WO2024026919A1 - 偏心旋磨头及其制造方法、驱动轴及介入式医疗设备 - Google Patents

偏心旋磨头及其制造方法、驱动轴及介入式医疗设备 Download PDF

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Publication number
WO2024026919A1
WO2024026919A1 PCT/CN2022/112204 CN2022112204W WO2024026919A1 WO 2024026919 A1 WO2024026919 A1 WO 2024026919A1 CN 2022112204 W CN2022112204 W CN 2022112204W WO 2024026919 A1 WO2024026919 A1 WO 2024026919A1
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Prior art keywords
eccentric
curved surface
base body
rotational
axis
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PCT/CN2022/112204
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English (en)
French (fr)
Inventor
沈斌
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广州博鑫医疗技术有限公司
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Priority claimed from CN202210938128.7A external-priority patent/CN115778498A/zh
Priority claimed from CN202210938139.5A external-priority patent/CN115778499A/zh
Application filed by 广州博鑫医疗技术有限公司 filed Critical 广州博鑫医疗技术有限公司
Publication of WO2024026919A1 publication Critical patent/WO2024026919A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions

Definitions

  • the invention relates to the technical field of medical devices, and in particular to an eccentric rotary atherectomy head and its manufacturing method, a drive shaft and interventional medical equipment.
  • Ischemic heart disease has gradually become one of the most lethal diseases.
  • the main cause is atherosclerosis: fat, fiber, and calcium deposit on the blood vessel walls to form plaques, which hinders the normal circulation of blood and leads to blood vessel obstruction.
  • interventional balloon and stent treatments are often used to push atherosclerotic plaques into the blood vessel walls to unblock blood vessels and treat ischemic heart disease and peripheral arterial disease.
  • the balloon and stent cannot fully open in the calcified blood vessels, making it difficult to achieve ideal therapeutic effects.
  • the main purpose of the present invention is to provide an eccentric rotational atherectomy head and its manufacturing method, drive shaft and interventional medical equipment to solve the technical problem of too high surgical risks in the prior art.
  • a first aspect of the present invention provides an eccentric rotational atherectomy head for interventional medical equipment.
  • the eccentric rotational atherectomy head has a connection hole for connecting with a flexible shaft; the eccentric rotational atherectomy head includes an eccentric base body and a grinding head.
  • Granular layer, the side surfaces of the eccentric matrix include a first curved surface, a second curved surface and a third curved surface,
  • the first curved surface and the second curved surface respectively cover at least two ends of the eccentric base body and are symmetrical about a central plane between the two ends of the eccentric base body. They are respectively parts of the same curved surface of revolution, and the The curved surface of revolution is formed by a smooth convex curve rotating around a central axis.
  • the central axis is the axis of the connecting hole.
  • the distance from each point on the convex curve to the central axis is along the distance from the end surface of the eccentric base body. The direction to said central plane gradually increases;
  • the third curved surface is at least part of a cylindrical surface, located in the middle section of the eccentric base body, and its axis of rotation is an eccentric axis, and the eccentric axis is parallel to and at a distance from the central axis of the connecting hole;
  • first curved surface and the second curved surface are partially connected at the central plane, forming at least one continuous smooth bus line on the side; the revolution curved surface intersects with the cylindrical surface to form a shape located respectively at each location.
  • the first intersecting line and the second intersecting line on both sides of the central plane; the part on the revolution curved surface between the central plane, the first intersecting line and the eccentric base body and its end surface on the same side is formed
  • the first curved surface is located on the central plane, the second intersecting line and the part of the eccentric base body and its end surface on the same side form the second curved surface, and the cylindrical surface is located on the first intersecting line.
  • the portion between the second intersecting line and the second intersecting line forms the third curved surface;
  • the abrasive grain layer is arranged on the side of the eccentric base body.
  • the first curved surface, the second curved surface and the third curved surface intersect at a point on the central plane.
  • the first curved surface and the second curved surface are connected in a partial area in the circumferential direction of the eccentric base body, and the first intersecting line and the second intersecting line are connected at the central plane. and smooth transition.
  • the convex curve is a circular arc, an elliptical arc, a parabola or a hyperbola.
  • the convex curve is an arc line
  • the eccentricity M between the eccentric axis and the central axis and the minimum wall thickness s of the eccentric base satisfy the following formula:
  • R [L 2 /4+(D/2+d/2-M+s) 2 ]/[2*(D/2+d/2-M+s)].
  • the eccentricity between the eccentric axis and the central axis is 0.05mm ⁇ 0.6mm; the maximum size of the eccentric base body in the radial direction is 1.0 ⁇ 2.5mm;
  • the axial dimension of the eccentric base body is 1.0 mm to 7.0 mm; the minimum wall thickness of the eccentric base body is greater than or equal to 0.05 mm.
  • the protruding height of the abrasive grains in the abrasive grain layer is 5-35 ⁇ m.
  • a second aspect of the present invention provides a drive shaft for interventional medical equipment, including a flexible shaft and an eccentric rotational atherectomy head according to any one of the above, and the eccentric rotational atherectomy head is disposed distal to the flexible shaft. In the end area, the connecting hole is plugged into the flexible shaft.
  • the flexible shaft is provided with a plurality of eccentric rotational burrs at intervals along its axial direction, and the eccentric directions of each of the eccentric rotational burrs are staggered in the circumferential direction of the flexible shaft, and
  • the radial maximum dimension of the eccentric burr head in the middle part is larger than the radial maximum dimension of the eccentric burr head in both end parts.
  • the radial maximum size of the plurality of eccentric rotational burrs gradually decreases from the middle to both ends.
  • a third aspect of the present invention provides an interventional medical device, including the drive shaft according to any one of the above.
  • a fourth aspect of the present invention provides a method for manufacturing an eccentric rotational atherectomy head for interventional medical equipment, including the steps:
  • the first curved surface and the second curved surface respectively cover at least two ends of the eccentric base body and are symmetrical about a central plane between the two ends of the eccentric base body. They are respectively parts of the same curved surface of revolution, and the The curved surface of revolution is formed by a smooth convex curve rotating around a central axis.
  • the central axis is the axis of the connecting hole.
  • the distance from each point on the convex curve to the central axis is along the distance from the end surface of the eccentric base body. The direction to said central plane gradually increases;
  • the third curved surface is at least part of a cylindrical surface, located in the middle section of the eccentric base body, and its axis of rotation is an eccentric axis, and the eccentric axis is parallel to and at a distance from the central axis of the connecting hole;
  • first curved surface and the second curved surface are partially connected at the central plane, forming at least one continuous smooth bus line on the side; the revolution curved surface intersects with the cylindrical surface to form a shape located respectively at each location.
  • the first intersecting line and the second intersecting line on both sides of the central plane; the part on the revolution curved surface between the central plane, the first intersecting line and the eccentric base body and its end surface on the same side is formed
  • the first curved surface is located on the central plane, the second intersecting line and the part of the eccentric base body and its end surface on the same side form the second curved surface, and the cylindrical surface is located on the first intersecting line.
  • the portion between the second intersecting line and the second intersecting line forms the third curved surface;
  • the abrasive grain layer is arranged on the side of the eccentric base body.
  • S200 Form an abrasive grain layer on the side of the eccentric base body to obtain an eccentric rotary grinding head.
  • a third aspect of the present invention provides that the abrasive grain layer is formed on the side of the eccentric base body by nickel plating or brazing.
  • the entire rotational grinding surface of the eccentric rotational grinding head includes three curved surfaces, and the two curved surfaces covering the two ends and the other curved surface are respectively formed around different axes of rotation.
  • the curved surfaces covering the two ends are respectively connected with
  • the other curved surface is connected at least partially, so that there is at least one continuous and smooth bus line on the entire rotational grinding surface.
  • the eccentricity When the eccentric rotational grinding head is used in interventional medical equipment, with the high-speed rotation of the flexible shaft, the eccentricity
  • the rotational atherectomy head only forms a line contact when it contacts the blood vessel wall at the third curved surface, while the contact with the blood vessel wall in other areas is point contact, especially the contact with the blood vessel wall at the position farthest from the central axis on the rotational atherectomy surface. It is also a point contact during rotation. Therefore, by controlling the proportion of the first curved surface, the second curved surface and the third curved surface in the entire rotational grinding surface, the area of point contact and line contact of the eccentric rotational grinding head during rotational grinding can be better controlled.
  • the friction generated at the moment of point contact There are less chips, so the grinding chips generated by rotational atherectomy can be discharged from the gap between the curved surface and the blood vessel wall as quickly as possible, and there will be basically no jamming or even blood vessel blockage caused by the delayed discharge of the grinding chips. Improved surgical safety.
  • Figure 1 is a schematic structural diagram of a preferred embodiment of the eccentric rotational burr head provided by the present invention
  • Figure 2 is a schematic longitudinal cross-sectional view of the eccentric rotary burr shown in Figure 1;
  • FIG. 3 is a schematic structural diagram of another preferred embodiment of the eccentric rotational burr head provided by the present invention.
  • Figure 4 is a schematic longitudinal cross-sectional view of the eccentric rotary burr shown in Figure 3;
  • Figure 5 is a schematic structural diagram of a preferred embodiment of the drive shaft provided by the present invention.
  • Figure 6 is a schematic structural diagram of another preferred embodiment of the drive shaft provided by the present invention.
  • Eccentric rotary grinding head 10. Connecting hole; 11. Central axis; 20. First curved surface; 21. First curve; 22. First phase line; 30. Third curved surface; 31. Eccentric axis; 32. Straight line ; 40. Second curved surface; 41. Second curve; 42. Second phase line; 50. Convex curve; 60. Central plane;
  • proximal end refers to the end close to the operator
  • distal end refers to the end far away from the operator. , that is, for the same component, if it only partially extends into the patient's body, the end that extends into the patient's body is the distal end, and the end outside the body that is close to the operator is the proximal end.
  • the invention provides an interventional medical device that can be used to treat cardiovascular and other diseases and perform atherosclerosis resection.
  • the interventional medical device includes a drive shaft, as shown in Figures 5 and 6.
  • the drive shaft includes a flexible shaft 200 and an eccentric rotational atherectomy head 100.
  • the eccentric rotational atherectomy head 100 is disposed at the distal area of the flexible shaft 200.
  • the eccentric rotational atherectomy head 100 The grinding head 100 has a connecting hole 10 for connecting to the flexible shaft 200.
  • the connecting hole 10 runs through the entire eccentric rotary grinding head 100 along the axial direction of the flexible shaft 200.
  • the flexible shaft 200 is inserted into the connecting hole 10 to connect the eccentric rotary grinding head. 200 is fixedly connected to the flexible shaft 200, and the connection method between the flexible shaft 200 and the eccentric rotational grinding head 100 can be bonding, welding or interference fit.
  • the flexible shaft 200 may be wound by multiple strands of spring wire.
  • eccentric rotary grinding heads usually no matter what kind of eccentric rotary grinding head, the grinding surface is either a cylindrical surface or a tapered surface, and it is only that the cylindrical surface or the tapered surface and the connecting hole form an eccentric arrangement.
  • blood vessels are basically cylindrical, when this kind of eccentric rotational grinding head is used for rotational grinding, whether it is a cylindrical surface or a conical surface, the generatrix everywhere in the circumferential direction of the entire rotational grinding surface is a straight line.
  • the rotational grinding head When the rotational grinding surface is in line contact with the blood vessel wall, the long-term line contact and the high-speed movement of the flexible shaft will cause the eccentric force to be relatively large, resulting in a large removal force and strong removal effect on the blood vessel wall tissue. It is not conducive to the control of the removal process, causing safety hazards and increasing the risk of surgery; and the intersection line between the conical surface and the cylindrical surface is relatively sharp. When the position of the eccentric rotational burr head changes, the intersection line is prone to cutting blood vessels. effect, further increasing the risk of surgery.
  • the eccentric rotational grinding head 100 of the present invention adopts a rotational grinding surface that combines a convex smooth curved surface and a cylindrical surface, and has at least one continuous smooth busbar on the entire rotational grinding surface.
  • the eccentric rotary burr head 100 includes an eccentric base body and an abrasive grain layer (not shown in the figure).
  • the connecting hole 10 is provided on the eccentric base body.
  • the eccentric base body includes side faces and end faces.
  • the end face refers to the central axis of the eccentric base body along the connecting hole 10.
  • 11 are two opposite surfaces, and the side surfaces are arranged around the central axis 11 of the connecting hole 10 . It is not limited to the side surfaces being rotated around the central axis 11 .
  • the side surface of the eccentric base body includes a first curved surface 20, a second curved surface 40 and a third curved surface 30.
  • the third curved surface 30 is at least part of the cylindrical surface and is located in the middle section of the eccentric base body. Its axis of rotation is the eccentric axis 31.
  • the eccentric axis 31 It is parallel to the central axis 11 of the connecting hole 10 and leaves a distance, which can be recorded as the eccentricity M.
  • the first curved surface 20 and the second curved surface 40 are both smooth convex curved surfaces. They cover at least two ends of the eccentric base body respectively.
  • the first curved surface 20 and the second curved surface 40 are symmetrical about the central plane 60 between the two ends of the eccentric base body. The two are respectively parts of the same revolution surface.
  • the revolution surface is formed by a smooth convex curve 50 rotating around the central axis 11.
  • the convex curve 50 is symmetrical about the central plane 60, and the distance between each point on it and the central axis 11 is It gradually increases along the direction from the end surface of the eccentric base body to the central plane 60 , that is, the convex curve 50 protrudes in a direction away from the central axis 11 , and its maximum protruding position is located at the central plane 60 .
  • the first curved surface 20 and the second curved surface 40 are partially connected at the central plane 60, forming at least one continuous smooth generatrix on the side of the eccentric base body.
  • the curved surface of revolution intersects with the cylindrical surface to form a first intersecting line (refer to the first phase line 22 which is part of the first intersecting line in the drawing) and a second intersecting line (refer to the appended drawing) respectively located on both sides of the central plane 60
  • the figure shows the second phase line 42) which is a part of the second intersecting line.
  • the part of the revolution curved surface between the central plane 60, the first intersecting line and the eccentric base body and its end surface on the same side forms the first curved surface 20, which is located on the central plane. 60.
  • the second intersecting line and the part of the eccentric base body and its end surface on the same side form the second curved surface 40
  • the part of the cylindrical surface between the first intersecting line and the second intersecting line forms the third curved surface 30, that is to say
  • the connecting line between the first curved surface 20 and the third curved surface 30 is at least part of the first intersecting line
  • the connecting line between the second curved surface 40 and the third curved surface is at least part of the second intersecting line.
  • the abrasive grain layer is arranged on the side of the eccentric base body, that is, the abrasive grain layer is set on the side of the eccentric base body, so that the abrasive grains are evenly distributed on the entire side, thereby forming the rotating grinding surface of the eccentric rotary grinding head (that is, the surface formed by the abrasive grain layer) .
  • the two ends of the eccentric base are the first end and the second end respectively.
  • the first curved surface 20 at least covers the first end
  • the second curved surface 40 at least covers the second end.
  • the first curved surface 20 extends from the first end to the second end.
  • the end extends toward the central plane 60 to cover other areas of the eccentric base body
  • the second curved surface 40 extends from the second end to the central plane 60 to cover other areas of the eccentric base body
  • the two curved surfaces will meet at the central plane 60, and the connecting portions It can be just one point (as shown in Figure 1), or it can cover the circumferential portion of the side surface (as shown in Figure 3).
  • the first curved surface 20 is the end surface and center plane of the first end on the convex curved surface. 60 and the first intersecting line
  • the second curved surface 40 is the area bounded by the end surface of the second end on the convex curved surface, the central plane 60 and the second intersecting line.
  • the side of the eccentric base can be considered as the intersection of the convex curved surface formed by the convex curve 50 rotating around the central axis 11 and the cylindrical surface.
  • the portion of the formed intersection line located on the side of the central plane 60 close to the first end is the first intersection.
  • the part located on the side of the central plane 60 close to the second end is the second intersecting line, but on the side of the eccentric base body, on the side of the first intersecting line close to the first end, the second intersecting line is close to the second
  • the side surface of the eccentric base body is formed by three connecting surfaces of revolution, and the generatrices of the first curved surface 20 and the second curved surface 40 are curves, namely the first curve 21 and the second curve 41 respectively.
  • the rotation axes of the curved surfaces 40 are the same, which are the central axis 11 of the connecting hole 10 .
  • the generatrix of the third curved surface 30 is a straight line, and the axis of rotation of the third curved surface 30 is set eccentrically relative to the central axis 11, which is the eccentric axis 31.
  • the center of gravity of the entire eccentric base formed in this way will deviate from the center line 11, at the maximum eccentricity of the eccentric base.
  • the generatrix on the eccentric base body is a continuous smooth curve at least past the maximum eccentricity point C.
  • the first curve 21, the second curve 41 and the eccentric axis 31 are located on the same side of the central axis 11.
  • the first curve 21 and the second curve 41 are arranged symmetrically about the central plane 60 . They are respectively two sections on the convex curve 50 , except that they meet at certain positions in the side circumferential direction (that is, the convex curve 50 ), they are spaced apart at certain positions on the circumferential direction of the side, that is, they are two discontinuous sections on the convex curve 50.
  • the first curve 21 is a smooth curve protruding away from the central axis 11.
  • One end of the curve 21 located at the first end is closer to the central axis 11 than the other end.
  • the distance from each point on the first curve 21 to the central axis 11 gradually increases from one end close to the first end to the other end. Therefore, the first curved surface 20 formed is a convex smooth curved surface.
  • the second curve 41 is also a convex smooth curve.
  • One end located at the second end is closer to the central axis 11 than the other end, and the second curve 41 The distance from each point on to the central axis 11 gradually increases from the second end to the other end.
  • the parts at both ends (in the axial direction) on the side of the eccentric base body have smaller radial dimensions relative to the outer contour of the middle part.
  • the rotational grinding surface of the entire eccentric rotational grinding head is in the middle. Large structure with small ends.
  • the above-mentioned central plane is perpendicular to the central axis 11 , that is, the central plane refers to the plane that passes through the center of the eccentric base along its axial direction and is perpendicular to the central axis 11 .
  • the maximum eccentricity point C of the eccentric base body refers to the position of the point with the greatest distance from the side of the eccentric base body to the central axis. When there is only one point at this position, it is located on the central plane (as shown in Figures 2 and 4). This can be recorded The position is the maximum eccentric position, the longitudinal section passing through this point refers to the cross section passing through the maximum eccentric position and the central axis 11 at the same time, and the maximum eccentric side refers to the side where the maximum eccentric point C is located.
  • the eccentric burr head 100 of the above embodiment When the eccentric burr head 100 of the above embodiment is working, in addition to rotating along with the rotation of the flexible shaft 200, the eccentric burr head 100 also rotates under the action of its eccentric mass, so that the diameter expansion grinding of the blood vessel wall can be achieved.
  • the effect is that by using the eccentric rotational atherectomy head 100 with a smaller outer diameter, the inner diameter of the blood vessel wall can be made larger than the outer diameter through rotational atherectomy, that is, a larger enlarged diameter can be obtained.
  • the rotational grinding surface of the eccentric rotational grinding head 100 includes three convex curved surfaces of revolution, and the first curved surface 20 and the second curved surface 40 are partially connected at the center surface, and there is at least one continuous line on the side of the eccentric base body.
  • the eccentricity of the present invention is Compared with other eccentric structures, when the geometric eccentricity (that is, the distance between the center of gravity of the eccentric base body and the axis of the flexible shaft) is the same, the eccentric mass of the rotary burr head of the present invention is smaller and the centrifugal force is also smaller. Therefore, it produces The grinding force is smaller, and the entire rotational grinding surface is smoother. When the position of the eccentric rotational grinding head changes, it will basically not have a cutting effect on the blood vessels. When the flexible shaft rotates at high speed, the eccentric rotational grinding head 100 only cuts the blood vessels at the first position. Line contact is formed when the tri-curved surface 30 contacts the blood vessel wall, while other areas are in point contact with the blood vessel wall.
  • the entire rotational grinding surface is It can better control the area of point contact and line contact of the eccentric rotational atherectomy head during rotational atherectomy, control the efficiency and grinding ability of intravascular plaque removal, and thus better realize the treatment of different diameters and positions.
  • both ends of the entire rotational abrasion surface are convex curved surfaces, a structure is formed that is large in the middle and small at the two ends.
  • none of the two curved surfaces contacts the blood vessel wall in the axial direction.
  • the amount of instantaneous rotational abrasion is small, and the instantaneous wear debris generated is relatively small. Therefore, the wear debris generated by rotational abrasion can be discharged from the gap between the curved surface and the blood vessel wall as quickly as possible. , there will be basically no jamming or even blood vessel blockage caused by delayed discharge of wear debris, further improving the safety of the surgery.
  • the distance between the eccentric axis 31 and the central axis 11, that is, the eccentricity M can be 0.05mm to 0.6mm, such as 0.05mm, 0.08mm, 0.1mm, 0.2mm, 0.3mm, 0.4mm, 0.5mm or 0.6mm, etc.
  • the larger the distance the larger the inner diameter of the blood vessel after rotational atherectomy.
  • the eccentricity of the entire eccentric rotary grinding head can be better controlled, thereby controlling the grinding force during the grinding process, which can not only improve the grinding efficiency, but also avoid damage to the blood vessel wall caused by too much grinding force. .
  • eccentric rotational grinding head 100 can also ensure the eccentricity amount and the rotational grinding effect while making the maximum size D of the eccentric base body in the radial direction 1.0mm to 2.5mm, such as 1.0mm, 1.2mm, 1.5mm, 1.8mm, 2.0mm, 2.2mm or 2.5mm, etc. It can be seen that while the present invention ensures the effect of rotational atherectomy, the eccentric rotational atherectomy head 100 of the present invention can be made smaller, so it can be applied to relatively thin blood vessels, thereby increasing the number of The scope of application of the eccentric rotary grinding head 100 is increased.
  • the size of the eccentric rotational burr head 100 along the direction of the central axis 11 can be 1.0 mm to 7.0 mm, such as 1.0 mm, 1.2 mm, 1.5 mm, 1.6mm, 1.8mm, 2.0mm, 2.5mm, 2.8mm, 3.0mm, 3.3mm, 3.6mm, 3.8mm, 4.0mm, 4.5mm, 5.0mm, 5.5mm, 6.0mm, 6.5mm, 6.8mm or 7.0mm Etc., when the size is larger, the efficiency of rotational atherectomy will be higher.
  • eccentric rotational atherectomy heads 100 of different lengths can be manufactured according to the condition of the lesion (such as the length of the plaque), so as to achieve better results by selecting rotational atherectomy heads of different lengths.
  • the head can not only ensure the safety of the operation, but also improve the efficiency of rotational atherectomy.
  • the minimum wall thickness s of the eccentric base body is greater than or equal to 0.05mm, such as 0.05mm, 0.06mm, 0.08mm or 0.1mm, etc., so as to ensure the strength of the eccentric burr head 100 while reducing the
  • the overall weight is small, the impact on the blood vessel wall is reduced, and the safety of the operation is further improved.
  • the diameter of the connecting hole 10 can be determined according to the flexible shaft 200 that matches it.
  • the diameter of the connecting hole 10 can be slightly larger than the diameter of the flexible shaft 200.
  • the two form a gap fit and are then connected by bonding, welding, etc.; the connecting hole 10 can also be used.
  • the diameter of the flexible shaft 200 is slightly smaller than that of the flexible shaft 200, and the two form an interference fit, that is, the connection between the two is achieved through interference fit.
  • the connection strength can also be increased through bonding, welding, etc. at the same time.
  • the diameter d of the connecting hole 10 can range from 0.55mm to 0.85mm, such as 0.55mm, 0.6mm, 0.65mm, 0.67mm, 0.7mm, 0.75mm, 0.8mm or 0.85mm, specifically when used for coronary blood vessels,
  • the diameter of the connecting hole 10 can be selected to be about 0.65 mm.
  • the diameter of the connecting hole 10 is 0.8 mm.
  • the distance between the eccentric axis 31 and the central axis 11 can first be determined through simulation experiments to satisfy the required grinding force, and then the maximum diameter of the eccentric base body can be selected while satisfying the distance range.
  • the direction dimension D is the smallest, so that the eccentric burr head can be adapted to more blood vessels while ensuring the grinding force, thereby increasing the applicable range of the eccentric burr head.
  • the structure of the present invention can be used to manufacture eccentric rotary grinding heads 100 with different maximum sizes D at the same eccentric distance M, and can also manufacture eccentric rotary grinding heads with different axial lengths L, and manufacture the first curved surface 20,
  • the third curved surface 30 and the second curved surface 40 can be combined in different ways (such as Figure 1, Figure 3 or even other embodiments described in detail below), or several ways can be combined to produce eccentric rotary burrs of various specifications. , to select the optimal eccentric rotational atherectomy head when using different blood vessels to achieve the optimal combination of rotational atherectomy effect and surgical safety.
  • the convex curve 50 is preferably a circular arc, an elliptical arc, a parabola or a hyperbola.
  • the first curve 21 and the second curve 41 are a circular arc, an elliptical arc, a parabola or a hyperbola.
  • the convex curve 50 (or the first curve 21 and the second curve 41) satisfies the circular formula, then the convex curve 50 (or the first curve 21 and the second curve 41) is a circular arc line ; If the elliptical formula is satisfied, then the convex curve 50 (or the first curve 21 and the second curve 41 ) is an elliptical arc; if the parabolic formula is satisfied, then the convex curve 50 (or the first curve 21 and the second curve 41 ) is an elliptical arc; 41) is a parabola; if it satisfies the hyperbola formula, the convex curve 50 (or the first curve 21 and the second curve 41) is a hyperbola, except that the hyperbola bulges outward (i.e., toward the central axis 11) relative to the central axis 11.
  • the intersection line of the first curved surface 20, the second curved surface 40 and the third curved surface 30 (i.e. the first phase) can be The intersecting line and the second intersecting line) are relatively smooth, which reduces the impact on blood vessels during rotational abrasion, reduces the processing difficulty, and increases the yield.
  • the convex curve 50 (or the first curve 21 and the second curve 41) is an elliptical arc, a parabola or a hyperbola, the intersection line of the first curved surface 20, the second curved surface 40 and the third curved surface 30 (i.e.
  • the convex curve 50 can also be other continuous smooth curves that want to bulge in a direction away from the central axis 11 .
  • the first curve 21 and the second curve 41 may also be other convex smooth curves.
  • the first phase line 22 may be a closed curve in the circumferential direction of the eccentric burr head 100. As shown in FIG. 1, the first phase line 22 may not be closed in the circumferential direction of the eccentric burr head 100, that is, it may be disconnected. area, as shown in Figure 3, the first phase wire 22 is broken into two parts at the maximum eccentricity. Of course, when the axial length of the eccentric base body is relatively small, the first phase wire 22 may be on the opposite side of the maximum eccentricity side ( That is, the lower side of Figure 3) is disconnected. In the same way, the second phase line 42 may be a closed curve in the circumferential direction of the eccentric rotational grinding head 100.
  • the second phase line 42 may not be closed in the circumferential direction of the eccentric rotational grinding head 100, that is, there is a break. open area, as shown in Figure 3.
  • the first phase line 22 and the second phase line 42 are both closed curves in the circumferential direction of the eccentric rotational grinding head 100 or are continuous at the maximum eccentricity C
  • the first phase line 22 and the second phase line 42 can be at the maximum eccentricity.
  • C intersects at a point, or connects to a smooth curve.
  • the smooth curve is a continuous section of the intersection line between the surface of revolution and the cylindrical surface.
  • the first curved surface 20 , the second curved surface 40 and the third curved surface 30 intersect at a point at the central plane 60 , that is, compared to the maximum eccentricity point C, as shown in Figures 1 and 2 , at the maximum eccentricity At C, there is basically no third curved surface 30, and the first curved surface 20 and the second curved surface 40 are connected, the first phase line 22 and the second phase line 42 are both continuous, and they intersect at one point at the maximum eccentricity point C, at On the longitudinal section passing through the maximum eccentricity point C, as shown in Figure 2, the maximum distance L1 from the first curve 21 and the second curve 41 to the eccentric axis 31 is equal to the radius L2 of the third curved surface 30.
  • the first curve 21 and the second curve 41 are directly connected to form a convex curve.
  • Only one continuous smooth busbar is formed on the side of the eccentric base body, which is the convex curve 50. In other words, the side is located in the circumferential direction. Points at the same position can be connected together to form a line.
  • the line passing through the maximum eccentricity point C is continuous and smooth and a complete convex curve; while each of the other lines is It includes two intervals of the first curve 21 and the second curve 41, and a straight line connecting the first curve 21 and the second curve 41 (that is, the generatrix of the cylindrical surface), or only the straight line.
  • This kind of eccentric rotary grinding head has point contact with the blood vessel wall at every position on this continuous smooth bus line, and the contact area is further reduced, while line contact is only possible in other areas with smaller eccentricity.
  • this eccentric rotational atherectomy head 100 the grinding impact force on the maximum eccentric side is significantly reduced.
  • the rotational atherectomy efficiency for plaques is relatively low, the safety is significantly improved, and it is especially suitable for some blood vessels with better safety.
  • Internal plaque treatment such as rotational atherectomy of intravascular plaques on the limbs or near the heart.
  • first curved surface 20 and the second curved surface 40 are connected in a partial area in the circumferential direction of the eccentric base body, and the first intersecting line and the second intersecting line are connected at the central plane 60 and transition smoothly.
  • first curved surface 20 and the second curved surface 40 are connected at more locations, and they are located along the side surface at the central plane 60
  • a connected structure is continuously formed in the circumferential direction, that is, there are only the first curved surface 20 and the second curved surface 40 near the maximum eccentricity point C, and there is no third curved surface 30 at all.
  • the first curved surface 20 (the part of the central plane 60 close to the first end) and the second curved surface 40 (the part of the central plane 60 close to the second end) are connected.
  • the first phase line 22 and the second phase line 42 are at this The areas are connected to form a smooth curve (i.e., the first intersecting line and the second intersecting line are connected together), and the first phase line 22 itself and the second phase line 42 themselves are respectively in this area (i.e., the maximum eccentricity point C ) is disconnected, that is to say, the first intersecting line located on the central plane 60 near the first end is disconnected into two spaced sections at the central plane 60 , and the first intersecting line located on the central plane 60 close to the second end The two intersecting lines are also broken into two spaced sections at the central plane 60.
  • each first curve 21 directly connects with the corresponding second curve 41 (that is, located at the same circumferential position), forming a convex shape.
  • Curve 50 in this way, more continuous and smooth busbars can be formed on the side of the eccentric base body.
  • This busbar is the convex curve 50.
  • points on the side at the same position in the circumferential direction can be connected to form a line.
  • the lines passing through the connecting area are continuous and smooth, and are complete convex curves; and among the other lines, each includes two intervals of the first curve 21 and the second curve 41, and connects the first curve 21 and the second curve 41.
  • the straight line of the first curve 21 and the second curve 41 (that is, the generatrix of the cylindrical surface), or only the straight line.
  • the maximum distance L1 from the first curve 21 and the second curve 41 to the eccentric axis 31 is smaller than the radius L2 of the third curved surface 30.
  • This eccentric rotational grinding head 100 on the maximum eccentric side and its vicinity, all positions can form point contact with the blood vessel wall. For the entire eccentric rotational grinding head, there are more points in contact with the blood vessel wall, and the grinding impact force on the maximum eccentric side is further reduced.
  • the efficiency of rotational atherectomy for plaques is relatively low, the safety is significantly improved, and it is suitable for some intravascular plaque treatments that require relatively high safety requirements, such as rotational atherectomy of intravascular plaques near the heart.
  • first curved surface 20 and the second curved surface 40 connect over a large area or only at one point, on the maximum eccentric side, 2 and the second phase line 42 will not form an edge, so that the first curved surface 20.
  • the transitions between the third curved surface 30 and the second curved surface 40 are smoother, thereby improving the efficiency of rotational abrasion while minimizing the chance of damage to blood vessels and further improving the safety of the operation.
  • the overall weight of the eccentric rotary grinding head can be determined by controlling the size of L1 relative to L2.
  • the curvature radius of the first curve 21 and the second curve 41 (or the curvature radius of the convex curve 50) can control the shape of the first curved surface 20 and the second curved surface 40, thereby controlling the effect of contact with the blood vessel wall during the rotational ablation process. force. Taking the first curve 21 and the second curve 41 as both arc lines as an example, the relationship between the physical quantities in the eccentric rotational burr 100 is given below.
  • the first curve 21 and the second curve 41 (or convex curve 50)
  • the radius of is R, then the radius R of the convex curve 50, the axial length L of the eccentric base, the maximum radial dimension D of the eccentric base, the diameter d of the connecting hole 10, the eccentricity M of the eccentric axis 31 and the central axis 11, And the minimum wall thickness s of the eccentric matrix satisfies the following formula::
  • R [L 2 /4+(D/2+d/2-M+s) 2 ]/[2*(D/2+d/2-M+s)].
  • the main part to be ground during rotational atherectomy is the part near the maximum eccentric side of the eccentric rotational atherectomy head 100, especially for diameter expansion (expanding the inner diameter of the blood vessel wall), however, the present invention
  • Other parts of the eccentric rotational grinding head 100 such as the part opposite to the maximum eccentricity point C, can also play a rotational grinding effect.
  • eccentric burr head 100 in the above embodiments is applied to the drive shaft, only one eccentric burr head 100 or multiple eccentric burr heads 100 may be provided in the distal area of the flexible shaft 200, especially for lesions.
  • a driving shaft with multiple eccentric rotary grinding heads 100 is selected, which can greatly improve the efficiency of rotational grinding.
  • the eccentric direction of each eccentric rotational burr 100 is in the circumferential direction of the flexible shaft 200.
  • Dislocation distribution that is, if viewed along the axial direction of the flexible shaft 200, the maximum eccentricity C of each eccentric rotary grinding head 100 is distributed along the circumferential direction of the flexible shaft 200.
  • multiple eccentric rotary grinding heads 100 are distributed along the circumferential direction of the flexible shaft 200. The grinding heads 100 are evenly distributed in the circumferential direction to avoid damage to the blood vessels caused by excessive centrifugal force on one side during rotation.
  • the eccentric burrs 100 on the same flexible shaft 200 may be the same (including shape and size), or they may be different.
  • the maximum radial size of the plurality of eccentric rotational burrs 100 gradually decreases from the middle to both ends.
  • the radial maximum size of the eccentric burr head 100 in the middle part is larger than the radial maximum size of the eccentric burr head 100 in the two end parts. That is to say, for the radial maximum size, each eccentric burr head 100 It gradually decreases from the middle to both ends in the axial direction, that is, a distribution of large sizes in the middle and small sizes at the two ends is formed.
  • the eccentric rotational grinding heads at both ends are The maximum radial dimension of the 100 can be 1mm.
  • the drive shaft arranged in this way can better control the revolution effect of the entire distal part during rotational atherectomy, thereby controlling the grinding force and improving the safety of the operation, and the eccentric rotational atherectomy head 100 with a smaller end , is also beneficial to better access to the lesion location during initial plaque contact.
  • the invention also provides a method for manufacturing an eccentric rotational burr for interventional medical equipment, which includes the steps:
  • a cylindrical blank with a third curved surface 30 can be formed first, and the axis of the cylindrical blank is the aforementioned eccentric axis 31; and then the eccentric base body is formed by removing material from the cylindrical blank. Specifically, the cylindrical blank can be removed first. The material outside the cylindrical blank forms two surfaces of revolution, namely the first curved surface 20 and the second curved surface 40. If the central axis 11 is used as the axis of rotation and the excess part on the cylindrical blank is removed, the first curved surface 20 and the second curved surface are obtained.
  • the side surfaces of the eccentric rotary grinding head 100 are smoother and easier to process.
  • the cylindrical blank can be processed into metal materials, such as stainless steel, copper, platinum-tungsten alloy, etc., and then eccentrically formed.
  • the abrasive grain layer can be formed on the side of the eccentric base body by nickel plating or brazing, wherein the abrasive grains in the abrasive grain layer can be diamond abrasive grains, CBN abrasive grains, SiC abrasive grains or alumina abrasive grains. , can be formed by the micro-powder of these abrasive grains, and can be connected to the eccentric base body by electroplating nickel or brazing.
  • the protruding height of the abrasive grains in the abrasive grain layer is preferably 5 ⁇ m to 35 ⁇ m, such as 5 ⁇ m, 8 ⁇ m, 10 ⁇ m, 12 ⁇ m, 15 ⁇ m, 20 ⁇ m, 22 ⁇ m, 25 ⁇ m, 30 ⁇ m, 33 ⁇ m or 35 ⁇ m. Excessive protruding height may cause excessive wear debris. If the protrusion height is too small, the amount of plaque removed during grinding is too small, and the grinding efficiency is too low. Using the above range can solve the above problems at the same time, that is, it can reduce wear debris. The size can also improve the efficiency of rotational grinding.
  • abrasive particles with a particle size of 10 to 50 ⁇ m can be selected during manufacturing.
  • the particle size of the abrasive particles can be 10um, 20um, 30um, 33um, 35um, 40um, 45um or 50um, etc.
  • the abrasive particles The combination with the flexible shaft 200 is stronger, and the grinding force is moderate, which will not cause damage to blood vessels, and the generated wear debris is basically below 30um, which is easily taken away by the blood or absorbed by the human body.
  • the eccentric rotary grinding head 100 and the flexible shaft 200 can be inserted and connected by ordinary silver/gold-tin welding, adhesive bonding, or the connection method mentioned above. form the drive shaft.
  • the cavity formed is not a regular cylindrical cavity. Therefore, the diameter of the blood vessel or the cavity formed by the blood vessel and the plaque is only for convenience of expression. It does not limit the cavity to be a cylindrical cavity.
  • the radial direction is only used for convenience of expression. It refers to the direction perpendicular to the axial direction of the component and pointing from the axis to the outer surface. It does not limit the component to be spherical, spherical, or spherical. Tri-curved surfaces, circles, etc.

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Abstract

一种用于介入式医疗设备的偏心旋磨头（100）及其制造方法、驱动轴、介入式医疗设备，偏心旋磨头（100）具有用于与柔性轴（200）连接的连接孔（10）；偏心旋磨头（100）包括偏心基体和其外侧的磨粒层，偏心基体的侧面包括第一曲面（20）、第二曲面（40）和第三曲面（30），第三曲面（30）为圆柱面上的至少部分；第一曲面（20）和第二曲面（40）关于偏心基体的中心平面（60）对称，二者分别为通过一条凸形曲线（50）绕连接孔（10）中心轴线（11）回转形成的凸形曲面上的部分，凸形曲线（50）上的各点到中心轴线（11）的距离沿着从偏心基体的端面到中心平面（60）的方向逐渐增大；且两个曲面（20，40）在偏心基体的中心平面（60）处部分相接，在其侧面上形成至少一条连续平滑的母线。既能使偏心旋磨头（100）适用的血管范围更广，又能够提高手术的可控性和安全性。

Description

偏心旋磨头及其制造方法、驱动轴及介入式医疗设备 技术领域
本发明涉及医疗器械技术领域，具体涉及一种偏心旋磨头及其制造方法、驱动轴及介入式医疗设备。
背景技术
缺血性心脏病逐渐成为致死性较高的疾病之一，其病因主要为动脉粥样硬化：脂肪、纤维、钙质在血管壁上沉着形成斑块，阻碍了血液的正常流通，导致血管阻塞。现有的技术中，常常采用介入球囊及支架治疗，将粥样硬化斑块推入血管壁内从而疏通血管、治疗缺血性心脏病以及周边动脉疾病。但对于严重钙化的病灶，以及特殊部位的病灶，如关节处，由于其内部空间太过狭窄，球囊及支架无法在钙化的血管中完全张开，难以达到理想的治疗效果。介于此，现有技术中，提出了一种动脉旋磨术来移除严重钙化的斑块的临床方案，可以采用介入式医疗设备进行，这种设备通过一根安装有旋磨头的柔性轴伸入血管内，通过驱动柔性轴旋转进而带动旋磨头转动，磨削斑块，以增加血管的有效空间。
现有的介入式医疗设备中，有的将旋磨头制作成偏心结构，如现有技术CN108882947A、CN105658159A，以增加旋磨头的扩径能力。然而，现有的这种偏心旋磨头，在进行旋磨时，偏心旋磨头各处与血管壁的接触面积都比较大，对血管壁的去除力太大，去除作用太强，不利于去除过程的控制，增加手术的风险，降低了手术的安全性。
发明内容
基于上述现状，本发明的主要目的在于提供一种偏心旋磨头及其制造方法、驱动轴及介入式医疗设备，以解决现有技术中手术风险太大的技术问题。
为实现上述目的，本发明采用的技术方案如下：
本发明的第一方面提供了一种用于介入式医疗设备的偏心旋磨头，所述偏心旋磨头具有用于与柔性轴连接的连接孔；所述偏心旋磨头包括偏心基体和磨粒层，所述偏心基体的侧面包括第一曲面、第二曲面和第三曲面，
所述第一曲面和所述第二曲面分别至少覆盖所述偏心基体的两端，且关于所述偏心基体两端之间的中心平面对称，二者分别为同一回转曲面上的部分，所述回转曲面通过一条平滑的凸形曲线绕中心轴线回转形成，所述中心轴线为连接孔的轴线，所述凸形曲线上的各点到所述中心轴线的距离沿着从所述偏心基体的端面到所述中心平面的方向逐渐增大；
所述第三曲面为圆柱面的至少部分，位于所述偏心基体的中间区段，其回转轴线为偏心轴线，所述偏心轴线与所述连接孔的中心轴线平行且留有距离；
其中，所述第一曲面和所述第二曲面在所述中心平面处部分相接，在所述侧面上形成至少一条连续平滑的母线；所述回转曲面与所述圆柱面相贯形成分别位于所述中心平面两侧的第一相贯线和第二相贯线；所述回转曲面上位于所述中心平面、所述第一相贯线以及所述偏心基体与其同侧端面之间的部分形成所述第一曲面，位于所述中心平面、所述第二相贯线以及所述偏心基体与其同侧端面的部分形成所述第二曲面，所述圆柱面上位于所述第一相贯线和所述第二相贯线之间的部分形成所述第三曲面；
所述磨粒层设置于所述偏心基体的侧面。
优选地，所述第一曲面、所述第二曲面和所述第三曲面在所述中心平面处相交于一点。
优选地，所述第一曲面和所述第二曲面在所述偏心基体的周向上的部分区域相接，所述第一相贯线与所第二相贯线在所述中心平面处相接且平滑过渡。
优选地，所述凸形曲线为圆弧线、椭圆弧线、抛物线或者双曲线。
优选地，所凸形曲线为圆弧线，所述凸形曲线的半径R、所述偏心基体的轴向长度L、所述偏心基体径向的最大尺寸D、所述连接孔的直径d、所述偏心轴线与所述中心轴线的偏心距M以及所述偏心基体的最小壁厚s满足下述公式：
R＝[L 2/4+(D/2+d/2-M+s) 2]/[2*(D/2+d/2-M+s)]。
优选地，所述偏心轴线与所述中心轴线的偏心距为0.05mm～0.6mm；所述偏心基体在径向上的最大尺寸为1.0～2.5mm；
优选地，所述偏心基体的轴向尺寸为1.0mm～7.0mm；所述偏心基体的最小壁厚大于或者等于0.05mm。
优选地，所述磨粒层中磨粒的突出高度为5～35μm。
本发明的第二方面提供了一种用于介入式医疗设备的驱动轴，包括柔性轴和上述任一项所述的偏心旋磨头，所述偏心旋磨头设置于所述柔性轴的远端区域，所述连接孔与所述柔性轴插装连接。
优选地，在所述远端区域，所述柔性轴沿其轴向间隔设置有多个偏心旋磨头，各所述偏心旋磨头的偏心方向在所述柔性轴的周向上错位分布，且中间部分的所述偏心旋磨头的径向最大尺寸大于两端部分的所述偏心旋磨头的径向最大尺寸。
优选地，沿所述柔性轴的轴向，多个所述偏心旋磨头的径向最大尺寸自中间向两端逐渐减小。
本发明的第三方面提供了一种介入式医疗设备，包括上述任一项所述的驱动轴。
本发明的第四方面提供了一种用于介入式医疗设备的偏心旋磨头的制造方法，包括步骤：
S100：制造偏心基体，所述偏心基体的侧面包括第一曲面、第二曲面和第三曲面，
所述第一曲面和所述第二曲面分别至少覆盖所述偏心基体的两端，且关于所述偏心基体两端之间的中心平面对称，二者分别为同一回转曲面上的部分，所述回转曲面通过一条平滑的凸形曲线绕中心轴线回转形成，所述中心轴线为连接孔的轴线，所述凸形曲线上的各点到所述中心轴线的距离沿着从所述偏心基体的端面到所述中心平面的方向逐渐增大；
所述第三曲面为圆柱面的至少部分，位于所述偏心基体的中间区段，其回转轴线为偏心轴线，所述偏心轴线与所述连接孔的中心轴线平行且留有距离；
其中，所述第一曲面和所述第二曲面在所述中心平面处部分相接，在所述侧面上形成至少一条连续平滑的母线；所述回转曲面与所述圆柱面相贯形成分别位于所述中心平面两侧的第一相贯线和第二相贯线；所述回转曲面上位于所述中心平面、所述第一相贯线以及所述偏心基体与其同侧端面之间的部分形成所述第一曲面，位于所述中心平面、所述第二相贯线以及所述偏心基体与其同 侧端面的部分形成所述第二曲面，所述圆柱面上位于所述第一相贯线和所述第二相贯线之间的部分形成所述第三曲面；
所述磨粒层设置于所述偏心基体的侧面。
S200：在所述偏心基体的侧面成型磨粒层，得到偏心旋磨头。
本发明的第三方面提供了，所述磨粒层通过镀镍或者钎焊方式成型于所述偏心基体的侧面。
【有益效果】
本发明的偏心旋磨头，设置偏心旋磨头的整个旋磨面包括三个曲面，且覆盖两端的两个曲面与另一曲面分别通过绕不同的回转轴线形成，覆盖两端的曲面在分别与另一曲面相接的同时还至少部分相接，使整个旋磨面上至少有一条连续平滑的母线，在偏心旋磨头在应用于介入式医疗设备时，随着柔性轴的高速旋转，偏心旋磨头仅在第三曲面处与血管壁接触时才形成线接触，而其它区域与血管壁的接触均为点接触，尤其是在旋磨面上距离中心轴线最远的位置与血管壁接触时也是点接触，从而通过控制第一曲面、第二曲面和第三曲面在整个旋磨面的占比，能够更好地控制偏心旋磨头在旋磨时的点接触和线接触的面积，控制血管内斑块磨除的效率和磨削能力，从而更好地实现对不同直径和位置处血管病变的治疗，且能够避免持续线接触对血管壁的损伤，以及持续线接触造成的持续大冲击力，且能够减小偏心旋磨头每一位置接触血管壁时的磨削量，进而能够大大降低偏心旋磨头旋磨中对血管壁的冲击，使整个旋磨过程都比较平稳，提升了手术的安全性；同时，由于整个旋磨面的两端部分均为凸形的光滑曲面，在轴向上这些曲面与血管壁的大多数位置都能够形成间隙，加之点接触瞬间产生的磨屑较少，因此旋磨产生的磨屑也能够很好地从曲面与血管壁之间的间隙尽快排出，基本不会出现由于磨屑排出不及时造成的卡顿甚至血管被堵塞的现象，进一步提升了手术的安全性。
本发明的其他有益效果，将在具体实施方式中通过具体技术特征和技术方案的介绍来阐述，本领域技术人员通过这些技术特征和技术方案的介绍，应能理解所述技术特征和技术方案带来的有益技术效果。
附图说明
以下将参照附图对本发明的优选实施方式进行描述。图中：
图1为本发明提供的偏心旋磨头的一种优选实施方式的结构示意图；
图2为图1所示的偏心旋磨头的纵截面示意图；
图3为本发明提供的偏心旋磨头的又一种优选实施方式的结构示意图；
图4为图3所示的偏心旋磨头的纵截面示意图；
图5为本发明提供的驱动轴的一种优选实施方式的结构示意图；
图6为本发明提供的驱动轴的另一种优选实施方式的结构示意图。
图中：
100、偏心旋磨头；10、连接孔；11、中心轴线；20、第一曲面；21、第一曲线；22、第一相接线；30、第三曲面；31、偏心轴线；32、直线；40、第二曲面；41、第二曲线；42、第二相接线；50、凸形曲线；60、中心平面；
200、柔性轴。
具体实施方式
以下基于实施例对本发明进行描述，但是本发明并不仅仅限于这些实施例。在下文对本发明的细节描述中，详尽描述了一些特定的细节部分，为了避免混淆本发明的实质，公知的方法、过程、流程、元件并没有详细叙述。
此外，本领域普通技术人员应当理解，在此提供的附图都是为了说明的目的，并且附图不一定是按比例绘制的。
除非上下文明确要求，否则整个说明书和权利要求书中的“包括”、“包含”等类似词语应当解释为包含的含义而不是排他或穷举的含义；也就是说，是“包括但不限于”的含义。
在本发明的描述中，需要理解的是，术语“第一”、“第二”等仅用于描述目的，而不能理解为指示或暗示相对重要性。此外，在本发明的描述中，除非另有说明，“多个”的含义是两个或两个以上。
需要说明的是，本发明的描述中，“远”和“近”是相对于介入式设备的操作者而言的，近端指靠近操作者近处的一端，远端指远离操作者的一端，即对同一部件来说，若其仅部分伸入患者体内，则伸入患者体内的一端为远端，位于体外靠近操作者的一端为近端。
本发明提供了一种介入式医疗设备，可以用于治疗心血管等疾病，进行动脉粥样硬化切除。介入式医疗设备包括驱动轴，如图5、图6所示，驱动轴包 括柔性轴200和偏心旋磨头100，偏心旋磨头100设置于柔性轴200的远端区域，具体地，偏心旋磨头100具有用于与柔性轴200连接的连接孔10，连接孔10沿柔性轴200的轴向贯通整个偏心旋磨头100，柔性轴200插装于连接孔10，以将偏心旋磨头200固定连接于柔性轴200上，柔性轴200与偏心旋磨头100的连接方式可以为粘接、焊接或者过盈配合等连接方式。其中，柔性轴200可以由多股弹簧丝缠绕而成。
现有技术中，虽然也有偏心旋磨头，但通常不论哪种偏心旋磨头，其旋磨面不是圆柱面就是锥形面，只是圆柱面或者锥形面与连接孔形成偏心设置。然而，由于血管基本为圆柱形，因此，这种偏心旋磨头在旋磨时，不论是圆柱面还是锥形面，其整个旋磨面周向的各处母线均为直线，因此，旋磨时旋磨面的各处与血管壁均形成线接触，长时间的线接触加之柔性轴的高速运动，偏心作用力会比较大，对血管壁组织产生较大去除力和较强的去除作用，不利于对去除过程的控制，造成安全隐患，增加了手术的风险；且圆锥面与圆柱面的相交线处比较尖锐，在偏心旋磨头的位姿变化时，相交线处易对血管产生切割作用，进一步增加了手术风险。
为了解决上述问题，本发明的偏心旋磨头100采用凸形的光滑曲面与圆柱面相结合的旋磨面，且使整个旋磨面上至少有一条连续平滑的母线，具体地，参考图1-图4，偏心旋磨头100包括偏心基体和磨粒层(图中未示出)，连接孔10设置于偏心基体上，偏心基体包括侧面和端面，端面指偏心基体沿连接孔10的中心轴线11相背离的两个面，侧面环绕连接孔10的中心轴线11设置，并非限定侧面是绕中心轴线11回转而成。偏心基体的侧面包括第一曲面20、第二曲面40和第三曲面30，第三曲面30为圆柱面的至少部分，位于偏心基体的中间区段，其回转轴线为偏心轴线31，偏心轴线31与连接孔10的中心轴线11平行且留有距离，可以记为偏心距M。
第一曲面20和第二曲面40均为光滑的凸形曲面，二者分别至少覆盖偏心基体的两端，第一曲面20和第二曲面40关于偏心基体两端之间的中心平面60对称，二者分别为同一回转曲面上的部分，该回转曲面通过一条平滑的凸形曲线50绕中心轴线11回转形成，凸形曲线50关于中心平面60对称，其上的各点到中心轴线11的距离沿着从偏心基体的端面到中心平面60的方向逐渐增大，即凸形曲线50向远离中心轴线11的方向突出，且其最大突出位置位于 中心平面60处。其中，第一曲面20和第二曲面40在中心平面60处部分相接，在偏心基体的侧面上形成至少一条连续平滑的母线。回转曲面与圆柱面相贯形成分别位于中心平面60两侧的第一相贯线(可以参考附图中为第一相贯线一部分的第一相接线22)和第二相贯线(可以参考附图中为第二相贯线一部分的第二相接线42)，回转曲面上位于中心平面60、第一相贯线以及偏心基体与其同侧端面之间的部分形成第一曲面20，位于中心平面60、第二相贯线以及偏心基体与其同侧端面的部分形成第二曲面40，圆柱面上位于第一相贯线和第二相贯线之间的部分形成第三曲面30，也就是说，第一曲面20与第三曲面30的相接线至少为第一相贯线的部分，第二曲面40与第三曲面的相接线至少为第二相贯线的部分。磨粒层设置于偏心基体的侧面，即在偏心基体的侧面设置磨粒层，使磨粒均匀地分布于整个侧面，从而形成偏心旋磨头的旋磨面(即磨粒层形成的表面)。
为方便下文的描述，可以记偏心基体的两端分别为第一端和第二端，第一曲面20至少覆盖第一端，第二曲面40至少覆盖第二端，第一曲面20自第一端向中心平面60延伸覆盖偏心基体的其他区域，第二曲面40自第二端向中心平面60延伸覆盖偏心基体的其他区域，且两个曲面在中心平面60处会相接，相接的部分可以仅为一点(如图1所示)，也可以覆盖侧面沿其周向上的部分(如图3所示)，具体地，第一曲面20为凸形曲面上第一端的端面、中心平面60和第一相贯线围成的区域，第二曲面40为凸形曲面上第二端的端面、中心平面60和第二相贯线围成的区域。偏心基体的侧面可以认为是凸形曲线50绕中心轴线11回转形成的凸形曲面与圆柱面相贯形成，形成的相贯线中位于中心平面60靠近第一端一侧的部分为第一相贯线，位于中心平面60靠近第二端一侧的部分为第二相贯线，只是偏心基体的侧面中，在第一相贯线靠近第一端的一侧、第二相贯线靠近第二端的一侧、以及第一相贯线和第二相贯线靠近最大偏心处的一侧均选择凸形曲面，在第一相贯线与第二相贯线之间选择圆柱面。
也就是说，偏心基体的侧面由三个回转面相接形成，第一曲面20和第二曲面40的母线为曲线，分别为第一曲线21和第二曲线41，第一曲面20、第二曲面40的回转轴线相同，均为连接孔10的中心轴线11。第三曲面30的母线为直线，第三曲面30的回转轴线相对于中心轴线11偏心设置，为偏心轴线 31，这样形成的整个偏心基体的重心会偏离中心线11，在偏心基体的最大偏心处C的纵截面上，如图2、图4所示，偏心基体上至少在过最大偏心处C的母线为连续平滑的曲线，在最大偏心处C所在的一侧，即图2中的上侧，第一曲线21、第二曲线41和偏心轴线31位于中心轴线11的同一侧。第一曲线21和第二曲线41关于中心平面60对称设置，二者分别为凸形曲线50上的两段，只是在侧面周向上的有的位置处二者相接(即为凸形曲线50)，在侧面周向上有的位置处二者相间隔，即二者为凸形曲线50上不连续的两段，第一曲线21为向远离中心轴线11的方向凸出的平滑曲线，第一曲线21中位于第一端的一端较另一端距离中心轴线11更近，具体地，第一曲线21上的各点到中心轴线11的距离从靠近第一端的一端到另一端逐渐增大，从而使形成的第一曲面20为凸形的光滑曲面。由于第一曲线21和第二曲线41关于中心平面对称，因此，第二曲线41也为凸形的光滑曲线，位于第二端的一端较其另一端距离中心轴线11更近，且第二曲线41上的各点到中心轴线11的距离从第二端到另一端逐渐增大。如此，偏心基体侧面上(在轴向上)位于两端的部分相对于中间的部分外轮廓的径向尺寸小，在侧面上形成磨粒层后，使整个偏心旋磨头的旋磨面为中间大两端小的结构。
其中，上述中心平面垂直于中心轴线11，即中心平面指过偏心基体沿其轴向的中心且垂直于中心轴线11的平面。偏心基体最大偏心处C指偏心基体的侧面上到中心轴线最大距离的点所在的位置，在该位置仅有一个点位时位于中心平面上(如图2、图4所示)，可以记该位置为最大偏心位置，过该处的纵截面指同时过最大偏心位置和中心轴线11的截面，最大偏心侧指最大偏心处C所在的一侧。
上述实施例的偏心旋磨头100工作时，偏心旋磨头100除了随着柔性轴200的转动自转外，在其偏心质量的作用下还会产生公转，从而对血管壁能够实现扩径磨削的作用，即采用较小外径的偏心旋磨头100即能够通过旋磨使血管壁的内径大于该外径，即获得更大的扩径直径。实验证明，当选用本发明的偏心旋磨头100的最大径向尺寸为1.0mm时，在柔性轴200转速为17万转/分钟时，对内径(指斑块形成的内径)与最大径向尺寸基本相等的血管进行旋磨，旋磨120秒后，得到的扩径尺寸达到1.5mm以上，基本能达到1.6mm，显然对于旋磨效率和扩径能力上来说都非常好，且对血管的冲击作用力也很 小。
本发明中，偏心旋磨头100的旋磨面包括三个凸形的回转曲面，且第一曲面20和第二曲面40在中心面处部分相接，在偏心基体的侧面上至少有一条连续平滑的母线，并至多中间区段包括第三曲面30，两边均为凸形的曲面，使整个偏心旋磨头100在轴向上形成两端小中间大的结构，如此，使本发明的偏心旋磨头相对于其他的偏心结构，在几何偏心量(即偏心基体的重心到于柔性轴的轴线的距离)相同的情况下，本发明的偏心质量更小，离心力也更小，因此，产生的磨削力较小，且整个旋磨面更为圆滑，在偏心旋磨头的位姿变化时基本不会对血管产生切割作用，在柔性轴高速旋转时，偏心旋磨头100仅在第三曲面30与血管壁接触时才形成线接触，而其他区域与血管壁接触时均为点接触，因此，通过控制第一曲面20、第二曲面40和第三曲面30在整个旋磨面的占比，能够更好地控制偏心旋磨头在旋磨时的点接触和线接触的面积，控制血管内斑块磨除的效率和磨削能力，从而更好地实现对不同直径和位置处血管病变的治疗；且在整个旋磨过程中不会一直与血管壁处于线接触，即使在最大偏心处也是点接触，从而能够避免偏心旋磨头100与血管壁由于持续线接触造成的损伤；且由于偏心旋磨头100的各处与血管壁的接触面积减小了，因此，偏心旋磨头100每一位置接触血管壁时的磨削量也减小了，也能够大大降低偏心旋磨头100旋磨中对血管壁的冲击，使整个旋磨过程都比较平稳，提升了手术的安全性。
同时，本发明中由于整个旋磨面的两端部分均为凸形的曲面，形成中间大两端小的结构，在旋磨过程中，沿轴向上，两个曲面中未与血管壁接触的部分与血管壁之间形成间隙，加之瞬间的旋磨量小，产生的瞬间磨屑又比较少，因此旋磨产生的磨屑均能够很好地从曲面与血管壁之间的间隙尽快排出，基本不会出现由于磨屑排出不及时造成的卡顿甚至血管被堵塞的现象，进一步提升了手术的安全性。
本发明的偏心旋磨头100中，偏心轴线31与中心轴线11的距离即偏心距M可以为0.05mm～0.6mm，如0.05mm、0.08mm、0.1mm、0.2mm、0.3mm、0.4mm、0.5mm或者0.6mm等等，该距离越大，能够使旋磨后的血管内径越大。采用该范围，能够更好地控制整个偏心旋磨头的偏心量，进而控制旋磨过程的磨削力，既能够提高磨削的效率，又能够避免太大的磨削力对血管壁造 成损伤。
采用上述偏心旋磨头100的结构，还能够在保证偏心量和旋磨效果的同时，使偏心基体在径向上的最大尺寸D为1.0mm～2.5mm，如1.0mm、1.2mm、1.5mm、1.8mm、2.0mm、2.2mm或者2.5mm等，可见，本发明在保证旋磨效果的同时，本发明的偏心旋磨头100能够制造的更小，因此能够应用于比较细的血管，从而增加了偏心旋磨头100的适用范围。
血管内的斑块有的比较长，有的比较短，偏心旋磨头100沿中心轴线11方向的尺寸即轴向长度L可以为1.0mm～7.0mm，如1.0mm、1.2mm、1.5mm、1.6mm、1.8mm、2.0mm、2.5mm、2.8mm、3.0mm、3.3mm、3.6mm、3.8mm、4.0mm、4.5mm、5.0mm、5.5mm、6.0mm、6.5mm、6.8mm或者7.0mm等，当该尺寸越大时旋磨的效率会越高，本发明中，可以根据病灶的情况(如斑块的长度)制造不同长度的偏心旋磨头100，以通过选择不同长度的旋磨头既能够保证手术的安全性，又能够提高旋磨的效率。
为了增加偏心旋磨头100的强度，偏心基体的最小壁厚s大于或者等于0.05mm，如0.05mm、0.06mm、0.08mm或者0.1mm等，以在保证偏心旋磨头100强度的同时，减小其整体的重量，降低对血管壁的冲击力，进一步提高手术的安全性。
连接孔10的直径可以根据与其配合的柔性轴200确定，连接孔10的直径可以稍大于柔性轴200的直径，二者形成间隙配合，之后通过粘接、焊接等方式连接；也可以连接孔10的直径略小于柔性轴200，二者形成过盈配合，即通过过盈配合实现二者的连接，当然，这种方式中，也可以同时通过粘接、焊接等方式增加连接强度。连接孔10的直径d可以在0.55mm～0.85mm，如0.55mm、0.6mm、0.65mm、0.67mm、0.7mm、0.75mm、0.8mm或者0.85mm等，具体如在用于冠脉血管时，连接孔10的直径可以选择0.65mm左右，在用于周动脉血管时，连接孔的直径为0.8mm。
具体地，对于偏心旋磨头100，可以先通过模拟实验确定偏心轴线31与中心轴线11的距离，使其满足所需的磨削力，之后在满足该距离范围的同时选择偏心基体的最大径向尺寸D最小，如此，能够在保证磨削力的同时使偏心旋磨头适应更多的血管，从而提升偏心旋磨头的适用范围。实际使用时，可以采用本发明的结构，在相同偏心距M时制造不同最大尺寸D的偏心旋磨头 100，还可以制造不同轴向长度L的偏心旋磨头，以及制造第一曲面20、第三曲面30和第二曲面40不同方式组合下(如附图1、图3甚至下文详述的其他实施例)的偏心旋磨头，或者几种方式组合制造各种规格的偏心旋磨头，以在不同血管使用时选择最优的偏心旋磨头，实现旋磨效果和手术安全性的最优组合。
其中，凸形曲线50优选为圆弧线、椭圆弧线、抛物线或者双曲线，相应地，第一曲线21和第二曲线41为圆弧线、椭圆弧线、抛物线或者双曲线，也就是说，凸形曲线50(或者说第一曲线21和第二曲线41)上的各点若满足圆形公式，则凸形曲线50(或者说第一曲线21和第二曲线41)为圆弧线；若满足椭圆公式，则凸形曲线50(或者说第一曲线21和第二曲线41)为椭圆弧线；若满足抛物线公式，则凸形曲线50(或者说第一曲线21和第二曲线41)为抛物线；若满足双曲线公式，则凸形曲线50(或者说第一曲线21和第二曲线41)为双曲线，只是该双曲线相对于中心轴线11是向外凸出(即向远离中心轴线11的方向凸出)的。当凸形曲线50(或者说第一曲线21和第二曲线41)为圆弧线时，既能够使第一曲面20、第二曲面40和第三曲面30的相贯线(即第一相贯线和第二相贯线)比较平滑，降低旋磨时对血管的冲击，又能够降低加工难度，增加成品率。当凸形曲线50(或者说第一曲线21和第二曲线41)为椭圆弧线、抛物线或者双曲线时，第一曲面20、第二曲面40和第三曲面30的相贯线(即第一相贯线和第二相贯线)更为平滑，旋磨的效果会更好。当然，凸形曲线50也可以为其他想远离中心轴线11的方向凸出的连续平滑的曲线。当然，第一曲线21和第二曲线41也可以为其他凸形的平滑曲线。
其中，第一相接线22在偏心旋磨头100的周向上可以为封闭曲线，如图1所示，第一相接线22在偏心旋磨头100的周向上也可以不封闭，即存在断开的区域，如图3所示在最大偏心处第一相接线22断开成两部分，当然在偏心基体轴向长度比较小的情况下，第一相接线22可能会最大偏心侧的对侧(即图3的下侧)断开。同理，第二相接线42在偏心旋磨头100的周向上可以为封闭曲线，如图1所示，第二相接线42在偏心旋磨头100的周向上也可以不封闭，即存在断开的区域，如图3所示。在第一相接线22和第二相接线42在偏心旋磨头100的周向上均为封闭曲线或者说在最大偏心处C连续时，第一相接线22和第二相接线42可以在最大偏心处C相交于一点，或者连接成 一条平滑的曲线，该平滑的曲线即为回转曲面与圆柱面相贯线中的一个连续区段。
一种实施例中，第一曲面20、第二曲面40和第三曲面30在中心平面60处相交于一点，即相较于最大偏心处C，如图1、图2所示，在最大偏心处C，基本没有第三曲面30，且第一曲面20和第二曲面40相接，第一相接线22和第二相接线42均连续，且二者在最大偏心处C相交于一点，在过最大偏心处C的纵截面上，如图2所示，第一曲线21和第二曲线41到偏心轴线31的最大距离L1等于第三曲面30的半径L2，该实施例中，在最大偏心处C，第一曲线21与第二曲线41直接相接，形成凸形曲线，在偏心基体的侧面上仅形成一条连续平滑的母线，该母线即凸形曲线50，换言之，侧面上位于周向同一位置的各点连接在一起能够形成一个线条，在这些线条中，仅有过最大偏心处C的这个线条才是连续平滑的，是完整的凸形曲线；而其他的线条中，每一条都包括两段间隔的第一曲线21和第二曲线41，以及连接第一曲线21和第二曲线41的直线(即圆柱面的母线)，或者只包括直线。这种偏心旋磨头，在这条连续平滑的母线上，各个位置均与血管壁为点接触，接触面积进一步减小，而仅在偏心较小的其他区域才可能出现线接触。采用这种偏心旋磨头100，在最大偏心侧的磨削冲击力明显降低，虽然对于斑块的旋磨效率相对低一些，但是安全性明显提高，尤其适用于对于安全性较好的一些血管内的斑块治疗，如四肢处或者心脏附近的血管内斑块的旋磨。
另一种实施例中，第一曲面20和第二曲面40在偏心基体的周向上的部分区域相接，第一相贯线与二相贯线在中心平面60处相接且平滑过渡。相对于第一曲面20与第二曲面40仅一点相接来说，在该实施例中，第一曲面20与第二曲面40相接的位置比较多，二者在中心平面60处沿着侧面的周向上连续形成相接的结构，即在最大偏心处C附近只有第一曲面20和第二曲面40，完全没有第三曲面30，如图3、图4所示，在最大偏心处C附近，第一曲面20(中心平面60靠近第一端的部分)和第二曲面40(中心平面60靠近第二端的部分)相接，此时，第一相接线22和第二相接线42在该区域相连接，形成平滑的曲线(即第一相贯线与第二相贯线连接在一起)，而第一相接线22自身和第二相接线42自身各自在该区域(即最大偏心处C附近)是被断开的，也就是说，位于中心平面60靠近第一端的第一相贯线，在中心平面60处被断开 成间隔的两段，位于中心平面60靠近第二端的第二相贯线，在中心平面60处也被断开成间隔的两段。该实施例中，在第一曲面20与第二曲面40的相接区域，每一条第一曲线21与对应(即位于同一周向位置处)的第二曲线41直接相接，形成一条凸形曲线50，如此，在偏心基体的侧面上能够形成较多的连续平滑的母线，该母线即凸形曲线50，换言之，侧面上位于周向同一位置的各点连接在一起能够形成一个线条，在这些线条中，过相接区域的这些线条是连续平滑的，是完整的凸形曲线；而其他的线条中，每一条都包括两段间隔的第一曲线21和第二曲线41，以及连接第一曲线21和第二曲线41的直线(即圆柱面的母线)，或者仅包括直线。在过最大偏心处C的纵截面上，如图4所示，第一曲线21和第二曲线41到偏心轴线31的最大距离L1小于第三曲面30的半径L2，这种偏心旋磨头100，在最大偏心侧以及其附近，各个位置均与血管壁能够形成点接触，对整个偏心旋磨头来说，与血管壁点接触的位置更多，在最大偏心侧的磨削冲击力进一步降低，虽然对于斑块的旋磨效率相对低一些，但是安全性明显提高，适用于对于安全性要求相对较高的一些血管内的斑块治疗，如心脏附近的血管内斑块的旋磨。
显然，不论是第一曲面20与第二曲面40相接较大区域，还是仅在一点处相接，在最大偏心侧，2和第二相接线42均不会形成棱角，从而使第一曲面20、第三曲面30和第二曲面40的各相接处过渡更为平滑，从而在提高旋磨效率的同时，尽可能降低对血管损伤的几率，进一步提高手术的安全性。
上述各实施例中，可以通过控制L1相对于L2的大小，确定偏心旋磨头的整体重量，L1越小，相当于去掉的圆柱坯料(下文详述)上的材料越多，则重量越小，在旋转时产生的偏心力越小。而第一曲线21和第二曲线41的曲率半径(或者说凸形曲线50的曲率半径)则能够控制第一曲面20和第二曲面40的形状，进而控制旋磨过程中接触血管壁的作用力。下面以第一曲线21和第二曲线41均为圆弧线为例给出偏心旋磨头100中各物理量的关系，其中，第一曲线21和第二曲线41(或者说凸形曲线50)的半径为R，则凸形曲线50的半径R、偏心基体的轴向长度L、偏心基体径向的最大尺寸D、连接孔10的直径d、偏心轴线31与中心轴线11的偏心距M，以及偏心基体的最小壁厚s满足下述公式：：
R＝[L 2/4+(D/2+d/2-M+s) 2]/[2*(D/2+d/2-M+s)]。
需要说明的是，由于对于偏心旋磨头100沿其轴向的长度选择不同，在最大偏心处C的对侧，可能只有第三曲面30，而没有第一曲面20和第二曲面40。另外，虽然本发明中，旋磨中主要进行磨削的部分为偏心旋磨头100的最大偏心侧附近的部分，尤其是对于扩径(扩大血管壁的内径)来说，但是，本发明的偏心旋磨头100中的其他部分，如最大偏心处C的对侧部分也能够起到旋磨作用。
上述各实施例中的偏心旋磨头100在应用于驱动轴时，柔性轴200的远端区域可以仅设置一个偏心旋磨头100，也可以设置多个偏心旋磨头100，尤其是对于病灶处长度较大时选用带有多个偏心旋磨头100的驱动轴，能够大大提高旋磨的效率。
具体地，在柔性轴200的远端区域，柔性轴200沿其轴向间隔设置有多个偏心旋磨头100的实施例中，各偏心旋磨头100的偏心方向在柔性轴200的周向上错位分布，即也就是说，如果沿着柔性轴200的轴向看过去，各偏心旋磨头100的最大偏心处C是沿着柔性轴200的周向分布的，优选地，多个偏心旋磨头100在周向上均匀分布，从而避免旋转时一侧离心力太大对血管造成损伤。
在多个偏心旋磨头100的实施例中，同一柔性轴200上的偏心旋磨头100可以相同(包括形状的和尺寸)，也可以不同。优选地，沿柔性轴200的轴向，多个偏心旋磨头100的径向最大尺寸自中间向两端逐渐减小。具体地，中间部分的偏心旋磨头100的径向最大尺寸大于两端部分的偏心旋磨头100的径向最大尺寸，也就是说，对于径向最大尺寸来说，各偏心旋磨头100在轴向上从中间向两端逐渐减小，即形成中间大两端小的分布，如中间的偏心旋磨头100的最大径向尺寸为1.5mm或者2.5mm时，两端的偏心旋磨头100的最大径向尺寸可以为1mm。采用这种方式布置的驱动轴，在旋磨中，能够更好地控制整个远端部分的公转效果，进而控制磨削力，提高手术的安全性，且端部较小的偏心旋磨头100，也有利于在于斑块初始接触时更好地进入病灶位置。
本发明还提供了一种用于介入式医疗设备的偏心旋磨头的制造方法，包括步骤：
S100：制造偏心基体，该偏心基体为上述任一实施例中的偏心基体；
S200：在偏心基体的侧面成型磨粒层，得到偏心旋磨头100。
其中，上述步骤S100中，可以先成型具有第三曲面30的圆柱坯料，该圆柱坯料的轴线为前述的偏心轴线31；之后通过在该圆柱坯料上去除材料形成偏心基体，具体地，可以先去除圆柱坯料外侧的材料，即形成两个回转面，分别为第一曲面20和第二曲面40，如以中心轴线11为回转轴线去除圆柱坯料上多余的部分，得到第一曲面20和第二曲面40，只是该回转轴线与形成圆柱坯料的回转轴线(即前述的偏心轴线31)不同；之后再去除内部材料形成连接孔10。采用这种制造方法，制造的偏心旋磨头100的侧面更为圆滑，且易于加工。
其中，圆柱坯料可以选择金属材料，如不锈钢、铜、铂钨合金等加工成形，之后偏心基体。
上述步骤S200中，磨粒层可以通过镀镍或者钎焊方式成型于偏心基体的侧面，其中，磨粒层中的磨粒可以为金刚石磨粒、CBN磨粒、SiC磨粒或者氧化铝磨粒，可以通过这些磨粒的微粉形成，具体可以通过电镀镍或者钎焊的方式与偏心基体连接。磨粒层中磨粒的突出高度优选为5μm～35μm，如5μm、8μm、10μm、12μm、15μm、20μm、22μm、25μm、30μm、33μm或者35μm，由于过大的突出高度有可能造成磨屑太大，不利于排出体外，甚至产生堵塞；而过小的突出高度磨削时去除的斑块量又太少，磨削效率太低，采用上述范围，能够同时解决上述问题，即能够降低磨屑的大小，又能够提升旋磨的效率。具体地，在制造中可以选择粒径在10～50μm的磨粒，如；磨粒的粒径可以为10um、20um、30um、33um、35um、40um、45um或者50um等，如此设置之后，磨粒与柔性轴200的结合更为牢固，且磨削力适度，不会对血管造成损伤，且产生的磨屑基本在30um以下，易被血液带走或者被人体吸收。
在制造好偏心旋磨头100后，可以将偏心旋磨头100与柔性轴200插装后，采用普通银/金锡焊接，或者胶粘接的方式连接，或者前文所述的连接方式连接，形成驱动轴。
需要说明的是，由于斑块不是规则的，形成的腔体也不是规则的圆柱形腔体，因此，上述所述的血管或者血管与斑块形成的腔体的直径仅是用于表述方便，并不限定腔体为圆柱形腔体，径向也仅仅是用于表述方便，指垂直于部件的轴向且从轴线指向外表面的方向，并不限定其所在的部件为球面、球形、第三曲面、圆形等。
本领域的技术人员能够理解的是，在不冲突的前提下，上述各优选方案可以自由地组合、叠加。
应当理解，上述的实施方式仅是示例性的，而非限制性的，在不偏离本发明的基本原理的情况下，本领域的技术人员可以针对上述细节做出的各种明显的或等同的修改或替换，都将包含于本发明的权利要求范围内。

Claims (14)

  1. 一种用于介入式医疗设备的偏心旋磨头，所述偏心旋磨头具有用于与柔性轴连接的连接孔；其特征在于，所述偏心旋磨头包括偏心基体和磨粒层，所述偏心基体的侧面包括第一曲面、第二曲面和第三曲面，
    所述第一曲面和所述第二曲面分别至少覆盖所述偏心基体的两端，且关于所述偏心基体两端之间的中心平面对称，二者分别为同一回转曲面上的部分，所述回转曲面通过一条平滑的凸形曲线绕中心轴线回转形成，所述中心轴线为连接孔的轴线，所述凸形曲线上的各点到所述中心轴线的距离沿着从所述偏心基体的端面到所述中心平面的方向逐渐增大；
    所述第三曲面为圆柱面的至少部分，位于所述偏心基体的中间区段，其回转轴线为偏心轴线，所述偏心轴线与所述连接孔的中心轴线平行且留有距离；
    其中，所述第一曲面和所述第二曲面在所述中心平面处部分相接，在所述侧面上形成至少一条连续平滑的母线；所述回转曲面与所述圆柱面相贯形成分别位于所述中心平面两侧的第一相贯线和第二相贯线；所述回转曲面上位于所述中心平面、所述第一相贯线以及所述偏心基体与其同侧端面之间的部分形成所述第一曲面，位于所述中心平面、所述第二相贯线以及所述偏心基体与其同侧端面的部分形成所述第二曲面，所述圆柱面上位于所述第一相贯线和所述第二相贯线之间的部分形成所述第三曲面；
    所述磨粒层设置于所述偏心基体的侧面。
  2. 根据权利要求1所述的偏心旋磨头，其特征在于，所述第一曲面、所述第二曲面和所述第三曲面在所述中心平面处相交于一点。
  3. 根据权利要求1所述的偏心旋磨头，其特征在于，所述第一曲面和所述第二曲面在所述偏心基体的周向上的部分区域相接，所述第一相贯线与所第二相贯线在所述中心平面处相接且平滑过渡。
  4. 根据权利要求1-3任一项所述的偏心旋磨头，其特征在于，所述凸形曲线为圆弧线、椭圆弧线、抛物线或者双曲线。
  5. 根据权利要求1所述的偏心旋磨头，其特征在于，所凸形曲线为圆弧线，所述凸形曲线的半径R、所述偏心基体的轴向长度L、所述偏心基体径向的最大尺寸D、所述连接孔的直径d、所述偏心轴线与所述中心轴线的偏心距 M以及所述偏心基体的最小壁厚s满足下述公式：
    R＝[L 2/4+(D/2+d/2-M+s) 2]/[2*(D/2+d/2-M+s)]。
  6. 根据权利要求1所述的偏心旋磨头，其特征在于，所述偏心轴线与所述中心轴线的偏心距为0.05mm～0.6mm；所述偏心基体在径向上的最大尺寸为1.0～2.5mm；
  7. 根据权利要求1所述的偏心旋磨头，其特征在于，所述偏心基体的轴向尺寸为1.0mm～7.0mm；所述偏心基体的最小壁厚大于或者等于0.05mm。
  8. 根据权利要求1-7任一项所述的偏心旋磨头，其特征在于，所述磨粒层中磨粒的突出高度为5～35μm。
  9. 一种用于介入式医疗设备的驱动轴，包括柔性轴和权利要求1-8任一项所述的偏心旋磨头，所述偏心旋磨头设置于所述柔性轴的远端区域，所述连接孔与所述柔性轴插装连接。
  10. 根据权利要求9所述的驱动轴，其特征在于，在所述远端区域，所述柔性轴沿其轴向间隔设置有多个偏心旋磨头，各所述偏心旋磨头的偏心方向在所述柔性轴的周向上错位分布，且中间部分的所述偏心旋磨头的径向最大尺寸大于两端部分的所述偏心旋磨头的径向最大尺寸。
  11. 根据权利要求10所述的驱动轴，其特征在于，沿所述柔性轴的轴向，多个所述偏心旋磨头的径向最大尺寸自中间向两端逐渐减小。
  12. 一种介入式医疗设备，其特征在于，包括权利要求9-11任一项所述的驱动轴。
  13. 一种用于介入式医疗设备的偏心旋磨头的制造方法，其特征在于，包括步骤：
    S100：制造偏心基体，所述偏心基体的侧面包括第一曲面、第二曲面和第三曲面，
    所述第一曲面和所述第二曲面分别至少覆盖所述偏心基体的两端，且关于所述偏心基体两端之间的中心平面对称，二者分别为同一回转曲面上的部分，所述回转曲面通过一条平滑的凸形曲线绕中心轴线回转形成，所述中心轴线为连接孔的轴线，所述凸形曲线上的各点到所述中心轴线的距离沿着从所述偏心基体的端面到所述中心平面的方向逐渐增大；
    所述第三曲面为圆柱面的至少部分，位于所述偏心基体的中间区段，其回转轴线为偏心轴线，所述偏心轴线与所述连接孔的中心轴线平行且留有距离；
    其中，所述第一曲面和所述第二曲面在所述中心平面处部分相接，在所述侧面上形成至少一条连续平滑的母线；所述回转曲面与所述圆柱面相贯形成分别位于所述中心平面两侧的第一相贯线和第二相贯线；所述回转曲面上位于所述中心平面、所述第一相贯线以及所述偏心基体与其同侧端面之间的部分形成所述第一曲面，位于所述中心平面、所述第二相贯线以及所述偏心基体与其同侧端面的部分形成所述第二曲面，所述圆柱面上位于所述第一相贯线和所述第二相贯线之间的部分形成所述第三曲面；
    S200：在所述偏心基体的侧面成型磨粒层，得到偏心旋磨头。
  14. 根据权利要求13所述的制造方法，其特征在于，所述磨粒层通过镀镍或者钎焊方式成型于所述偏心基体的侧面。
PCT/CN2022/112204 2022-08-05 2022-08-12 偏心旋磨头及其制造方法、驱动轴及介入式医疗设备 WO2024026919A1 (zh)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999008609A1 (en) * 1997-08-14 1999-02-25 Shturman Cardiology Systems, Inc. Eccentric rotational atherectomy device
CN102046100A (zh) * 2008-05-30 2011-05-04 心血管系统公司 用于高速腔内斑块旋磨装置的偏心研磨和切割头
CN111012448A (zh) * 2019-08-20 2020-04-17 上海微创医疗器械（集团）有限公司 旋磨装置
CN215384376U (zh) * 2021-03-26 2022-01-04 重庆西山科技股份有限公司 医用摆磨头及医用磨削刀具
CN114129227A (zh) * 2022-02-08 2022-03-04 广州博鑫医疗技术有限公司 偏心旋磨头的制造工装、制造方法和介入式旋磨装置
CN114368161A (zh) * 2021-11-25 2022-04-19 广州博鑫医疗技术有限公司 一种偏心旋磨组件的制造方法及偏心旋磨组件

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999008609A1 (en) * 1997-08-14 1999-02-25 Shturman Cardiology Systems, Inc. Eccentric rotational atherectomy device
CN102046100A (zh) * 2008-05-30 2011-05-04 心血管系统公司 用于高速腔内斑块旋磨装置的偏心研磨和切割头
CN111012448A (zh) * 2019-08-20 2020-04-17 上海微创医疗器械（集团）有限公司 旋磨装置
CN215384376U (zh) * 2021-03-26 2022-01-04 重庆西山科技股份有限公司 医用摆磨头及医用磨削刀具
CN114368161A (zh) * 2021-11-25 2022-04-19 广州博鑫医疗技术有限公司 一种偏心旋磨组件的制造方法及偏心旋磨组件
CN114129227A (zh) * 2022-02-08 2022-03-04 广州博鑫医疗技术有限公司 偏心旋磨头的制造工装、制造方法和介入式旋磨装置

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