CN116407221A

CN116407221A - Excision device

Info

Publication number: CN116407221A
Application number: CN202111677042.5A
Authority: CN
Inventors: 黎稳; 张�雄; 郑迪
Original assignee: Lifetech Scientific Shenzhen Co Ltd
Current assignee: Lifetech Scientific Shenzhen Co Ltd
Priority date: 2021-12-31
Filing date: 2021-12-31
Publication date: 2023-07-11

Abstract

The invention belongs to the technical field of medical instruments, and particularly relates to a cutting device, which comprises a handle body, a catheter communicated with the handle body and a cutter head assembly arranged at the far end of the catheter, wherein a bending adjusting assembly is arranged on the catheter and comprises a first bending adjusting point, a second bending adjusting point and a bending adjusting connecting piece used for connecting the first bending adjusting point and the second bending adjusting point, and a control assembly used for controlling the bending adjusting assembly is arranged on the handle body. According to the cutting device, the bending radius of the distal catheter is adjusted through the bending adjusting assembly, so that the catheter is offset towards a preset direction, the orientation of the cutter head assembly is controlled, the risks of scratching blood vessels and perforating blood vessels are reduced, and the ideal vessel diameter can be obtained through multiple cutting.

Description

Excision device

Technical Field

The invention belongs to the technical field of medical appliances, and particularly relates to a cutting device.

Background

With the increasing degree of aging of the population of China and the change of dietary structure, the incidence of vascular lesions is rapidly increased. Peripheral arterial disease is one of vascular lesions, and the main cause of peripheral arterial disease is atherosclerosis, which is often manifested by ischemic changes of limbs, celiac arteries, carotid arteries, renal arteries and the like, and the treatment method mainly comprises basic treatment based on drug treatment, including open surgical treatment represented by classical surgical bypass surgery and recently developed endovascular intervention.

Although surgical bypass has a relatively superior long-term patency, endovascular access treatment techniques are increasingly accepted by clinicians and patients with their minimally invasive, safe, effective, and repeatable advantages. Among them, external Zhou Bankuai atherectomy is mainly directed to femoral, popliteal and below-knee arterial stenosis or occlusion.

However, the existing excision system for external Zhou Bankuai atherectomy has the risk of easily scratching the vessel wall during the catheter pushing process. In clinical application, the excision system can make the rotary cutter head offset towards a certain angle through adjusting the bending radius of the distal tube body so as to more thoroughly remove the blocking plaque in the blood vessel. However, in the bending state, the distal end of the catheter forms a certain angle with the blood vessel, so that the catheter and the blood vessel are uneven in axial direction, the blood vessel is easy to scratch, and even the blood vessel is perforated.

Therefore, a new technical means is needed to solve the above-mentioned problems of the prior art.

Disclosure of Invention

The invention aims to at least solve the problem that the cutter head component is easy to scratch the inner wall of a blood vessel when the conventional cutting device bends a catheter.

The invention provides a cutting device which comprises a handle body, a guide pipe communicated with the handle body and a tool bit assembly arranged at the far end of the guide pipe, wherein a bending adjusting assembly is arranged on the guide pipe and comprises a first bending adjusting point, a second bending adjusting point and a bending adjusting connecting piece, wherein the first bending adjusting point and the second bending adjusting point are arranged on the guide pipe, and a control assembly for controlling the bending adjusting assembly is arranged on the handle body.

According to the cutting device, the bending radius of the distal catheter is adjusted through the bending adjusting assembly, so that the catheter is offset towards a preset direction, the orientation of the cutter head assembly is controlled, the risks of scraping blood vessels and perforating blood vessels are reduced, and the ideal vessel diameter can be obtained through multiple cutting.

In addition, the excision device according to the invention may have the following additional technical features:

in some embodiments of the present invention, the bending adjustment connecting piece is fixedly connected with the first bending adjustment point, the bending adjustment connecting piece is movably connected with the second bending adjustment point, the distance between the first bending adjustment point and the distal end of the catheter is smaller than that between the second bending adjustment point and the distal end of the catheter, and the first bending adjustment point is arranged on the other side relative to the second bending adjustment point.

In some embodiments of the present invention, the bending adjustment connector includes a bending adjustment control wire, a control wire cavity for the bending adjustment control wire to pass through is provided on the catheter, the second bending adjustment point is provided at a distal end of the control wire cavity, and the bending adjustment control wire passes through the second bending adjustment point and is fixedly connected to the first bending adjustment point after rotating around the catheter.

In some embodiments of the present invention, the control assembly includes a control seat disposed on the handle body and a wire takeup movably connected to the control seat, the wire takeup being connected to the bending control wire and configured to pull the bending control wire to adjust the posture of the catheter.

In some embodiments of the present invention, a torque shaft connected to the tool bit assembly is disposed within the catheter, and a driving mechanism for driving the torque shaft to rotate is disposed within the handle body.

In some embodiments of the present invention, the cutter head assembly includes a limiting seat connected to the catheter and a rotary cutter head disposed on the limiting seat, the rotary cutter head is fixedly connected to one end of the torque shaft, the torque shaft drives the rotary cutter head to rotate and connect to the limiting seat, and a protective sleeve covering the side surface of the rotary cutter head is disposed on the limiting seat.

In some embodiments of the present invention, the catheter includes an inner tube and an outer tube disposed outside the inner tube, the inner tube is sleeved outside the torque shaft, the torque shaft is in clearance fit with the inner tube, and a braid layer is disposed between the inner tube and the outer tube.

In some embodiments of the present invention, the handle body is provided with a discharge channel connected to the catheter, and the discharge channel is communicated with the external space of the catheter and the handle body.

In some embodiments of the present invention, the torque shaft passes through the discharge channel and is connected to the driving mechanism, and the driving mechanism includes a power source, a driving transmission assembly for connecting the power source and the torque shaft, and a power source electrically connected to the power source.

In some embodiments of the invention, the vent lumen comprises a main lumen in communication with the conduit and a waste tube disposed laterally of the main lumen, the torque shaft passing through the waste tube.

Drawings

FIG. 1 is a schematic view of a cutting device according to a first embodiment of the present invention;

FIG. 2 is a schematic view showing an internal structure of a handle body according to a first embodiment of the present invention;

FIG. 3 is a schematic view of a driving transmission assembly according to a first embodiment of the present invention;

FIG. 4 is a schematic view of a cutter head assembly according to a first embodiment of the present invention;

FIG. 5 is a schematic view of a catheter according to an embodiment of the present invention;

FIG. 6 is a schematic structural diagram of a bending adjustment assembly according to a first embodiment of the present invention;

FIG. 7 is a schematic view of a catheter according to a first embodiment of the present invention after bending;

FIG. 8 is a schematic view showing the overall structure of a control unit according to the first embodiment of the present invention;

FIG. 9 is a cross-sectional view of a control assembly according to a first embodiment of the present invention;

FIG. 10 is a side view in cross-section of a control assembly in accordance with a first embodiment of the present invention;

FIG. 11 is a schematic view of the whole structure of the adjusting module in the first embodiment of the invention when cutting at low speed;

FIG. 12 is a schematic view showing the overall structure of the conditioning module in a high-speed cutting mode according to the first embodiment of the present invention;

FIG. 13 is a schematic view showing a part of the structure of a regulating module at the time of low-speed cutting in accordance with the first embodiment of the present invention;

FIG. 14 is a partial structural view of a conditioning module at high speed cutting in accordance with an embodiment of the present invention;

fig. 15 is a schematic view of the structure of the governor key in the first embodiment of the present invention;

FIG. 16 is a schematic view showing the overall structure of a detachable connection portion in accordance with the first embodiment of the present invention;

FIG. 17 is an exploded view of a handle body in accordance with a first embodiment of the present invention;

FIG. 18 is a schematic view of a portion of a latch assembly according to a first embodiment of the present invention;

FIG. 19 is a diagram showing a connection structure between a handle body and a handle cover in accordance with the first embodiment of the present invention;

FIG. 20 is a diagram showing a connection structure between a handle body and a driving mechanism in accordance with the first embodiment of the present invention;

FIG. 21 is a schematic view of a portion of a latch assembly according to a first embodiment of the present invention;

FIG. 22 is a schematic view of a catheter and bending assembly in accordance with a second embodiment of the present invention;

FIG. 23 is a schematic view showing the overall structure of a handle body in a third embodiment of the present invention;

FIG. 24 is a schematic view showing the internal structure of a control unit in accordance with a third embodiment of the present invention;

FIG. 25 is a schematic view showing the overall structure of a handle body in a fourth embodiment of the present invention;

FIG. 26 is a schematic view showing the internal structure of a control unit in a fourth embodiment of the present invention;

FIG. 27 is a schematic view showing a part of the structure of a control unit in a fourth embodiment of the present invention;

FIG. 28 is a schematic perspective view of a handle body in a fifth embodiment of the present invention;

FIG. 29 is a schematic view showing the internal structure of a handle body in a fifth embodiment of the present invention;

FIG. 30 is an exploded view of a handle body in a fifth embodiment of the present invention;

FIG. 31 is a schematic view showing a part of the structure of a catheter in a fifth embodiment of the present invention;

FIG. 32 is an enlarged view at A of FIG. 29 in a fifth embodiment of the invention;

fig. 33 is an enlarged view at B of fig. 29 in a fifth embodiment of the present invention.

Detailed Description

Exemplary embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. While exemplary embodiments of the present invention are shown in the drawings, it should be understood that the present invention may be embodied in various forms and should not be limited to the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art.

It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only, and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises," "comprising," "includes," "including," and "having" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and/or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their performance in the particular order described or illustrated, unless an order of performance is explicitly stated. It should also be appreciated that additional or alternative steps may be used.

Although the terms 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 limited by these terms. 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.

For ease of description, spatially relative terms, such as "inner," "outer," "lower," "below," "upper," "above," and the like, may be used herein to describe one element or feature's relationship to another element or feature as illustrated in the figures. 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 "over" the other elements or features. Thus, the example term "below … …" may include both upper and lower orientations. The device may be otherwise oriented (rotated 90 degrees or in other directions) and the spatial relative relationship descriptors used herein interpreted accordingly.

For ease of description, the following description uses the terms "proximal" and "distal", wherein "proximal" refers to the end proximal to the operator and "distal" refers to the end distal to the operator, the phrase "axial direction" should be understood herein to mean the direction in which the interventional element is advanced and expelled, and the direction perpendicular to the "axial direction" is defined as the "radial direction".

Example 1

An embodiment of the present invention provides a cutting device, as shown in fig. 1 to 3, comprising a handle body 100, a catheter 200 connected to the handle body 100, and a cutter head assembly 300 disposed at a distal end of the catheter 200, wherein a torque shaft 210 connected to the cutter head assembly 300 is disposed in the catheter 200. Referring to fig. 5, a bending unit 220 for bending a distal end portion of the catheter 200 is provided to the catheter 200, and a driving mechanism 400 detachably coupled to the handle body 100 is provided to the handle body 100. As shown in connection with fig. 11, the drive mechanism 400 includes a drive module 410 for driving the torque shaft 210 in rotation and an adjustment module 420 for controlling the drive module 410 to adjust the torque of the torque shaft 210.

According to the invention, the bending radius of the distal catheter 200 is regulated by the bending regulating component 220, so that the catheter 200 is deviated towards a preset direction, the direction of the cutter head component 300 is controlled, the risks of scratching blood vessels and perforating blood vessels are reduced, and the ideal vessel diameter can be obtained through multiple cutting; meanwhile, an adjusting module 420 for adjusting the torque of the torque shaft 210 is provided, so that when the plaque excision device resects a harder plaque, the plaque excision can be smoother by adjusting the torque of the torque shaft 210; on the other hand, by providing the driving mechanism 400 detachably connected to the handle body 100, the driving mechanism 400 can be recycled, and the use cost of the atherectomy device is reduced.

Specifically, as shown in fig. 4, the tool bit assembly 300 includes a limiting seat 310 connected to the catheter 200 and a rotary cutter bit 320 disposed on the limiting seat 310, the rotary cutter bit 320 is fixedly connected to one end of the torque shaft 210, the torque shaft 210 drives the rotary cutter bit 320 to rotate and connect to the limiting seat 310, and a protective sleeve 330 covering the side surface of the rotary cutter bit 320 is disposed on the limiting seat 310.

As shown in fig. 5, the catheter 200 includes an inner tube 230 and an outer tube 240 disposed outside the inner tube 230, the inner tube 230 is sleeved outside the torque shaft 210, the torque shaft 210 is in clearance fit with the inner tube 230, and the torque shaft 210 penetrates through the entire inner cavity of the inner tube 230.

Further, a braid 250 is disposed between the inner tube 230 and the outer tube 240, wherein the braid 250 is specifically a mesh braid formed by braiding nickel-titanium wires. The inner tube 230 and the outer tube 240 are connected through the braiding layer 250, so that the toughness of the catheter 200 is enhanced, when the catheter 200 penetrates into a branch vessel or passes through a bending part of the vessel, the catheter 200 cannot be partially sunken and bent, the completeness of a lumen of the catheter 200 can be ensured, the trafficability of a resected plaque is ensured, and the plaque cannot be blocked at the bending part of the catheter 200.

Specifically, the rotary cutter 320 is fixed at the end of the torque shaft 210 by welding, and the torque shaft 210 rotates to drive the rotary cutter 320 to rotate. The rotary cutter head 320 is provided with a cutter head clamping groove 321, the distal end of the limiting seat 310 is provided with a limiting boss 311, and the limiting boss 311 is matched with the cutter head clamping groove 321 in a clamping way, so that axial and radial limiting between the rotary cutter head 320 and the limiting seat 310 is realized.

Wherein, the rotary cutter head 320, the limiting seat 310 and the protective sleeve 330 are all made of stainless steel. Meanwhile, the distal end of the limiting seat 310 is provided with an elastic spring plate 312, and the limiting boss 311 is disposed on the spring plate 312. Because the cutter head assembly 300 is integrally made of a hard metal material, the assembly process of the rotary cutter head 320 and the limiting seat 310 is complicated. In this embodiment, the elastic piece 312 is disposed at the distal end of the limiting seat 310, and the elastic piece 312 has elasticity and can generate elastic deformation during assembly, so that the limiting boss 311 is smoothly clamped into the tool bit clamping groove 321. The protective sleeve 330 covers the outside of the spacing seat 310, and meanwhile, the protective sleeve 330 clings to the outer surface of the spacing seat 310, so after the assembly of the protective sleeve 330 is completed, the elastic sheet 312 is limited between the rotary cutter bit 320 and the protective sleeve 310, thereby completing the clamping fit between the spacing boss 312 and the bit clamping groove 321, and further realizing the axial and radial spacing between the rotary cutter bit 320 and the spacing seat 310.

Catheter 200 includes inner tube 230, braid 250, and outer tube 240 in that order from inside to outside, and inner tube 230, braid 250, and outer tube 240 are integrally formed by means of heat fusion. Further, a spring tube 260 is disposed at the distal end of the catheter 200, the spring tube 260 is sleeved outside the braid 250, or the braid 250 is sleeved outside the spring tube 260, and the spring tube 260 is axially fixed with the braid 250 by welding. In this embodiment, the spring tube 260 is sleeved outside the braid 250. By providing a spring tube 260 at the distal end of the catheter 200, compliance and resiliency of the distal end of the catheter 200 is enhanced. In other embodiments, the spring tube 260 may also be embedded within the outer tube 240.

In this application, the bending resistance of the braid 250 is good, and the torsion resistance of the spring tube 260 is good. Therefore, the braid 250 is disposed in the catheter 200, and the spring tube 260 is disposed at the distal end of the catheter 200, so that the distal end of the catheter 200 can be given consideration to bending resistance and torque resistance, when the catheter 200 is bent, the braid 250 and the spring tube 260 cooperate to avoid local concave deformation of the catheter 200 due to bending, so that the deformation of the lumen of the catheter 200 can be maintained under the condition of bending the catheter 200, the clearance between the catheter 200 and the torque shaft 210 is ensured to sufficiently pass through plaque or thrombus, and smooth operation is ensured. While maintaining good vascular passability so that catheter 200 is smoother when entering more complex curved vessels.

The protective sleeve 330 is fixed to the outer tube 240 by hot melting, and the outer tube 240 is a TPU tube or a Pebax tube, and in this embodiment, the outer tube 240 is made of Pebax.

Wherein, referring to fig. 2, a buffer sleeve 270 is disposed on the catheter 200, the catheter 200 is connected with the handle body 100 through the buffer sleeve 270, the buffer sleeve 270 is connected with the housing of the handle body 100 in a matching manner, and the buffer sleeve 270 is made of TPU or other rubber or plastic materials. The buffer sleeve 270 is made of soft materials, so that vibration of the catheter 200 during rotary cutting can be eliminated, and vibration transmitted to the handle body 100 can be obviously reduced, thereby providing conditions for fine operation of an operator.

Further, as shown in connection with fig. 11 and 12, the driving mechanism 400 further includes a driving housing 430, a power source 411, and a driving transmission assembly 412 for connecting the power source 411 and the torque shaft 210. The adjustment module 420 includes an adjustment transmission assembly 421 coupled to the drive transmission assembly 412 and a shift assembly 422, the shift assembly 422 for controlling the mating relationship of the adjustment transmission assembly 421 and the drive transmission assembly 412 to adjust the torque of the torque shaft 210, and a power assembly 413 for driving the power source 411 is disposed within the drive housing 430.

Specifically, the power source 411 is a motor disposed in the driving housing 430, and the power assembly 413 is a battery disposed in the driving housing 430 and electrically connected to the motor. The power source 411 is powered by the power source 413, and the power source 411 drives the torque shaft 210 to rotate through the driving transmission assembly 412, so that the torque shaft 210 rotates to rotate the rotary cutter head 320 arranged at the distal end, and plaque in the blood vessel is removed. The handle body 100 is further provided with a switch 160, and the operating state of the motor is controlled by the switch 160.

In other embodiments, a power supply assembly 413 for connecting to an external power source and electrically connected to the power source 411 may also be provided on the driving housing 430. That is, when the driving power source 411 is required to operate, an external power source is connected through the power supply assembly 413, and the power supply assembly 413 includes a power outlet provided at the driving housing 430. By arranging the power socket, the sterilization difficulty and cost of the handle body 100 and internal components can be reduced, and the weight and transportation difficulty of the whole machine can be reduced.

Further, as shown in fig. 2, the handle body 100 is provided with a discharge channel 500 connected to the catheter 200, the discharge channel 500 communicates with the external space between the catheter 200 and the handle body 100, and the torque shaft 210 passes through the discharge channel 500 and is connected to the driving mechanism 400. The exhaust channel 500 includes a main cavity 510 connected to the catheter 200 and a waste pipe 520 provided at a side of the main cavity 510, the torque shaft 210 passes through the main cavity 510 and is connected to an external space of the handle body 100, and a guide wire cavity 211 penetrating the torque shaft 210 is provided in the torque shaft 210.

Specifically, the torque shaft 210 is spirally disposed. In operation of the atherectomy device, the motor drives the torque shaft 210 in rotation, and because the torque shaft 210 is helically disposed, the torque shaft 210 may carry plaque tissue back out of the catheter 200 during rotation.

The guidewire lumen 211 in the torque shaft 210 is used to pass a guidewire that is used to extend into a blood vessel or branch vessel prior to insertion or movement of the catheter 200 to establish an access path for the catheter 200 so that the catheter 200 can move along the access path established by the guidewire.

Wherein the proximal end of the outer tube 240 is adhesively secured to the main lumen 510, and plaque tissue excised by the rotary cutter head 320 is expelled from the catheter 200 into the discharge lumen 500 through the gap between the torque shaft 210 and the inner tube 230 as the torque shaft 210 rotates, the main lumen 510 of the discharge lumen 500 temporarily accommodates the excised plaque tissue, and finally the plaque tissue is expelled through the waste tube 520. The exhaust tube 520 is disposed near the proximal end portion of the main lumen 510 and is inclined in the atherectomy direction, thereby facilitating the expulsion of plaque.

In this embodiment, as shown in fig. 5 to 7, the handle body 100 is provided with a control component 140 for controlling the bending component 220, and the bending component 220 includes at least two bending points 221 and a bending connecting piece 222 for connecting the bending points 221. Referring to fig. 3, the control assembly 140 includes a control seat 141 disposed on the handle body 100 and a wire takeup device 142 movably connected to the control seat 141, where the wire takeup device 142 is used for connecting the bending adjustment connecting piece 222 and pulling the bending adjustment connecting piece 222 to adjust the posture of the catheter 200.

The bending point 221 includes a first bending point 2213 and a second bending point 2214 disposed on the catheter 200, the bending connecting member 222 is fixedly connected with the first bending point 2213, the bending connecting member 222 is movably connected with the second bending point 2214, the first bending point 2213 is spaced from the distal end of the catheter 200 by a smaller distance than the second bending point 2214, and the first bending point 2213 is disposed on the other side opposite to the second bending point 2214.

The bending adjustment connector 222 comprises a bending adjustment control line 2225, a control line cavity 2226 for the bending adjustment control line 2225 to pass through is arranged on the catheter 200, a second bending adjustment point 2214 is arranged at the distal end of the control line cavity 2226, and the bending adjustment control line 2225 passes through the second bending adjustment point 2214 and is fixedly connected to the first bending adjustment point 2213 after rotating around the catheter 200. In the present embodiment, in order to make the orientation of the tool bit assembly 300 the same as that of the catheter 200, the first bending point 2213 and the second bending point 2214 are disposed 180 degrees apart in the circumferential direction.

Specifically, a control wire lumen 2226 is provided within catheter 200, and control wire lumen 2226 may be provided within outer tube 240 or within inner tube 230. The first bending point 2213 is a fixed point fixedly arranged on the braid 250 and is fixedly connected with the bending control line 2225 through the fixed point, and the second bending point 2214 is an endpoint of the distal end of the control line cavity 2226.

In this embodiment, the first bending point 2213 is a fixing ring welded and fixed on the braid 250, and the fixing ring presses and fixes the bending control line 2225 on the braid 250, or the bending control line 2225 is welded and fixed with the fixing ring. The first bending point 2213 is set to be annular, so that multiphase connection of the bending control line 2225 is met, and angle adjustment and fixation of the bending control line are facilitated.

One end of the bending control line 2225 is connected to the wire takeup device 142, and the other end of the bending control line 2225 first penetrates out of the control line cavity 2226, and then is fixed on the first bending point 2213 after spiral rotation by 180 degrees along the gap between the inner tube 230 and the braid 250. The rotation angle of the bending control line 2225 may be 170 degrees or 190 degrees, so long as the second bending point 2214 is relatively disposed at the opposite side of the first bending point 2213, the direction of the tool bit assembly 300 after bending is substantially the same as that of the catheter 200.

Further, the axial length of the spiral portion of the bending control wire 2225 extending out of the second bending point 2214 and fixed between the first bending points 2213 is set to be 1 to 3 times the outer diameter size 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 is 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 is too large, which is unfavorable for operation. Accordingly, in the present embodiment, the axial length of the spiral portion of the bending control wire 2225 extending out of the second bending point 2214 and fixed between the first bending points 2213 is set to be 2 times the outer diameter size of the outer tube 240.

Further, in this embodiment, by adjusting the wire takeup device 142, the bending control wire 2225 is controlled to move in the control wire cavity 2226 or the inner tube 230, and since the bending control wire 2225 is spirally rotated 180 degrees along the inner tube 230 at the distal end of the catheter 200, when the bending control wire 2225 is controlled to shrink, the bending control wire 2225 has both axial force and radial force on the distal end of the catheter 200, so that the axial and radial displacement of the cutter head assembly 300 can be controlled, and the S-shaped bending of the cutter head assembly 300 can be realized. Because the bend control line 2225 is rotated 180 degrees, the blade assembly 300 can be maintained in the same axial direction as the catheter 200, reducing the risk of the blade assembly 300 scratching the vessel wall. And the cutter head assembly 300 cuts plaque in the blood vessel before and after bending, so that the blood vessel can obtain a larger lumen.

As shown in fig. 8 to 10, the control assembly of the present embodiment includes a control seat disposed on the handle body and a wire takeup movably connected to the control seat, and the wire takeup 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, one end of the control seat 141 facing the push rod 151 is provided with a push groove 1411, and the other end of the control seat 141 is rotatably connected with the other end of the control groove 150. Thus, the control seat 141 is axially fixed in the control slot 150 by the cooperation of the top slot 1411 and the top rod 151, and the control seat 141 can be rotatably connected to the handle body 100 by the cooperation of the top slot 1411 and the top rod 151.

The wire takeup device 142 is disposed in the control seat 141, and a clamping portion 143 for clamping the bending control wire 2225 is disposed on the wire takeup device 142. The locking member 1421 is an internal thread disposed on an inner wall of the control seat 141 and an external thread disposed on an outer wall of the wire takeup device 142, the wire takeup device 142 is in threaded connection with the control seat 141, and the internal thread on the control seat is in self-locking threaded engagement with the external thread on the wire takeup device. After the doctor loosens the wire collector, the wire collector can not move relative to the control seat due to relative self-locking of the internal thread and the external thread, so that the self-locking of the wire collector is realized.

The control seat 141 is internally provided with a slide bar 144, the slide bar 144 is arranged along the axial direction of the control seat 141, the wire takeup device 142 is connected with the slide bar 144 in a sliding way, a rotation limiting surface 1441 is arranged between the slide bar 144 and the wire takeup device 142, so that the wire takeup device 142 can translate along the length direction of the slide bar 144 and cannot rotate relative to the slide bar 144, namely, a screw rod linkage relation is formed.

Therefore, when the control seat 141 is rotated, the wire takeup device 142 can slide on the slide rod 144 and move relative to the control seat 141 under the linkage of the threaded fit, and the wire takeup device 142 clamps the bending control wire 2225, and the bending control wire 2225 moves relative to the handle body 100 along with the wire takeup device 142, so as to control the catheter 200 to perform bending action.

In a further embodiment of the present application, as shown in fig. 11-15, the drive transmission assembly 412 includes a first transmission member 4121 coupled to the torque shaft 210, a second transmission member 4122 coupled to the power source 411, and a third transmission member 4123 disposed on the drive housing 430, the third transmission member 4123 being coupled between the first transmission member 4121 and the second transmission member 4122.

As shown in fig. 13, the adjustment transmission assembly 421 includes a fourth transmission member 4211 coaxially disposed with the second transmission member 4122 and a fifth transmission member 4212 coaxially disposed with the third transmission member 4123, the shift assembly 422 includes a driver shaft 4221 connected to the output shaft of the power source 411 and a shift lever 4222 connected to the driver shaft 4221, the third transmission member 4123 and the fifth transmission member 4212 are both disposed on the driver shaft 4221, and the driver shaft 4221 is slidingly connected to the output shaft and rotates synchronously; the shift 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.

Specifically, the driving members of 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, and the third transmission member 4123 is a transmission gear disposed on the driving housing 430. The driving gear, the transmission gear and the output gear are sequentially meshed and connected.

In addition, the adjustment transmission assembly 421 of the present embodiment is provided with a second set of gear assemblies, namely a fourth transmission member 4211 and a fifth transmission member 4212. The fourth gear 4211 is a large speed gear coaxially provided with the second gear 4122, and the fifth gear 4212 is a small speed gear coaxially provided with the third gear 4123.

Specifically, the fourth transmission member 4211 and the second transmission member 4122 are both disposed on the driving axle 4221, the motor directly drives the output shaft to rotate, and the driving axle 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 via a driven wheel shaft 4224, and the fifth transmission member 4212 and the third transmission member 4123 are coaxially rotated by the driven wheel shaft 4224.

The driving wheel shaft 4221 is fixedly connected with the shift lever 4222, a speed adjusting key 4223 is arranged at the tail end of the shift lever 4222, and the speed adjusting key 4223 is slidably connected with the handle body 100. As shown in fig. 15, the driving housing 430 is provided with a low speed limit groove 4113 and a high speed limit groove 4113, when the rotary cutter head 320 is in the low speed cutting, the speed adjusting key 4223 is located in the low speed limit groove 4113, and the second transmission member 4122, the third transmission member 4123 and the first transmission member 4121 are sequentially engaged.

The specific working principle of the driving module 410 of this embodiment is as follows: when the power source 411 works and the second transmission member 4122 is driven to rotate by the power source 411, that is, the motor starts to operate and drives the second transmission member 4122 to operate. The second transmission member 4122 transmits the rotation speed to the third transmission member 4123 by engaging with the third transmission member 4123, the third transmission member 4123 transmits the speed to the first transmission member 4121 by engaging with the first transmission member 4121, the first transmission member 4121 transmits the speed to the torque shaft 210, and the torque shaft 210 drives the rotary cutter head 320 to rotate, thereby completing the low-speed gear cutting. In the case of a low gear cut, the rotational speed of the torque shaft is lower and the torque is greater.

When the high-low gear is switched, the speed regulating key 4223 is shifted to enable the speed regulating key 4223 to move to the high-speed limiting groove 4113, the shift lever 4222 is driven by the speed regulating key 4223 to move, and the movement of the speed regulating lever drives the driving wheel shaft 4221 to move and enables the second transmission member 4122 to be disengaged from the third transmission member 4123. Since the fourth transmission member 4211 and the second transmission member 4122 are both disposed on the driving axle 4221, the fourth transmission member 4211 also moves along with the driving axle 4221 and is engaged with the fifth transmission member 4212 to complete the switching of the gear engagement relationship.

In the present embodiment, the number of teeth of the fourth transmission member 4211 is greater than the number of teeth of the second transmission member 4122, and the number of teeth of the fifth transmission member 4212 is less than the number of teeth of the third transmission member 4123. Accordingly, the rotation speed of the fifth power transmission member 4212 is higher in the power transmission state in which the fourth power transmission member 4211 is meshed with the fifth power transmission member 4212 than in the power transmission state in which the second power transmission member 4122 is meshed with the driven gear.

Since the rotation speed of the fifth transmission member 4212 is higher, and the fifth transmission member 4212 transmits the higher rotation speed to the third transmission member 4123 through the driven wheel shaft 4224, the third transmission member 4123 is engaged with the first transmission member 4121, and thus the rotation speed of the first transmission member 4121 is higher, the high gear cutting of the rotary cutter head 320 is completed. When the gear is cut at high speed, the rotational speed of the torque shaft is higher and the torque is smaller.

Based on the above scheme of the present embodiment, by providing additional gear sets in the adjusting module 420, that is, the fourth driving member 4211 and the fifth driving member 4212, and adjusting the engagement relationship between the gear assemblies through the gear shifting assembly 422, the high-speed and low-speed gear adjustment of the rotational speed of the rotary cutter head 320 is achieved, and further the high-torque and low-torque adjustment of the torque of the rotary cutter head 320 is achieved. The doctor can flexibly select the cutting speed according to the plaque texture, so that the phenomenon of blocking of the cutter head is avoided, the use stability is improved, and the vascular injury is avoided.

In conventional cutting, the physician may choose to use a high gear to maximize atherectomy efficiency. When the plaque is blocked or is difficult to be resected, especially when the plaque or thrombus is blocked at the bending part of the catheter 200 due to bending of the catheter 200, a doctor can select a low gear to improve the torque of the torque shaft 210, so that the plaque or thrombus is prevented from being difficult to pass through the bending part of the catheter 200, the catheter 200 is prevented from being blocked, the rotary cutter head 320 is prevented from being blocked, and the smooth operation is ensured.

In other embodiments, additional gear assemblies may be provided to increase the number of adjustable gears, such as to achieve three-gear adjustability, thereby providing more options for the practitioner. Moreover, the above-mentioned speed regulation scheme is only an example, and any mechanical structure capable of realizing torque adjustment of the torque shaft is within the protection scope of the present application.

In other embodiments, when the driving mode of the external power supply is adopted, the output torque of the torque shaft can be dynamically controlled by dynamically adjusting the output power of the external power supply, so that the use stability is ensured.

Further, as shown in fig. 16 to 21, the handle body 100 is provided with an assembling portion 110 for assembling the driving mechanism 400, the driving mechanism 400 includes a driving housing 430 for accommodating the driving module 410 and the adjusting module 420, and a detachable connection portion 130 is provided between the driving housing 430 and the assembling portion 110. Wherein, a sealing structure 4124 is provided between the driving transmission assembly 412 and the handle body 100.

The detachable design of the driving mechanism 400 is adopted in the embodiment, firstly, convenience is provided for early sterilization, the power supply assembly 413 with larger sterilization difficulty in the driving mechanism 400 can be independently sterilized, then the rapid assembly is carried out by disassembling the connecting part 130, the overall sterilization difficulty of the cutting device and the production assembly speed are reduced, and the production efficiency is improved. Secondly, after the excision device is used, the parts obtained through disassembly can be used secondarily according to the medical standard within the allowable range, so that the utilization rate of the parts is improved, and the use cost is reduced. In addition, after the excision device is used, each part can be quickly disassembled, and the parts are flexibly classified, recycled and scrapped according to medical specifications, so that the recycling difficulty and cost are reduced.

The detachable connection part 130 includes a hooking component 131 and a clamping component 132 disposed between the assembly part 110 and the driving housing 430, the hooking component 131 and the clamping component 132 are disposed at two ends of the assembly part 110, and an ejector 133 is disposed between the driving housing 430 and the bottom of the assembly part 110.

Specifically, the assembly portion 110 is an assembly groove provided on the handle body 100 for mounting the driving mechanism 400, the driving mechanism 400 is provided in the assembly portion 110, and the driving mechanism 400 is detachably connected to the handle body 100. The driving mechanism 400 is specifically detachably connected to the assembly portion 110 through the driving housing 430, so that the whole driving mechanism 400 can be detachably replaced, and the driving module 410 and the adjusting module 420 are both installed in the driving housing 430.

In this embodiment, the driving mechanism 400 is integrally configured to be detachable, so that the driving mechanism 400 can be recycled under the condition of meeting the specification. And the driving mechanism 400 and the handle body 100 can be classified and recycled according to medical use specifications.

Further, as shown in fig. 18, the engaging component 132 is disposed at the proximal end of the handle body 100, and the hooking component 131 is disposed at the distal end of the handle body 100. The locking assembly 132 includes a locking pin 1321 slidably connected to the driving housing 430 and a locking key 1322 disposed on the locking pin 1321, where the locking key 1322 is integrally formed with the locking pin 1321, or the locking pin 1321 and the locking key 1322 are separately formed and then adhered and fixed.

The inner wall of the assembly part 110 is provided with a locking hole 1323 for being in snap connection with the locking pin 1321, and a user can drive the locking pin 1321 to move by pulling the locking key 1322 and control the locking pin 1321 to be inserted into the locking hole 1323 so as to fix the locking pin 1321 and the locking hole 1323, or control the locking pin 1321 to be separated from the locking hole 1323 so as to separate the locking pin 1321 from the locking hole 1323. When the locking pin 1321 is inserted into the locking hole 1323, the driving mechanism 400 is in a fixed state with the fitting portion 110, and when the locking pin 1321 is disengaged from the locking hole 1323, the driving mechanism 400 is in a separated state with the fitting portion 110.

Wherein, locking clip 1324 is provided at the bottom of locking key 1322, locking fixed slot 1325 and separation fixed slot 1326 are provided on the surface of driving housing 430, separation fixed slot 1326 is located away from locking hole 1323 relative to locking fixed slot 1325, locking fixed slot 1325 and separation fixed slot 1326 are used for being fixed with locking clip 1324 respectively. When the locking key 1322 drives the locking pin 1321 to move toward the direction approaching to the locking hole 1323 and the locking clip 1324 is snapped into the locking slot 1325, the locking pin 1321 is inserted into the locking hole 1323 and the driving mechanism 400 is snapped and fixed with the assembly portion 110. When the locking key 1322 drives the locking pin 1321 to move in a direction away from the locking hole 1323 and causes the locking clip 1324 to be snap-coupled in the separation fixing groove 1326, the locking pin 1321 is separated from the locking hole 1323 and causes the driving mechanism 400 to be separated from the fitting portion 110.

Wherein, an ejector 133 for ejecting the driving mechanism 400 is provided between the driving housing 430 and the bottom of the fitting portion 110, and the ejector 133 is preferably a spring. That is, when the locking pin 1321 is disengaged from the locking hole 1323, the ejector 133 automatically ejects the driving mechanism 400 from the fitting portion 110, thereby facilitating the user to take out the driving mechanism 400.

The hooking component 131 is disposed at the other end of the driving housing 430 opposite to the locking pin 1321, and the hooking component 131 includes a hook 1311 disposed on the distal end surface of the driving housing 430 and a hooking groove 1312 disposed on the inner surface of the fitting part 110 and hooked with the hook 1311.

When the driving mechanism 400 is fixed in the fitting portion 110, the hook 1311 is first hooked with the hooking groove 1312, so that the distal end of the driving mechanism 400 is fixed to the fitting portion 110, and then the locking key 1322 of the locking assembly 132 is inserted into the locking hole 1323, so that the distal end of the driving mechanism 400 is fixed to the fitting portion 110.

When the driving mechanism 400 is taken out of the fitting portion 110, the locking key 1322 of the engaging member 132 is first separated from the locking hole 1323 to separate the proximal end of the driving mechanism 400 from the fitting portion 110, and then the hook 1311 is taken out of the hook groove 1312 to separate the distal end of the driving mechanism 400 from the fitting portion 110.

In this embodiment, 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.

As shown in fig. 19, the distal end of the handle upper cover 120 is fixed to the hooking groove 1312 of the handle body 100 through a fastening structure, and an upper cover plug 123 is disposed at the distal end of the handle upper cover 120, where the upper cover plug 123 is plug-connected to the hooking groove 1312. The proximal end of the handle upper cover 120 is provided with a plug board 121, the plug board 121 is arranged between the driving housing 430 and the hooking groove 1312, and the plug board 121 is provided with a plug hole 122 matched with the locking pin 1321. After the upper cover latch 123 of the handle upper cover 120 is engaged with the hooking groove 1312, the handle body 100 is attached to the driving housing 430, and then the locking key 1322 is operated to move toward the locking hole 1323. The locking key 1322 is first inserted through the insertion hole 122 of the insertion plate 121 and then inserted into the retraction hole, achieving the purpose of simultaneously fixing the handle cover 120 and the driving mechanism 400 to the handle body 100.

The mode that sets up handle upper cover 120 on actuating mechanism 400 has protected actuating mechanism 400, prevents actuating mechanism 400 from damaging because of factors such as external collision. In addition, after the handle body 100 and the driving mechanism 400 are disassembled, the related split pieces can be classified, recovered and scrapped according to the related physiotherapy rules.

In this embodiment, the bending unit 220 is disposed at the distal end of the handle body 100, so that the physician can conveniently operate the bending unit during surgery, the catheter 200 is inserted into the handle body 100 from the distal end of the handle body 100, the catheter 200 is connected to the handle body 100 through the buffer sleeve 270, and the proximal end of the catheter 200 is fixed to the discharge channel 500 disposed at the middle of the handle body 100.

The discharge lumen 500 is provided in the middle of the handle body 100, the torque shaft 210 penetrates the handle body 100, the torque shaft 210 firstly penetrates the catheter 200 and penetrates the main cavity 510 from the catheter 200, plaque or thrombus sent out from the catheter 200 falls into the main cavity 510 and is discharged from the waste tube, and the waste tube is obliquely provided relative to the main cavity 510, so that plaque or thrombus is discharged conveniently.

The torque shaft 210 passes through the discharge lumen 500 and is connected to the handle body 100 by a bearing, and the guide wire lumen 211 of the torque shaft 210 is communicated with the external space of the handle body 100, so that the guide wire passes through the torque shaft 210 through the guide wire lumen 211 and passes out from the distal end of the torque shaft 210, thereby establishing a passage for the catheter 200 to pass into a blood vessel.

Wherein the drive mechanism 400 is disposed over the catheter 200 and the exhaust lumen 500, and the drive transmission assembly 412 is disposed at the proximal end of the exhaust lumen 500 and is coupled to the torque shaft 210. So that plaque or thrombus exits the handle body 100 through the exhaust lumen 500 disposed distally of the drive transmission assembly 412, the plaque or thrombus does not contact the drive transmission assembly 412.

And a sealing design is adopted between the driving transmission assembly 412 and the discharge cavity 500, that is, a sealing structure 4124 is arranged between the first transmission member 4121 and the handle body 100, the sealing structure 4124 comprises a rolling bearing fixed on the handle body 100 and a sealing ring for sealing the rolling bearing, and the torque shaft 210 passes through the rolling bearing and is fixed and connected with the rolling bearing in a sealing manner. Specifically, the gap between the torque shaft 210 and the rolling bearing may be filled with solder, and welded and fixed, and then the rolling bearing and the handle body 100 may be sealed by a seal ring. Thus, the driving mechanism 400 of the present embodiment can be kept clean after use, thereby facilitating recycling and being capable of being reused.

In summary, the bending radius of the distal catheter 200 is adjusted by the bending adjustment assembly 220, so that the catheter 200 is offset towards a predetermined direction, the orientation of the tool bit assembly 300 is controlled, the risks of scratching blood vessels and perforating blood vessels are reduced, and an ideal blood vessel diameter can be obtained through multiple excision. Meanwhile, an adjusting module 420 for adjusting the torque of the torque shaft 210 is provided, so that the atherectomy device can more smoothly atherectomy when the atherectomy device is cutting a harder plaque by adjusting the torque of the torque shaft 210. On the other hand, by providing the driving mechanism 400 detachably connected to the handle body 100, the driving mechanism 400 can be recycled, and the use cost of the atherectomy device is reduced.

Example two

In the second embodiment of the present invention, as shown in fig. 22, the same points as those of the first embodiment are not repeated, and the second embodiment is different from the first embodiment in that the bending point 221 includes a bending fixing member 2211 disposed on the catheter 200 and a return fixing member 2212 disposed on the cutter head assembly 300, the bending connecting member 222 is used for connecting the bending fixing member 2211 and the return fixing member 2212, the return fixing member 2212 is disposed at the proximal end of the cutter head assembly 300, and the bending fixing member 2211 is disposed at the other side of the catheter 200 opposite to the return fixing member 2212.

The bending adjustment connector 222 includes a bending adjustment connection wire 2221 and a return connection wire 2222, and the guide tube 200 is provided with a bending adjustment wire cavity 2223 through which the bending adjustment connection wire 2221 passes and a return wire cavity 2224 through which the return connection wire 2222 passes. The bending adjustment connection line 2221 is used for connecting the control assembly 140 and the bending adjustment fixture 2211, and the return connection line 2222 is used for connecting the control assembly 140 and the return fixture 2212.

A return fixture 2212 is provided at the proximal end of tool bit assembly 300, and a bending fixture 2211 is provided on the other side of catheter 200 relative to return fixture 2212. The bending fixture 2211 is disposed on the other side of the catheter 200 with respect to the return fixture 2212, preferably the bending fixture 2211 is disposed 180 degrees apart from the return fixture 2212 in the circumferential direction.

Specifically, a bend-adjusting wire lumen 2223 and a return wire lumen 2224 are disposed within the catheter 200, with the bend-adjusting wire lumen 2223 and the return wire lumen 2224 both disposed within the outer tube 240 or between the outer tube 240 and the braid 250. One end of the bending adjustment connection wire 2221 is connected to the bending adjustment fixing member 2211, and then penetrates through the bending adjustment wire cavity 2223, and the other end is connected to the control assembly 140. One end of the return wire 2222 is connected to the bending adjustment fixture 2211, and then penetrates through the return wire cavity 2224, and the other end is connected to the control assembly 140.

The bending connection line 2221 and the return connection line 2222 are respectively fixed on the wire takeup device 142, and when a doctor rotates the control seat 141, the wire takeup device 142 slides on the slide bar 144 relative to the control seat 141, thereby simultaneously pulling the bending connection line 2221 and the return connection line 2222, and adjusting the postures of the catheter 200 and the cutter head assembly 300.

Wherein, return mounting 2212 sets up on the protective cover 330, and return mounting 2212 is the fixed plate that sets up on the protective cover 330, and return connecting wire 2222 and fixed plate welded fastening, perhaps be provided with the connecting hole on the return mounting 2212, and return connecting wire 2222 passes the connecting hole and tie a knot fixedly. The bending fixing member 2211 is a fixing ring arranged on the braid 250 of the catheter 200, and the fixing ring presses and fixes the bending connecting wire 2221 on the braid 250, or the bending connecting wire 2221 and the fixing ring are welded and fixed.

Since the bending fixture 2211 is disposed at the other side of the catheter 200 with respect to the return fixture 2212, when the wire takeup 142 pulls the bending connection wire 2221 and the return connection wire 2222 simultaneously, the bending connection wire 2221 controls the axial displacement of the catheter 200 through the bending fixture 2211, and the return fixture 2212 controls the radial displacement of the cutter head assembly 300 through the return fixture 2212. Under the combined action of the bending-adjusting connecting wire 2221 and the return connecting wire 2222, the cutter head assembly 300 is enabled to realize S-shaped bending adjustment, so that the cutter head assembly 300 and the catheter 200 are kept in the same axial direction, and the risk of the cutter head assembly 300 scratching the vascular wall is reduced. And the cutter head assembly 300 cuts plaque in the blood vessel before and after bending, so that the blood vessel can obtain a larger lumen.

The present embodiment achieves S-shaped bending of the catheter 200 and the cutter head assembly 300 by the bending adjustment assembly 220, so that when cutting plaque in a blood vessel, the cutting area can be increased by bending the catheter 200 and the cutter head assembly 300. Meanwhile, the cutter head assembly 300 is basically guaranteed to be in the same direction as the axial direction of the catheter 200 under the action of the return fixing piece 2212, so that the blood vessel wall is not cut by mistake in the pushing process of the cutter head assembly 300, and the risk that the cutter head assembly 300 scratches the blood vessel wall is greatly reduced. Compared with the bending mode in the prior art, the vascular bending device can enable the blood vessel to obtain a larger lumen, and can ensure safety during cutting.

Example III

In the third embodiment of the present invention, as shown in fig. 23 and 24, the same features as those of the first embodiment are not repeated, and the third embodiment is different from the first embodiment in that the handle body 100 is provided with a control slot 150, the control assembly 140 is disposed in the control slot 150, the control seat 141 is fastened and fixed in the control slot 150, the wire takeup device 142 includes a slide button 145 slidably connected to the control seat 141 and a connection point 1451 disposed on the slide button 145, the connection point 1451 is used for connecting a bending adjustment connecting member 222, and the bending adjustment connecting member 222 is a bending adjustment connecting wire 2221.

Specifically, the 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 disposed along the length direction of the control seat 141. The sliding block 1413 is provided with a fixing hole 1414, and one end of the sliding button 145 of the control seat 141 facing the sliding block 1413 is provided with a fixing post 1452, and the fixing post 1452 passes through the fixing hole 1414, so that the sliding button 145 is connected to the sliding block 1413 through the fixing post 1452. A control spring 146 is arranged between the slide button 145 and the slide block 1413, the slide button 145 and the slide block 1413 are simultaneously and slidably connected to the control seat 141, and the control spring 146 has initial pressure, so that the slide button 145 is tightly attached to the inner wall of the control seat 141.

The locking member 1421 is a rough contact surface between the sliding button 145 and the control seat 141, when the control assembly 140 is in a natural state, the control spring 146 drives the sliding button 145 to be tightly attached to the inner wall of the control seat 141, and the sliding button 145 and the control seat 141 do not move relatively under the action of friction force due to the rough contact surface between the sliding button 145 and the control seat 141, so as to realize the self-locking of the wire collector 142. When the slide button 145 is pressed toward the inside of the control seat 141, the control spring 146 is compressed, and the slide button 145 is separated from the control seat 141, and at this time, the slide button 145 can move relative to the control seat 141.

In other embodiments, the locking member 1421 may also be a bump and groove structure disposed between the sliding button 145 and the control seat 141 and engaged with each other, so as to enhance the bonding strength of the sliding button 145 and the control seat 141 during fitting. In a natural state, the control spring 146 drives the sliding button 145 to be tightly attached to the inner wall of the control seat 141, so that the self-locking of the wire collector 142 is realized through the mutual clamping of the convex points and the groove structures.

In this embodiment, the slide button 145 is provided with a threaded hole, the connection point 1451 is a screw screwed to the slide button 145, and the bending connector 222 is adhesively fixed in the threaded hole during assembly, and then the screw is screwed into the threaded hole for secondary fixation.

In a specific operation, an operator presses the sliding button 145 to separate the sliding button 145 from the contact surface of the control seat 141, and the spring slides the sliding button 145 along the axial direction of the catheter 200 to drive the bending adjustment connector 222 to move along the axial direction of the catheter 200, so as to adjust the posture of the catheter 200 and bend the tool bit assembly 300. In the operation process, the operator does not need to press the sliding button 145 all the time, and meanwhile, the operator can realize the bending operation of the tool bit assembly 300 only by one hand, so that the operation burden is reduced, and the operation convenience is improved. In addition, through the adjustment mode of translation, the adjustment stroke is accurate, can realize adjusting the accurate controllability of bent angle.

Example IV

The fourth embodiment of the present invention provides a cutting device, as shown in fig. 25 to 27, and the fourth embodiment is the same as the first embodiment, and the fourth embodiment is different from the first embodiment in that a control groove 150 is provided on the handle body 100, the control assembly 140 is disposed in the control groove 150, the control seat 141 is fastened and fixed in the control groove 150, the wire takeup device 142 includes a knob 147 rotatably connected to the control seat 141 and a locking member 1421 for fastening the knob, the locking member 1421 is a locking pin 148 for fastening the knob 147, the locking pin 148 is slidably connected to the control seat 141, and a locking groove 1472 for fastening the locking pin 148 is provided on the knob 147. Wherein a stop spring 1481 is provided between the stop pin 148 and the inner wall of the control seat 141.

The knob 147 is provided with a rotary clamping block 1471, the rotary clamping block 1471 is used for connecting the bending adjusting connecting piece 222, the bending adjusting connecting piece 222 is a bending adjusting connecting wire 2221, and the knob 147 is rotated to enable the bending adjusting connecting piece 222 to be wound on the rotary clamping block 1471, so that the purpose of pulling the bending adjusting connecting piece 222 to adjust the posture of the catheter 200 is achieved. In a natural state, the stop spring 1481 drives the stop pin to move toward the knob 147 and to snap into the stop groove 1472. When it is desired to rotate the knob 147, the stopper pin 148 is slid in a direction away from the knob 147 so that the stopper pin 148 is separated from the stopper groove 1472, and the knob 147 can be rotated. When it is necessary to lock the knob 147, the stopper pin 148 is released, and the stopper spring 1481 drives the stopper pin 148 to slide in a direction approaching the knob 147, so that the stopper pin 148 engages with the stopper groove 1472, and the knob 147 is not rotatable.

In a further embodiment of the present application, the control assembly 140 further includes a locking safety assembly 1422 for preventing false touches, and the locking safety assembly 1422 is disposed between the control stand 141 and the wire takeup 142.

Specifically, a positioning column 1415 is further disposed in the control seat 141, a positioning spring 1416 is sleeved on the positioning column 1415, and the positioning spring 1416 is disposed between the control seat 141 and the knob 147. The knob 147 can move along the axial direction of the knob, and a locking safety component 1422 is disposed between the rotary clamping block 1471 and the control seat 141, wherein the locking safety component 1422 is a clamping structure 149. The clamping structure 149 includes a clamping groove 1491 disposed at one end of the rotary clamping block 1471 facing the knob 147, and a clamping block 1492 disposed at one end of the control seat 141 facing the rotary clamping block 1471, where the knob 147 cannot rotate when the clamping block 1492 is clamped and fixed with the clamping groove 1491.

In a specific operation, in a natural state, the positioning spring 1416 pushes the knob 147 outwards, so that the clamping structure 149 between the rotary clamping block 1471 and the control seat 141 is clamped and fixed. At the same time, the stopper pin 148 is engaged with the stopper groove 1472 by the stopper spring 1481. When the stopper pin 148 is inserted into the stopper groove 1472, the stopper pin 148 is located between the knob 147 and the control seat 141, and the path of the axial movement of the knob 147 is blocked, so that the knob 147 cannot be pressed, and the engagement connection between the engagement block 1492 and the engagement groove 1491 cannot be released, and therefore, the knob 147 cannot be rotated in a natural state. When it is desired to turn the knob 147, the operator first slides the stop pin 148 away from the knob 147 to disengage the stop pin 148 from the stop groove 1472 and then presses the knob 147 inwardly, the detent spring 1416 is forced to compress and simultaneously disengage the detent feature 149, i.e., the detent block 1492 is disengaged from the detent groove 1491, at which time the knob 147 may be turned.

Therefore, the control component 140 of the present embodiment realizes double locking of the wire collector 142 by providing an additional locking safety component 1422 between the control seat 141 and the wire collector 142, improves the reliability of the structure, and ensures that the posture of the cutter head component 300 will not change when a doctor advances the cutter head component 300 to cut plaque. Only when a doctor pushes the stop pin 148 and presses the knob 147 at the same time, the knob 147 can be rotated, the direction of the cutter head assembly 300 is not changed due to false touch, and the cut of the rotary cutter head 320 is avoided, so that the occurrence of medical accidents is avoided, and the smooth operation is further ensured.

Example five

In the fifth embodiment of the present invention, as shown in fig. 29 to 33, the same points as those of the first embodiment are not repeated, and the difference between the fifth embodiment and the first embodiment is that the driving mechanism 400 is disposed in the handle body 100, and the catheter 200 is detachably connected with the driving mechanism 400.

Specifically, as shown in fig. 2, 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 source 413, the power source 411 is used for driving the power shaft 4111 to rotate, and the catheter 200 is detachably connected to the power shaft 4111 through the connection module 440. The power source 411 is a motor, the motor is used for driving the torque shaft 210 to rotate, and the power component 413 is a battery electrically connected to the motor.

As shown in fig. 31 to 33, a transmission shaft 212 is disposed at a proximal end of the torque shaft 210, a socket 4112 is disposed at a distal end of the power shaft 4111, and the transmission shaft 212 is plugged into the socket 4112 and rotates synchronously with the power shaft 4111. The transmission shaft 212 is provided with a clamping groove 2121, and the connection module 440 includes a clamping positioning component 441 in clamping connection with the clamping groove 2121, and a clamping control component 442 for controlling the clamping positioning component 441.

In this embodiment, the torque shaft 210 specifically includes a shaft body 213 and a winding spring 214 disposed on the shaft body 213, where the winding spring 214 is spirally wound and fixed on the shaft body 213, and can be fixed by welding, and the rotation direction of the winding spring 214 is opposite to the rotation direction of the shaft body 213. When the motor drives the torque shaft 210 to rotate, the wrap spring 214 opposite to the rotation direction of the shaft body 213 can more rapidly send out plaque in the catheter 200, improving the excision efficiency.

Further, at least one limiting block 2122 is disposed on the transmission shaft 212, a limiting groove 4113 is disposed on an inner wall of the plugging groove 4112, and after the transmission shaft 212 is plugged into the plugging groove 4112, the limiting block 2122 is adapted to the limiting groove 4113 to circumferentially fix the transmission shaft 212 to the power shaft 4111. In this embodiment, three limiting blocks 2122 distributed in a circumferential array are disposed on the transmission shaft 212, and the three limiting blocks 2122 are in plug-in form fit with the limiting grooves 4113 to play a role in synchronously rotating the power shaft 4111 and the transmission shaft 212 in the circumferential direction, so that the torque shaft 210 and the power shaft 4111 synchronously rotate.

Further, the clamping and positioning assembly 441 includes a clamping piece 4411, a positioning piece 4412 and a connecting end 4413, wherein the clamping piece 4411 is disposed on the power shaft 4111 and is used for being clamped and connected with the clamping groove 2121, the positioning piece 4412 is movably connected with the power shaft 4111, the positioning piece 4412 is used for positioning the clamping piece 4411, the connecting end 4413 is used for connecting the clamping control piece 443 and the clamping piece 4411, and the clamping control assembly 442 controls the clamping piece 4411 to be clamped and connected with or separated from the clamping groove 2121 by controlling the connecting end 4413.

When the transmission shaft 212 is inserted into the bottom of the plugging slot 4112, the head end of the clamping piece 4411 is clamped and connected to the clamping slot 2121, and the clamping piece 4411 is axially fixed to the power shaft 4111 through the positioning piece 4412, so that when the clamping piece 4411 is clamped and connected to the clamping slot 2121, the axial displacement of the transmission shaft 212 and the power shaft 4111 is limited.

In the present embodiment, the clamping member 4411 is a clamping spring plate with a head end bent toward the transmission shaft 212, and 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, the positioning piece 4412 passes through the through hole on the clamping piece 4411 and is connected with the power shaft 4111 in a threaded manner, so that the clamping piece 4411 is axially fixed with the power shaft 4111, and the clamping piece 4411 can rotate by taking the positioning piece 4412 as a center point, so that the clamping piece is connected with the clamping groove 2121 in a clamping manner or is separated from the clamping groove 2121.

The connection end 4413 is integrally formed on the clamping piece 4411, the connection end 4413 is arranged at the tail end of the clamping piece 4411, the connection end 4413 is a driving spring piece, and the driving spring piece is bent towards a direction deviating from the power shaft 4111. When the connecting end 4413 is pressed toward the power shaft 4111, the clip 4411 rotates about the positioning member 4412 as a midpoint, so that the head end of the clip 4411 is disengaged from the clip groove 2121, and the power shaft 4111 and the transmission shaft 212 can be separated in the axial direction.

The clamping control assembly 442 comprises a shaft sleeve 4421 arranged on the handle body 100, a fixed end 4422 fixedly arranged on the inner side of the shaft sleeve 4421, a movable end 4423 movably connected with the shaft sleeve 4421, and a clamping control piece 443, wherein the movable end 4423 is arranged between the positioning piece 4412 and the connecting end 4413, the clamping control piece 443 is used for controlling the movable end 4423 to move, and the power shaft 4111 passes through the fixed end 4422 and the movable end 4423 and then is connected with the transmission shaft 212.

The fixed end 4422 is a fixed bearing connected to the power shaft 4111, and the movable end 4423 is a sliding block slidably connected to the sleeve 4421 in the axial direction of the sleeve 4421. The locking control member 443 includes an elastic member 4433 connected to the fixed end 4422 and the movable end 4423, and a pull cord 4431 for controlling the position of the sliding block.

The end of the pull cord 4431 is provided with a pull ring 4432, the connecting end 4413 is integrally connected with the clip 4411, the proximal end of the connecting end 4413 is tilted, and the movable end 4423 slides between the connecting end 4413 and the clip 4411.

Specifically, the fixed end 4422 is fixedly connected to the inner side of the sleeve 4421 and to the power shaft 4111, and the power shaft 4111 rotates with the positioning member 4412 as a base point. An elastic piece 4433 is arranged between the movable end 4423 and the positioning piece 4412, the elastic piece 4433 is used for driving the movable end 4423 to slide in a direction away from the positioning piece 4412, a pull rope 4431 is arranged on one end, close to the movable end 4423, of the elastic piece 4433 or on the movable end 4423, one end of the pull rope 4431 is connected with the elastic piece 4433 or the movable end 4423, the other end of the pull rope 4431 is connected with a pull ring 4432 on the outer side of the handle body 100, and an operator can pull the pull rope 4431 through the pull ring 4432 so as to enable the movable end 4423 to move in a direction towards the fixed end 4422. Wherein, elastic piece 4433 is a spring, stay 4431 is nickel titanium wire, and the nickel titanium wire is welded on the spring.

In the initial state, the movable end 4423 is located at a side far from the fixed bearing under the action of the elastic member 4433, and at this time, the movable end 4423 is located on the clamping member 4411, and the head end of the clamping member 4411 is clamped and connected in the clamping groove 2121. When the operator pulls the pull cord 4431, the movable end 4423 moves toward the fixed end 4422 in the axial direction of the sleeve 4421 and presses the connecting end 4413 from both sides, so that the connecting end 4413 moves toward the power shaft 4111 and rotates the clip 4411 with the positioning member 4412 as a midpoint, and the head end of the clip 4411 is disengaged from the clip groove 2121, and at this time, the power shaft 4111 can be axially separated from the transmission shaft 212.

As described above, in the present embodiment, by providing the clamping and positioning assembly 441 and the clamping and control assembly 442, the torque shaft 210 can be axially detachably connected to the power shaft 4111, and the torque shaft 210 and the power shaft 4111 are coaxially rotated by the cooperation of the limiting block 2122 and the limiting groove 4113, and the motor outputs torque and drives the torque shaft 210 to rotate by the power shaft 4111.

The handle body 100 is provided with a collecting portion 170, the collecting portion 170 is covered on the outer side of the proximal end of the catheter 200, and the collecting portion 170 is used for collecting plaque discharged from the catheter 200. And the collecting portion 170 is detachably connected to the handle body 100, and the proximal end of the catheter 200 is detachably connected to the collecting portion 170. The proximal end of the catheter 200 is provided with a buffer tube 270, the buffer tube 270 is provided with a seal groove 271, and the handle body 100 and the collecting portion 170 are connected to the catheter 200 through the seal groove 271, respectively.

In this embodiment, the collecting portion 170 is disposed at the bottom of the distal end of the handle body 100, and a collecting cavity is provided between the collecting portion 170 and the handle body 100, through which the resected plaque is accommodated. The proximal end of catheter 200 is fixedly attached to the distal end of buffer catheter 200 or the proximal end of catheter 200 is fixedly attached to the proximal end of buffer catheter 200. The torque shaft 210 sequentially passes through the catheter 200 and the buffer catheter 200 and extends into the collection portion 170, and plaque or thrombus flushed out by the catheter 200 falls into the collection portion 170.

The sleeve 4421 is fixedly connected to the handle body 100 and protrudes toward the collecting portion 170, and other components of the locking control assembly 442 are disposed in the inner cavity of the sleeve 4421. One end of the power shaft 4111 is connected to the power source 411, and the other end of the power shaft 4111 penetrates out of the shaft housing 4421 and is connected to the transmission shaft 212.

Since the proximal end of the catheter 200 is connected to the buffer cannula 270, plaque or thrombus in the catheter 200 will fall into the collection portion 170 after passing through the buffer cannula 270 due to the high speed rotation of the torque shaft 210 and its own weight, and will not follow the torque shaft 210 further forward. Thereby protecting the snap control assembly 442 disposed within the sleeve 4421.

Further, as shown in fig. 30, the length of the shaft body 213 of the present 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 coil spring 214 is not provided on the shaft body 213 of the spacer. By the above-mentioned scheme, after plaque or thrombus discharged from the catheter 200 moves to the proximal end of the coil spring 214, the plaque or thrombus falls into the collecting portion 170 due to the high-speed rotation of the torque shaft 210 and self-gravity, so that it is ensured that the plaque or thrombus does not move forward, and the clamping control assembly 442 is affected.

Specifically, the buffer sleeve 270 is fixedly disposed on the catheter 200, the buffer sleeve 270 is made of silica gel, a seal groove 271 is disposed on the buffer sleeve 270, the seal groove 271 is recessed around the circumference of the buffer sleeve 270 and forms a ring-shaped groove, and after the buffer sleeve 270 is combined with the handle body 100 and the collecting portion 170, edges of the handle body 100 and the collecting portion 170 are connected through the buffer groove so as to be sealed.

Through the above technical solution of the present embodiment, a doctor can replace the catheter 200 according to actual use situations. In particular, the collection portion 170 is first removed, and then the pull ring 4432 on the handle body 100 is pulled, and a pulling force is transmitted to the elastic member 4433 along the pull cord 4431 through the pull ring 4432 to move the movable end 4423 toward the fixed end 4422. During the movement of the movable end 4423, the movable end 4423 gradually presses over the connecting end 4413, causing the tilted connecting end 4413 to move toward the power shaft 4111. The clip 4411 fitted into the clip groove 2121 gradually disengages from the clip groove 2121 by the interlocking action of the connecting end 4413. When the clip 4411 is entirely disengaged from the clip groove 2121, the operator can detach the torque shaft 210 and thus the power shaft 4111 in the axial direction.

When a new torque shaft 210 is installed, the tab 4432 is pulled first, the torque shaft 210 is inserted into the insertion groove 4112, the tab 4432 is released, and after confirming that the clip 4411 is clipped into the clip groove 2121, the collecting portion 170 is mounted on the handle body 100.

The design of the replaceable catheter 200 is adopted in the embodiment, so that the flexibility and economy of the operation are improved, the problem that plaque or thrombus cannot be timely discharged out of a blood vessel due to blockage of the catheter 200, so that a distal embolism is caused, and the life safety of a patient is ensured.

The present invention is not limited to the above-mentioned embodiments, and any changes or substitutions that can be easily understood by those skilled in the art within the technical scope of the present invention should be included in the scope of the present invention. Therefore, the protection scope of the invention is subject to the protection scope of the claims.

Claims

1. The utility model provides a cutting device, includes the handle body, communicate in the pipe of handle body and setting are in the tool bit subassembly of pipe distal end, its characterized in that, be provided with on the pipe and transfer curved subassembly, it is in to transfer curved subassembly including setting up first accent curved point, the second accent curved point on the pipe and be used for connecting first accent curved point with the curved connecting piece of accent curved point of second, be provided with on the handle body and be used for controlling transfer curved subassembly's control assembly.

2. The ablation device of claim 1, wherein the bend-adjusting connector is fixedly connected to the first bend-adjusting point, the bend-adjusting connector is movably connected to the second bend-adjusting point, the first bend-adjusting point is spaced a smaller distance from the distal end of the catheter than the second bend-adjusting point, and the first bend-adjusting point is disposed on the other side relative to the second bend-adjusting point.

3. The ablation device of claim 2, wherein the bend-adjusting connector comprises a bend-adjusting control wire, wherein a control wire lumen is provided in the catheter for the bend-adjusting control wire to pass through, wherein the second bend-adjusting point is provided at a distal end of the control wire lumen, and wherein the bend-adjusting control wire passes through the second bend-adjusting point and is fixedly connected to the first bend-adjusting point after rotating around the catheter.

4. The ablation device of claim 3, wherein the control assembly comprises a control seat disposed on the handle body and a wire takeup movably connected to the control seat, the wire takeup being connected to the bend adjustment control wire and configured to pull the bend adjustment control wire to adjust the posture of the catheter.

5. The cutting device of claim 1, wherein a torque shaft is disposed within the catheter and coupled to the cutter head assembly, and a drive mechanism is disposed within the handle body for driving rotation of the torque shaft.

6. The cutting device of claim 5, wherein the cutter head assembly comprises a limiting seat connected to the catheter and a rotary cutter head arranged on the limiting seat, the rotary cutter head is fixedly connected to one end of the torque shaft, the torque shaft drives the rotary cutter head to rotate and be connected to the limiting seat, and a protective sleeve covering the side face of the rotary cutter head is arranged on the limiting seat.

7. The ablation device of claim 5, wherein the catheter comprises an inner tube and an outer tube disposed outside the inner tube, the inner tube is sleeved outside the torque shaft, the torque shaft is in clearance fit with the inner tube, and a braid is disposed between the inner tube and the outer tube.

8. The ablation device of claim 5, wherein the handle body is provided with a vent lumen connected to the catheter, the vent lumen being in communication with an exterior space of the catheter and the handle body.

9. The ablation device of claim 8, wherein the torque shaft passes through the exhaust channel and is coupled to the drive mechanism, the drive mechanism including a power source, a drive transmission assembly for coupling the power source to the torque shaft, and a power source electrically coupled to the power source.

10. The ablation device of claim 8, wherein the evacuation lumen comprises a main lumen in communication with the catheter and a waste tube disposed laterally of the main lumen, the torque shaft passing through the lumen.