Plaque removing device

Abstract

The plaque removing device comprises a sheathing canal and a tool bit assembly arranged at the far end of the sheathing canal, the tool bit assembly comprises a tool bit, a claw sleeve and a sleeve, the tool bit is assembled on the claw sleeve, and the tool bit and the claw sleeve are sleeved with the sleeve; the tool bit comprises a tool base, a center base arranged at the far end of the tool base and a cutting edge, the center base and the tool base are coaxially arranged, and the cutting edge is arranged on one side of the center base and can be unfolded or folded relative to the center base. According to the plaque removing device, the cutting edge of the tool bit can be unfolded or folded according to the working state, and particularly when the tool bit penetrates through a bent blood vessel part, the cutting edge can be folded so that the outer diameter of the cutting edge can be reduced, and the situation that the tool bit scratches the blood vessel wall in the moving process is avoided.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a plaque removal device. Background Art

[0002] Arteriosclerosis obliterans is a common disease, mainly referring to arteriosclerosis and the continuous expansion of atherosclerotic substances in large and medium-sized arteries of the lower extremities and the formation of secondary thrombus, which can cause stenosis and occlusion of the arterial wall, resulting in chronic or acute ischemia of the limbs. With the progress of the aging society and the changes in eating habits and lifestyles, the incidence of arteriosclerosis obliterans of the lower extremities has been increasing year by year, and severe lower limb ischemia can lead to amputation or death.

[0003] Atherectomy is an interventional treatment method for arteriosclerosis, and it involves using an intravascular device to mechanically remove plaque from the arterial wall. The plaque removal device can allow the removal of plaque from the arterial wall, quickly remove or reduce the embolic load such as thrombus and plaque, and reduce the risk of tissue damage caused by stretching or scratching the arterial wall.

[0004] Generally, a cutting head is provided at the distal end of the sheath of the plaque removal device. During the process of inserting the sheath and the cutting head into the diseased site with plaque, it is necessary to bend the distal end of the sheath so that the sheath can better conform to the tortuous or highly branched blood vessels, reducing the difficulty of intervention. When the existing plaque removal device passes through tortuous or highly branched blood vessels, the cutting head often scratches the blood vessel wall, resulting in damage to the inner wall of the blood vessel and unexpected complications.

[0005] Therefore, a new technical solution is needed to solve the above problems. Summary of the Invention

[0006] The purpose of the present invention is to at least solve the problem that the cutting head is prone to scratching the inner wall of the blood vessel when passing through a curved blood vessel. In view of the defects of the prior art, a plaque removal device is provided.

[0007] The present invention solves its technical problems through the following technical solutions:

[0008] According to the technical solution of the present invention, a plaque removal device is provided, including a sheath and a cutting head assembly provided at the distal end of the sheath. The cutting head assembly includes a cutting head, a claw sleeve, and a sleeve. The cutting head is assembled on the claw sleeve, and the sleeve is sleeved outside the cutting head and the claw sleeve. The cutting head includes a knife base, a central seat provided at the distal end of the knife base, and a cutting edge. The central seat is coaxially arranged with the knife base, and the cutting edge is provided on one side of the central seat. The cutting edge can be unfolded or folded relative to the central seat.

[0009] According to the above embodiments of the present invention, when the cutting edge is in the folded state, the unfolded arc surface of the cutting edge is smaller than the outer diameter of the sleeve, which can prevent the cutting head from scraping the inner wall of the blood vessel during pushing or retracting, especially when the cutting head passes through a curved blood vessel part, it can prevent the inner wall of the blood vessel from being scratched because the cutting edge abuts against the inner wall of the blood vessel during the movement. When the cutting edge is in the unfolded state, the unfolded arc surface of the cutting edge is greater than or equal to the outer diameter of the sleeve, which is convenient for the cutting head to excise plaques or thrombi.

[0010] In some embodiments of the present invention, the cutting head further includes positioning posts and a resilient member. At least two positioning posts are provided at the distal end of the tool base. At least two positioning posts are circumferentially and uniformly arranged around the outer periphery of the central seat. The resilient member and the cutting edge are respectively arranged on the positioning posts. Under the elastic force of the resilient member, the cutting edge is folded onto the central seat with the positioning post as the axis.

[0011] In some embodiments of the present invention, a socket hole is axially provided at the root of the cutting edge. The cutting edge is sleeved outside the positioning post through the socket hole. The resilient member is arranged between the positioning post and the cutting edge. The rotation direction of the resilient member driving the cutting edge is the same as the rotation direction of the cutting head.

[0012] In some embodiments of the present invention, the central seat includes a first abutting surface that abuts against the cutting edge, and the cutting edge includes a second abutting surface that abuts against the central seat; when the cutting head is in the unfolded state, the central seat and the cutting edge abut against each other through the first abutting surface and the second abutting surface, so that the cutting edge extends along the radial direction of the tool base.

[0013] In some embodiments of the present invention, the cutting head further includes a reinforcing rib provided on the tool base. The reinforcing rib is located on the side opposite to the folding direction of the cutting edge and is used to support the cutting edge from the side.

[0014] In some embodiments of the present invention, a plurality of spiral walls are provided on the outer peripheral surface of the tool base. The spiral walls are arranged in a spiral shape. A spiral groove is defined between adjacent spiral walls. The spiral groove is used to send the tissue chopped by the cutting head into the sheath tube.

[0015] In some embodiments of the present invention, two cutting edges are provided on the tool base. The two cutting edges are oppositely arranged on both sides of the central seat. At least four circumferentially and uniformly arranged spiral walls are provided on the outer peripheral surface of the tool base; or

[0016] Three cutting edges are provided on the tool base and are circumferentially and uniformly arranged around the central seat. Three circumferentially and uniformly arranged spiral walls are provided on the outer peripheral surface of the tool base. The spiral walls are arranged in one-to-one correspondence with the cutting edges, and the spiral walls and the cutting edges have the same pitch.

[0017] In some embodiments of the present invention, a second cutting edge is provided on the radial outer edge of the cutting edge. The second cutting edge is connected to the cutting edge by a hinge, and a torsion spring is provided inside the hinge. The torsion direction of the torsion spring is the same as that of the elastic member.

[0018] In some embodiments of the present invention, the outer diameter after the cutting edge and the second cutting edge are unfolded is greater than the outer diameter of the sleeve. A centering balloon is provided at the distal end of the sheath tube; the outer diameter after the centering balloon is inflated is smaller than the inner diameter of the target blood vessel and greater than the outer diameter after the cutting edge and the second cutting edge are unfolded.

[0019] In some embodiments of the present invention, the outer cutting edge of the cutting edge can be a sharp edge or a blunt edge. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] By reading the following detailed description of the preferred embodiments, various other advantages and benefits will become clear to those of ordinary skill in the art. The drawings are only for the purpose of showing the preferred embodiments and are not considered to be a limitation of the present invention. Moreover, throughout the drawings, the same reference numerals are used to represent the same components. Among them:

[0021] Figure 1 is an exploded view of the parts of the plaque removal device in Embodiment 1 of the present invention;

[0022] Figure 2 is Figure 1 a partial enlarged view of part A in

[0023] Figure 3 is a structural diagram of the bending adjustment knob in Embodiment 1 of the present invention;

[0024] Figure 4 is a structural diagram of the plaque removal device in Embodiment 1 of the present invention;

[0025] Figure 5 is a sectional structural diagram of the sheath tube in Embodiment 1 of the present invention;

[0026] Figure 6 is Figure 5 a partial enlarged view of part B in

[0027] Figure 7 is a structural diagram of the cooperation between the rotary connection mechanism and the bending adjustment control mechanism in Embodiment 1 of the present invention;

[0028] Figure 8 is a structural diagram of the second moving member in Embodiment 1 of the present invention;

[0029] Figure 9Schematic diagram of the liquid drainage component in Embodiment 1 of the present invention;

[0030] Figure 10 Schematic diagrams of the assembled state and disassembled state of the cutter head component in Embodiment 1 of the present invention;

[0031] Figure 11 Schematic diagram of the power output mechanism in Embodiment 1 of the present invention;

[0032] Figure 12 Schematic diagram of the guide wire locking component in Embodiment 1 of the present invention;

[0033] Figure 13 Schematic diagram of the plaque removal device in Embodiment 2 of the present invention;

[0034] Figure 14 Schematic diagram of the plaque removal device in Embodiment 2 of the present invention;

[0035] Figure 15 Schematic diagram of the bending adjustment control mechanism in Embodiment 2 of the present invention;

[0036] Figure 16 Schematic diagram of the rotary connection mechanism in Embodiment 2 of the present invention;

[0037] Figure 17 Schematic diagram of the cutter head component in Embodiment 3 of the present invention;

[0038] Figure 18 Schematic diagram of the structure when the cutting edge is folded in Embodiment 3 of the present invention;

[0039] Figure 19 Schematic diagram of the structure when the cutter head is deployed in Embodiment 3 of the present invention;

[0040] Figure 20 Exploded view of the cutter head in Embodiment 3 of the present invention;

[0041] Figure 21 Schematic diagram of the structure of the cutting edge in Embodiment 3 of the present invention;

[0042] Figure 22 Axial view of the cutter head when it is deployed in Embodiment 3 of the present invention;

[0043] Figure 23 Axial view of the cutter head when it is folded in Embodiment 3 of the present invention;

[0044] Figure 24 Schematic diagram of the structure when the cutter head is deployed in Embodiment 4 of the present invention;

[0045] Figure 25Schematic structural diagram when the cutter head is folded in Embodiment 4 of the present invention;

[0046] Figure 26 Schematic structural diagram when the cutter head is deployed in Embodiment 5 of the present invention;

[0047] Figure 27 Exploded view of the cutter head in Embodiment 5 of the present invention;

[0048] Figure 28 Schematic structural diagram when a central balloon is provided on the sheath tube in Embodiment 5 of the present invention.

[0049] The reference numerals in the drawings are shown as follows:

[0050] 100. Plaque removal device; 10. Sheath tube; 101. Bending adjustment channel; 11. Inner layer tube; 12. Braided layer; 13. Outer layer tube; 20. Handle; 21. First housing; 22. Second housing; 201. Stopping groove; 2011. First side wall; 2012. Second side wall; 202. First rib; 2021. First round hole; 203. Second rib; 2031. Second round hole; 204. Third rib; 2041. First sliding groove; 205. Limiting rib; 30. Rotary connection mechanism; 31. Transmission knob; 311. First strip-shaped protrusion; 32. Rotating part; 321. First tube body; 322. Second tube body; 3201. First sliding structure; 33. Rotating shaft; 34. First bevel gear; 35. Second bevel gear; 36. Bevel gear pair; 40. Bending adjustment control mechanism; 41. Driving assembly; 411. Bending adjustment knob; 4111. Stopping part; 412. Rocker; 413. Connecting rod; 414. Intermediate shaft; 415. Second strip-shaped protrusion; 42. Moving assembly; 421. First moving part; 4211. First main body; 4212. First slider; 4213. Columnar connecting part; 4214. First annular protrusion; 4215. Second annular protrusion; 4216. Annular groove; 422. Second moving part; 4221. Second main body; 42211. Limiting hole; 4222. Rotating connection part; 4223. First fixing hole; 4224. Second fixing hole; 42201. Second sliding structure; 423. Pin; 51. Bending adjustment wire; 52. Imaging part; 53. Torque shaft; 54. Stress diffusion tube; 60. Drainage assembly; 61. Three-way pipe; 611. First tubular part; 612. Second tubular part; 613. Drainage part; 62. Rotary drum; 63. Sealing ring; 70. Blade head assembly; 71. Blade head; 711. Limiting groove; 72. Claw sleeve; 721. Body part; 722. Claw-shaped part; 7221. Limiting protrusion; 73. Sleeve; 74. Knife base; 741. Central seat; 7411. First abutting surface; 742. Positioning column; 7421. End cap; 7422. Welding hole; 743. Reinforcing rib; 744. Spiral wall; 745. Spiral groove; 75. Cutting edge; 751. Second abutting surface; 752. Insertion hole; 753. Step hole; 76. Rebound part; 77. Second blade part; 771. Hinge; 78. Centering balloon; 80. Power output mechanism; 81. Transmission component; 82. First bearing; 83. Second bearing; 84. Bearing sleeve; 85. Motor; 86. Wire; 87. Switch; 88. Switch slider; 89. Battery; 90. Guide wire locking assembly; 91. First locking part; 92. Second locking part; 921. Second stopping step; 93. Elastic pad. Detailed implementation mode

[0051] Exemplary embodiments of the present invention will now be described in more detail with reference to the accompanying drawings. Although the exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided so that the present invention can be more thoroughly understood and the scope of the present invention can be fully conveyed to those skilled in the art.

[0052] It should be understood that the terms used herein are for the purpose of describing particular example embodiments only and are not intended to be limiting. Unless the context clearly dictates otherwise, the singular forms "a", "an", and "the" as used herein may also include the plural forms. The terms "comprising", "including", "containing", and "having" are inclusive and thus specify the presence of the stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or combinations thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their execution in the particular order described or illustrated, unless explicitly stated as an order of execution. It should also be understood that additional or alternative steps may be used.

[0053] Although the terms first, second, third, etc. may be used herein to describe multiple elements, components, regions, layers, and / or sections, these elements, components, regions, layers, and / or sections should not be limited by these terms. These terms may be used only to distinguish one element, component, region, layer, or section from another. Unless the context clearly indicates otherwise, terms such as "first", "second", and other numerical terms when used herein do not imply an order or sequence. Thus, the first element, component, region, layer, or section discussed below may be referred to as the second element, component, region, layer, or section without departing from the teachings of the example embodiments.

[0054] For ease of description, spatial relative relationship terms may be used herein to describe the relationship of one element or feature shown in the figures to another element or feature, such as "inner", "outer", "inside", "outside", "below", "beneath", "above", "over", etc. Such spatial relative relationship terms are intended to include different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is rotated, an element described as "below" or "beneath" another element or feature will then be oriented "above" or "over" the other element or feature. Thus, the example term "below" can include both an orientation above and below.

[0055] It should be noted that "distal" and "proximal" are used as directional terms, which are commonly used terms in the field of interventional medical devices, where "distal" refers to the end away from the operator during surgery, and "proximal" refers to the end close to the operator during surgery. Axial refers to the direction parallel to the line connecting the distal center and the proximal center of the medical device; radial refers to the direction perpendicular to the above axial direction.

[0056] Please combine Figure 1 , Figure 4 , Figure 5 and Figure 10 As shown, the present invention proposes a plaque removal device 100, which includes a handle 20, a sheath 10, a rotating connection mechanism 30, a bending wire 51, a bending control mechanism 40, a drainage assembly 60, a blade assembly 70, a torque shaft 53, a power output mechanism 80 and a guide wire locking assembly 90.

[0057] The handle 20 includes a first shell 21 and a second shell 22 that match each other, and a accommodating cavity is defined between the first shell 21 and the second shell 22. At least part of the rotating connection mechanism 30, the bending control mechanism 40, the drainage assembly 60 and the power output mechanism 80 are arranged inside the accommodating cavity, so that the appearance of the plaque removal device 100 is simpler, which is convenient for the doctor's operation. In addition, the first shell 21 and the second shell 22 can prevent external objects from intervening between the movable components of each driving mechanism, thereby reducing the probability of jamming during the operation of each driving mechanism.

[0058] Please combine Figure 4 and Figure 16 As shown, the rotation connection mechanism 30 includes a transmission knob 31 and a rotating member 32 of transmission connection. The rotating member 32 is arranged in the accommodating cavity, and the rotating member 32 is connected to the handle 20 in a manner that it can rotate around the axis of the sheath tube 10 relative to the handle 20, that is, the rotating member 32 can rotate around the axis of the sheath tube 10 relative to the handle 20, and based on the connection method between the rotating member 32 and the handle 20, the rotating member 32 can be limited to move along the axial direction of the sheath tube 10 relative to the handle 20. The transmission knob 31 is rotatably disposed on the handle 20 and connected to the rotating member 32. The proximal end of the sheath 10 extends into the accommodating cavity and is connected to the rotating member 32. In the process of driving the transmission knob 31 to rotate, the transmission knob 31 can drive the rotating member 32 to rotate around the axis of the sheath 10 relative to the handle 20, so that the rotating member 32 drives the sheath 10 to rotate relative to the handle 20 to change the bending direction of the head end of the sheath 10. In the process of the sheath 10 intervening in the lesion site with plaque inside the blood vessel, the sheath 10 can pass through the winding blood vessel site or enter the branch blood vessel more smoothly.

[0059] In the plaque removal device proposed by the present invention, during the process of adjusting the bending direction of the distal end of the sheath tube, the handle does not need to be rotated. Only by rotating the transmission knob, the sheath tube connected to the rotating member can be driven to rotate relative to the handle, so as to change the bending direction of the distal end of the sheath tube. Compared with the way of manually controlling the overall rotation of the handle, the rotation angle of the sheath tube is more accurate and controllable, the operation is simple, and the operation difficulty of the doctor is reduced.

[0060] It should be noted that the rotating member 32 can be rotatably connected to the handle 20 in various connection ways. For example, in some embodiments, the rotating member is arranged as a tubular structure, a cylindrical cavity is formed in the accommodating cavity of the handle, the rotating member is rotatably arranged in the cavity, and protrusions and annular grooves for limiting are respectively arranged on the outer peripheral surface of the rotating member and the inner wall surface of the cavity. The annular groove extends along the circumferential direction of the rotating member, and the protrusion is slidably arranged in the annular groove. During the process of the rotating member rotating relative to the handle, the protrusion and the annular groove can limit the axial movement of the rotating member relative to the handle.

[0061] In other embodiments, an annular groove can be arranged along the circumferential direction of the rotating member. Rib structures are respectively arranged on the inner walls of the first housing and the second housing and are arranged opposite to each other. A through hole for the rotating member to pass through is defined between the two rib structures. The rotating member is rotatably arranged in the through hole, and the rib structure extends into the annular groove. By the stop cooperation between the rib structure and the two side walls of the annular groove opposite to each other, the axial movement of the rotating member relative to the handle is restricted.

[0062] Among them, the transmission connection between the transmission knob 31 and the rotating member 32 includes: the transmission knob 31 is directly connected to the rotating member 32, or the transmission knob 31 is indirectly connected to the rotating member 32 through transmission parts such as gears, so that the rotating member 32 can be driven to rotate when the transmission knob 31 is rotated.

[0063] As Figure 1 shown, the bending control mechanism 40 is movably arranged on the handle 20. The bending control mechanism 40 includes a driving component 41 and a moving component 42 which are in transmission connection. The driving component 41 can drive the moving component 42 to move axially relative to the handle 20 along the sheath tube 10.

[0064] As Figure 5 and Figure 6As shown in the figure, the tube wall of the sheath tube 10 is provided with a bending adjustment channel 101 extending along the axial direction of the sheath tube 10. The distal end of the bending adjustment channel 101 extends to a position near the distal end of the sheath tube 10. The proximal end of the bending adjustment wire 51 forms an opening on the outer peripheral surface of the sheath tube 10 near the proximal end. The bending adjustment wire 51 is movably arranged in the bending adjustment channel 101, which can prevent the bending adjustment wire 51 from contacting the torque shaft 53 and the like inside the sheath tube 10, and avoid interference between the rotation of the knob shaft and the bending adjustment wire 51. The distal end of the bending adjustment wire 51 extends to the distal end of the bending adjustment channel 101 and is connected to the sheath tube 10 at the distal end or a position near the distal end of the sheath tube 10. The proximal end of the bending adjustment wire 51 extends out of the sheath tube 10 through the opening and is connected to the moving component 42. Therefore, the bending adjustment control mechanism 40 can pull the proximal end of the bending adjustment wire 51 to move axially along the sheath tube 10, and then apply a pulling force to the distal end of the sheath tube 10 by using the bending adjustment wire 51 to achieve the bending of the head end of the sheath tube 10.

[0065] For eccentric calcified lesions, the sheath tube 10 can be first driven to rotate around its own axis by using the rotary connection mechanism 30 to adjust the bending direction of the sheath tube 10, and then the distal head end of the sheath tube 10 can be bent by using the bending adjustment wire 51, so that the distal head end of the sheath tube 10 bends towards one side, so that the cutter head assembly 70 arranged at the distal end of the sheath tube 10 can be aligned with the position of the eccentric calcified lesion, and the eccentric calcified lesion in the inner wall of the blood vessel can be specifically removed by using the cutter head assembly 70, improving the removal effect of the eccentric calcified lesion. It should also be emphasized that in the present invention, the rotation angle of the sheath tube 10 is accurately controlled by the transmission knob 31 and the rotating part 32, the direction position of the sheath tube 10 after rotation can be accurately controlled, the alignment accuracy between the cutter head assembly 70 and the eccentric calcified lesion after bending is improved, and the risk of the cutter head assembly 70 cutting the intima of the blood vessel is reduced. During the actual operation of the doctor, the plaque removal device 100 can be placed flat on the operating table for pushing operation, and the doctor only needs to rotate the transmission knob 31 and the bending adjustment knob 411 to accurately realize the bending direction and bending angle of the head end of the sheath tube 10. Compared with the way of the doctor manually rotating the handle 20, the technical solution of the present invention makes the process of rotating and bending the sheath tube 10 have better stability.

[0066] Further, as Figure 7 shown, the moving component 42 includes a first moving part 421 and a second moving part 422. The first moving part 421 is in transmission connection with the driving component. The second moving part 422 is connected to the first moving part 421 in a manner that can rotate relative to the first moving part 421 around the axis of the sheath tube 10. One of the second moving part 422 and the rotating part 32 is provided with a first sliding structure 3201 extending along the axial direction of the sheath tube 10, and the other is provided with a second sliding structure 42201 slidably connected to the first sliding structure 3201. The sliding cooperation between the first sliding structure 3201 and the second sliding structure 42201 can limit the rotation of the rotating part 32 relative to the second moving part 422. The proximal end of the bending adjustment wire 51 is connected to the second moving part 422.

[0067] Please refer to Figure 4 and Figure 7 As shown, the functions of the first sliding structure 3201 and the second sliding structure 42201 are that they allow the first moving member 421 and the second moving member 422 to move axially relative to the rotating member 32 along the sheath tube 10, so as to facilitate pulling the proximal end of the bending wire 51 to move axially through the moving assembly 42 by means of the rotary connection mechanism 30. However, the functions of the first sliding structure 3201 and the second sliding structure 42201 also include preventing relative rotation between the second moving member 422 and the rotating member 32. When the rotating member 32 is driven to rotate to drive the sheath tube 10 to rotate relative to the handle 20, the rotating member 32 drives the second moving member 422 to rotate with the rotating member 32, so that the proximal end of the bending wire 51 connected to the second rotating member 32 rotates with the second moving member 422. During the rotation of the sheath tube 10 relative to the handle 20, the bending wire 51 and the sheath tube 10 remain relatively stationary with respect to each other. Therefore, it is possible to avoid the bending wire 51 being wound around the sheath tube 10 when the sheath tube 10 rotates, and to avoid interference between the bending wire 51 and the sheath tube 10 during the rotation of the sheath tube 10.

[0068] As Figure 7 shown, one of the first sliding structure 3201 and the second sliding structure 42201 can be set as an axially extending chute, and the other of them can be set as a slider that slidably cooperates with the rib.

[0069] In other embodiments, the first sliding structure 3201 and the second sliding structure 42201 can be set in a variety of different structural forms. For example, one of the first sliding structure and the second sliding structure can be set as an axially extending sliding rod, and the other of them can be set as a sliding hole that slidably cooperates with the sliding rod; or in some other embodiments, one of the first sliding structure and the second sliding structure can be set as an axially extending rib, and the other of them can be set as a chute that slidably cooperates with the rib.

[0070] Please refer to Figure 4 and Figure 7 shown, the first moving member 421, the second moving member 422 and the rotating member 32 are respectively in a hollow cylindrical structure. In the direction from the distal end to the proximal end of the sheath tube 10, the sheath tube 10 sequentially passes through the rotating member 32, the second moving member 422 and the first moving member 421. The outer peripheral surface of the sheath tube 10 is fixedly connected to the inner peripheral surface of the rotating member 32, and the sheath tube 10 can move axially relative to the first moving member 421 and the second moving member 422.

[0071] Among them, the first moving member 421 and the second moving member 422 are respectively sleeved outside the sheath tube 10, and at least one of the first moving member 421 and the second moving member 422 can define the sliding direction of the moving assembly 42 by slidingly cooperating with the sheath tube 10. It should also be noted that by sleeving the rotating member 32, the first moving member 421 and the second moving member 422 on the outside of the sheath tube 10 in sequence, and directly connecting the rotating member 32 to the outer peripheral surface of the sheath tube 10, the structures of the rotary connection mechanism 30 and the bending control mechanism 40 are simple and compact, which is beneficial to the miniaturization of the plaque removal device 100.

[0072] Furthermore, please refer to Figure 4 and Figure 9 As shown, the drainage assembly 60 is located on the proximal side of the bending control mechanism 40. The proximal end of the sheath tube 10 passes through the proximal end of the first moving member 421 and is connected to the drainage assembly 60. After the cutter head assembly 70 cuts and removes the diseased plaque in the blood vessel, the drainage assembly 60 uses a negative pressure device to suck the plaque into the sheath tube 10 and discharge it through the drainage assembly 60. Specifically, the drainage assembly 60 includes a three-way pipe 61, a rotating cylinder 62 and a sealing ring 63. The three-way pipe 61 is fixedly arranged on the handle 20. The three-way pipe 61 includes a first tubular part 611, a second tubular part 612 communicating with the first tubular part 611, and a drainage part 613 communicating with the first tubular part 611 and the second tubular part 612 respectively. The drainage part 613 is used to communicate with the negative pressure device. One end of the rotating cylinder 62 is sleeved outside the proximal end of the sheath tube 10 and is fixedly connected to the sheath tube 10. The other end of the rotating cylinder 62 is rotatably sleeved outside the first tubular part 611. The sealing ring 63 is sleeved between the rotating cylinder 62 and the first tubular part 611. Since the sheath tube 10 can rotate relative to the handle 20, the rotating cylinder 62 is rotatably connected to the first tubular part 611, so that the rotating cylinder 62 can rotate together with the sheath tube 10, and the sealing ring 63 seals the gap between the rotating cylinder 62 and the first tubular part 611 to prevent liquid leakage.

[0073] Furthermore, please refer to Figure 1 and Figure 10 As shown, the cutter head assembly 70 is arranged at the distal end of the sheath tube 10 and has a rotatable cutter head 71. The torque shaft 53 passes through the sheath tube 10 and the three-way pipe 61. The distal end of the torque shaft 53 is connected to the cutter head 71. The proximal end of the torque shaft 53 extends out of the sheath tube 10 from the proximal end of the second tubular part 612 and is connected to the power output mechanism 80. The power output mechanism 80 can drive the torque shaft 53 to rotate around its own axis, and then drive the cutter head 71 to rotate to cut and remove the plaque in the blood vessel.

[0074] Please refer to Figure 12 and Figure 13As shown, the guide wire locking assembly 90 is provided at the proximal end of the handle 20. The guide wire locking assembly 90 includes an elastic pad 93, and a first locking member 91 and a second locking member 92 which are oppositely arranged. The elastic pad 93 is provided with a through hole communicating with the second tubular portion 612. The through hole allows the guide wire to pass through. The first locking member 91 is movably connected to the second locking member 92 and clamps the elastic pad 93 between the first locking member 91 and the second locking member 92. During the process of the second locking member 92 moving relative to the first locking member 91, the elastic pad 93 can be squeezed. Under the squeezing action, the through hole of the elastic pad 93 is compressed and deformed to lock the guide wire, preventing the guide wire from rotating together with the cutter head 71 during the operation and damaging the blood vessel.

[0075] Please refer to Figure 4 、 Figure 13 and Figure 14 As shown, the rotary connection mechanism 30, the bending control mechanism 40, the drainage assembly 60, the power output mechanism 80, and the guide wire locking assembly 90 are arranged in sequence from the distal end to the proximal end, so that a plurality of different functional areas are formed on the handle 20 one by one from the distal end to the proximal end. The functional area refers to: the sheath tube 10 rotation control area corresponding to the rotary connection mechanism 30, the bending wire 51 bending control area corresponding to the bending control mechanism 40, the drainage control area corresponding to the drainage assembly 60, the cutter head 71 rotary cutting control area corresponding to the power output mechanism 80, and the guide wire locking control area corresponding to the guide wire locking assembly 90. In this embodiment, the multiple functional areas of the plaque removal device are distinct from the distal end to the proximal end, enabling the doctor to more clearly and orderly control various operations for performing the plaque removal surgery, making the operation of the plaque removal device 100 more concise and reducing the probability of operation errors during the doctor's surgery.

[0076] The technical solution of the present invention will be further described in detail below in conjunction with specific embodiments.

[0077] Embodiment 1

[0078] In this embodiment, please refer to Figure 1 、 Figure 4 、 Figure 5 and Figure 10 As shown, according to an embodiment of the present invention, a plaque removal device 100 is provided. The plaque removal device 100 includes a handle 20, a sheath tube 10, a rotary connection mechanism 30, a bending wire 51, a bending control mechanism 40, a drainage assembly 60, a cutter head assembly 70, a torque shaft 53, a power output mechanism 80, a guide wire locking assembly 90, and a stress diffusion tube 54.

[0079] As Figure 1 and Figure 4As shown, the handle 20 includes a first housing 21 and a second housing 22 that are opposed to each other, and a receiving cavity is defined between the first housing 21 and the second housing 22. At least some components of the rotary connection mechanism 30, the bending control mechanism 40, the liquid discharge assembly 60, and the power output mechanism 80 are arranged in sequence in the receiving cavity from the distal end to the proximal end.

[0080] The stress diffusion tube 54 is tubular, and the outer diameter of the stress diffusion tube 54 gradually increases in the direction from the distal end to the proximal end. An annular groove extending along the circumferential direction of the stress diffusion tube 54 is provided on the outer peripheral surface of the stress diffusion tube 54. The stress diffusion tube 54 is rotatably provided at the distal end of the handle 20, and the wall of the handle 20 is embedded in the annular groove to limit the stress diffusion tube 54 and prevent the stress diffusion tube 54 from moving axially relative to the handle 20. The material hardness of the stress diffusion tube 54 is less than that of the sheath tube 10, so as to avoid bending of the connection part between the sheath tube 10 and the handle 20 when the sheath tube 10 is bent.

[0081] As Figure 5 and Figure 6 shown, the sheath tube 10 includes an outer layer tube 13, a braided layer 12, and an inner layer tube 11. The braided layer 12 is sleeved outside the inner layer tube 11, and the outer layer tube 13 is sleeved outside the braided layer 12. Among them, the outer layer tube 13 and the braided layer 12 are combined into one body by a hot melt process. A developer 52 is also provided in the tube wall of the sheath tube 10. The developer 52 is annular and is sleeved between the braided layer 12 and the outer tube layer, and the developer 52 is arranged close to the distal end of the sheath tube 10. A bending channel 101 is also provided between the outer layer tube 13 and the braided layer 12. The bending channel 101 extends along the axial direction of the sheath tube 10. The distal end of the bending channel 101 is connected to the developer 52. The proximal end of the bending channel 101 forms an opening on the outer peripheral surface of the sheath tube 10. The proximal end of the bending channel 101 is close to the proximal end of the sheath tube 10. The distal end of the bending wire 51 is sleeved on the developer 52 at the distal end of the bending channel 101, and the proximal end of the bending wire 51 extends out of the sheath tube 10 through the opening at the proximal end of the bending channel 101. When the proximal end of the bending wire 51 is pulled axially, the distal end of the bending wire 51 can apply a lateral pulling force to the head end of the sheath tube 10 through the developer 52, causing the head end of the sheath tube 10 to bend, thereby realizing the bending of the distal head end of the sheath tube 10.

[0082] As Figure 1 and Figure 4 shown, the sheath tube 10 is inserted through the stress diffusion tube 54, and the proximal end of the sheath tube 10 extends into the receiving cavity, and the proximal end of the sheath tube 10 sequentially passes through the rotary connection mechanism 30 and the bending control mechanism 40 and is connected to the liquid discharge assembly 60.

[0083] Please refer to Figure 4 , Figure 7As shown, the rotary connection mechanism 30 includes a rotating member 32 and a transmission knob 31 that are drivingly connected. Specifically, the rotating member 32 has a circular tubular structure. The rotating member 32 includes a first tube body 321 and a second tube body 322 that are connected and communicate with each other. The inner diameter of the second tube body 322 is larger than that of the first tube body 321, and the outer diameter of the second tube body 322 is larger than that of the first tube body 321. The first tube body 321 is located on the side of the distal end relative to the second tube body 322. The transmission knob 31 has a disc-shaped structure. The transmission knob 31 is sleeved on the outer peripheral surface of the first tube body 321 and fixedly connected to the first tube body 321. In this embodiment, the outer peripheral surface of the first tube body 321 is provided with protruding connection keys, and the inner peripheral surface of the transmission knob 31 is provided with key grooves that cooperate with the connection keys. The connection keys are inserted into the key grooves to limit the relative rotation between the first tube body 321 and the transmission knob 31. Moreover, the transmission knob 31 is also fixedly bonded to the rotating member 32 to prevent the transmission knob 31 and the rotating member 32 from moving relative to each other axially. The key grooves and the connection keys are not shown in the drawings. The sheath tube 10 is inserted through the rotating member 32, and the outer peripheral surface of the sheath tube 10 is fixedly bonded to the inner peripheral surface of the first tube body 321, so that the sheath tube 10 is fixed to the rotating member 32. Driving the transmission knob 31 to rotate can drive the rotating member 32 and the sheath tube 10 to rotate relative to the handle 20 together, so as to precisely control the rotation angle of the sheath tube 10 and change the bending direction of the head end of the sheath tube 10.

[0084] Please refer to Figure 1 , Figure 4 and Figure 7 As shown, on the inner walls of the first housing 21 and the second housing 22, two first ribs 202 and two second ribs 203 that are spaced apart are sequentially provided in the direction from the distal end to the proximal end. The first ribs 202 and the second ribs 203 extend in the radial direction of the sheath tube 10. When the first housing 21 and the second housing 22 are joined together, the first ribs 202 form a first circular hole 2021 that cooperates with the first tube body 321, so that the first tube body 321 is rotatably inserted through the first circular hole 2021. The second ribs 203 form a second circular hole 2031 that cooperates with the second tube body 322, so that the second tube body 322 is rotatably inserted through the second circular hole 2031. The transmission knob 31 is located in the cavity between the two first ribs 202. The transmission knob 31 is limited by the two first ribs 202 to prevent the transmission knob 31 from moving axially along the sheath tube 10. The cavity also forms an opening on one side of the handle 20, so that the outer peripheral contour of the transmission knob 31 is exposed outside the handle 20, facilitating turning the transmission knob 31 to drive the rotating member 32 to rotate around the axis of the sheath tube 10.

[0085] Please refer to Figure 1 , Figure 4 and Figure 7As shown, the bending control mechanism 40 includes a driving assembly 41 and a moving assembly 42 that are drivingly connected. The driving assembly 41 can drive the moving assembly 42 to move axially relative to the handle 20 along the sheath 10. The proximal end of the bending wire 51 is connected to the moving assembly 42, and the bending of the distal end of the sheath 10 can be controlled through the bending control mechanism 40. The driving assembly 41 includes a bending knob 411, a rocker 412, and a connecting rod 413. The moving assembly 42 includes a first moving member 421 and a second moving member 422. Specifically, the first moving member 421 includes a tubular first body 4211, a first slider 4212, and a columnar connecting portion 4213 provided on the outer peripheral surface of the first body 4211. The first body 4211 is slidably sleeved outside the sheath 10. The first moving member 421 can move axially relative to the sheath 10 along the axis of the sheath 10. Two third ribs 204 extending along the axis of the sheath 10 are provided on the inner wall of the first housing 21. The two third ribs 204 are arranged in parallel and at intervals, and a first chute 2041 extending axially is defined between the two third ribs 204. The first slider 4212 is slidably disposed in the first chute 2041. Through the cooperation of the first slider 4212 and the first chute 2041, it is defined that the first moving member 421 can move axially relative to the handle 20 and the sheath 10 along the axis of the sheath 10, and the first moving member 421 is restricted from rotating circumferentially relative to the handle 20 and the sheath 10 along the axis of the sheath 10.

[0086] The columnar connecting portion 4213 has a cylindrical structure, and the axis of the columnar connecting portion 4213 is perpendicular to the axis of the first body 4211. The bending knob 411 is rotatably disposed on the second housing 22. The rotating shaft of the bending knob 411 passes through the second housing 22 and extends into the accommodating cavity and is fixedly connected to the rocker 412 disposed in the accommodating cavity. The two ends of the connecting rod 413 are respectively pivotally connected to the rocker 412 and the columnar portion of the first moving member 421, so that the bending knob 411, the rocker 412, the connecting rod 413, and the first moving member 421 together form a crank-slider mechanism. By rotating the bending knob 411, the first moving member 421 can be driven to reciprocate axially on the handle 20 along the axis of the sheath 10.

[0087] The second moving member 422 includes a tubular second main body 4221, a rotary connection portion 4222 communicating with the proximal end of the second main body 4221, and a second sliding structure 42201 provided on the outer peripheral surface of the second main body 4221. The second tube body 322 of the rotating member 32 is sleeved outside the second main body 4221, and a first sliding structure 3201 slidably engaged with the second sliding structure 42201 is provided on the second tube body 322. In this embodiment, the first sliding structure 3201 is a chute extending along the axial direction of the sheath 10, and the second sliding structure 42201 is configured as a slider slidably engaged with the second chute. Through the cooperation of the chute and the slider, the second moving member 422 can move axially relative to the rotating member 32 along the sheath 10, but the second moving member 422 and the rotating member 32 remain relatively fixed in the circumferential direction of the sheath 10.

[0088] The rotary connection portion 4222 is configured as a cylindrical structure, and the first moving member 421 and the second moving member 422 are rotatably connected by bearings. Specifically, the outer ring of the bearing is sleeved inside the rotary connection portion 4222 and is fixedly connected with the rotary connection portion 4222 through interference fit. The distal end of the first main body 4211 is inserted into the inner ring of the bearing and is fixedly connected with the inner ring of the bearing through interference fit, so that the first moving member 421 and the second moving member 422 can rotate relative to each other in the circumferential direction of the sheath 10.

[0089] Further, as Figure 8 shown, an axially extending first fixing hole 4223 is provided on the distal end face of the second moving member 422, and a second fixing hole 4224 communicating with the fixing hole is provided on the outer peripheral surface of the second moving member 422. The proximal end of the bending adjustment wire can penetrate into the second fixing hole 4224 through the first fixing hole 4223 and is fixed by gluing or fixed by a pin 423, so as to fixedly connect the proximal end of the bending adjustment wire with the second moving member 422.

[0090] In this embodiment, the bending adjustment control mechanism 40 is configured as a crank-slider mechanism. By rotating the bending adjustment knob 411, the first moving member 421 and the second moving member 422 can be driven to quickly move axially along the sheath 10 through the rocker 412 and the connecting rod 413, so as to drive the proximal end of the bending adjustment wire 51 to move to realize the bending of the sheath 10. Compared with mechanisms such as nut screws, the bending adjustment knob 411 in the crank-slider mechanism can make the slider have a larger moving distance through a small rotation angle, so that the head end of the sheath 10 has higher sensitivity in bending and can improve the bending efficiency.

[0091] It should also be noted that, based on the cooperation between the rotary connection mechanism 30 and the bending control mechanism 40, the second moving member 422 can rotate relative to the first moving member 421 along the circumferential direction of the sheath 10 but remains fixed to the first moving member 421 in the axial direction of the sheath 10. When the sheath 10 is bent through the bending control mechanism 40, driven by the bending adjustment knob 411, the rocker 412, and the connecting rod 413, the first moving member 421 can drive the second moving member 422 to move along the axial direction of the sheath 10. The second moving member 422 drives the proximal end of the bending wire 51 to move, thereby enabling the bending of the sheath 10. At the same time, the second moving member 422 can also move relative to the rotating member 32 along the axial direction of the sheath 10 but remains fixed to the rotating member 32 in the circumferential direction of the sheath 10. When the bending angle of the sheath 10 is adjusted through the rotary connection mechanism 30, the rotating member 32 drives the second moving member 422 to rotate with the rotating member 32, so that the proximal end of the bending wire 51 connected to the second rotating member 32 rotates together with the second moving member 422. It should be noted that during the rotation of the sheath 10 relative to the handle 20, the bending wire 51 and the sheath 10 can remain relatively stationary with respect to each other. Therefore, it is possible to avoid the bending wire 51 being wound around the sheath 10 when the sheath 10 is rotated and prevent interference between the bending wire 51 and the sheath 10.

[0092] In addition, as Figure 1 shown, the rotary connection mechanism 30 and the bending control mechanism 40 are inside the handle 20 and are arranged side by side in the radial direction. Compared with the prior art, the present application can simultaneously achieve the head-end bending and circumferential rotation functions of the sheath 10, and separately control the bending and rotation of the sheath 10 through the bending adjustment knob 411 and the transmission knob 31, without additionally increasing the volume of the handle 20.

[0093] Please refer to Figure 1 、 Figure 2 and Figure 3 shown, a stop groove 201 is provided on the outer side wall of the second housing 22. A stop portion 4111 is provided on the side wall surface of the bending adjustment knob 411 facing the second housing 22. The stop groove 201 is in a fan shape. Along the rotation direction of the bending adjustment knob 411, the stop groove 201 includes a first side wall 2011 and a second side wall 2012 arranged at intervals. The stop portion 4111 extends into the stop groove 201 and is located between the first side wall 2011 and the second side wall 2012. The stop portion 4111 can be in stop cooperation with the first side wall 2011 and the second side wall 2012 respectively. By limiting the rotation range of the bending adjustment knob 411 through the stop groove 201, the bending angle of the head end of the sheath 10 can be controlled within a controllable range. For example, the bending angle range of the head end of the sheath 10 is 0° to 45°, improving the reliability of the plaque removal device 100.

[0094] In addition, the existing sheath bending method of the screw slider requires rotating the knob several times to finally achieve the bending of the sheath tip end, while the bending control mechanism 40 of the present application has a small rotation stroke of the bending knob 411 during bending, which provides convenience for the doctor to operate the handle and improves the efficiency of the operation.

[0095] Please combine Figure 4 and Figure 9 As shown, the drainage assembly 60 includes a three-way pipe 61, a rotating cylinder 62 and a sealing ring 63. The three-way pipe 61 is fixedly arranged on the handle 20. The three-way pipe 61 includes a first tubular portion 611, a second tubular portion 612 connected to the first tubular portion 611, and a drainage portion 613 connected to the second tubular portion 612. The first tubular portion 611 and the second tubular portion 612 are both arranged in the accommodating cavity and fixedly connected to the handle 20. The first tubular portion 611 and the second tubular portion 612 are connected to the handle 20. 12 are coaxially arranged with the sheath tube 10, one end of the liquid discharge part 613 is connected with the second tubular part 612, the other end of the liquid discharge part 613 extends out of the handle 20 and is used to communicate with the negative pressure device, one end of the rotating cylinder 62 is sleeved outside the proximal end of the sheath tube 10 and is fixed to the sheath tube 10 through UV glue curing and bonding, the other end of the rotating cylinder 62 is rotatably sleeved outside the first tubular part 611, and the sealing ring 63 is sleeved between the rotating cylinder 62 and the first tubular part 611. Since the sheath tube 10 can rotate relative to the handle 20, the rotating cylinder 62 is rotatably connected with the first tubular part 611, so that the rotating cylinder 62 can rotate with the sheath tube 10, and the sealing ring 63 is used to seal the gap between the rotating cylinder 62 and the first tubular part 611 to prevent leakage. Among them, UV glue refers to shadowless glue, which is also called photosensitive glue and ultraviolet light curing glue. UV is the abbreviation of Ultraviolet Rays in English.

[0096] Please combine Figure 1 and Figure 10 As shown, the cutter head assembly 70 is disposed at the distal end of the sheath tube 10 , and the cutter head assembly 70 includes a claw sleeve 72 , a sleeve 73 and a cutter head 71 . Specifically, the claw sleeve 72 includes a tubular main body portion 721 and a plurality of claw-shaped portions 722 arranged at the distal end of the main body portion 721. The proximal end of the main body portion 721 is bonded and fixed to the sheath tube 10 by UV glue curing. The claw-shaped portion 722 extends along the axial direction of the main body portion 721. The plurality of claw-shaped portions 722 are arranged in sequence at intervals along the circumference of the main body portion 721. Each claw-shaped portion 722 is provided with a limiting protrusion 7221 protruding toward the inner cavity of the main body portion 721. The outer peripheral surface of the cutting head 71 is provided with a limiting groove 711 extending along the circumference of the cutting head 71. The proximal end of the cutting head 71 is rotatably arranged in the claw sleeve 72, and the limiting protrusion 7221 extends into the limiting groove 711. The cooperation between the limiting protrusion 7221 and the limiting groove 711 can limit the axial movement of the cutting head 71 relative to the claw sleeve 72 along the sheath tube 10.

[0097] In this embodiment, the purpose of providing the claw-shaped portion 722 at the distal end of the claw sleeve 72 is to smoothly install the cutter head 71 into the claw sleeve 72. During the process of inserting the cutter head 71 into the claw sleeve 72, the claw-shaped portion 722 can be bent and deformed outward along the circumferential direction of the claw sleeve 72 under the extrusion of the cutter head 71. After the limit protrusion 7221 extends into the limit groove 711, the claw-shaped portion 722 can elastically recover, and through the cooperation of the limit protrusion 7221 and the limit groove 711, it can prevent the cutter head 71 from falling off the claw sleeve 72 during the rotary cutting process, thereby improving the safety of the operation.

[0098] The sleeve 73 is sleeved outside the claw sleeve 72 and the cutter head 71. The sleeve 73 is connected to the claw sleeve 72 by welding, so that the sleeve 73 and the claw sleeve 72 are connected as a whole. The sleeve 73 can provide a supporting force for the claw-shaped portion 722 along the radial direction of the claw sleeve 72, prevent the claw-shaped portion 722 from bending and deforming along the radial direction during the rotation of the cutter head 71, and can further improve the stability of the cutter head 71 during rotation and prevent the cutter head 71 from falling off the claw sleeve 72.

[0099] The torque shaft 53 is disposed through the sheath 10. The cutter head 71 is connected to the distal end of the torque shaft 53 by a laser welding process. The proximal end of the torque shaft 53 extends out of the proximal end of the sheath 10 and sequentially passes through the first tubular portion 611 and the second tubular portion 612 and is connected to the power output mechanism 80. The power output mechanism 80 can drive the torque shaft 53 to rotate, so that the torque shaft 53 drives the cutter head 71 to rotate, so that the cutter head 71 can cut and remove plaques or eccentric calcified lesions inside the blood vessel.

[0100] Both the cutter head 71 and the torque shaft 53 are provided with wire guide holes for the guide wire to pass through. The guide wire can pass through the wire guide holes as a whole, so as to facilitate the intervention of the cutter head assembly 70 and the sheath 10 in the plaque removal device 100 to the lesion site under the guiding action of the guide wire.

[0101] Please refer to Figure 12 and Figure 13As shown, the guide wire locking assembly 90 includes a first locking member 91, a second locking member 92, and an elastic pad 93. The first locking member 91 is tubular and fixed to the proximal end of the handle 20. The first locking member 91 is coaxially arranged with the sheath 10. A first stop step (not shown in the figure) is convexly provided on the inner wall surface of the first locking member 91. External threads are provided on the outer peripheral surface of the first locking member 91. The second locking member 92 is tubular and sleeved outside the first locking member 91. Internal threads that are thread-mated with the external threads are provided on the inner peripheral surface of the second locking member 92. A second stop step 921 is convexly provided on the inner peripheral surface of the second locking member 92. Both ends of the elastic pad 93 are respectively arranged inside the first locking member 91 and the second locking member 92, and the elastic pad 93 is located between the first stop step and the second stop step 921. The elastic pad 93 is provided with a through hole. The guide wire can sequentially pass through the guide wire hole and the through hole. After the cutter head assembly 70 intervenes at the lesion position, by rotating the second locking member 92, the second locking member 92 moves axially relative to the first locking member 91 along the sheath 10, and the first stop step and the second stop step 921 approach each other, so that the first stop step and the second stop step 921 can squeeze the elastic pad 93. Under the squeezing action, the through hole of the elastic pad 93 compresses and deforms to lock the guide wire, preventing the guide wire from rotating together with the cutter head 71 during the operation and causing damage to blood vessels. In this embodiment, the elastic pad 93 is a silica gel pad.

[0102] Please refer to Figure 1 , Figure 4 and Figure 11 As shown, the power output mechanism 80 includes a transmission assembly 81, a first bearing 82, a second bearing 83, a bearing sleeve 84, a motor 85, a wire 86, a switch 87, a switch slider 88, and a storage battery 89. The outer ring of the first bearing 82 is sleeved in the stepped hole of the second tubular portion 612 and fixed to the second tubular portion 612. The outer ring of the second bearing 83 is sleeved in the distal end of the first locking member 91 and fixed to the first locking member 91. The bearing sleeve 84 is sleeved outside the torque shaft 53 and fixedly connected to the torque shaft 53 by laser welding. Both ends of the bearing sleeve 84 are fixedly connected to the inner ring of the first bearing 82 and the inner ring of the second bearing 83 respectively. The motor 85 is fixedly arranged inside the handle 20. The storage battery 89 supplies power to the motor 85 through the wire 86. The motor 85 is turned on through the switch 87, and the rotating shaft of the motor 85 rotates. The rotating shaft of the motor 85 is in transmission connection with the bearing sleeve 84 through the transmission assembly 81 to drive the bearing sleeve 84 to rotate, and then the bearing sleeve 84 drives the torque shaft 53 and the cutter head 71 to rotate, realizing the rotation function of the cutter head 71. In this embodiment, the transmission assembly 81 includes a first gear and a second gear that mesh with each other. The first gear is fixedly connected to the rotating shaft of the motor 85, and the second gear is fixedly connected to the bearing sleeve 84. Among them, the first gear and the second gear are spur gears. Using gear transmission in the transmission device can achieve the stability of transmission and reduce noise at the same time.

[0103] Embodiment 2

[0104] The differences between Embodiment 2 and Embodiment 1 will be described below. For the same or similar parts between Embodiment 2 and Embodiment 1, they will not be elaborated here.

[0105] In this embodiment, please refer to Figure 13 、 Figure 14 and Figure 16 As shown, the rotary connection mechanism 30 includes a rotating member 32, a transmission knob 31, a rotating shaft 33 and a bevel gear pair 36. The rotating member 32 is tubular and sleeved outside the sheath tube 10 and adhered to the sheath tube 10. A limiting rib 205 is provided inside the handle 20. The rotating member 32 is rotatably stuck on the limiting rib 205, so that the rotating member 32 can rotate relative to the handle 20 along the circumferential direction of the sheath tube 10, and the movement of the rotating member 32 along the axial direction of the sheath tube 10 relative to the handle 20 is restricted by the limiting effect of the limiting rib 205. The bevel gear pair 36 includes a first bevel gear 34 and a second bevel gear 35 that mesh with each other. The rotating shaft 33 is rotatably passed through the handle 20. One end of the rotating shaft 33 outside the handle 20 is connected to the transmission knob 31, and one end of the rotating shaft 33 inside the handle 20 is connected to the first bevel gear 34. The second bevel gear 35 is connected to the rotating member 32. By rotating the transmission knob 31, the rotational power can be transmitted to the rotating member 32 through the rotating shaft 33 and the bevel gear pair 36 to drive the rotating member 32 to rotate. The rotating member 32 can drive the sheath tube 10 to rotate relative to the handle 20 around its own axis, so as to adjust the bending direction of the sheath tube 10.

[0106] Please refer to Figure 13 、 Figure 14 and Figure 15 As shown, the bending control mechanism 40 includes a bending knob 411, an intermediate shaft 414, a rocker 412, a connecting rod 413, a first moving member 421 and a second moving member 422. Specifically, the first moving member 421 includes a tubular first main body 4211 and a columnar connecting portion 4213 provided on the outer peripheral surface of the first main body 4211. The first main body 4211 is slidably sleeved outside the sheath tube 10. The first moving member 421 can move axially along the sheath tube 10 relative to the sheath tube 10. The columnar connecting portion 4213 has a cylindrical structure, and the axis of the columnar connecting portion 4213 is perpendicular to the axis of the first main body 4211. The intermediate shaft 414 is rotatably passed through the handle 20. One end of the intermediate shaft 414 outside the handle 20 is connected to the bending knob 411, and one end of the intermediate shaft 414 inside the handle 20 is connected to the rocker 412. Both ends of the connecting rod 413 are pivotally connected to the rocker 412 and the columnar connecting portion 4213 of the first moving member 421 respectively, so that the bending knob 411, the intermediate shaft 414, the rocker 412, the connecting rod 413, the first moving member 421 and the second moving member 422 together form a crank-slider mechanism. By rotating the bending knob 411, the first moving member 421 and the second moving member 422 can be driven to make reciprocating movements along the axial direction of the sheath tube 10.

[0107] Further, the second moving member 422 includes a tubular second main body 4221 and a second sliding structure 42201 provided on the outer peripheral surface of the second main body 4221. The rotating member 32 is provided with a first sliding structure 3201 extending along the axial direction of the sheath 10. The first sliding structure 3201 is a chute extending along the axial direction of the sheath 10. The second sliding structure 42201 is configured as a slider slidably engaged with the second chute. The slider is slidably inserted into the chute. Through the cooperation of the chute and the slider, the second moving member 422 can move axially relative to the rotating member 32 along the sheath 10, but the second moving member 422 and the rotating member 32 remain relatively fixed in the circumferential direction of the sheath 10.

[0108] Wherein, the outer peripheral surface of the first main body 4211 is further provided with a first annular protrusion 4214 and a second annular protrusion 4215 which are spaced apart. An annular groove 4216 is defined between the first annular protrusion 4214 and the second annular protrusion 4215. The outer peripheral surface of the second main body 4221 is provided with a limiting hole 42211 communicating with the inner cavity of the second main body 4221. The second main body 4221 is rotatably sleeved outside the first main body 4211. The limiting hole 42211 and the annular groove 4216 are correspondingly arranged. A pin 423 is fixedly arranged in the limiting hole 42211. One end of the pin 423 extends into the annular groove 4216. Axially along the sheath 10, the pin 423 can respectively engage with the first annular protrusion 4214 and the second annular protrusion 4215 to stop, so that the first moving member 421 can rotate relative to the second moving member 422 in the circumferential direction of the sheath 10, and the first moving member 421 is restricted from moving axially relative to the second moving member 422 along the sheath 10.

[0109] In this embodiment, as Figure 15 and Figure 16 shown, the side surface of the transmission knob 31 facing the housing is provided with a plurality of first strip-shaped protrusions 311, and the side surface of the bending adjustment knob 411 facing the housing is provided with a plurality of second strip-shaped protrusions 415. The first strip-shaped protrusions 311 and the second strip-shaped protrusions 415 are respectively in contact with the surface of the handle 20 housing, realizing the friction fixation effect after pulling the bending wire 51.

[0110] Embodiment 3

[0111] The differences between Embodiment 3 and Embodiment 1 will be described below. For the same or similar parts between Embodiment 3 and Embodiment 1, they will not be repeated here.

[0112] As Figures 17 to 23As shown, the cutter head 71 is fixed on the torque shaft 53 by welding. The claw sleeve 72 is clamped with the cutter head 71 through the claw portion 722, and the sleeve 73 is sleeved outside the claw sleeve 72. Among them, the cutter head 71 includes a cutter base 74, a center seat 741, positioning columns 742, cutting edges 75 and a resilient member 76. The center seat 741 and the positioning columns 742 are both arranged at the distal end of the cutter base 74. The center seat 741 is coaxially arranged with the cutter base 74. At least two positioning columns 742 are arranged on the cutter base 74, and the two positioning columns 742 are respectively arranged on both sides of the center seat 741. When there are more than two positioning columns 742 on the cutter base 74, the multiple positioning columns 742 are circumferentially and evenly arranged on the cutter base 74 with the center seat 741 as the axis. At the root of the cutting edge 75, a socket hole 752 is arranged along its axial direction. The cutting edge 75 is sleeved outside the positioning column 742 through the socket hole 752. The resilient member 76 is arranged on the positioning column 742 and connected with the cutting edge 75. The resilient member 76 is used to drive the cutting edge 75 to rotate circumferentially around the positioning column 742, so as to fold onto the center seat 741. The rotation direction of the resilient member 76 driving the cutting edge 75 is the same as the rotation direction of the torque shaft 53 driving the cutter head 71.

[0113] The center seat 741 includes a first abutting surface 7411 that abuts against the cutting edge 75. The cutting edge 75 includes a second abutting surface 751 that abuts against the center seat 741. When the cutter head 71 is in the unfolded state, the center seat 741 and the cutting edge 75 abut against each other through the first abutting surface 7411 and the second abutting surface 751. At this time, the cutting edge 75 extends along the radial direction of the cutter base 74, so that the cutting edge 75 can cut thrombus or plaque.

[0114] Reinforcing ribs 743 are also arranged on the cutter base 74. The reinforcing ribs 743 are located on the side opposite to the folding direction of the cutting edge 75. The reinforcing ribs 743 are used to support the side surface of the cutting edge 75. When the center seat 741 and the cutting edge 75 abut against each other through the first abutting surface 7411 and the second abutting surface 751, the reinforcing ribs 743 also abut against the side surface of the cutting edge 75 at the same time, so as to further enhance the connection strength between the cutting edge 75 and the cutter base 74.

[0115] Specifically, the resilient member 76 is a torsion spring. The torsion spring is inserted from the positioning column 742, and the position where the bottom of the torsion spring contacts the cutter base 74 is fixed by welding. After the torsion spring is fixed, the cutting edge 75 is sleeved onto the positioning column 742 from the upper part of the torsion spring, and the upper end of the torsion spring is welded and fixed to the cutting edge 75. A stepped hole 753 is arranged at the top end of the socket hole 752. The aperture of the stepped hole 753 is larger than the aperture of the socket hole 752. An end cap 7421 is arranged in the stepped hole 753. After the resilient member 76 and the cutting edge 75 are sequentially connected to the positioning column 742, the end cap 7421 is inserted into the stepped hole 753, and the end cap 7421 is welded and fixed to the positioning column 742 through the welding hole 7422 in the middle of the end cap 7421, so as to realize the assembly of the cutter head 71.

[0116] In this embodiment, the cutter head 71 can retract or deploy the cutting edge 75 according to its stopped or rotating state. When the cutter head 71 is in the initial non-rotating state, the cutting edge 75 of the cutter head 71 is in the default folded state under the elastic force of the elastic member 76. When the switch 87 of the handle 20 is turned on, the cutter head 71 rotates driven by the torque shaft 53, and the cutting edge 75 is thrown outward under the action of the rotational force. In this state, the cutter head 71 can excise thrombus or plaque. When the excision operation is completed, the switch 87 is turned off to stop the rotation of the torque shaft 53, and at this time, the cutting edge 75 returns to the folded state under the torsional force of the elastic member 76.

[0117] Among them, when the cutting edge 75 is in the folded state, the unfolded arc surface of the cutting edge 75 is smaller than the outer diameter of the sleeve 73, which can prevent the cutter head 71 from scraping the inner wall of the blood vessel during pushing or retracting. In particular, when the cutter head 71 passes through the curved blood vessel part, it can prevent the inner wall of the blood vessel from being scratched because the cutting edge 75 abuts against the inner wall of the blood vessel during the movement. When the cutting edge 75 is in the unfolded state, the unfolded arc surface of the cutting edge 75 is greater than or equal to the outer diameter of the sleeve 73, which is convenient for the cutter head 71 to excise plaque or thrombus.

[0118] Among them, the shape of the outer edge of the cutting edge 75 can be a sharp edge to adapt to the excision of thrombus, or it can be selected as a blunt edge to adapt to the excision of plaque.

[0119] A spiral wall 744 is provided on the outer peripheral surface of the cutter base 74. A spiral groove 745 is defined between adjacent spiral walls 744. The spiral groove 745 is used to send the shredded thrombus or plaque excised by the cutting edge 75 into the sheath 10 and discharge it from the blood vessel. The number of spiral walls 744 is greater than or equal to the number of cutting edges 75. In this embodiment, two oppositely arranged cutting edges 75 are provided on the cutter base 74, and at least four circumferentially uniformly arranged spiral walls 744 are provided on the outer peripheral surface of the cutter base 74, and the spiral walls 744 are spirally arranged.

[0120] Among them, when two oppositely arranged cutting edges 75 are provided, the cutting impact force of a single cutting edge 75 on thrombus or plaque is greater, which is beneficial to excise atherosclerotic plaque. Four spiral walls 744 circumferentially uniformly arranged around the cutter base 74 define four spiral grooves 745. When the number of spiral grooves 745 is greater than or equal to four, the more numerous and dense spiral grooves 745 are more conducive to sending the shredded atherosclerotic plaque debris into the sheath 10, so as to adapt to the excision of atherosclerotic plaque in the blood vessel.

[0121] Embodiment 4

[0122] The differences between Embodiment 4 and Embodiment 3 will be described below. The same or similar parts between Embodiment 2 and Embodiment 1 will not be repeated here.

[0123] In this embodiment, asFigure 24 As shown in Figure 25 FIG. 2, three cutting edges 75 are provided on the tool base 74. The three cutting edges 75 are evenly arranged circumferentially around the tool base 74. Three circumferentially evenly arranged spiral walls 744 are provided on the outer peripheral surface of the tool base 74. The spiral walls 744 are arranged in one-to-one correspondence with the cutting edges 75, and the spiral walls 744 and the cutting edges 75 have the same pitch. Among them, the three relatively arranged cutting edges 75 are beneficial to the thrombus tissue in the blood vessel. The three spiral walls 744 corresponding to the cutting edges 75 one by one define three spiral grooves 745. The spiral grooves 745 are not only located between two adjacent spiral walls 744, but also located between two adjacent cutting edges 75, making the conduction path of thrombus fragmentation smoother. The tool head 71 designed in this way is more suitable for the resection of thrombus in the blood vessel.

[0124] Example 5

[0125] The differences between Example 5 and Example 3 will be described below. The same or similar parts between Example 2 and Example 1 will not be elaborated here.

[0126] As Figures 26 to 28 shown in FIG. 3, a second blade part 77 is further provided on the radially outer edge of the cutting edge 75. The second blade part 77 and the cutting edge 75 are connected by a hinge 771. The hinge 771 is arranged on the edge of the cutting edge 75 on the side close to the folding direction of the cutting edge 75. A torsion spring is arranged inside the hinge 771, and the torsion direction of the torsion spring inside the hinge 771 is the same as the torsion direction of the return spring 76. Thus, in the static state of the initial torque shaft 53, the cutting edge 75 and the second blade part 77 are folded under the action of torsion. When the torque shaft 53 rotates to drive the tool head 71 to rotate, the cutting edge 75 and the second blade part 77 are synchronously unfolded, so as to realize the resection of thrombus or plaque.

[0127] In this embodiment, the tool head 71 adopts a double-layer folded cutting edge 75 and a second blade part 77. In the folded state, the unfolded arc surface of the double-layer folded cutting edge 75 and the second blade part 77 is smaller than the unfolded arc surface of the single-layer folded cutting edge 75. Therefore, the outer diameter of the cutting edge 75 and the second blade part 77 after unfolding can be either equivalent to the outer diameter of the sleeve 73 or larger than the outer diameter of the sleeve 73. When the outer diameter of the cutting edge 75 and the second blade part 77 after unfolding is larger than the outer diameter of the sleeve 73, it can better adapt to the situation of more serious blood vessel blockage, that is, the congestion area of thrombus or plaque in the blood vessel is larger than half of the inner diameter of the blood vessel. The doctor can use the tool head 71 to perform the resection of thrombus or plaque in the middle of the blood vessel, especially the resection of plaque.

[0128] When the outer diameter of the cutting edge 75 and the second cutting part 77 of the cutter head 71 after deployment is greater than the outer diameter of the sleeve 73, in order to better center the sheath 10 and avoid the cutting edge 75 of the deployed cutter head 71 from cutting the inner wall of the blood vessel, a centering balloon 78 is provided at the distal end of the sheath 10. The outer diameter of the centering balloon 78 after inflation is smaller than the inner diameter of the target blood vessel and greater than the outer diameter of the cutting edge 75 and the second cutting part 77 after deployment. Thus, it can not only center the sheath 10 to avoid the cutting edge 75 of the cutter head 71 from cutting the inner wall of the blood vessel, but also enable the sheath 10 to move within the blood vessel to achieve the purpose of removing thrombus or plaque, and ensure unobstructed blood flow, avoiding the phenomenon of local ischemia of the patient caused by a long operation.

[0129] The above are only the preferred specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed by the present invention should be covered by the protection scope of the present invention. Therefore, the protection scope of the present invention should be subject to the protection scope of the claims.

Claims

1. A plaque removal device, characterized in that, It includes a sheath tube and a cutter head assembly arranged at the distal end of the sheath tube. The cutter head assembly includes a cutter head, a claw sleeve and a sleeve. The cutter head is assembled on the claw sleeve, and the sleeve is sleeved outside the cutter head and the claw sleeve. The cutter head includes a cutter base, a central seat arranged at the distal end of the cutter base and a cutting edge. The central seat is coaxially arranged with the cutter base, and the cutting edge is arranged on one side of the central seat. The cutting edge can be unfolded or folded relative to the central seat.

2. The plaque removal device according to claim 1, characterized in that, The cutter head further includes positioning posts and a resilient member. At least two positioning posts are arranged at the distal end of the cutter base. At least two positioning posts are circumferentially and evenly arranged around the central seat. The resilient member and the cutting edge are respectively arranged on the positioning posts. Under the elastic force of the resilient member, the cutting edge is folded onto the central seat with the positioning posts as the axis.

3. The plaque removal device according to claim 2, wherein, An insertion hole is axially arranged at the root of the cutting edge. The cutting edge is sleeved outside the positioning posts through the insertion hole. The resilient member is arranged between the positioning posts and the cutting edge. The driving direction of the resilient member for the cutting edge is the same as the rotation direction of the cutter head.

4. The plaque removal device according to claim 3, wherein, The central seat includes a first abutting surface abutting against the cutting edge, and the cutting edge includes a second abutting surface abutting against the central seat. When the cutter head is in the unfolded state, the central seat and the cutting edge are abutted through the first abutting surface and the second abutting surface, so that the cutting edge extends along the radial direction of the cutter base.

5. The plaque removal device according to claim 4, wherein, The cutter head further includes a reinforcing rib arranged on the cutter base. The reinforcing rib is located on the side opposite to the folding direction of the cutting edge and is used to support the cutting edge from the side.

6. The plaque removal device according to claim 2, wherein, A plurality of spiral walls are arranged on the outer peripheral surface of the cutter base. The spiral walls are arranged in a spiral shape. A spiral groove is defined between adjacent spiral walls. The spiral groove is used to send the tissue chopped by the cutter head into the sheath tube.

7. The plaque removal device according to claim 6, characterized in that, Two cutting edges are arranged on the cutter base. The two cutting edges are oppositely arranged on both sides of the central seat. At least four circumferentially and evenly arranged spiral walls are arranged on the outer peripheral surface of the cutter base; or Three cutting edges circumferentially and evenly arranged around the central seat are arranged on the cutter base. Three circumferentially and evenly arranged spiral walls are arranged on the outer peripheral surface of the cutter base. The spiral walls are arranged in one-to-one correspondence with the cutting edges, and the spiral pitch of the spiral walls is the same as that of the cutting edges.

8. The plaque removal device according to any one of claims 3, characterized in that, A second cutting edge part is arranged on the radial outer edge of the cutting edge. The second cutting edge part is connected to the cutting edge through a hinge. A torsion spring is arranged inside the hinge. The torsion direction of the torsion spring is the same as the torsion direction of the resilient member.

9. The plaque removal device according to claim 8, wherein, The outer diameter after the cutting edge and the second cutting edge part are unfolded is greater than the outer diameter of the sleeve. A central balloon is arranged at the distal end of the sheath tube. The outer diameter after the central balloon is inflated is less than the inner diameter of the target blood vessel and greater than the outer diameter after the cutting edge and the second cutting edge part are unfolded.

10. The plaque removal device according to claim 1, wherein, The outer edge shape of the cutting edge can be a sharp edge or a blunt edge.

Images