WO2022134955A1 - Dispositif de valvulotomie et méthode de valvulotomie - Google Patents

Dispositif de valvulotomie et méthode de valvulotomie Download PDF

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Publication number
WO2022134955A1
WO2022134955A1 PCT/CN2021/131250 CN2021131250W WO2022134955A1 WO 2022134955 A1 WO2022134955 A1 WO 2022134955A1 CN 2021131250 W CN2021131250 W CN 2021131250W WO 2022134955 A1 WO2022134955 A1 WO 2022134955A1
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WO
WIPO (PCT)
Prior art keywords
blades
valvulotomy
blade
distal end
driving rod
Prior art date
Application number
PCT/CN2021/131250
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English (en)
Chinese (zh)
Inventor
王柏栋
丘信炯
张庭超
Original Assignee
杭州德晋医疗科技有限公司
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
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Publication date
Priority claimed from CN202011552263.5A external-priority patent/CN114668457B/zh
Priority claimed from CN202023157960.9U external-priority patent/CN215384441U/zh
Application filed by 杭州德晋医疗科技有限公司 filed Critical 杭州德晋医疗科技有限公司
Publication of WO2022134955A1 publication Critical patent/WO2022134955A1/fr

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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
    • 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
    • A61B17/3209—Incision instruments
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B34/00—Computer-aided surgery; Manipulators or robots specially adapted for use in surgery
    • A61B34/20—Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges

Definitions

  • the present disclosure relates generally to the field of medical device technology, and more particularly, to valvulotomy devices and methods of incising valves.
  • Aortic valve stenosis is mainly caused by the sequelae of rheumatic fever, congenital aortic valve structural abnormalities, or senile aortic valve degeneration or calcification.
  • aortic valve stenosis there are bicuspid valve deformities, tricuspid valve deformities, etc., of which the most common is bicuspid valve deformity.
  • bicuspid valve deformity is the congenital aortic valve with only two leaflets 1, which is called bicuspid aortic valve (BAV for short), and in the classification standard of aortic valve leaflets, it is also A condition similar to a bicuspid valve caused by calcified fusion of the original tricuspid valve is classified as BAV.
  • the present disclosure relates to a valvulotomy device comprising a drive assembly and two blades, the drive assembly including a mount, a drive rod, and a control, the proximal ends of the two blades being respectively connected to the proximal ends of the mount
  • the distal end is rotatably connected, the side of each of the blades facing away from the other blade is provided with a cutting edge, and the distal end of the driving rod moves through the mounting seat and is connected to the control piece, the driving rod and the control piece Located between the two blades, the driving rod drives the control member to push up the two blades and abut the two blades, and when the two blades are in the open state, the space between the two blades is The included angle is less than 180°.
  • the mounting seat includes a fixing portion and a through groove axially extending through the middle portion of the fixing portion, the driving rod slidably penetrates the through groove, and the two blades rotate respectively connected to opposite sides of the fixing portion.
  • the central axes of the two blades are both parallel to the central axis of the valvulotomy device
  • the control member includes a distal end to the drive rod.
  • a columnar structure whose ends are fixedly connected, the proximal end of the columnar structure has a V-shaped cut surface, the side of the distal end of the blade away from the blade is an inclined surface structure, and the driving rod drives the V-shaped cut surface of the columnar structure Contact with the inclined surface structures of the two blades and push the two blades apart.
  • the angle of the V-shaped cut surface is greater than or equal to the angle of inclination of the bevel structure relative to the central axis of the blade.
  • the fixing portion includes a platform and protrusions disposed on opposite sides of the distal end of the platform, the through groove penetrates the platform and is located between the two protrusions, and the two The opposite sides of the protruding block are respectively provided with grooves, and the proximal ends of the two blades are respectively rotatably arranged in the two grooves.
  • a side of the proximal end of the blade away from the cutting edge is provided with a first limiting member, and when the central axis of the blade is parallel to the central axis of the valvulotomy device, the first limiting member is The stopper is in contact with the platform.
  • the fixing part includes a platform and a boss provided in the middle of the platform, the through groove penetrates the boss, and the proximal ends of the two blades are respectively connected to the boss in rotation on opposite sides.
  • a second limiting member is provided on the side surface of the boss in contact with the two blades, a third limiting member is axially provided at the proximal end of the blade, and the central axis of the blade is provided with a second limiting member.
  • the third limiting member When being parallel to the central axis of the valvulotomy device, the third limiting member abuts against the second limiting member.
  • control member includes a stent with a proximal end fixedly connected to the mounting base, a distal end of the stent fixedly connected with a distal end of the drive rod, the stent radially expandable or When retracted, the drive rod drives the stent to expand radially to push apart two blades.
  • the stent is made of a shape memory material and the proximal dimension of the stent after expansion is greater than the angle between the two blades.
  • the drive assembly further includes a cannula in which a distal end of the stent is received and secured to a proximal end of the cannula, the distal end of the cannula being connected to the drive The distal end of the rod is fixedly connected.
  • the driving assembly further includes an elastic member, the proximal ends of the two blades are respectively rotatably connected on opposite sides of the mounting seat, and the two ends of the elastic member are respectively connected with the two blades.
  • the proximal end of the blade is fixedly connected, and the elastic member is arranged near the connection between the blade and the mounting seat.
  • the valvulotomy device further includes a tubular body assembly comprising an outer tube, an intermediate tube movably inserted through the outer tube, and an inner tube movably inserted through the intermediate tube
  • the distal end of the inner tube is fixedly connected with the proximal end of the driving rod, and the distal end of the intermediate tube is fixedly connected with the proximal end of the mounting seat.
  • the tube body assembly further includes a guard ring fixedly attached to the distal end of the outer tube.
  • the valvulotomy device further includes an operating component, the operating component includes a handle and a first operating member and a second operating member provided on the handle, the first operating member and the The proximal end of the inner tube is connected, and the second operating member is connected with the proximal end of the intermediate tube or the outer tube.
  • the operating component includes a handle and a first operating member and a second operating member provided on the handle, the first operating member and the The proximal end of the inner tube is connected, and the second operating member is connected with the proximal end of the intermediate tube or the outer tube.
  • the present disclosure relates to a method of incising a valve, comprising:
  • the valvulotomy device of the present disclosure is passed through the valve of the living body, so that the two blades are completely located on one side of the valve, and the two blades are not opened at this time, so the two blades are not opened.
  • the valve is in a stenotic state due to the adhesion of the calcified junction between the valves;
  • Both of the blades are closed and the valvulotomy device is then withdrawn from the organism.
  • the valves include, but are not limited to, aortic, mitral, tricuspid, and pulmonary valves.
  • the organism is a human.
  • the control member pushes the two blades away and abuts against the two blades under the driving of the driving rod, so that the opposite cutting edges of the two blades can cut the valve.
  • the angle between the two blades is less than 180° when they are opened, the blade is inclined relative to the valve, and the contact between the blade and the valve during the cutting process is similar to point contact, the contact area is small, and the blade can cut easily.
  • the valve requires less pulling force; on the other hand, the driving rod can drive the control member to control the opening angle of the two blades, thereby controlling the cutting range of the blade to the valve, making the cutting more precise and controllable, and reducing the risk during the operation. , improve the success rate of surgery.
  • Figure 1 is a bicuspid valve deformity of the aortic valve
  • FIG. 2 is a schematic structural diagram of the valvulotomy device provided in Embodiment 1 of the present disclosure
  • FIG. 3 is a partial exploded view of the valvulotomy device provided in Embodiment 1 of the present disclosure
  • FIG. 4 is another schematic structural diagram of the valvulotomy device provided in Embodiment 1 of the present disclosure.
  • FIG. 5 is a schematic structural diagram of a mounting seat provided in Embodiment 1 of the present disclosure.
  • FIG. 6 is a schematic structural diagram of a control member provided in Embodiment 1 of the present disclosure.
  • FIG. 7 and 8 are schematic structural diagrams of a blade provided in Embodiment 1 of the present disclosure.
  • FIG. 9 is a cross-sectional view of the valvulotomy device provided in Embodiment 1 of the present disclosure.
  • FIG. 10 is another structural schematic diagram of the valvulotomy device provided in Embodiment 1 of the present disclosure.
  • 11 to 16 are schematic views of the operation of the valvulotomy device provided in the first embodiment of the present disclosure.
  • FIG. 17 is a schematic structural diagram of the valvulotomy device provided in Embodiment 2 of the present disclosure.
  • FIG. 18 is a schematic structural diagram of a mounting seat provided in Embodiment 2 of the present disclosure.
  • FIG. 19 is a schematic structural diagram of a blade provided in Embodiment 2 of the present disclosure.
  • FIG. 20 is a schematic structural diagram of the valvulotomy device provided in Embodiment 3 of the present disclosure.
  • FIG. 21 is another schematic structural diagram of the valvulotomy device provided in Embodiment 3 of the present disclosure.
  • FIG. 22 is a partially exploded view of the valvulotomy device provided in Embodiment 3 of the present disclosure.
  • FIG. 23 is another schematic structural diagram of the valvulotomy device provided in Embodiment 3 of the present disclosure.
  • Fig. 24 is a partial enlarged view at E in Fig. 23;
  • 25 to 29 are schematic structural diagrams of the stent provided in Embodiment 3 of the present disclosure.
  • the proximal end refers to the end closer to the operator, while the distal end refers to the end farther away from the operator;
  • the axial direction refers to the end parallel to the medical device. The direction of the line connecting the center of the distal end and the center of the proximal end of the instrument.
  • the valvulotomy device 100 provided according to the first embodiment of the present disclosure includes a driving assembly 120 , two blades 110 , a tube assembly 130 , and an operating assembly 140 .
  • the driving assembly 120 includes a mounting seat 121 , a driving rod 122 , and a control member 123 .
  • the proximal ends of the two blades 110 are respectively rotatably connected with the distal ends of the mounting base 121 , and a cutting edge 111 is provided on the side of each blade 110 facing away from the other blade 110 .
  • the distal end of the driving rod 122 moves through the mounting seat 121 and is connected to the control member 123.
  • the driving rod 122 and the control member 123 are located between the two blades 110.
  • the driving rod 122 drives the control member 123 to push the two blades 110 away and abut against the two blades 110. Blade 110.
  • the included angle between the two blades 110 is less than 180°.
  • the two blades 110 are respectively rotatably connected to the mounting seat 121, and the driving rod 122 penetrates the mounting seat 121 and is connected to the control member 123, so that the driving rod 122 can drive the control member 123 to the distal end of the mounting seat 121.
  • Activity the two blades 110 are respectively rotatably connected to the mounting seat 121, and the driving rod 122 penetrates the mounting seat 121 and is connected to the control member 123, so that the driving rod 122 can drive the control member 123 to the distal end of the mounting seat 121.
  • a blade 111 is provided on the side of one blade 110 of the two blades 110 away from the other blade 110 , and the two blades 110 can be driven by the movement of the control member 123 Rotate to open, that is, the control member 123 can push the two blades 110 away and abut the two blades 110, so that when the two blades 110 are in the open state, the angle between the two blades 110 is less than 180°, at this time the two blades 110 Blades 111 opposite 110 can cut the valve.
  • the angle between the two blades 110 when they are opened is less than 180°, the blade 111 of the blade 110 is inclined relative to the valve, and the contact between the blade 111 and the valve during the cutting process is similar to point contact, and the contact area is small, The blade 111 can cut the valve more easily, and the required pulling force is small; on the other hand, since the control member 123 pushes the two blades 110 and abuts against the two blades 110, the opening angle of the blades 110 can be controlled.
  • the driving rod 122 can drive the contact position between the control member 123 and the two blades 110 to control the opening angles of the two blades 110, thereby controlling the cutting range of the blade 110 to the valve, making the cutting more precise and controllable, and realizing the valve Precise cutting reduces risks during surgery and improves the success rate of surgery.
  • the included angle between the two blades 110 can be adjusted by the control member 123 , and the maximum included angle between the two blades 110 is less than 180°. In this way, it is ensured that when the two blades 110 are in the open state, the contact between the blade edge 111 and the valve is close to point contact, and the contact area is small.
  • the central axis X of the two blades 110 is parallel to the central axis Y of the valvulotomy device 100 . In this way, when the two blades 110 are in the closed state, the space occupied by the two blades 110 is as small as possible, which facilitates the passage of the valvulotomy device 100 through the blood vessel.
  • the mounting seat 121 includes a fixing portion 1211 and a through groove 1212 axially extending through the middle of the fixing portion 1211 , and the driving rod 122 is slidably inserted through the through groove 1212 .
  • a through groove 1212 is defined in the middle of the fixing portion 1211 in the axial direction.
  • the distal end of the driving rod 122 is connected to the control member 123 through the through groove 1212.
  • the driving rod 122 can move axially along the through groove 1212, thereby driving the control member 123 to move axially.
  • the cross-sectional shape of the through groove 1212 in the radial direction may be square, circular or other shapes.
  • the cross-sectional shape of the through slot 1212 in the radial direction matches the outer contour of the drive rod 122, which can reduce the resistance between the through slot 1212 and the drive rod 122, and facilitate the drive rod 122 to move in the through slot.
  • the two blades 10 are rotatably connected to opposite sides of the fixing portion 1211 respectively.
  • the two blades 110 when no external force is applied to the two blades 110, the two blades 110 will not rotate freely relative to the mounting seat 121, that is, the transition of the two blades 110 between the open state and the closed state requires the assistance of an external force, so that the Accidental opening of the blade 110 resulting in damage to the tissue or delivery catheter is avoided.
  • the fixing portion 1211 includes a platform 121a and protrusions 121b disposed on opposite sides of the distal end of the platform 121a, and the through groove 1212 penetrates the platform 121a and is located between the two protrusions 121b.
  • the opposite sides of the two projections 121b are respectively provided with grooves 121d, and the proximal ends of the two blades 110 are respectively rotatably disposed in the two grooves 121d.
  • the proximal end of the blade 110 is a circular structure
  • the groove 121d is a semi-circular groove to accommodate the proximal end of the blade 110 .
  • the blade 110 is rotatably connected to the protrusion 121b. When the blade 110 rotates relative to the protrusion 121b, the groove 121d can accommodate the proximal end of the blade 110, so that the blade 110 can be rotated more smoothly, thereby realizing the opening of the two blades 110. and closed.
  • the mounting base 121 further includes a connecting piece 1213 for fixing the blade 110 and the protrusion 121b so that the blade 110 can rotate around the protrusion 121b.
  • the proximal end of the blade 110 is provided with a first through hole 112, and the bump 121b is provided with a second through hole 121c.
  • the connecting piece 1213 passes through the first through hole 112 and the second through hole 121c to connect the blade 110 and the protrusion 121b so that the blade 110 can rotate relative to the protrusion 121b.
  • the connector 1213 is a pin.
  • the rotational connection between the blade 110 and the projection 121b is not limited to the rotational connection through the connecting piece, and the rotational connection can also be achieved by means of screw connection, riveting and the like.
  • the middle of the driving rod 122 can be a hollow sliding groove 1221 that does not pass through both sides, so that the connecting piece 1213 connecting the two blades 110 and the protrusion 121b can be avoided when passing through the through groove 1212 of the mounting seat 121, thereby ensuring the driving force
  • the rod 122 can move axially along the through groove 1212 of the mounting seat 121 .
  • the side of the proximal end of the blade 110 away from the blade edge 111 is provided with a first limiting member 113.
  • the first limiting member 113 is in contact with the platform 121a.
  • the first limiting member 113 can be a limiting block protruding from the proximal end of the blade 110.
  • the limiting block rotates with the blade 110 and abuts against the platform 121a;
  • the plane of the limiting block is in contact with the surface of the platform 121 a, and the blades 110 are restricted from continuing to rotate in the direction away from the cutting edge 111 .
  • the blade 110 will rotate towards the side of the blade 111 under the action of external force, but cannot rotate in the direction away from the blade 111.
  • the setting of the first limiter 113 effectively avoids the blade 110
  • the reverse phenomenon that may occur during the rotation improves the safety performance of the valvulotomy device 100 .
  • the structure of the mounting seat 121 and the connection method between the blade 110 and the mounting seat 121 are not limited to this embodiment.
  • the functions that can be achieved by the cooperation of the blade 110 and the mounting seat 121 should mainly include the rotation of the blade 110 around the mounting seat 121, the rotation of the blade 110 The anti-reverse function of the device, and the function of the drive rod 122 passing through the mounting seat 121.
  • the control member 123 includes a columnar structure 1231 fixedly connected with the distal end of the driving rod 122 , and a conical structure 1232 disposed at the distal end of the columnar structure 1231 .
  • the distal end of the driving rod 122 is fixedly connected to the columnar structure 1231, and the connection methods include but are not limited to welding, bonding, riveting, screw connection and the like.
  • the tapered structure 1232 disposed at the distal end of the columnar structure 1231 can ensure that the valvulotomy device 100 has good passability when entering the human body, and will not damage the inner wall of the blood vessel or other tissues.
  • the proximal end of the columnar structure 1231 has a V-shaped cut surface 1233 , and the side of the distal end of the blade 110 away from the cutting edge 111 is an inclined surface structure 114 .
  • the driving rod 122 drives the V-shaped cut surface 1233 of the columnar structure 1231 to contact the inclined surface structures 114 of the two blades 110 and push the two blades 110 apart.
  • the inclined surface structure 114 can be a straight inclined surface or a circular arc inclined surface, so as to provide a suitable angle for the control member 123 to push the two blades 110 in the closed state.
  • the V-shaped cut surface 1233 includes a first cut surface and a second cut surface.
  • first tangent plane and the second tangent plane are respectively inclined symmetrically with respect to the axial direction, and the proximal ends of the two intersect to form a V shape.
  • first and second cut planes are at the same angle with respect to the axial direction.
  • the drive rod 122 drives the control member 123 toward the proximal end
  • the first cut surface and the second cut surface of the V-shaped cut surface 1233 at the proximal end of the control member 123 are in contact with the inclined surface structures 114 of the two blades 110 respectively, and follow the drive rod.
  • 22 drives the control member 123 to move further proximally, and uses the V-shaped cut surface 1233 of the control member 123 to push the two blades 110 away from the central axis Y of the valvulotomy device 100, thereby opening the two blades 110.
  • the opening angle of the two blades 110 can be controlled by controlling the contact position between the V-shaped cut surface of the control member 23 and the two blades 110, thereby accurately controlling the range of valve cutting and improving the success rate of the operation.
  • the angle of the V-shaped cut surface 1233 is A, and it can be understood that the angle A of the V-shaped cut surface refers to the included angle between each cut surface and the horizontal plane.
  • the inclination angle of the inclined surface structure 114 relative to the central axis X of the blade 110 is B.
  • the angle A of the V-shaped cut surface 1233 is greater than or equal to the inclination angle B of the inclined surface structure 114 relative to the central axis X of the blade 110 .
  • the blade 110 is a single-sided cutting edge, and the cutting edge may be a single cutting edge or a double cutting edge, as long as the cutting edge 111 has sufficient sharpness.
  • the blade 110 has the same width as a whole, and the cutting edge 111 is substantially parallel to the central axis X of the blade 110 . Since the blade 111 completely penetrates the blade 110, a sharp blade will be formed at the distal end of the blade 110. When the blade 110 is opened to the maximum angle, the sharp blade may scratch blood vessels/tissues, causing serious medical accidents.
  • the cutting edge 111 of the blade 110 does not completely penetrate the blade 10 , and an uncut edge is formed at the distal end and/or the proximal end of the blade 110 . Blunt mouth.
  • the distal end of the blade 110 is configured as a smooth arc to ensure the safety of the valvulotomy device 100 during use.
  • the tube body assembly 130 includes an outer tube 131 , a middle tube 132 movably penetrated through the outer tube 131 , and an inner tube 133 movably penetrated through the middle tube 132 .
  • the distal end of the inner tube 133 is fixedly connected with the proximal end of the driving rod 122
  • the distal end of the intermediate tube 132 is fixedly connected with the proximal end of the mounting seat 121 .
  • the outer tube 131 and the middle tube 132 are both hollow tubes.
  • the driving rod 122 can be moved axially in the middle tube 132 by operating the inner tube 133, thereby driving the control member 123 to move axially to open the two blades 110 or close the two blades 110; by operating the middle tube 132 or
  • the outer tube 131 receives the two blades 110 in the closed state into the outer tube 131 .
  • the control member 123 axially moves to the proximal end to open the two blades 110, in addition to the control member 123 itself controlling the opening angles of the two blades 110, the distal end of the outer tube 131 can also limit the opening angles of the two blades 110 .
  • the tube body assembly 130 further includes a protection ring 134 , and the protection ring 134 is fixedly connected to the distal end of the outer tube 131 .
  • the function of the protection ring 134 is to prevent the cutting edge 111 of the blade 110 from contacting the distal edge of the outer tube 131 when the blade 110 is opened and closed, thereby causing damage to the contact surface.
  • the distal end of the outer tube 131 is fixedly connected with the protection ring 134, and the fixed connection method includes welding or bonding.
  • the guard ring 134 may be a metal ring.
  • the outer tube 131 is axially movable relative to the intermediate tube 132 .
  • the middle tube 132 is accommodated in the outer tube 131 , and the distal end of the middle tube 132 is fixedly connected to the proximal end of the mounting seat 121 , and the fixed connection method includes but is not limited to bonding, welding and the like.
  • the middle tube 132 can also move axially relative to the outer tube 131 and the inner tube 133 .
  • the inner tube 133 is accommodated in the middle tube 132 , and the inner tube 133 is axially movable relative to the middle tube 132 .
  • the inner tube 133 may be a solid tube or a hollow tube.
  • the inner tube 133 has good compliance performance, high tensile strength, and good pushing performance.
  • the inner tube 133 includes, but is not limited to, one or more of a flexible steel pipe, a spring tube with a mandrel, a helical hollow multi-strand wire, and a mechanical flexible shaft.
  • the distal end of the inner tube 133 is fixedly connected with the proximal end of the driving rod 122, and the fixed connection method includes, but is not limited to, welding, bonding, welding, and the like.
  • the driving rod 122 and the inner tube 133 can be integrally formed, which makes the driving of the driving rod 122 more stable and improves the success rate of the operation.
  • the valvulotomy device 100 further includes an operating assembly 140, and the operating assembly 140 includes a handle and a first operating member and a second operating member provided on the handle.
  • the first operating member is connected to the proximal end of the inner tube 133
  • the second operating member is connected to the proximal end of the intermediate tube 132 or the outer tube 131 .
  • the first operating member can indirectly control the driving rod 122, so that the driving rod 122
  • the control member 123 is driven to move in the axial direction, thereby opening the two blades 110 or closing the two blades 110 .
  • the second operating member can be connected with the outer tube 131 , and the movement range of the outer tube 131 in the axial direction is controlled by the second operating member, so as to retract the two blades 110 into the outer tube 131 or remove the two blades 110 from the outer tube 131 release.
  • the second operating member can be connected with the middle tube 132, and the movement range of the middle tube 132 in the axial direction is controlled by the second operating member, so as to retract the two blades 110 into the outer tube 131 or remove the two blades 110 from the outer tube 131 released.
  • the proximal end of the inner tube 133 is connected with the first operating member, and the inner tube 133 is driven to move axially along the intermediate tube 132 by the first operating member.
  • the proximal end of the middle tube 132 is fixedly connected with the handle, and the middle tube 132 is completely fixed with the handle and the driving assembly 120 without relative movement.
  • the proximal end of the outer tube 131 is connected to the second operating member, and the second operating member drives the outer tube 131 to move axially along the middle tube 132 .
  • the outer tube 131 can also be directly sleeved outside the middle tube 132 without being connected to the second operating member, and the outer tube 131 can be moved axially along the middle tube 132 by directly pulling the outer tube 131 .
  • control member 123 when the control member 123 is indirectly controlled to move toward the proximal end of the valvulotomy device 100 through the first operating member, and the outer tube 131 is moved toward the proximal end of the valvulotomy device 100 by an appropriate distance, the control member 123 can The two blades 110 are pushed apart and made into a V shape, and then the two open blades 110 are used to cut the adhered or thickened valve.
  • the opening angle C of the two blades 110 and the cutting range D of the two blades 110 can be controlled by controlling the distance that the control member 123 and the outer tube 131 move toward the proximal end of the valvulotomy device 100 .
  • the outer tube 131 can be pulled to move toward the proximal end of the valvulotomy device 100, and then the driving rod 122 is operated to drive the control member 123 to move toward the proximal end, The blade 110 will be pushed away by the control member 123 and limited by the protective ring 134 at the distal end of the outer tube 131 to the opening angle.
  • the control member 123 bears against the blades 110 on the side of the two blades 110 that face away from the cutting edge, preventing the two blades 110 from closing after being subjected to the force of the valve.
  • the control rod 122 is controlled to push the control member 123 toward the distal end of the valvulotomy device 100 , and then the outer tube 131 is pulled to the valvulotomy device 100 Distal movement, thereby closing the two blades 110 or reducing the extent to which the two blades 110 can cut the valve.
  • the included angle between the two blades 110 is between 0° and 130°.
  • the included angle between the two blades 110 is 0°, the two blades 110 are in a closed state, and the two blades 110 can be accommodated in the outer tube 131 .
  • the included angle between the two blades 110 is 130°, the opening angle of the two blades 110 reaches the maximum, and at this time, the cutting range D of the two blades 110 reaches the maximum range.
  • the maximum cutting range of the two blades 110 is between 28mm-30mm.
  • the following takes the expansion of the aortic valve 1 as an example to specifically describe the operation process of the valvulotomy device 100 of the present embodiment. It can be understood that the operation process of this embodiment is also applicable to the expansion of other valves, such as the mitral valve, the tricuspid valve, and the pulmonary valve.
  • LA indicates the left atrium
  • LV indicates the left ventricle.
  • the valvulotomy device 100 Under the guidance of external detection equipment such as CT and ultrasound, the valvulotomy device 100 is passed through the stenotic aortic valve 1, so that the two blades 110 of the valvulotomy device 100 are completely located in the aortic valve 1 close to the left ventricle LV-1 side. At this time, the two blades 110 of the valvulotomy device 100 are not opened, and the aortic valve 1 is in a stenotic state due to the calcified junction being adhered together.
  • external detection equipment such as CT and ultrasound
  • S3 operate the second operating member to slowly withdraw the outer tube 131 toward the proximal end of the valvulotomy device 100, and simultaneously operate the first operating member to pull the control member 123 toward the proximal end of the valvulotomy device 100, thereby opening the two blades 110 to A suitable angle, and under the guidance of external detection equipment such as CT and ultrasound, ensure that the cutting edge 111 on the blade 110 is aligned with the adhesion position of the aortic valve 1 .
  • the two blades 110 can be opened to a certain angle first, and then the opening angle is gradually increased to cut the aortic valve 1 .
  • Embodiment 2 is a diagrammatic representation of Embodiment 1:
  • the difference between the valvulotomy device 200 provided according to the second embodiment of the present disclosure and the valvulotomy device 100 of the first embodiment is that the structure of the mounting seat 221 a is different.
  • the valvulotomy device 200 includes two blades 210 and a driving assembly 220 .
  • the drive assembly 220 includes a mount 221a, a drive rod 223, and a control member 224.
  • the blade 210 is rotatably connected to the mount 221a.
  • the mounting seat 221 a includes a fixing portion 221 and a through groove 222 axially extending through the middle portion of the fixing portion 221 .
  • the fixing part 221 includes a platform 2211 and a boss 2212 located in the middle of the platform 2211 , the through groove 222 penetrates the boss 2212 , and the proximal ends of the two blades 210 are respectively connected to two opposite sides of the boss 2212 in rotation.
  • the boss 2212 is provided at the distal end of the platform 2211, the boss 2212 is provided with a third through hole 2213 radially passing through the boss 2212, and the connecting piece penetrates the first through hole of the blade 210 and passes through the third through hole 2213.
  • the three through holes 2213 are used to rotatably connect the blade 210 and the boss 2212 .
  • the two blades 210 are respectively rotatably connected to opposite sides of the boss 2212, and the rotational connection methods include but are not limited to connection methods such as pins, rivets, and bolts.
  • the through groove 222 penetrates through the boss 2212 and the platform 2211 in turn in the axial direction, and the driving rod can move in the axial direction in the through groove 222 .
  • the sides of the boss 2212 in contact with the two blades 210 are respectively provided with second limiting members 2214 , and the proximal ends of the blades 210 are provided with third limiting members 212 along the axial direction.
  • the third limiting member 212 abuts against the second limiting member 2214 .
  • the second limiting member 2214 may be a limiting block adjacent to the side of the boss 2212
  • the third limiting member 212 may be a limiting block disposed along the axial direction at the proximal end of the blade 210.
  • the difference between the valvulotomy device 300 provided according to the third embodiment of the present disclosure and the valvulotomy device 100 of the first embodiment is that the structure of the driving assembly 320 is different.
  • control member 323 expands radially to control the opening of the two blades 310 .
  • the opening angles of the two blades 310 are accurately controlled, thereby controlling the cutting range of the valve by the valvulotomy device 300, making the cutting more precise and controllable, and reducing the risks during the operation. Improve the success rate of surgery.
  • the valvulotomy device 300 includes a drive assembly 320, two blades 310, a tube assembly 330, and a steering assembly.
  • the tube body assembly 330 includes an inner tube 331 , a middle tube 332 sleeved on the inner tube 331 , and an outer tube 333 sleeved on the middle tube 332 .
  • the drive assembly 320 includes a mount 321 , a drive rod 322 , and a control member 323 .
  • the distal end of the driving rod 322 moves through the mounting seat 321 and is connected to the control member 323 , and the driving rod 322 and the control member 323 are located between the two blades 310 .
  • the proximal end of the driving rod 322 is fixedly connected to the inner tube 331
  • the proximal end of the mounting seat 321 is fixedly connected to the intermediate tube 332 .
  • the two blades 310 are respectively disposed on opposite sides of the mounting seat 321 , and the two blades 310 are rotatably connected to the mounting seat 321 .
  • the side of each blade 110 facing away from the other blade 110 is provided with a cutting edge 111.
  • the rotational connection between the blade 310 and the mounting seat 321 may be hinged, screwed, riveted or the like.
  • the two blades 310 are hinged with the mount 321, and the blades 310 can be rotated about the hinge point with the mount 321.
  • the hinge may be a pin-assisted welding manner.
  • the control member 323 includes a bracket 325 whose proximal end is fixedly connected with the mounting base 321 .
  • the bracket 325 is disposed between the two blades 310 , and the two blades 310 are symmetrically distributed on both sides of the bracket 325 .
  • the proximal end of the bracket 325 is fixedly connected with the distal end of the mounting seat 321 , that is, the proximal end of the bracket 325 cannot be separated from the mounting seat 321 to achieve relative movement therebetween.
  • the distal end of the bracket 325 is fixedly connected with the distal end of the driving rod 322 , the bracket 325 can expand or contract in the radial direction, and the driving rod 322 drives the bracket 325 to expand and push the two blades 310 in the radial direction.
  • the bracket 325 is axially provided with a hollow channel through which the driving rod 322 penetrates. Since the driving rod 322 penetrates the mounting seat 321, the driving rod 322 can move in the axial direction in the mounting seat 321, the proximal end of the bracket 325 is fixedly connected with the mounting seat 321, and the distal end of the bracket 325 is fixedly connected with the driving rod 322, so the bracket The distal end of 325 can follow the driving rod 322 to move in the axial direction, while the proximal end of the stent 325 is stationary relative to the mounting seat 321 , so that the stent 325 expands or contracts radially under the driving of the driving rod 322 .
  • the two blades 310 can be pushed apart, so that the two blades 310 are opened at a certain angle, so as to control the range of the two blades 310 to cut the valve.
  • the stent 325 is in the expanded state, the stent 325 is in partial contact with the two blades 310 .
  • the driving assembly 320 also includes an elastic member 324 , a sleeve 326 , and a fixed head 327 .
  • the proximal ends of the two blades 310 are rotatably connected to the opposite sides of the mounting seat 321 respectively, and the two ends of the elastic member 324 are respectively fixedly connected to the proximal ends of the two blades 310, so that the two blades 310 are connected to each other through the elastic member 324.
  • the elastic member 324 is disposed near the connection between the blade 310 and the mounting seat 321 . It can be understood that the central axis of the elastic member 324 is perpendicular to the central axis Y of the valvulotomy device 300 .
  • the two blades 310 are always subjected to a radially opposite pulling force, so that the two blades 310 tend to approach each other.
  • the central axis X of the blades 310 is parallel to the central axis Y of the valvulotomy device 300 .
  • the elastic member 324 provides elastic force to automatically close the two blades 310, thereby avoiding the failure of the instrument caused by the inability of the blades 310 to close during use.
  • the elastic member 324 can be a spring.
  • the distal end of the bracket 325 can be accommodated in the sleeve 326 and fixed with the proximal end of the sleeve 326 , and the distal end of the sleeve 326 is fixedly connected with the distal end of the driving rod 322 .
  • the bracket 325 and the driving rod 322 can be directly fixedly connected, or the bracket 325 can be indirectly fixedly connected to the driving rod 322 through the sleeve 326 .
  • the way of fixed connection includes but is not limited to the way of welding, bonding or snap ring socket.
  • the distal end of the sleeve 326 can be fixedly connected with the fixed head 327, and the fixed head 327 can be fixedly connected with the driving rod 322.
  • the fixed connection method includes but is not limited to welding or integral injection molding.
  • the function of the fixing head 327 is to ensure that the valvulotomy device 300 has good passability when entering the human body, and does not damage the inner wall of the blood vessel or other tissues.
  • the fixed head 327 may be a TIP head.
  • the distal end of the bracket 325 is driven by the fixing head 327 at the distal end of the driving rod 322 to move in the axial direction and toward the proximal end, Since the proximal end of the bracket 325 is fixed to the mounting seat 321, the proximal end of the bracket 325 does not move relative to the axial direction, so that the distance between the distal end and the proximal end of the bracket 325 will gradually decrease, and the bracket 325 will gradually decrease in the radial direction. expansion.
  • the blade 310 will be driven by the radially expanded bracket 325 to overcome the elastic force exerted by the elastic member 324 on the blade 310 to rotate around the hinge point on the mounting seat 321 , thereby opening the two blades 310 .
  • the two blades 310 are V-shaped when opened.
  • the driving rod 322 is controlled to move in the axial direction and toward the distal end, and the distal end of the bracket 325 will follow the moving direction of the driving rod 322 under the pulling of the fixed head 327 at the distal end of the driving rod 322 at the same time.
  • the distance between the distal end and the proximal end of the stent 325 is gradually increased, and the stent 325 is gradually contracted in the radial direction. Since the two blades 310 drive the elastic member 324 to stretch during the opening process, the two blades 310 in the open state are also gradually increased by the elastic force of the elastic member 324 .
  • the blade 310 When the bracket 325 is in the process of shrinking, the blade 310 will be gradually closed with the radial contraction of the bracket 325 under the elastic force of the elastic member 324 until the radial diameter of the bracket 325 reaches the minimum value, the blade 310 will also be completely closed, Return to the state it was in before opening.
  • the bracket 325 is made of shape memory materials, including shape memory materials such as nickel-titanium-based shape memory alloys, copper-nickel-based shape memory alloys, copper-aluminum-based shape memory alloys, and copper-zinc shape memory alloys. This facilitates the expansion or contraction of the stent 325 in the radial direction and has good deformability.
  • the size of the proximal end of the stent 325 after expansion is larger than the angle between the two blades 310 , which ensures that the stent 325 can push the two blades 310 and keep the two blades 310 in an open state.
  • the stent 325 can expand or contract radially when subjected to an axial force. When the stent 325 is in a retracted state, the entirety tends to be cylindrical. The stent 325 assumes a spherical shape in the expanded state.
  • the stent 325 may be a corrugated structure, a rod-like structure, a mesh-like structure, or a combination thereof.
  • the wave structure refers to a structure formed by a multi-layer combination in which wave-shaped units are connected end to end as a circle.
  • the rod-like structure is formed by interconnecting different support rods and distributed in multiple layers.
  • the mesh structure refers to a structure formed by a plurality of individual small meshes interlaced and connected to each other.
  • the bracket 325 can be processed by cutting a whole pipe, or can be formed by braiding and integrally forming. Of course, the bracket 325 can also be processed by partial weaving and partial cutting, and the parts of the bracket 325 with different processing methods can be fixed to each other by welding or by using connectors. In the third embodiment, the structure and processing method of the bracket 325 are not limited, and the structures and processing methods listed above are all applicable.
  • the stent 325 can expand or contract in the radial direction, and the stent 325 has a certain strength when it is radially expanded, it can overcome the elastic force of the elastic member 324 to open the two blades 310, and when the blade 310 is under the force of cutting the valve tissue In this case, the radial expansion state can be maintained without shrinking.

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

Abstract

La présente invention concerne un dispositif de valvulotomie (100) comprenant un ensemble d'entraînement (120) et deux lames (110). L'ensemble d'entraînement (120) comprend une base de montage (121), une tige d'entraînement (122) et un élément de commande (123) ; les extrémités proximales des deux lames (110) sont respectivement reliées de manière rotative à l'extrémité distale de la base de montage (121) ; un côté de chaque lame (110) en face de l'autre lame (110) est pourvu d'un bord de coupe (111) ; l'extrémité distale de la tige d'entraînement (122) pénètre de manière mobile dans la base de montage (121) et est reliée à l'élément de commande (123) ; la tige d'entraînement (122) et l'élément de commande (123) sont situés entre les deux lames (110) ; la tige d'entraînement (122) entraîne l'élément de commande (123) pour écarter les deux lames (110) et pour venir buter contre les deux lames (110) ; et lorsque les deux lames (110) sont dans un état ouvert, l'angle entre les deux lames (110) est inférieur à 180°.
PCT/CN2021/131250 2020-12-24 2021-11-17 Dispositif de valvulotomie et méthode de valvulotomie WO2022134955A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
CN202011552263.5A CN114668457B (zh) 2020-12-24 2020-12-24 瓣膜切开装置
CN202023157960.9U CN215384441U (zh) 2020-12-24 2020-12-24 瓣膜切开装置
CN202023157960.9 2020-12-24
CN202011552263.5 2020-12-24

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WO2022134955A1 true WO2022134955A1 (fr) 2022-06-30

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Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070185513A1 (en) * 2001-06-29 2007-08-09 Woolfson Steven B Method and apparatus for resecting and replacing an aortic valve
US20080255595A1 (en) * 2005-03-04 2008-10-16 Dale Buchbinder Valvulotome
CN102985018A (zh) * 2010-06-22 2013-03-20 勒梅特微管股份有限公司 跨线瓣膜刀
CN104352265A (zh) * 2014-11-10 2015-02-18 陈良龙 二叶经皮主动脉瓣切开器
CN206166997U (zh) * 2016-08-19 2017-05-17 上海交通大学医学院附属上海儿童医学中心 一种新型的肺动脉瓣膜切开成形器
CN211243911U (zh) * 2019-08-12 2020-08-14 杭州德晋医疗科技有限公司 可回收的瓣膜夹合器及瓣膜夹合器回收系统
CN111920550A (zh) * 2020-10-19 2020-11-13 上海介入医疗器械有限公司 一种瓣膜修复装置、递送装置及瓣膜修复系统
CN211934427U (zh) * 2019-11-19 2020-11-17 杭州德晋医疗科技有限公司 可独立控制的瓣膜夹合系统

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20070185513A1 (en) * 2001-06-29 2007-08-09 Woolfson Steven B Method and apparatus for resecting and replacing an aortic valve
US20080255595A1 (en) * 2005-03-04 2008-10-16 Dale Buchbinder Valvulotome
CN102985018A (zh) * 2010-06-22 2013-03-20 勒梅特微管股份有限公司 跨线瓣膜刀
CN104352265A (zh) * 2014-11-10 2015-02-18 陈良龙 二叶经皮主动脉瓣切开器
CN206166997U (zh) * 2016-08-19 2017-05-17 上海交通大学医学院附属上海儿童医学中心 一种新型的肺动脉瓣膜切开成形器
CN211243911U (zh) * 2019-08-12 2020-08-14 杭州德晋医疗科技有限公司 可回收的瓣膜夹合器及瓣膜夹合器回收系统
CN211934427U (zh) * 2019-11-19 2020-11-17 杭州德晋医疗科技有限公司 可独立控制的瓣膜夹合系统
CN111920550A (zh) * 2020-10-19 2020-11-13 上海介入医疗器械有限公司 一种瓣膜修复装置、递送装置及瓣膜修复系统

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