WO2023125962A1 - 瓣膜治疗装置 - Google Patents

瓣膜治疗装置 Download PDF

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Publication number
WO2023125962A1
WO2023125962A1 PCT/CN2022/144055 CN2022144055W WO2023125962A1 WO 2023125962 A1 WO2023125962 A1 WO 2023125962A1 CN 2022144055 W CN2022144055 W CN 2022144055W WO 2023125962 A1 WO2023125962 A1 WO 2023125962A1
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WO
WIPO (PCT)
Prior art keywords
valve
treatment device
cutting
support
valve treatment
Prior art date
Application number
PCT/CN2022/144055
Other languages
English (en)
French (fr)
Inventor
任弘
王永胜
Original Assignee
杭州诺纳生物医疗科技有限公司
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Publication date
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Publication of WO2023125962A1 publication Critical patent/WO2023125962A1/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
    • A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
    • A61B2018/00345—Vascular system
    • A61B2018/00351—Heart
    • A61B2018/00369—Heart valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1405—Electrodes having a specific shape
    • A61B2018/1412—Blade

Definitions

  • the invention relates to the field of medical devices, in particular to a valve treatment device.
  • the aortic valve is located between the left ventricle and the aorta, and consists of three leaflets that join together along the commissure to prevent the return of blood injected into the aorta to the left ventricle.
  • the surface of the aortic valve becomes calcified, causing the aortic valve to stiffen and cause symptoms such as the aortic valve not closing or opening (or opening to a lesser extent, ie, stenosis).
  • bicuspid aortic valve malformation (BAV, Bicuspid Aortic Valve) (there are calcifications in the leaflets, and the two leaflets adhere to each other) is also one of the causes of aortic valve stenosis.
  • the structure of the valve By cutting the calcium on the surface of the valve, the structure of the valve can be softened, and the structure of the valve leaflet can be restored to elasticity, thereby reducing the stenosis of the valve.
  • transcatheter aortic valve replacement which has the advantages of less trauma, high safety, and quick postoperative recovery, is often required for treatment.
  • An object of the present invention is to solve the deficiencies in the prior art, and provide a valve treatment device capable of cutting the valve.
  • valve treatment device includes a sheath tube, the sheath tube has a central axis; a first support assembly, the first support assembly includes a first operating member and the second support assembly A first support part connected to an operating element, the first support part has a compressed form compressed in the radial direction and accommodated in the sheath tube, and an expanded form expanded radially after being released from the sheath tube, wherein
  • the first support part in the expanded form has a pre-curved arc surface extending away from the central axis of the sheath, and the first operating member is adapted to be operated so that the first support part conforming to the surface of the valve in an expanded configuration, wherein the pre-curved arc surface of the first support portion protrudes toward the central axis of the sheath; and a cutting assembly comprising A second operating member and a cutting member connected to the second operating member, the second operating member is adapted to be operated to break at least part of the valve.
  • valve treatment device which includes:
  • the connecting shaft can be slidably accommodated in the sheath;
  • a support assembly arranged on the connecting shaft and located at the proximal end of the valve, the support assembly is used to support the valve;
  • a cutting assembly comprising a cutting member coupled to the connecting shaft, the cutting member configured to fragment at least a portion of the valve;
  • the first guard is arranged at one end of the connecting shaft close to the cutting assembly, the first guard is arranged opposite to the support assembly, the first guard is located at the distal end of the support assembly, and The first protection part is used for shielding and protecting the cutting part.
  • the present invention at least has the following advantages and positive effects:
  • the first support part accommodated in the sheath can be initially released from the sheath by pushing the first operating part to initially fit the valve, and then the first operating part can be further pushed to make the first
  • the support part is further expanded to its fully expanded form, and conforms to the valve and presses down the valve, and then operates the second operating part to make the cutting part cut the valve.
  • the first support part has a pre-bent arc surface
  • the first support part when the first support part is released from the sheath, it will not be squeezed by external pressure, and the first support part will automatically return to its pre-bend arc surface, and at the same time,
  • the first operating member applies a pushing force to the proximal end along the axial direction of the blood vessel, so that the first support part is further bent along the pre-curved arc surface, so as to conform to the valve and press the valve.
  • the valve under the upward impact of the blood flow and the downward pressure of the first supporting part, the valve is stably clamped, and it is not easy to float or free under the impact of the blood flow, so that the cutting piece can be more stable and precise cut the valve.
  • there is no need to provide supporting parts on both sides of the valve to clamp the valve the structure is simple and compact, and the risk of damage to the valve is reduced.
  • valve treatment device of the present invention cuts the valve
  • the doctor pushes the valve treatment device to the position of the valve to be cut through the blood vessel.
  • the valve is supported and positioned on one side of the valve by the supporting component.
  • the cutting assembly is then manipulated so that the cutting member moves toward the valve.
  • the first guard is arranged on the other side of the valve relative to the support assembly, therefore, during the movement of the cutter towards the valve, the first guard can shield and protect the cutter to prevent the cutter from contacting the blood vessel before cutting the valve
  • the inner wall causes scratches on the inner wall of the blood vessel, which improves the safety of the above-mentioned valve treatment device.
  • Fig. 1 is a positional relationship diagram between a valve treatment device and a valve according to an embodiment of the present invention
  • Fig. 2 is a perspective view of the valve treatment device according to the first embodiment of the present invention.
  • Fig. 3 is an exploded view of the valve treatment device shown in Fig. 2;
  • Fig. 4 is a perspective view of the first support part of the valve treatment device shown in Fig. 2;
  • Fig. 5 is a side view of the first supporting part shown in Fig. 4;
  • Fig. 6 is a bottom view of the first supporting part shown in Fig. 4;
  • Fig. 7 is a schematic diagram of the cutting blade passing through the avoidance part of the first support part shown in Fig. 4;
  • Fig. 8 is a schematic diagram of the cutting blade extending into the avoidance portion of the first support portion shown in Fig. 4;
  • Fig. 9 is an alternative embodiment of the first supporting part shown in Fig. 4;
  • Figure 10 is an exploded view of the cutting assembly of the valve treatment device shown in Figure 4.
  • FIG. 11 is a cross-sectional view of the cutting assembly of the valve treatment device shown in FIG. 4;
  • Figure 12 is a perspective view of another alternative embodiment of the cutting assembly shown in Figure 10;
  • Figure 13 is an exploded view of the cutting assembly shown in Figure 12;
  • Figure 14 is a perspective view of yet another alternative embodiment of the cutting assembly shown in Figure 10;
  • Figure 15 is a cross-sectional view of the cutting assembly shown in Figure 14;
  • Figure 16 shows that the cutting blade of the cutting assembly shown in Figure 15 is in one of the extreme positions
  • Figure 17 shows that the cutting blade of the cutting assembly shown in Figure 15 is in another extreme position
  • Fig. 18 is a perspective view of a valve treatment device according to a second embodiment of the present invention.
  • Fig. 19 shows the compressed form of the second support part of the valve treatment device shown in Fig. 18;
  • Fig. 20 is a perspective view of the valve treatment device shown in Fig. 1;
  • Fig. 21 is a perspective view of another angle of the valve treatment device shown in Fig. 20;
  • Fig. 22 is a front view of the valve treatment device shown in Fig. 20;
  • Fig. 23 is a schematic diagram of the cutting blade of the valve treatment device shown in Fig. 22 cutting the valve;
  • Fig. 24 is a structural schematic diagram of the cutting blade of the valve treatment device shown in Fig. 22 in a folded state;
  • Fig. 25 is a schematic structural view of the first protective part of the valve treatment device shown in Fig. 20;
  • Fig. 26 is a schematic structural view of the opening structure of the first guard shown in Fig. 25;
  • Fig. 27 is a schematic structural view of another embodiment of the first protective member shown in Fig. 26;
  • Fig. 28 is a schematic structural view of the first protective part shown in Fig. 26 with winding holes;
  • Fig. 29 is a structural schematic view of the first protective member shown in Fig. 28 provided with a protective structure;
  • Fig. 30 is a schematic structural view of another embodiment of the first protective member shown in Fig. 29;
  • Fig. 31 is a structural schematic view of the first guard shown in Fig. 26 provided with a curved portion;
  • Figure 32 is a side view of the first guard shown in Figure 26;
  • Fig. 33 is a sectional view along A-A of the first protective member in Fig. 32;
  • Fig. 34 is a sectional view along B-B of the first protective member in Fig. 32;
  • Fig. 35 is a schematic structural view of another embodiment of the first protective member shown in Fig. 22;
  • Fig. 36 is a schematic structural view of another embodiment of the first protective member shown in Fig. 22;
  • Fig. 37 is a schematic structural view of another embodiment of the first protective element shown in Fig. 25 .
  • Cutting assembly 31, 31a, 31b, cutting blade; 311, blade; 312, knife back; 32, 32a, 32b, conveying member; 320, 320a, 320b, first opening; 321, 321a, 321b, chute; 322, hole; 33, 33a, 33b, adjustment piece; 330, 330a, receiving cavity; 331a, 331b, convex column; 332a, second chute; 34, 34a, 34b, 34b support member; 340b, U-shaped opening; 341a, 341b, boss; 342a, groove; 35, first operating member; 310a, rotating shaft;
  • Support assembly 41. Second operating member; 42. Support portion; 42a, first section; 42b, second section; 42c, free end; 42e, initial section; 421, first surface; 422, second section Two surfaces; 424, support ribs; 425, grid; 426, connection end; 43, support arm; 430, resisting part; 431, vent hole; 44, 44a, avoidance part; 45, hollow hole;
  • first and second are used for descriptive purposes only, and cannot be interpreted as indicating or implying relative importance or implicitly specifying the quantity of indicated technical features.
  • a feature defined as “first” or “second” may explicitly or implicitly include one or more of said features.
  • “plurality” means two or more, unless otherwise specifically defined.
  • distal end herein refers to the end of the device away from the operator
  • proximal end refers to the end of the device close to the operator.
  • valve treatment device in this embodiment can be used for operations such as cutting a valve.
  • the valve treatment device of this embodiment is particularly suitable for cutting the aortic valve.
  • the valve treatment device provided in this application is not limited to cutting valves, and can also be used to cut other lesions.
  • valve treatment device of this embodiment when used to cut the aortic valve of the human heart, an incision can be made at the femoral artery, and the valve treatment device can be inserted into the blood vessel 90 from the incision, and passed along the blood vessel 90. Aortic arch, ascending aorta, reaching 91 places of aortic valve. At this time, the valve 91 and the blood vessel wall surround to form a sinus cavity, the first surface 911 of the valve 91 serves as the sinus wall of the sinus cavity, and the second surface 912 of the valve 91 is opposite to the blood flow of the heart.
  • the valve treatment device of this embodiment includes a sheath tube 10 with coincident central axes, a connecting shaft 20 , a cutting assembly 30 , and a first support assembly 40 .
  • the connecting shaft 20 , the cutting assembly 30 , and the first support assembly 40 are all disposed in the sheath 10 and can be operated to protrude at least partially from the distal end of the sheath 10 .
  • the sheath tube 10 enters the blood vessel 90 from the incision, the connecting shaft 20, the cutting assembly 30, and the first support assembly 40 are wrapped by the sheath tube 10 and enter the blood vessel 90 together with the sheath tube 10, and are transported along the blood vessel 90 to the position of the valve to be cut .
  • the most distal end of the valve treatment device is also provided with a tapered tip 11 , which can guide the entire valve treatment device through the blood vessel 90 and prevent the front end of the device from damaging the tissues in the blood vessel 90 .
  • the tapered tip 11 can be fixed on the front end of the connecting shaft 20 .
  • the tapered tip 11 normally does not enter the sheath 10 .
  • a sheath 10 extends proximally from the distal end of the valve treatment device.
  • the sheath 10 can be made of hypotube and/or polymer material.
  • the sheath tube 10 has a central axis. It can be understood that the central axis extends along the length direction of the sheath tube 10 , and the central axis passes through the lumen of the sheath tube 10 .
  • the central axis coincides with the central axis of the valve treatment device.
  • the connecting shaft 20 is slidably accommodated in the sheath tube 10 .
  • the connecting shaft 20 may be a solid cylinder inside, or a hollow cylinder inside, or may be formed by partially cutting a cylinder, or may be formed by bending a sheet-like structure.
  • the connecting shaft 20 can be operated to slide in the axial direction of the sheath tube 10 or in the length direction of the sheath tube 10 .
  • the cutting assembly 30 and the first supporting assembly 400 are arranged in the sheath tube 10 through the connecting shaft 20 .
  • the connecting shaft 20 may be a hollow tubular structure.
  • the first support assembly 40 and the first guard 50 are formed on the connecting shaft 20 .
  • the cutting assembly 30 is accommodated in the connecting shaft 20 .
  • a window 22 is provided on the side wall of the connecting shaft 20 for the cutting element to protrude from.
  • the first supporting component 40 is disposed at the proximal end of the connecting shaft 20 .
  • the cutting assembly 30 is used for cutting the valve.
  • the cutting assembly 30 is accommodated on the connecting shaft 20 , and in a state of use, the cutting assembly 30 is located at the distal side of the valve 91 .
  • the cutting assembly 30 includes a first operating member 35 and a cutting member.
  • the first operating member 35 is adapted to be operated to reciprocate the cutting member between the proximal end and the distal end of the connecting shaft 20 .
  • the first operating member 35 can transmit push force and pull force to move the cutting member.
  • the first operating member 35 may be a traction guide wire. During the cutting operation of the cutting member, the cutting member moves towards the valve and from the distal side of the valve to the proximal side of the valve.
  • the cutter includes a breaking portion for breaking the valve 91 .
  • the disruptor may disrupt at least part of the valve 91 .
  • the cutting member can divide the valve 91 along the radial direction of the blood vessel, and can also destroy part of the calcification on the valve 91 .
  • the specific operation content of the cutting member on the valve 91 is not limited here.
  • the cutting member can be a cutting blade 31 .
  • the cutting blade 31 may include an edge 311 and a back 312 .
  • the blade 311 faces toward the connecting shaft 20 .
  • the blade back 312 faces away from the connecting shaft 20 .
  • the blade 311 is used to cut the valve.
  • the broken portion of the cutting blade 31 is the blade 311 .
  • the surface of the blade back 312 includes a smoothly extending transition surface.
  • the cutting blade 31 is also electrically connected to the high-frequency ablation instrument, wherein the cutting blade 31 is insulated except the cutting tip or a part of the cutting tip (surface coating or spraying, etc.) can be used to ensure energy concentrated,.
  • the cutting blade 31 combines mechanical cutting and electric cutting at the same time, and the cutting effect is better.
  • the cutting blade 31 can be fixed, and the entire cutting assembly 30 can be pulled proximally, thereby cutting the valve.
  • the cutting blade 31 can also be moved independently along a circular arc path to cut the valve.
  • the cutting assembly 30 may also be configured to disrupt at least a portion of the valve in a non-contact manner.
  • the cutting element may not be a sharp blade, but a structure made of conductive material.
  • the cutting element may also be an electroablation element electrically connected to an ablation power source. Then the breaking part of the cutting element is the energy release end of the electroablation element.
  • the electrical ablation element may be, for example, a high-frequency ablation device, and the cutting element receives the energy delivered by the electrical ablation element, and breaks at least part of the valve in a non-contact manner. At least part of the broken valve may be through the valve along the thickness direction, or may be calcification on the surface of the broken valve but not broken the valve.
  • the cutting assembly 30 further includes a conveying member 32 , an adjusting member 33 slidably connected to the conveying member 32 , and a support member 34 hinged to the adjusting member 33 .
  • the cutting blade 31 is hingedly connected to the supporting member 34 and the conveying member 32 , and the cutting blade 31 is configured to be driven to rotate along the linear motion of the conveying member 32 via the supporting member 34 and the adjusting member 33 .
  • the conveying element 32 is in the shape of a tube, and a first opening 320 extending in the axial direction and passing through a side wall thereof is formed on it.
  • the adjusting member 33 is accommodated in the conveying member 32 .
  • the adjusting member 33 is in the shape of a longitudinal rod, and has a receiving cavity 330 therein.
  • the receiving cavity 330 extends axially and penetrates the adjusting member 33 radially.
  • the support member 34 and the cutting blade 31 can be moved to be accommodated in the accommodation chamber 330 of the adjustment member 33, and therefore also accommodated in the conveying member 32, and can extend from the adjustment member 33 and the conveying member 32 via the accommodation chamber 330 and the first opening 320. out so that the cutting blade 31 cuts.
  • the sidewall of the conveying member 32 is provided with elongated sliding slots 321 , preferably two sets of sliding slots 321 arranged at intervals in the axial direction.
  • the adjustment member 33 is provided with two protrusions, namely the protrusion 331a and the protrusion 331b.
  • the protruding post 331 a and the protruding post 331 b are slidably engaged with the corresponding two slide slots 321 , so that the adjusting member 33 is slidably received in the conveying member 34 .
  • the slide groove 321 can also limit the protrusions 331a and 331b, thereby limiting the sliding displacement of the adjusting member 33, so as to prevent dead spots during movement.
  • the supporting member 34 is configured as a U-shaped member with a U-shaped opening 340, and its closed end is hinged to the adjusting member 33 through one of the protrusions 331a.
  • the U-shaped opening 340 is to make it easier for the cutting blade 31 to be installed on the support member 34, and the cutting blade 31 can rotate around the support member 34.
  • the U-shaped opening can also be replaced by other features. 340 , or directly hinge the cutting blade 31 to the support 34 without providing a U-shaped opening 340 on the support 34 .
  • the open end of the support member 34 is hinged to approximately the middle of the cutting blade 31 .
  • An end of the cutting blade 31 away from its cutting tip is hinged to the conveying member 32 through a rotating shaft 310 , wherein the rotating shaft 310 is inserted into two opposite holes 322 on the conveying member 32 .
  • the two hinge points of the cutting blade 31, which are respectively hinged to the supporting member 34 and the conveying member 32, are located on both radial sides of the adjusting member 33, that is, on both sides of the plane where the central axis of the boss 331a and the boss 331b are located. In other words, the cutting The two hinge points on the blade 31 are not on the same plane as the boss 331a and the boss 331b, which can effectively avoid dead spots during movement.
  • the first operating member 35 drives the adjusting member 33 to slide along the conveying member 32, the adjusting member 33 drives the supporting member 34 to swing, and the supporting member 34 drives the cutting blade 31 to rotate with the rotating shaft 310 as the center of the circle, and because
  • the design of the U-shaped opening 340 and the receiving cavity 330 ensures that the cutting blade 31 can rotate within a certain range. More specifically, when the first operating member 35 is pulled, the cutting blade 31 can rotate clockwise as shown in FIG. The size is convenient for transportation; at this time, in order to prevent dead spots, a corresponding protrusion 331b can also be used to abut against the cutting tip of the cutting blade 31, thereby forming a limited fit structure.
  • the cutting blade 31 When the first operating member 35 is pushed, the cutting blade 31 can rotate in the counterclockwise direction as shown until its cutting tip protrudes from the receiving cavity 330 for cutting; similarly, in order to prevent dead spots, the support member 34 The closed end of the blade abuts against the cutting tip of the cutting blade 31.
  • the cutting blade 31 can also be driven by other structures.
  • the kinematic state of cutting blade 31 can comprise 4 kinds of forms, namely: strut the shape, and cutting blade 31 is at first by being housed in the conveying member 32, drives support member 34 through adjusting member 33 to make cutting blade 31 support from conveying member 32 open.
  • the blade 311 of the cutting blade 31 is aligned with the valve to be cut, and the operating member 35 is pulled to make the cutting blade 31 translate from the distal end to the proximal end, thereby completing the cutting action on the valve 91 .
  • the cutting blade 31 is retracted from the proximal end to the distal end.
  • the folded state when the cutting blade 31 returns to its original position, continue to push the operating member 35, so that the cutting blade 31 can be folded into the conveying member 32 for convenient conveying.
  • the valve treatment device further includes a catheter 24 fixedly connected to both ends of the delivery member 32 and a drive shaft 25 .
  • the whole device is used to pass a guide wire, and the guide wire is used to establish a channel in the blood vessel to guide the whole device along the guide wire into the blood vessel.
  • the drive shaft 25 can be used to connect another guide wire to enable the cutting assembly 30 to be moved in and out of the sheath 10 as a whole.
  • the cutting assembly 30 and the first support assembly 10 are independently driven.
  • the cutting assembly 30 and the first support assembly 10 can also be fixedly connected, so that the cutting assembly 30 and the first support assembly 10 can be driven into or out of the sheath tube 10 as long as the drive shaft 25 is used.
  • the distal end of the cutting assembly 30 is preferably connected with a tapered tip 11 as shown in FIG. 18 , so as to guide the entire device through the blood vessel and prevent the front end of the device from damaging the tissues in the blood vessel.
  • the cutting blade 31 can also be driven by other structures.
  • the cutting assembly 30a includes a conveying member 32a, an adjusting member 33a slidably connected with the conveying member 32a, a support member 34a hinged with the adjusting member 33a, and a supporting member 34a and
  • the conveying member 32a is hinged to the cutting blade 31a, and the cutting blade 31a is configured to be driven to rotate along the linear motion of the conveying member 32a by the adjusting member 33a via the support member 34a.
  • the conveying member 32a is in the shape of a tube, and is provided with a first opening 320a extending axially and penetrating through its side wall, and two elongated first sliding grooves 321a extending radially opposite to each other.
  • the adjusting member 33a is substantially tubular and accommodated in the conveying member 32a. It is provided with a receiving chamber 330a extending axially and penetrating through its side wall, and two radially opposite long strips extending axially.
  • the second sliding slot 332a wherein the receiving cavity 330a faces the first opening 320a. It can be understood that in other embodiments, the adjustment member can also adopt other shapes and/or configurations.
  • the support part 34a is configured as a U-shaped part with a U-shaped opening 340a.
  • the closed end of the support member 34a is connected to a protruding post 341a, the protruding post 341a passes through the adjustment member 33a and is rotatably connected thereto, and the protruding post 341a is slidably engaged in the first slide groove 321a.
  • the open end of the support member 34a is hinged to the substantially middle portion of the cutting blade 31a.
  • One end of the cutting blade 31a away from its cutting tip is hinged with the delivery member 32a through a rotating shaft 310a, wherein the approximate middle of the support member 34a is provided with a groove 342a sunken from one side thereof, and the rotating shaft 310a runs through the cutting blade 31a away from its cutting tip One end, and sequentially pass through the groove 342a of the support member 34a, the second sliding groove 332a of the adjusting member 33a to be rotationally connected with the conveying member 32a, wherein the rotating shaft 310a is slidingly connected with the second sliding groove 332a.
  • the protrusion 341a slides in the first slide groove 321a following the adjusting member 33a, thereby driving the supporting member 34a to swing, and the supporting member 34a then drives the cutting
  • the blade 31a rotates around the rotating shaft 310a. More specifically, when the first operating member 35 pushes the regulating member 33a to slide forward (far end), the boss 341a slides from right to left (as shown in FIG.
  • the support member 34a swings so that the rotating shaft 310a breaks away from the groove 342a, and the cutting blade 31a can rotate to make its cutting tip protrude from the receiving cavity 330a for cutting; when the first operating member 35 is pulled to adjust When the member 33a slides backward, the boss 341a slides from left to right in the first sliding groove 321a, and the second sliding groove 332a slides backward relative to the rotating shaft 310a, and the supporting member 34a swings so that the groove 342a engages with the rotating shaft 310a again , the cutting blade 31a can be rotated so that its cutting tip is accommodated in the receiving cavity 330a.
  • the cutting assembly 30b includes a delivery member 32b, an adjustment member 33b slidably connected to the delivery member 32b, a support member 34b hinged to the adjustment member 33b, and
  • the cutting blade 31b is hinged to the supporting member 34b and the conveying member 32b, and the cutting blade 31b is configured to be driven to rotate by the linear motion of the adjusting member 33b along the conveying member 32b via the supporting member 34b.
  • the conveying member 32b is in the shape of a tube, and is provided with a first opening 320b extending axially and penetrating through its side wall, and two elongated first slide grooves 321b extending radially opposite to each other.
  • the cross-section of the adjustment member 33b is generally a short T-shaped structure, and is slidably accommodated in the conveying member 32b.
  • the supporting part 34b is configured as a U-shaped part with a U-shaped opening 340b.
  • the closed end of the supporting member 34b is connected to a protruding post 341b, the protruding post 341b passes through the adjustment member 33b and is rotatably connected thereto, and the protruding post 341b is slidably engaged in the first slide groove 321b.
  • the open end of the support member 34b is hinged to the substantially middle portion of the cutting blade 31b.
  • One end of the cutting blade 31b away from its cutting tip is hinged to the conveying member 32b via a rotating shaft 310b.
  • the first supporting component 40 is located at the proximal side of the valve 91 .
  • the first support assembly 40 is used to support the proximal side of the valve 91 .
  • the first supporting assembly 40 includes a second operating member 41 and a first supporting portion 42 connected to the second operating member 41 .
  • the first support portion 42 is connected to the second operating member 41 through the connection end 426 .
  • a plurality of first support portions 42 distributed along the circumferential direction of the connection end 426 may also be provided.
  • the second operating member 41 can be a tubular structure accommodated in the sheath tube 10 .
  • the first supporting part 42 is fixedly connected to the proximal end of the connecting shaft 20, and the first supporting part 42 is arranged on the proximal end side of the valve, so that the first supporting part 42 can be synchronized with the connecting shaft 20 relative to the sheath tube 10 slide.
  • the first support portion 42 has a compressed form that is compressed in the radial direction and accommodated in the sheath tube 10, and is formed under the compression of the inner wall of the sheath tube 10, and after being released from the sheath tube 10 as shown in FIG.
  • the expanded form formed by the self-transformation of the expansion.
  • the second operating member 41 is adapted to be operated to make the first supporting portion 42 be in a compressed state or an expanded state.
  • the first supporting part 42 can be converted into a compressed form by pulling the second operating member 41 backward or pushing the sheath 10 forward to be accommodated in the sheath 10 .
  • the first supporting part 42 can be released from the sheath tube 10 by pushing the second operating member 41 forward or pulling the sheath tube 10 backward to transform into an expanded configuration. That is to say, the first supporting part 42 is made of elastic material, and the first supporting part 42 can be naturally stretched to form an expanded shape in the state shown in FIG. After the first supporting part 42 protrudes from the sheath tube 10 , it can return to the expanded form shown in FIG. 3 by its own elastic restoring force without external force.
  • the second operating member 41 may be a proximal portion of the connecting shaft 20 . Then the cutting assembly 30 and the first supporting assembly 40 are independently driven and controlled. It can be understood that, in other embodiments, the first operating member 35 of the cutting assembly 30 and the second operating member 41 of the first support assembly 40 can also be drivenly connected, so long as the first operating member 35 or the second operating member 41 , that is, to drive the cutting assembly 30 and the first support assembly 40 to move into or out of the sheath tube 10 as a whole.
  • the second operating member 41 preferably includes a catheter or a pulling wire slidably accommodated in the sheath tube 10 , the proximal end of which is connected to a handle (not shown in the figure).
  • the handle drives the second operating member 41 to slide in the sheath tube 10 , so that the first supporting part 42 can move into or out of the sheath tube 10 .
  • the second operating member 41 includes a catheter. The second operating member 41 is fixedly connected to the starting end of the first section 41a through the connecting end 426.
  • the connecting shaft 20 is sleeved on the second operating member 41 and is preferably fixedly connected with the second operating member 41 .
  • the connecting shaft 20 and the second operating member 41 may also be driven independently, thereby independently driving the second protecting member 60 and the first supporting portion 42 .
  • the first support portion 42 has a compressed form that is compressed in the radial direction and accommodated in the sheath tube 10, and is formed under the compression of the inner wall of the sheath tube 10, and after being released from the sheath tube 10 as shown in FIG. Expansive self-deformation forms an expanded shape.
  • the first support portion 42 is an elastic member configured to elastically bend and deform from a compressed state to an expanded state when the external pressure is removed.
  • the first supporting part 42 can be converted into a compressed form by pulling the second operating member 41 backward or pushing the sheath 10 forward to be accommodated in the sheath 10 .
  • the first supporting part 42 can be released from the sheath tube 10 by pushing the second operating member 41 forward or pulling the sheath tube 10 backward to transform into an expanded configuration.
  • the first support part 42 has a pre-curved arc surface extending outward from the connecting end 426 toward a direction away from the central axis L of the sheath tube 10 to a free end 42c, wherein the pre-bend arc surface
  • the surface protrudes toward the central axis of the sheath tube 10 , in other words, the groove formed by the pre-curved arc faces away from the central axis of the sheath tube 10 .
  • the first support portion 42 is used to support the first surface 911 of the valve 91 .
  • the first supporting portion 42 may be an elastic member.
  • the first supporting portion 42 may be a metal sheet.
  • the bottom of the first supporting portion 42 is connected to the connecting shaft 20 .
  • the first support portion 42 is configured to be elastically deformable from a compressed configuration to an expanded configuration when the external pressure is removed.
  • the first supporting part 42 can be converted into a compressed form by pulling the second operating member 41 backward or pushing the sheath 10 forward to be accommodated in the sheath 10 .
  • the first supporting part 42 can be released from the sheath tube 10 by pushing the second operating member 41 forward or pulling the sheath tube 10 backward to transform into an expanded configuration.
  • the top of the first support portion 42 expands radially.
  • the sheath tube 10 of the valve treatment device is transported to the position of the valve 91 to be cut; by withdrawing the sheath tube 10 to the proximal end or pushing the first support assembly 40 forward to the distal end, the receiving The first support portion 42 within the sheath 10 is released from within the sheath 10 to transition from the compressed configuration to the expanded configuration; the first support portion 42 in the expanded configuration is compliantly pressed against the first surface 911 of the valve 91 .
  • the valve treatment device of this embodiment is especially suitable for cutting the aortic valve.
  • the first support portion 42 has a pre-curved arc surface. Therefore, when the first supporting part 42 is released from the sheath tube 10 and is not squeezed by external pressure, the first supporting part 42 will automatically return to its pre-curved arc surface, and at the same time, the second operating part 41 is aligned along the axial direction of the blood vessel. A pushing force is applied to the proximal end, so that the first support portion 42 is further bent along the pre-curved arc surface, so as to conform to the valve and press the valve.
  • the leaflets of the valve 91 to be cut are stably clamped, and are not easy to float or free under the impact of the blood flow, so that the cutting blade 31 can cut the valve 91 more stably and accurately.
  • there is no need to provide supporting parts on both sides of the valve 91 to clamp the valve 91 the structure is simple, and the risk of damage to the valve 91 is reduced.
  • the first support portion 42 in the expanded form of the first support portion 42 , includes an arc-shaped first support portion 42 extending outward and toward the distal end away from the central axis L of the sheath tube 10 .
  • the abutting portion 430 abuts against the valve leaflet VL.
  • the first supporting portion 42 can more conformably fit on the wall of the sinus cavity of the valve, so as to support and position the valve more stably.
  • the arc-shaped abutment portion 430 of the first support portion 42 abuts against the wall of the sinus cavity of the valve, which can effectively prevent the first support portion 42 from causing damage to the valve, and has a good positioning effect.
  • the second section 42b of the first support portion 42 first bends and extends from the abutting portion 430 toward the proximal end and away from the central axis L of the sheath 10 , and then further toward the proximal end and toward the center of the sheath 10
  • the direction of the axis L bends to extend to the free end 42c, which helps to prevent the free end 42c from scratching the blood vessel.
  • the bending radius R of the second section 42b is preferably in the range of 1-3mm, more preferably 1-2mm, and most preferably 1.5mm, which helps the first supporting part 42 to more stably rest on the sinus cavity wall of the valve .
  • the angle ⁇ between the tangent of the free end 42c and the central axis L of the sheath tube 10 is preferably in the range of 10-60°, more preferably 20-30°, and most preferably 26°, which helps to prevent the free end more effectively.
  • End 42c scratches the blood vessel.
  • the tangent to the free end 42c is substantially parallel to the tangent to the initial segment 42e of the first section 42a.
  • the angle between the tangent of the initial section 42e of the first section 42a and the central axis L of the sheath tube 10, that is, the angle at which the initial section 42e of the first section 42a deviates from the central axis L of the sheath tube 10, also It is preferably in the range of 10-60°, more preferably 20-30°, and most preferably 26°, which helps the first supporting part 42 fit better on the wall of the sinus cavity.
  • the maximum central angle corresponding to the two sides of the first support part 42 in the circumferential direction (that is, the two sides of the first support part 42 in the circumferential direction are respectively
  • the maximum included angle) ⁇ between the line connecting the central axis L of the sheath tube 10 is in the range of 5-180°, preferably in the range of 10-90°, preferably in the range of 10-60°, More preferably in the range of 30-40°, most preferably 33°.
  • the first supporting part 42 in this embodiment has a more compact structure.
  • the free end 42c has a maximum central angle ⁇ , which helps the free end 42c of the first supporting part 42 to more stably attach to the wall of the sinus cavity.
  • the maximum width W of the first support portion 42 along the circumferential direction is preferably in the range of 2-20 mm, most preferably in the range of 5-10 mm.
  • the free end 42c has a maximum width W.
  • the sinus cavities of human heart valves have a larger opening at the top and a narrower bottom.
  • the first supporting part 42 of this embodiment can not only be easily inserted into the bottom of the sinus cavity, but also can be easily aligned and positioned to cut the middle part of the valve.
  • the first support portion 42 is made of elastically deformable material, so that the first support portion 42 can be easily accommodated in the sheath tube 10 while stably supporting the valve. More preferably, the first supporting portion 42 is made of a shape memory material, such as nickel-titanium alloy. Thus, when the first support portion 42 in the compressed configuration is released from the sheath 10, the first support portion 42 can self-expand to its expanded configuration.
  • the first supporting portion 42 is cut and bent from a metal sheet, and includes a plurality of supporting ribs 424 . A plurality of support ribs 424 encloses one or more grids 425 .
  • the first supporting portion 42 may also be made of metal wire in other ways.
  • the first supporting portion 42 may also be a single metal wire structure.
  • the first supporting portion 42 may also be formed by twisting a plurality of metal wires.
  • the first supporting portion 42 may also be formed by braiding a plurality of metal wires.
  • the first supporting portion 42 is provided with at least one escape portion 44 .
  • the escaping portion 44 is used to evacuate the cutting blade 31 .
  • the first support portion 42 has a first surface 421 and a second surface 422 on both sides in the thickness direction.
  • the escape portion 44 runs through the first surface 421 and the second surface 422 of the first supporting portion 42 .
  • the avoidance portion 44 is located approximately in the middle of the first supporting portion 42 so that the cutting blade 31 can be aimed at the middle of the valve 91 for cutting.
  • the cutting blade 31 can cut through the avoiding portion 44 to the second surface 422 protruding from the first supporting portion 42 . It can be understood that, in other embodiments, as shown in FIG. 17 , the cutting blade 31 may not penetrate through the escape portion 44 , but only protrude into the avoidance portion 44 for cutting.
  • the escape portion 44 may be formed by one of the grids 425 . It can also be understood that in other implementation manners, the escape portion can also adopt other forms. As shown in FIG. 9 , the escape portion 44 a is recessed from the first surface 421 of the first support portion 42 toward the second surface 422 of the first support portion 42 without penetrating through the second surface 422 of the first support portion 42 . When cutting, the cutting blade 31 protrudes into the avoidance portion 44 a and is blocked by the support ribs of the first support portion 42 made of solid material.
  • the escape portion 44 is formed in the middle of the first supporting portion 42 .
  • the escape portion 44 may be a via hole, or a groove (not shown) formed by the top of the first supporting portion 42 being depressed downward. And the groove can be open on the top of the first supporting part 42 . When the cutting blade 31 passes through the groove, the top end of the first supporting portion 42 is prevented from interfering with the cutting blade 31 .
  • hollow holes 45 are formed on both sides of the escape portion 44 .
  • the hollow hole 45 can enhance the elasticity of the first supporting part 42 .
  • the top of the first supporting portion 42 includes two opposite supporting arms 43 .
  • the supporting arm 43 includes an arc-shaped abutting portion 430 extending outward and toward the distal end in a direction away from the central axis L of the sheath tube 10 .
  • the abutting portion 430 is used to abut against the valve 91 .
  • the support arm 43 can more conformably fit on the wall of the sinus cavity of the valve 91 , so as to support and position the valve 91 more stably. Furthermore, by abutting against the wall of the sinus cavity of the valve 91 by the abutting portion 430 of the support arm 43 , it can effectively prevent the support arm 43 from causing damage to the valve, and the positioning effect is good.
  • the abutting portion 430 is also provided with air holes 431 to avoid adhesion between the abutting portion 430 and the valve 91 when the abutting portion 430 and the valve 91 are attached and supported.
  • the valve treatment device 200 of this embodiment further includes a second support assembly 70 , wherein the cutting assembly 30 is located in the second support assembly 70 .
  • the first support portion 42 in this embodiment may adopt the first support portion 42 in the previous embodiment, and details will not be repeated here.
  • the second support assembly 70 includes a second support portion 71 located at its distal end, and a third operating member 73 fixedly connected to the second support portion 71, specifically, the proximal end of the second support portion 71 is connected to the third operating member 73 connected, the distal end of the second supporting part 71 is free to move.
  • the second supporting part 71 has a compressed form that is radially compressed and accommodated in the sheath tube 10 as shown in FIG.
  • the distal end of the second support part 71 moves close to the proximal end during expansion, and in the expanded form of the first support part 42 and the expanded form of the second support part 71, the first support part 42 is located the proximal end of the second supporting part 71 .
  • the second supporting portion 71 may be made of nickel-titanium alloy, stainless steel or other suitable materials.
  • the third operating member 73 may include a catheter or pull wire slidably received within the sheath 10 . Further, in this embodiment, the third operating member 73 is slidably accommodated in the second operating member 41 configured as a conduit.
  • the second supporting portion 71 assumes a compressed state as shown in FIG. 19 under the constraint of the second operating member 41 . And when the third operating member 73 pushes the second supporting portion 71 to release from the second operating member 41 and the sheath 10 , the second supporting portion 71 self-expands to the expanded configuration shown in FIG. 18 .
  • the second supporting part 71 When cutting the valve, the second supporting part 71 can be pushed forward by the third operating part 73 to be released from the second operating part 41 and the sheath tube 10. At this time, the second supporting part 71 self-expands to its expanded form, and then Slowly withdraw the entire device so that the second supporting part 71 is gently supported on the lower surface of the valve; then push the second operating member 41 forward so that the first supporting part 42 is released from the sheath tube 10 to self-deform to the expanded configuration, and Press the first support part 42 on the upper surface of the valve, at this time, the valve is stably clamped between the first support part 42 and the second support part 71; then drive the second support part located in the cage shape
  • the cutting blade 31 in 71 passes through the mesh of the second support part 71 in the expanded form, so that the cutting blade 31 can reach the position where the valve can be cut, and then the cutting can be performed.
  • this device When this device is used to cut human heart valves, even if the systole does not pump blood outwards (that is, the blood flow that does not hit the valve upwards), it can pass through the first support part 42 and the second support part 71. Hold the valve firmly. In this case, the first supporting part 42 can keep the valve stable without pressing down the valve excessively.
  • the second operating member 41 can also be pushed forward first, so that the first support portion 42 is released from the sheath tube 10 to self-deform to an expanded configuration, and the first support portion 42 is pressed against the upper surface of the valve; Push the third operating part 73 forward, so that the second support part 71 is released from the second operating part 41 and the sheath tube 10.
  • the second support part 71 self-expands to the expanded configuration, and pulls the second support part 71 to support At the lower surface of the valve; at this time, the valve is stably clamped between the first support part 42 and the second support part 71; the cutting blade 31 located in the second support part 71 of the cage shape is driven to penetrate Cutting can be performed by passing through the mesh of the expanded second support portion 71 so that the cutting blade 31 reaches a position where the valve can be cut.
  • this device is used to cut human heart valves, even if the systole does not pump blood outwards (that is, the blood flow that does not hit the valve upwards), it can pass through the first support part 42 and the second support part 71. Hold the valve firmly. In this case, the first supporting part 42 can keep the valve stable without pressing down the valve excessively.
  • the proximal end of the second support part 71 may be fixedly connected to the first operating member, and the distal end of the second supporting part 71 may be fixedly connected to the third operating member.
  • the proximal end of the second support part 71 is fixed, and the distal end of the second support part 71 is driven away from the proximal end of the second support part 71 through the third operating member, so that the second support part 71
  • the two supporting parts 71 are axially compressed to present a compressed state.
  • the proximal end of the second support part 71 is fixed, and the distal end of the second support part 71 is driven close to the proximal end of the second support part 71 through the third operating member, so that the second support part 71
  • the two support portions 71 are radially expanded to present an expanded configuration.
  • the third operating member is preferably in the form of a pulling wire. At this time, the third operating member may be accommodated in the first operating member, or arranged in the sheath tube 10 side by side with the first operating member.
  • the aortic valve consists of three leaflets VL. Adhesions exist between adjacent leaflets, and calcifications adhere to each leaflet. Adhesions and calcifications limit the normal opening and closing of the valve leaflet VL.
  • the cutting blade 31 of the valve treatment device cuts the adhesion between the leaflets of the aortic valve, so that the two leaflets are separated, so as to restore the normal opening and closing function of the valve. This can effectively solve the stenosis of the native valve due to adhesion and fibrosis at the junction of the valve, and can also be used to solve the problem of valve leaflet adhesion caused by structural valve degeneration after valve replacement.
  • the cutting blade 31 of the valve treatment device cuts the middle position of the leaflet of the aortic valve, so that the leaflet is divided into two pieces. This can effectively prevent the risk of coronary artery blockage after transcatheter aortic valve replacement, and the procedure is simple to operate.
  • valve treatment device in any of the above-mentioned embodiments can also be used in the case where any suitable valve needs to be cut, for example, the valve treatment device in any of the above-mentioned embodiments can also be used to cut Calcium, etc.
  • the present invention also provides a valve treatment device which further includes a first protection member 50 .
  • the first guards 50 are disposed inside the sheath 10 and are operable to at least partially protrude from the distal end of the sheath 10 .
  • the first guard 50 is disposed in the sheath 10 through the connecting shaft 20 .
  • the first guard 50 is disposed on the distal end of the connecting shaft 20 .
  • the first guard 50 is disposed on an end of the connecting shaft 20 close to the cutting assembly 30 .
  • the first guard 50 is disposed opposite to the first support assembly 40 .
  • the first guard 50 is disposed on the distal side of the first supporting component 40 .
  • the first protection member 50 is used to shield and protect the cutting member, so as to prevent the cutting member from contacting the inner wall of the blood vessel, so as to protect the blood vessel.
  • a movement area for the cutting element to reciprocate is formed between the first guard 50 and the first support assembly 40 , and the first guard 50 shields and protects the destructive part located in the movement area.
  • the first support assembly 40 can also shield and protect the broken portion of the cutting member.
  • the first guard 50 and the first support assembly 40 can shield and protect the damaged part located in the movement area. Therefore, the first protection member 50 and the first support assembly 40 can shield the damaged part before the cutting member cuts the valve.
  • the first guard 50 is used to shield and protect the cutting edge 311 of the cutting blade 31 .
  • the first protection element 50 is used to shield and protect the energy release end of the electroablation element.
  • the first protection part 50 can also shield and protect the cutting part.
  • the first guard 50 not only shields the damaged portion of the cutting element, but also shields and protects other parts of the cutting element, such as the back of the cutting blade 31 and the main structure of the electroablation element. Therefore, the first protection member 50 can also prevent other parts of the cutting member from damaging tissues such as the inner wall of blood vessels.
  • the first guard 50 can transform from the collapsed state to the stretched state, and shield and protect the cutting blade 31 that translates to the position of the valve. After the cutting blade 31 completes the cutting of the valve, the first guard 50 can also shield and protect the cutting blade 31 from the retracted state to the folded state.
  • the cutting edge 311 of the cutting blade 31 is shielded and protected by the first guard 50, so as to avoid contact and cutting between the cutting blade 31 and the inner wall of the blood vessel 90, prevent damage to the inner wall of the blood vessel 90, and enhance Safety of the valve therapy device.
  • the distal end of the first guard 50 is connected to the distal end of the connecting shaft 20 , and the other end (proximal end) of the first guard 50 is located above the cutting blade 31 and extends along the moving track of the cutting blade 31 .
  • the first guard 50 may include an elastic sheet 51 .
  • the distal end of the elastic sheet 51 is connected to the connecting shaft 20 , and the elastic sheet 51 can resist against the cutting blade 31 .
  • the elastic sheet 51 is deformed away from the central axis, and when the cutting blade 31 returns to the collapsed state, the elastic sheet 51 is deformed toward the central axis.
  • the knife back 312 of the cutting blade 31 and the elastic piece 51 are opposed to each other and relatively move, since the surface of the knife back 312 includes a smoothly extending transition surface, the relative movement between the knife back 312 and the elastic piece 51 can be kept smooth , to avoid the relative movement between the cutting blade 31 and the elastic sheet 51 from being stuck during the process of the cutting blade 31 changing its form.
  • the elastic piece 51 includes a plurality of folded arms and a curved portion disposed between the two folded arms.
  • the distal end of the elastic piece 51 is located at the bottom of the elastic piece 51 and is connected with the connecting shaft 20 .
  • the bent portion near the bottom of the elastic piece 51 is bent away from the central axis, so as to increase the angle between the bottom of the elastic piece 51 and the central axis.
  • the bent portion at the free end of the elastic piece 51 is bent toward the central axis, so as to reduce the angle between the free end of the elastic piece and the central axis.
  • the angle between the free end of the elastic sheet 51 and the central axis should be as small as possible to avoid direct contact between the free end of the elastic sheet 51 and the inner wall of the blood vessel, and avoid damage to the inner wall of the blood vessel by the free end of the elastic sheet 51 .
  • the elastic sheet 51 includes 3 folding arms and 2 bending portions.
  • the plurality of folded arms include a first folded arm 511 , a second folded arm 512 and a third folded arm 513 sequentially from the bottom to the top of the elastic piece 51 .
  • the two bending portions include a first bending portion 514 and a second bending portion 515 arranged in sequence from the bottom to the top.
  • the quantity of the folding arms and the bending parts is not limited here. There can also be 4 or 5 folding arms, and 3 or 4 bending parts.
  • the hole structure 52 can enhance the elasticity of the elastic sheet 51 and reduce the hardness of the elastic sheet 51 , so that the cutting blade 31 can easily push away the elastic sheet 51 and make the cutting blade 31 in a stretched state.
  • the first bending portion 514 and the second bending portion 515 are both provided with hole structures 52 .
  • the hole structure 52 at the first bending portion 514 and the hole structure 52 at the second bending portion 515 may also communicate with each other.
  • the hole structure 52 can enhance the elasticity at the bent portion. It can be understood that the hole structure 52 may be a square hole or a linear hole. The specific shape of the hole structure 52 is not limited here. In other embodiments, the hole structure 52 can also be omitted.
  • the opening position of the hole structure 52 is close to the bottom of the elastic sheet 51 to avoid the contact position between the first guard 50 and the cutting blade 31 , and prevent the hole structure 52 from interfering with the sliding of the cutting blade 31 .
  • the free end of the elastic piece 51 is provided with a protective structure 53 , and the surface of the protective structure 53 is a smooth transition. Since the free end of the elastic sheet 51 is provided with a protective structure 53, the protective structure 53 can make the surface of the free end of the elastic sheet 51 smooth, further preventing the free end of the elastic sheet 51 from cutting the inner wall of the blood vessel. It can be understood that the protective structure 53 may be a winding layer structure, a protective sheath or a protective layer.
  • the free end of the elastic piece 51 may also be provided with a winding hole 531 .
  • the winding layer structure is wound in the winding hole 531 .
  • the winding layer structure may be formed by winding wires on the edge of the winding hole 531 .
  • a protective sleeve may also be sleeved on the edge of the wire winding hole 531 .
  • the protective sheath can be a sleeve.
  • the casing protects the edge of the winding hole 531 .
  • wire winding holes 531 there can be one or more wire winding holes 531 , and the shape of the wire winding holes 531 can be square or circular.
  • the shape and number of the winding holes are not limited here, as long as the winding holes 531 can make the free end of the elastic sheet 51 be formed with protective structures such as winding layers and protective sleeves.
  • the edge of the winding hole 531 can also be provided with a protective layer, and the protective layer can be a layer structure attached to the surface of the elastic sheet made of a soft material with good biocompatibility, etc., and the free end of the elastic sheet 51 can also be protected. Protection, to prevent the elastic sheet 51 from touching the inner wall of the blood vessel.
  • the free end of the elastic piece 51 may also be provided with a bent portion 54 . That is, the bent portion 54 is provided at the end of the third folding arm 513 .
  • the bent portion 54 can bend the free end of the elastic piece 51 toward the connecting shaft 20 , and can also prevent the free end of the elastic piece 51 from damaging the inner wall of the blood vessel.
  • the cutting edge 311 of the cutting blade 31 needs to pass through the free end of the elastic sheet 51, so that the cutting blade 31 can cut into the valve 91, thereby Perform cutting operations.
  • the cutting edge 311 of the cutting blade 31 needs to pass through the curved portion 54 and pass through the escape portion 44 . Since the free end of the elastic sheet 51 is provided with a curved portion 54 , in order to avoid interference of the curved portion 54 with the movement of the cutting blade 31 .
  • the curved portion 54 defines a channel 541 for passing the cutting blade 31 .
  • the cutting blade 31 moves to the free end of the elastic sheet 51, and the cutting edge 311 of the cutting blade 31 can pass through the channel 541 smoothly, thereby realizing the cutting operation.
  • the channel 541 can be a slit or a groove, as long as it can pass through the cutting blade 31 .
  • the cross section of the folded arm of the elastic piece 51 may be arc-shaped.
  • the cross section at the junction of the two folding arms is straight.
  • the side of the folding arm facing the cutting blade 31 is an arc-shaped concave surface, and the elastic sheet 51 has a relatively large elastic force, so that the elastic sheet 51 and the cutting blade 31 are held against each other. Even when the cutting blade 31 is in different moving positions, the elastic sheet 51 It also keeps against the cutting blade 31 , and the elastic sheet 51 continuously protects the cutting blade 31 .
  • the elastic sheet 51 is not limited to being folded.
  • the elastic piece 51 in the extending direction of the elastic piece 51 , can also be arc-shaped, or, please refer to FIG. 36 , the elastic piece 51 can also be straight and inclined toward the proximal end.
  • the elastic sheet 51 has high elasticity, so that the cutting blade 31 pushes away the elastic sheet 51 and stretches smoothly.
  • the cross section of the elastic piece 51 may be straight or arc-shaped.
  • the above-mentioned valve treatment device is also provided with a second protective member 60 .
  • the second guard 60 is disposed on the proximal side of the valve, and the second guard 60 is located on the proximal side of the first support portion 42 .
  • the second guard 60 is disposed opposite to the escape portion 44 and covers the escape portion 44 .
  • the cutting edge of the cutting blade passes through the escape portion 44, the cutting edge can abut against the second guard 60, and the second guard 60 is used to shield and protect the cutting member after passing through the valve, so as to prevent the cutting blade 31 from contacting the inner wall of the blood vessel .
  • the first protection member 50 and the second protection member 60 can also protect other tissues, and the specific type of the protection organization is not limited here, that is, the first protection member 50 and the second protection member 60 Tissues other than the valve to be cut can be protected within the scope of the working environment where the valve treatment device is located.
  • the second protection member 60 may be an elastic metal sheet.
  • the second guard 60 is configured such that the second guard 60 adheres to the second surface 422 of the first supporting portion 42 to cover the escape portion 44 when it is not abutted by the cutting blade 31 .
  • the second guard 60 will be pushed away to protrude from the plane where the first supporting portion 42 is located. Therefore, during operation, the second protective member 60 can also play the role of developing. Specifically, with the help of the imager, when it is observed that the cutting blade 31 passes through the avoidance portion 44 to abut against the second guard 60, so that the second guard 60 leaves the first supporting portion 42, it means that the cutting blade 31 has pierced.
  • the cutting blade 31 can be fixed at this time, and then the entire cutting assembly 30 can be pulled proximally to cut the entire valve. This effectively solves the problem that it is inconvenient to observe whether the cutting blade has punctured the valve through an imager because the cutting blade is small.
  • the second guard 60 can also be configured to have a certain gap with the second surface 422 of the first supporting portion 42 when it is not abutted by the cutting blade 31 .
  • the gap can be used for the cutting blade to move, cut through the valve, and abut against the second guard 60 .
  • the position of the second guard 60 corresponds to the avoidance portion 44 so as to protect the tissue from being damaged by the cutting blade 31 passing through the avoidance portion 44 .
  • the first support portion 42 can be formed by cutting the two support arms 43 and the avoidance portion 44, then while the formation of the avoidance portion 44, the second support arm 42 can also be formed at the corresponding position of the avoidance portion 44.
  • Guard 60 the first support portion 42 and the second protection member 60 may also be integrally structured.
  • the shape of the second guard 60 can be adapted to the shape of the escape portion 44 . Therefore, the structure of the second protective member 60 is simple, the manufacturing difficulty is reduced, and the manufacturing is convenient.
  • the connecting shaft 20 , the first protection member 50 , the first support portion 42 and the second protection member 60 are integrally structured.
  • the first guard 50 , the first support portion 42 and the second guard 60 are all formed by cutting the sidewall of the connecting shaft 20 . Reducing the connection process between the first guard 50 , the first support part 42 , the second guard 60 and the connecting shaft 20 greatly reduces the structural complexity of the valve treatment device and improves the operation accuracy.
  • the valve treatment device further includes a connecting rod 81 , a slider 82 and a pulling wire 83 .
  • the first protection member 80 may be straight or arc-shaped in its extending direction.
  • the bottom end of the first protective member 80 is hinged on the connecting shaft 20 .
  • the slider 82 is slidably disposed on the connecting shaft 20 .
  • the traction wire 83 is drivingly connected to the slider 82 , and the two ends of the connecting rod 81 are hinged to the slider 82 and the first protection member 50 respectively.
  • the slider 82 is driven by the pulling wire 83 to slide along the connecting shaft 20 , and the movement of the slider 82 drives the first protection member 80 to approach or move away from the cutting member.
  • the first guard 80 is pushed and pulled by the connecting rod 81 to open and close the first guard 80 .
  • the opening and closing of the first guard 80 correspond to the expanded form and the folded form of the cutting blade 31 respectively.
  • the first guard 80 is driven by the linkage of the pulling wire 83, the slider 82 and the connecting rod 81, it can also be
  • the opening and closing of the cutting blade 31 corresponding to the expansion and folding changes can also make the first guard 80 shield and protect the cutting blade 31 .
  • the above embodiments are just examples of structures.
  • the structures in each embodiment are not combined structures of the valve treatment device.
  • the structures in multiple embodiments can be used in any combination.
  • the cross section of the first guard 50 may also be arc-shaped, which can also increase the elasticity of the first guard 50 .

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Abstract

本发明涉及一种瓣膜治疗装置。所述瓣膜治疗装置包括鞘管，所述鞘管具有一中心轴线；第一支撑组件，所述第一支撑组件包括第一操作件以及与所述第一操作件连接的第一支撑部，所述第一支撑部具有沿径向压缩并收容于所述鞘管内的压缩形态、以及从所述鞘管释放后沿径向扩张的扩张形态，其中处于所述扩张形态的所述第一支撑部具有远离所述鞘管的所述中心轴线延伸的预弯曲弧面，所述第一操作件适于被操作以使所述第一支撑部在所述扩张形态下顺应性贴合于所述瓣膜的表面，其中所述第一支撑部的所述预弯曲弧面朝向所述鞘管的所述中心轴线凸起；以及切割组件，所述切割组件包括第二操作件以及与所述第二操作件连接的切割件，所述第二操作件适于被操作以使切割件破碎所述瓣膜的至少部分。

Description

瓣膜治疗装置 技术领域
本发明涉及医疗器械领域，特别涉及一种瓣膜治疗装置。
背景技术
主动脉瓣位于左心室和主动脉之间，包括三个沿接合缘对合的瓣叶，用于抑制射入主动脉的血流回流入左心室。在一些情况下，主动脉瓣的表面会钙化，导致主动脉瓣变硬而出现一些症状，例如主动脉瓣关不拢或打不开(或打开程度小，即出现狭窄)。此外，主动脉瓣二叶瓣化畸形(BAV,Bicuspid Aortic Valve)(瓣叶处有钙化物，两片瓣叶之间相互粘连)也是导致主动脉瓣狭窄的原因之一。
通过切割瓣膜表面的钙质可以软化瓣膜结构，使瓣叶结构恢复弹性，从而减轻瓣膜狭窄。然而，对于重度主动脉瓣狭窄患者，常需要采用具有创伤小、安全性高、术后恢复快等优点的经导管主动脉瓣置换术进行治疗。然而，经导管主动脉瓣置换术后仍具有潜在的冠状动脉阻塞以及主动脉瓣再狭窄的风险。而对瓣膜进行切割可以预防此风险的发生。
发明内容
本发明的一个目的在于解决现有技术中所存在的不足，而提供一种能够实现瓣膜切割的瓣膜治疗装置。
为解决上述技术问题，本发明采用如下技术方案：
本发明一方面提供一种瓣膜治疗装置，所述瓣膜治疗装置包括鞘管，所述鞘管具有一中心轴线；第一支撑组件，所述第一支撑组件包括第一操作件以及与所述第一操作件连接的第一支撑部，所述第一支撑部具有沿径向压缩并收容于所述鞘管内的压缩形态、以及从所述鞘管释放后沿径向扩张的扩张形态，其中处于所述扩张形态的所述第一支撑部具有远离所述鞘管的所述中心轴线延伸的预弯曲弧面，所述第一操作件适于被操作以使所述第一支撑部在所述扩张形态下顺应性贴合于所述瓣膜的表面，其中所述第一支撑部的所述预弯曲弧面朝向所述鞘管的所述中心轴线凸起；以及切割组件，所述切割组件包括第二操作件以及与所述第二操作件连接的切割件，所述第二操作件适于被操作以使破碎所述瓣膜的至少部分。
本发明另一方面提供一种瓣膜治疗装置，所述瓣膜治疗装置包括：
鞘管，所述鞘管具有一中心轴线；
连接轴，可滑动收容于所述鞘管内；
支撑组件，设于所述连接轴上，且位于瓣膜的近端侧，所述支撑组件用于支撑所述瓣膜；
切割组件，包括连接于所述连接轴的切割件，所述切割件用于破碎所述瓣膜的至少部分；及
第一防护件，设于所述连接轴靠近所述切割组件的一端，所述第一防护件与所述支撑组件相对设置，所述第一防护件设于所述支撑组件远端侧，所述第一防护件用于对所述切割件进行遮挡保护。
由上述技术方案可知，本发明至少具有如下优点和积极效果：
本发明的瓣膜治疗装置在切割瓣膜时，可通过推动第一操作件从而使收容在鞘管内的第一支撑部从鞘管初步释放进而初步贴合瓣膜，然后进一步推动第一操作件使得第一支撑部进一步扩张至其完全扩张形态，并顺应性地贴合瓣膜并下压瓣膜，再操作第二操作件使得切割件对瓣膜进行切割即可。特别地，由于第一支撑部具有预弯曲弧面，因此，当第一支撑部从鞘管内释放后即不受外部压力挤压，第一支撑部将自动恢复至其预弯曲弧面，同时，第一操作件沿血管的轴向向近端施加推力，以使得第一支撑部沿预弯曲弧面进一步弯曲，从而顺应瓣膜并压合瓣膜。切割过程中，在血流的向上的冲击作用以及第一支撑部的下压作用下，瓣膜被稳定夹持，而不容易在血流冲击作用下浮动或者游离，使得切割件可以更稳定和精确地切割瓣膜。此外，也无需在瓣膜的两侧均设置支撑部以夹持瓣膜，结构简单紧凑，降低了对瓣膜的损伤风险。
本发明的瓣膜治疗装置在切割瓣膜时，医生经血管将瓣膜治疗装置推动至待切割瓣膜位置处。通过支撑组件于瓣膜的一侧支撑定位瓣膜。再操作切割组件，使得切割件朝向瓣膜移动。第一防护件相对于支撑组件设于瓣膜的另一侧，因此，在切割件朝向瓣膜移动的过程中，第一防护件能够对切割件进行遮挡保护，以防止切割件在切割瓣膜之前接触血管内壁，造成血管内壁的划伤，提高了上述瓣膜治疗装置的安全性。
附图说明
图1是本发明一实施方式的瓣膜治疗装置与瓣膜之间的位置关系图；
图2是本发明第一实施例的瓣膜治疗装置的立体图；
图3是图2所示瓣膜治疗装置的爆炸图；
图4是图2所示瓣膜治疗装置的第一支撑部的立体图；
图5是图4所示第一支撑部的侧视图；
图6是图4所示第一支撑部的仰视图；
图7是切割刀片贯穿图4所示第一支撑部的避让部的示意图；
图8是切割刀片伸入图4所示第一支撑部的避让部内的示意图；
图9是图4所示第一支撑部的一替换实施例；
图10是图4所示瓣膜治疗装置的切割组件的分解图；
图11是图4所示瓣膜治疗装置的切割组件的剖视图；
图12是图10所示切割组件的另一替换实施例的立体图；
图13是图12所示切割组件的分解图；
图14是图10所示切割组件的又一替换实施例的立体图；
图15是图14所示切割组件的剖视图；
图16示出了图15所示切割组件的切割刀片处于其中一极限位置；
图17示出了图15所示切割组件的切割刀片处于另一极限位置；
图18是本发明第二实施例的瓣膜治疗装置的立体图；
图19示出了图18所示瓣膜治疗装置的第二支撑部的压缩形态；
图20是图1所示的瓣膜治疗装置的立体图；
图21是图20所示的瓣膜治疗装置的另一角度的立体图；
图22是图20所示的瓣膜治疗装置的主视图；
图23是图22所示的瓣膜治疗装置的切割刀片对瓣膜进行切割时的示意图；
图24是图22所示的瓣膜治疗装置的切割刀片处于收折状态的结构示意图；
图25是图20所示的瓣膜治疗装置的第一防护件的结构示意图；
图26是图25所示的第一防护件开设有孔结构的结构示意图；
图27是图26所示的第一防护件的另一实施方式的结构示意图；
图28是图26所示的第一防护件开设有绕线孔的结构示意图；
图29是图28所示的第一防护件设有保护结构的结构示意图；
图30是图29所示的第一防护件的另一实施方式的结构示意图；
图31是图26所示的第一防护件设有回弯部的结构示意图；
图32是图26所示的第一防护件的侧视图；
图33是图32中第一防护件沿A-A的剖视图；
图34是图32中第一防护件沿B-B的剖视图；
图35是图22所示的第一防护件的另一实施方式的结构示意图；
图36是图22所示的第一防护件的另一实施方式的结构示意图；
图37是图25所示的第一防护件的另一实施方式的结构示意图。
附图标记说明如下：
10、鞘管；11、锥形尖端；
20、连接轴；22、窗口；24、导管；25、驱动轴；；
30、切割组件；31、31a、31b、切割刀片；311、刀刃；312、刀背；32、32a、32b、输送件；320、320a、320b、第一开口；321、321a、321b、滑槽；322、孔；33、33a、33b、调节件；330、330a、收容腔；331a、331b、凸柱；332a、第二滑槽；34、34a、34b、34b支撑件；340b、U形开口；341a、341b、凸柱；342a、凹槽；35、第一操作件；310a、转轴；
40、支撑组件；41、第二操作件；42、支撑部；42a、第一区段；42b、第二区段；42c、自由端；42e、初始段；421、第一表面；422、第二表面；424、支撑筋；425、网格；426、连接端；43、支撑臂；430、抵持部；431、透气孔；44、44a、避让部；45、镂空孔；
50、80、第一防护件；51、弹性片；511、第一折臂；512、第二折臂；513、第三折臂；514、第一弯折部；515、第二弯折部；52、孔结构；53、保护结构；531、绕线孔；54、回弯部；541、通道；
60、第二防护件；
70、第二支撑组件；71、第二支撑部；73、第三操作件；
81、连杆；82、滑块；83、牵引丝；
90、血管；91、瓣膜；911、第一表面；912、第二表面。
具体实施方式
体现本发明特征与优点的典型实施方式将在以下的说明中详细叙述。应理解的是本发明能够在不 同的实施方式上具有各种的变化，其皆不脱离本发明的范围，且其中的说明及图示在本质上是当作说明之用，而非用以限制本发明。
在本申请的描述中，需要理解的是，在附图所示的实施例中，方向或位置关系的指示(诸如上、下、左、右、前和后等)仅是为了便于描述本申请和简化描述，而不是指示或暗示所指的装置或元件必须具有特定的方位、以特定的方位构造和操作。当这些元件处于附图所示的位置时，这些说明是合适的。如果这些元件的位置的说明发生改变时，则这些方向的指示也相应地改变。
此外，术语“第一”、“第二”仅用于描述目的，而不能理解为指示或暗示相对重要性或者隐含指明所指示的技术特征的数量。由此，限定有“第一”、“第二”的特征可以明示或者隐含地包括一个或者更多个所述特征。在本申请的描述中，“多个”的含义是两个或两个以上，除非另有明确具体的限定。
以下结合本说明书的附图，对本公开的较佳实施方式予以进一步地详尽阐述。
事先需要说明的是，本文的远端指装置的远离操作者的一端，近端指装置的靠近操作者的一端。
本实施方式中的瓣膜治疗装置可以用于对瓣膜进行切割等操作。特别地，本实施方式的瓣膜治疗装置尤其适合于切割主动脉瓣膜。需要说明的是，本申请提供的瓣膜治疗装置不限于对瓣膜进行切割，还可以用于对其他病灶进行切割操作。
请参阅图1，当将本实施方式的瓣膜治疗装置用于切割人体心脏主动脉瓣时，可以在股动脉处切一个切口，将瓣膜治疗装置可以从该切口插入血管90，并沿血管90经主动脉弓、升主动脉，到达主动脉瓣91处。此时，瓣膜91与血管壁围合形成窦腔，瓣膜91的第一表面911作为该窦腔的窦腔壁，瓣膜91的第二表面912与心脏的血流相对。
本实施方式的瓣膜治疗装置包括中心轴线重合的鞘管10、连接轴20、切割组件30、第一支撑组件40。连接轴20、切割组件30、第一支撑组件40均设于鞘管10内，且可以被操作以从鞘管10的远端至少部分的伸出。鞘管10从切口进入血管90内，连接轴20、切割组件30、第一支撑组件40被鞘管10包裹并随着鞘管10一同进入血管90，并沿血管90输送至待切割瓣膜位置处。
该瓣膜治疗装置的最远端还设有锥形尖端11，锥形尖端11可以引导整个瓣膜治疗装置穿过血管90，防止装置的前端损伤血管90内的组织。锥形尖端11可以固定设于连接轴20的前端。锥形尖端11通常情况下不进入鞘管10内。
鞘管10从瓣膜治疗装置的远端向近端延伸。鞘管10可以由海波管和/或高分子材料制成。鞘管10具有一中心轴线，可以理解的是，中心轴线沿着鞘管10的长度方向延伸，且中心轴线穿设于鞘管10的管腔。该中心轴线与瓣膜治疗装置的中心轴线相互重合。
连接轴20可滑动收容于鞘管10内。可以理解的是，连接轴20可以为内部实心的圆柱体，也可以是内部空心的圆柱体，也可以是由圆柱体被部分的切割形成，也可以由片状结构弯曲形成等。连接轴20能够被操作以沿鞘管10的轴向或者沿鞘管10的长度方向滑动。切割组件30、第一支撑组件400通过连接轴20设于鞘管10内。
具体地，连接轴20可以为中空管状结构。第一支撑组件40、第一防护件50形成于连接轴20上。切割组件30收容于连接轴20内。连接轴20的侧壁上开设有用于供切割件伸出的窗口22。且，第一支撑组件40设于连接轴20的近端。
请参阅图2及图3，切割组件30用于对瓣膜进行切割操作。切割组件30收容于连接轴20上，且在使用的状态下，切割组件30位于瓣膜91的远端侧。切割组件30包括第一操作件35及切割件。第一操作件35适于被操作使切割件在连接轴20的近端和远端之间往复运动。第一操作件35可以传导推力和拉力，使切割件移动。第一操作件35可以为牵引导丝。在切割件切割操作的时候，切割件朝向瓣膜移动并由瓣膜的远端侧移动至瓣膜的近端侧。
切割件包括用于破坏瓣膜91的破坏部。破坏部可以破碎瓣膜91的至少部分。切割件可以将瓣膜91沿血管径向进行分割，也可以对瓣膜91上的部分钙化部分进行破坏。此处对切割件对瓣膜91的具体操作内容不做限定。
请参阅图4，切割件可以为切割刀片31。切割刀片31可以包括刀刃311和刀背312。刀刃311朝向连接轴20方向。刀背312背向连接轴20。刀刃311用于切割瓣膜。该切割刀片31的破坏部为刀刃311。刀背312的表面包括平滑延伸的过渡面。
优选地，切割刀片31还与高频消融仪电连接，其中切割刀片31除了其切割尖端或切割尖端的一部分之外的其余部分均绝缘(可采用表面覆膜或喷涂等方式)，以保证能量集中,。如此，切割刀片31同时结合了机械切割和电切割，切割效果更佳。切割时，可以固定切割刀片31，向近端提拉整个切割组件30，从而切割瓣膜。或者，也可以使切割刀片31独立地沿圆弧路径运动，从而切割瓣膜。
在其他实施方式中，切割组件30还可以被配置为通过非接触式对瓣膜的至少部分进行破碎。该切割件可以不是锋利的刀片，而是通过可以导电的材料制成的结构。切割件也可以为与消融电源电连接 的电消融元件。则该切割件的破坏部为电消融元件的能量释放端。电消融元件例如可以是高频消融仪，切割件接收电消融元件传递的能量，通过非接触式破碎瓣膜的至少部分。破碎瓣膜的至少部分可以是沿厚度方向穿透瓣膜，也可以是破碎瓣膜表面的钙化物但是并不破碎瓣膜。
请参阅图4及图5，切割组件30还包括输送件32、与输送件32滑动连接的调节件33、与调节件33铰接的支撑件34。切割刀片31与支撑件34和输送件32铰接连接，且切割刀片31配置为经由支撑件34、被调节件33沿输送件32的直线运动驱动转动。
具体地，请参阅图6，本实施方式中，输送件32呈管状，其上设有一沿轴向延伸并贯穿其一侧壁的第一开口320。调节件33收容于输送件32内。本实施方式中，调节件33呈纵长杆状，且其内设有收容腔330。优选地，收容腔330沿轴向延伸并沿径向贯穿调节件33。支撑件34和切割刀片31可移动至收容在调节件33的收容腔330内，因此也收容在输送件32内，并可经由收容腔330和第一开口320从调节件33和输送件32伸出，以便切割刀片31进行切割。
更具体地，输送件32的侧壁上设有长条形的滑槽321，优选具有两组沿轴向间隔布置的滑槽321。相应地，调节件33上设有两个凸柱，分别为凸柱331a和凸柱331b。凸柱331a和凸柱331b可滑动地接合于相应的两滑槽321，以使得调节件33可滑动地接收在输送件34内。特别地，滑槽321还可对凸柱331a和凸柱331b进行限位，进而限制调节件33的滑动位移，以防止运动过程中出现死点。
优选地，支撑件34构造成一具有U形开口340的U形件，且其封闭端通过其中一凸柱331a与调节件33铰接。需要说明的是，U形开口340是为了使切割刀片31更容易的安装于支撑件34，且切割刀片31可以绕支撑件34转动，在其它实施方式中，也可以通过其它特征代替U形开口340，或者直接使切割刀片31铰接于支撑件34而不在支撑件34上设置U形开口340。继续参阅图6，在优选实施方式中，支撑件34的开口端与切割刀片31的大致中部的部位铰接。切割刀片31的远离其切割尖端的一端通过转轴310与输送件32铰接，其中转轴310插入至输送件32上的相对的两孔322。切割刀片31的分别与支撑件34和输送件32铰接的两个铰接点分别位于调节件33的径向两侧，即位于凸柱331a和凸柱331b中轴线所在平面的两侧，换言之，切割刀片31上的两个铰接点与凸柱331a和凸柱331b不在同一平面，这可有效避免运动过程中出现死点。
当需要切割刀片31转动时，通过第一操作件35驱动调节件33沿输送件32滑动，调节件33驱动支撑件34摆动，支撑件34再驱动切割刀片31以转轴310为圆心转动，且由于U形开口340和收容腔330的设计保证了切割刀片31可在一定范围内转动。更具体地，当拉动第一操作件35时，切割刀片31可沿如图6所示的顺时针方向转动至使其切割尖端收容在收容腔330内，以减小切割组件30整体的径向尺寸，方便输送；此时，为防止出现死点，还可利用相应的一凸柱331b抵顶切割刀片31的切割尖端，从而形成限位配合结构。当推动第一操作件35时，切割刀片31可沿图示的逆时针方向转动至使其切割尖端从收容腔330伸出以进行切割；类似地，为防止出现死点，可利用支撑件34的封闭端抵顶切割刀片31的切割尖端。
可以理解地，在其他实施方式中，切割刀片31也可以采用其他结构驱动。
因此，切割刀片31的运动状态可以包括4种形态，即：撑开形态，切割刀片31首先由收容于输送件32内，经调节件33带动支撑件34使切割刀片31从输送件32内撑开。切割形态，切割刀片31的刀刃311对准待切割瓣膜，拉动操作件35，使切割刀片31由远端朝向近端平移，从而完成对瓣膜91的切割动作。退回形态，当完成切割动作后，切割刀片31由近端向远端退回。收折形态，当切割刀片31退回到位后，继续推动操作件35，可以使切割刀片31收折于输送件32内，以便于输送。
再次参考图3，本实施方式中，瓣膜治疗装置还包括与输送件32的两端固定连接的导管24以及驱动轴25。贯穿整个装置，用于穿设导丝，该导丝用于在血管内建立通道以引导整个装置沿着导丝进入血管内。驱动轴25可用于连接另一导丝，从而使得切割组件30能够整体移入或移出鞘管10。换言之，本实施方式中，切割组件30和第一支撑组件10是分别独立驱动的。可以理解地，在其他实施方式中，切割组件30和第一支撑组件10也可以固定连接，如此，只要通过驱动轴25即可驱动切割组件30和第一支撑组件10整体移入或移出鞘管10。本实施方式中，切割组件30的远端还优选连接一如图18所示的锥形尖端11，以引导整个装置穿过血管，防止装置的前端损伤血管内的组织。
可以理解地，在其他实施方式中，切割刀片31也可以采用其他结构驱动。
请参阅图6及图7，在一替代实施方式中，切割组件30a包括输送件32a、与输送件32a滑动连接的调节件33a、与调节件33a铰接的支撑件34a、以及与支撑件34a和输送件32a铰接的切割刀片31a，且切割刀片31a配置为经由支撑件34a、被调节件33a沿输送件32a的直线运动驱动转动。
具体地，输送件32a呈管状，其上设有一沿轴向延伸并贯穿其一侧壁的第一开口320a、以及径向相对的两个沿轴向延伸的长条状的第一滑槽321a。调节件33a大致呈管状，并收容于输送件32a内，其上设有一沿轴向延伸并贯穿其一侧壁的收容腔330a、以及径向相对的两个沿轴向延伸的长条状的第 二滑槽332a，其中收容腔330a朝向第一开口320a。可以理解地，在其他实施方式中，调节件也可以采用其他形状和/或构造。支撑件34a构造成一具有U形开口340a的U形件。支撑件34a的封闭端连接一凸柱341a，凸柱341a贯穿调节件33a并与之转动连接，且凸柱341a可滑动地接合至第一滑槽321a内。支撑件34a的开口端与切割刀片31a的大致中部的部位铰接。切割刀片31a的远离其切割尖端的一端通过转轴310a与输送件32a铰接，其中支撑件34a的大致中部位置设有自其一侧凹陷的凹槽342a，转轴310a贯穿切割刀片31a的远离其切割尖端的一端，并依次穿过支撑件34a的凹槽342a、调节件33a的第二滑槽332a至与输送件32a转动连接，其中转轴310a与第二滑槽332a滑动连接。
当调节件33a被第一操作件35驱动以在输送件32a内滑动时，凸柱341a跟随调节件33a一起在第一滑槽321a内滑动，从而带动支撑件34a摆动，支撑件34a再驱动切割刀片31a以转轴310a为圆心进行转动。更具体地，当第一操作件35推动调节件33a向前(远端)滑动时，凸柱341a在第一滑槽321a内从右向左(图7所示)滑动，且第二滑槽332a相对转轴310a向前滑动，支撑件34a摆动以使得转轴310a从凹槽342a脱离，切割刀片31a可转动至使其切割尖端从收容腔330a伸出以进行切割；当第一操作件35拉动调节件33a向后滑动时，凸柱341a在第一滑槽321a内从左向右滑动，且第二滑槽332a相对转轴310a向后滑动，支撑件34a摆动以使得凹槽342a再次与转轴310a接合，切割刀片31a可转动至使其切割尖端收容在收容腔330a内。
又或者，如图8和图9所示，在另一替代实施方式中，切割组件30b包括输送件32b、与输送件32b滑动连接的调节件33b、与调节件33b铰接的支撑件34b、以及与支撑件34b和输送件32b铰接的切割刀片31b，且切割刀片31b配置为经由支撑件34b、被调节件33b沿输送件32b的直线运动驱动转动。
具体地，输送件32b呈管状，其上设有一沿轴向延伸并贯穿其一侧壁的第一开口320b、以及径向相对的两个沿轴向延伸的长条状的第一滑槽321b。调节件33b的截面大致呈长度较短的T字形构造，并可滑动地收容于输送件32b内。支撑件34b构造成一具有U形开口340b的U形件。支撑件34b的封闭端连接一凸柱341b，凸柱341b贯穿调节件33b并与之转动连接，且凸柱341b可滑动地接合至第一滑槽321b内。支撑件34b的开口端与切割刀片31b的大致中部的部位铰接。切割刀片31b的远离其切割尖端的一端通过转轴310b与输送件32b铰接。
当调节件33b被第二操作件(例如一导丝)驱动以在输送件32b内滑动时，凸柱341b在第一滑槽321b内滑动，从而带动支撑件34b摆动，支撑件34b再驱动切割刀片31b以转轴310b为圆心进行转动。图10示出了通过推动调节件33b使得切割刀片31b逆时针转动至使其切割尖端收容在U形开口340b内的一极限位置，图11示出了通过拉动调节件33b使得切割刀片31b顺时针转动至使其切割尖端远离U形开口340b的另一极限位置。
请再次参阅图2及图3，第一支撑组件40位于瓣膜91的近端侧。第一支撑组件40用于对瓣膜91的近端侧支撑。第一支撑组件40包括第二操作件41以及与第二操作件41连接的第一支撑部42。可选地，第一支撑部42通过连接端426与第二操作件41连接。可以理解地，在其他实施例中，也可以设置多个沿连接端426的周向分布的第一支撑部42。第二操作件41可以为收容于鞘管10内的管状结构。第一支撑部42的一端固定连接于连接轴20的近端，且第一支撑部42设于瓣膜的近端侧，从而使第一支撑部42能够随连接轴20同步的相对于鞘管10滑动。第一支撑部42具有沿径向压缩并收容于鞘管10内的、在鞘管10的内壁挤压下形成的压缩形态、以及如图1所示的从鞘管10释放后、沿径向扩张的自变形成的扩张形态。
第二操作件41适于被操作使第一支撑部42处于压缩形态或扩张形态。第一支撑部42可通过向后拉动第二操作件41或向前推动鞘管10而收容至鞘管10内而转变成压缩形态。第一支撑部42可通过向前推动第二操作件41或向后拉动鞘管10而从鞘管10释放而转变成扩张形态。也就是说，第一支撑部42为弹性材料制成，第一支撑部42可以以图3所示的状态自然伸展形成扩张形态，第一支撑部42也可以被弹性压缩于鞘管10内。当第一支撑部42从鞘管10内伸出后，不需要外力就可以靠自身的弹性恢复力而恢复成图3所示的扩张形态。
具体在本实施方式中，第二操作件41可以为连接轴20的近端部分。则切割组件30和第一支撑组件40是分别独立驱动操控的。可以理解地，在其他实施方式中，切割组件30的第一操作件35和第一支撑组件40的第二操作件41也可以驱动连接，如此，只要通过第一操作件35或第二操作件41，即可驱动切割组件30和第一支撑组件40整体移入或移出鞘管10。
本实施方式中，第二操作件41优选为包括可滑动地收容于鞘管10内的导管或牵引丝，其近端连接手柄(图未示出)。通过手柄驱动第二操作件41在鞘管10内滑动，从而使得第一支撑部42可以移动至鞘管10内或从鞘管10内移出。本实施方式中，第二操作件41包括导管。第二操作件41通过连 接端426与第一区段41a的起始端固定连接。
连接轴20套设在第二操作件41上并优选与第二操作件41固定连接。如此，当第二操作件41驱动第一支撑部42进入或者移出鞘管10时，第二防护件60也可以跟随第一支撑部42一起进入或者移出鞘管10，操作方便。当然，在其他实施例中，连接轴20和第二操作件41也可以被独立驱动，进而独立驱动第二防护件60和第一支撑部42。
第一支撑部42具有沿径向压缩并收容于鞘管10内的、在鞘管10的内壁挤压下形成的压缩形态、以及如图2所示的从鞘管10释放后、沿径向扩张的自变形形成的扩张形态。优选地，第一支撑部42为弹性件，弹性件被配置为在撤销外界压力时能够从压缩形态弹性弯曲变形至扩张形态。第一支撑部42可通过向后拉动第二操作件41或向前推动鞘管10而收容至鞘管10内而转变成压缩形态。第一支撑部42可通过向前推动第二操作件41或向后拉动鞘管10而从鞘管10释放而转变成扩张形态。
在第一支撑部21的扩张形态中，第一支撑部42具有从连接端426朝向远离鞘管10的中心轴线L的方向向外延伸至一自由端42c的预弯曲弧面，其中预弯曲弧面朝向鞘管10的中心轴线凸起，换言之，预弯曲弧面围合形成的凹槽背离鞘管10的中心轴线。
具体在本实施方式中，第一支撑部42用于对瓣膜91的第一表面911进行支撑。第一支撑部42可以为弹性件。具体地，第一支撑部42可以为金属片。第一支撑部42的底部与连接轴20连接。第一支撑部42被配置为在撤销外界压力时能够从压缩形态弹性弯曲变形至扩张形态。第一支撑部42可通过向后拉动第二操作件41或向前推动鞘管10而收容至鞘管10内而转变成压缩形态。第一支撑部42可通过向前推动第二操作件41或向后拉动鞘管10而从鞘管10释放而转变成扩张形态。在第一支撑部42的扩张形态中，第一支撑部42的顶部沿径向扩张。
参考图1，需要切割瓣膜时，将瓣膜治疗装置的鞘管10输送至待切割的瓣膜91位置处；通过向近端后撤鞘管10或者向远端前推第一支撑组件40，使得收容在鞘管10内的第一支撑部42从鞘管10内释放以从压缩形态转变为扩张形态；将处于扩张形态的第一支撑部42顺应性地压在瓣膜91的第一表面911上。在瓣膜91的与第一表面911相对的第二表面912处释放切割组件30的切割刀片31，使得瓣膜91的待切割部分位于第一支撑部42和切割刀片31之间；最后再驱动切割刀片31以切割瓣膜91即可。切割过程中，由于第一支撑部42支撑在瓣膜91的第一表面911上，因此，切割刀片31可以稳定和精准地切割瓣膜91，且通过第一支撑部42支撑瓣膜91，结构精简。特别地，本实施例的瓣膜治疗装置尤其适合于切割主动脉瓣膜。
参考图2及图3，并且，第一支撑部42具有预弯曲弧面。因此，当第一支撑部42从鞘管10内释放后即不受外部压力挤压，第一支撑部42将自动恢复至其预弯曲弧面，同时，第二操作件41沿血管的轴向向近端施加推力，以使得第一支撑部42沿预弯曲弧面进一步弯曲，从而顺应瓣膜并压合瓣膜。因此，在血流的冲击作用、以及第一支撑部42的压合作用下，待切割的瓣膜91的瓣叶被稳定夹持，而不容易在血流冲击作用下浮动或者游离，使得切割刀片31可以更稳定和精准地切割瓣膜91。此外，也无需在瓣膜91的两侧均设置支撑部以夹持瓣膜91，结构简单，降低了对瓣膜91的损伤风险。
请参阅图12及图13，优选地，在第一支撑部42的扩张形态中，第一支撑部42包括远离鞘管10的中心轴线L的方向向外并朝向远端延伸的弧形的第一区段42a、以及自第一区段42a进一步地向近端向内弯曲延伸至自由端42c的第二区段42b，其中第一区段42a和第二区段42b的连接部形成用于与瓣叶VL抵顶的抵持部430。这种第一支撑部42可以更顺应地贴合在瓣膜的窦腔壁上，从而更稳定地支撑和定位瓣膜。进一步地，通过第一支撑部42的弧形的抵持部430抵顶在瓣膜的窦腔壁上，可有效地防止第一支撑部42对瓣膜造成损伤，且定位效果佳。
优选地，第一支撑部42的第二区段42b先自抵持部430朝向近端并远离鞘管10的中心轴线L的方向弯曲延伸，再进一步地朝向近端并朝向鞘管10的中心轴线L的方向弯曲延伸至自由端42c，这有助于防止自由端42c刮伤血管。第二区段42b的弯曲半径R优选在1～3mm的范围内，更优选1～2mm，最优选1.5mm，这有助于第一支撑部42更稳定地抵靠在瓣膜的窦腔壁上。自由端42c的切线与鞘管10的中心轴线L之间的夹角α优选在10～60°的范围内，更优选20～30°，最优选26°，这有助于更有效地防止自由端42c刮伤血管。还优选地，自由端42c的切线与第一区段42a的初始段42e的切线大致平行。换言之，第一区段42a的初始段42e的切线与鞘管10的中心轴线L之间的夹角，也即第一区段42a的初始段42e偏离鞘管10的中心轴线L的角度，也优选在10～60°的范围内，更优选20～30°，最优选26°，这有助于第一支撑部42更好地贴合在窦腔壁上。
请参阅图13及图14，在垂直于鞘管10的中心轴线L的平面内，第一支撑部42周向两侧对应的最大圆心角(即，第一支撑部42的周向两侧分别与鞘管10的中心轴线L的连线之间的最大夹角)β在5～180°的范围内，优选在10～90°的范围内，较佳地在10～60°的范围内，更优选在30～40°的范围内，最优选33°。与在周向上360度延伸的支撑部相比，本实施方式的第一支撑部42结构更紧凑。 优选地，自由端42c具有最大圆心角β，这有助于第一支撑部42的自由端42c更稳定地贴合在窦腔壁。第一支撑部42沿周向的最大宽度W优选在2～20mm的范围内，最优选在5～10mm的范围内。优选地，自由端42c具有最大宽度W。实践中，人体心脏瓣膜的窦腔顶部的敞口较大，底部较窄。第一支撑部42沿周向的宽度如果太大，则不容易插入窦腔底部；而第一支撑部42的沿周向的宽度如果太小，又不容易对准和定位瓣膜。本实施方式的第一支撑部42不仅能够方便地插入窦腔底部，而且容易对准和定位瓣膜，以对瓣膜的中部进行切割。
再次参阅图12，如前，优选地，第一支撑部42由能够产生弹性弯曲变形材料制成，以便第一支撑部42可容易地收容至鞘管10，同时稳定地支撑瓣膜。更优选第一支撑部42由形状记忆材料制成，例如由镍钛合金制成。由此，当处于压缩形态的第一支撑部42从鞘管10释放时，第一支撑部42可自膨胀至其扩张形态。本实施方式中，第一支撑部42由金属片切割并弯曲而成，包括多个支撑筋424。多个支撑筋424围合形成一个或多个网格425。
在其他实施方式中，第一支撑部42也可以由金属丝采用其他方式。例如，第一支撑部42也可以为单根金属丝结构。或者，第一支撑部42也可以由多根金属丝捻绕而成。或者，第一支撑部42也可以由多根金属丝编织形成。
并且，请参阅图12，第一支撑部42设有至少一避让部44。避让部44用于避让切割刀片31。
请参阅图15及图16，第一支撑部42的厚度方向上的两侧具有第一表面421和第二表面422。避让部44贯穿第一支撑部42的第一表面421和第二表面422。避让部44位于第一支撑部42大致中部位置，以便切割刀片31可以对准瓣膜91的中部进行切割。切割刀片31可以穿过避让部44至突出于第一支撑部42的第二表面422进行切割。可以理解地，在其他实施方式中，如图17所示，切割刀片31也可以不贯穿避让部44，而仅伸入至避让部44内进行切割。
在本实施方式中，避让部44可以由其中一网格425形成。还可以理解地，在其他实施方式中，避让部也可以采用其他形态。如图9所示，避让部44a自第一支撑部42的第一表面421朝向第一支撑部42的第二表面422凹陷，而不贯穿第一支撑部42的第二表面422。切割时，切割刀片31伸入避让部44a内，并被第一支撑部42的由实体材料制成的支撑筋所阻挡。
在其他实施方式中，请参阅图20，第一支撑部42的中部形成有该避让部44。避让部44可以是过孔，也可以是由第一支撑部42的顶部向下凹陷形成的凹槽(图未示)。并且该凹槽可以于第一支撑部42的顶部开放。当切割刀片31经过凹槽的时候，避免第一支撑部42的顶端与切割刀片31发生干涉。
请参阅图20，避让部44的两侧开设有镂空孔45。镂空孔45可以增强第一支撑部42的弹性。
第一支撑部42的顶部包括两相对设置的支撑臂43。支撑臂43包括远离鞘管10的中心轴线L的方向向外并朝向远端延伸的弧形的抵持部430。抵持部430用于与瓣膜91抵顶。支撑臂43可以更顺应地贴合在瓣膜91的窦腔壁上，从而更稳定地支撑和定位瓣膜91。进一步地，通过支撑臂43的抵持部430抵顶在瓣膜91的窦腔壁上，可有效地防止支撑臂43对瓣膜造成损伤，且定位效果佳。
并且，抵持部430还开设有透气孔431，以避免抵持部430与瓣膜91相互贴合支撑的时候，抵持部430与瓣膜91之间形成粘连。
参考图18及图19，本实施方式的瓣膜治疗装置200还包括第二支撑组件70，其中切割组件30位于第二支撑组件70内。
具体地，本实施方式的第一支撑部42可以采用前面实施方式的第一支撑部42，在此不再赘述。第二支撑组件70包括位于其远端的第二支撑部71、以及与第二支撑部71固定连接的第三操作件73，具体地，第二支撑部71的近端与第三操作件73连接，第二支撑部71的远端自由活动。第二支撑部71具有如图19所示的沿径向压缩并收容在鞘管10内的压缩形态、以及如图18所示的从鞘管10释放并沿径向扩张的大致呈球笼形的、网状的扩张形态，扩张时第二支撑部71的远端靠近近端移动，且在第一支撑部42的扩张形态和第二支撑部71的扩张形态中，第一支撑部42位于第二支撑部71的近端。第二支撑部71可以由镍钛合金、不锈钢或其他合适的材料制成。第三操作件73可以包括可滑动地收容于鞘管10内的导管或牵引丝。进一步地，本实施方式中，第三操作件73可滑动地收容于构造为导管的第二操作件41内。当第三操作件73拉动第二支撑部71至接收在第二操作件41内时，第二支撑部71在第二操作件41的束缚下呈现如图19所示的压缩形态。而当第三操作件73推动第二支撑部71使其从第二操作件41和鞘管10释放时，第二支撑部71自膨胀至如图18所示的扩张形态。
当切割瓣膜时，可以先通过第三操作件73向前推送第二支撑部71使其从第二操作件41和鞘管10释放，此时第二支撑部71自膨胀至其扩张形态，然后缓慢地回撤整个装置使得第二支撑部71轻轻地支撑在瓣膜的下表面；再向前推送第二操作件41使得第一支撑部42从鞘管10释放而自变形至扩张形态，并将第一支撑部42压合在瓣膜的上表面，此时，瓣膜即被稳定地夹持在第一支撑部42和第二 支撑部71之间；再驱动位于球笼状的第二支撑部71内的切割刀片31以穿过处于扩张形态的第二支撑部71的网孔，使得切割刀片31到达能够切割瓣膜的位置，即可进行切割。当这种装置用于切割人体心脏瓣膜时，即使遇到心脏收缩部没有向外泵血(即没有向上冲击瓣膜的血流)的情况，也可以通过第一支撑部42和第二支撑部71稳定夹持瓣膜。在此情况下，第一支撑部42可以不需要过度地向下挤压瓣膜也可以保持瓣膜稳定。
或者，也可以先向前推送第二操作件41，使得第一支撑部42从鞘管10释放而自变形至扩张形态，并将第一支撑部42压合在瓣膜的上表面；然后再向前推送第三操作件73，使得第二支撑部71从第二操作件41和鞘管10释放，此时第二支撑部71自膨胀至扩张形态，并将第二支撑部71提拉至支撑在瓣膜的下表面；此时，瓣膜即被稳定地夹持在第一支撑部42和第二支撑部71之间；再驱动位于球笼状的第二支撑部71内的切割刀片31以穿过处于扩张形态的第二支撑部71的网孔，使得切割刀片31到达能够切割瓣膜的位置，即可进行切割。当这种装置用于切割人体心脏瓣膜时，即使遇到心脏收缩部没有向外泵血(即没有向上冲击瓣膜的血流)的情况，也可以通过第一支撑部42和第二支撑部71稳定夹持瓣膜。在此情况下，第一支撑部42可以不需要过度地向下挤压瓣膜也可以保持瓣膜稳定。
可以理解地，在其他实施方式中，也可以采用其他方式驱动第二支撑部71以在其压缩形态和扩张形态之间转变。例如，可以将第二支撑部71的近端与第一操作件固定连接，将第二支撑部71的远端与第三操作件固定连接。当需要使得第二支撑部71呈现压缩形态时，固定第二支撑部71的近端，通过第三操作件驱动第二支撑部71的远端远离第二支撑部71的近端，从而使第二支撑部71轴向压缩而呈现压缩形态。当需要使第二支撑部71呈现扩张形态时，固定第二支撑部71的近端，通过第三操作件驱动第二支撑部71的远端靠近第二支撑部71的近端，从而使第二支撑部71径向膨胀而呈现扩张形态。在此情况下，第三操作件优选形态为牵引丝。此时，第三操作件可以收容于第一操作件内，也可以与第一操作件并排设置在鞘管10内。
下面将示例性介绍前述任一瓣膜治疗装置的用途。主动脉瓣包括三个瓣叶VL。相邻瓣叶之间存在粘连物，且每一瓣叶上还粘附有钙化物。粘连物和钙化物限制了瓣叶VL的正常开启、关闭。瓣膜治疗装置的切割刀片31切割主动脉瓣的瓣叶之间的粘连物，以使得两瓣叶分开，从而恢复瓣膜恢复正常的开启、关闭功能。这可有效解决原生瓣膜因瓣膜交界处粘连和纤维化导致的狭窄问题，也可以用于解决瓣膜置换术后，结构性瓣膜退化导致的瓣叶粘连问题。瓣膜治疗装置的切割刀片31切割主动脉瓣的瓣叶的中部位置，以使得瓣叶分成两片。这可以有效预防经导管主动脉瓣置换术后的冠状动脉阻塞风险，手术过程操作简单。
可以理解地，在其他实施方式中，前述任一实施方式的瓣膜治疗装置还可用于任何合适瓣膜的需要切割的情况，例如，前述任一实施方式的瓣膜治疗装置还可以用于切割瓣膜上的钙化物等。
请参阅图20及图21，本发明还提供一种瓣膜治疗装置还包括及第一防护件50。第一防护件50均设于鞘管10内，且可以被操作以从鞘管10的远端至少部分的伸出。第一防护件50通过连接轴20设于鞘管10内。第一防护件50设于连接轴20的远端。
第一防护件50设于连接轴20靠近切割组件30的一端。第一防护件50与第一支撑组件40相对设置。第一防护件50设于第一支撑组件40远端侧。第一防护件50用于对切割件进行遮挡保护，以防止切割件接触血管内壁，从而可以对血管进行保护。
具体在本实施方式中，第一防护件50与第一支撑组件40之间形成供切割件往复运动的运动区域，第一防护件50对位于运动区域内的破坏部进行遮挡保护。同时，第一支撑组件40也可以对切割件的破环部进行遮挡保护。第一防护件50及第一支撑组件40能够对位于该运动区域内的破坏部进行遮挡保护。因此，第一防护件50及第一支撑组件40可以对在切割件切割瓣膜之前的破坏部进行遮挡。当切割件为切割刀片的时候，则第一防护件50用于对切割刀片31的刀刃311进行遮挡保护。当切割件为电消融元件的时候，则第一防护件50用于对电消融元件的能量释放端进行遮挡保护。
并且，当切割件的破坏部对瓣膜进行切割之后，当切割件的破坏部退回到该运动区域内时，第一防护件50也可以对切割件进行遮挡保护。
并且，第一防护件50不仅对切割件的破坏部进行遮挡，也可以对切割件的其他部分进行遮挡保护，例如，切割刀片31的刀背、电消融元件的主体结构等部分。因此，第一防护件50同样也可以防止切割件的其他部分损坏血管内壁等组织。
具体在本实施方式中，请参阅图22、图23及图24，第一防护件50可以对由收折形态变换至撑开形态，并对平移至瓣膜位置的切割刀片31进行遮挡保护，当切割刀片31对瓣膜切割完成之后，第一防护件50还可以对由退回形态变换至收折形态的切割刀片31进行遮挡保护。
在本实施方式的瓣膜治疗装置中，通过第一防护件50对切割刀片31的刀刃311进行遮挡保护，避免切割刀片31与血管90内壁之间发生触碰切割等，防止破坏血管90内壁，增强该瓣膜治疗装置的 安全性。
第一防护件50的远端连接于连接轴20的远端，第一防护件50的另一端(近端)位于切割刀片31的上方，并沿切割刀片31的移动轨迹延伸。
第一防护件50可以包括弹性片51。弹性片51的远端与连接轴20连接，弹性片51能够与切割刀片31相抵持。当切割刀片31处于撑开形态时，弹性片51远离中心轴线产生形变，并在切割刀片31恢复为收折形态的过程中，弹性片51朝向中心轴线的方向恢复形变。在切割刀片31的刀背312与弹性片51相互抵持，并发生相对运动的时候，由于刀背312的表面包括平滑延伸的过渡面，则刀背312与弹性片51之间的相对运动能够保持顺滑，避免在切割刀片31变换形态的过程中，切割刀片31与弹性片51之间的相对运动发生卡顿。
弹性片51包括多个折臂及设置于两折臂之间呈弯曲状的弯折部。弹性片51的远端位于弹性片51的底部，并与连接轴20连接。靠近弹性片51的底部的弯折部背向中心轴线弯曲，以增大弹性片51的底部与中心轴之间的夹角。位于弹性片51自由端的弯折部朝向中心轴线弯曲，以减小弹性件的自由端与中心轴之间的夹角。则弹性片51的自由端与中心轴之间的夹角尽可能小，以避免弹性片51的自由端与血管内壁之间形成直接抵顶，避免弹性片51的自由端损坏血管内壁。
请参阅图25，具体在本实施方式中，弹性片51包括3个折臂及2个弯折部。多个折臂自弹性片51的底部到顶部依次包括第一折臂511、第二折臂512及第三折臂513。两个弯折部包括自底部至顶部依次设置的第一弯折部514、第二弯折部515。折臂及弯折部的数量此处不做限定。折臂还可以为4、5个等，弯折部还可以为3、4个等。
请参阅图26，并且，至少一弯折部开设有孔结构52。该孔结构52可以增强弹性片51的弹性，减小弹性片51的硬度，使切割刀片31容易顶开弹性片51，使切割刀片31处于撑开状态。具体在本实施方式中，第一弯折部514与第二弯折部515均开设有孔结构52。
或者，请参阅图27，第一弯折部514处的孔结构52与第二弯折部515的孔结构52也可以相互贯通。该孔结构52可以增强弯折部处的弹性。可以理解，孔结构52可以为方孔，也可以为线形孔。此处对孔结构52的具体形状不做限定。在其他实施方式中，孔结构52也可以省略。
该孔结构52的开设位置靠近弹性片51的底部，以避开第一防护件50与切割刀片31的抵顶位置，避免孔结构52对切割刀片31的滑移产生干涉。
请参阅图28及图29，并且，弹性片51的自由端设有保护结构53，保护结构53的表面为光滑过渡。由于弹性片51的自由端设有保护结构53，该保护结构53可以使弹性片51的自由端的表面圆滑，进一步避免弹性片51的自由端割伤血管内壁。可以理解，保护结构53可以为绕线层结构、防护套或防护层。
具体在本实施方式中，弹性片51的自由端也可以开设有绕线孔531。该绕线孔531内缠绕有绕线层结构。该绕线层结构可以为丝线在绕线孔531的边沿上缠绕形成。或者，绕线孔531的边沿上也可以套设有防护套。该防护套可以为套管。套管将绕线孔531的边沿进行防护。
请参阅图30，绕线孔531可以为一个或多个，绕线孔531的形状可以为方形或者圆形。此处对绕线孔的形状及个数不做限定，只要绕线孔531能够使弹性片51的自由端处形成有绕线层、防护套等保护结构即可。
或者，绕线孔531的边沿也可以设有防护层，防护层可以为生物相容性好的柔软材料制成的附着于弹性片表面的层结构等，同样可以对弹性片51的自由端进行防护，避免弹性片51触碰到血管内壁。
请参阅图31，在本实施方式中，弹性片51的自由端还可以设有回弯部54。即，在第三折臂513的末端设有该回弯部54。该回弯部54可以使弹性片51的自由端朝向连接轴20方向弯曲，也可以起到避免弹性片51的自由端损坏血管内壁。
具体在本实施方式中，当切割刀片31以撑开形态朝向瓣膜91移动的时候，切割刀片31的刀刃311需要穿过弹性片51的自由端，以使切割刀片31能够切入瓣膜91内，从而实现切割操作。当切割刀片31对瓣膜进行切割的时候，切割刀片31的刀刃311需要经过回弯部54、穿过避让部44。由于弹性片51的自由端处设有回弯部54，为避免回弯部54对切割刀片31的移动产生干涉。回弯部54开设有用于通过切割刀片31的通道541。切割刀片31运动到弹性片51的自由端处，切割刀片31的刀刃311可以顺利通过通道541，实现切割操作。通道541可以是切缝也可以是凹槽，只要能够通过切割刀片31即可。
请参阅图32及图33，弹性片51的折臂的横截面可以为弧形。请参阅图34，在两个折臂的交接处的横截面为平直状。折臂朝向切割刀片31的侧面为弧形凹面，则弹性片51具有较大的弹力，使弹性片51与切割刀片31保持抵持，即使切割刀片31处于不同运动位置的时候，则弹性片51也会与切割 刀片31保持抵靠，弹性片51对切割刀片31进行持续保护。
在其他实施方式中，弹性片51不局限于为折叠状。请参阅图35，在弹性片51延伸方向上，弹性片51还可以为弧形，或者，请参阅图36，弹性片51还可以为朝向近端倾斜的平直形。弹性片51具有较高的弹性，以便于切割刀片31顶开弹性片51，顺利撑开。并且，弹性片51的横截面可以为平直状或为弧形。
请参阅图20及图21，上述瓣膜治疗装置还设有第二防护件60。第二防护件60设于瓣膜的近端侧，且第二防护件60位于第一支撑部42的近端侧，第二防护件60与避让部44相对设置，并覆盖避让部44。当切割刀片的刀刃贯穿避让部44时，切割刀刃可以与第二防护件60抵顶，第二防护件60用于对穿过瓣膜之后的切割件进行遮挡保护，以防止切割刀片31接触血管内壁。
具体在本申请中，第一防护件50及第二防护件60还可以对其他组织进行保护，此处对保护组织的具体类型不做限定，即，第一防护件50及第二防护件60可以对该瓣膜治疗装置所处工作环境范围内，除待切割瓣膜以外的组织进行保护。
本实施方式中，第二防护件60可以为具有弹性的金属片。第二防护件60被配置为在未被切割刀片31抵顶时，第二防护件60贴合于第一支撑部42的第二表面422以覆盖避让部44。当切割刀片抵顶至第二防护件60上时候，第二防护件60会被顶开，突出第一支撑部42所在的平面。因此，手术时，第二防护件60还能起到显影的作用。具体地，在影像仪的帮助下，当观察到切割刀片31穿过避让部44至抵顶第二防护件60，使得第二防护件60离开第一支撑部42时，说明切割刀片31已经刺破了待切割的瓣膜，此时即可固定切割刀片31，然后向近端提拉整个切割组件30，从而切割整个瓣膜。这有效地解决了由于切割刀片较小而不便于通过影像仪观察切割刀片是否刺破了瓣膜的问题。
可以理解地，在其他实施方式中，第二防护件60也可以被配置为未被切割刀片31抵顶时与第一支撑部42的第二表面422具有一定间隙。当切割刀片31贯穿避让部44的时候，该间隙可以供切割刀片移动，并切穿瓣膜，与第二防护件60相互抵持。只要第二防护件60的位置与避让部44对应从而能够保护组织免受贯穿避让部44的切割刀片31的损伤即可。
具体在本实施方式中，第一支撑部42可以通过切割形成两支撑臂43及避让部44，则在该避让部44的形成的同时，还可以于避让部44的对应位置处，形成第二防护件60。因此，第一支撑部42与第二防护件60还可以为一体结构。第二防护件60的形状可以与避让部44的形状相互适配。因此，第二防护件60的结构简单，降低制作难度，制作方便。
具体在本实施方式中，连接轴20、第一防护件50、第一支撑部42及第二防护件60为一体结构。第一防护件50、第一支撑部42及第二防护件60均为连接轴20的侧壁切割形成。减少第一防护件50、第一支撑部42及第二防护件60与连接轴20之间的连接工序，使上述瓣膜治疗装置结构复杂性大大降低，并提高了操作精度。
请参阅图37，在其他实施方式中，瓣膜治疗装置还包括连杆81、滑块82及牵引丝83。第一防护件80在其延伸方向可以为平直形，也可以为弧形。第一防护件80的底端铰接于连接轴20上。滑块82可滑动设于连接轴20上。牵引丝83与滑块82驱动连接，连杆81的两端分别与滑块82与第一防护件50铰接。滑块82受牵引丝83驱动沿连接轴20滑动，滑块82移动带动第一防护件80靠近或远离切割件。因此，当牵引丝83对滑块82拉动的时候，第一防护件80受连杆81推拉使得第一防护件80打开和关闭。第一防护件80的打开和关闭分别对应切割刀片31的撑开形态和收折形态。在此实施方式中，即使切割刀片31与第一防护件80之间不存在相互抵顶的作用，但第一防护件80受牵引丝83、滑块82及连杆81的联动驱动，也可以随切割刀片31的撑开与收折变化相应进行打开和关闭，同样可以使第一防护件80对切割刀片31进行遮挡保护。
以上各实施方式只是结构的举例性说明，各实施方式中的结构之间并非瓣膜治疗装置的组合结构，在无结构冲突的情况下，多个实施方式中的各结构可任意组合使用。如：当第一防护件50不是折臂形状的时候，第一防护件50的横截面也可以为弧形，同样可以增加第一防护件50的弹性。
虽然已参照几个典型实施方式描述了本发明，但应当理解，所用的术语是说明和示例性、而非限制性的术语。由于本发明能够以多种形式具体实施而不脱离发明的精神或实质，所以应当理解，上述实施方式不限于任何前述的细节，而应在随附权利要求所限定的精神和范围内广泛地解释，因此落入权利要求或其等效范围内的全部变化和改型都应为随附权利要求所涵盖。

Claims (45)

  1. 一种瓣膜治疗装置，其特征在于，所述瓣膜治疗装置包括：
    鞘管，所述鞘管具有一中心轴线；
    第一支撑组件，所述第一支撑组件包括第一操作件以及与所述第一操作件连接的第一支撑部，所述第一支撑部具有沿径向压缩并收容于所述鞘管内的压缩形态、以及从所述鞘管释放后沿径向扩张的扩张形态，其中处于所述扩张形态的所述第一支撑部具有远离所述鞘管的所述中心轴线延伸的预弯曲弧面，所述第一操作件适于被操作以使所述第一支撑部在所述扩张形态下顺应性贴合于所述瓣膜的表面，其中所述第一支撑部的所述预弯曲弧面朝向所述鞘管的所述中心轴线凸起；以及
    切割组件，所述切割组件包括第二操作件以及与所述第二操作件连接的切割件，所述第二操作件适于被操作以使破碎所述瓣膜的至少部分。
  2. 根据权利要求1所述的瓣膜治疗装置，其特征在于，所述切割件被配置为电连接有消融元件，以接收所述消融元件传递的能量，通过非接触式破碎所述瓣膜的至少部分。
  3. 根据权利要求1所述的瓣膜治疗装置，其特征在于，所述切割件包括与所述第二操作件连接的切割刀片，所述第二操作件适于被操作以使所述切割刀片切割位于所述第一支撑部和所述切割刀片之间的所述瓣膜。
  4. 根据权利要求3所述的瓣膜治疗装置，其特征在于，所述切割刀片被配置为电连接有消融元件，以接收所述消融元件传递的能量，通过接触式切割所述瓣膜的至少部分。
  5. 根据权利要求1所述的瓣膜治疗装置，其特征在于，所述第一支撑部具有与所述第一操作件连接的连接端，所述第一支撑部包括第一区段，在所述扩张形态中，所述第一区段自所述连接端朝向远离所述鞘管的所述中心轴线向外并朝向远端延伸，所述第一区段具有预弯曲的弧面。
  6. 根据权利要求5所述的瓣膜治疗装置，其特征在于，所述第一支撑部还包括第二区段，所述第一区段与所述第二区段的连接处形成用于抵顶所述瓣膜的表面的抵持部，在所述扩张形态中，所述第二区段自所述抵持部朝向近端延伸，所述第二区段远离所述抵持部的一端为自由端，所述第二区段具有预弯曲的弧面。
  7. 根据权利要求6所述的瓣膜治疗装置，其特征在于，在所述扩张形态中，所述第二区段先自所述抵持部朝向近端并远离所述鞘管的所述中心轴线的方向弯曲延伸，再进一步地朝向近端并朝向所述鞘管的所述中心轴线的方向弯曲延伸至所述自由端。
  8. 根据权利要求6所述的瓣膜治疗装置，其特征在于，所述第二区段的弯曲半径在1mm～3mm的范围内；且/或所述自由端的切线与所述鞘管的所述中心轴线之间的夹角在10°～60°的范围内。
  9. 根据权利要求1所述的瓣膜治疗装置，其特征在于，在垂直于所述鞘管的所述中心轴线的平面内，所述第一支撑部的周向两侧对应的最大圆心角在10°～60°的范围内；且/或所述第一支撑部沿所述鞘管的周向的最大宽度在2mm～20mm的范围内。
  10. 根据权利要求1所述的瓣膜治疗装置，其特征在于，所述第一支撑部为弹性件，所述弹性件被配置为在撤销外界挤压力时能够由所述压缩状态弹性弯曲变形至所述扩张形态。
  11. 根据权利要求1所述的瓣膜治疗装置，其特征在于，所述第一支撑部为单根金属丝结构；或所述第一支撑部为多个金属丝捻绕结构；或所述第一支撑部为多根金属丝编织结构。
  12. 根据权利要求1所述的瓣膜治疗装置，其特征在于，所述第一支撑部为被切割的金属片结构，所述第一支撑部包括多个支撑筋，多个所述支撑筋围合形成一个或多个网格。
  13. 根据权利要求3所述的瓣膜治疗装置，其特征在于，所述第一支撑部具有在其厚度方向上的两侧的第一表面和第二表面，所述第一支撑部上设有避让部，所述避让部自所述第一表面朝向所述第二表面凹陷，或者贯穿所述第一表面和所述第二表面，所述避让部用于使所述切割刀片穿过以切割所述瓣膜。
  14. 根据权利要求3所述的瓣膜治疗装置，其特征在于，所述第一支撑部具有在其厚度方向上的两侧的第一表面和第二表面，所述第一支撑部上设有避让部，所述避让部贯穿所述第一表面和所述第二表面，所述避让部用于使所述切割刀片穿过以切割所述瓣膜，所述第一支撑组件还包括连接所述第一支撑部的保护片，所述保护片被配置为至少部分覆盖所述避让部，以防止所述切割刀片接触血管内壁。
  15. 根据权利要求14所述的瓣膜治疗装置，其特征在于，所述保护片被配置为未被所述切割刀片抵顶时贴合于所述第二表面以覆盖所述避让部，且在被所述切割刀片抵顶时弹性变形并脱离所述第二表面；或所述保护片被配置为未被所述切割刀片抵顶时覆盖所述避让部且与所述第二表面具有间距。
  16. 根据权利要求1所述的瓣膜治疗装置，其特征在于，所述第一操作件包括可滑动地收容于所述鞘管内的导管或牵引丝。
  17. 根据权利要求16所述的瓣膜治疗装置，其特征在于，所述瓣膜治疗装置还包括第二支撑组件，所述第二支撑组件包括：第二支撑部，所述第二支撑部具有沿径向压缩收容于所述鞘管内的压缩形态和从所述鞘管释放沿径向扩张的扩张形态；以及第三操作件，所述第三操作件连接所述第二支撑部，所述第三操作件用于被操作以使在扩张形态的所述第二支撑部与在扩张状态的所述第一支撑部配合夹持所述瓣膜。
  18. 根据权利要求17所述的瓣膜治疗装置，其特征在于，所述第三操作件包括可滑动地收容于所述鞘管内的导管或牵引丝。
  19. 根据权利要求18所述的瓣膜治疗装置，其特征在于，所述第二支撑部的近端与所述第一操作件固定连接，所述第二支撑部的远端与所述第三操作件固定连接，所述第三操作件被配置为驱动所述第二支撑部的远端靠近或远离所述第二支撑部的近端，从而使所述第二支撑部在扩张形态和压缩形态之间切换。
  20. 根据权利要求18所述的瓣膜治疗装置，其特征在于，所述第一操作件包括可滑动地设置于所述鞘管内的导管，所述第三操作件的至少部分可滑动地设置于所述第一操作件内，所述第二支撑部在所述第一操作件的束缚下呈现压缩形态，且所述第二支撑部在从所述第一操作件释放后能够自膨胀至扩张形态。
  21. 根据权利要求3所述的瓣膜治疗装置，其特征在于，所述切割组件还包括输送件、调节件以及支撑件，所述调节件与所述第二操作件连接并与所述输送件滑动连接，所述支撑件与所述调节件铰接，所述切割刀片与所述支撑件和所述输送件铰接，所述第二操作件适于被操作以使所述调节件在所述输送件上滑动，进而驱动所述支撑件摆动，从而使所述切割刀片相对所述输送件转动。
  22. 根据权利要求21所述的瓣膜治疗装置，其特征在于，所述输送件呈管状，且具有一沿轴向延伸并贯穿其侧壁的第一开口，所述支撑件和所述切割刀片可移动至所述输送件内或可经由所述第一开口从所述输送件伸出。
  23. 根据权利要求22所述的瓣膜治疗装置，其特征在于，所述输送件的侧壁上设有滑槽，所述调节件上设有凸柱，所述凸柱可滑动地嵌设于所述滑槽以使得所述调节件在所述输送件内滑动，且所述凸柱的滑动距离被所述滑槽的长度限定从而限定所述切割刀片相对所述输送件的转动角度范围。
  24. 根据权利要求23所述的瓣膜治疗装置，其特征在于，所述调节件设有朝向所述第一开口的收容腔，所述支撑件和所述切割刀片能够经由所述收容腔伸出所述调节件或缩回至所述调节件内。
  25. 一种瓣膜治疗装置，其特征在于，所述瓣膜治疗装置包括：
    鞘管，所述鞘管具有一中心轴线；
    连接轴，可滑动收容于所述鞘管内；
    支撑组件，设于所述连接轴上，且位于瓣膜的近端侧，所述支撑组件用于支撑所述瓣膜；
    切割组件，包括连接于所述连接轴的切割件，所述切割件用于破碎所述瓣膜的至少部分；及
    第一防护件，设于所述连接轴靠近所述切割组件的一端，所述第一防护件与所述支撑组件相对设置，所述第一防护件设于所述支撑组件远端侧，所述第一防护件用于对所述切割件进行遮挡保护。
  26. 根据权利要求25所述的瓣膜治疗装置，其特征在于，所述切割件包括用于破坏所述瓣膜的破坏部，所述第一防护件与所述支撑组件之间形成供所述切割件往复运动的运动区域，所述第一防护件对位于所述运动区域内的所述破坏部进行遮挡保护。
  27. 根据权利要求25所述的瓣膜治疗装置，其特征在于，所述切割组件位于所述瓣膜的远端侧，且能够收容于所述连接轴内，所述切割组件还包括第一操作件，所述第一操作件适于被操作使所述切割件移动，所述切割件朝向所述瓣膜移动并由所述瓣膜的远端侧移动至所述瓣膜的近端侧以破碎所述瓣膜的至少部分；所述切割件在所述第一操作件的操控下，能够在所述连接轴的近端和远端之间往复运动。
  28. 根据权利要求25所述的瓣膜治疗装置，其特征在于，所述支撑组件包括第二操作件以及与所述第二操作件连接的支撑部，所述支撑部具有沿径向压缩并收容于所述鞘管内的压缩形态、以及从所述鞘管释放后沿径向扩张的扩张形态，所述支撑部连接于所述连接轴的近端，所述第二操作件适于被操作使所述支撑部处于所述压缩形态或所述扩张形态，且所述支撑部设于瓣膜的近端侧；所述第一防护件连接于所述连接轴的远端，所述切割组件设于所述连接轴上，所述切割件在所述第二操作件的操控下，在所述连接轴的近端和远端之间往复运动。
  29. 根据权利要求27所述的瓣膜治疗装置，其特征在于，所述第一操作件操作驱动所述切割件分别处于收折形态或撑开形态，所述第一防护件的另一端位于所述切割件的上方，并沿所述切割件的移动轨迹延伸。
  30. 根据权利要求29所述的瓣膜治疗装置，其特征在于，所述第一防护件包括弹性片，所述弹性片的一端与所述连接轴连接，所述弹性片的另一端与所述切割件相抵持，当所述切割件处于撑开形态时，所述弹性片产生远离所述中心轴线的形变，并在所述切割件恢复为收折形态时，所述弹性片恢复形变至所述中心轴线上。
  31. 根据权利要求30所述的瓣膜治疗装置，其特征在于，所述弹性片包括多个折臂及设置于两所述折臂之间呈弯曲状的弯折部，靠近所述弹性片的底部的所述弯折部背向所述中心轴弯曲，位于所述弹性片的自由端的弯折部朝向中心轴线弯曲。
  32. 根据权利要求31所述的瓣膜治疗装置，其特征在于，至少一所述弯折部开设有孔结构。
  33. 根据权利要求30所述的瓣膜治疗装置，其特征在于，在所述弹性片由远端及近端的延伸方向上，所述弹性片为弧形，或为背向所述中心轴线倾斜的平直形。
  34. 根据权利要求30所述的瓣膜治疗装置，其特征在于，所述弹性片的自由端设有保护结构，所述保护结构的表面为光滑过渡。
  35. 根据权利要求34所述的瓣膜治疗装置，其特征在于，所述保护结构为绕线结构、防护套或防护层。
  36. 根据权利要求30所述的瓣膜治疗装置，其特征在于，所述弹性片的自由端设有回弯部，所述回弯部朝向所述连接轴弯曲。
  37. 根据权利要求36所述的瓣膜治疗装置，其特征在于，所述回弯部开设有用于通过所述切割件的通道。
  38. 根据权利要求31所述的瓣膜治疗装置，其特征在于，所述弹性片的弯折部的横截面为平直状，及/或所述折臂的横截面为弧形。
  39. 根据权利要求25所述的瓣膜治疗装置，其特征在于，所述切割件为切割刀片，所述切割刀片包括刀刃和刀背，所述刀背的表面包括平滑延伸的过渡面，所述第一防护件与所述刀背相抵持，用于对所述刀刃进行遮挡保护。
  40. 根据权利要求25所述的瓣膜治疗装置，其特征在于，还包括连杆、滑块及牵引丝，所述第一防护件铰接于所述连接轴上，所述滑块可滑动设于所述连接轴上，所述牵引丝与所述滑块驱动连接，所述连杆的两端分别与所述滑块与所述第一防护件铰接，所述滑块受所述牵引丝驱动沿所述连接轴滑动，所述滑块移动带动所述第一防护件靠近或远离所述切割件。
  41. 根据权利要求25所述的瓣膜治疗装置，其特征在于，还包括第二防护件，所述第二防护件设于所述瓣膜的近端侧，且所述第二防护件位于所述支撑组件的近端侧，所述第二防护件用于对穿过所述瓣膜之后的所述切割件进行遮挡保护。
  42. 根据权利要求41所述的瓣膜治疗装置，其特征在于，所述支撑组件设有供所述切割件穿过的避让部，且所述第二防护件与所述避让部相对设置，所述切割件穿过所述避让部并与所述第二防护件相抵持。
  43. 根据权利要求41所述的瓣膜治疗装置，其特征在于，所述第二防护件与所述支撑组件为一体结构。
  44. 根据权利要求41所述的瓣膜治疗装置，其特征在于，所述支撑组件及所述第二防护件设于所述连接轴的近端，所述第一防护件设于所述连接轴的远端，所述切割组件收容于所述连接轴内，所述连接轴的侧壁上开设于用于供所述切割件伸出的窗口。
  45. 根据权利要求41所述的瓣膜治疗装置，其特征在于，所述连接轴、所述第一防护件、所述支撑组件及所述第二防护件为一体结构。
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Publication number Priority date Publication date Assignee Title
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Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190069920A1 (en) * 2016-03-14 2019-03-07 Université Catholique de Louvain Device for clean excision of a heart valve
CN209789963U (zh) * 2019-03-15 2019-12-17 李浩超 一种可调节瓣膜切割宽度的切割器械
WO2020234763A1 (en) * 2019-05-19 2020-11-26 Pi-Cardia Ltd. Transcatheter valve laceration device and method
CN212490262U (zh) * 2020-08-05 2021-02-09 杭州德晋医疗科技有限公司 瓣膜扩张装置及瓣膜扩张系统
CN112969426A (zh) * 2018-11-14 2021-06-15 美敦力公司 用于制备用于经导管瓣膜置换程序的瓣膜的装置和方法
CN113693782A (zh) * 2020-05-22 2021-11-26 杭州德晋医疗科技有限公司 瓣膜扩张器及瓣膜扩张系统
CN215130891U (zh) * 2020-12-30 2021-12-14 杭州德晋医疗科技有限公司 带加强件的瓣膜扩张装置和瓣膜扩张系统

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190069920A1 (en) * 2016-03-14 2019-03-07 Université Catholique de Louvain Device for clean excision of a heart valve
CN112969426A (zh) * 2018-11-14 2021-06-15 美敦力公司 用于制备用于经导管瓣膜置换程序的瓣膜的装置和方法
CN209789963U (zh) * 2019-03-15 2019-12-17 李浩超 一种可调节瓣膜切割宽度的切割器械
WO2020234763A1 (en) * 2019-05-19 2020-11-26 Pi-Cardia Ltd. Transcatheter valve laceration device and method
CN113693782A (zh) * 2020-05-22 2021-11-26 杭州德晋医疗科技有限公司 瓣膜扩张器及瓣膜扩张系统
CN212490262U (zh) * 2020-08-05 2021-02-09 杭州德晋医疗科技有限公司 瓣膜扩张装置及瓣膜扩张系统
CN215130891U (zh) * 2020-12-30 2021-12-14 杭州德晋医疗科技有限公司 带加强件的瓣膜扩张装置和瓣膜扩张系统

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