WO2021032141A1 - 旋磨装置和包括旋磨装置的医疗器械 - Google Patents

旋磨装置和包括旋磨装置的医疗器械 Download PDF

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Publication number
WO2021032141A1
WO2021032141A1 PCT/CN2020/110133 CN2020110133W WO2021032141A1 WO 2021032141 A1 WO2021032141 A1 WO 2021032141A1 CN 2020110133 W CN2020110133 W CN 2020110133W WO 2021032141 A1 WO2021032141 A1 WO 2021032141A1
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WIPO (PCT)
Prior art keywords
rotational atherectomy
block
rotational
base
rotary grinding
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PCT/CN2020/110133
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English (en)
French (fr)
Inventor
岳斌
季晓飞
孙是澈
姚映忠
Original Assignee
上海微创医疗器械（集团）有限公司
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Application filed by 上海微创医疗器械（集团）有限公司 filed Critical 上海微创医疗器械（集团）有限公司
Priority to EP20854433.8A priority Critical patent/EP4005513A4/en
Priority to US17/637,390 priority patent/US20220313306A1/en
Publication of WO2021032141A1 publication Critical patent/WO2021032141A1/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
    • A61B17/320783—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions through side-hole, e.g. sliding or rotating cutter inside catheter
    • 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
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • 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
    • A61B17/320016—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes
    • A61B17/32002—Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes with continuously rotating, oscillating or reciprocating cutting instruments
    • 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
    • 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
    • A61B17/320725—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with radially expandable cutting or abrading elements
    • 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
    • A61B2017/320004—Surgical cutting instruments abrasive
    • 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
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • 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
    • A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
    • A61B2017/320766—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven eccentric

Definitions

  • This application relates to the field of medical devices, and in particular to a rotational atherectomy device and medical equipment including the rotational atherectomy device.
  • Atherosclerosis is more common in the large and middle arteries. It is characterized by thickening of the vessel wall and narrowing of the lumen caused by the formation of fibrolipid plaques in the arterial intima. It is mainly distributed in the intima of the arteries in the heart and brain. Because the diseased arterial lumen is narrowed or even blocked, causing diseases such as myocardial infarction and cerebral infarction, atherosclerosis is the cardiovascular disease with the highest mortality rate. Atherosclerotic plaques are generally located in the vasculature of the coronary arteries or peripheral arteries, and may exhibit different characteristics depending on the texture of the plaque. In current medical practice, for severely calcified lesions, atherectomy devices are usually used for pretreatment.
  • the principle of treatment with the atherectomy device is to use the rotational atherectomy device to rotate and grind the vascular lesions at high speed to remove calcified or fibrotic atherosclerotic plaques, unblock the blood vessels blocked by the plaques, and obtain an enlarged smooth Blood vessel lumen to facilitate subsequent stent implantation.
  • rotational atherectomy has become a more clinical application to remove atheroma Means to harden plaque.
  • the current rotational atherectomy catheter mainly includes a flexible drive shaft and a grinding head carried by the distal end of the drive shaft and covered with wear-resistant materials such as diamond particles.
  • the drive shaft drives the grinding head to rotate at a high speed (approximately 150000-190000rpm), advance, contact and grind and remove the disease.
  • the use of rotational atherectomy for coronary plaque can be applied to highly calcified lesions. Rotational atherectomy and then stent placement can increase the success rate of interventional therapy and reduce complications.
  • the current rotational atherectomy head cannot adjust the size of the grinding aperture during the process of dredging the lesion. It is necessary to frequently replace different specifications of rotational atherectomy catheters when treating plaques, and the outer diameter of the rotational atherectomy head is large, making it difficult to pass through narrow Blood vessels.
  • a rotational atherectomy device and a medical instrument including the rotational atherectomy device are provided.
  • the rotational atherectomy device includes a drive shaft and a rotational atherectomy assembly connected to the drive shaft.
  • the rotational atherectomy assembly includes a base and a rotational atherectomy block.
  • the rotational atherectomy block is relatively movable It is movably assembled on the base, and when the rotational atherectomy assembly rotates, the rotational atherectomy block moves away from the base.
  • the center of mass of the rotational atherectomy assembly does not coincide with the drive shaft.
  • the base includes a cavity, and the rotary grinding block is arranged in the cavity.
  • the cavity has a narrow top and a wide bottom shape
  • the rotational grinding block is an arch shape with a top narrow and a wide bottom along the radial direction of the drive shaft.
  • the base includes two cavities arranged symmetrically, the number of the rotational atherectomy blocks is two, and the two rotational atherectomy blocks are respectively arranged in the two cavities.
  • the cavity is provided with an opening, and the rotational grinding block partially protrudes out of the opening as the base rotates.
  • rotational grinding block is clamped at the opening when it moves to the maximum displacement position along with the rotation of the base.
  • the area of the bottom of the rotary grinding block is larger than the area of the opening.
  • the rotational atherectomy assembly includes a connecting piece, and the base is connected to the rotational atherectomy block through the connecting piece.
  • the connecting piece adjusts the rotational atherectomy block and the rotational atherectomy block. The distance between the pedestals.
  • the connecting member is movably connected to the base through a hinge.
  • a slot is provided on the base, and when the rotational atherectomy assembly is in a non-rotating state, the connecting piece and/or the rotational atherectomy block are located in the slot.
  • the connecting member is a spring.
  • rotational grinding block is arched along the radial direction of the drive shaft.
  • a grinding layer is provided on the surface of the rotary grinding block.
  • the medical device includes the above-mentioned rotational atherectomy device.
  • the medical device further includes a power source, which is connected to the rotational atherectomy device and drives the rotational atherectomy device to rotate.
  • the rotational atherectomy component is arranged at the end of the drive shaft and is used to abrade and remove plaques at the lesion site.
  • the rotational atherectomy block can expand outward and make a rotational movement around the rotational axis of the rotational atherectomy assembly.
  • the rotary grinding block is provided with a grinding layer, so that the touched lesion plaque is broken and ground away.
  • the rotational atherectomy device As the rotational speed of the rotational atherectomy assembly changes, the radius of rotation of the rotational atherectomy block under the centrifugal force and the force of the external lesion changes, which in turn causes the rotational atherectomy assembly to form a centroid offset and different rotation dimensions, so that the rotational atherectomy device can rotate At the same time, it continuously expands the grinding area, automatically adjusts the size of the grinding aperture, and finally realizes the removal of lesions in different ranges.
  • Fig. 1 is a perspective view of the initial state of the rotational atherectomy device in Example 1 of the application.
  • Example 2 is a main cross-sectional view of the initial state of the rotational atherectomy device in Example 1 of the application.
  • Fig. 3 is a side cross-sectional view of the rotational atherectomy device in the first embodiment of the application in the initial state.
  • Fig. 4 is a perspective view of the rotational atherectomy device in the first embodiment of the application in a moving state.
  • Fig. 5 is a main cross-sectional view of the rotational atherectomy device in the first embodiment of the application when it is in motion.
  • Fig. 6 is a side cross-sectional view of the rotational atherectomy device according to the first embodiment of the application in a moving state.
  • Fig. 7 is a perspective view of the initial state of the rotational atherectomy device in Example 2 of the application.
  • Fig. 8 is a main cross-sectional view of the initial state of the rotational atherectomy device in Example 2 of the application.
  • Fig. 9 is a side cross-sectional view of the rotational atherectomy device in the embodiment 2 of the application in the initial state.
  • Fig. 10 is a perspective view of the rotational atherectomy device according to the second embodiment of the application in a moving state.
  • Fig. 11 is a main cross-sectional view of the rotational atherectomy device in the second embodiment of the application in a moving state.
  • Fig. 12 is a side cross-sectional view of the rotational atherectomy device according to the second embodiment of the application in a moving state.
  • Fig. 13 is a main cross-sectional view of the rotational atherectomy device in Example 3 of the application.
  • FIG. 14 is a side cross-sectional view of the rotational atherectomy device according to Example 3 of the application.
  • Fig. 15 is a main cross-sectional view of the rotational atherectomy device according to Example 4 of the application.
  • FIG. 1 shows a perspective view of the initial state of the rotational atherectomy device in Example 1 of the present application.
  • the rotational atherectomy assembly 1 is arranged at the end of the drive shaft 2.
  • the drive shaft 2 is a flexible shaft with a slender structure and is used to drive the rotational movement of the rotational atherectomy assembly 1.
  • the rotational atherectomy assembly 1 includes a base 11 and a rotational atherectomy block 12.
  • the base 11 has an eccentric structure, so that the center of mass of the rotational atherectomy assembly 1 does not coincide with the drive shaft 2.
  • One side of the base 11 includes a through hole 111, and the drive shaft 2 can extend into the through hole 111 to be integrated with the base 11.
  • the rotary grinding block 12 is arranged in the cavity on the other side of the base 11.
  • the cavity is provided with an opening, so that the rotational grinding block 12 can move in the cavity.
  • the rotational atherectomy block 12 is deflected outward under the action of centrifugal force, away from the rotation axis A and rotates around the rotation axis A.
  • the rotation axis A mentioned here refers to the central axis of the drive shaft 2 and the base 1 after being sleeved together.
  • the rotational atherectomy assembly 1 can rotate around the rotation axis A.
  • the centrifugal force received by the rotational atherectomy block 12 gradually increases, and the rotational atherectomy block 12 gradually extends to the outside of the cavity, so that the rotational atherectomy block 12 contacts the external lesion and grinds it.
  • the resistance of the rotational atherectomy block 12 is reduced, and after the rotational speed of the rotational atherectomy assembly 1 is increased, the rotational atherectomy block 12 can further move outward to contact the lesion and grind it until Move to the position of maximum displacement and snap it to the opening of the cavity.
  • the rotational atherectomy block 12 can gradually grind the lesions at the contact site and move to the maximum displacement, thereby achieving the goal of deviating the center of mass and increasing the rotational atherectomy size.
  • the rotational atherectomy assembly 1 is an eccentric rotational atherectomy head, and the center of mass of the rotational atherectomy assembly 1 does not coincide with the drive shaft 2.
  • the rotational grinding block 12 and the drive shaft 2 are respectively located on both sides of the center of mass.
  • Figures 2 and 3 show a front cross-sectional view and a side cross-sectional view of the initial state of the rotational atherectomy device in Example 1 of the present application.
  • the other side of the base 11 includes a cavity 13.
  • the cavity 13 has an opening at the top, and the rotary grinding block 12 is arranged in the cavity 13 and can move in the cavity 13.
  • the two ends of the cavity 13 have inclined surfaces, so that the cavity 13 has a narrow top and a wide bottom shape, for example, a trapezoidal structure with a narrow top and a wide bottom.
  • “Up” refers to the direction away from the drive shaft, and “down” refers to the direction close to the drive shaft 2.
  • the two side walls of the cavity 13 are arc-shaped.
  • the rotational grinding block 12 is arranged in the cavity 13, and the end of the rotational grinding block 12 along the axial direction of the drive shaft 2 is inclined, and along the radial direction of the drive shaft 2, it has a shape with a narrow top and a wide bottom, as narrow as above.
  • the lower wide arch, and the area of the bottom of the rotational atherectomy block 12 is greater than the area of the opening of the cavity 13, so that the rotational atherectomy block 12 can move in a direction perpendicular to the plane of the opening of the cavity 13 and move to the maximum displacement.
  • FIGS 4 to 6 show schematic diagrams of the rotational atherectomy device of Example 1 of the present application in a moving state.
  • the rotational atherectomy block 12 When the rotational atherectomy assembly 1 is at the maximum speed, the rotational atherectomy block 12 is moved to the maximum displacement under the action of the maximum centrifugal force. Due to the restriction of the opening of the cavity 13 inside the base 11, the rotational atherectomy block 12 is clamped at the opening and can rotate around the rotation axis A.
  • the rotational atherectomy assembly 1 rotates at different speeds from static to the maximum rotational speed, the rotational atherectomy block 12 is subjected to centrifugal force of different magnitudes and moves along a direction perpendicular to the plane where the opening of the cavity 13 is located.
  • the grinding assembly 1 is built into the vascular lesion during use, and can grind the contacted lesion when the rotational abrasion block 12 rotates, thereby reducing the external resistance. After the lesions in contact with the rotary grinding block 12 are grinded, the rotary grinding block 12 further extends out of the opening of the cavity 13 under the action of centrifugal force until it is clamped at the opening, so that the grinding size of the rotary grinding block 12 Keep increasing.
  • the rotational atherectomy assembly 1 moves to the next lesion, the rotational atherectomy block 12 is pressured to return to the original state, and then prepares for the next step of grinding.
  • the outer surface of the rotary grinding block 12 is covered with a grinding layer 121.
  • the rotational atherectomy assembly 1 rotates, the rotational atherectomy block 12 is subjected to the centrifugal force to extend out of the cavity 13 and contact the lesion plaque, the abrasive layer 121 on its surface can act on the lesion plaque, breaking and abrading the lesion plaque, Make the lesion plaque ablate.
  • the rotating assembly 1 can have different rotation speeds when rotating, the distance that the rotational abrasive block 12 moves outwards during rotation can be changed, and therefore, the lesions and plaques at different positions around the rotational abrasive block 12 can be ground to achieve grinding
  • the automatic adjustment of the size of the cut hole will eventually clear the blood vessel blocked by the plaque and obtain an enlarged smooth blood vessel lumen.
  • FIGS 7 to 9 show schematic diagrams of the initial state of the rotational atherectomy device in Example 2 of the present application.
  • the rotational atherectomy assembly 1 is in the shape of an ellipse, and the rotational atherectomy assembly 1 is sleeved on the drive shaft 2 to form a structure with a rotation axis A.
  • the upper and lower parts of the base 14 (that is, the parts of the base 14 on both sides of the rotation axis A) are symmetrically provided with cavities 16.
  • Two rotational atherectomy blocks 15 are respectively arranged in the two cavities 16, so that the rotational atherectomy assembly 1 During the rotation, the two rotary grinding blocks 15 can be moved away from the rotation axis A under the action of centrifugal force, thereby improving the grinding efficiency.
  • both ends of the cavity 16 along the axial direction of the drive shaft 2 are arc-shaped.
  • the two sides of the cavity 16 along the radial direction of the drive shaft 2 are arc-shaped, and the corresponding rotational grinding block 15 is an arched structure with a narrow top and a wide bottom.
  • the bottom area of the block 15 is larger than the opening area of the cavity 16, so that when the rotational atherectomy block 15 moves along a plane perpendicular to the opening of the cavity 16 to the maximum displacement, it can be clamped at the opening.
  • FIGS 10 to 12 are schematic diagrams of Example 2 of the present application in the moving state.
  • the rotational atherectomy assembly 1 rotates to the maximum speed
  • the two rotational atherectomy blocks 15 move away from the rotation axis A under the action of the maximum centrifugal force .
  • the movement reaches the maximum displacement, it is clamped at the opening of the cavity 16.
  • the rotational atherectomy block 15 can contact the lesion plaque to the maximum extent, break up and grind the lesion plaque.
  • the outward movement distance of the two rotational atherectomy blocks 15 can be changed, and therefore the lesions at different positions around the rotational atherectomy blocks 15 can be ground. , So as to realize the automatic adjustment of the grinding aperture size, and finally clear the blood vessels blocked by the plaque, and obtain an enlarged smooth blood vessel lumen.
  • the outer surface of the rotary grinding block 15 is covered with a grinding layer 151.
  • the rotational atherectomy assembly 1 rotates, the rotational atherectomy block 15 is extended out of the cavity 16 by the centrifugal force and contacts the lesion plaque, the abrasive layer 151 on its surface can act on the lesion plaque, breaking and abrading the lesion plaque, Make the lesion plaque ablate.
  • the rotary grind block of Example 1 and Example 2 and the corresponding cavity structure are different.
  • the structure principle is that the rotary grind block can be stored in the cavity in the static state, and the rotary grind block can be stored in the dynamic state. Part of it extends to the outside of the cavity and is clamped to the opening of the cavity; and when the speed drops, as the centrifugal force of the rotary grind block decreases, the rotary grind block can gradually recover to its own weight or external pressure.
  • the position in the initial state. Therefore, the embodiments listed in the present application are only a preferred manner, and do not mean that all the implementation manners of the present application can be exhausted. Therefore, those skilled in the art can derive by simple logic and apply other similar cavity structures.
  • Example 2 uses two rotational grinding blocks in a symmetrical manner. Compared with the one rotational grinding block of Example 1, Example 2 has better grinding efficiency, while the eccentric structure of Example 1 has greater grinding efficiency. Grinding range. Therefore, those skilled in the art can design different combinations according to actual needs and apply them to different types of atherosclerotic plaque removal solutions.
  • FIGS 13 and 14 show schematic diagrams of the rotational atherectomy device in Example 3 of the present application.
  • the rotational atherectomy assembly 1 is arranged at the end of the drive shaft 2.
  • the base 17 has a cylindrical shape and is sleeved on the end of the drive shaft 2.
  • the curved strip-shaped rotational grinding block 18 is arranged above the base 17 (that is, the rotational grinding block 18 is arranged on the base 17 on the side of the drive shaft 2), and the rotational grinding block 18 and the base 17 are connected to each other through three springs 19 connection.
  • the rotational atherectomy block 18 When the drive shaft 2 drives the rotational atherectomy assembly 1 to rotate, the rotational atherectomy block 18 is affected by the centrifugal force and the traction spring 19 expands outward and gradually moves away from the rotation axis A. When the rotation speed is gradually reduced, the rotational grinding block 18 is gradually restored to the initial state under the traction force of the spring 19.
  • the upper surface of the rotary grinding block 18 (that is, the surface away from the drive shaft 2) is provided with a grinding layer 181.
  • the abrasive layer 181 can contact the lesion plaque, break and grind the lesion plaque, thereby dredging the blocked blood vessel.
  • the rotary grind block 18 can be rotated in different ranges under the traction of the spring 19, thereby realizing the function of automatically adjusting the grinding aperture.
  • the maximum radius of rotation of the rotational grinding block 18 is affected by the elastic coefficient of the spring 19. Therefore, by selecting springs 19 with different elastic coefficients, the range of the grinding aperture can be further expanded. Therefore, the third embodiment has better applicability.
  • FIG. 15 shows the main cross-sectional view of the rotational atherectomy device according to Embodiment 4 of the present application, in which the rotational atherectomy assembly 1 is arranged at the end of the drive shaft 2.
  • the rotational atherectomy assembly 1 includes a base 17 and a rotational atherectomy block 20.
  • the rotational atherectomy block 20 is connected with a relatively rigid connecting arm 21.
  • the connecting arm 21 is movably connected to the base 17 through a hinge 22.
  • a slot is provided on the base 17.
  • the rotational atherectomy block 20 moves away from the base 17 due to centrifugal force.
  • the abrasive layer on the rotary atherectomy block 20 contacts the lesion plaque, breaks and grinds the lesion plaque, thereby dredging the blocked blood vessel.
  • the centrifugal force obtained by the rotary grinding block 20 increases synchronously, and the rotation radius of the rotary grinding block 20 gradually increases, so as to achieve the purpose of adjusting the grinding aperture, and then can grind away the different ranges Lesions.
  • the rotational atherectomy device provided in this application needs to be inserted into the living body during use. Therefore, it is required that the material suitable for the rotational atherectomy component can meet the requirements of biomedicine.
  • the constituent material of the rotational atherectomy component is composed of one or more metal materials. Including but not limited to stainless steel, nickel, titanium, tungsten.
  • the grinding layer on the surface of the rotary grinding block is used to grind the lesion plaque, so its constituent materials can enhance the wear ability of the rotary grinding block, including but not limited to diamond, fused quartz, titanium nitride, tungsten carbide, silicon carbide One or more combination materials.
  • the rotational atherectomy assembly adopts different structural designs and material selections.
  • the rotational atherectomy block has a smaller outline in a static state, which facilitates the rotational atherectomy assembly to reach the lesion through the blood vessel;
  • the centrifugal force generated under high-speed rotation increases the outer diameter profile of the rotary grinding block and offsets the center of mass, thereby realizing the ability to automatically adjust the grinding aperture.
  • the technical solution provided by this application reduces the size of the rotational atherectomy assembly in a static state, so that it can better reach the lesion through the blood vessel; the grinding aperture can be adjusted by the change of the rotational speed of the rotational atherectomy block, thereby reducing constant replacement during use
  • the frequency of the rotary grinding device is easy to operate and has better economic benefits.
  • the present application provides a medical device for removing intravascular plaque.
  • the medical device includes the rotational atherectomy device described in the above embodiment.
  • the medical device also includes a power source, which is connected with the rotational atherectomy device for driving the rotation of the rotational atherectomy device.
  • the rotational atherectomy device is driven to rotate by the power source, so that the rotational atherectomy block of the rotational atherectomy device can move away from the axis of rotation under the action of centrifugal force, thereby grinding away the touched intravascular lesions and rotating the atherectomy device.
  • the device can generate different rotation radii according to the different driving force provided by the power source, thereby achieving the purpose of grinding lesions in different ranges in the blood vessel, reducing the problem of frequent replacement of the rotational atherectomy device during use by the operator, and has better Market application prospects.

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Abstract

一种旋磨装置，包括驱动轴（2），以及与驱动轴（2）连接的旋磨组件（1），旋磨组件（1）包括基座（11）和旋磨块（12），旋磨块（12）可相对活动地组装在基座（11）上，旋磨组件（1）旋转时，旋磨块（12）向远离基座（11）的方向移动。由旋磨组件（1）组成的旋磨头，降低了静止状态下旋磨头的外部尺寸，因而能够更好的通过血管到达病灶处；通过高速旋转下产生的离心力改变旋磨头的运动半径和开通病变的尺寸，能够达到自动调节磨削孔径的目的，从而减少在使用中不断更换旋磨头的频率。

Description

旋磨装置和包括旋磨装置的医疗器械
援引加入
本申请要求于2019年8月20日提交中国专利局、申请号为201910769429X、发明名称为“旋磨装置”的中国专利申请的优先权，其全部内容通过引用结合在本申请中。
技术领域
本申请涉及医疗器械领域，特别是涉及一种旋磨装置以及包括旋磨装置的医疗器械。
背景技术
动脉粥样硬化多见于大、中动脉中，以在动脉内膜形成纤维脂质斑块致管壁增厚、管腔狭窄为特征，主要分布在心脏、脑部动脉内膜中。由于病变的动脉管腔狭窄甚至阻塞，引起如心肌梗塞、脑梗塞等病症，因此动脉粥样硬化是死亡率最高的心血管疾病。动脉粥样硬化斑块一般位于冠状动脉或外周动脉的脉管***，并且根据斑块的质地可能呈现出不同的特征。目前在医学实践中，对于严重钙化病变，通常采用动脉粥样硬化切除装置进行预处理。
采用动脉粥样硬化切除装置进行处理的原理是通过旋磨装置在血管病变处高速旋转磨削，祛除钙化或纤维化的动脉硬化斑块，疏通被斑块堵塞的血管，从而获得扩大的光滑的血管内腔，以方便后续支架的植入。在对血管开口处、分叉处的狭窄病变，以及偏心、长节段、严重刮花的狭窄病变进行介入治疗时，冠状动脉斑块旋磨术已成为临床应用较多的一种祛除粥样硬化斑块的手段。
目前的旋磨导管主要包括柔性驱动轴和驱动轴的远端承载的被金刚石颗粒等耐磨材料覆盖的磨头。驱动轴带动磨头高速(大约150000-190000rpm)旋转，向前推进、接触并磨削祛除病变。采用冠状动脉斑块旋磨术进行治疗，能够适用于高度钙化的病变，先进行旋磨，再置入支架，可提高介入治疗的成功率，同时减少并发症的发生。
但是，目前的旋磨头在疏通病变过程中无法调节磨削孔径大小，对于斑块进行处理时需要频繁更换不同规格的旋磨导管，且旋磨头的外径尺寸较大，难以通过狭窄的血管。
发明内容
根据本申请公开的各种示例性实施例，提供一种旋磨装置以及包括旋磨装置的医疗器械。
本申请的一方面提供一种旋磨装置，旋磨装置包括驱动轴以及与所述驱动轴连接的旋磨组件，所述旋磨组件包括基座和旋磨块，所述旋磨块相对可活动地组装在所述基座上，所述旋磨组件旋转时，所述旋磨块向远离所述基座的方向移动。
进一步地，所述旋磨组件的质心与所述驱动轴不重合。
进一步地，所述基座包括空腔，所述旋磨块设置在所述空腔内。
进一步地，所述空腔呈上窄下宽的形状，所述旋磨块沿驱动轴的径向方向呈上窄下宽的拱形。
进一步地，所述基座包括对称设置的两个所述空腔，所述旋磨块的数量为两个，并且两个所述旋磨块分别设置在两个所述空腔内。
进一步地，所述空腔设有开口，所述旋磨块随着所述基座的旋转而部分地伸出所述开口。
进一步地，所述旋磨块随着所述基座的旋转而移动到最大位移处时卡接在所述开口处。
进一步地，所述旋磨块底部的面积大于所述开口的面积。
进一步地，所述旋磨组件包括连接件，所述基座通过所述连接件与所述旋磨块连接，当所述旋磨组件旋转时，所述连接件调节所述旋磨块与所述基座之间的距离。
进一步地，所述连接件通过铰链与所述基座可活动地连接。
进一步地，所述基座上设置有狭槽，当所述旋磨组件处于非旋转状态时，所述连接件和/或所述旋磨块位于所述狭槽内。
进一步地，所述连接件为弹簧。
进一步地，所述旋磨块沿所述驱动轴的径向方向呈拱形。
进一步地，所述旋磨块的表面上设置有研磨层。
本申请的另一方面提供一种医疗器械，用于去除血管内斑块。该医疗器械包括以上所述的旋磨装置。
进一步地，该医疗器械还包括动力源，所述动力源与所述旋磨装置连接，驱动所述旋磨装置旋转。
根据本申请所提供的旋磨装置，旋磨组件设置在驱动轴端部，用于对病灶部位斑块进行磨削祛除。随着旋磨组件的转动，旋磨块能够向外扩展，并绕旋磨组件的旋转轴线做旋转运动。旋磨块上设有研磨层，从而将接触到的病灶斑块打碎磨削掉。随着旋磨组件的转速的变化，旋磨块在离心力以及外部病灶的作用力下转动的半径发生变化，进而使旋磨组件形成质心偏移和不同的旋转尺寸，从而旋磨装置可在旋转的同时不断扩大磨削面积，自动调节磨削孔径大小，最终实现祛除不同范围内的病灶斑块。
对于本申请的各种具体结构及其作用与效果，将在下面结合附图作出进一步详细的说明。
附图说明
为了更清楚地说明本实施例或现有技术中的技术方案，下面将对实施例或现有技术描述中所需要使用的附图作简单地介绍。显而易见地，下面描述中的附图仅仅是本申请的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他实施例的附图。
图1为本申请实施例1的旋磨装置初始状态立体图。
图2为本申请实施例1的旋磨装置初始状态主剖视图。
图3为本申请实施例1的旋磨装置初始状态侧剖视图。
图4为本申请实施例1的旋磨装置于运动状态时立体图。
图5为本申请实施例1的旋磨装置于运动状态时主剖视图。
图6为本申请实施例1的旋磨装置于运动状态时侧剖视图。
图7为本申请实施例2的旋磨装置初始状态立体图。
图8为本申请实施例2的旋磨装置初始状态主剖视图。
图9为本申请实施例2的旋磨装置初始状态侧剖视图。
图10为本申请实施例2的旋磨装置于运动状态时立体图。
图11为本申请实施例2的旋磨装置于运动状态时主剖视图。
图12为本申请实施例2的旋磨装置于运动状态时侧剖视图。
图13为本申请实施例3的旋磨装置主剖视图。
图14为本申请实施例3的旋磨装置侧剖视图。
图15为本申请实施例4的旋磨装置主剖视图。
具体实施方式
下面将结合附图对本申请实施例中的技术方案做进一步清楚、完整的描述，但需要说明的是，以下实施例仅是本申请中的部分优选实施例，并不涉及本申请技术方案所涵盖的全部实施例。
需要说明的是，在本申请的描述中，当元件被称为“固定于”另一个元件，它可以直接在另一个元件上或者也可以存在居中的元件。当一个元件被认为是“连接”另一个元件，它可以是直接连接到另一个元件或者可能同时存在居中元件。
除非另有定义，本文所使用的所有的技术和科学术语与属于本申请的技术领域的技 术人员通常理解的含义相同。本文中在本申请的说明书中所使用的术语只是为了描述具体的实施例的目的，不是旨在于限制本申请。本文所使用的术语“和/或”包括一个或多个相关的所列项目的任意的和所有的组合。
图1所示的是本申请实施例1的旋磨装置初始状态立体图。旋磨组件1设置在驱动轴2的端部。驱动轴2为细长结构的柔性轴，用于驱动旋磨组件1的旋转运动。旋磨组件1包括一个基座11和一个旋磨块12。基座11为偏心结构，使得旋磨组件1的质心与驱动轴2不重合。基座11的一侧包括通孔111，驱动轴2能够伸入到通孔111中从而与基座11结合为一体。旋磨块12设置在基座11另一侧的空腔之中。该空腔设有开口，使旋磨块12能够在空腔中活动。当驱动轴2转动从而带动旋磨组件1旋转时，旋磨块12受到离心力的作用向外偏移，远离旋转轴线A并绕旋转轴线A做旋转运动。此处所说的旋转轴线A，指的是驱动轴2与基座1套接在一起后的中心轴线。当驱动轴2转动时，旋磨组件1能够绕旋转轴线A转动。
随着旋磨组件1转速的增大，旋磨块12受到的离心力逐渐增大，旋磨块12逐渐伸出到空腔外部，使得旋磨块12与外部病灶接触并对其进行磨削。消除病灶斑块后，旋磨块12所受到的阻力变小，进而增大旋磨组件1的转速后，旋磨块12能够进一步地向外移动而与病灶接触并对其进行磨削，直至移动到最大位移处并卡接在空腔的开口处。因此，旋磨块12能够随着旋磨组件1旋转速度的增加，逐渐磨削接触部位的病灶并逐步移动到最大位移处，从而实现质心偏离和增大旋磨尺寸的目标。
在一种优选实施例中，旋磨组件1为偏心旋磨头，旋磨组件1的质心与驱动轴2不重合。旋磨块12与驱动轴2分别位于质心的两侧。
图2和图3所示的是本申请实施例1的旋磨装置初始状态的主剖视图和侧剖视图。结合图1至图3所示，基座11的另一侧包括空腔13。空腔13顶部具有开口，旋磨块12设置在空腔13之中，并能够于空腔13中活动。如图2所示，沿驱动轴2的轴向方向，空腔13两端具有斜面，使空腔13呈上窄下宽的形状，例如，呈上窄下宽的梯形结构，其中此处“上”是指远离驱动轴的方向，“下”是指靠近驱动轴2的方向。如图3所示，沿驱动轴2的径向方向，空腔13的两个侧壁呈圆弧状。旋磨块12设置在空腔13内，旋磨块12沿驱动轴2的轴向方向的端部呈斜面，沿驱动轴2的径向方向呈顶部较窄、底部较宽的形状，如上窄下宽的拱形，且旋磨块12底部的面积大于空腔13的开口的面积，使得旋磨块12能够沿垂直于空腔13的开口所在的平面的方向运动并在运动到最大位移处时卡接在开口上。
图4至图6所示的是本申请实施例1的旋磨装置于运动状态时的示意图，当旋磨组件1处于最大转速时，旋磨块12受到最大离心力的作用运动到最大位移处，由于受到基 座11内部空腔13的开口的限制，旋磨块12被卡接在开口处并能够绕旋转轴线A做旋转运动。当旋磨组件1在从静止到最大转速之间的不同转速下转动时，旋磨块12受到不同大小的离心力作用而沿着垂直于空腔13开口所在的平面的方向运动，同时，由于旋磨组件1在使用中内置于血管病灶处，在旋磨块12转动时能够对接触到的病灶进行磨削，从而减少其外部所受的阻力。当与旋磨块12接触到的病灶被磨削掉后，旋磨块12在离心力作用下进一步伸出空腔13的开口直至被卡接在开口处，从而使得旋磨块12的磨削尺寸不断增大。当旋磨组件1移动到下一个病灶处时，旋磨块12受到压力恢复到最初状态，进而为下一步磨削做好准备。
为了更好的实现磨削效果，旋磨块12的外表面覆盖一层研磨层121。当旋磨组件1旋转时，旋磨块12受离心力的作用伸出空腔13并接触到病灶斑块后，其表面的研磨层121能够作用在病灶斑块上，打破并磨损病灶斑块，使病灶斑块能够消融。由于旋转组件1在旋转时可具有不同的转速，因此旋磨块12在旋转时向外移动的距离可发生改变，并因此可磨削旋磨块12周围不同位置的病灶斑块，从而实现磨削孔径大小的自动调节，最终疏通被斑块堵塞的血管，获得扩大的光滑的血管内腔。
图7至图9所示的是本申请实施例2的旋磨装置初始状态示意图，旋磨组件1呈椭圆球状，旋磨组件1套接在驱动轴2上构成具有旋转轴线A的结构。基座14上下部分(即基座14的位于旋转轴线A两侧的部分)对称地开设有空腔16。2个旋磨块15分别设置在两个空腔16中，使得旋磨组件1在旋转过程中，两个旋磨块15能够在离心力作用下远离旋转轴线A，从而提升磨削效率。
如图8所示，空腔16沿驱动轴2的轴向方向的两端呈圆弧状。如图9所示，空腔16沿驱动轴2的径向方向的两个侧面呈圆弧状，与之对应的旋磨块15呈顶部较窄、底部较宽的拱形结构，且旋磨块15的底部面积大于空腔16的开口面积，使得旋磨块15沿垂直于空腔16的开口所在的平面运动到最大位移处时，能够卡接在开口处。
图10至图12所示的是本申请实施例2的于运动状态时的示意图，当旋磨组件1旋转到最大转速时，两个旋磨块15在最大离心力的作用下远离旋转轴线A运动，当运动到最大位移处时卡接在空腔16的开口处。此时，旋磨块15能够最大范围地接触到病灶斑块，将病灶斑块打碎并磨削。当旋磨组件1在静止和最大转速之间的不同转速下转动时，两个旋磨块15向外移动的距离可发生改变，并因此可磨削旋磨块15周围不同位置的病灶斑块，从而实现磨削孔径大小的自动调节，最终疏通被斑块堵塞的血管，获得扩大的光滑的血管内腔。
此外，旋磨块15的外表面覆盖一层研磨层151。当旋磨组件1旋转时，旋磨块15受离心力的作用伸出空腔16并接触到病灶斑块后，其表面的研磨层151能够作用在病灶斑 块上，打破并磨损病灶斑块，使病灶斑块能够消融。
需要说明的是，实施例1和实施例2的旋磨块以及与之配套的空腔结构不同，其结构原理是，在静态时旋磨块能够存放于空腔内，动态时旋磨块能够部分伸出到空腔外部并卡接在空腔的开口处；而当转速下降时，随着旋磨块所受离心力的降低，旋磨块能够在自重或者外部压力作用下，逐渐恢复到其初始状态时的位置。因此，本申请所列举的实施例仅是一种优选方式，并不意味着能够穷尽本申请的所有实施方式，因此，本领域的技术人员可以通过简单逻辑推导，适用其他类似的空腔结构。
实施例2采用了上下对称方式的两个旋磨块，相比于实施例1的一个旋磨块，实施例2具有更好的磨削效率，而实施例1的偏心结构则具有更大的磨削范围。因此，本领域的技术人员可以根据实际需要，设计不同的组合，使之应用于不同类型的祛除粥样硬化斑块方案之中。
图13、图14所示的是本申请实施例3的旋磨装置示意图。其中，旋磨组件1设置在驱动轴2的端部。基座17呈圆筒状，套接在驱动轴2的端部。曲面条状的旋磨块18设置在基座17的上方(即旋磨块18设置于驱动轴2一侧的基座17上)，通过3个弹簧19将旋磨块18和基座17相连接。当驱动轴2带动旋磨组件1转动时，旋磨块18受离心力作用牵引弹簧19向外扩张，逐渐远离旋转轴线A。当转速逐渐降低时，旋磨块18受弹簧19的牵引力作用，逐渐恢复到初始状态。
旋磨块18的上表面(即远离驱动轴2的表面)设置有研磨层181。当旋磨块18在转动时，研磨层181能够接触到病灶斑块，将病灶斑块打碎并磨削，从而疏通被堵塞的血管。采用实施例3的旋磨装置，旋磨块18能够在弹簧19的牵引下在不同范围内转动，从而实现自动调节磨削孔径的功能。此外，旋磨块18的最大旋转半径受弹簧19的弹性系数影响，因此，通过选择不同弹性系数的弹簧19，可以进一步扩大磨削孔径的范围，因而实施例3具有更好的适用性。
图15所示的是本申请实施例4的旋磨装置主剖视图，其中，旋磨组件1设置在驱动轴2的端部。旋磨组件1包括基座17和旋磨块20。旋磨块20与相对刚性的连接臂21连接。连接臂21通过铰链22与基座17可活动地连接。优选地，基座17上设置有狭槽。当旋磨组件1处于非旋转状态时，连接臂21和/或旋磨块20可以位于狭槽内。当驱动轴2驱动旋磨组件1旋转时，因为离心力的作用使旋磨块20向远离基座17的方向运动。位于旋磨块20上的研磨层接触到病灶斑块，将病灶斑块打碎并磨削，从而疏通被堵塞的血管。随着驱动轴2的转速的增加，旋磨块20获得的离心力同步上升，旋磨块20的旋转半径逐渐增大，从而达到调整其磨削孔径的目的，进而能够磨削掉不同范围内的病灶。
本申请所提供的旋磨装置，在使用中需要置入到生物体内，因此要求适用旋磨组件 的材料能够满足生物医学的要求，旋磨组件的组成材料由一种或多种金属材料组成，包括但不限于不锈钢、镍、钛、钨。旋磨块表面的研磨层用于对病灶斑块磨削处理，因此其构成材料能够增强旋磨块的磨损能力，包括但不限于金刚石、融凝石英、氮化钛、碳化钨、碳化硅中的一种或多种组合材料。需要说明的是，以上所述材料并不能穷尽本申请所提供技术方案涉及的全部材料，能够与本申请所提供技术方案具有同等功效，本领域技术人员通过简单分析便能够替换适用的其他类型的材料，同样被本申请所允许。此外，为了使本申请所提供的旋磨组件更好的置入到生物体内，在驱动轴的另一个端部设置有手持部，从而方便医务工作人员的操作。
根据本申请所提供的旋磨装置，旋磨组件通过不同的结构设计和材料选择，一方面使旋磨块在静止状态下具有较小的轮廓，方便旋磨组件通过血管到达病变处；另一方面通过高速旋转下产生的离心力使旋磨块的外径轮廓增加以及质心偏移，从而实现自动调节磨削孔径的能力。本申请提供的技术方案，降低了静止状态下旋磨组件的尺寸，因而能够更好的通过血管到达病灶处；通过旋磨块的转速的变化调节磨削孔径大小，从而减少在使用中不断更换旋磨装置的频率，操作简便，具有更好的经济效益。
此外，本申请提供一种医疗器械，用于去除血管内斑块。该医疗器械包括以上实施例所述的旋磨装置。此外，该医疗器械还包括动力源，动力源与旋磨装置连接，用于驱动旋磨装置的旋转。在使用中，通过动力源驱动旋磨装置转动，使旋磨装置的旋磨块能够在离心力作用下做远离旋转轴线的周向运动，进而将接触到的血管内病灶磨削掉，并且旋磨装置能够根据动力源提供的不同驱动力，产生不同的旋转半径，进而达到磨削血管内不同范围内的病灶的目的，减低操作人员在使用中需要频繁更换旋磨装置的问题，具有更好的市场应用前景。
以上所述实施例的各技术特征可以进行任意的组合，为使描述简洁，未对上述实施例中的各个技术特征所有可能的组合都进行描述，然而，只要这些技术特征的组合不存在矛盾，都应当认为是本说明书记载的范围。
以上所述实施例仅表达了本申请的几种实施方式，其描述较为具体和详细，但并不能因此而理解为对申请专利范围的限制。应当指出的是，对于本领域的普通技术人员来说，在不脱离本申请构思的前提下，还可以做出若干变形和改进，这些都属于本申请的保护范围。因此，本申请专利的保护范围应以所附权利要求为准。

Claims (17)

  1. 一种旋磨装置，其特征在于，所述旋磨装置包括驱动轴以及与所述驱动轴连接的旋磨组件，所述旋磨组件包括基座和旋磨块，所述旋磨块相对可活动地组装在所述基座上，所述旋磨组件旋转时，所述旋磨块向远离所述基座的方向移动。
  2. 根据权利要求1所述的旋磨装置，其特征在于，所述旋磨组件的质心与所述驱动轴不重合。
  3. 根据权利要求1所述的旋磨装置，其特征在于，所述基座包括空腔，所述旋磨块设置在所述空腔内。
  4. 根据权利要求3所述的旋磨装置，其特征在于，所述空腔呈上窄下宽的形状，所述旋磨块沿驱动轴的径向方向呈上窄下宽的拱形。
  5. 根据权利要求3所述的旋磨装置，其特征在于，所述基座包括对称设置的两个所述空腔，所述旋磨块的数量为两个，并且两个所述旋磨块分别设置在两个所述空腔内。
  6. 根据权利要求3所述的旋磨装置，其特征在于，所述空腔设有开口，所述旋磨块随着所述基座的旋转而部分地伸出所述开口。
  7. 根据权利要求6所述的旋磨装置，其特征在于，所述旋磨块随着所述基座的旋转而移动到最大位移处时卡接在所述开口处。
  8. 根据权利要求7所述的旋磨装置，其特征在于，所述旋磨块底部的面积大于所述开口的面积。
  9. 根据权利要求1所述的旋磨装置，其特征在于，所述旋磨组件包括连接件，所述基座通过所述连接件与所述旋磨块连接，当所述旋磨组件旋转时，所述连接件调节所述旋磨块与所述基座之间的距离。
  10. 根据权利要求9所述的旋磨装置，其特征在于，所述连接件通过铰链与所述基座可活动地连接。
  11. 根据权利要求10所述的旋磨装置，其特征在于，所述基座上设置有狭槽，当所述旋磨组件处于非旋转状态时，所述连接件和/或所述旋磨块位于所述狭槽内。
  12. 根据权利要求10所述的旋磨装置，其特征在于，所述连接件为刚性旋转臂。
  13. 根据权利要求9所述的旋磨装置，其特征在于，所述连接件为弹簧。
  14. 根据权利要求1所述的旋磨装置，其特征在于，所述旋磨块沿所述驱动轴的径向方向呈拱形。
  15. 根据权利要求1所述的旋磨装置，其特征在于，所述旋磨块的表面上设置有研磨层。
  16. 一种医疗器械，用于去除血管内斑块，其特征在于，所述医疗器械包括如权利要 求1-15中任一项所述的旋磨装置。
  17. 根据权利要求16所述的医疗器械，其特征在于，所述医疗器械还包括动力源，所述动力源与所述旋磨装置连接，驱动所述旋磨装置旋转。
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