WO2023125539A1 - 一种切除装置 - Google Patents

一种切除装置 Download PDF

Info

Publication number
WO2023125539A1
WO2023125539A1 PCT/CN2022/142344 CN2022142344W WO2023125539A1 WO 2023125539 A1 WO2023125539 A1 WO 2023125539A1 CN 2022142344 W CN2022142344 W CN 2022142344W WO 2023125539 A1 WO2023125539 A1 WO 2023125539A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
assembly
bending
cutter head
handle body
Prior art date
Application number
PCT/CN2022/142344
Other languages
English (en)
French (fr)
Inventor
黎稳
张�雄
郑迪
房金锋
王泽洋
Original Assignee
先健科技(深圳)有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from CN202111677863.9A external-priority patent/CN116407224A/zh
Priority claimed from CN202111677839.5A external-priority patent/CN116407222A/zh
Priority claimed from CN202111677042.5A external-priority patent/CN116407221A/zh
Priority claimed from CN202111672557.6A external-priority patent/CN116407218A/zh
Priority claimed from CN202111677854.XA external-priority patent/CN116407223A/zh
Priority claimed from CN202111678798.1A external-priority patent/CN116407225A/zh
Application filed by 先健科技(深圳)有限公司 filed Critical 先健科技(深圳)有限公司
Publication of WO2023125539A1 publication Critical patent/WO2023125539A1/zh

Links

Images

Classifications

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

Definitions

  • the invention belongs to the technical field of medical instruments, and in particular relates to a resection device.
  • Peripheral arterial disease is one of the vascular lesions.
  • the main cause of peripheral arterial disease is atherosclerosis, which often manifests as ischemic changes in the extremities, celiac artery, carotid artery, and renal artery.
  • the treatment methods mainly include drug therapy.
  • the main basic treatment includes open surgical treatment represented by classic surgical bypass and newly developed endovascular interventional treatment.
  • peripheral atherectomy is mainly for the stenosis or occlusion of the femoral, popliteal and infra-knee arteries.
  • the existing peripheral atherectomy system has the risk of easily scratching the vessel wall during catheter pushing.
  • the resection system can adjust the bending radius of the distal tube body to make the rotary cutter head deviate at a certain angle, so as to more thoroughly remove the occluded plaque in the blood vessel.
  • the distal end of the catheter will form a certain angle with the blood vessel, which will cause the catheter and the blood vessel to be axially uneven, easily scratch the blood vessel, and even perforate the blood vessel.
  • the purpose of the present invention is at least to solve the problem that the cutting head assembly is easy to scratch the inner wall of the blood vessel when the existing cutting device adjusts the bending catheter.
  • the present invention proposes a resection device, which includes a handle body, a catheter connected to the handle body, and a knife head assembly arranged at the distal end of the catheter, wherein the catheter is provided with a bending assembly, and the bending adjustment
  • the assembly includes a first bend adjustment point, a second bend adjustment point, and a bend adjustment connector for connecting the first bend adjustment point and the second bend adjustment point on the catheter.
  • a control assembly for controlling the bend adjustment assembly is provided.
  • the bending radius of the distal catheter is adjusted by the bending assembly, so that the catheter is deflected in a predetermined direction, and the orientation of the cutter head assembly is controlled to reduce the risk of scratching blood vessels and blood vessel perforation, and can pass multiple times Resection to obtain the ideal vessel diameter.
  • the resection device according to the present invention may also have the following additional technical features:
  • the bending adjustment connector is fixedly connected to the first bending adjustment point
  • the bending adjustment connecting member is movably connected to the second bending adjustment point
  • the first bending adjustment The distance between the bending point and the distal end of the catheter is smaller than the distance between the second bending point and the distal end of the catheter, and the first bending point is set at another position relative to the second bending point. side.
  • the bend adjustment connector includes a bend adjustment control wire
  • the catheter is provided with a control wire cavity for the bend adjustment control wire to pass through, and the second bend adjustment point It is arranged at the far end of the control wire cavity, and the bend adjustment control wire passes through the second bend adjustment point and is fixedly connected to the first bend adjustment point after rotating around the catheter.
  • control assembly includes a control seat arranged on the handle body and a wire retractor movably connected to the control seat
  • the wire retractor is connected to the bending adjustment
  • the control wire is used to pull the bending control wire to adjust the posture of the catheter.
  • the conduit is provided with a torque shaft connected to the cutter head assembly, and the handle body is provided with a driving mechanism for driving the torque shaft to rotate.
  • the cutter head assembly includes a limit seat connected to the conduit and a rotary cutter head arranged on the limit seat, the rotary cutter head is fixedly connected to One end of the torque shaft, which drives the rotary cutter head to rotate, is connected to the limit seat, and the limit seat is provided with a protective sleeve covering the side of the rotary cutter head.
  • the catheter includes an inner tube and an outer tube arranged outside the inner tube, the inner tube is sleeved on the outside of the torque shaft, and the torque shaft is connected to the The inner tube is clearance fit, and a braided layer is arranged between the inner tube and the outer tube.
  • the handle body is provided with a discharge lumen connected to the conduit, and the discharge lumen communicates with the conduit and the external space of the handle body.
  • the torque shaft passes through the discharge cavity and is connected to the driving mechanism
  • the driving mechanism includes a power source for connecting the power source and the torque shaft The drive transmission assembly and the power supply electrically connected to the power source.
  • the discharge lumen includes a main cavity connected to the catheter and a waste discharge pipe disposed on a side of the main cavity, and the torque shaft passes through the main cavity.
  • FIG. 1 is a schematic structural view of a resection device in Embodiment 1 of the present invention.
  • FIG. 2 is a schematic diagram of the internal structure of the handle body in Embodiment 1 of the present invention.
  • Fig. 3 is a schematic structural view of the drive transmission assembly in Embodiment 1 of the present invention.
  • FIG. 4 is a schematic structural view of the cutter head assembly in Embodiment 1 of the present invention.
  • FIG. 5 is a schematic structural view of a catheter in Embodiment 1 of the present invention.
  • FIG. 6 is a schematic structural view of the bending assembly in Embodiment 1 of the present invention.
  • Fig. 7 is a schematic structural view of the bent catheter in Embodiment 1 of the present invention.
  • Embodiment 8 is a schematic diagram of the overall structure of the control assembly in Embodiment 1 of the present invention.
  • Fig. 9 is a sectional view of the control assembly in Embodiment 1 of the present invention.
  • Fig. 10 is a side view of a section of a control assembly in Embodiment 1 of the present invention.
  • Fig. 11 is a schematic diagram of the overall structure of the adjusting module in the first embodiment of the present invention when it is in low-speed cutting;
  • Fig. 12 is a schematic diagram of the overall structure of the regulating module in the first embodiment of the present invention when it is in high-speed cutting;
  • Fig. 13 is a schematic diagram of part of the structure of the adjustment module during low-speed cutting in Embodiment 1 of the present invention.
  • Fig. 14 is a partial structural diagram of the adjustment module during high-speed cutting in Embodiment 1 of the present invention.
  • Fig. 15 is a schematic structural view of the speed control key in Embodiment 1 of the present invention.
  • Fig. 16 is a schematic diagram of the overall structure of the detachable connection part in Embodiment 1 of the present invention.
  • Fig. 17 is an exploded view of the handle body in Embodiment 1 of the present invention.
  • Fig. 18 is a partial structural schematic diagram of the engaging assembly in Embodiment 1 of the present invention.
  • Fig. 19 is a schematic diagram of the connection structure between the handle body and the handle upper cover in Embodiment 1 of the present invention.
  • Fig. 20 is a schematic diagram of the connection structure between the handle body and the driving mechanism in Embodiment 1 of the present invention.
  • Fig. 21 is a partial structural schematic diagram of the engaging assembly in Embodiment 1 of the present invention.
  • Fig. 22 is a schematic structural view of the catheter and the bending assembly in Embodiment 2 of the present invention.
  • Fig. 23 is a schematic diagram of the overall structure of the handle body in Embodiment 3 of the present invention.
  • Fig. 24 is a schematic diagram of the internal structure of the control assembly in Embodiment 3 of the present invention.
  • Fig. 25 is a schematic diagram of the overall structure of the handle body in Embodiment 4 of the present invention.
  • Fig. 26 is a schematic diagram of the internal structure of the control assembly in Embodiment 4 of the present invention.
  • Fig. 27 is a partial structural schematic diagram of the control assembly in Embodiment 4 of the present invention.
  • Fig. 28 is a schematic perspective view of the three-dimensional structure of the handle body in Embodiment 5 of the present invention.
  • Fig. 29 is a schematic diagram of the internal structure of the handle body in Embodiment 5 of the present invention.
  • Fig. 30 is an exploded view of the handle body in Embodiment 5 of the present invention.
  • Fig. 31 is a partial structural schematic diagram of the catheter in Embodiment 5 of the present invention.
  • Fig. 32 is an enlarged view at A of Fig. 29 in Embodiment 5 of the present invention.
  • Fig. 33 is an enlarged view at B of Fig. 29 in Embodiment 5 of the present invention.
  • first, second, third, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be referred to as These terms are limited. These terms may be only used to distinguish one element, component, region, layer or section from another region, layer or section. Terms such as “first,” “second,” and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context.
  • spatial relative terms may be used herein to describe the relationship of one element or feature as shown in the figures with respect to another element or feature, such as “inner”, “outer”, “inner”. “, “Outside”, “Below”, “Below”, “Above”, “Above”, etc.
  • Such spatially relative terms are intended to encompass 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 turned over, elements described as “below” or “beneath” other elements or features would then be oriented “above” or “beneath” the other elements or features. feature above”. Thus, the example term “below” can encompass both an orientation of above and below.
  • the device may be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.
  • proximal and distal refers to the end near the operator, “distal” refers to the end away from the operator, and the phrase “axial “Direction” in this patent should be understood as the direction in which the intervention element is pushed and pushed out, and the direction perpendicular to the "axial direction” is defined as the "radial direction”.
  • Embodiment 1 of the present invention proposes a resection device, as shown in FIGS.
  • a torque shaft 210 connected to the cutter head assembly 300 is disposed inside.
  • the catheter 200 is provided with a bend adjustment assembly 220 for adjusting the distal end of the catheter 200
  • the handle body 100 is provided with a driving mechanism 400 detachably connected to the handle body 100 .
  • the driving mechanism 400 includes a driving module 410 for driving the torque shaft 210 to rotate and an adjusting module 420 for controlling the driving module 410 to adjust the torque of the torque shaft 210 .
  • the bending radius of the distal catheter 200 is adjusted by the bending assembly 220, so that the catheter 200 is shifted toward a predetermined direction, and the orientation of the cutter head assembly 300 is controlled to reduce the risk of scratching blood vessels and blood vessel perforation, which can be obtained by multiple resections.
  • Ideal blood vessel diameter at the same time, an adjustment module 420 for adjusting the torque of the torque shaft 210 is provided, so that when the atherectomy device removes a hard plaque, the torque of the torque shaft 210 can be adjusted to make the plaque excision more smooth ;
  • the driving mechanism 400 can be recycled, reducing the cost of using the atherectomy device.
  • the cutter head assembly 300 includes a limit seat 310 connected to the conduit 200 and a rotary cutter head 320 arranged on the limit seat 310 , the rotary cutter head 320 is fixedly connected to the torque shaft 210 At one end, the torque shaft 210 drives the rotary cutter head 320 to rotate and is connected to the limit seat 310 , and the limit seat 310 is provided with a protective cover 330 covering the side of the rotary cutter head 320 .
  • the catheter 200 includes an inner tube 230 and an outer tube 240 arranged on the outside of the inner tube 230.
  • the inner tube 230 is sleeved on the outside of the torque shaft 210.
  • the torque shaft 210 and the inner tube 230 are clearance fit.
  • the torque shaft 210 It runs through the entire lumen of the inner tube 230 .
  • a braided layer 250 is disposed between the inner tube 230 and the outer tube 240, wherein the braided layer 250 is specifically a braided mesh, and the braided mesh is formed by weaving nickel-titanium wires.
  • the inner tube 230 and the outer tube 240 are connected by the braided layer 250, thereby enhancing the toughness of the catheter 200, and when the catheter 200 penetrates into a branch blood vessel or passes through a curved part of a blood vessel, the catheter 200 will not be partially concave and bent , which can ensure the integrity of the lumen of the catheter 200 and ensure the passage of the resected plaque so that the plaque will not be blocked at the bend of the catheter 200 .
  • the rotary cutter head 320 is fixed on the end of the torque shaft 210 by welding, and the torque shaft 210 rotates to drive the rotary cutter head 320 to rotate.
  • the rotary cutter head 320 is provided with a cutter head slot 321, and the far end of the limit seat 310 is provided with a limit boss 311, and the limit boss 311 is engaged with the cutter head groove 321, thereby realizing the rotation of the rotary cutter head 320.
  • the rotary cutter head 320, the limit seat 310 and the protective cover 330 are all made of stainless steel.
  • the distal end of the limiting seat 310 is provided with an elastic elastic piece 312 , and the limiting boss 311 is arranged on the elastic piece 312 .
  • the cutter head assembly 300 is made of hard metal as a whole, the assembly process of the rotary cutter head 320 and the limiting seat 310 is complicated.
  • an elastic piece 312 is provided at the far end of the limiting seat 310 , and the elastic piece 312 is elastic and can be elastically deformed during assembly, so that the limiting boss 311 can be smoothly inserted into the cutter head slot 321 .
  • the protective cover 330 is set on the outside of the limit seat 310, and the protective cover 330 is close to the outer surface of the limit seat 310. Therefore, after the assembly of the protective cover 330 is completed, the shrapnel 312 is limited between the rotary cutter head 320 and the protective cover. 310, so as to complete the clamping fit between the limit boss 312 and the cutter head slot 321, and then realize the axial and radial limit between the rotary cutter head 320 and the limit seat 310.
  • the catheter 200 includes an inner tube 230 , a braided layer 250 and an outer tube 240 sequentially from the inside to the outside, and the inner tube 230 , the braided layer 250 and the outer tube 240 are formed as a whole by thermal fusion. Further, the distal end of the catheter 200 is provided with a spring tube 260, and the spring tube 260 is sleeved on the outside of the braided layer 250, or the braided layer 250 is sleeved on the outside of the spring tube 260, and the spring tube 260 is welded to the braided layer 250. Axially fixed. In this embodiment, the spring tube 260 is sleeved on the outer side of the braided layer 250 . By disposing the spring tube 260 at the distal end of the catheter 200, the compliance and resilience of the distal end of the catheter 200 are enhanced. In other embodiments, the spring tube 260 can also be embedded in the outer tube 240 .
  • the braided layer 250 since the braided layer 250 has good bending resistance, the spring tube 260 has good torque resistance. Therefore, the braided layer 250 is arranged in the catheter 200, and the spring tube 260 is arranged at the distal end of the catheter 200, so that the distal end of the catheter 200 can take into account the performance of bending resistance and torque resistance.
  • the braid 250 and the spring tube 260 avoids local concave deformation of the catheter 200 due to bending, and can maintain the deformation of the lumen of the catheter 200 when the catheter 200 is bent, ensuring that the catheter 200 and the torque shaft 210 The gap between them is enough to pass the plaque or thrombus to ensure the smooth operation. At the same time, it can also maintain good blood vessel passability, so that the catheter 200 can enter more complicated and curved blood vessels more smoothly.
  • the protective cover 330 and the outer tube 240 are fixed by thermal fusion, and the outer tube 240 is a TPU tube or a Pebax tube.
  • the outer tube 240 is made of Pebax material.
  • a buffer sleeve 270 is provided on the catheter 200, and the catheter 200 is connected to the handle body 100 through the buffer sleeve 270. It is made of TPU, or other rubber or plastic materials.
  • the buffer sleeve 270 is set as a soft material, which can eliminate the vibration of the catheter 200 during rotary cutting, and the vibration transmitted to the handle body 100 will be significantly reduced, thereby providing conditions for the fine operation of the operator.
  • the driving mechanism 400 further includes a driving housing 430 , a power source 411 and a drive transmission assembly 412 for connecting the power source 411 and the torque shaft 210 .
  • the adjustment module 420 includes an adjustment transmission assembly 421 connected to the drive transmission assembly 412 and a shift assembly 422.
  • the shift assembly 422 is used to control the cooperation between the adjustment transmission assembly 421 and the drive transmission assembly 412 to adjust the torque of the torque shaft 210.
  • the drive housing The body 430 is provided with a power supply assembly 413 for driving the power source 411 .
  • the power source 411 is a motor disposed in the driving housing 430
  • the power supply assembly 413 is a battery disposed in the driving housing 430
  • the battery is electrically connected to the motor.
  • the power supply assembly 413 supplies power to the power source 411
  • the power source 411 drives the torque shaft 210 to rotate through the drive transmission assembly 412, and the torque shaft 210 rotates to rotate the rotary cutter head 320 disposed at the distal end, thereby removing plaque in the blood vessel.
  • the handle body 100 is also provided with a switch 160 through which the working state of the motor is controlled.
  • a power supply assembly 413 for connecting to an external power supply and electrically connected to the power source 411 may also be provided on the driving housing 430 . That is, when it is necessary to drive the power source 411 to work, an external power source is connected through the power supply assembly 413 , and the power supply assembly 413 includes a power socket provided on the drive housing 430 . By providing a power socket, the difficulty and cost of sterilization of the handle body 100 and internal components can be reduced, and the weight and transportation difficulty of the whole machine can be reduced.
  • the handle body 100 is provided with a discharge lumen 500 connected to the conduit 200 , the discharge lumen 500 communicates with the outer space of the conduit 200 and the handle body 100 , and the torque shaft 210 passes through the discharge lumen 500 And connected to the drive mechanism 400 .
  • the discharge lumen 500 includes a main cavity 510 connected to the catheter 200 and a waste tube 520 arranged on the side of the main cavity 510.
  • the torque shaft 210 passes through the main cavity 510 and communicates with the external space of the handle body 100.
  • the torque shaft 210 A guide wire cavity 211 passing through the torque shaft 210 is disposed inside.
  • the torque shaft 210 is arranged in a helical shape.
  • the motor drives the torque shaft 210 to rotate. Since the torque shaft 210 is arranged in a helical shape, the torque shaft 210 can bring the plaque tissue back out of the catheter 200 during the rotation.
  • the guide wire lumen 211 in the torque shaft 210 is used to penetrate the guide wire, and the guide wire is used to extend into the blood vessel or branch blood vessel before the catheter 200 is inserted into the blood vessel or moved, so as to establish the access path of the catheter 200, so that the catheter 200 Able to move along the access pathway established by the guide wire.
  • the proximal end of the outer tube 240 is glued and fixed to the main lumen 510, and the plaque tissue excised by the rotary cutter head 320 passes through the gap between the torque shaft 210 and the inner tube 230, and is released from the catheter along with the rotation of the torque shaft 210. 200 is discharged into the discharge channel 500 , the main cavity 510 of the discharge channel 500 temporarily accommodates the resected plaque tissue, and finally the plaque tissue is discharged through the waste discharge tube 520 .
  • the waste discharge tube 520 is arranged near the proximal end of the main cavity 510 and is arranged obliquely along the direction of plaque removal, so as to facilitate the discharge of the plaque.
  • the handle body 100 is provided with a control assembly 140 for controlling the bend adjustment assembly 220 , and the bend adjustment assembly 220 includes at least two bend adjustment points 221 and a The bend connector 222 at point 221.
  • the control assembly 140 includes a control seat 141 disposed on the handle body 100 and a wire retractor 142 movably connected to the control seat 141.
  • the wire retractor 142 is used for connecting the bending adjustment connector 222 and for pulling The connecting piece 222 is bent to adjust the posture of the catheter 200 .
  • the bend adjustment point 221 includes a first bend adjustment point 2213 and a second bend adjustment point 2214 arranged on the catheter 200, the bend adjustment connector 222 is fixedly connected to the first bend adjustment point 2213, and the bend adjustment connector 222 is connected to the second bend adjustment point 2214.
  • the bending point 2214 is movably connected, the distance between the first bending point 2213 and the distal end of the catheter 200 is smaller than the distance between the second bending point 2214 and the distal end of the catheter 200, and the first bending point 2213 is arranged at a distance relative to the second The other side of the bending point 2214.
  • the bend adjustment connector 222 includes a bend adjustment control wire 2225.
  • the catheter 200 is provided with a control wire cavity 2226 for the bend adjustment control wire 2225 to pass through.
  • the second bend adjustment point 2214 is arranged at the far end of the control wire cavity 2226.
  • the wire 2225 passes through the second bending point 2214 and is fixedly connected to the first bending point 2213 after rotating around the catheter 200 .
  • the first bending point 2213 and the second bending point 2214 are set with a difference of 180 degrees in the circumferential direction.
  • a control wire lumen 2226 is disposed inside the catheter 200 , and the control wire lumen 2226 can be disposed inside the outer tube 240 or inside the inner tube 230 .
  • the first bending point 2213 is a fixed point fixedly arranged on the braided layer 250 , and is fixedly connected with the bending control line 2225 through the fixed point, and the second bending point 2214 is the distal end point of the control line cavity 2226 .
  • the first bending point 2213 is a fixing ring welded and fixed on the braided layer 250, and the fixing ring presses and fixes the bending control line 2225 on the braiding layer 250, or the bending control line 2225 and the fixing ring Welding fixed.
  • the first bending point 2213 is a fixing ring welded and fixed on the braided layer 250, and the fixing ring presses and fixes the bending control line 2225 on the braiding layer 250, or the bending control line 2225 and the fixing ring Welding fixed.
  • One end of the bending control line 2225 is connected to the wire take-up device 142, and the other end of the bending control line 2225 first passes through the control line cavity 2226, and then spirally rotates 180 degrees along the gap between the inner tube 230 and the braid 250, Fixed on the first bending point 2213.
  • the rotation angle of the bending control line 2225 can also be 170 degrees or 190 degrees, as long as the second bending point 2214 is relatively set on the opposite side of the first bending point 2213, it can be ensured that after the bending, the cutter head Assembly 300 is generally oriented in the same direction as catheter 200 .
  • the axial length of the helical part of the bending control line 2225 protruding from the second bending point 2214 and fixed between the first bending points 2213 is set to be 1 to 3 times the outer diameter of the outer tube 240 . If the axial length between the first bending point 2213 and the second bending point 2214 is too long, the bending effect will be poor. If the axial length between the first bending point 2213 and the second bending point 2214 is too short, the stress required for bending will be too large, which is not conducive to operation. Therefore, in this embodiment, the axial length of the helical part of the bending control line 2225 protruding from the second bending point 2214 and fixed between the first bending point 2213 is set to be twice the outer diameter of the outer tube 240 .
  • the present embodiment controls the bending control wire 2225 to move in the control wire cavity 2226 or the inner tube 230 by adjusting the wire take-up device 142, since the bending control wire 2225 spirally rotates 180 degrees along the inner tube 230 at the distal end of the catheter 200 Therefore, when controlling the contraction of the bending control line 2225, the bending control line 2225 has both axial force and radial force on the distal end of the catheter 200, thereby controlling the axial and radial displacement of the cutter head assembly 300, so Make the cutter head assembly 300 realize S-shaped bending.
  • the axial direction of the cutter head assembly 300 and the catheter 200 can be kept in the same direction, reducing the risk of the cutter head assembly 300 scratching the vessel wall.
  • the cutter head assembly 300 removes the plaque in the blood vessel before and after the bending adjustment, so that the blood vessel can obtain a larger lumen.
  • the control assembly of this embodiment includes a control seat arranged on the handle body and a wire retractor movably connected to the control seat, and the wire retractor includes a locking member 1421 for self-locking.
  • the handle body 100 is provided with a control groove 150, the control assembly 140 is arranged in the control groove 150, one end of the control groove 150 is provided with a push rod 151, the end of the control seat 141 facing the push rod 151 is provided with a top groove 1411, and the end of the control seat 141 is provided with a top groove 1411.
  • the other end is rotatably connected to the other end of the control groove 150 . Therefore, the control seat 141 is axially fixed in the control groove 150 through the cooperation of the top groove 1411 and the ejector rod 151 , and the control seat 141 can be rotatably connected to the handle body 100 through the cooperation of the top groove 1411 and the ejector rod 151 .
  • the wire take-up 142 is disposed in the control seat 141 , and the wire take-up 142 is provided with a clamping portion 143 for clamping the bending control wire 2225 .
  • the locking member 1421 is an internal thread provided on the inner wall of the control seat 141 and an external thread provided on the outer wall of the wire take-up device 142. Cooperate with the external thread on the wire take-up as a self-locking thread. After the doctor loosens the wire take-up, the wire take-up will not move relative to the control seat due to the relative self-locking of the internal thread and the external thread, thereby realizing the self-locking of the wire take-up.
  • a slide bar 144 is arranged inside the control seat 141, and the slide bar 144 is arranged along the axial direction of the control seat 141.
  • the wire take-up 142 is slidably connected to the slide bar 144, and a rotation limiting surface is arranged between the slide bar 144 and the wire take-up 142. 1441, so that the wire take-up device 142 can translate along the length direction of the slide bar 144, and cannot rotate relative to the slide bar 144, that is, a screw linkage relationship is formed.
  • the wire take-up device 142 can slide on the slide bar 144 and move relative to the control seat 141 under the linkage of the screw fit, and the wire take-up device 142 clamps the bending adjustment control line 2225, and the bending adjustment control line 2225
  • the wire 2225 follows the wire retractor 142 and moves relative to the handle body 100 , thereby controlling the catheter 200 to perform a bending action.
  • the drive transmission assembly 412 includes a first transmission member 4121 connected to the torque shaft 210 , a second transmission member 4122 connected to the power source 411 , and a drive housing
  • the third transmission member 4123 on the body 430 is connected between the first transmission member 4121 and the second transmission member 4122 .
  • the adjustment transmission assembly 421 includes a fourth transmission member 4211 coaxially arranged with the second transmission member 4122 and a fifth transmission member 4212 coaxially arranged with the third transmission member 4123 .
  • the driving wheel shaft 4221 of the output shaft of the power source 411 and the lever 4222 connected to the driving wheel shaft 4221, the third transmission member 4123 and the fifth transmission member 4212 are all arranged on the driving wheel shaft 4221, and the driving wheel shaft 4221 is slidingly connected and synchronized with the output shaft Rotation; the lever 4222 is used to drive the second transmission member 4122 to connect with the third transmission member 4123 or to drive the fourth transmission member 4211 to connect with the fifth transmission member 4212 .
  • the transmission elements in this embodiment are all gears.
  • the power source 411 is a motor
  • the first transmission member 4121 is an output gear connected to the torque shaft 210
  • the second transmission member 4122 is a driving gear connected to the motor
  • the third transmission member 4123 is an output gear arranged on the drive housing 430. Transmission gear.
  • the driving gear, the transmission gear and the output gear are sequentially meshed and connected.
  • the adjustment transmission assembly 421 of this embodiment is provided with a second set of gear assemblies, that is, the fourth transmission member 4211 and the fifth transmission member 4212 .
  • the fourth transmission member 4211 is a large speed-regulating gear arranged coaxially with the second transmission member 4122
  • the fifth transmission member 4212 is a small speed-regulating gear arranged coaxially with the third transmission member 4123 .
  • the fourth transmission member 4211 and the second transmission member 4122 are both arranged on the driving wheel shaft 4221, the motor directly drives the output shaft to rotate, and the driving wheel shaft 4221 is slidably connected to the output shaft of the motor and rotates synchronously with the output shaft of the motor.
  • the fifth transmission member 4212 is connected to the third transmission member 4123 through the driven wheel shaft 4224 , and the fifth transmission member 4212 and the third transmission member 4123 rotate coaxially through the driven wheel shaft 4224 .
  • the driving wheel shaft 4221 is fixedly connected with the driving lever 4222 , and the end of the driving lever 4222 is provided with a speed regulating key 4223 , and the speed regulating key 4223 is slidably connected to the handle body 100 .
  • the drive housing 430 is provided with a low-speed limiting groove 4113 and a high-speed limiting groove 4113.
  • the speed regulating key 4223 is located in the low-speed limiting groove 4113, and the first The second transmission member 4122, the third transmission member 4123 and the first transmission member 4121 are sequentially meshed and connected.
  • the specific working principle of the driving module 410 in this embodiment is as follows: when the power source 411 works and drives the second transmission member 4122 to rotate through the power source 411, that is, the motor starts to run and drives the second transmission member 4122 to rotate.
  • the second transmission member 4122 transmits the rotational speed to the third transmission member 4123 by meshing with the third transmission member 4123, and the third transmission member 4123 transmits the speed to the first transmission member 4121 by meshing with the first transmission member 4121, and the first transmission member
  • the 4121 then transmits the speed to the torque shaft 210, and the torque shaft 210 drives the rotary cutter head 320 to rotate to complete the low-speed cutting.
  • the rotational speed of the torque shaft is relatively low, and the torque is relatively large.
  • the number of teeth of the fourth transmission member 4211 is greater than the number of teeth of the second transmission member 4122
  • the number of teeth of the fifth transmission member 4212 is smaller than the number of teeth of the third transmission member 4123 . Therefore, the rotation speed of the fifth transmission member 4212 is higher in the transmission state where the fourth transmission member 4211 is engaged with the fifth transmission member 4212 than in the transmission state where the second transmission member 4122 is engaged with the driven gear.
  • the third transmission member 4123 meshes with the first transmission member 4121, thereby The rotation speed of the first transmission member 4121 is higher, and the high-speed cutting of the rotary cutter head 320 is completed.
  • the rotational speed of the torque shaft is higher and the torque is less.
  • doctors can choose high-speed gear to maximize the efficiency of plaque removal.
  • the doctor can choose a low gear to increase the torque of the torque shaft 210, Prevent plaque or thrombus from passing through the bending part of the catheter 200, ensure that the catheter 200 will not be blocked, and prevent the rotary cutter head 320 from being stuck, so as to ensure the smooth progress of the operation.
  • an additional gear assembly can also be provided to increase the number of adjustable gears, for example, to realize three gears adjustable, thereby providing doctors with more choices.
  • speed regulation scheme is only an example, and any mechanical structure capable of adjusting the torque of the torque shaft falls within the protection scope of the present application.
  • the output torque of the torque shaft can be dynamically controlled by dynamically adjusting the output power of the external power supply, so as to ensure the stability of use.
  • the handle body 100 is provided with an assembly part 110 for assembling the drive mechanism 400.
  • the drive mechanism 400 includes a drive housing 430 for accommodating the drive module 410 and the adjustment module 420.
  • the drive housing A detachable connection part 130 is provided between the body 430 and the assembly part 110 .
  • a sealing structure 4124 is provided between the drive transmission assembly 412 and the handle body 100 .
  • the driving mechanism 400 through the detachable design of the driving mechanism 400, firstly, it provides convenience for pre-sterilization, and can separately sterilize the power supply component 413 in the driving mechanism 400, which is difficult to sterilize, and then quickly carry out the sterilization by disassembling the connecting part 130. Assembling reduces the difficulty of sterilization and the speed of production and assembly of the resection device as a whole, and improves production efficiency. Secondly, after the resection device is used, the disassembled parts can be used again within the scope allowed by medical regulations, which improves the utilization rate of the parts and reduces the use cost. In addition, after the resection device is used, each component can be disassembled quickly, and can be sorted, recycled and scrapped flexibly according to medical specifications, reducing the difficulty and cost of recycling.
  • the dismounting connection part 130 includes a hook assembly 131 and a snap assembly 132 arranged between the assembly part 110 and the drive housing 430, the hook assembly 131 and the snap assembly 132 are respectively arranged at both ends of the assembly part 110, and the drive housing An ejector 133 is disposed between the bottom of the assembly part 110 and the assembly part 110 .
  • the assembly portion 110 is an assembly groove provided on the handle body 100 for installing the driving mechanism 400
  • the driving mechanism 400 is disposed in the assembly portion 110
  • the driving mechanism 400 is detachably connected to the handle body 100 .
  • the driving mechanism 400 is detachably connected to the assembly part 110 through the driving housing 430 , so as to realize the detachable replacement of the driving mechanism 400 as a whole.
  • the driving module 410 and the adjusting module 420 are installed in the driving housing 430 .
  • the driving mechanism 400 is configured as a detachable structure as a whole, so that the driving mechanism 400 can be recycled under the condition of compliance. Moreover, the driving mechanism 400 and the handle body 100 can be sorted and recycled according to medical use regulations.
  • the engaging component 132 is disposed at the proximal end of the handle body 100
  • the hooking component 131 is disposed at the distal end of the handle body 100
  • the engaging assembly 132 includes a locking pin 1321 slidably connected to the drive housing 430 and a locking key 1322 arranged on the locking pin 1321.
  • the locking key 1322 is integrally formed with the locking pin 1321, or the locking pin 1321 is integrated with the locking pin 1321.
  • the tight key 1322 is bonded and fixed after separate molding.
  • the inner wall of the assembly part 110 is provided with a locking hole 1323 for engagement with the locking pin 1321, the user can drive the locking pin 1321 to move by turning the locking key 1322, and control the locking pin 1321 to insert into the locking hole 1323 To realize the fixing of the locking pin 1321 and the locking hole 1323 , or control the locking pin 1321 to disengage from the locking hole 1323 so as to realize the separation of the locking pin 1321 and the locking hole 1323 .
  • the locking pin 1321 is inserted into the locking hole 1323 , the driving mechanism 400 and the assembly part 110 are in a fixed state, and when the locking pin 1321 is out of the locking hole 1323 , the driving mechanism 400 and the assembly part 110 are in a separated state.
  • the bottom of the locking key 1322 is provided with a locking clip 1324
  • the surface of the drive housing 430 is provided with a locking and fixing groove 1325 and a separation and fixing groove 1326, and the separation and fixing groove 1326 is set away from the locking hole 1323 relative to the locking and fixing groove 1325,
  • the locking fixing groove 1325 and the separating fixing groove 1326 are respectively used to engage and fix with the locking clip 1324 .
  • an ejecting member 133 for ejecting the driving mechanism 400 is disposed between the driving housing 430 and the bottom of the assembly part 110 , and the ejecting member 133 is preferably a spring. That is, when the locking pin 1321 is disengaged from the locking hole 1323 , the pop-up member 133 automatically pops up the driving mechanism 400 from the assembly portion 110 , so that it is convenient for the user to take out the driving mechanism 400 .
  • the hooking assembly 131 is arranged on the other end of the driving housing 430 opposite to the locking pin 1321.
  • the hooking assembly 131 includes a hook 1311 arranged on the distal end surface of the driving housing 430 and an inner surface of the assembly part 110 connected to the hook 1311. Hook slot 1312 for hook connection.
  • the hook 1311 is hooked and connected with the hook groove 1312 at first, so that the far end of the driving mechanism 400 is fixed to the assembly part 110, and then the locking key of the engaging assembly 132 1322 is inserted into the locking hole 1323 to realize the fixing of the distal end of the driving mechanism 400 and the assembly part 110 .
  • the locking key 1322 of the engaging assembly 132 is separated from the locking hole 1323 at first, so that the proximal end of the driving mechanism 400 is separated from the assembly part 110, and then the hook 1311 is removed from the hook. Take it out from the hanging slot 1312 to realize the separation of the distal end of the driving mechanism 400 from the assembly part 110 .
  • the handle body 100 is further provided with a handle upper cover 120 detachably connected to the handle body 100 and disposed outside the driving mechanism 400 .
  • the far end of the handle upper cover 120 and the hooking groove 1312 of the handle body 100 are fixed through an engaging structure, and the far end of the handle upper cover 120 is provided with an upper cover latch 123 , wherein the upper cover latch 123
  • the socket is connected to the hooking groove 1312 .
  • the proximal end of the handle upper cover 120 is provided with an inserting plate 121 , and the inserting plate 121 is arranged between the drive housing 430 and the hooking groove 1312 , and the inserting plate 121 is provided with an insertion hole 122 matched with the locking pin 1321 .
  • the handle body 100 is attached to the drive housing 430 and installed, and then the locking key 1322 is operated to move toward the locking hole 1323 .
  • the locking key 1322 passes through the insertion hole 122 on the insert plate 121 first, and then is inserted into the indentation hole, so as to achieve the purpose of fixing the handle upper cover 120 and the driving mechanism 400 on the handle body 100 at the same time.
  • the driving mechanism 400 is protected by setting the handle upper cover 120 on the driving mechanism 400 to prevent the driving mechanism 400 from being damaged due to factors such as external collisions.
  • the relevant disassembled parts can be sorted, recycled and scrapped according to relevant physiotherapy regulations.
  • the bending assembly 220 is arranged at the distal end of the handle body 100, so as to facilitate the operation of the doctor during the operation.
  • the buffer sleeve 270 is connected, and the proximal end of the catheter 200 is fixed to the discharge lumen 500 provided in the middle of the handle body 100 .
  • the discharge lumen 500 is arranged in the middle of the handle body 100, the torque shaft 210 runs through the handle body 100, the torque shaft 210 first passes through the catheter 200 and penetrates the main cavity 510 from the catheter 200, the plaque or thrombus sent out from the catheter 200 It falls into the main cavity 510 and is discharged from the waste discharge tube.
  • the waste discharge tube is inclined relative to the main cavity 510 to facilitate the discharge of plaque or thrombus.
  • the torque shaft 210 passes through the discharge cavity 500 and is connected to the handle body 100 through a bearing.
  • the guide wire cavity 211 of the torque shaft 210 is connected to the outer space of the handle body 100, so that the guide wire passes through the guide wire cavity 211 to penetrate the torque shaft 210 and pass through the distal end of the torque shaft 210, thereby establishing a passage for the catheter 200 to enter the blood vessel.
  • the driving mechanism 400 is disposed above the catheter 200 and the discharge lumen 500 , and the drive transmission assembly 412 is disposed at the proximal end of the discharge lumen 500 and connected with the torque shaft 210 . Therefore, the plaque or thrombus is discharged from the handle body 100 through the discharge channel 500 provided at the distal end of the drive transmission assembly 412 , and the plaque or thrombus will not contact the drive transmission assembly 412 .
  • a sealing design is adopted between the driving transmission assembly 412 and the discharge chamber 500, that is, a sealing structure 4124 is provided between the first transmission member 4121 and the handle body 100, and the sealing structure 4124 includes a rolling bearing fixed on the handle body 100 and a sealing structure for sealing.
  • the sealing ring of the rolling bearing, the torque shaft 210 passes through the rolling bearing, and is fixedly and sealingly connected with the rolling bearing.
  • the gap between the torque shaft 210 and the rolling bearing can be filled with solder and fixed by welding, and then the rolling bearing and the handle body 100 can be sealed by a sealing ring. Therefore, the driving mechanism 400 of this embodiment can be kept clean after use, so that it is easy to recycle and can be reused.
  • the present application uses the bending assembly 220 to adjust the bending radius of the distal catheter 200, so that the catheter 200 is shifted toward a predetermined direction, and the orientation of the cutter head assembly 300 is controlled to reduce the risk of scratching blood vessels and blood vessel perforation.
  • the ideal vascular diameter was obtained by resection.
  • an adjustment module 420 for adjusting the torque of the torque shaft 210 is provided, so that when the atherectomy device excises hard plaques, the torque of the torque shaft 210 can be adjusted to make plaque excision more smooth.
  • the driving mechanism 400 detachably connected to the handle body 100, the driving mechanism 400 can be used repeatedly, reducing the use cost of the atherectomy device.
  • Embodiment 2 of the present invention proposes a resection device, as shown in FIG. 22 , and the similarities between Embodiment 2 and Embodiment 1 will not be repeated.
  • the difference between Embodiment 2 and Embodiment 1 is that the bending point 221 includes a bending adjustment fixing part 2211 arranged on the catheter 200 and a return fixing part 2212 arranged on the cutter head assembly 300.
  • the bending adjustment connecting part 222 is used to connect the bending adjustment fixing part 2211 and the return fixing part 2212.
  • the fixing part 2212 is arranged at the proximal end of the cutter head assembly 300 , and the bending adjustment fixing part 2211 is arranged on the other side of the catheter 200 relative to the return fixing part 2212 .
  • the bend adjustment connector 222 includes a bend adjustment connection line 2221 and a return connection line 2222.
  • the catheter 200 is provided with a bend adjustment line cavity 2223 for the bend adjustment connection line 2221 to pass through and a return position for the return connection line 2222 to pass through. Wire lumen 2224.
  • the bending adjustment connecting line 2221 is used to connect the control assembly 140 and the bending adjustment fixing part 2211
  • the return connecting line 2222 is used to connect the control assembly 140 and the returning fixing part 2212 .
  • the return fixing part 2212 is arranged at the proximal end of the cutter head assembly 300 , and the bending adjustment fixing part 2211 is arranged on the other side of the catheter 200 relative to the return fixing part 2212 .
  • the bending adjustment fixing part 2211 is arranged on the other side of the catheter 200 relative to the return fixing part 2212 , and preferably the bending adjustment fixing part 2211 and the return fixing part 2212 are arranged at a difference of 180 degrees in the circumferential direction.
  • the catheter 200 is provided with a bending line cavity 2223 and a return line cavity 2224 , and the bending line cavity 2223 and the return line cavity 2224 are both arranged in the outer tube 240 or between the outer tube 240 and the braid 250 .
  • One end of the bending adjustment connecting wire 2221 is connected to the bending adjustment fixing member 2211 , and then passes through the bending adjustment wire cavity 2223 , and the other end is connected to the control assembly 140 .
  • One end of the return connection line 2222 is connected to the bending adjustment fixture 2211 , and then passes through the return line cavity 2224 , and the other end is connected to the control assembly 140 .
  • the bend adjustment connecting line 2221 and the return connecting line 2222 are respectively fixed on the wire take-up device 142.
  • the wire take-up device 142 slides on the sliding rod 144 relative to the control seat 141, thereby simultaneously pulling the bending adjustment
  • the connection line 2221 and the return connection line 2222 are used to adjust the postures of the catheter 200 and the cutter head assembly 300 .
  • the return fixing part 2212 is arranged on the protective cover 330, the return fixing part 2212 is a fixed plate arranged on the protective cover 330, the return connecting line 2222 is welded and fixed with the fixing plate, or the return fixing part 2212 is provided with Connecting hole, the return connecting wire 2222 passes through the connecting hole and is fixed by knotting.
  • the bend-adjusting fixture 2211 is a fixing ring arranged on the braid 250 of the catheter 200, and the fixing ring presses and fixes the bend-adjusting connecting wire 2221 on the braid 250, or the bending-adjusting connecting wire 2221 and the fixing ring are welded and fixed.
  • the bending adjustment fixing part 2211 Since the bending adjustment fixing part 2211 is arranged on the other side of the catheter 200 relative to the return fixing part 2212, when the wire take-up 142 pulls the bending adjustment connecting line 2221 and the return connecting line 2222 at the same time, the bending adjustment connecting line 2221 passes through
  • the bending adjustment fixing part 2211 controls the axial displacement of the catheter 200
  • the return fixing part 2212 controls the radial displacement of the cutter head assembly 300 through the returning fixing part 2212 .
  • the cutter head assembly 300 Under the combined effect of the bending connecting line 2221 and the return connecting line 2222, the cutter head assembly 300 can realize S-shaped bending, so that the cutter head assembly 300 and the catheter 200 can maintain the same axial direction, reducing the abrasion of the cutter head assembly 300 Risk to blood vessel walls.
  • the cutter head assembly 300 removes the plaque in the blood vessel before and after the bending adjustment, so that the blood vessel can obtain a larger lumen.
  • the S-shaped bending of the catheter 200 and the cutter head assembly 300 is realized through the bend adjustment assembly 220, so that when cutting intravascular plaque, the cutting area can be increased by adjusting the bend catheter 200 and the cutter head assembly 300 .
  • the cutter head assembly 300 since the cutter head assembly 300 is in the same direction as the axial direction of the catheter 200 under the action of the return fixing member 2212, the blade assembly 300 will not accidentally cut the blood vessel wall during the advancement of the cutter head assembly 300. Risk of assembly 300 abrading the vessel wall.
  • the present application can not only obtain a larger lumen of the blood vessel, but also ensure the safety during cutting.
  • Embodiment 3 of the present invention proposes a resection device, as shown in FIG. 23 and FIG. 24 , the similarities between Embodiment 3 and Embodiment 1 will not be repeated, and the difference between Embodiment 3 and Embodiment 1 is that
  • the handle body 100 is provided with a control groove 150
  • the control assembly 140 is arranged in the control groove 150
  • the control seat 141 is engaged and fixed in the control groove 150
  • the wire take-up 142 includes a slide button 145 which is slidably connected to the control seat 141 and is arranged on
  • the connection point 1451 on the slide button 145 is used for connecting the bending adjustment connecting piece 222
  • the bending adjusting connecting piece 222 is the bending adjusting connecting line 2221 .
  • control seat 141 is provided with a sliding slot 1412 and a sliding block 1413 slidably connected to the sliding slot 1412 , and the sliding slot 1412 is arranged along the length direction of the control seat 141 .
  • the slider 1413 is provided with a fixing hole 1414, and the slider 145 of the control seat 141 is provided with a fixing column 1452 toward one end of the slider 1413, and the fixing column 1452 passes through the fixing hole 1414, so that the slider 145 is connected to the Slider 1413.
  • a control spring 146 is disposed between the slider 145 and the slider 1413 , the slider 145 and the slider 1413 are slidably connected to the control seat 141 at the same time, and the control spring 146 has an initial pressure so that the slider 145 is tightly attached to the inner wall of the control seat 141 .
  • the locking member 1421 is a rough contact surface arranged between the slide button 145 and the control seat 141.
  • the control spring 146 drives the slide button 145 to be close to the inner wall of the control seat 141.
  • a rough contact surface is provided between the sliding button 145 and the control seat 141 , so the sliding button 145 and the control seat 141 will not move relative to each other under the action of friction, and the self-locking of the wire take-up 142 is realized.
  • the control spring 146 is compressed, and the sliding button 145 is separated from the control seat 141 , and the sliding button 145 can move relative to the control seat 141 at this time.
  • the locking member 1421 can also be a protruding point and groove structure arranged between the sliding button 145 and the control seat 141 and engaged with each other, so as to enhance the combination of the sliding button 145 and the control seat 141 when fitting strength.
  • the control spring 146 drives the sliding button 145 to be in close contact with the inner wall of the control seat 141 , so that the self-locking of the wire take-up 142 is realized through the interlocking of the convex point and the groove structure.
  • the sliding button 145 is provided with a threaded hole, and the connection point 1451 is a screw threadedly connected to the sliding button 145.
  • the bending adjustment connector 222 is glued and fixed in the threaded hole, and then the screw is screwed. into the threaded hole for secondary fixation.
  • the operator presses the sliding button 145 to separate the sliding button 145 from the bonding surface of the control seat 141, and the spring slides the sliding button 145 along the axial direction of the guide tube 200, driving the bending adjustment connector 222 along the guide tube 200.
  • Move in the axial direction to realize the posture adjustment of the catheter 200 and adjust the bending of the cutter head assembly 300 .
  • the operator does not need to press the slide button 145 all the time, and at the same time, the operator only needs one hand to realize the bending operation of the cutter head assembly 300, which reduces the operation burden and improves the operation convenience.
  • the adjustment stroke is precise, and the precise and controllable bending angle can be realized.
  • Embodiment 4 of the present invention proposes a resection device, as shown in FIG. 25 to FIG. 27 , the similarities between Embodiment 4 and Embodiment 1 will not be repeated, and the difference between Embodiment 4 and Embodiment 1 is that
  • the handle body 100 is provided with a control slot 150
  • the control assembly 140 is arranged in the control slot 150
  • the control seat 141 is engaged and fixed in the control slot 150
  • the wire take-up device 142 includes a knob 147 which is rotatably connected to the control seat 141 and is used for locking
  • the locking piece 1421 is engaged with the knob
  • the locking piece 1421 is a stop pin 148 used to engage and fix the knob 147.
  • the stop pin 148 is slidably connected to the control seat 141. Moving groove 1472.
  • a stop spring 1481 is disposed between the stop pin 148 and the inner wall of the control seat 141 .
  • the rotary clamp 1471 is arranged on the knob 147, and the rotary clamp 1471 is used to connect the bend adjustment connector 222, and the bend adjustment connector 222 is a bend adjustment connecting line 2221, and the knob 147 is turned to make the bend adjustment connector 222 wrap around the rotation clamp 1471 , so as to achieve the purpose of pulling the bend adjustment connecting piece 222 to adjust the posture of the catheter 200 .
  • the stop spring 1481 drives the stop pin to move towards the knob 147 and is engaged in the stop slot 1472 .
  • the stop pin 148 is slid away from the knob 147 so that the stop pin 148 is separated from the stop slot 1472 , and the knob 147 can be rotated at this time.
  • the stop pin 148 When the knob 147 needs to be locked, the stop pin 148 is released, and the stop spring 1481 drives the stop pin 148 to slide toward the direction close to the knob 147, so that the stop pin 148 engages with the stop slot 1472, and the knob 147 cannot rotate at this time.
  • control assembly 140 further includes a locking safety assembly 1422 for preventing accidental touch, and the locking safety assembly 1422 is arranged between the control seat 141 and the wire retractor 142 .
  • a positioning post 1415 is provided inside the control seat 141 , and a positioning spring 1416 is sheathed on the positioning post 1415 , and the positioning spring 1416 is provided between the control seat 141 and the knob 147 .
  • the knob 147 can move along its own axial direction, and a locking safety component 1422 is arranged between the rotating clamp block 1471 and the control seat 141 , wherein the locking safety component 1422 is a locking structure 149 .
  • the clamping structure 149 includes a clamping groove 1491 disposed on the end of the rotating clamping block 1471 facing the knob 147 and a clamping block 1492 disposed on the end of the control seat 141 facing the rotating clamping block 1471. When the clamping block 1492 and the clamping groove 1491 When engaged and fixed, the knob 147 cannot be rotated.
  • the positioning spring 1416 pushes the knob 147 outward, so that the locking structure 149 between the rotating clamp block 1471 and the control seat 141 is engaged and fixed.
  • the stop pin 148 is engaged with the stop groove 1472 under the drive of the stop spring 1481 .
  • the stop pin 148 is located between the knob 147 and the control seat 141, blocking the axial movement path of the knob 147, so the knob 147 cannot be pressed, and the locking block cannot be released.
  • 1492 is engaged with the locking groove 1491, therefore, in a natural state, the knob 147 cannot be rotated.
  • the operator When the knob 147 needs to be turned, the operator first slides the stop pin 148 away from the knob 147, so that the stop pin 148 is separated from the stop groove 1472, and then presses the knob 147 inwardly, and the positioning spring 1416 is compressed by force, and simultaneously The locking structure 149 is separated, that is, the locking block 1492 is separated from the locking slot 1491 , and the knob 147 can be turned at this time.
  • the control assembly 140 of this embodiment realizes the double locking of the wire retractor 142 by setting an additional locking safety assembly 1422 between the control seat 141 and the wire retractor 142, which improves the reliability of the structure and ensures that the doctor can
  • the posture of the cutter head assembly 300 does not change. Only when the doctor pushes the stop pin 148 and presses the knob 147 at the same time, can the knob 147 be turned, and the orientation of the cutter head assembly 300 will not be changed due to accidental touch, avoiding the rotary cutter head 320 from cutting blood vessels, thereby avoiding medical accidents occurrence, thereby ensuring the smooth progress of the operation.
  • Embodiment 5 of the present invention proposes a resection device, as shown in Fig. 29 to Fig. 33 , the similarities between Embodiment 5 and Embodiment 1 will not be repeated, and the difference between Embodiment 5 and Embodiment 1 is that
  • the driving mechanism 400 is disposed in the handle body 100 , and the catheter 200 is detachably connected to the driving mechanism 400 .
  • the driving mechanism 400 includes a driving module 410 disposed in the handle body 100.
  • the driving module 410 includes a power shaft 4111, a power source 411, and a power supply assembly 413.
  • the power source 411 is used to drive the power shaft 4111 to rotate.
  • the conduit 200 is detachably connected to the power shaft 4111 through the connection module 440 .
  • the power source 411 is a motor, and the motor is used to drive the torque shaft 210 to rotate, and the power supply component 413 is a battery electrically connected to the motor.
  • the proximal end of the torque shaft 210 is provided with a transmission shaft 212
  • the distal end of the power shaft 4111 is provided with an insertion slot 4112
  • the transmission shaft 212 is inserted into the insertion slot 4112 and connected with the power Shaft 4111 rotates synchronously.
  • the transmission shaft 212 is provided with a clamping slot 2121
  • the connection module 440 includes a clamping positioning component 441 which is clamped and connected with the clamping slot 2121 and a clamping control component 442 for controlling the clamping positioning component 441 .
  • the torque shaft 210 specifically includes a shaft body 213 and a coil spring 214 arranged on the shaft body 213, wherein the coil spring 214 is helically wound and fixed on the shaft body 213, and can be fixed by welding.
  • the rotation direction of 214 is opposite to the rotation direction of the shaft body 213 .
  • the transmission shaft 212 is provided with at least one limit block 2122, and the inner wall of the insertion slot 4112 is provided with a limit slot 4113, after the transmission shaft 212 is inserted into the insertion slot 4112, the limit block 2122 is used
  • the limit groove 4113 is adapted to fix the transmission shaft 212 to the power shaft 4111 in the circumferential direction.
  • the transmission shaft 212 is provided with three limit blocks 2122 distributed in a circular array, and the three limit blocks 2122 cooperate with the limit groove 4113 to make the power shaft 4111 and the drive shaft 212 direction synchronous rotation, so that the torque shaft 210 and the power shaft 4111 rotate synchronously.
  • the clamping and positioning assembly 441 includes a clamping piece 4411, a positioning piece 4412 and a connecting end 4413.
  • the clamping piece 4411 is arranged on the power shaft 4111 and is used for engaging and connecting with the clamping slot 2121.
  • the positioning piece 4412 is movably connected to The power shaft 4111, the positioning part 4412 are used for the positioning of the clamping part 4411, the connecting end 4413 is used for connecting the clamping control part 443 and the clamping part 4411, and the clamping control component 442 controls the clamping part by controlling the connecting end 4413 4411 is engaged with or separated from the locking groove 2121 .
  • the head end of the clamping piece 4411 is snapped and connected to the clamping groove 2121. Since the clamping piece 4411 is axially fixed to the power shaft 4111 through the positioning piece 4412, when the clamping The axial displacement of the transmission shaft 212 and the power shaft 4111 is limited when the connecting piece 4411 is engaged with the engaging groove 2121 .
  • the engaging member 4411 is a clamping spring whose head end is bent toward the transmission shaft 212
  • the positioning member 4412 is a fixing bolt screwed to the power shaft 4111 .
  • the clamping piece 4411 is provided with a through hole for the positioning piece 4412 to pass through. By passing the positioning piece 4412 through the through hole on the clamping piece 4411 and screwing it to the power shaft 4111, the clamping piece 4411 is axially fixed and connected to the power shaft 4111.
  • the power shaft 4111 and the engaging member 4411 can rotate with the positioning member 4412 as the center point, so as to be engagingly connected to the engaging groove 2121 or disengaged from the engaging groove 2121 .
  • the connecting end 4413 is integrally formed on the clamping member 4411 .
  • the connecting end 4413 is disposed at the tail end of the clamping member 4411 .
  • the connecting end 4413 is a driving elastic piece, and the driving elastic piece is bent in a direction away from the power shaft 4111 .
  • the connection end 4413 is squeezed toward the direction of the power shaft 4111, the clamping piece 4411 rotates with the positioning piece 4412 as the midpoint, so that the head end of the clamping piece 4411 is disengaged from the clamping groove 2121, so that the power shaft 4111 and the transmission
  • the shaft 212 is axially separable.
  • the snap-in control assembly 442 includes a shaft sleeve 4421 arranged on the handle body 100, a fixed end portion 4422 fixedly arranged inside the shaft sleeve 4421, a movable end portion 4423 movably connected with the shaft sleeve 4421, and a snap-in control member 443, the movable end portion 4423 is set between the positioning part 4412 and the connecting end 4413, and the clamping control part 443 is used to control the movement of the movable end 4423.
  • the power shaft 4111 passes through the fixed end 4422 and the movable end 4423 and connects to the transmission shaft 212.
  • the fixed end part 4422 is a fixed bearing connected with the power shaft 4111
  • the movable end part 4423 is a sliding pressure block slidingly connected with the shaft sleeve 4421 along the axial direction of the shaft sleeve 4421 .
  • the locking control member 443 includes an elastic member 4433 connected to the fixed end portion 4422 and the movable end portion 4423 and a pull cord 4431 for controlling the position of the sliding pressing block.
  • the end of the pull cord 4431 is provided with a pull ring 4432, the connecting end 4413 is integrally connected with the clamping member 4411, the proximal end of the connecting end 4413 is raised, and the movable end 4423 slides between the connecting end 4413 and the clamping member 4411 shift.
  • the fixed end portion 4422 is fixedly connected to the inner side of the shaft sleeve 4421 and connected to the power shaft 4111 , and the power shaft 4111 rotates with the positioning member 4412 as the base point.
  • An elastic member 4433 is provided between the movable end 4423 and the positioning member 4412. The elastic member 4433 is used to drive the movable end 4423 to slide away from the positioning member 4412.
  • the end of the elastic member 4433 close to the movable end 4423 or the movable end 4423 is provided with a drawstring 4431, one end of the drawstring 4431 is connected to the elastic member 4433 or the movable end 4423, and the other end of the drawstring 4431 is connected to the draw ring 4432 on the outside of the handle body 100, the operator can pull through the draw ring 4432 Pull the rope 4431 to make the movable end 4423 move toward the direction of the fixed end 4422 .
  • the elastic member 4433 is a spring
  • the stay cord 4431 is a nickel-titanium wire
  • the nickel-titanium wire is welded on the spring.
  • the movable end 4423 In the initial state, the movable end 4423 is located on the side away from the fixed bearing under the force of the elastic member 4433. At this time, the movable end 4423 is located on the clamping member 4411, and the head end of the clamping member 4411 is snapped and connected to inside the clamping groove 2121.
  • the movable end portion 4423 moves toward the fixed end portion 4422 along the axial direction of the sleeve 4421, and squeezes the connecting end portion 4413 from both sides, so that the connecting end portion 4413 faces the power shaft 4111 direction, and make the clamping member 4411 rotate with the positioning member 4412 as the midpoint, so that the head end of the clamping member 4411 disengages from the engaging groove 2121.
  • the power shaft 4111 and the transmission shaft 212 can be separated axially.
  • this embodiment provides the clamping positioning component 441 and the clamping control component 442, so that the torque shaft 210 can be detachably connected to the power shaft 4111 in the axial direction, and through the cooperation of the limit block 2122 and the limit groove 4113, the The torque shaft 210 rotates coaxially with the power shaft 4111 , and the motor outputs torque to drive the torque shaft 210 to rotate through the power shaft 4111 .
  • the handle body 100 is provided with a collecting part 170 , and the collecting part 170 is arranged on the outside of the proximal end of the catheter 200 , and the collecting part 170 is used to collect the plaque discharged from the catheter 200 .
  • the collection part 170 is detachably connected to the handle body 100
  • the proximal end of the catheter 200 is detachably connected to the collection part 170 .
  • the proximal end of the catheter 200 is provided with a buffer sleeve 270
  • the buffer sleeve 270 is provided with a sealing groove 271
  • the handle body 100 and the collection part 170 are respectively connected to the catheter 200 through the sealing groove 271 .
  • the collection part 170 is arranged at the bottom of the distal end of the handle body 100, and a collection cavity is provided between the collection part 170 and the handle body 100, and the resected plaque is accommodated through the collection cavity.
  • the proximal end of the catheter 200 is fixedly connected to the distal end of the buffer catheter 200 , or the proximal end of the catheter 200 is fixedly connected to the proximal end of the buffer catheter 200 .
  • the torque shaft 210 sequentially passes through the catheter 200 and the buffer catheter 200 and extends into the collection part 170 , and the plaque or thrombus flushed out by the catheter 200 falls into the collection part 170 .
  • the bushing 4421 is fixedly connected to the handle body 100 and protrudes toward the collecting portion 170 , and other parts of the locking control assembly 442 are disposed in the inner cavity of the bushing 4421 .
  • One end of the power shaft 4111 is connected to the power source 411 , and the other end of the power shaft 4111 passes through the sleeve 4421 and is connected to the transmission shaft 212 .
  • the proximal end of the catheter 200 is connected to the buffer sleeve 270, the plaque or thrombus in the catheter 200 will fall into the collection part 170 due to the high-speed rotation of the torque shaft 210 and its own gravity after passing through the buffer sleeve 270, instead of Will continue to move forward following the torque shaft 210 .
  • the clamping control assembly 442 disposed in the sleeve 4421 is protected.
  • the length of the shaft body 213 in this embodiment is greater than the length of the coil spring 214, and a spacer is provided between the proximal end of the coil spring 214 and the transmission shaft 212, and the shaft body 213 located in the spacer
  • the coil spring 214 is not provided on it.
  • the buffer sleeve 270 is fixedly arranged on the catheter 200, the buffer sleeve 270 is made of silica gel, the buffer sleeve 270 is provided with a sealing groove 271, and the sealing groove 271 is recessed around the circumference of the buffer sleeve 270 in the buffer sleeve 270. , forming a ring-shaped groove.
  • the doctor can replace the catheter 200 according to the actual use situation.
  • first remove the collection part 170 then pull the pull ring 4432 on the handle body 100, and transmit the pulling force along the pull cord 4431 to the elastic member 4433 through the pull ring 4432, so that the movable end 4423 faces the fixed end Part 4422 moves.
  • the movable end portion 4423 gradually presses over the connecting end portion 4413 , so that the raised connecting end portion 4413 moves toward the power shaft 4111 .
  • the engaging member 4411 embedded in the engaging groove 2121 is gradually disengaged from the engaging groove 2121 .
  • the operator can disassemble the torque shaft 210 and thus the power shaft 4111 in the axial direction.
  • This embodiment adopts the design of replaceable catheter 200, which improves the flexibility and economy of the operation, avoids plaque or thrombus that cannot be discharged from the blood vessel in time due to the blockage of the catheter 200, and causes distal embolism, ensuring the life of the patient Safety.

Landscapes

  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

一种切除装置，包括手柄本体（100）、连通于手柄本体（100）的导管（200）以及设置在导管（200）远端的刀头组件（300），其中，导管（200）上设置有调弯组件（220），调弯组件（220）包括设置在导管（200）上的第一调弯点（2213）、第二调弯点（2214）以及用于连接第一调弯点（2213）和第二调弯点（2214）的调弯连接件（222），手柄本体（100）上设置有用于控制调弯组件（220）的控制组件（140）。通过调弯组件（220）调节远端导管（200）的弯曲半径，使导管（200）朝向预定方向偏移，并控制刀头组件（300）的朝向，降低刮伤血管及血管穿孔的风险，能够通过多次切除得到理想的血管管径。

Description

一种切除装置 技术领域
本发明属于医疗器械技术领域，具体涉及一种切除装置。
背景技术
随着中国人口老龄化程度的日益加深及饮食结构的改变，血管病变发病率急剧上升。外周动脉疾病是血管病变的其中之一，外周动脉疾病的主要病因是动脉粥样硬化，常表现为四肢、腹腔动脉、颈动脉和肾动脉等缺血性改变，治疗方法主要包括以药物治疗为主的基础治疗，包括经典的外科旁路术为代表的开放式外科手术治疗和新近发展的血管腔内介入治疗。
虽然外科旁路术具有相对优越的长期通畅率，但是血管腔内介入治疗技术以其微创、安全有效、可重复性的优势逐步被临床医生和患者所接受。其中，外周斑块旋切术主要针对股、腘及膝下动脉狭窄或闭塞。
然而现有的外周斑块旋切术的切除系统存在导管推送过程中容易刮伤血管壁的风险。在临床应用中，切除系统可以通过调节远端管身的弯曲半径，使旋切刀头朝一定角度偏移进而能更彻底的清除血管中的堵塞斑块。但是在调弯状态下，导管远端会与血管形成一定角度，导致导管与血管轴向不平，容易刮伤血管，甚至使血管穿孔。
因此，需要一种新的技术手段解决现有技术的上述问题。
发明内容
本发明的目的是至少解决现有切除装置在调弯导管时，刀头组件容易刮伤血管内壁的问题。
本发明提出了一种切除装置，包括手柄本体、连通于所述手柄本体的导管以及设置在所述导管远端的刀头组件，其中，所述导管上设置有调弯组件，所述调弯组件包括设置在所述导管上的第一调弯点、第二调弯点以及用于连接所述第一调弯点和所述第二调弯点的调弯连接件，所述手柄本体上设置有用于控制所述调弯组件的控制组件。
通过本发明中的切除装置，通过调弯组件调节远端导管的弯曲半径，使导管朝向预定方向偏移，并控制刀头组件的朝向，降低刮伤血管及血管穿孔的风险，能够通过多次切除得到理想的血管管径。
另外，根据本发明的切除装置，还可具有如下附加的技术特征：
在本发明的一些实施方式中，其中，所述调弯连接件与所述第一调弯点固定连接，所述调弯连接件与所述第二调弯点活动连接，所述第一调弯点与所述导管远端的距离相比所述第二调弯点与所述导管远端的距离更小，所述第一调弯点设置在相对于所述第二调弯点的另一侧。
在本发明的一些实施方式中，其中，所述调弯连接件包括调弯控制线，所述导管上设置有用于所述调弯控制线穿过的控制线腔， 所述第二调弯点设置在所述控制线腔的远端，所述调弯控制线穿过所述第二调弯点且绕所述导管旋转后固定连接于所述第一调弯点。
在本发明的一些实施方式中，其中，所述控制组件包括设置在所述手柄本体上的控制座以及活动连接于所述控制座的收线器，所述收线器连接于所述调弯控制线且用于牵拉所述调弯控制线以调整所述导管的姿态。
在本发明的一些实施方式中，其中，所述导管内设置有连接于所述刀头组件的扭矩轴，所述手柄本体内设置有用于驱动所述扭矩轴转动的驱动机构。
在本发明的一些实施方式中，其中，所述刀头组件包括连接于所述导管的限位座以及设置在所述限位座上的旋切刀头，所述旋切刀头固定连接于所述扭矩轴的一端，所述扭矩轴驱动所述旋切刀头转动连接于所述限位座，所述限位座上设置有罩设在所述旋切刀头侧面的保护套。
在本发明的一些实施方式中，其中，所述导管包括内管以及设置在所述内管外侧的外管，所述内管套设在所述扭矩轴的外侧，所述扭矩轴与所述内管为间隙配合，所述内管与外管之间设置有编织层。
在本发明的一些实施方式中，其中，所述手柄本体上设置有连接于所述导管的排出腔道，所述排出腔道连通于所述导管与所述手柄本体的外部空间。
在本发明的一些实施方式中，其中，所述扭矩轴穿过所述排出 腔道并连接于所述驱动机构，所述驱动机构包括动力源、用于连接所述动力源与所述扭矩轴的驱动传动组件以及电性连接于所述动力源的电源。
在本发明的一些实施方式中，其中，所述排出腔道包括连通于所述导管的主腔体以及设置在所述主腔体侧面的排废管，所述扭矩轴穿过所述。
附图说明
图1为本发明的实施例一中切除装置的结构示意图；
图2为本发明的实施例一中手柄本体的内部结构示意图；
图3为本发明的实施例一中驱动传动组件的结构示意图；
图4为本发明的实施例一中刀头组件的结构示意图；
图5为本发明的实施例一中导管的结构示意图；
图6为本发明的实施例一中调弯组件的结构示意图；
图7为本发明的实施例一中导管弯曲后的结构示意图；
图8是本发明的实施例一中控制组件的整体结构示意图；
图9为本发明的实施例一中控制组件的剖面图；
图10为本发明的实施例一中控制组件的剖面的侧视图；
图11为本发明的实施例一中调节模块处于低速切割时的整体结构示意图；
图12是本发明的实施例一中调节模块处于高速切割时的整体结构示意图；
图13是本发明的实施例一中低速切割时调节模块的部分结构示意图；
图14是本发明的实施例一中高速切割时调节模块的部分结构示意图；
图15是本发明的实施例一中调速键的结构示意图；
图16是本发明的实施例一中拆卸连接部的整体结构示意图；
图17是本发明的实施例一中手柄本体的爆炸图；
图18是本发明的实施例一中卡合组件的部分结构示意图；
图19是本发明的实施例一中手柄本体与手柄上盖的连接结构示意图；
图20是本发明的实施例一中手柄本体与驱动机构的连接结构示意图；
图21是本发明的实施例一中卡合组件的部分结构示意图；
图22是本发明的实施例二中导管和调弯组件的结构示意图；
图23是本发明的实施例三中手柄本体的整体结构示意图；
图24是本发明的实施例三中控制组件的内部结构示意图；
图25是本发明的实施例四中手柄本体的整体结构示意图；
图26是本发明的实施例四中控制组件的内部结构示意图；
图27是本发明的实施例四中控制组件的部分结构示意图；
图28是本发明的实施例五中手柄本体的立体结构示意图；
图29是本发明的实施例五中手柄本体的内部结构示意图；
图30是本发明的实施例五中手柄本体的爆炸图；
图31是本发明的实施例五中导管的部分结构示意图；
图32是本发明的实施例五中图29的A处的放大图；
图33是本发明的实施例五中图29的B处的放大图。
具体实施方式
下面将参照附图更详细地描述本发明的示例性实施方式。虽然附图中显示了本发明的示例性实施方式，然而应当理解，可以以各种形式实现本发明而不应被这里阐述的实施方式所限制。相反，提供这些实施方式是为了能够更透彻地理解本发明，并且能够将本发明的范围完整的传达给本领域的技术人员。
应理解的是，文中使用的术语仅出于描述特定示例实施方式的目的，而无意于进行限制。除非上下文另外明确地指出，否则如文中使用的单数形式“一”、“一个”以及“所述”也可以表示包括复数形式。术语“包括”、“包含”、“含有”以及“具有”是包含性的，并且因此指明所陈述的特征、步骤、操作、元件和/或部件的存在，但并不排除存在或者添加一个或多个其它特征、步骤、操作、元件、部件、和/或它们的组合。文中描述的方法步骤、过程、以及操作不解释为必须要求它们以所描述或说明的特定顺序执行，除非明确指出执行顺序。还应当理解，可以使用另外或者替代的步骤。
尽管可以在文中使用术语第一、第二、第三等来描述多个元件、部件、区域、层和/或部段，但是，这些元件、部件、区域、层和/或部段不应被这些术语所限制。这些术语可以仅用来将一个元件、 部件、区域、层或部段与另一区域、层或部段区分开。除非上下文明确地指出，否则诸如“第一”、“第二”之类的术语以及其它数字术语在文中使用时并不暗示顺序或者次序。
为了便于描述，可以在文中使用空间相对关系术语来描述如图中示出的一个元件或者特征相对于另一元件或者特征的关系，这些相对关系术语例如为“内部”、“外部”、“内侧”、“外侧”、“下面”、“下方”、“上面”、“上方”等。这种空间相对关系术语意于包括除图中描绘的方位之外的在使用或者操作中装置的不同方位。例如，如果在图中的装置翻转，那么描述为“在其它元件或者特征下面”或者“在其它元件或者特征下方”的元件将随后定向为“在其它元件或者特征上面”或者“在其它元件或者特征上方”。因此，示例术语“在……下方”可以包括在上和在下的方位。装置可以另外定向(旋转90度或者在其它方向)并且文中使用的空间相对关系描述符相应地进行解释。
为了便于描述，以下描述使用术语“近端”和“远端”，其中“近端”是指的是离操作者近的一端，“远端”是指远离操作者的一端，短语“轴向方向”，本专利里应当被理解成表示介入元件被推进和推出的方向，与“轴向方向”相垂直的方向定义为“径向方向”。
实施例一
本发明的实施例一提出了一种切除装置，如图1至图3所示，包括手柄本体100、连通于手柄本体100的导管200以及设置在导管200远端的刀头组件300，导管200内设置有连接于刀头组件300的 扭矩轴210。结合图5所示，导管200上设置有用于调弯导管200远端部位的调弯组件220，手柄本体100上设置有可拆卸连接于手柄本体100的驱动机构400。结合图11所示，驱动机构400包括用于驱动扭矩轴210转动的驱动模块410以及用于控制驱动模块410以调节扭矩轴210扭矩的调节模块420。
本发明通过调弯组件220调节远端导管200的弯曲半径，使导管200朝向预定方向偏移，并控制刀头组件300的朝向，降低刮伤血管及血管穿孔的风险，能够通过多次切除得到理想的血管管径；同时，设置用于调节扭矩轴210扭矩的调节模块420，以使斑块切除装置在切除较硬的斑块时，可以通过调整扭矩轴210的扭矩使斑块切除更加顺畅；另一方面，通过设置可拆卸连接于手柄本体100的驱动机构400，以使驱动机构400可以循环使用，降低斑块切除装置的使用成本。
具体的，如图4所示，刀头组件300包括连接于导管200的限位座310以及设置在限位座310上的旋切刀头320，旋切刀头320固定连接于扭矩轴210的一端，扭矩轴210驱动旋切刀头320转动连接于限位座310，限位座310上设置有罩设在旋切刀头320侧面的保护套330。
如图5所示，导管200包括内管230以及设置在内管230外侧的外管240，内管230套设在扭矩轴210的外侧，扭矩轴210与内管230为间隙配合，扭矩轴210贯穿内管230的整个内腔。
进一步地，内管230与外管240之间设置有编织层250，其中， 编织层250具体为编织网，编织网通过镍钛丝编织形成。内管230和外管240之间通过编织层250连接，从而增强了导管200的韧性，在导管200穿入分支血管，或者通过血管的弯曲部位时，导管200不会出现局部凹陷折弯的现象，能够保证导管200的管腔完整，保证了切除的斑块的通过性，使斑块不会堵在导管200折弯处。
具体的，旋切刀头320通过焊接的方式固定在扭矩轴210的端部，扭矩轴210转动从而带动旋切刀头320转动。旋切刀头320上设置有刀头卡槽321，限位座310的远端设置有限位凸台311，限位凸台311与刀头卡槽321卡接配合，从而实现旋切刀头320与限位座310之间的轴向和径向限位。
其中，旋切刀头320、限位座310与保护套330均为不锈钢材质。同时，限位座310的远端设置有具有弹性的弹片312，限位凸台311设置在弹片312上。由于刀头组件300整体通过硬质金属材质制成，因此旋切刀头320与限位座310的装配工艺复杂。本实施例通过在限位座310的远端设置弹片312，而弹片312具有弹性，能够在装配时产生弹性形变，以使限位凸台311顺利的卡入刀头卡槽321中。保护套330罩设在限位座310的外侧，同时保护套330紧贴限位座310的外表面，因此在完成保护套330的装配后，弹片312被限制在旋切刀头320与保护套310之间，从而完成限位凸台312与刀头卡槽321的卡接配合，进而实现旋切刀头320与限位座310之间的轴向和径向限位。
导管200由内至外依次包括内管230、编织层250以及外管240， 并且内管230、编织层250以及外管240通过热熔的方式形成一个整体。进一步地，导管200的远端设置有弹簧管260，弹簧管260套设在编织层250的外侧，或编织层250套设在弹簧管260的外侧，弹簧管260通过焊接的方式与编织层250轴向固定。在本实施例中，弹簧管260套设在编织层250的外侧。通过在导管200的远端设置弹簧管260，从而增强导管200远端的顺应性和回弹性。在其他实施例中，弹簧管260还可以埋设在外管240内。
本申请中，由于编织层250的抗折弯性能好，弹簧管260的抗扭矩性能好。因此，导管200内设置编织层250，并且采用在导管200的远端设置弹簧管260的结构，能够使得导管200远端能够兼顾抗折弯以及抗扭矩性能，当导管200进行调弯时，通过编织层250与弹簧管260的配合，避免了导管200因弯曲而出现局部的内凹形变，能够在实现导管200弯曲的情况下，维持导管200的管腔的形变，保证导管200与扭矩轴210之间的间隙足够通过斑块或血栓，确保手术顺利进行。同时还能够保持良好的血管通过性，使得导管200在进入较复杂弯曲的血管时，更加顺畅。
保护套330与外管240通过热熔的方式固定，外管240为TPU管或Pebax管，在本实施例中，外管240采用Pebax材质。
其中，结合图2，导管200上设置有缓冲套管270，导管200通过缓冲套管270与手柄本体100连接，缓冲套管270与手柄本体100的外壳通过卡合方式配合连接，缓冲套管270为TPU材质，或者其他橡胶或者塑料材质。缓冲套管270设置为软性材质，能够消除导 管200在旋切时的震动，传递至手柄本体100的震动会明显减小，从而为操作者的精细操作提供条件。
进一步地，结合图11与图12所示，驱动机构400还包括驱动壳体430、动力源411以及用于连接动力源411与扭矩轴210的驱动传动组件412。调节模块420包括与驱动传动组件412连接的调节传动组件421以及换挡组件422，换挡组件422用于控制调节传动组件421与驱动传动组件412的配合关系以调节扭矩轴210的扭矩，驱动壳体430内设置有用于驱动动力源411的电源组件413。
具体的，动力源411为设置在驱动壳体430内的电机，电源组件413为设置在驱动壳体430内的电池，电池与电机电性连接。电源组件413为动力源411供电，动力源411通过驱动传动组件412带动扭矩轴210转动，扭矩轴210转动以使设置在远端的旋切刀头320转动，从而切除血管中的斑块。手柄本体100上还设置有开关160，通过开关160控制电机的工作状态。
在其他实施例中，还可以在驱动壳体430上设置用于连接外部电源且电性连接于动力源411的电源组件413。即当需要驱动动力源411工作时，通过电源组件413连接外部电源，电源组件413包括设置在驱动壳体430上的电源插口。通过设置电源插口的形式，能够降低手柄本体100及内部元器件杀菌消毒的难度及成本，并降低整机的重量和运输难度。
进一步地，结合图2所示，手柄本体100上设置有连接于导管200的排出腔道500，排出腔道500连通于导管200与手柄本体100 的外部空间，扭矩轴210穿过排出腔道500并连接于驱动机构400。排出腔道500包括连通于导管200的主腔体510以及设置在主腔体510侧面的排废管520，扭矩轴210穿过主腔体510且连通于手柄本体100的外部空间，扭矩轴210内设置有贯通扭矩轴210的导丝腔211。
具体的，扭矩轴210呈螺旋状设置。在斑块切除装置工作时，电机驱动扭矩轴210转动，由于扭矩轴210呈螺旋状设置，因此扭矩轴210可以在转动的过程中将斑块组织向后带出导管200。
扭矩轴210内的导丝腔211用于穿入导丝，导丝用于在导管200伸入血管或者移动之前，先伸入血管或者分支血管，以建立导管200的路入通路，使得导管200能够沿导丝建立的路入通路移动。
其中，外管240的近端与主腔体510粘接固定，由旋切刀头320切除的斑块组织通过扭矩轴210与内管230之间的间隙，随着扭矩轴210的转动从导管200中排出到排出腔道500内，排出腔道500的主腔体510暂时容纳切除的斑块组织，并最终通过排废管520将斑块组织排出。排废管520设置在靠近主腔体510的近端部位，并且沿斑块切除的方向倾斜设置，从而便于斑块的排出。
在本实施例中，如图5至图7所示，手柄本体100上设置有用于控制调弯组件220的控制组件140，调弯组件220包括至少两个调弯点221以及用于连接调弯点221的调弯连接件222。结合图3所示，控制组件140包括设置在手柄本体100上的控制座141以及活动连接于控制座141的收线器142，收线器142用于连接调弯连接件222 且用于牵拉调弯连接件222以调整导管200的姿态。
其中，调弯点221包括设置在导管200上的第一调弯点2213以及第二调弯点2214，调弯连接件222与第一调弯点2213固定连接，调弯连接件222与第二调弯点2214活动连接，第一调弯点2213与导管200远端的距离相比第二调弯点2214与导管200远端的距离更小，第一调弯点2213设置在相对于第二调弯点2214的另一侧。
调弯连接件222包括调弯控制线2225，导管200上设置有用于调弯控制线2225穿过的控制线腔2226，第二调弯点2214设置在控制线腔2226的远端，调弯控制线2225穿过第二调弯点2214且绕导管200旋转后固定连接于第一调弯点2213。在本实施例中，为了使刀头组件300的朝向与导管200相同，因此第一调弯点2213和第二调弯点2214在周向上相差180度设置。
具体的，导管200内设置有控制线腔2226，控制线腔2226可以设置在外管240的内部或者内管230的内部。其中，第一调弯点2213为固定设置在编织层250上的固定点，通过固定点与调弯控制线2225固定连接，第二调弯点2214为控制线腔2226远端的端点。
在本实施例中，第一调弯点2213为焊接固定在编织层250上的固定环，固定环将调弯控制线2225压紧固定在编织层250上，或者调弯控制线2225与固定环焊接固定。通过将第一调弯点2213设置为环形，从而满足调弯控制线2225的多相位连接，方便调弯控制线的角度调节和固定。
调弯控制线2225的一端连接于收线器142，调弯控制线2225 的另一端首先穿出控制线腔2226，然后顺着内管230与编织层250之间的间隙螺旋旋转180度后，固定在第一调弯点2213上。其中，调弯控制线2225的旋转角度还可以为170度或者190度，只要保证第二调弯点2214相对设置在第一调弯点2213的对侧，即可保证在调弯后，刀头组件300的朝向与导管200大致相同。
进一步地，调弯控制线2225伸出第二调弯点2214并固定在第一调弯点2213之间的螺旋部分的轴向长度设置为外管240外径尺寸的1倍至3倍。若第一调弯点2213与第二调弯点2214之间的轴向长度过长，则会导致调弯效果不佳。若第一调弯点2213与第二调弯点2214之间的轴向长度过短，则会导致调弯所需应力过大，不利于操作。因此，在本实施例中，调弯控制线2225伸出第二调弯点2214并固定在第一调弯点2213之间的螺旋部分的轴向长度设置为外管240外径尺寸的2倍。
进一步地，本实施例通过调节收线器142，控制调弯控制线2225在控制线腔2226或者内管230中移动，由于调弯控制线2225在导管200的远端沿着内管230螺旋旋转180度，因此控制调弯控制线2225收缩时，调弯控制线2225对导管200远端既有轴向作用力、也有径向作用力，从而能控制刀头组件300轴向及径向位移，故而使刀头组件300实现S形调弯。由于调弯控制线2225旋转180度，因此能够使刀头组件300与导管200轴向保持相同方向，降低刀头组件300擦伤血管壁的风险。而刀头组件300调弯前与调弯后切除血管内斑块，能使血管获得更大的管腔。
如图8至图10所示，本实施例的控制组件包括设置在手柄本体上的控制座以及活动连接于控制座的收线器，收线器包括用于自锁定的锁定件1421。
手柄本体100上设置有控制槽150，控制组件140设置在控制槽150内，控制槽150的一端设置有顶杆151，控制座141朝向顶杆151的一端设置有顶槽1411，控制座141的另一端转动连接于控制槽150的另一端。从而控制座141通过顶槽1411与顶杆151的配合轴向固定在控制槽150内，且控制座141能够通过顶槽1411与顶杆151的配合，转动连接于手柄本体100。
收线器142设置在控制座141内，收线器142上设置有用于夹持调弯控制线2225的夹持部143。其中，锁定件1421为设置在控制座141的内壁的内螺纹以及设置在收线器142的外壁上设置的外螺纹，收线器142与控制座141通过螺纹连接，且控制座上的内螺纹与收线器上的外螺纹为自锁螺纹配合。医生在松开收线器以后，收线器因内螺纹与外螺纹相对自锁而不会与控制座相对移动，从而实现收线器的自锁定。
控制座141内设置有滑杆144，滑杆144沿控制座141的轴向方向设置，收线器142滑动连接于滑杆144，滑杆144与收线器142之间设置有转动限位面1441，从而收线器142能够沿滑杆144的长度方向平移，不能与滑杆144相对转动，即形成丝杆联动关系。
因此，当转动控制座141时，收线器142在螺纹配合的联动下能够在滑杆144上滑移并相对控制座141移动，并且收线器142夹 持调弯控制线2225，调弯控制线2225跟随收线器142相对手柄本体100移动，从而控制导管200进行弯曲动作。
在本申请的进一步实施例中，如图11至图15示，驱动传动组件412包括与扭矩轴210连接的第一传动件4121、与动力源411连接的第二传动件4122以及设置在驱动壳体430上的第三传动件4123，第三传动件4123连接在第一传动件4121与第二传动件4122之间。
如图13所示，调节传动组件421包括与第二传动件4122同轴设置的第四传动件4211以及与第三传动件4123同轴设置的第五传动件4212，换挡组件422包括连接于动力源411的输出轴的主动轮轴4221以及连接于主动轮轴4221的拨杆4222，第三传动件4123与第五传动件4212均设置在主动轮轴4221上，主动轮轴4221与输出轴滑动连接且同步转动；拨杆4222用于驱动第二传动件4122与第三传动件4123连接或驱动第四传动件4211与第五传动件4212连接。
具体的，本实施例的传动件均为齿轮。其中，动力源411为电机，第一传动件4121为连接于扭矩轴210的输出齿轮，第二传动件4122为连接于电机的主动齿轮，第三传动件4123为设置在驱动壳体430上的传动齿轮。主动齿轮、传动齿轮和输出齿轮依次啮合连接。
另外，本实施例的调节传动组件421设置了第二组齿轮组件，即第四传动件4211和第五传动件4212。其中，第四传动件4211为与第二传动件4122同轴设置的大调速齿轮，第五传动件4212为与 第三传动件4123同轴设置的小调速齿轮。
具体的，第四传动件4211为与第二传动件4122均设置在主动轮轴4221上，电机直接驱动输出轴转动，主动轮轴4221滑动连接于电机的输出轴且与电机的输出轴同步转动。第五传动件4212通过从动轮轴4224连接于第三传动件4123，第五传动件4212与第三传动件4123通过从动轮轴4224同轴转动。
其中，主动轮轴4221与拨杆4222固定连接，拨杆4222的末端设置有调速键4223，调速键4223滑动连接于手柄本体100。如图15所示，驱动壳体430上设置有低速限位槽4113以及高速限位槽4113，当旋切刀头320处于低速挡切割时，调速键4223位于低速限位槽4113，且第二传动件4122、第三传动件4123和第一传动件4121依次啮合连接。
本实施例的驱动模块410具体工作原理如下：当动力源411工作，并通过动力源411带动第二传动件4122转动时，即电机开始运转并带动第二传动件4122运转。第二传动件4122通过与第三传动件4123啮合将转速传递给第三传动件4123，第三传动件4123通过与第一传动件4121啮合将速度传递给第一传动件4121，第一传动件4121再将速度传递给扭矩轴210，扭矩轴210带动旋切刀头320转动，完成低速挡切割。低速挡切割时，扭矩轴的转速较底，而扭矩较大。
当进行高低档位切换时，拨动调速键4223，以使调速键4223移动至高速限位槽4113，拨杆4222在调速键4223的带动下移动， 调速杆的移动带动主动轮轴4221移动并使第二传动件4122与第三传动件4123脱离啮合。由于第四传动件4211与第二传动件4122均设置在主动轮轴4221上，因此第四传动件4211也跟随主动轮轴4221一起移动，并与第五传动件4212啮合，完成齿轮啮合关系的切换。
在本实施例中，第四传动件4211的齿数大于第二传动件4122的齿数，第五传动件4212的齿数小于第三传动件4123的齿数。因此，第四传动件4211与第五传动件4212相啮合的传动状态，与第二传动件4122与从动齿轮相啮合传动状态相比，第五传动件4212的转速更高。
由于第五传动件4212的转速更高，且第五传动件4212将更高的转速通过从动轮轴4224传递至第三传动件4123，第三传动件4123与第一传动件4121相啮合，从而第一传动件4121的转速更高，完成旋切刀头320的高速挡切割。当高速挡切割时，扭矩轴的转速更高，而扭矩较小。
基于本实施例的上述方案，通过在调节模块420中设置额外的齿轮组，即第四传动件4211和第五传动件4212，并通过换挡组件422调节各齿轮组件之间的啮合关系，从而实现了旋切刀头320转速的高速、低速挡位可调，进而实现了旋切刀头320扭矩的高扭矩、低扭矩可调。医生可以根据斑块的质地灵活选用切割速度，避免刀头卡停的现象，提高了使用的稳定性，避免血管损伤。
在常规切割时，医生可以选用高速挡，从而实现斑块切除效率的最大化。当遇到斑块堵塞或者斑块难以切除的情况时，尤其是因 导管200调弯而导致斑块或血栓卡在导管200的弯曲部位时，医生可以选用低速挡以提高扭矩轴210的扭矩，避免斑块或血栓难以通过导管200的弯曲部位，保证导管200不会发生堵塞，并避免旋切刀头320卡停的情况发生，保证手术的顺利进行。
在其他实施例中，还可以设置额外的齿轮组件，以增加可调挡位的数量，例如实现三挡可调，从而为医生提供更多的选择。并且，上述调速方案仅为示例，任何可以实现扭矩轴扭矩调整的机械结构均在本申请的保护范围内。
在其他实施例中，当采用外接电源的驱动方式时，还可以通过动态调整外接电源的输出功率的方式，以动态的控制扭矩轴的输出扭矩，从而保证使用的稳定性。
进一步地，如图16至图21所示，手柄本体100上设置有用于装配驱动机构400的装配部110，驱动机构400包括用于容纳驱动模块410与调节模块420的驱动壳体430，驱动壳体430与装配部110之间设置有拆卸连接部130。其中，驱动传动组件412与手柄本体100之间设置有密封结构4124。
本实施例通过驱动机构400可拆卸式设计，首先，为前期灭菌提供了便利，能够对驱动机构400中灭菌难度较大的电源组件413进行单独灭菌，然后通过拆卸连接部130进行快速组装，降低了切除装置整体的灭菌难度以及生产装配速度，提高了生产效率。其次，在切除装置使用以后，拆卸得到的零部件可以根据医用规范允许范围内二次使用，提高了零部件的利用率，降低了使用成本。另外， 在切除装置在使用完毕以后，可以快速的将各个零部件进行拆卸，根据医用规范灵活的进行分类回收与报废，降低了回收难度及成本。
拆卸连接部130包括设置在装配部110与驱动壳体430之间的钩挂组件131以及卡合组件132，钩挂组件131与卡合组件132分别设置在装配部110的两端，驱动壳体430与装配部110的底部之间设置有弹出件133。
具体的，装配部110为设置在手柄本体100上用于安装驱动机构400的装配槽，驱动机构400设置在装配部110内，且驱动机构400可拆卸连接于手柄本体100。驱动机构400具体通过驱动壳体430可拆卸连接于装配部110的方式，实现驱动机构400整体的可拆卸更换，驱动模块410和调节模块420均安装在驱动壳体430内。
本实施例通过将驱动机构400整体设置为可拆卸结构，从而驱动机构400在符合规范的情况下，可循环使用。并且驱动机构400和手柄本体100可以根据医用使用规范进行分类回收。
进一步地，如图18所示，卡合组件132设置在手柄本体100的近端，钩挂组件131设置在手柄本体100的远端。卡合组件132包括滑动连接于驱动壳体430的锁紧销1321以及设置在锁紧销1321上的锁紧键1322，锁紧键1322与锁紧销1321一体成型，或者锁紧销1321与锁紧键1322分体成型后粘接固定。
装配部110的内壁上设置有用于与锁紧销1321卡合连接的锁紧孔1323，用户可以通过拨动锁紧键1322带动锁紧销1321移动，并控制锁紧销1321插入锁紧孔1323中以实现锁紧销1321与锁紧孔 1323的固定，或者控制锁紧销1321脱离与锁紧孔1323的插接以实现锁紧销1321与锁紧孔1323的分离。当锁紧销1321插入锁紧孔1323中时，驱动机构400与装配部110处于固定状态，当锁紧销1321脱离锁紧孔1323时，驱动机构400与装配部110处于分离状态。
其中，锁紧键1322的底部设置有锁紧卡件1324，驱动壳体430表面上设置有锁定固定槽1325和分离固定槽1326，分离固定槽1326相对锁定固定槽1325远离锁紧孔1323设置，锁定固定槽1325与分离固定槽1326分别用于与锁紧卡件1324卡合固定。当锁紧键1322带动锁紧销1321朝向靠近锁紧孔1323的方向移动，并使锁紧卡件1324卡合连接于锁定固定槽1325内时，锁紧销1321插入锁紧孔1323中，并使得驱动机构400与装配部110卡接固定。当锁紧键1322带动锁紧销1321朝向远离锁紧孔1323的方向移动，并使锁紧卡件1324卡合连接于分离固定槽1326内时，锁紧销1321与锁紧孔1323分离，并使得驱动机构400与装配部110分离。
其中，驱动壳体430与装配部110的底部之间设置有用于将驱动机构400弹出的弹出件133，弹出件133优选为弹簧。即当锁紧销1321与锁紧孔1323脱离后，弹出件133自动将驱动机构400从装配部110内弹起，从而方便用户将驱动机构400取出。
钩挂组件131设置在驱动壳体430相对锁紧销1321的另一端，钩挂组件131包括设置在驱动壳体430远端端面上的挂钩1311以及设置在装配部110的内表面且与挂钩1311钩挂连接的钩挂槽1312。
在将驱动机构400固定在装配部110内时，首先将挂钩1311与 钩挂槽1312钩挂连接，从而实现驱动机构400的远端与装配部110固定，然后将卡合组件132的锁紧键1322与锁紧孔1323插接，实现驱动机构400的远端与装配部110固定。
在将驱动机构400从装配部110内取出时，首先将卡合组件132的锁紧键1322与锁紧孔1323分离，实现驱动机构400的近端与装配部110分离，然后将挂钩1311从钩挂槽1312中取出，实现驱动机构400的远端与装配部110分离。
在本实施例中，手柄本体100上还设置有可拆卸连接于手柄本体100且设置在驱动机构400外侧的手柄上盖120。
其中，结合图19所示，手柄上盖120的远端与手柄本体100的钩挂槽1312通过卡合结构固定，手柄上盖120的远端设置有上盖插销123，其中，上盖插销123插接连接于钩挂槽1312。手柄上盖120的近端设置有插板121，插板121设置在驱动壳体430与钩挂槽1312之间，插板121上设置有与锁紧销1321配合的插孔122。当手柄上盖120的上盖插销123与钩挂槽1312卡合固定后，将手柄本体100贴合驱动壳体430设置，然后操作锁紧键1322朝向锁紧孔1323的方向移动。锁紧键1322首先穿过插板121上的插孔122，然后插入缩进孔中，实现同时将手柄上盖120和驱动机构400固定在手柄本体100上的目的。
本申请通过在驱动机构400上设置手柄上盖120的方式，保护了驱动机构400，防止驱动机构400因外界碰撞等因素损坏。另外，在将手柄本体100与驱动机构400拆卸后，可以根据相关理疗规定 对相关拆分件进行分类回收与报废。
在本实施例中，调弯组件220设置在手柄本体100的远端，从而方便医生在术中的操作，导管200从手柄本体100的远端穿入手柄本体100，导管200与手柄本体100通过缓冲套管270连接，导管200的近端固定于设置在手柄本体100中部的排出腔道500。
排出腔道500设置在手柄本体100的中部，扭矩轴210贯穿手柄本体100，扭矩轴210首先贯穿导管200并从导管200中穿入主腔体510，从导管200中被送出的斑块或血栓掉落至主腔体510中，并从排废管中排出，排废管相对主腔体510倾斜设置，便于斑块或血栓排出。
扭矩轴210从排出腔道500中穿出，并通过一轴承连接于手柄本体100，扭矩轴210的导丝腔211连通于手柄本体100的外部空间，从而导丝通过导丝腔211贯穿扭矩轴210并从扭矩轴210的远端穿出，从而为导管200建立路入血管的通路。
其中，驱动机构400设置在导管200以及排出腔道500的上方，驱动传动组件412设置在排出腔道500的近端并与扭矩轴210连接。从而斑块或者血栓通过设置在驱动传动组件412远端的排出腔道500排出手柄本体100，斑块或者血栓不会接触到驱动传动组件412。
并且驱动传动组件412与排出腔道500之间采用密封设计，即第一传动件4121与手柄本体100之间设置有密封结构4124，密封结构4124包括固定在手柄本体100上的滚动轴承以及用于密封滚动轴承的密封圈，扭矩轴210穿过滚动轴承，并与滚动轴承固定并密封 连接。具体的，可通过焊料填满扭矩轴210与滚动轴承之间的间隙，并焊接固定，然后通过密封圈对滚动轴承与手柄本体100进行密封。从而，本实施例的驱动机构400在使用后能够保持洁净，从而便于回收，并且能够二次利用。
综上，本申请通过调弯组件220调节远端导管200的弯曲半径，使导管200朝向预定方向偏移，并控制刀头组件300的朝向，降低刮伤血管及血管穿孔的风险，能够通过多次切除得到理想的血管管径。同时，设置用于调节扭矩轴210扭矩的调节模块420，以使斑块切除装置在切除较硬的斑块时，可以通过调整扭矩轴210的扭矩使斑块切除更加顺畅。另一方面，通过设置可拆卸连接于手柄本体100的驱动机构400，以使驱动机构400可以循环使用，降低斑块切除装置的使用成本。
实施例二
本发明的实施例二提出了一种切除装置，如图22所示，实施例二与实施例一的相同之处不再赘述，实施例二与实施例一的不同之处在于，调弯点221包括设置在导管200上的调弯固定件2211以及设置在刀头组件300上的回位固定件2212，调弯连接件222用于连接调弯固定件2211和回位固定件2212，回位固定件2212设置在刀头组件300的近端，调弯固定件2211设置在导管200相对于回位固定件2212的另一侧。
调弯连接件222包括调弯连接线2221以及回位连接线2222，导管200上设置有用于调弯连接线2221穿过的调弯线腔2223以及用 于回位连接线2222穿过的回位线腔2224。调弯连接线2221用于连接控制组件140以及调弯固定件2211，回位连接线2222用于连接控制组件140以及回位固定件2212。
回位固定件2212设置在刀头组件300的近端，调弯固定件2211设置在导管200相对于回位固定件2212的另一侧。调弯固定件2211设置在导管200相对于回位固定件2212的另一侧，优选调弯固定件2211与回位固定件2212在周向上相差180度设置。
具体的，导管200内设置有调弯线腔2223以及回位线腔2224，调弯线腔2223和回位线腔2224均设置在外管240中或者设置在外管240与编织层250之间。调弯连接线2221的一端连接于调弯固定件2211，然后贯穿调弯线腔2223后，另一端连接于控制组件140。回位连接线2222的一端连接于调弯固定件2211，然后贯穿回位线腔2224后，另一端连接于控制组件140。
调弯连接线2221与回位连接线2222分别固定在收线器142上，当医生转动控制座141时，收线器142在滑杆144上相对控制座141滑移，从而同时牵拉调弯连接线2221和回位连接线2222，从而调整导管200和刀头组件300的姿态。
其中，回位固定件2212设置在保护套330上，回位固定件2212为设置在保护套330上的固定板，回位连接线2222与固定板焊接固定，或者回位固定件2212上设置有连接孔，回位连接线2222穿过连接孔并打结固定。调弯固定件2211为设置在导管200的编织层250上的固定环，固定环将调弯连接线2221压紧固定在编织层250上， 或者调弯连接线2221与固定环焊接固定。
由于调弯固定件2211设置在导管200相对于回位固定件2212的另一侧，因此当收线器142同时牵拉调弯连接线2221和回位连接线2222时，调弯连接线2221通过调弯固定件2211控制导管200轴向位移，回位固定件2212通过回位固定件2212控制刀头组件300径向位移。在调弯连接线2221和回位连接线2222的综合作用下，使刀头组件300实现S形调弯，从而使刀头组件300与导管200轴向保持相同方向，降低刀头组件300擦伤血管壁的风险。而刀头组件300调弯前与调弯后切除血管内斑块，能使血管获得更大的管腔。
本实施例通过调弯组件220实现了导管200与刀头组件300的S形调弯，从而在切割血管内斑块时，可以通过调弯导管200和刀头组件300，使得切割的面积增大。同时，由于刀头组件300在回位固定件2212的作用下，与导管200的轴向基本保证方向相同，因此在刀头组件300推进过程中，不会误切割血管壁，大大降低了刀头组件300擦伤血管壁的风险。相比现有技术的调弯方式，本申请既能够使血管获得更大的管腔，又能保证切割时的安全性。
实施例三
本发明的实施例三提出了一种切除装置，如图23与图24所示，实施例三与实施例一的相同之处不再赘述，实施例三与实施例一的不同之处在于，手柄本体100上设置有控制槽150，控制组件140设置在控制槽150内，控制座141卡合固定在控制槽150内，收线器142包括滑动连接于控制座141的滑钮145以及设置在滑钮145 上的接线点1451，接线点1451用于连接调弯连接件222，调弯连接件222为调弯连接线2221。
具体的，控制座141上设置有滑槽1412以及滑动连接于滑槽1412的滑块1413，滑槽1412沿控制座141的长度方向设置。滑块1413上设置有固定孔1414，控制座141的滑钮145朝向滑块1413的一端设置有固定柱1452，固定柱1452穿过在固定孔1414，以使滑钮145通过固定柱1452连接于滑块1413。滑钮145与滑块1413之间设置有控制弹簧146，滑钮145与滑块1413同时滑动连接于控制座141，且控制弹簧146具有初始压力，使得滑钮145紧贴于控制座141内壁。
其中，所述锁定件1421为设置在滑钮145与控制座141之间的粗糙接触面，当控制组件140处于自然状态时，控制弹簧146驱动滑钮145紧贴于控制座141的内壁，由于滑钮145与控制座141之间设置有粗糙接触面，因此滑钮145与控制座141在摩擦力的作用下不会相对移动，实现收线器142的自锁定。当向控制座141的内部按压滑钮145时，控制弹簧146受力压缩，且滑钮145与控制座141分离，此时滑钮145可以相对控制座141移动。
在其他实施例中，锁定件1421还可以为设置在滑钮145与控制座141之间且相互卡合的凸点与凹槽结构，以增强滑钮145和控制座141在贴合时的结合强度。在自然状态下，控制弹簧146驱动滑钮145紧贴于控制座141内壁，从而通过凸点与凹槽结构相互卡合，实现收线器142的自锁定。
在本实施例中，滑钮145上设置有螺纹孔，接线点1451为螺纹连接于滑钮145的螺丝，在装配时，将调弯连接件222粘接固定在螺纹孔中，然后将螺丝拧入螺纹孔中进行二次固定。
具体操作时，操作者通过按压滑钮145，以使滑钮145与控制座141的贴合面分离，弹簧沿导管200的轴向方向滑动滑钮145，带动调弯连接件222沿导管200的轴向方向移动，实现导管200的姿态调整，对刀头组件300进行调弯。手术过程中，操作者不需要一直按压滑钮145，同时，操作者仅需要单手即可实现刀头组件300的调弯操作，减轻了操作负担，提高了操作便利性。另外，通过平移的调节方式，调节行程精确，可以实现调弯角度的精确可控。
实施例四
本发明的实施例四提出了一种切除装置，如图25至图27所示，实施例四与实施例一的相同之处不再赘述，实施例四与实施例一的不同之处在于，手柄本体100上设置有控制槽150，控制组件140设置在控制槽150内，控制座141卡合固定在控制槽150内，收线器142包括转动连接于控制座141的旋钮147以及用于卡合所述旋钮的锁定件1421，锁定件1421为用于将旋钮147卡合固定的止动销148，止动销148滑动连接于控制座141，旋钮147上设置有与止动销148卡合连接的止动槽1472。其中，止动销148与控制座141的内壁之间设置有止动弹簧1481。
旋钮147上设置有旋转夹块1471，旋转夹块1471用于连接调弯连接件222，调弯连接件222为调弯连接线2221，转动旋钮147以 使调弯连接件222缠绕在旋转夹块1471上，从而实现牵拉调弯连接件222以调整导管200姿态的目的。在自然状态下，止动弹簧1481驱动止动销朝向旋钮147的方向移动，并卡接在止动槽1472内。当需要转动旋钮147时，向远离旋钮147的方向滑动止动销148，以使止动销148与止动槽1472分离，此时可转动旋钮147。当需要锁定旋钮147时，放开止动销148，止动弹簧1481驱动止动销148朝向靠近旋钮147的方向滑动，以使止动销148与止动槽1472卡合，此时旋钮147不可转动。
在本申请进一步实施方案中，控制组件140还包括用于防止误触的锁定保险组件1422，所述锁定保险组件1422设置在控制座141与收线器142之间。
具体的，控制座141内还设置有定位柱1415，定位柱1415上套设有定位弹簧1416，定位弹簧1416设置在控制座141与旋钮147之间。其中，旋钮147可以沿自身轴向方向移动，且旋转夹块1471与控制座141之间设置有锁定保险组件1422，其中，锁定保险组件1422为卡位结构149。其中，卡位结构149包括设置在旋转夹块1471朝向旋钮147一端的卡位槽1491以及设置在控制座141朝向旋转夹块1471一端的卡位块1492，当卡位块1492与卡位槽1491卡合固定时，旋钮147无法转动。
在具体操作时，在自然状态下，定位弹簧1416向外推动旋钮147，以使旋转夹块1471与控制座141之间的卡位结构149卡合固定。同时，止动销148在止动弹簧1481的驱动下与止动槽1472处 于卡合状态。而当止动销148插接在止动槽1472中时，止动销148位于旋钮147与控制座141之间，挡住了旋钮147轴向移动的路径，因此旋钮147无法按压，也无法解除卡位块1492与卡位槽1491的卡合连接，因此，在自然状态下，旋钮147无法转动。当需要转动旋钮147时，操作者首先向远离旋钮147的方向滑动止动销148，以使止动销148与止动槽1472分离，然后向内按压旋钮147，定位弹簧1416受力被压缩，同时使卡位结构149分离，即卡位块1492与卡位槽1491分离，此时可以转动旋钮147。
因此，本实施例的控制组件140通过在控制座141与收线器142之间设置额外的锁定保险组件1422，实现了收线器142的双重锁定，提高了结构的可靠性，保证了医生在推进刀头组件300以切割斑块时，刀头组件300的姿态不会发生变化。仅当医生同时推动止动销148并按压旋钮147时，才能转动旋钮147，不会因为误触而导致刀头组件300的朝向发生变化，避免了旋切刀头320切伤血管，从而避免医疗事故的发生，进而保证了手术的顺利进行。
实施例五
本发明的实施例五提出了一种切除装置，如图29至图33所示，实施例五与实施例一的相同之处不再赘述，实施例五与实施例一的不同之处在于，驱动机构400设置在手柄本体100内，导管200与驱动机构400可拆卸连接。
具体的，结合图2所示，驱动机构400包括设置在手柄本体100内的驱动模块410，驱动模块410包括动力轴4111、动力源411以 及电源组件413，动力源411用于驱动动力轴4111转动，导管200通过连接模块440可拆卸连接于动力轴4111。其中，动力源411为电机，电机用于驱动扭矩轴210转动，电源组件413为电性连接于电机的电池。
其中，结合图31至图33所示，扭矩轴210的近端设置有传动轴212，动力轴4111的远端设置有插接槽4112，传动轴212插接在插接槽4112内且与动力轴4111同步转动。传动轴212上设置有卡接槽2121，连接模块440包括与卡接槽2121卡合连接的卡接定位组件441以及用于控制卡接定位组件441的卡接控制组件442。
在本实施例中，扭矩轴210具体包括轴本体213以及设置在轴本体213上的绕簧214，其中，绕簧214呈螺旋状缠绕并固定在轴本体213上，可通过焊接固定，绕簧214的旋转方向与轴本体213的旋转方向相反。当电机驱动扭矩轴210旋转时，与轴本体213旋转方向相反的绕簧214能够更迅速的将导管200中的斑块送出，提高切除效率。
进一步地，传动轴212上设置有至少一个限位块2122，插接槽4112的内壁上设置有限位槽4113，在传动轴212插接在插接槽4112内以后，限位块2122用于与限位槽4113适配以将传动轴212周向固定于动力轴4111。在本实施例中，传动轴212上设置有三个圆周阵列分布的限位块2122，三个限位块2122通过与限位槽4113插接形式配合，起到使动力轴4111和传动轴212圆周方向同步转动的作用，以使扭矩轴210与动力轴4111同步转动。
进一步地，卡接定位组件441包括卡接件4411、定位件4412以及连接端部4413，卡接件4411设置在动力轴4111上并用于与卡接槽2121卡合连接，定位件4412活动连接于动力轴4111，定位件4412用于卡接件4411的定位，连接端部4413用于连接卡接控制件443以及卡接件4411，卡接控制组件442通过控制连接端部4413以控制卡接件4411与卡接槽2121卡合连接或分离。
当传动轴212插入至插接槽4112的底部时，卡接件4411的头端卡合连接于卡接槽2121，由于卡接件4411通过定位件4412与动力轴4111轴向固定，因此当卡接件4411与卡接槽2121卡合连接时，限制了传动轴212与动力轴4111的轴向位移。
在本实施例中，卡接件4411为头端朝向传动轴212弯曲的卡位弹片，定位件4412为螺纹连接于动力轴4111的固定螺栓。卡接件4411上设置有用于定位件4412穿过的通孔，通过将定位件4412穿过卡接件4411上的通孔并螺纹连接于动力轴4111，以使卡接件4411轴向固定与动力轴4111，并且卡接件4411能够以定位件4412为中心点转动，从而卡合连接于卡接槽2121或者从卡接槽2121内脱离。
连接端部4413一体成型于卡接件4411，连接端部4413设置在卡接件4411的尾端，连接端部4413为驱动弹片，且驱动弹片朝向背离动力轴4111的方向弯曲。当朝向动力轴4111的方向挤压连接端部4413时，卡接件4411以定位件4412为中点转动，从而卡接件4411的头端从而卡接槽2121内脱离，使动力轴4111与传动轴212可沿轴向分离。
卡接控制组件442包括设置在手柄本体100上轴套4421、固定设置在轴套4421内侧的固定端部4422、与轴套4421活动连接的活动端部4423以及卡接控制件443，活动端部4423设置定位件4412与连接端部4413之间，卡接控制件443用于控制活动端部4423移动，动力轴4111穿过固定端部4422以及活动端部4423后连接件于传动轴212。
固定端部4422为与动力轴4111连接的固定轴承，活动端部4423为沿轴套4421的轴向方向与轴套4421滑动连接的滑动压块。卡接控制件443包括连接于固定端部4422与活动端部4423的弹性件4433以及用于控制滑动压块位置的拉绳4431。
拉绳4431的末端设置有拉环4432，连接端部4413与卡接件4411一体连接，连接端部4413的近端翘起，活动端部4423在连接端部4413与卡接件4411之间滑移。
具体的，固定端部4422固定连接于轴套4421的内侧，并连接于动力轴4111，动力轴4111以定位件4412为基点转动。活动端部4423与定位件4412之间设置有弹性件4433，弹性件4433用于驱动活动端部4423朝向远离定位件4412的方向滑移，弹性件4433靠近活动端部4423的一端或者活动端部4423上设置有拉绳4431，拉绳4431的一端连接于弹性件4433或者活动端部4423，拉绳4431的另一端连接于手柄本体100外侧的拉环4432，操作者可以通过拉环4432牵拉拉绳4431，以使活动端部4423朝向固定端部4422的方向移动。其中，弹性件4433为弹簧，拉绳4431为镍钛丝，镍钛丝焊 接在弹簧上。
在初始状态时，活动端部4423在弹性件4433的作用力下，位于远离固定轴承的一侧，此时活动端部4423位于卡接件4411上，卡接件4411的头端卡合连接在卡接槽2121内。当操作者通过牵拉拉绳4431时，活动端部4423沿轴套4421的轴向方向朝向固定端部4422移动，并从两侧挤压连接端部4413，使得连接端部4413朝向动力轴4111的方向移动，并使卡接件4411以定位件4412为中点转动，从而卡接件4411的头端脱离卡接槽2121，此时，动力轴4111与传动轴212可以轴向分离。
由上，本实施例通过设置卡接定位组件441和卡接控制组件442，使得扭矩轴210可以轴向可拆卸连接于动力轴4111，并通过限位块2122和限位槽4113的配合，使扭矩轴210与动力轴4111同轴转动，电机输出扭矩并通过动力轴4111驱动扭矩轴210转动。
手柄本体100上设置有收集部170，收集部170罩设在导管200近端的外侧，收集部170用于收集从导管200中排出的斑块。并且收集部170与手柄本体100可拆卸连接，导管200的近端与收集部170可拆卸连接。导管200的近端设置有缓冲套管270，缓冲套管270上设置有密封槽271，手柄本体100与收集部170分别通过密封槽271与导管200连接。
在本实施例中，收集部170设置在手柄本体100远端的底部，收集部170与手柄本体100之间设置有收集腔体，通过收集腔体容纳切除的斑块。导管200的近端固定连接于缓冲导管200的远端， 或者导管200的近端固定连接于缓冲导管200的近端。扭矩轴210依次穿过导管200以及缓冲导管200并伸入收集部170内，由导管200冲排出的斑块或者血栓掉落在收集部170内。
轴套4421固定连接于手柄本体100且朝向收集部170的方向突出，卡接控制组件442的其它部件均设置在轴套4421的内腔中。动力轴4111的一端连接于动力源411，且动力轴4111的另一端穿出轴套4421并与传动轴212连接。
由于导管200的近端连接于缓冲套管270，因此导管200中的斑块或者血栓在通过缓冲套管270以后就会因扭矩轴210的高速旋转和自身重力落入收集部170内，而不会跟随扭矩轴210继续向前移动。从而保护了设置在轴套4421内的卡接控制组件442。
进一步地，如图30所示，本实施例的轴本体213的长度大于绕簧214的长度，且绕簧214近端与传动轴212之间的设置有间隔段，位于间隔段的轴本体213上未设置绕簧214。通过上述方案，由导管200中排出的斑块或者血栓移动至绕簧214的近端后，就会因扭矩轴210的高速旋转和自身重力落入收集部170内，从而保证了斑块或者血栓不会继续向前移动，而对卡接控制组件442造成影响。
具体的，缓冲套管270固定设置在导管200上，缓冲套管270为硅胶材质，缓冲套管270上设置有密封槽271，密封槽271绕缓冲套管270的一周向缓冲套管270内部凹陷，形成一圈环形的凹槽，缓冲套管270与手柄本体100和收集部170组合后，手柄本体100和收集部170的边缘通过缓冲槽连接从而密封。
通过本实施例的上述技术方案，医生可以根据实际使用情况更换导管200。具体操作时，首先将收集部170取下，然后拉动手柄本体100上的拉环4432，通过拉环4432将拉力沿着拉绳4431传递到弹性件4433上，以使活动端部4423朝向固定端部4422移动。在活动端部4423移动的过程中，活动端部4423逐渐压过连接端部4413，使翘起的连接端部4413朝向动力轴4111移动。在连接端部4413的联动作用下，嵌入卡接槽2121的卡接件4411逐渐从卡接槽2121中脱离。当卡接件4411整体从卡接槽2121内脱离时，操作者可以沿轴向将扭矩轴210从而动力轴4111上拆卸。
在装入新的扭矩轴210时，首先牵拉拉环4432，然后将扭矩轴210插入插接槽4112中，然后放开拉环4432，确认卡接件4411卡入卡接槽2121后，将收集部170安装在手柄本体100上。
本实施例采用了可更换导管200的设计，提高了手术的灵活性和经济性，避免了因导管200的堵塞导致斑块或者血栓无法及时排出血管，而造成远端栓塞，保证了病人的生命安全。
以上，仅为本发明较佳的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到的变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以权利要求的保护范围为准。

Claims (60)

  1. 一种切除装置，包括手柄本体、连通于所述手柄本体的导管以及设置在所述导管远端的刀头组件，其特征在于，所述导管上设置有调弯组件，所述调弯组件包括设置在所述导管上的第一调弯点、第二调弯点以及用于连接所述第一调弯点和所述第二调弯点的调弯连接件，所述手柄本体上设置有用于控制所述调弯组件的控制组件。
  2. 根据权利要求1所述的切除装置，其特征在于，所述调弯连接件与所述第一调弯点固定连接，所述调弯连接件与所述第二调弯点活动连接，所述第一调弯点与所述导管远端的距离相比所述第二调弯点与所述导管远端的距离更小，所述第一调弯点设置在相对于所述第二调弯点的另一侧。
  3. 根据权利要求2所述的切除装置，其特征在于，所述调弯连接件包括调弯控制线，所述导管上设置有用于所述调弯控制线穿过的控制线腔，所述第二调弯点设置在所述控制线腔的远端，所述调弯控制线穿过所述第二调弯点且绕所述导管旋转后固定连接于所述第一调弯点。
  4. 根据权利要求3所述的切除装置，其特征在于，所述控制组件包括设置在所述手柄本体上的控制座以及活动连接于所述控制座的收线器，所述收线器连接于所述调弯控制线且用于牵拉所述调弯控制线以调整所述导管的姿态。
  5. 根据权利要求1所述的切除装置，其特征在于，所述导管内设置有连接于所述刀头组件的扭矩轴，所述手柄本体内设置有用于驱动所述扭矩轴转动的驱动机构。
  6. 根据权利要求5所述的切除装置，其特征在于，所述刀头组件包括连接于所述导管的限位座以及设置在所述限位座上的旋切刀头，所述旋切刀头固定连接于所述扭矩轴的一端，所述扭矩轴驱动所述旋切刀头转动连接于所述限位座，所述限位座上设置有罩设在所述旋切刀头侧面的保护套。
  7. 根据权利要求5所述的切除装置，其特征在于，所述导管包括内管以及设置在所述内管外侧的外管，所述内管套设在所述扭矩轴的外侧，所述扭矩轴与所述内管为间隙配合，所述内管与外管之间设置有编织层。
  8. 根据权利要求5所述的切除装置，其特征在于，所述手柄本体上设置有连接于所述导管的排出腔道，所述排出腔道连通于所述导管与所述手柄本体的外部空间。
  9. 根据权利要求8所述的切除装置，其特征在于，所述扭矩轴穿过所述排出腔道并连接于所述驱动机构，所述驱动机构包括动力源、用于连接所述动力源与所述扭矩轴的驱动传动组件以及电性连接于所述动力源的电源。
  10. 根据权利要求8所述的切除装置，其特征在于，所述排出腔道包括连通于所述导管的主腔体以及设置在所述主腔体侧面的排废管，所述扭矩轴穿过所述。
  11. 一种切除装置，包括手柄本体、连通于所述手柄本体的导管以及设置在所述导管远端的刀头组件，其特征在于，还包括调弯组件和控制组件，所述调弯组件包括设置在所述导管上的调弯固定 件、设置在所述刀头组件上的回位固定件以及用于连接所述调弯固定件和所述回位固定件的调弯连接件，所述手柄本体上设置有用于控制所述调弯连接件的控制组件。
  12. 根据权利要求11所述的切除装置，其特征在于，所述回位固定件设置在所述刀头组件的近端，所述调弯固定件设置在所述导管相对于所述回位固定件的另一侧。
  13. 根据权利要求12所述的切除装置，其特征在于，所述调弯连接件包括调弯连接线以及回位连接线，所述导管上设置有用于所述调弯连接线穿过的调弯线腔以及用于所述回位连接线穿过的回位线腔；所述调弯连接线用于连接所述控制组件以及所述调弯固定件，所述回位连接线用于连接所述控制组件以及所述回位固定件。
  14. 根据权利要求13所述的切除装置，其特征在于，所述控制组件包括设置在所述手柄本体上的控制座以及活动连接于所述控制座的收线器，所述收线器连接于所述调弯连接线以及所述回位连接线，所述收线器用于牵拉所述调弯连接线以及所述回位连接线以调整所述导管以及刀头组件的姿态。
  15. 根据权利要求11所述的切除装置，其特征在于，所述导管内设置有连接于所述刀头组件的扭矩轴，所述手柄本体内设置有用于驱动所述扭矩轴转动的驱动机构，所述导管远端的内部嵌设有用于增强所述导管抗扭矩性能的弹簧管。
  16. 根据权利要求15所述的切除装置，其特征在于，所述刀头组件包括连接于所述导管的限位座以及设置在所述限位座上的旋切 刀头，所述旋切刀头固定连接于所述扭矩轴的一端，所述扭矩轴驱动所述旋切刀头转动连接于所述限位座，所述限位座上设置有罩设在所述旋切刀头侧面的保护套；所述旋切刀头上设置有刀头卡槽，所述限位座上设置有与所述刀头卡槽卡接配合的限位凸台。
  17. 根据权利要求15所述的切除装置，其特征在于，所述导管包括内管以及设置在所述内管外侧的外管，所述内管套设在所述扭矩轴的外侧，所述扭矩轴与所述内管为间隙配合，所述内管与外管之间设置有编织层；所述弹簧管套设在所述编织层的外侧，或所述编织层套设在所述弹簧管的外侧，所述弹簧管与所述编织层固定连接。
  18. 根据权利要求15所述的切除装置，其特征在于，所述手柄本体上设置有连接于所述导管的排出腔道，所述排出腔道连通于所述导管与所述手柄本体的外部空间。
  19. 根据权利要求18所述的切除装置，其特征在于，所述扭矩轴穿过所述排出腔道并连接于所述驱动机构，所述驱动机构包括动力源、用于连接所述动力源与所述扭矩轴的驱动传动组件以及电性连接于所述动力源的电源。
  20. 根据权利要求19所述的切除装置，其特征在于，所述排出腔道包括连通于所述导管的主腔体以及设置在所述主腔体侧面的排废管，所述扭矩轴穿过所述。
  21. 一种切除装置，包括手柄本体、连通于所述手柄本体的导管以及设置在所述导管远端的刀头组件，所述导管内设置有连接于 所述刀头组件的扭矩轴，其特征在于，所述导管上设置有用于调弯所述导管远端部位的调弯组件，所述手柄本体上设置有用于控制所述调弯组件的控制组件，所述控制组件包括设置在所述手柄本体上的控制座以及活动连接于所述控制座的收线器，所述收线器包括用于自锁定的锁定件。
  22. 根据权利要求21所述的切除装置，其特征在于，所述控制组件还包括用于防止误触的锁定保险组件，所述锁定保险组件设置在所述控制座的内部且位于所述控制座与所述收线器之间。
  23. 根据权利要求21所述的切除装置，其特征在于，所述调弯组件包括至少两个调弯点以及用于连接所述调弯点的调弯连接件；所述收线器用于连接所述调弯连接件且用于牵拉所述调弯连接件以调整所述导管和/或所述刀头组件的姿态。
  24. 根据权利要求23所述的切除装置，其特征在于，所述调弯点包括设置在所述导管上的调弯固定件以及设置在所述刀头组件上的回位固定件，所述调弯连接件用于连接所述调弯固定件和所述回位固定件，所述回位固定件设置在所述刀头组件的近端，所述调弯固定件设置在所述导管相对于所述回位固定件的另一侧。
  25. 根据权利要求24所述的切除装置，其特征在于，所述调弯连接件包括调弯连接线以及回位连接线，所述导管上设置有用于所述调弯连接线穿过的调弯线腔以及用于所述回位连接线穿过的回位线腔；所述调弯连接线用于连接所述控制组件以及所述调弯固定件，所述回位连接线用于连接所述控制组件以及所述回位固定件。
  26. 根据权利要求23所述的切除装置，其特征在于，所述调弯点包括设置在所述导管上的第一调弯点以及第二调弯点，所述调弯连接件与所述第一调弯点固定连接，所述调弯连接件与所述第二调弯点活动连接，所述第一调弯点与所述导管远端的距离相比所述第二调弯点与所述导管远端的距离更小，所述第一调弯点设置在相对于所述第二调弯点的另一侧。
  27. 根据权利要求26所述的切除装置，其特征在于，所述调弯连接件包括调弯控制线，所述导管上设置有用于所述调弯控制线穿过的控制线腔，所述第二调弯点设置在所述控制线腔的远端，所述调弯控制线穿过所述第二调弯点且绕所述导管旋转后固定连接于所述第一调弯点。
  28. 根据权利要求21所述的切除装置，其特征在于，所述刀头组件包括连接于所述导管的限位座以及设置在所述限位座上的旋切刀头，所述旋切刀头固定连接于所述扭矩轴的一端，所述扭矩轴驱动所述旋切刀头转动连接于所述限位座，所述限位座上设置有罩设在所述旋切刀头侧面的保护套。
  29. 根据权利要求21所述的切除装置，其特征在于，所述导管包括内管以及设置在所述内管外侧的外管，所述内管套设在所述扭矩轴的外侧，所述扭矩轴与所述内管为间隙配合，所述内管与外管之间设置有编织层。
  30. 根据权利要求1所述的切除装置，其特征在于，所述手柄本体上设置有连接于所述导管的排出腔道，所述排出腔道连通于所 述导管与所述手柄本体的外部空间，所述扭矩轴穿过所述排出腔道并连接于所述驱动机构；所述排出腔道包括连通于所述导管的主腔体以及设置在所述主腔体侧面的排废管，所述扭矩轴穿过所述主腔体且连通于所述手柄本体的外部空间，所述扭矩轴内设置有贯通所述扭矩轴的导丝腔。
  31. 一种切除装置，包括手柄本体、连通于所述手柄本体的导管以及设置在所述导管远端的刀头组件，所述导管内设置有连接于所述刀头组件的扭矩轴，其特征在于，所述导管上设置有用于调弯所述导管远端部位的调弯组件，所述手柄本体上设置有驱动机构，所述驱动机构包括用于驱动所述扭矩轴转动的驱动模块以及用于控制所述驱动模块以调节所述扭矩轴扭矩的调节模块。
  32. 根据权利要求31所述的切除装置，其特征在于，所述驱动模块包括动力源以及用于连接所述动力源与所述扭矩轴的驱动传动组件；所述调节模块包括与所述驱动传动组件连接的调节传动组件以及换挡组件，所述换挡组件用于控制调节传动组件与所述驱动传动组件的配合关系以调节所述扭矩轴的扭矩。
  33. 根据权利要求32所述的切除装置，其特征在于，所述驱动传动组件包括与所述扭矩轴连接的第一传动件、与所述动力源连接的第二传动件以及设置在所述驱动壳体上的第三传动件，所述第三传动件连接在所述第一传动件与所述第二传动件之间。
  34. 根据权利要求33所述的切除装置，其特征在于，所述调节传动组件包括与所述第一传动件同轴设置的第四传动件以及与所述 第三传动件同轴设置的第五传动件，所述换挡组件包括连接于所述动力源的输出轴的主轮轴以及连接于所述主轮轴的拨杆，所述第三转动件与所述第五转动件均设置在所述主轮轴上，所述主轮轴与所述输出轴滑动连接且同步转动；所述拨杆用于驱动所述第二传动件与所述第三传动件连接或驱动所述第四传动件与所述第五传动件连接。
  35. 根据权利要求32所述的切除装置，其特征在于，所述驱动壳体内设置有用于驱动所述动力源的电源组件，或所述驱动壳体上设置有用于连接外部电源且电性连接于所述动力源的电源组件。
  36. 根据权利要求31所述的切除装置，其特征在于，所述驱动机构可拆卸连接于所述手柄本体，所述手柄本体上设置有用于装配所述驱动机构的装配部以及可拆卸连接于所述手柄本体且设置在所述驱动机构外侧的手柄上盖，所述驱动机构包括用于容纳所述驱动模块与所述调节模块的驱动壳体，所述驱动壳体与所述装配槽之间设置有拆卸连接部。
  37. 根据权利要求31所述的切除装置，其特征在于，所述手柄本体上设置有用于控制所述调弯组件的控制组件，所述调弯组件包括至少两个调弯点以及用于连接所述调弯点的调弯连接件；所述控制组件包括设置在所述手柄本体上的控制座以及活动连接于所述控制座的收线器，所述收线器用于连接所述调弯连接件且用于牵拉所述调弯连接件以调整所述导管和/或所述刀头组件的姿态。
  38. 根据权利要求31所述的切除装置，其特征在于，所述刀头 组件包括连接于所述导管的限位座以及设置在所述限位座上的旋切刀头，所述旋切刀头固定连接于所述扭矩轴的一端，所述扭矩轴驱动所述旋切刀头转动连接于所述限位座，所述限位座上设置有罩设在所述旋切刀头侧面的保护套。
  39. 根据权利要求31所述的切除装置，其特征在于，所述导管包括内管以及设置在所述内管外侧的外管，所述内管套设在所述扭矩轴的外侧，所述扭矩轴与所述内管为间隙配合，所述内管与外管之间设置有编织层。
  40. 根据权利要求31所述的切除装置，其特征在于，所述手柄本体上设置有连接于所述导管的排出腔道，所述排出腔道连通于所述导管与所述手柄本体的外部空间，所述扭矩轴穿过所述排出腔道并连接于所述驱动机构；所述排出腔道包括连通于所述导管的主腔体以及设置在所述主腔体侧面的排废管，所述扭矩轴穿过所述主腔体且连通于所述手柄本体的外部空间，所述扭矩轴内设置有贯通所述扭矩轴的导丝腔。
  41. 一种切除装置，包括手柄本体、连通于所述手柄本体的导管以及设置在所述导管远端的刀头组件，其特征在于，所述导管内设置有连接于所述刀头组件的扭矩轴，所述手柄本体上设置有用于驱动所述扭矩轴转动的驱动机构以及用于装配所述驱动机构的装配部，所述驱动机构可拆卸连接于所述装配部。
  42. 根据权利要求41所述的切除装置，其特征在于，所述驱动机构包括可拆卸连接于所述装配部的驱动壳体以及设置在所述驱动 壳体内的驱动模块，所述驱动壳体与所述装配部之间设置有拆卸连接部。
  43. 根据权利要求42所述的切除装置，其特征在于，所述拆卸连接部包括设置在所述装配部与所述驱动壳体之间的钩挂组件以及卡合组件，所述钩挂组件与所述卡合组件分别设置在所述装配部的两端，所述驱动壳体与所述装配部的底部之间设置有弹出件。
  44. 根据权利要求43所述的切除装置，其特征在于，所述手柄本体上设置有可拆卸连接于所述手柄本体且设置在所述驱动机构外侧的手柄上盖，所述驱动模块包括用于驱动所述扭矩轴转动的动力源以及用于连接所述动力源与所述扭矩轴的驱动传动组件，所述驱动传动组件与所述手柄本体之间设置有密封结构。
  45. 根据权利要求44所述的切除装置，其特征在于，所述驱动传动组件包括第一传动件以及与所述第一传动件连接的第二传动件，所述动力源驱动所述第二传动件连接，所述第一传动件用于带动所述扭矩轴转动，所述密封结构设置在所述第一传动件与所述手柄本体之间。
  46. 根据权利要求42所述的切除装置，其特征在于，所述驱动模块还包括用于驱动所述动力源的电源组件，或所述驱动壳体上设置有用于连接外部电源且电性连接于所述动力源的电源组件。
  47. 根据权利要求42所述的切除装置，其特征在于，所述驱动机构还包括调节模块，所述调节模块用于控制所述驱动模块以调节所述扭矩轴的扭矩。
  48. 根据权利要求41所述的切除装置，其特征在于，所述刀头组件包括连接于所述导管的限位座以及设置在所述限位座上的旋切刀头，所述旋切刀头固定连接于所述扭矩轴的一端，所述扭矩轴驱动所述旋切刀头转动连接于所述限位座，所述限位座上设置有罩设在所述旋切刀头侧面的保护套。
  49. 根据权利要求41所述的切除装置，其特征在于，所述导管包括内管以及设置在所述内管外侧的外管，所述内管套设在所述扭矩轴的外侧，所述扭矩轴与所述内管为间隙配合，所述内管与外管之间设置有编织层。
  50. 根据权利要求41所述的切除装置，其特征在于，所述手柄本体上设置有连接于所述导管的排出腔道，所述排出腔道连通于所述导管与所述手柄本体的外部空间，所述扭矩轴穿过所述排出腔道并连接于所述驱动机构；所述排出腔道包括连通于所述导管的主腔体以及设置在所述主腔体侧面的排废管，所述扭矩轴穿过所述主腔体且连通于所述手柄本体的外部空间，所述扭矩轴内设置有贯通所述扭矩轴的导丝腔。
  51. 一种切除装置，包括手柄本体、连通于所述手柄本体的导管以及设置在所述导管远端的刀头组件，其特征在于，所述导管内设置有连接于所述刀头组件的扭矩轴，所述手柄本体上设置有用于驱动所述扭矩轴转动的驱动机构，所述导管与所述驱动机构可拆卸连接。
  52. 根据权利要求51所述的切除装置，其特征在于，所述驱动 机构包括设置在所述手柄本体内的驱动模块，所述驱动模块包括动力轴、用于驱动所述动力轴转动的动力源以及电源组件，所述导管通过连接模块可拆卸连接于所述动力轴。
  53. 根据权利要求52所述的切除装置，其特征在于，所述扭矩轴的近端设置有传动轴，所述动力轴的远端设置有插接槽，所述传动轴插接在所述插接槽内且与所述动力轴同步转动；所述传动轴上设置有卡接槽，所述连接模块包括与所述卡接槽卡合连接的卡接定位组件以及用于控制所述卡接定位组件的卡接控制组件。
  54. 根据权利要求53所述的切除装置，其特征在于，所述卡接定位组件包括设置在所述动力轴上且与所述卡接槽卡合连接的卡接件、活动连接于所述动力轴且用于定位所述卡接件的定位件以及连接于所述卡接控制组件与所述卡接件的连接端部，所述卡接控制组件通过控制所述连接端部以控制所述卡接件与所述卡接槽卡合连接或分离。
  55. 根据权利要求54所述的切除装置，其特征在于，所述卡接控制组件包括设置在所述手柄本体上轴套、固定设置在所述轴套内侧的固定端部、与所述轴套活动连接且设置在所述定位件与所述连接端部之间的活动端部以及用于控制所述活动端部移动的卡接控制件，所述动力轴穿过所述固定端部以及所述活动端部后连接件于所述传动轴。
  56. 根据权利要求55所述的切除装置，其特征在于，所述固定段部为与所述动力轴连接的固定轴承，所述活动端部为沿所述轴套 的轴向方向与所述轴套滑动连接的滑块，所述卡接控制件包括连接于所述固定轴承与所述滑块的弹性件以及用于控制所述滑块位置的拉绳。
  57. 根据权利要求56所述的切除装置，其特征在于，所述拉绳的末端设置有拉环，所述连接端部与所述卡接件一体连接，所述连接端部的近端翘起，所述滑块在所述连接端部与所述卡接件之间滑移。
  58. 根据权利要求51所述的切除装置，其特征在于，所述手柄本体上设置有收集部，所述收集部可拆卸连接于所述手柄本体且罩设在所述导管近端的外侧，所述导管的近端与所述收集部可拆卸连接；所述导管的近端设置有缓冲座，所述缓冲座上设置有密封槽，所述手柄本体与所述收集部分别通过所述密封槽与所述导管连接。
  59. 根据权利要求51所述的切除装置，其特征在于，所述刀头组件包括连接于所述导管的限位座以及设置在所述限位座上的旋切刀头，所述旋切刀头固定连接于所述扭矩轴的一端，所述扭矩轴驱动所述旋切刀头转动连接于所述限位座，所述限位座上设置有罩设在所述旋切刀头侧面的保护套。
  60. 根据权利要求51所述的切除装置，其特征在于，所述导管包括内管以及设置在所述内管外侧的外管，所述内管套设在所述扭矩轴的外侧，所述扭矩轴与所述内管为间隙配合，所述内管与外管之间设置有编织层。
PCT/CN2022/142344 2021-12-31 2022-12-27 一种切除装置 WO2023125539A1 (zh)

Applications Claiming Priority (12)

Application Number Priority Date Filing Date Title
CN202111677863.9A CN116407224A (zh) 2021-12-31 2021-12-31 一种切除装置
CN202111677854.X 2021-12-31
CN202111677839.5A CN116407222A (zh) 2021-12-31 2021-12-31 一种切除装置
CN202111677042.5A CN116407221A (zh) 2021-12-31 2021-12-31 一种切除装置
CN202111672557.6A CN116407218A (zh) 2021-12-31 2021-12-31 一种切除装置
CN202111677854.XA CN116407223A (zh) 2021-12-31 2021-12-31 一种切除装置
CN202111677042.5 2021-12-31
CN202111677863.9 2021-12-31
CN202111672557.6 2021-12-31
CN202111678798.1A CN116407225A (zh) 2021-12-31 2021-12-31 一种切除装置
CN202111677839.5 2021-12-31
CN202111678798.1 2021-12-31

Publications (1)

Publication Number Publication Date
WO2023125539A1 true WO2023125539A1 (zh) 2023-07-06

Family

ID=86997913

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CN2022/142344 WO2023125539A1 (zh) 2021-12-31 2022-12-27 一种切除装置

Country Status (1)

Country Link
WO (1) WO2023125539A1 (zh)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116898535A (zh) * 2023-07-28 2023-10-20 哈尔滨工业大学 一种微创手术病灶切除捕获装置

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN202020777U (zh) * 2011-03-31 2011-11-02 先健科技(深圳)有限公司 可调弯导管
CN105662540A (zh) * 2015-12-15 2016-06-15 宁波华科润生物科技有限公司 一种带标测功能的可调弯组织去除器械
US20170296222A1 (en) * 2016-04-14 2017-10-19 Covidien Lp Tissue-removing catheter with adjustment mechanism
CN213283248U (zh) * 2020-06-22 2021-05-28 康沣生物科技(上海)有限公司 一种可调弯鞘管
CN214181407U (zh) * 2020-09-10 2021-09-14 杭州德柯医疗科技有限公司 可控制鞘管调弯的手柄及介入器械
CN215135535U (zh) * 2020-12-15 2021-12-14 张海军 一种智能导管调弯系统

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN202020777U (zh) * 2011-03-31 2011-11-02 先健科技(深圳)有限公司 可调弯导管
CN105662540A (zh) * 2015-12-15 2016-06-15 宁波华科润生物科技有限公司 一种带标测功能的可调弯组织去除器械
US20170296222A1 (en) * 2016-04-14 2017-10-19 Covidien Lp Tissue-removing catheter with adjustment mechanism
CN213283248U (zh) * 2020-06-22 2021-05-28 康沣生物科技(上海)有限公司 一种可调弯鞘管
CN214181407U (zh) * 2020-09-10 2021-09-14 杭州德柯医疗科技有限公司 可控制鞘管调弯的手柄及介入器械
CN215135535U (zh) * 2020-12-15 2021-12-14 张海军 一种智能导管调弯系统

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116898535A (zh) * 2023-07-28 2023-10-20 哈尔滨工业大学 一种微创手术病灶切除捕获装置
CN116898535B (zh) * 2023-07-28 2024-05-17 哈尔滨工业大学 一种微创手术病灶切除捕获装置

Similar Documents

Publication Publication Date Title
EP1037560B1 (en) Rotational atherectomy device with exchangeable drive shaft cartridge
AU2002340217B2 (en) Self-indexing coupling for rotational angioplasty device
EP2617372B1 (en) Material removal device
JP4754474B2 (ja) 可変速度カッターを備えた生検装置
WO2023125539A1 (zh) 一种切除装置
US20110087254A1 (en) Rotational atherectomy device with keyed exchangeable drive shaft
AU2002340217A1 (en) Self-indexing coupling for rotational angioplasty device
CN115089269B (zh) 旋切式血管减容设备
CN116407221A (zh) 一种切除装置
CN116407225A (zh) 一种切除装置
CN116407223A (zh) 一种切除装置
CN116407222A (zh) 一种切除装置
CN116407218A (zh) 一种切除装置
CN116407224A (zh) 一种切除装置
CN111870320B (zh) 外科器械
CN115005932A (zh) 一种微创手术使用的可更换刀杆的超声刀
CN112043336A (zh) 一种自动吻合器
CN111884419A (zh) 驱动装置
CN220025115U (zh) 一种操作方便的封堵器
CN115624372B (zh) 一种手术器械
CN212438963U (zh) 支架植入器驱动机构及医疗支架植入装置
CN114305534B (zh) 一种鞘管拉绳配合调节器
CN214966314U (zh) 一种神经血管切割钳
CN211213362U (zh) 一种膝关节半月板术用工具
JP2007097687A (ja) ワイヤ操作具および血管内異物除去用ワイヤセット

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 22914792

Country of ref document: EP

Kind code of ref document: A1