a spindle. In this case, the maximum diameter of the distal end of the intermediate portion 11c is equal to the maximum diameter of the proximal end of the distal end portion 11a, and the maximum diameter of the proximal end of the intermediate portion 11c is equal to the maximum diameter of the distal end of the proximal end portion 11b. For reference, see Figures 1 to 6 .
[0066] In a specific embodiment, the rotating burr 11 can include a substrate 112, wherein the substrate 112 is provided with the hollow structure of the rotating burr 11, and the rotating layer 111 is covered on the outer surface of the substrate 112. The rotating layer 111 is composed of rotating particles made of one or more rotating materials. The rotating particles can be partially embedded in the substrate 112 for fixation. The thickness of the rotating layer 111 can be set to 20-120 μm, such as 20 μm, 40 μm, 50 μm or 100 μm. The thickness of the rotating layer 111 can be understood as the height protruding from the surface of the substrate 112. The thickness of the rotating layer 111 should not be too large or too small. If it is too large, it will increase the static diameter of the rotating burr, and if it is too small, it will reduce the rotating effect of removing the lesions.
[0067] The material of the rotating particles is not particularly limited in the present application. The rotating particles can be made of one or more suitable rotating materials. For example, the rotating particles can be made of one or more materials selected from the group consisting of diamond, fused quartz, titanium nitride, tungsten carbide, silicon carbide, etc. The material of the substrate 112 is also not particularly limited in the present application. The substrate 112 can be made of one or more suitable materials, but can be a metal material or a non-metal material. For example, the substrate 112 can be made of one or more metal materials such as stainless steel, nickel, etc. Further, the material of the substrate 112 also includes a radiopaque material, such as one or more combinations of tungsten, platinum, iridium, etc.
[0068] To enhance the ability of the rotary atherectomy device 10 to cross a stenosis, the diameter of the rotary atherectomy device 10 is preferably tapered both axially distally and axially proximally. When the diameter of the rotary atherectomy device 10 is tapered axially distally, forward atherectomy is facilitated by the distal portion 11a, and the smaller diameter of the distal portion 11a relative to the intermediate portion 11c facilitates the distal portion 11a of the rotary atherectomy device 10 to contact and atherectomize the stenosis first. When the diameter of the rotary atherectomy device 10 is tapered axially proximally, reverse atherectomy is facilitated by the proximal portion 11b when the device is withdrawn, and the smaller diameter of the proximal portion 11b relative to the intermediate portion 11c facilitates the proximal portion 11b of the rotary atherectomy device 10 to contact and atherectomize the stenosis first when the device is withdrawn. Further, the distal portion 11a of the rotary atherectomy device 10 has a smaller minimum diameter than the proximal portion 11b of the rotary atherectomy device 10, such that the distal-most diameter of the rotary atherectomy device 10 is minimized, thereby facilitating the passage of the rotary atherectomy device 10 through a stenotic vessel and catheter to the site of the stenosis. Further, the distal portion 11a of the rotary atherectomy device 10 has a larger maximum diameter than the proximal portion 11b of the rotary atherectomy device 10, which facilitates increased extension of the distal portion 11a and facilitates the passage of the rotary atherectomy device 10 through a stenotic vessel and catheter to the site of the stenosis. In the present embodiment, the rotary atherectomy device 10 is a spindle having a smooth outer surface and a shape that is tapered to have a smaller diameter at the distal and proximal ends and a larger diameter at the intermediate portion.
[0069] The diameter of the distal portion 11a of the rotary atherectomy device 10 is generally selected to be compatible with the diameter of the guide body 13. In one embodiment, the diameter of the distal portion 11a of the rotary atherectomy device 10 is 0.13-0.66 mm, such as 0.13 mm, 0.2 mm, 0.3 mm minimum diameter and 0.66 mm maximum diameter.
[0070] The diameter of the proximal portion 11b of the rotary atherectomy device 10 is generally selected to be compatible with the diameter of the drive shaft 12. In one embodiment, the diameter of the proximal portion 11b of the rotary atherectomy device 10 is 0.5-1.2 mm, such as 0.5 mm, 0.7 mm, 1.0 mm minimum diameter and 1.2 mm maximum diameter.
[0071] In view of the fact that the inner part of the rotating burr 11 not only needs to pass through the guide body 13, but also needs to connect the connecting part 121 of the driving shaft 12, and the guide body 13 needs to pass through the driving shaft 12, therefore, the maximum diameter of the middle part 11c of the rotating burr 11 is set according to the diameter of the guide body 13 and the diameter of the driving shaft 12. In an embodiment, the maximum diameter of the middle part 11c of the rotating burr 11 is 0.66-4.0 mm, such as 0.66 mm, 1.25 mm, 2.0 mm or 4.0 mm. It should also be understood that the middle part 11c of the rotating burr 11 should not be understood in a narrow sense as an absolute middle position, but should be understood as a part of any length between the distal end part 11a and the proximal end part 11b.
[0072] As a preferred embodiment, the rotating burr device 10 itself can include a guide body 13, which is used to pass through the hollow structure of the driving shaft 12 and the hollow structure of the rotating burr 11, and the guide body 13 extends from the distal end of the rotating burr 11. The rotating burr 11 and the driving shaft 12 can rotate and axially move relative to the guide body 13, so that the driving shaft 12 travels and rotates along the guide body 13. However, in other embodiments of the present application, the guide body 13 is used as an external structure in combination with the rotating burr device 10.
[0073] In order to ensure the connection strength between the distal end of the driving shaft 12 and the rotating burr 11, the connecting part 121 of the driving shaft 12 is usually inserted into the hollow structure of the rotating burr 11 for connection. In an embodiment, the hollow structure of the rotating burr 11 is composed of a distal end hollow structure and a proximal end hollow structure which are in communication with each other, the cavity diameter of the distal end hollow structure is adapted to the diameter of the guide body 13, the cavity diameter of the proximal end hollow structure is larger than that of the distal end hollow structure, and the proximal end hollow structure is fixedly connected with the connecting part 121. It can be understood that the distal end hollow structure is used to directly pass through the guide body 13, the proximal end hollow structure is used to directly pass through the connecting part 121 of the driving shaft 12, and the guide body 13 passes through the driving shaft 12.
[0074] Figure 1 and Figure 2An alternative embodiment of the connection between the drive shaft 12 and the rotational atherectomy head 11 is shown. In this exemplary embodiment, the hollow structure of the rotational atherectomy head 11 is composed of a distal hollow structure 113 and a proximal hollow structure 114 which are in communication with each other. Both the distal hollow structure 113 and the proximal hollow structure 114 are cylindrical cavities with coincident central axes, the cavity diameter of the distal hollow structure 113 is adapted to the diameter of the guide wire, and the cavity diameter of the proximal hollow structure 114 is adapted to the overall diameter of the drive shaft 12. In this case, the drive shaft 12 is a constant-diameter hollow tubular structure, and the connecting portion 121 of the drive shaft 12 enters the proximal hollow structure 114 and is fixedly connected to the proximal hollow structure 114, for example by crimping the connecting portion 121 to the proximal hollow structure 114. By "crimping", it is meant that the diameter of the drive shaft 12 is greater than the cavity diameter of the proximal hollow structure 114, and the connecting portion 121 is fixedly connected to the proximal hollow structure 114 by deforming the connecting portion 121. In this embodiment, the central axes of the distal hollow structure 113, the proximal hollow structure 114, and the drive shaft 12 coincide.
[0075] However, the present application does not make any special requirements for the connection between the connecting portion 121 and the rotational atherectomy head 11, and in addition to crimping, the connection can also be fixed by, for example, welding, adhesive bonding, or other mechanical connection methods.
[0076] In an alternative embodiment, the drive shaft 12 can be provided as a variable-diameter hollow tubular structure. Figure 6 Another alternative embodiment of the connection between the drive shaft 12 and the rotational atherectomy head 11 is shown. In this exemplary embodiment, the connecting portion 121 is inserted into the proximal hollow structure 114 from the proximal opening of the rotational atherectomy head 11, and the radial dimension of the proximal opening is less than or equal to the diameter of the proximal end of the connecting portion 121, so that the rotational atherectomy head 11 is limited from being separated from the drive shaft 12 by the proximal opening, and the rotational atherectomy head 11 and the drive shaft 12 are prevented from being separated and falling off during the rotational atherectomy process. At this time, the connecting portion 121 and the proximal hollow structure 114 are also fixedly connected by, for example, welding or adhesive bonding. In this embodiment, the central axes of the distal hollow structure 113, the proximal hollow structure 114, and the constant-diameter portion 121 of the drive shaft 12 coincide.
[0077] Further, when the rotational atherectomy head 11 is a spindle, the shape of the proximal hollow structure 114 is adapted to the shape of the spindle, and the shape of the connecting portion 121 is adapted to the spindle-like shape of the proximal hollow structure 114, for example the diameter of the connecting portion 121 gradually increases and then gradually decreases along the axial direction from the proximal end to the distal end. At this time, the rotational atherectomy head 11 can be provided as a hollow shell, which can reduce the mass of the rotational atherectomy head 11, so as to reduce the influence of the centrifugal force on the movement state of the rotational atherectomy head 11.
[0078] The distal portion 11a and proximal portion 11b of the burr head 11 may have different or the same bending radii. Generally, the bending radius of the distal portion 11a of the burr head 11 is greater than or equal to the bending radius of the proximal portion 11b of the burr head 11. Preferably, the bending radius of the distal portion 11a of the burr head 11 is greater than the bending radius of the proximal portion 11b of the burr head 11, so that the distal portion 11a is more gentle to improve the ability to pass through lesions.
[0079] The structure of the rotary grinding head 11 will be further described below with reference to specific embodiments.
[0080] Figures 1 to 3 An exemplary embodiment of the rotary grinding head 11 is shown. For example... Figures 1 to 3 As shown, the average thickness of the spun polishing layer 111 is 50 μm, the spun polishing particles of the spun polishing layer 111 are diamond, the substrate 112 is a combination of stainless steel and nickel, the spun polishing head 11 is a spindle shape tapering at both ends, and the spun polishing head 11 has a minimum diameter at its distal portion 11a, which allows for better spun polishing and entry into narrow passages; the bending radius of the distal portion 11a of the spun polishing head 11 is 4.5 mm, the bending radius of the proximal portion 11b of the spun polishing head 11 is 3.5 mm, the minimum diameter of the distal portion 11a of the spun polishing head 11 is 0.30 mm, the maximum diameter of the middle portion 11c of the spun polishing head 11 is 1.25 mm, and the minimum diameter of the proximal portion 11b of the spun polishing head 11 is 0.75 mm. In actual use, after the first pass of the lesion by the rotator head 11, the rotator head 11 can be further rotated by centrifugal force to increase the rotator diameter. The single rotator head 11 located at the far end of the drive shaft 12 is not affected by the force generated by the additional rotator head 11. Therefore, the distance between the centroid 14 and the central axis of the hollow structure does not change, and the centrifugal force and the rotation diameter are stable, making the rotator process controllable.
[0081] More in detail, such as Figure 4 As shown, within the illustrated blood vessel 31, the connecting portion 121 of the drive shaft 12 is connected to the rotary burr head 11. The outer surface of the rotary burr head 11 is completely covered by the rotary burr layer 111. The distal portion 11a of the rotary burr head 11 has a minimum diameter, and the rotary burr layer 111 of the distal portion 11a of the rotary burr head 11 can first contact and rotary burr open the stenotic lesion 32. Figure 5As shown, in a common scenario, due to the elasticity of the blood vessel 31, when the operator pushes the rotational atherectomy device 10 distally, the rotational atherectomy head 11 may travel along the guide body 13 past the stenotic lesion 32. The diameter of the stenotic lesion 32 is smaller than the maximum diameter of the rotational atherectomy head 11, causing the rotational atherectomy head 11 to be stuck by the stenotic lesion 32 and unable to be directly withdrawn. However, due to the proximal conical surface of the rotational atherectomy head 11 and its rotational atherectomy layer 111, the rotational atherectomy head 11 can perform reverse rotational atherectomy when withdrawn, thereby atherecting and opening the lesion.
[0082] Figure 6 Another exemplary embodiment of the rotary grinding head 11 is shown. For example... Figure 6 As shown, the average thickness of the spun layer 111 is 100 μm, the substrate 112 is made of nickel and has a shell structure, the spun particles are diamond, and the spun head 11 is a spindle shape tapering at both ends. The spun head 11 has a minimum diameter at its distal portion 11a, which allows for better spun grinding and entry into narrow passages. The bending radius of the distal portion 11a of the spun head 11 is 3 mm, the bending radius of the proximal portion 11b of the spun head 11 is 3 mm, the minimum diameter of the distal portion 11a of the spun head 11 is 0.20 mm, the maximum diameter of the middle portion 11c of the spun head 11 is 2.0 mm, and the minimum diameter of the proximal portion 11b of the spun head 11 is 1.0 mm. The working principle of this scheme can also be referred to... Figure 4 and Figure 5 This will not be described in detail here.
[0083] refer to Figure 4 and 5 The rotary abrasion device 10 can be delivered to the target location inside the body via a conduit 41. Furthermore, coolant and / or lubricant (generally saline or other biocompatible liquid) can be delivered to the rotary abrasion device 10 through the delivery channel in the conduit 41.
[0084] In summary, the rotary grinding device and rotary grinding equipment provided by the present invention have at least the following advantages:
[0085] 1) By setting the burr head at the distal end of the drive shaft, the distal end of the burr device becomes a burr head with burr function. At this time, during the operation, there is no need to screw the distal end of the drive shaft into or squeeze through the narrow lesion. It is only necessary to make the burr head contact the lesion and perform burr. Therefore, the burr effect and passability are good, and the surgical risk is reduced and the success rate of the operation is improved.
[0086] 2) By offsetting the center of mass of the structure formed by connecting the rotary grinding head and the connecting part on the driving shaft, the rotary grinding head can self-adjust the rotary grinding diameter during the opening of the lesion during the rotary grinding process, effectively removing the lesion, thereby avoiding the configuration of multiple rotary grinding heads of different sizes, avoiding frequent equipment, reducing the operation time, and reducing the operation risk. Especially, the static diameter of the rotary grinding head can be set smaller, making the rotary grinding device easier to pass through the narrow blood vessels and catheters to reach the lesion blood vessel position, reducing the operation difficulty; Because the static diameter of the rotary grinding head can be smaller, the rotary grinding head is not easy to block the blood flow in the narrow lesion blood vessel, nor will it block the flow of cooling liquid and / or lubricating liquid to the distal end, further reducing the operation risk and increasing the operation safety;
[0087] 3) Only one rotary grinding head is provided, and the rotary grinding head is arranged at the distal end of the driving shaft, thereby reducing the axial length of the entire driving shaft and reducing the influence of the driving shaft on the distal lesion and the normal blood vessel during the rotary grinding process. Especially, the eccentric arrangement of the rotary grinding head makes the centrifugal force during the rotary grinding process controllable, without affecting the movement state of the rotary grinding head and the force on the blood vessel, thereby reducing the uncontrollable risk during the operation and increasing the operation safety. At the same time, the arrangement of one rotary grinding head will not increase the overall hardness of the driving shaft, and the flexibility of the driving shaft can be ensured to improve its ability to pass through the blood vessels and catheters.
[0088] In addition, when the entire outer surface of the rotary grinding head is covered with a rotary grinding layer, the rotary grinding head can realize bidirectional rotary grinding. When the rotary grinding head stalls while passing through the narrow lesion, it can still grind the lesion to achieve retreatment. Not only is the rotary grinding efficiency higher, but the operation risk is also lower.
[0089] It can be understood that when the center of mass of the structure does not coincide with the central axis of the hollow structure, under the action of centrifugal force, the rotary grinding head will deviate from its rotation center to form revolution when the driving rotary grinding head and the driving shaft rotate around the central axis of the hollow structure. By adjusting the rotation speed of the rotary grinding head, the revolution diameter of the rotary grinding head can be controlled. For example, if the rotation speed increases, the rotary grinding diameter increases, thereby realizing a rotary grinding diameter larger than the static rotary grinding head size, thereby reducing the static size of the rotary grinding head and avoiding the number of times of replacing the rotary grinding head. Moreover, multiple rotary grinding heads with different static diameters do not need to be arranged. At this time, the rotary grinding diameter larger than the static rotary grinding head size can also enable blood, cooling liquid / lubricating liquid to flow around the rotary grinding head, reducing the risk of the rotary grinding head blocking the blood flow in the blood vessel.
[0090] It should also be understood that the above discloses the preferred embodiments for implementing the present application, but the present application is not limited to the scope disclosed by the above embodiments. Any transformation based on the structure provided by the above embodiments belongs to the scope protected by the present application, and those skilled in the art can deduce from the above embodiments.
Claims
1. A rotational atherectomy device for intravascular surgery, characterized in that, The device comprises a driving shaft, a guide body and a rotational atherectomy head; the rotational atherectomy head is one; the driving shaft has a connecting part at the distal end, the connecting part is connected with the rotational atherectomy head; the rotational atherectomy head and the driving shaft both have a hollow structure extending through in the axial direction, the hollow structure is used for the guide body to pass through; the rotational atherectomy head and the driving shaft can rotate and move axially relative to the guide body; wherein the center of mass of the structure formed by the rotational atherectomy head and the connecting part is not coincident with the central axis of the hollow structure; The rotational atherectomy head is spindle-shaped, and comprises a base and a rotational atherectomy layer, the rotational atherectomy layer is covered on the outer surface of the base, the rotational atherectomy layer is composed of rotational atherectomy particles, and the base is arranged as a shell structure; the hollow structure of the rotational atherectomy head is composed of a distal hollow structure and a proximal hollow structure which are in communication with each other, the cavity diameter of the distal hollow structure is adapted to the diameter of the guide body, and the cavity diameter of the proximal hollow structure is greater than that of the distal hollow structure; The diameter of the connecting part increases from the proximal end to the distal end in the axial direction, and the shape of the connecting part is adapted to the shape of the proximal hollow structure; the driving shaft further has an equal-diameter part connected with the proximal end of the connecting part, and the equal-diameter part, the proximal hollow structure, the distal hollow structure and the central axis of the guide body are coincident; The connecting part is inserted into the proximal hollow structure from the proximal opening of the rotational atherectomy head, the radial dimension of the proximal opening is less than or equal to the diameter of the proximal end of the connecting part, so as to limit the rotational atherectomy head from separating from the driving shaft, and the proximal hollow structure is fixedly connected with the connecting part.
2. The rotational atherectomy device of claim 1 wherein, The diameter of the distal part of the rotational atherectomy head gradually increases from the distal end to the proximal end in the axial direction, and the outer surface of the distal part of the rotational atherectomy head is covered with the rotational atherectomy layer.
3. The rotational atherectomy device of claim 2 wherein, The diameter of the proximal part of the rotational atherectomy head gradually decreases from the distal end to the proximal end in the axial direction, the outer surface of the proximal part of the rotational atherectomy head is covered with the rotational atherectomy layer, and / or the outer surface of the intermediate part formed between the distal part and the proximal part of the rotational atherectomy head is covered with the rotational atherectomy layer.
4. The rotational atherectomy device of claim 3 wherein, The intermediate part has an equal diameter, or the diameter of the intermediate part gradually increases from the distal end to the proximal end and then gradually decreases in the axial direction.
5. The rotational atherectomy device of any of claims 2-4, wherein, The thickness of the rotational atherectomy layer is 20-120 μm.
6. The rotational atherectomy device of any of claims 1-4, wherein, The diameter of the rotational atherectomy head gradually decreases from the distal end to the proximal end in the axial direction.
7. The rotational atherectomy device of claim 6 wherein, The rotational atherectomy head has at least one of the following characteristics: The minimum diameter of the distal part of the rotational atherectomy head is less than the minimum diameter of the proximal part of the rotational atherectomy head; The maximum diameter of the distal part of the rotational atherectomy head is less than the maximum diameter of the proximal part of the rotational atherectomy head; The bending radius of the distal part of the rotational atherectomy head is greater than or equal to the bending radius of the proximal part of the rotational atherectomy head.
8. The rotational atherectomy device of claim 6 wherein, The rotational atherectomy head has at least one of the following characteristics: The diameter of the distal part of the rotational atherectomy head is 0.13-0.66 mm; The diameter of the intermediate part formed between the distal part and the proximal part of the rotational atherectomy head is 0.66-4.0 mm; The diameter of the proximal part of the rotational atherectomy head is 0.5-1.2 mm.
9. A rotational atherectomy device, characterized by, The rotary abrasive device as claimed in any one of claims 1-8, wherein the rotary abrasive device is connected to a driving shaft of a driving device, and the driving device is configured to drive the rotary abrasive device to rotate. The rotary abrasive device as claimed in any one of claims 1-8, wherein the rotary abrasive device is connected to a driving shaft of a driving device, and the driving device is configured to drive the rotary abrasive device to rotate.
Citation Information
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