CN113995480B - High-speed driving shaft for insertion type rotary grinding device and insertion type rotary grinding device - Google Patents
High-speed driving shaft for insertion type rotary grinding device and insertion type rotary grinding device Download PDFInfo
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- CN113995480B CN113995480B CN202011026107.5A CN202011026107A CN113995480B CN 113995480 B CN113995480 B CN 113995480B CN 202011026107 A CN202011026107 A CN 202011026107A CN 113995480 B CN113995480 B CN 113995480B
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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
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
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- H—ELECTRICITY
- H02—GENERATION; CONVERSION OR DISTRIBUTION OF ELECTRIC POWER
- H02K—DYNAMO-ELECTRIC MACHINES
- H02K7/00—Arrangements for handling mechanical energy structurally associated with dynamo-electric machines, e.g. structural association with mechanical driving motors or auxiliary dynamo-electric machines
- H02K7/14—Structural association with mechanical loads, e.g. with hand-held machine tools or fans
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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
- 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
Abstract
The invention provides a high-speed driving shaft and an intervention type rotary grinding device, wherein the driving shaft comprises a rigid shaft and a flexible shaft which are connected with each other, the flexible shaft comprises an inner layer coil group and an outer layer coil group which are attached and have opposite surrounding directions, at two ends of the flexible shaft, outer layer spring wires are connected with each other in a welding way, the inner layer spring wires are connected with each other in a welding way, and the inner layer coil group and the outer layer coil group are connected with each other in a welding way; the part that rigid shaft was kept away from to the flexible shaft forms and grinds the district soon, grinds the interval and is provided with two or three and grinds the layer soon to grind same plaque, and the tip that a layer of grinding is located the flexible shaft soon in the outside, so that grind the layer soon and rotate around self axis high-speed pivoted the time, can rotate around the vascular inner wall. The invention can be applied to a wider range of blood vessels and has higher operation safety.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a high-speed driving shaft for an interventional type rotational grinding device and the interventional type rotational grinding device.
Background
The interventional medical device is a medical instrument commonly used in the prior medical technology, such as atherosclerosis and other diseases, ischemic heart disease gradually becomes one of the more fatal diseases, and the main causes of the disease are atherosclerosis: fat, fiber and calcium deposit on the vessel wall to form plaques, which obstruct the normal circulation of blood and cause the vessel obstruction. In the prior art, intervention saccule and stent treatment are often adopted, and atherosclerotic plaques are pushed into blood vessel walls so as to dredge blood vessels and treat ischemic heart disease and peripheral artery diseases. However, for the seriously calcified lesion and the lesion of a special part, such as a joint, because the inner space of the lesion is too narrow, the balloon and the stent can not be completely opened in the calcified blood vessel, and the ideal treatment effect is difficult to achieve. In view of the foregoing, a clinical solution for rotational atherectomy to remove heavily calcified plaque has been proposed in the prior art, and accordingly an interventional rotational atherectomy device has been developed that extends into the blood vessel through a flexible shaft with a rotational atherectomy head that abrades the plaque by rotation to increase the available space in the blood vessel.
The flexible shaft of the existing interventional type rotational grinding device is usually made of a spirally wound steel wire, a rotational grinding head is connected onto the flexible shaft, the diameter of the rotational grinding head generally has multiple sizes, in a surgical operation, a rotational grinding layer with a smaller diameter is often used for performing rotational grinding drilling on a plaque, and then an eccentric rotational grinding head with a larger diameter is replaced for performing rotational grinding. There are also some techniques to improve the flexible shaft and the rotational grinding head, for example, US20170262035a1 discloses a rotational grinding head on a spirally wound drive shaft, which is provided with an eccentric or symmetrical rotational grinding head on the outside of the flexible shaft, which may be in the form of a shuttle or a plurality of spaced abrasive layers. Also, for example, US355848333A discloses a three-wire spiral wound drive shaft having a plurality of abrasive tips disposed thereon. However, in these techniques, the eccentric and shuttle-shaped rotational head has a large volume, a large grinding force, and a large impact on blood vessels; when the rotary grinding head rotates at a high speed, grinding dust under grinding is difficult to discharge as soon as possible, and the rotary grinding head can be blocked. To the structure of a plurality of heads of grinding soon, it grinds different plaques simultaneously, can influence each other, and is difficult to control, and grinding effect is poor.
In addition, the flexible shaft is usually made of a spirally wound steel wire, which has a certain rigidity when it rotates around its own axis in a spiral direction, and in order to increase the torque transmission, a flexible shaft wound with three layers of independent coils is disclosed in patent US20135080728a1, and the three layers of flexible shaft have a larger rigidity and can better transmit the torque. However, the rigidity is increased, the flexibility is poor, when the rotary grinding head rotates, the rotary grinding head is driven to rotate only around the axis of the rotary grinding head, and the rotary grinding head is basically ground at a certain position on the circumference of a blood vessel all the time, so that the temperature at the position is quickly increased, and the influence on blood is large; the structure has poor flexibility and is not beneficial to passing through the blood vessel; at the same time, the three-layer structure must increase the diameter of the whole flexible shaft, so that the flexible shaft is less prone to pass through the blood vessel and is more difficult to move along the circumference of the blood vessel. However, in any case, the end of the flexible shaft is also prone to loosening when rotating at a high speed, and a protective sleeve is often required to be connected to the distal end side of the flexible shaft, so that when the flexible shaft extends into a blood vessel, the protective sleeve at the end of the flexible shaft contacts with a plaque first, and in the initial contact period, the flexible shaft does not have grinding force on the plaque, so that the contact force between the flexible shaft and the plaque is too large, and the large impact on the blood vessel affects the transmission of torque.
Disclosure of Invention
In view of the above-mentioned situation, the main object of the present invention is to provide a high-speed driving shaft for an insertion type rotational grinding apparatus and an insertion type rotational grinding apparatus, so as to solve the problems of the conventional insertion type rotational grinding apparatus.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows:
a first aspect of the invention provides a high speed drive shaft for an interventional rotational atherectomy device, the interventional rotational atherectomy device comprising a drive mechanism and a rotational atherectomy mechanism, the rotational atherectomy mechanism comprising a guide wire and the drive shaft sliding along the guide wire; the driving mechanism comprises a driving motor, a driving gear connected with the driving motor and a transmission gear meshed with the driving gear,
the driving shaft is of a hollow structure and is used for the guide wire to penetrate through, the driving shaft comprises a flexible shaft and a rotary grinding layer, the first end of the flexible shaft is used for being connected with the transmission gear and comprises an inner coil group and an outer coil group which are in interference fit, the inner coil group comprises a plurality of strands of inner spring wires which are spirally wound and mutually attached, the outer coil group comprises a plurality of strands of outer spring wires which are spirally wound on the outer surface of the inner coil group and mutually attached, the spiral winding directions of the outer spring wires and the inner spring wires are opposite, the outer spring wires are mutually welded and connected at two ends of the flexible shaft, the inner spring wires are mutually welded and connected, and meanwhile, the inner coil group and the outer coil group are welded and connected; so that the driving shaft can rotate around the axis of the driving shaft in the forward direction and the reverse direction at high speed;
the second end side of flexible shaft is equipped with revolves the mill district revolve the mill district, the surface interval of outer coil group is provided with two or three revolve the mill layer to carry out the grinding to the plaque of same department, each revolve the mill layer be the cylinder barrel structure, encircle in the surface of flexible shaft, and one of them revolve the mill layer and be located the tip of flexible shaft.
Preferably, the outer diameter of the rotary grinding layer is 0.7-0.9 mm, and the thickness is 120-200 um.
Preferably, the rotational grinding layer comprises a nickel matrix surrounding the flexible shaft and abrasive particles at least uniformly distributed on the surface of the nickel matrix, the height of the abrasive particles protruding out of the surface of the nickel matrix is 10-20 um, and the density of the abrasive particles is 350-2000 particles/square millimeter.
Preferably, the abrasive particles are diamond abrasive particles or CBN abrasive particles; the grain diameter of the abrasive grains is 10-50 um.
Preferably, the axial dimension of each spin-grinding layer along the flexible shaft is 1.2-4 mm; the distance between two adjacent spin-grinding layers is 2-5 mm.
Preferably, the outer surface of the rotational grinding layer is provided with a groove, and the groove extends to two ends of the rotational grinding layer in the axial direction of the flexible shaft.
Preferably, the groove is a spiral groove, the spiral surrounding direction of the spiral groove is opposite to the spiral surrounding direction of the outer layer spring wire, and the thread pitch of the spiral groove is 1-2 mm.
Preferably, the groove is provided with a strip, and the depth of the strip is 1/3-1/2 of the thickness of the spin-grinding layer.
Preferably, the outer diameter of the flexible shaft is 0.6-0.8 mm; the diameter of the outer layer spring wire is 0.1-0.15 mm; the diameter of the inner layer spring wire is 0.05-0.1 mm.
The invention provides an interventional rotational grinding device, which comprises a driving mechanism and a rotational grinding mechanism, wherein the rotational grinding mechanism comprises a driving shaft and a guide wire which is arranged in a hollow structure of the driving shaft in a penetrating way, so that the driving shaft slides along the guide wire; the driving mechanism comprises a driving motor, a driving gear connected with the driving motor and a transmission gear meshed with the driving gear, and the transmission gear is connected with the flexible shaft so as to transmit the torque of the driving motor to the flexible shaft through the driving gear and the transmission gear.
Has the advantages that:
the interventional rotational grinding device directly plates the rotational grinding layer on the outer surface of the flexible shaft to form the rotational grinding head, the volume of the whole rotational grinding head is smaller, even if the plaque is larger, the rotational grinding head can easily reach the center of the plaque, when in operation, the driving shaft rotates at high speed, the whole rotational grinding head rotates around the axis of the driving shaft, the rotation of the rotational grinding head can drive surrounding blood to move, the formed fluid pressure field can push the rotational grinding head to rotate around the circumferential direction of the inner wall of the blood vessel (specifically, a cavity formed by the plaque and the inner wall of the blood vessel), namely, the rotational grinding head revolves around the circumferential direction of the inner wall of the blood vessel while rotating around the axis of the rotational grinding head, and as the ground amount of the plaque is larger and larger, the diameter of the cavity is larger and the orbital diameter of the rotational grinding head is gradually increased, so that the plaque is gradually ground. By adopting the structure, the rotary grinding head does not need to be replaced in the operation, the operation time can be reduced, and the damage probability of replacing the rotary grinding head to the blood vessel is reduced; and although the driving shaft rotates at a high speed, the mass of the rotary grinding head is relatively small because the rotary grinding head rotates and revolves simultaneously, so that the grinding force is relatively small compared with the rotary grinding head with a large diameter, the impact on blood vessels is reduced, and the safety of the operation is greatly improved.
In the intervention type rotational grinding device, the plurality of rotational grinding layers form a flexible structure and are used for grinding plaques at the same position, different grinding layers can be used for grinding when the driving shaft moves forwards and backwards, gaps are reserved between the adjacent rotational grinding layers, and grinding dust can enter blood as soon as possible through the gaps, so that the rapid discharge of the grinding dust is facilitated. And the small-diameter rotational grinding layer structure can increase the range of the diameter of the blood vessel applied by the intervention type rotational grinding device, and the flexible structure formed by a plurality of rotational grinding layers can also be applied to more complicated blood vessel structures, such as the rotational grinding of a bifurcation blood vessel.
Further, the flexible shaft is arranged to be of a double-layer structure which is surrounded reversely, the transmission of torque can be increased, a structure with two layers of opposite winding is selected, even if the clamping stagnation occurs to the rotary grinding head, the flexible shaft can be rotated reversely to enable the flexible shaft to be easier to withdraw from the clamping stagnation position, and the flexible shaft can be well prevented from being loosened due to the interaction of the spring wires on the inner layer and the outer layer. Furthermore, the two ends of the flexible shaft are respectively welded and connected, so that the inner layer and the outer layer are prevented from being loosened when the flexible shaft rotates at a high speed, a protective sleeve is omitted, and meanwhile, the end part of the flexible shaft is provided with the rotary grinding layer, so that when the flexible shaft is just in contact with the plaque, the contact force between the flexible shaft and the blood vessel can be reduced due to the grinding effect of the rotary grinding layer, and the grinding is more stable.
Other advantages of the present invention will be described in the detailed description, and those skilled in the art will understand the technical features and technical solutions presented in the description.
Drawings
Preferred embodiments of the present invention will be described below with reference to the accompanying drawings. In the figure:
FIG. 1 is a schematic structural view of a preferred embodiment of a drive shaft provided by the present invention;
FIG. 2 is an axial view of a preferred embodiment of the drive shaft provided by the present invention;
FIG. 3 is a partial schematic view of a hidden portion of an outer coil assembly of a preferred embodiment of a flexible shaft in accordance with the present invention;
FIG. 4 is a partial cross-sectional view of a preferred embodiment of a drive shaft and guidewire provided in accordance with the present invention;
FIG. 5 is an exploded view of a preferred embodiment of the interventional rotational atherectomy device provided in accordance with the present invention;
FIG. 6 is a partial cross-sectional view of a preferred embodiment of an interventional rotational atherectomy device provided by the present invention;
FIG. 7 is a schematic structural view of a preferred embodiment of a cannula assembly of the interventional rotational atherectomy device of the present invention;
FIG. 8 is a schematic structural diagram of an interventional rotational atherectomy device of the present invention before and after rotational atherectomy;
FIG. 9 is a schematic diagram of the revolution and rotation of the rotational layer in the blood vessel in the interventional rotational atherectomy device of the present invention;
FIG. 10 is a force analysis graph of the layer of FIG. 9;
fig. 11 is a schematic diagram illustrating the comparison of the component forces of the rotational layer moving in the blood vessel in the interventional rotational atherectomy device of the present invention.
In the figure:
10. a housing; 11. a chute; 12. a bottom case; 13. a shell cover; 14. a card slot; 15. a connecting plate;
20. a drive mechanism; 21. a drive motor; 22. a drive gear; 23. a transmission gear; 24. a guide rail; 25. a motor supporting seat;
30. a rotary grinding mechanism; 31. a guide wire; 32. a drive shaft; 321. a rigid shaft; 322. a flexible shaft; 3221. an inner coil assembly; 3221a, an inner layer spring wire; 3222. an outer coil group; 3222a, an outer layer spring wire; 323. spin-grinding the layer; 33. a bushing assembly; 331. a sheath tube; 332. a motor supporting tube; 333. a first support tube; 334. a second support tube; 35. an output connector; 351. a cooling medium input port; 352. a pipe body; 353. a first flange; 354. a second flange; 355. a cooling medium outlet; 356. bonding glue;
40. a cooling pipeline;
50. a control circuit board;
70. a guide wire pressing mechanism; 71. a base; 72. a compression assembly;
80. a blood vessel; 81. calcified tissue; 82. grinding chips; 84. blood.
Detailed Description
The present invention will be described below based on examples, but the present invention is not limited to only these examples. In the following detailed description of the present invention, certain specific details are set forth in order to avoid obscuring the nature of the present invention, well-known methods, procedures, and components have not been described in detail.
Further, those of ordinary skill in the art will appreciate that the drawings provided herein are for illustrative purposes and are not necessarily drawn to scale.
Unless the context clearly requires otherwise, throughout the description and the claims, the words "comprise", "comprising", and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is, what is meant is "including, but not limited to".
In the description of the present invention, it is to be understood that the terms "first," "second," and the like are used for descriptive purposes only and are not to be construed as indicating or implying relative importance. In addition, in the description of the present invention, "a plurality" means two or more unless otherwise specified.
The application provides an interventional type rotational atherectomy device, which can be used for treating cardiovascular diseases and the like to carry out atherectomy. As shown in fig. 1 to 8, the interventional type rotational grinding device comprises a driving mechanism 20 and a rotational grinding mechanism 30, wherein the driving mechanism 20 comprises a driving motor 21, a driving gear 22 connected with the driving motor 21, and a transmission gear 23 meshed with the driving gear 22, and the diameter of the driving gear 22 is larger than that of the transmission gear 23, so that the high-speed rotation of the rotational grinding mechanism 30 is realized through the meshing of the gears. The rotational grinding mechanism 30 includes a driving shaft 32 and a guide wire 31, wherein the driving shaft 32 is a hollow structure for the guide wire 31 to pass through, that is, the guide wire 31 is inserted into the hollow structure of the driving shaft 32, so that the driving shaft 32 slides along the guide wire 31, that is, the guide wire 31 serves as a track for the entire driving shaft 32 to slide, and plays a guiding role in guiding the sliding of the driving shaft 32.
With continued reference to fig. 1-4, the driving shaft 32 includes a flexible shaft 322 and a rotational grinding layer 323, a first end of the flexible shaft 322 is used to connect (directly or indirectly) with the driving gear 23, the flexible shaft 322 includes an inner coil set 3221 and an outer coil set 3222 arranged in an abutting manner, the inner coil set 3221 includes a plurality of inner spring wires 3221a spirally wound and abutted against each other, the outer coil set 3222 includes a plurality of outer spring wires 3222a spirally wound around an outer surface of the inner coil set 3221 and abutted against each other, a spiral winding direction of the outer spring wires 3222a is opposite to that of the inner spring wires 3221a, that is, each inner spring wire 3221a is tightly wound to form the inner coil set 3221, each outer spring wire 3222a is tightly wound to form the outer coil set 3222, and if the outer spring wire 3222a is wound in a right direction, the inner spring wire 3221a is wound in a left direction; if the outer layer spring wire 3222a is wound leftwards, the inner layer spring wire 3221a is wound rightwards; at the two ends of the flexible shaft 322, the outer layer spring wires 3222a are welded to each other, the inner layer spring wires 3221a are welded to each other, and the inner layer coil group 3221 and the outer layer coil group 3222 are welded to each other, that is, at the two ends of the flexible shaft 322, the spring wires are welded together, and specifically, polishing can be performed after welding, so that the end surfaces of the spring wires are flat and smooth.
Wherein, the second end side (i.e. the part far away from the driving mechanism 20) of the flexible shaft 322 is provided with a rotational grinding area, in the rotational grinding area, the outer surface of the outer layer coil group 3222 is provided with two or three rotational grinding layers 323 circumferentially surrounding the flexible shaft 322 at intervals to grind the plaque at the same position, and the rotational grinding layers 323 are in a cylindrical barrel structure and surround the outer surface of the flexible shaft 322, one of the rotational grinding layers 323 is located at the end part of the flexible shaft 322, that is, in the rotational grinding area, the outer surface of the outer layer coil group 3222 is provided with two or three rotational grinding layers 323, each rotational grinding layer 323 covers the whole circumferential direction of the flexible shaft 322 to form a rotational grinding head, two adjacent rotational grinding layers 323 and the flexible shaft 322 located between the two rotational grinding layers 323 form a gap, and in these rotational grinding layers 323, the end surface of one of them is coplanar with the end surface (referring to the end surface of the second end) of the flexible shaft 322.
In the intervention type rotational atherectomy device, the rotational atherectomy layer 323 rotates at a high speed in the blood vessel and revolves along the blood vessel wall, as shown in fig. 9, a calcified tissue 81 is formed on the blood vessel wall 80, the rotational atherectomy layer 323 generates abrasive dust 82 when the calcified tissue 81 is rotationally abraded, the abrasive dust 82 is taken away under the driving of the flowing blood 84, wherein a hollow circle on the calcified tissue 81 is a jumping track of the rotational atherectomy layer 323, the stress condition of the rotational atherectomy layer 323 is as shown in fig. 10, and the rotational atherectomy layer 323 is subjected to fluid pressure FHContact force FCAgainst centrifugal force FΩ. Wherein, FH,tAnd FH,nRespectively fluid pressure FHComponents in the tangential and radial directions, FC,tAnd FC,nThe components of the contact force in the tangential and radial directions, respectively. The force during the experiment was measured in the tangential direction under the following conditions: fH,t-F C,t0, in the forward direction: fC,n-FH,n-F C0. The comparison of the force levels shown in FIG. 11 is obtained by experiment, wherein 4mm and 6mm in the figure represent bloodThe diameter of the pipe can be seen from the figure, the value of the fluid pressure on the radial component is far smaller than that of the contact force, the value of the centrifugal force is closer to that of the contact force, the value of the centrifugal force is increased along with the increase of the rotating speed, the centrifugal force determines the revolution speed of the rotating layer, and the higher the centrifugal force is, the higher the revolution speed is.
In the above-mentioned insertion type rotational grinding device, the rotational grinding layer 323 is directly arranged on the outer surface of the flexible shaft 322 to form a rotational grinding head, the volume of the whole rotational grinding head is small, so that even if the plaque is large, the rotary grinding head can easily reach the center of the plaque, the driving shaft 32 rotates at a high speed during operation, the rotary grinding head rotates around the axis of the driving shaft 32 due to the small volume and mass of the whole rotary grinding head, the rotation of the rotary grinding head can drive the surrounding blood to move, the formed fluid pressure field can push the rotary grinding head to rotate circumferentially around the inner wall of the blood vessel (particularly a cavity formed by the plaque and the inner wall of the blood vessel), the rotating grinding head revolves around the circumference of the inner wall of the blood vessel while rotating around the axis of the rotating grinding head, the diameter of the cavity is increased along with the increase of the ground plaque, and the orbital diameter of the rotating grinding head is increased gradually, so that the plaque is ground gradually.
With this configuration, the first aspect causes the rotary grinding head to grind the plaque in the circumferential direction by the revolution of the rotary grinding head, instead of always grinding a certain position in the circumferential direction of the blood vessel, and thus can reduce the rise in blood temperature caused by grinding as much as possible. In the second aspect, the rotary grinding head does not need to be replaced in the operation, so that the operation time can be reduced, and the damage probability of replacing the rotary grinding head to the blood vessel is reduced. In the third aspect, the grinding layer 323 is in a cylindrical structure, and compared with other structures such as an ellipsoid structure, the thickness of each part is uniform, and the grinding layer 323 can be thinner, so that the whole grinding head is lighter in mass, smaller in grinding force and higher in safety. Although the driving shaft 32 rotates at a high speed, because the rotational head rotates and revolves simultaneously and the volume and the mass of the rotational head are relatively small, compared with the rotational head with a large diameter, such as the shuttle-shaped rotational head mentioned in the background art, the grinding force of the present invention is relatively small, the amplitude can be reduced by more than 90%, the contact force with blood vessels is reduced, and the impact on the blood vessels is reduced; the small-diameter rotational grinding layer 323 structure can increase the range of the diameter of a blood vessel applied by the interventional rotational grinding device, meanwhile, the plurality of rotational grinding heads arranged at intervals form a flexible structure, the flexible structure can be applied to more complex blood vessel structures, such as plaques at the position of a bifurcation blood vessel (usually, the intersection of the large-diameter blood vessel and the small-diameter blood vessel), the rotational grinding heads firstly perform rotational grinding on part of plaques in the large-diameter blood vessel and then can directly enter the small-diameter blood vessel for rotational grinding, so that different rotational grinding heads are in contact with the plaques by sliding the flexible shaft 322 along the guide wire 31, the plaques in the area can be ground by adopting different rotational grinding heads, and the application range and the operation efficiency of the interventional rotational grinding device are further improved; meanwhile, the area of the flexible small-diameter rotary grinding head for grinding blood vessels is approximately circular, as shown in fig. 8, the left graph is the blood vessel structure before grinding, and the right graph is the blood vessel structure after grinding, so that the whole rotary grinding process is relatively stable, and calcified tissues can be effectively removed. In the fourth aspect, in the process of high-speed rotation of the rotary grinding head, more grinding dust is generated, and if the grinding dust cannot be discharged as soon as possible, the rotary grinding head may be blocked or even jammed.
In the prior art, the flexible shaft is generally in a single-layer spiral structure, even if the rotary grinding head structure is adopted, the rotary grinding head cannot be completely guaranteed not to be blocked or stuck, when the rotary grinding head is blocked or stuck, the blocked rotary grinding head can be favorably withdrawn in a reverse rotation mode, but if the driving shaft 32 is directly and reversely rotated, the flexible shaft can be loosened, in the prior art, the driving force of the driving shaft 322 is usually increased, and the driving shaft 32 is axially pulled to withdraw the rotary grinding head from the stuck position, so that secondary injury can be easily caused to blood vessels, in the invention, the flexible shaft 322 is arranged in a double-layer structure which reversely surrounds, so that when the flexible shaft 322 is reversely rotated, the inner layer spring wire and the outer layer spring wire interact, and the flexible shaft can be well prevented from being loosened; and adopt this kind of double-deck reverse structure, relative three-layer structure of encircleing, can enough improve the pliability of flexible axle, can guarantee the transmission of moment of torsion again, the diameter of whole flexible axle 322 also can not too big moreover, is favorable to the motion in the blood vessel. Furthermore, the two ends of the flexible shaft 322 are respectively welded and connected, so that the spring wires at the two ends are integrated, the looseness of the inner layer, the outer layer and each layer of spring wires caused by the high-speed rotation and the reverse rotation of the flexible shaft 322 can be avoided as much as possible, the protective sleeve at the end part of the flexible shaft 322 is omitted, the reliability of the driving shaft 32 is improved, and the assembly efficiency of the whole intervention type rotary grinding device is improved; meanwhile, the end part of the flexible shaft 322 is provided with the rotational grinding layer 323, when the flexible shaft 322 is in contact with the plaque in the initial stage, due to the grinding effect of the rotational grinding layer 323, the contact force between the flexible shaft 322 and the plaque can be reduced, and the impact of the flexible shaft 322 on the blood vessel can be reduced.
In particular, in order to better reduce the size of the whole rotational head, and to facilitate the rotation and revolution in the blood vessel, preferably, the outer diameter of the rotational layer 323 is 0.7-0.9 mm, such as 0.7mm, 0.75mm, 0.76mm, 0.78mm, 0.8mm, 0.83mm, 0.85mm, 0.88mm, 0.9mm, and the like, and the outer diameter of the rotational head formed by such a rotational layer 323 is smaller, so that the flexibility of the rotational head can be better increased, and the rotational head can be adapted to more complicated blood vessels.
The thickness of the rotational grinding layer 323 is 120-200 um, such as 120um, 130um, 150um, 160um, 175um, 185m, 190um, 195um, 200um and the like, and the thickness of the rotational grinding layer 323 is moderate, so that the rotational grinding layer 323 can be suitable for blood vessels with a wider diameter range, and can ensure the connection reliability between the rotational grinding layer 323 and the flexible shaft 322, thereby improving the safety of the operation.
The rotational grinding layer 323 comprises a nickel matrix surrounding the flexible shaft 322 and abrasive grains uniformly distributed on the surface of the nickel matrix, namely the abrasive grains are distributed on the surface of the nickel matrix only, or the abrasive grains are distributed on the whole nickel matrix and the surface of the nickel matrix uniformly, preferably, the former, the thickness of the rotational grinding layer 323 refers to the thickness of the whole nickel matrix and the abrasive grains, and in order to improve the grinding effect, the height of the abrasive grains protruding out of the surface of the nickel matrix is 10-20 um, such as 10um, 12um, 15um, 16m, 18um, 19um, 20um and the like; and the density of the abrasive particles is 500-2000 particles/square millimeter, such as 500 particles/square millimeter, 550 particles/square millimeter, 600 particles/square millimeter, 800 particles/square millimeter, 1000 particles/square millimeter, 1500 particles/square millimeter, 1800 particles/square millimeter, 2000 particles/square millimeter, etc.
The abrasive particles are diamond abrasive particles or CBN abrasive particles; the particle diameter of grit is 10 ~ 50um, if 10um, 20um, 30um, 35um, 40um, 50um etc. adopt the parameter of this scope, can increase the combination reliability of grit and nickel base member, and the combination of rotary grinding layer 323 and flexible axle 322 is more firm, and the grinding force is moderate, can not cause the damage to the blood vessel, and the abrasive dust that produces simultaneously is basically below 30um, is taken away and the human absorption easily by blood.
The rotational grinding layer 323 rotates in the blood vessel at a high speed and simultaneously revolves along the blood vessel wall, and continuously bounces radially to grind calcified tissues (namely plaques), so that calcified lesions in the blood vessel are removed. The revolving rotational grinding layer 323 may not only cut calcified tissues in blood vessels, but also contact normal blood vessel tissues, thereby damaging normal blood vessels. The process that the rotational abrasion layer contacts with the calcified tissue and the normal blood vessel is researched and found, the rotational abrasion layer rotating at a high speed drives surrounding fluid to move, and therefore a dynamic pressure film is produced between the rotational abrasion layer and the blood vessel wall. When the calcified tissue is desired to be milled in a rotating way, the dynamic pressure film between the rotating milling layer 323 and the calcified tissue is smaller than the protruding height of the surface abrasive particles of the nickel base so as to achieve the aim of removing the calcified tissue; when the rotational layer 323 contacts with the normal blood vessel, the thickness of the dynamic pressure film between the rotational layer 323 and the blood vessel is preferably larger than the protruding height of the abrasive particles, so that the abrasive particles of the grinding wheel cannot contact with and cut the normal blood vessel. Hamrock et al teach the formula for calculating hydrodynamic squeeze film:
H＝7.43REU0.65W-0.21(1-0.85e-0.31)
wherein the content of the first and second substances,
where R and R are the radii of two objects (in this application, one is the layer 323 for rotational grinding and the other is the vascular wall or calcified tissue) at the point of contact, EG and EB are the elastic moduli of the two objects in contact with each other, vG and vB are the linear velocities of the two objects at the point of contact, μ B and μ G are the poisson's ratios of the two objects in contact, and w is the positive pressure between the objects in contact. Wherein the calcified tissue simulating material is ox bone and the blood vessel simulating material is PVC. Substituting the corresponding parameters into the formula, wherein the calculation result shows that when the rotary grinding layer 323 is contacted with the calcified tissue with larger elastic modulus, the thickness of a hydrodynamic film between the rotary grinding layer 323 and the calcified tissue is smaller, so that the rotary grinding layer 323 is directly contacted with the calcified tissue to grind the calcified tissue; when the rotational abrasion layer 323 is in contact with a normal blood vessel wall, the dynamic pressure membrane between the rotational abrasion layer 323 and the blood vessel wall is thick, so that the rotational abrasion layer 323 is spaced from the blood vessel, and the rotational abrasion layer 323 cannot abrade the normal blood vessel.
The rotational grinding layer 323 can be formed on the flexible shaft 322 by spraying or the like, and preferably, the rotational grinding layer 323 is formed on the surface of the flexible shaft 322 by electroplating, so that the connection between the rotational grinding layer 323 and the flexible shaft 322 is firmer, and the safety of the operation is improved. Specifically, the rotational atherectomy layer 323 includes a nickel matrix coating the outer surface of the flexible shaft 322 and abrasive particles uniformly distributed throughout the nickel matrix.
Each of the spin-milled layers 323 has a length of 1.2-4mm, such as 1.2mm, 1.5mm, 1.8mm, 2.0mm, 2.3mm, 2.5mm, 2.8mm, 3.0mm, 3.2mm, 3.5mm, 3.9mm, 4.0mm, and the like. By adopting the rotary grinding layers 323 with the size, the length of each rotary grinding layer 323 is proper, when plaque is ground, the flexible shaft 322 is easier to move flexibly when moving forwards or backwards, the grinding efficiency is improved, and the effect is more obvious when the flexible shaft moves in blood vessels with special structures. Further, the distance (the size along the axial direction of the flexible shaft 323) between two adjacent rotational grinding layers 323 is 2-5 mm, that is, the length of the gap between two adjacent rotational grinding layers 323 is 2-5 mm, such as 2mm, 3mm, 4mm, 5mm, etc., after the arrangement, the length of the whole rotational grinding area can meet the grinding requirement of a plaque, and the rotational grinding area is matched with the preferable outer diameter, length, etc. of the rotational grinding layers 323, so that the movement of the rotational grinding head is more flexible, and the ground grinding dust can be discharged into flowing blood more quickly.
The outer surface of the rotational grinding layer 323 is provided with grooves, the grooves extend to two ends of the rotational grinding layer 323 in the axial direction of the flexible shaft 322, namely the grooves axially penetrate through the rotational grinding layer 323 along the flexible shaft 322, and after the grooves are arranged, in the process that the rotational grinding layer 323 rotates around the axis of the flexible shaft 322, peripheral blood can be better driven to move through the grooves, so that the rotational grinding head can better form revolution; and the abrasive dust generated by grinding can be taken out along the groove as soon as possible, so that the probability of the clamping of the rotary grinding head is further reduced. Of course, the grooves may be provided only in a certain portion of the layer 323 in the axial direction thereof, or may extend through only one end surface of the layer 323 in the axial direction of the flexible shaft 322.
Specifically, the grooves may be linear grooves or curved grooves, and in a preferred embodiment, the grooves are spiral grooves, so that the revolution motion of the rotational head 323 and the discharge of the abrasive dust along the spiral grooves to the gap between two adjacent rotational grinding layers 323 or outside the rotational grinding zone can be further facilitated, and the discharge of the abrasive dust into the circulating blood can be further facilitated. Further, it is preferable that the spiral direction of the spiral groove is opposite to the spiral direction of the outer spring wire 3222a, so that the grinding dust entering the spiral groove can be easily separated from the rotational grinding layer 323, and the grinding effect is prevented from being affected by the grinding dust. Of course, the spiral winding direction of the spiral groove may also coincide with the spiral winding direction of the outer layer spring wire 3222 a.
The spiral groove can encircle the rotational grinding layer 323 for half cycle, one cycle, two cycles, three cycles or other encircling modes, when the number of encircling cycles is more, the rotational grinding layer 323 moves at high rotating speed, so that the generated abrasive dust is discharged too long in path and too slow in speed; if the number of the surrounding circles is too small, such as less than or equal to half a circle, the abrasive dust entering the spiral groove may be stuck at the bottom of the groove, which is not favorable for discharging the abrasive dust. Preferably, the pitch of the spiral groove may be 1-2 mm, such as 1mm, 1.2mm, 1.5mm, 1.8mm, 2.0mm, so that the abrasive dust is more easily discharged out of the rotational grinding zone. The helical groove spirals around the layer 323 a revolution when the length of the layer 323 (i.e., the axial dimension along the flexible shaft 322) is small.
The number of the grooves is more, which is more beneficial to discharge the abrasive dust as soon as possible, and considering that the diameter ratio of the rotational grinding layer 323 is smaller and the surface area is originally smaller, if too many grooves are arranged, the number of the portions of the rotational grinding layer 323 having the grinding function is smaller, the grinding speed is too slow, and the operation efficiency is reduced, and preferably, one groove is arranged.
If the groove is too deep, the abrasive dust entering the groove is not easy to discharge, and the bonding reliability of the rotational grinding layer 323 and the flexible shaft 322 is easy to damage due to the fact that the thickness of the rotational grinding layer 323 at the position is too small; if the spiral groove is too shallow, the grinding dust may not enter the groove, but directly adhere to the surface of the grinding portion of the layer 323 (i.e., the portion of the layer 232 where the groove is removed), which affects the grinding effect. In a preferred embodiment of the present invention, the depth of the grooves is 1/3-1/2 of the thickness of the layer 323, e.g., 1/3, 5/12, 1/2, etc. The grinding area of the surface of the layer 323 for the rotational grinding is reduced and the grinding force is weakened if the width of the groove is too large, and further preferably, the width of the groove is equal to the depth thereof.
In a preferred embodiment of the invention, the grooves are spiral grooves, the thread pitch of each groove is 1-2 mm, and two ends of each spiral groove respectively extend to two end faces of the rotary grinding layer 323, so that grinding chips generated by grinding can enter the spiral grooves, and along with the flow of blood, the grinding chips can be flushed, and then can be discharged along the spiral grooves as soon as possible.
Wherein the stiffness of the guidewire 31 is less than the stiffness of the flexible shaft 322 to enable the guidewire 31 to better conform to the extended path of the blood vessel. Preferably, the guide wire has a diameter of 0.15-0.25 mm, such as 0.15mm, 0.06mm, 0.18mm, 0.20mm, 0.22mm, 0.23mm, 0.24mm, 0.25mm, etc.
In order to reduce the damage to blood vessels, the high-speed rotational atherectomy device of the present invention has a high rotational speed of 17 to 25 ten thousand revolutions per minute of the drive shaft 32, but this high rotational speed is generally used only in the rotational atherectomy mode, and the rotational speed is set to a relatively low value in the non-rotational atherectomy mode. Of course, the rotation speed of 17-25 ten thousand revolutions per minute is not used in the spin-grinding state, but a lower rotation speed, such as 9000 revolutions per minute, may be set.
Wherein, the spiral direction of the outer layer spring wire 3222a may be the same as or opposite to the rotation direction of the rotation shaft of the driving motor 21, and in a preferred embodiment, the spiral direction of the outer layer spring wire 3222a is the same as the rotation direction of the rotation shaft of the driving motor 21 in the grinding state, so as to better enable the flexible shaft 322 to be in a wound state in the grinding state, better transmit torque, and further improve the grinding speed.
Specifically, the outer layer spring wire 3222a and the inner layer spring wire 3221a may be spring wires with circular cross sections, or spring wires with other cross-sectional shapes.
It is understood that if the flexible shaft 322 is too rigid, it is beneficial to transmit torque, but when the flexible shaft 322 rotates, the rotational abrasion layer 323 may only abrade a certain position or a small area in the circumference of the blood vessel in a short time, and the revolving speed is slow, which is not beneficial to the rotational abrasion layer 323 revolving in the blood vessel. In order to solve the problem, and considering that the inner diameter of a human blood vessel is basically 4-6 mm, if the flexible shaft 322 is too thin, the inner layer spring wire 3221a and the outer layer spring wire 3222a forming the flexible shaft are too thin, the rigidity of the whole flexible shaft 322 is insufficient, and the transmission of torque is influenced; if the flexible shaft 322 is too thick, it will occupy a larger space in the radial direction of the blood vessel, and the blood flow velocity will be slower in the blood vessel that is originally blocked, for this reason, in a preferred embodiment of the present invention, the outer diameter of the flexible shaft 322 is 0.6-0.8 mm, such as 0.6mm, 0.65mm, 0.7mm, 0.75mm, 0.8mm, and the diameter of the outer layer spring wire 3222a is greater than or equal to the diameter of the inner layer spring wire 3221a, specifically, the diameter of the outer layer spring wire 3222a is preferably 0.1-0.15 mm, such as 0.1mm, 0.11mm, 0.12mm, 0.13mm, 0.14mm, 0.15mm, etc.; the diameter of the inner spring wire 3221a is 0.05-0.1 mm, 0.05mm, 0.06mm, 0.08mm, 0.09mm, 1mm and the like, the outer spring wire 3222a and the inner spring wire 3221a in the range are selected to be wound to form the flexible shaft 322 in the range, the rigidity of torque transmission can be better met, the rigidity is not too strong, and the flexible shaft 322 only occupies less than one fourth of the radial dimension of the blood vessel space, so that a sufficient movement space is provided for the rotational grinding head, and therefore the rotational grinding head can be better guaranteed to form revolution movement along the circumferential direction of the blood vessel in the process of rotating around the axis of the flexible shaft 322, and further form circumferential grinding; and this arrangement minimizes the effect of the flexible shaft 322 on blood flow.
The outer spring wire 3222a and the inner spring wire 3221a are made of 304 stainless steel or 304v stainless steel, and the stainless steel made of the materials has the characteristics of high strength and good toughness, so that torque transmission can be better realized, and revolution can be better formed.
The number of strands of the outer layer spring wire 3222a and the number of strands of the inner layer spring wire 3221a may be 1 to 6, the number of strands of the outer layer spring wire 3222a and the number of strands of the inner layer spring wire 3221a may be equal or unequal, and preferably, the number of strands of the outer layer spring wire and the number of strands of the inner layer spring wire are selected to be 3, 4 or 6, so that dense winding between each layer of the outer layer coil group 3222 and each layer of the inner layer coil group 3221 is better achieved, and tight attaching between the two layers is achieved. In the same layer (such as all in the inner coil group or all in the outer coil group), the starting ends of the multiple spring wires are uniformly distributed on the same circumference, and the pitch of the single spring wire is equal to the number of the spring wires in the layer and the diameter of the single spring wire in the layer.
When the flexible shaft rotates at a high speed, friction may occur between the flexible shaft 322 and the guide wire 31 inserted therein, and in order to reduce wear of the flexible shaft and the guide wire 31, the inner surface of the flexible shaft 322 and the outer surface of the guide wire 31 are respectively provided with an anti-friction coating, which may be formed on the inner surface of the flexible shaft 322 and the outer surface of the guide wire 31 by surface treatment or spraying. The friction reducing coating may be a polytetrafluoroethylene coating.
For convenience of connection, the driving shaft 32 may further include a rigid shaft 321, the flexible shaft 322 is connected to the transmission gear 23 through the rigid shaft 321, and specifically, the flexible shaft 322 may be inserted into the rigid shaft 321 and welded to the rigid shaft 321, the rigid shaft 321 is in interference fit with the transmission gear 23 to transmit the power of the driving motor 21 to the driving shaft 32, and an axial direction of the rigid shaft 321 is parallel to a sliding direction of the driving mechanism 20, specifically, an axial direction of the driving shaft of the driving motor 21 and an axial direction of a rotation shaft of the transmission gear 23.
It should be noted that, although some preferred structural parameters of the flexible shaft 322 and the rotational grinding layer 323 are given in the above embodiments, the present invention is not limited to the above specific numerical range.
The driving motor 21 of the present invention is preferably a coreless brushless dc motor, which has small friction, high energy conversion efficiency, rapid start and brake, extremely rapid response, and can easily and sensitively adjust the rotating speed in a high-speed running state. The diameter of the driving gear 22 is larger than that of the transmission gear 23, and the gear ratio of the driving gear to the transmission gear is 3: 1-5: 1, such as 3:1, 4:1, 5:1, preferably 4:1, so that high-speed motion is realized through gear transmission, and the rotating speed of the driving shaft 32 can reach 17-25 ten thousand revolutions per minute when grinding. Furthermore, the driving motor 21 is a stepless speed regulating motor to better adapt to the grinding requirement in the operation.
The interventional rotational atherectomy device further comprises a housing 10, and a drive mechanism 20 is slidably mounted in the housing 10 in a direction parallel to the axis of rotation of the drive motor 21 itself. Referring to fig. 5, the driving mechanism 20 further includes a guide rail 24 fixed in the housing 10 and a motor support 25 slidably coupled to the guide rail 24, the guide rail 24 extends in a direction parallel to the axial direction of the rigid shaft 321, and the driving motor 21 is mounted on the motor support 25. In order to ensure the installation and sliding stability of the driving motor 21 and further improve the controllability of the flexible shaft 322 entering and exiting the blood vessel, two motor supporting seats 25 are provided, two guide rails 24 are arranged in parallel, each motor supporting seat 25 is respectively in sliding fit with the two guide rails 24, and the driving motor 21 is installed between the two motor supporting seats 25.
The driving assembly 20 further includes an operating handle 26 and a sliding block 27 connected to each other, the sliding block 27 is connected to the driving motor 21, and the two can be directly connected or connected through a connecting member or the like, as shown in fig. 5, the sliding block 27 is connected to the driving motor 21 through the motor support 25. The casing 10 is provided with a sliding groove 11 parallel to the guide rail 24, the sliding block 27 is slidably connected to the sliding groove 11, the operating handle 26 extends out of the casing 10, and an operator can push the driving mechanism 20 to slide by pushing the operating handle 26, so that the operation of the operator is facilitated. Further, the operating handle 26 is connected with the sliding block 27 by a screw thread, the projection of the operating handle 26 is at least partially positioned outside the sliding chute 11 in the axial direction of the operating handle 26 (the axial direction of the screw thread), the operating handle 26 and the sliding block 27 are slightly loosened when the driving mechanism 20 is slid, the operating handle 26 and the sliding block 27 are locked when the driving mechanism 20 is slid to a required position, and the driving mechanism 20 is fixed relative to the shell 10, so that the driving mechanism 20 can be prevented from unnecessarily sliding in the operation to influence the normal operation of the operation.
As the driving mechanism 20 slides, the flexible shaft 322 slides relative to the housing 10, but the flexible shaft 322 is relatively flexible, and the portion inside the housing 10 may bend or otherwise fail during movement, and cannot slide along the axial direction of the rigid shaft 321, which increases the difficulty of handling, and for this reason, in a preferred embodiment of the present invention, the rotational grinding mechanism 30 further includes a sleeve assembly 33, as shown in fig. 5-7, and the driving shaft 32 is slidably inserted into the sleeve assembly 33. The cannula assembly 33 includes a sheath tube 331 connected to the front end of the housing 10 and extending out of the housing 10, a motor support tube 332 located in the housing 10, a first support tube 333 and a second support tube 334, wherein the sheath tube 331, the motor support tube 332, the first support tube 333 and the second support tube 334 are coaxially arranged, the sheath tube 331 can protect the flexible shaft 322 located outside the housing 10 and facilitate the flexible shaft 322 to enter the blood vessel. The motor supporting tube 332 is fixed to the motor supporting seat 25, and when two motor supporting seats 25 are provided, two ends of the motor supporting tube 332 may be respectively inserted into and fitted with the two motor supporting seats 25, specifically, may be in interference fit; one end of the first supporting tube 333 is fixed with the front end of the housing 10, and the other end is inserted in the motor supporting tube 332 in a sliding manner; one end of the second support tube 334 is slidably inserted into one end of the rigid shaft 321 far away from the flexible shaft 322, and the other end is fixed to the rear end of the housing 10, that is, the motor support tube 332, the first support tube 333 and the second support tube 334 are all located in the housing 10, the motor support tube 332 is fixedly connected to the motor support seat 25, and can slide together with the driving mechanism 20 sliding with respect to the housing 10, the sheath tube 331, the first support tube 333 and the second support tube 334 are always in a stationary state with respect to the housing 10, during the sliding process of the driving mechanism 20, the motor support tube 332 slides relative to the first support tube 333, and the second support tube 334 slides relative to the rigid shaft 321, so that the rotational grinding area on the flexible shaft 322 extends out of or retracts into the sheath tube 331. After the arrangement, the flexible shaft 322 is limited between the guide wire 31 and the sleeve assembly 33 in the whole movement process, so that the probability of uncontrollable bending, winding and other problems of the flexible shaft is reduced, and the controllability of the whole interventional type rotational grinding device is improved.
In order to better reduce the influence of grinding on blood, the interventional rotational grinding device further comprises a cooling pipeline 40, the rotational grinding mechanism 30 further comprises an output joint 35 installed in the front end of the housing 10, as shown in fig. 6 and 7, the output joint 35 is of a hollow structure, two ends of the output joint 35 are respectively connected with the sheath tube 331 and the first supporting tube 333, a cooling medium input port 351 is arranged on a side wall of the output joint 35, one end of the cooling pipeline 40 is connected with the medium input port 351, and the other end of the cooling pipeline extends out of the housing 10, wherein the cooling medium can be selected from physiological saline. In this embodiment, the flexible shaft 322 is inserted into the output connector 35, and the coolant mirror cooling line 40 enters the output connector 35 and then flows into the blood vessel through the sheath 331.
With continued reference to fig. 7, the output connector 35 includes a tube 352, a first flange 353 and a second flange 354 connected to two ends of the tube, wherein the first flange 353 is a square structure and is used for being clamped in the housing 10; the second flange 354 is located on the outer side of the housing 10, and the cooling medium outlet 355 of the output joint 35 is arranged on the side of the second flange 354 facing away from the pipe body 352; the cooling medium inlet 351 is provided in the pipe body 352, and the sheath 331 and the cooling medium outlet 355 are inserted and connected, specifically, they may be fixed by an adhesive 356 after being inserted. The first flange 353 has a square structure, so that the output structure 35 can be prevented from rotating in the installation process, and is convenient to be positioned and installed with the shell 10.
The housing 10 includes a bottom case 12 and a housing cover 13 detachably connected to each other, and the bottom case 12 and the housing cover 13 may be connected by screws, or by clamping. The guide rail 24 is fixedly connected to the bottom housing 12, and may also be integrally formed with the bottom housing 12, i.e., the two may be a single component. In the embodiment in which the output connector 35 includes the first flange 353 having a square structure, the housing 10 is provided therein with the engaging groove 14, the side wall of the engaging groove 14 is provided with a through hole, the first flange 353 is engaged with the engaging groove 14, and the tube body 352 and the first supporting tube 333 are inserted into the through hole. The clamping groove 14 may be formed by two connecting plates 15, the clamping groove 14 and the through hole may be formed only by the connecting plate 15 on the bottom case 12, or the two connecting plates 15 may be formed on the bottom case 12 and the case cover 13, the clamping groove 14 is formed in the space between the two connecting plates 15, and the through hole is formed at a position where the pipe 352, the first supporting pipe 333, and other pipes, such as the cooling pipe 40, need to pass through.
It is understood that the interventional type rotational polishing apparatus further includes a control circuit board 50, the control circuit board 50 is disposed in the housing 10, and the electrical connection structure 72 is connected to the control circuit board 50. Further, the temperature detecting assembly 70 further includes an indicator lamp 73, the indicator lamp 73 is connected to the control circuit board 50, and when the interventional type rotational grinding device is in the normal working state and the abnormal working state, the control circuit board 50 controls the indicator lamp 73 to display different states, such as different colors. Specifically, the indicator lamp 73 is a two-color diode, and when the interventional type rotational grinding device is in a normal working state, the indicator lamp 73 is controlled to display green, and when the interventional type rotational grinding device is in an abnormal working state, the indicator lamp 73 is controlled to display red.
In order to better control the protrusion length of the guide wire 31 during the operation, in a preferred embodiment of the present invention, the interventional rotational atherectomy device further comprises a guide wire hold-down mechanism 70, wherein the guide wire hold-down mechanism 70 is fixed in the housing 10 and located at the rear end (i.e., the end away from the sheath 331), when the guide wire hold-down mechanism 70 is released, the guide wire 31 can protrude into or withdraw from the blood vessel, and when the guide wire hold-down mechanism 70 is locked, the guide wire 31 is fixed relative to the housing 10. Specifically, the guide wire pressing mechanism 70 may include a base 71 and a pressing assembly 72, wherein the pressing assembly 72 can be close to or far away from the base 71, and when the pressing assembly 72 is close to the base 71, the guide wire 31 positioned between the base 71 and the pressing assembly 72 can be pressed; when compression assembly 72 is away from base 71, guidewire 31 is free to move. The base 71 is fixed to the housing 10, and may be integrated with the housing 10, as shown in fig. 5, and is integrated with the bottom shell 12.
When the interventional rotational abrasion device is used, the guide wire 31 firstly enters a blood vessel to guide the sheath tube 331 and the flexible shaft 322, then the sheath tube 331 and the flexible shaft 322 enter the blood vessel together, the rotational abrasion region is always retracted into the sheath tube 331 before the end part of the sheath tube 331 reaches a plaque, when the sheath tube 331 reaches the plaque, the driving motor 21 is started, the rotational abrasion region is pushed to extend out of the sheath tube 331 through the sliding of the driving mechanism 20, the rotating speed of the driving motor 21 is increased when the rotational abrasion layer 323 contacts the plaque, the plaque is ground, in the whole grinding process, the forward and backward of the rotational abrasion region can be realized through the sliding of the driving mechanism 20, and a plurality of rotational abrasion heads are arranged at intervals, so that the rotational abrasion head can grind the plaque in the forward and backward processes, and the grinding efficiency is improved.
It should be noted that, since the plaque is not regular and the formed cavity is not a regular cylindrical cavity, the diameter of the blood vessel or the cavity formed by the blood vessel and the plaque is only for convenience of description, and the cavity is not limited to be a cylindrical cavity.
It will be appreciated by those skilled in the art that the above-described preferred embodiments may be freely combined, superimposed, without conflict.
It will be understood that the embodiments described above are illustrative only and not restrictive, and that various obvious and equivalent modifications and substitutions for details described herein may be made by those skilled in the art without departing from the basic principles of the invention.
Claims (9)
1. A high speed drive shaft for an interventional rotational atherectomy device, the interventional rotational atherectomy device comprising a drive mechanism and a rotational atherectomy mechanism, the rotational atherectomy mechanism comprising a guide wire and the drive shaft sliding along the guide wire; the driving mechanism comprises a driving motor, a driving gear connected with the driving motor and a transmission gear meshed with the driving gear, and is characterized in that,
the driving shaft is of a hollow structure and is used for the guide wire to penetrate through, the driving shaft comprises a flexible shaft and a rotary grinding layer, the first end of the flexible shaft is used for being connected with the transmission gear and comprises an inner coil group and an outer coil group which are in interference fit, the inner coil group comprises a plurality of strands of inner spring wires which are spirally wound and mutually attached, the outer coil group comprises a plurality of strands of outer spring wires which are spirally wound on the outer surface of the inner coil group and mutually attached, the spiral winding directions of the outer spring wires and the inner spring wires are opposite, the outer spring wires are mutually welded and connected at two ends of the flexible shaft, the inner spring wires are mutually welded and connected, and meanwhile, the inner coil group and the outer coil group are welded and connected; so that the driving shaft can rotate around the axis of the driving shaft in the forward direction and the reverse direction at high speed;
a second end side of the flexible shaft is provided with a rotary grinding area, two or three rotary grinding layers are arranged on the outer surface of the outer-layer coil group at intervals in the rotary grinding area so as to grind patches at the same position, each rotary grinding layer is of a cylindrical structure and surrounds the outer surface of the flexible shaft, and one rotary grinding layer is positioned at the end part of the flexible shaft;
the outer surface of the rotary grinding layer is provided with a groove, and the groove extends to two ends of the rotary grinding layer in the axial direction of the flexible shaft.
2. The drive shaft of claim 1, wherein the rotational grinding layer has an outer diameter of 0.7 to 0.9mm and a thickness of 120 to 200 um.
3. The drive shaft of claim 1, wherein the rotational grinding layer comprises a nickel matrix surrounding the flexible shaft and abrasive particles uniformly distributed on at least the surface of the nickel matrix, wherein the abrasive particles protrude from the surface of the nickel matrix by a height of 10-20 um and have a density of 350-2000 particles/mm.
4. The drive shaft of claim 3, wherein the abrasive particles are diamond abrasive particles or CBN abrasive particles; the grain diameter of the abrasive grains is 10-50 um.
5. The drive shaft of claim 1, wherein each of the rotational atherectomy layers has an axial dimension along the flexible shaft of 1.2-4 mm; the distance between two adjacent rotary grinding layers is 2-5 mm.
6. The drive shaft as claimed in claim 5, wherein the groove is a spiral groove having a spiral winding direction opposite to that of the outer layer spring wire and having a pitch of 1 to 2 mm.
7. The drive shaft of claim 6, wherein the groove is provided with a stripe having a depth of 1/3-1/2 of the thickness of the rotational grinding layer.
8. The drive shaft of claim 1, wherein the flexible shaft has an outer diameter of 0.6 to 0.8 mm; the diameter of the outer layer spring wire is 0.1-0.15 mm; the diameter of the inner layer spring wire is 0.05-0.1 mm.
9. An interventional rotational atherectomy device, comprising a drive mechanism and an atherectomy mechanism, the atherectomy mechanism comprising the drive shaft of any of claims 1 to 8 and a hollow guide wire disposed through the drive shaft such that the drive shaft slides along the guide wire; the transmission gear is connected with the flexible shaft to transmit the torque of the driving motor to the flexible shaft through the driving gear and the transmission gear.
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