CN215384441U

CN215384441U - Valve cutting device

Info

Publication number: CN215384441U
Application number: CN202023157960.9U
Authority: CN
Inventors: 王柏栋; 丘信炯; 张庭超
Original assignee: Hangzhou Valgen Medtech Co Ltd
Current assignee: Hangzhou Valgen Medtech Co Ltd
Priority date: 2020-12-24
Filing date: 2020-12-24
Publication date: 2022-01-04
Anticipated expiration: 2030-12-24

Abstract

The utility model discloses a valve incision device. The valvotomy device comprises a drive assembly and two blades. The drive assembly includes a mount, a drive rod, and a control member. The near ends of the two blades are respectively connected with the far end of the mounting seat in a rotating way, and one side of each blade, which is far away from the other blade, is provided with a cutting edge. The distal end activity of actuating lever runs through the mount pad and is connected the control piece, and actuating lever and control piece are located between two blades, and two blades are backed up and are leaned on two blades to actuating lever drive control piece. When the two blades are in the opening state, the included angle between the two blades is less than 180 degrees. According to the valve incision device provided by the embodiment of the utility model, the contact between the knife edge and the valve is similar to point contact in the cutting process, the contact area is small, the knife edge can easily cut the valve, and the required tension is small; meanwhile, the driving rod can drive the control piece to control the opening angles of the two blades, so that the cutting range of the blades on the valve is controlled, and the cutting is more accurate and controllable.

Description

Valve cutting device

Technical Field

The utility model relates to the technical field of medical instruments, in particular to a valve incision device.

Background

Aortic stenosis is mainly caused by sequelae of rheumatic fever, congenital aortic valve dysplasia, or senile aortic valve degeneration or calcification. The aortic stenosis is classified according to different lesion structural forms, including bileaflet valve deformity, trileaflet valve deformity, etc., wherein bileaflet valve deformity is common. Referring to fig. 1, a bilobal malformation, i.e., an aortic valve inherently has only two leaflets 1, which is called a Bilobal Aortic Valve (BAV), and in the classification standard of the aortic valve, the case of a bilobal valve caused by calcific fusion in the original trilobal valve is also classified as BAV.

In the prior art, valvular stenosis is treated by cutting the valve adhesion site with a bicuspid percutaneous aortic valvulotomy device. The cutter comprises a conveying device and a cutting device capable of being contained in the conveying device, wherein the cutting device comprises two fixing frames and a blade embedded and installed on the fixing frames. When the valve needs to be cut, the two fixing frames are unfolded to form a straight line shape which is vertical to the axis of the conveying device, the blades on the fixing frames are aligned to the valve adhesion part under the ultrasonic guidance, and the blades are pulled to the aortic valve direction from the left ventricle with proper force, so that the adhered valve is cut. However, the valvulotome has the following defects in practical use:

1) the blade is in a straight line shape after being opened, and is in a parallel state with the valve, the contact area between the blade and the valve is too large, and the valve can be cut by very large pulling force.

2) The length of the opened blade is fixed and can not be changed, the length which can be cut by the valve cutter can not be changed, the cutting lengths which are respectively required by valves with different adhesion degrees are different due to different physiological anatomical structures and different calcification degrees, and the valve cutter can not effectively adjust and control the cutting length, so that the problem of incomplete cutting or excessive cutting can be caused.

SUMMERY OF THE UTILITY MODEL

In order to solve the technical problem or at least partially solve the technical problem, the utility model provides a valve incision device, which comprises a driving assembly and two blades, wherein the driving assembly comprises a mounting seat, a driving rod and a control piece, the proximal ends of the two blades are respectively and rotatably connected with the distal end of the mounting seat, one side of each blade, which is far away from the other blade, is provided with a cutting edge, the distal end and/or the proximal end of each blade form a blunt opening without cutting edges, the distal end of the driving rod movably penetrates through the mounting seat and is connected with the control piece, the driving rod and the control piece are positioned between the two blades, the driving rod drives the control piece to push the two blades open and abut against the two blades, and when the two blades are in an open state, the included angle between the two blades is less than 180 °.

Compared with the prior art, the technical scheme provided by the embodiment of the utility model has the following advantages:

in the valve cutting device provided by the embodiment of the utility model, the control part jacks the two blades and abuts against the two blades under the driving of the driving rod, so that the cutting edges of the two blades which are opposite to each other can cut the valve. On one hand, because the included angle between the two blades is less than 180 degrees when the two blades are opened, the knife edge inclines relative to the valve, the contact between the knife edge and the valve is similar to point contact in the cutting process, the contact area is small, the knife edge can easily cut the valve, and the required pulling force is small; on the other hand, the driving rod can drive the control piece to control the opening angles of the two blades, so that the cutting range of the blades on the valve is controlled, the cutting is more accurate and controllable, the risk in the operation process is reduced, and the operation success rate is improved.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the utility model and together with the description, serve to explain the principles of the utility model.

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious for those skilled in the art that other drawings can be obtained according to the drawings without inventive exercise.

In the drawings:

FIG. 1 is an aortic valve with a bileaflet valve malformation;

FIG. 2 is a schematic structural diagram of a valvulotomy device provided in accordance with an embodiment of the present invention;

FIG. 3 is a partially exploded view of a valvulotomy device provided in accordance with an embodiment of the utility model;

FIG. 4 is another structural schematic view of a valvulotomy device provided in accordance with an embodiment of the present invention;

FIG. 5 is a schematic structural diagram of a mounting base according to an embodiment of the present invention;

FIG. 6 is a schematic structural diagram of a control member according to an embodiment of the present invention;

fig. 7 and 8 are schematic structural views of a blade according to a first embodiment of the present invention;

FIG. 9 is a cross-sectional view of a valvulotomy device provided in accordance with an embodiment of the utility model;

FIG. 10 is a schematic view of another embodiment of a valvulotomy device provided in accordance with an embodiment of the utility model;

FIGS. 11-16 are schematic views illustrating the operation of a valvulotomy device provided in accordance with an embodiment of the present invention;

FIG. 17 is a schematic structural view of a valvulotomy device provided in the second embodiment of the utility model;

fig. 18 is a schematic structural diagram of a mounting base according to a second embodiment of the present invention;

FIG. 19 is a schematic structural diagram of a blade provided in accordance with a second embodiment of the present invention;

FIG. 20 is a schematic structural diagram of a valvulotomy device provided in the third embodiment of the utility model;

FIG. 21 is another structural schematic view of a valvulotomy device provided in the third embodiment of the utility model;

FIG. 22 is a partially exploded view of a valvulotomy device provided in accordance with a third embodiment of the utility model;

FIG. 23 is a schematic view of another structure of the valvulotomy device provided in the third embodiment of the utility model;

fig. 24 is a partial enlarged view at E in fig. 23;

fig. 25 to 29 are schematic structural views of a bracket according to a third embodiment of the present invention.

Detailed Description

For a more clear understanding of the technical features, objects and effects of the present invention, embodiments of the present invention will now be described in detail with reference to the accompanying drawings. In the following description, it is to be understood that the orientations and positional relationships indicated by "front", "rear", "upper", "lower", "left", "right", "longitudinal", "lateral", "vertical", "horizontal", "top", "bottom", "inner", "outer", "leading", "trailing", and the like are configured and operated in specific orientations based on the orientations and positional relationships shown in the drawings, and are only for convenience of describing the present invention, and do not indicate that the device or element referred to must have a specific orientation, and thus, are not to be construed as limiting the present invention.

It is also noted that, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," "disposed," and the like are intended to be inclusive and mean, for example, that they may be fixedly connected, detachably connected, or integrally formed; can be mechanically or electrically connected; either directly or indirectly through intervening media, either internally or in any other relationship. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element or intervening elements may also be present. The terms "first", "second", "third", etc. are only for convenience in describing the present technical solution, and are not to be construed as indicating or implying relative importance or implicitly indicating the number of technical features indicated, whereby the features defined as "first", "second", "third", etc. may explicitly or implicitly include one or more of such features. The specific meanings of the above terms in the present invention can be understood by those skilled in the art according to specific situations.

In the following description, for purposes of explanation and not limitation, specific details are set forth, such as particular system structures, techniques, etc. in order to provide a thorough understanding of the embodiments of the utility model. It will be apparent, however, to one skilled in the art that the present invention may be practiced in other embodiments that depart from these specific details. In other instances, detailed descriptions of well-known systems, devices, circuits, and methods are omitted so as not to obscure the description of the present invention with unnecessary detail.

In the description of the present invention, it should be noted that, in the field of interventional medical devices, the proximal end refers to the end closer to the operator, and the distal end refers to the end farther from the operator; axial refers to a direction parallel to the line joining the center of the distal end and the center of the proximal end of the medical device. The foregoing definitions are for convenience only and are not to be construed as limiting the present invention.

The first embodiment is as follows:

referring to fig. 2 to 16, a valvotomy device 100 according to an embodiment of the utility model comprises a driving assembly 120, two blades 110, a tube assembly 130 and an operating assembly 140.

Referring to fig. 2 to 6, 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 rotatably connected to the distal ends of the mounting seats 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 movably penetrates through the mounting seat 121 and is connected with the control member 123, the driving rod 122 and the control member 123 are located between the two blades 110, and the driving rod 122 drives the control member 123 to push the two blades 110 open and abut against the two blades 110. The angle between the two blades 110 is less than 180 ° when the two blades 110 are in the open position.

In the valvulotomy device 100, the two blades 110 are respectively rotatably connected to the mounting seat 121, and the driving rod 122 penetrates through 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 move at the distal end of the mounting seat 121. Because the two blades 110 are respectively arranged on two sides of the mounting seat 121, and the cutting edge 111 is arranged on one side of one blade 110 of the two blades 110, which is away from the other blade 110, the two blades 110 can be driven to rotate to open through the movement of the control member 123, that is, the control member 123 can push the two blades 110 open and abut against the two blades 110, so that when the two blades 110 are in an open state, an included angle between the two blades 110 is less than 180 °, and at this time, the cutting edge 111 of the two blades 110 opposite to each other can cut the valve.

On one hand, because the included angle between the two blades 110 is less than 180 degrees when the two blades 110 are opened, the knife edges 111 of the blades 110 are inclined relative to the valve, the contact between the knife edges 111 and the valve is similar to point contact in the cutting process, the contact area is small, the knife edges 111 can easily cut the valve, and the required pulling force is small; on the other hand, when the control member 123 jacks up the two blades 110 and abuts against the two blades 110, the opening angle of the blades 110 can be controlled, and the driving rod 122 can drive the contact position between the control member 123 and the two blades 110 to control the opening angle of the two blades 110, so that the cutting range of the blades 110 on the valve is controlled, the cutting is more accurate and controllable, the valve is accurately cut, the risk in the operation process is reduced, and the success rate of the operation is improved.

In the present invention, when the two blades 110 are in the open state, 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 °. Thus, when the two blades 110 are in the open state, the contact between the blade edges 111 and the valve is similar to point contact, and the contact area is small. When the two blades 110 are in the closed state, the central axis X of both blades 110 is parallel to the central axis Y of the valvotomy device 100. In this way, when the two blades 110 are in the closed state, the two blades 110 occupy as little space as possible, facilitating passage of the valvulotomy device 100 from the vessel.

Referring to fig. 5, the mounting seat 121 includes a fixing portion 1211 and a through groove 1212 axially penetrating through a middle portion of the fixing portion 1211, and the driving rod 122 is slidably disposed in the through groove 1212. A through groove 1212 is axially formed in the middle of the fixing portion 1211, the distal end of the driving rod 122 passes through the through groove 1212 to be connected to the control member 123, and the driving rod 122 can axially move along the through groove 1212, so as to drive the control member 123 to axially move. The cross-sectional shape of the through groove 1212 in the radial direction may be square, circular, or other shapes. Preferably, the cross-sectional shape of the channel 1212 in the radial direction matches the outer profile of the drive rod 122, which reduces drag between the channel 1212 and the drive rod 122, facilitating sliding of the drive rod 122 within the channel 1212. The two blades 10 are rotatably connected to opposite sides of the fixing portion 1211, respectively. When the driving rod 122 moves axially, the driving rod 122 drives the control member 123 to move towards the mounting seat 121 to push the two blades 110 open or move away from the mounting seat 121 to close the two blades 110. It should be noted that when no external force is applied to the two blades 110, the two blades 110 do not rotate freely relative to the mounting seat 121, i.e., the two blades 110 need to be switched between the open state and the closed state with the assistance of the external force, so as to avoid the damage to the tissue or the delivery catheter caused by the accidental opening of the blades 110.

Specifically, the fixing portion 1211 includes a platform 121a and protrusions 121b disposed on opposite sides of a distal end of the platform 121a, and the through groove 1212 extends through the platform 121a and is located between the two protrusions 121 b. The opposite sides of the two protrusions 121b are respectively provided with a groove 121d, and the proximal ends of the two blades 110 are respectively rotatably arranged in the two grooves 121 d. It will be appreciated that the proximal end of the blade 110 is a circular configuration and the recess 121d is a semi-circular recess to receive the proximal end of the blade 110. The blade 110 is rotatably coupled to the protrusion 121b, and the recess 121d can receive the proximal end of the blade 110 when the blade 110 rotates relative to the protrusion 121b, so that the blade 110 can rotate more smoothly to open and close the two blades 110.

The mount 121 further includes a connector 1213, the connector 1213 being used to fix the blade 110 and the tab 121b such that the blade 110 can rotate about the tab 121 b. The proximal end of the blade 110 is provided with a first through hole 112, and the projection 121b is provided with a second through hole 121 c. The connection member 1213 connects the blade 110 and the protrusion 121b through the first and second through

holes

112 and 121c so that the blade 110 can rotate relative to the protrusion 121 b. In one embodiment, the connecting members 1213 are pins. Of course, the rotational connection between the blade 110 and the protrusion 121b is not limited to the rotational connection via a connector, and may be achieved by screwing, riveting, or the like. The driving rod 122 may have a hollow sliding slot 1221 in the middle, but not through the two sides, so that when passing through the through slot 1212 of the mounting seat 121, the driving rod 122 can avoid the connecting member 1213 connecting the two blades 110 and the protrusion 121b, thereby ensuring that the driving rod 122 can move axially along the through slot 1212 of the mounting seat 121.

Referring to fig. 7 and 8, a first stopper 113 is disposed on a side of the proximal end of the blade 110 away from the blade 111, and when the central axis X of the blade 110 is parallel to the central axis Y of the valvotomy device 100, the first stopper 113 contacts the platform 121 a. Specifically, the first limiting member 113 may be a limiting member protruding from the proximal end of the blade 110, and when the two blades 110 are closed, the limiting member rotates along with the blade 110 and abuts against the platform 121 a; when the two blades 110 are in the closed state, the plane of the stopper is in close contact with the surface of the platform 121a, and the blades 110 are restricted from continuing to rotate in the direction away from the cutting edge 111. After the two blades 110 are closed, the blades 110 are rotated towards one side of the blade 111 under the action of external force, and cannot be rotated towards the direction away from the blade 111, and the arrangement of the first limiting member 113 effectively avoids the reverse rotation phenomenon which may occur in the rotation process of the blades 110, thereby improving the safety performance of the valve incision device 100.

Of course, the structure of the mounting seat 121 and the connection manner of the blade 110 and the mounting seat 121 are not limited to the embodiment, and the functions that can be realized by the cooperation of the blade 110 and the mounting seat 121 mainly include the rotation of the blade 110 around the mounting seat 121, the anti-reverse function of the blade 110, and the function of the driving rod 122 penetrating through the mounting seat 121.

Referring to fig. 6, the control member 123 includes a cylindrical structure 1231 fixedly connected to the distal end of the driving rod 122, and a tapered structure 1232 disposed at the distal end of the cylindrical structure 1231. The distal end of the driving rod 122 is fixedly connected to the column 1231 by welding, bonding, riveting, screwing, etc. The tapered structure 1232 at the distal end of the post 1231 ensures that the valvulotomy device 100 has good access to the body without damaging the inner wall of the vessel or other tissue.

The proximal end of the post 1231 has a V-shaped cut 1233 and the side of the distal end of the blade 110 facing away from the cutting edge 111 is a beveled structure 114. The driving rod 122 drives the V-shaped cut 1233 of the cylindrical structure 1231 to contact the ramp structures 114 of the two blades 110 and push the two blades 110 apart. It will be appreciated that the ramp structure 114 may be a straight ramp or a curved ramp to provide a suitable angle for the control member 123 to open the two blades 110 in the closed position. The V-shaped cut 1233 includes a first cut and a second cut. Wherein, the first tangent plane and the second tangent plane are respectively arranged obliquely and symmetrically relative to the axial direction, and the proximal ends of the first tangent plane and the second tangent plane are intersected to form a V shape. Preferably, the first and second cut planes are at the same angle relative to the axial direction.

When the driving rod 122 drives the control member 123 proximally, 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 respectively in contact with the inclined surface structures 114 of the two blades 110, and the two blades 110 are pushed away from the central axis Y of the valvotomy device 100 by the V-shaped cut surface 1233 of the control member 123 as the driving rod 22 drives the control member 123 to move further proximally, so as to open the two blades 110. Thus, the opening angle of the two blades 110 can be controlled by controlling the contact position between the V-shaped section of the control part 23 and the two blades 110, so that the cutting range of the valve is accurately controlled, and the success rate of the operation is improved.

Referring to fig. 6 and 7, the angle of the V-shaped cut 1233 is a, and it will be understood that the angle a of the V-shaped cut refers to the angle between each cut and the horizontal plane. The bevel structure 114 is inclined at an angle B relative to the central axis X of the blade 110. The angle a of the V-shaped cutting surface 1233 is greater than or equal to the inclination angle B of the bevel structure 114 relative to the central axis X of the blade 110. Therefore, the V-shaped cut surface 1233 of the control member 123 has good compliance when contacting the inclined surface structure 114 of the blade 110, and the two blades 110 can be more easily ejected by using the V-shaped cut surface 1233 of the control member 123 without the V-shaped cut surface 1233 and the inclined surface structure 114 abutting each other, thereby avoiding the problem that the two blades 110 are blocked when being opened, or enabling the two blades 110 to be opened only by a large withdrawing force.

Blade 110 is unilateral edging, and the blade can be single blade, also can be double-edged, only needs to guarantee that blade 111 has sufficient sharpness. The blade 110 is generally of equal width with the cutting edge 111 being substantially parallel to the central axis X of the blade 110. Since the cutting edge 111 completely penetrates the blade 110 and forms a sharp cutting edge at the distal end of the blade 110, when the blade 110 is opened to a maximum angle, the sharp cutting edge may scratch the blood vessel/tissue, causing serious medical accidents. Therefore, in order to prevent the occurrence of laceration of blood vessels/tissues during the cutting process, in the embodiment of the present invention, the cutting edge 111 of the blade 110 does not completely penetrate the blade 10, and an uncut blunt port is formed at the distal end and/or the proximal end of the blade 110. Preferably, the distal end of the blade 110 is configured as a smooth arc, which ensures the safety of the valvulotomy device 100 during use.

Referring to fig. 9, the tube assembly 130 includes an outer tube 131, an intermediate tube 132 movably disposed within the outer tube 131, and an inner tube 133 movably disposed within the intermediate tube 132. The distal end of inner tube 133 is fixedly attached to the proximal end of drive rod 122, and the distal end of intermediate tube 132 is fixedly attached to the proximal end of mount 121. It is understood that the outer tube 131 and the intermediate tube 132 are both hollow tubes. Thus, the inner tube 133 can be operated to axially move the driving rod 122 in the middle tube 132, so as to axially move the control member 123 to open the two blades 110 or close the two blades 110; the two blades 110 in the closed state can be retracted into the outer tube 131 by operating the middle tube 132 or the outer tube 131. When the control member 123 moves axially toward the proximal end to open the two blades 110, the distal end of the outer tube 131 may also limit the opening angle of the two blades 110, in addition to the control member 123 itself controlling the opening angle of the two blades 110.

The body assembly 130 further includes a protective ring 134, the protective ring 134 being fixedly attached to the distal end of the outer tube 131. The protection ring 134 functions to prevent the blade edge 111 of the blade 110 from contacting the distal edge of the outer tube 131 to cause damage to the contact surface when the blade 110 is opened and closed. The distal end of the outer tube 131 is fixedly connected to the protection ring 134 by 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 intermediate tube 132 is received in the outer tube 131, and the distal end of the intermediate tube 132 is fixedly connected to the proximal end of the mounting seat 121 by means including, but not limited to, bonding, welding, etc. The intermediate tube 132 is also axially movable relative to the outer tube 131 and the inner tube 133.

The inner tube 133 is received in the intermediate tube 132, and the inner tube 133 is axially movable relative to the intermediate tube 132. The inner tube 133 may be a solid tube or a hollow tube. The inner tube 133 has good compliance, high tensile strength, and good push performance. The inner tube 133 includes, but is not limited to, one or more of a flexible steel tube, a spring-loaded tube with a mandrel, a helical hollow multi-strand wire, and a mechanical flexible shaft. The distal end of inner tube 133 is fixedly attached to the proximal end of drive rod 122 by means including, but not limited to, welding, gluing, welding, etc. Of course, the driving rod 122 and the inner tube 133 may be integrally formed, so that the driving of the driving rod 122 is more stable, and the success rate of the operation is improved.

The valvotomy device 100 further comprises an operating assembly 140, wherein the operating assembly 140 comprises a handle and a first operating member and a second operating member arranged on the handle. A first operating member is connected to the proximal end of the inner tube 133 and a second operating member is connected to the proximal end of the intermediate tube 132 or the outer tube 131. Thus, the range of the axial movement of the inner tube 133 can be controlled by controlling the first operating member, and since the driving rod 122 is connected to the inner tube 133, the first operating member can indirectly control the driving rod 122, so that the driving rod 122 drives the control member 123 to move in the axial direction, thereby opening the two blades 110 or closing the two blades 110. The second operating member may be coupled to the outer tube 131, and controls a range of movement of the outer tube 131 in the axial direction by the second operating member, thereby retracting the two blades 110 into the outer tube 131 or releasing the two blades 110 from the outer tube 131. Of course, a second operating member may be connected to the middle tube 132, and the range of movement of the middle tube 132 in the axial direction is controlled by the second operating member, thereby retracting the two blades 110 into the outer tube 131 or releasing the two blades 110 from the outer tube 131.

In one embodiment, the proximal end of the inner tube 133 is coupled to a first operating member, by which the inner tube 133 is moved axially along the intermediate tube 132. The proximal end of the intermediate tube 132 is fixedly attached to the handle, and the intermediate tube 132 is completely fixed from relative movement with the handle and the drive assembly 120. The proximal end of the outer tube 131 is connected to a second operating member, by which the outer tube 131 is driven to move axially along the intermediate tube 132. Of course, the outer tube 131 may also be directly sleeved outside the middle tube 132, and is not connected to the second operating member, and the outer tube 131 is directly pulled to realize the axial movement of the outer tube 131 along the middle tube 132.

In operation, when the control member 123 is indirectly controlled by the first operating member to move towards the proximal end of the valvulotomy device 100, and the outer tube 131 moves towards the proximal end of the valvulotomy device 100 by a suitable distance, the control member 123 can push the two blades 110 open and make the two blades 110 form a V shape, so that the two opened blades 110 can be used for cutting the adhered or thickened valve.

Referring to fig. 10, the angle C at which the two blades 110 are open and the range D at which the two blades 110 cut can be controlled by controlling the control member 123 and the distance the outer tube 131 moves towards the proximal end of the valvulotomy device 100. When two blades 110 are required to open a larger angle to cut a larger range of valves, the outer tube 131 can be pulled to move towards the proximal end of the valvulotomy device 100, and then the driving rod 122 is operated to move the control member 123 towards the proximal end, so that the blades 110 are pushed open by the control member 123 and limited in the opening angle by the protection ring 134 at the distal end of the outer tube 131. At the same time, the control member 123 abuts against the blades 110 on the side of the blades 110 facing away from the knife edge, preventing the blades 110 from closing after being subjected to the force of the valve. When it is desired to close both blades 110 or to reduce the extent to which both blades 110 cut the valve, the control rod 122 is controlled to push the control member 123 towards the distal end of the valvulotomy device 100, and then the outer tube 131 is pulled to move towards the distal end of the valvulotomy device 100, thereby closing both blades 110 or reducing the extent to which both blades 110 cut the valve.

Preferably, the included angle between the two blades 110 is between 0 ° and 130 °. When 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 received in the outer tube 131. When the included angle between the two blades 110 is 130 °, the opening angle of the two blades 110 is maximized, and the cutting range D of the two blades 110 is maximized. Preferably, the maximum cutting range of the two blades 110 should be between 28mm and 30 mm.

Referring to fig. 11 to 16, the following describes the operation of the valvotomy device 100 according to the present embodiment, taking the expansion of the aortic valve 1 as an example. It will be appreciated that the procedure of the present embodiment is also applicable to the dilation of other valves, such as the mitral valve, tricuspid valve, pulmonary valve, and the like. In the figure, LA denotes the left atrium and LV denotes the left ventricle.

S1: puncture in femoral artery through the puncture ware, after the puncture is accomplished, reach aortic valve 1 through femoral artery through the aortic arch with transferring curved conveyor.

S2: the valvotomy device 100 is guided by external detection equipment such as CT, ultrasound, etc. to pass through the stenotic aortic valve 1, so that the blades 110 of the valvotomy device 100 are completely positioned on the side of the aortic valve 1 close to the left ventricle LV. At this time, the blades 110 of the valvulotomy device 100 are not opened, and the aortic valves 1 are stuck together due to calcified junctions, so that the aortic valves 1 are in a narrow state.

S3: the second operating member is operated to slowly withdraw the outer tube 131 towards the proximal end of the valvulotomy device 100, and the first operating member is operated to pull the control member 123 towards the proximal end of the valvulotomy device 100, thereby opening the two blades 110 to a proper angle and ensuring that the blade edges 111 are aligned with the adhesion position of the aortic valve 1 under the guidance of external detection equipment such as CT, ultrasound, etc. Of course, in order to ensure the cutting effect of the aortic valve 1, the two blades 110 may be opened to a certain angle, and then the opening angle is slowly increased to cut the aortic valve 1.

S4: after the knife edges 111 are completely positioned, the handle is held and the aortic valve 1 incision device 100 is slowly pulled from the left atrium LA to the aorta by proper force, and the knife edges 111 on the blades 110 are used to cut off the adhered or thickened aortic valve 1. In the process of pulling the valve incision device 100, the opening angle C of the blades 110 is continuously adjusted in the above manner according to the detection results of external detection equipment such as CT and ultrasound, and the expansion of the opening angles of the two blades 110 is stopped until the cutting effect reaches an ideal value, thereby completing the final cutting.

S5: when the cutting and expanding of the aortic valve 1 reach the desired effect, the first and second operating members are operated to completely close the two blades 110 and ensure that the two blades 110 are completely retracted into the outer tube 131, and then the valvulotomy device 100 and the entire bending conveyor are withdrawn outside the body.

Example two:

referring to fig. 17 to 19, a valvulotomy device 200 according to a second embodiment of the present invention is different from the valvulotomy device 100 of the first embodiment in that a mounting seat 221a has a different structure.

In this embodiment, the valvotomy device 200 comprises two blades 210 and a drive assembly 220. Drive assembly 220 includes a mount 221a, a drive rod 223, and a control member 224. The blade 210 is rotatably coupled to the mounting seat 221 a. The mounting seat 221a includes a fixing portion 221 and a through groove 222 axially penetrating through a middle portion of the fixing portion 221. The fixing portion 221 includes a platform 2211 and a boss 2212 disposed in the middle of the platform 2211, the through slot 222 penetrates through the boss 2212, and the proximal ends of the two blades 210 are respectively rotatably connected to two opposite sides of the boss 2212.

Specifically, the boss 2212 is disposed at the distal end of the platform 2211, the boss 2212 is provided with a third through hole 2213 radially penetrating the boss 2212, and the connecting member penetrates the first through hole of the blade 210 and penetrates the third through hole 2213 to rotatably connect the blade 210 with the boss 2212. The two blades 210 are rotatably connected to opposite sides of the boss 2212, respectively, and the rotatable connection includes, but is not limited to, pins, rivets, bolts, and the like. The through slot 222 axially penetrates through the boss 2212 and the platform 2211 in sequence, and the driving rod can axially move in the through slot 222.

The side surfaces of the boss 2212, which are in contact with the two blades 210, are respectively provided with a second stopper 2214, and the proximal end of the blade 210 is provided with a third stopper 212 along the axial direction. When the central axis X of the blade 210 is parallel to the central axis Y of the valvotomy device 200, the third stop member 212 abuts against the second stop member 2214. Specifically, the second retaining member 2214 may be a retaining member next to the side surface of the boss 2212, and the third retaining member 212 may be a retaining member disposed at the proximal end of the blade 210 along the axial direction, so that when the two blades 210 are completely closed, the side surfaces of the two retaining members abut against each other and contact each other, and the blade 210 is prevented from continuing to rotate in the direction away from the cutting edge 211. In this way, it is ensured that the blades 210 can only rotate towards the blade edge 211 when the two blades 210 are closed, the possibility of reverse rotation of the blades 210 is avoided, and the safety of the valvotomy device 200 is improved.

Example three:

referring to fig. 20 to 29, a valvulotomy device 300 according to a third embodiment of the utility model is different from the valvulotomy device 100 of the first embodiment in that the driving assembly 320 has a different structure.

In this embodiment, the control member 323 is radially expanded to control the opening of the two blades 310. The opening angle of the two blades 310 is accurately controlled by controlling the radial expansion degree of the control part 323, so that the cutting range of the valve cutting device 300 on the valve is controlled, the cutting is more accurate and controllable, the risk in the operation process is reduced, and the operation success rate is improved.

Referring to fig. 20-24, the valvulotomy device 300 includes a drive assembly 320, two blades 310, a tube assembly 330, and a steering assembly. The tube assembly 330 includes an inner tube 331, an intermediate tube 332 sleeved on the inner tube 331, and an outer tube 333 sleeved on the intermediate tube 332. The driving assembly 320 includes a mounting seat 321, a driving rod 322, and a control member 323. The distal end of the driving rod 322 movably penetrates through the mounting seat 321 and is connected with 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 with the inner tube 331, and the proximal end of the mounting seat 321 is fixedly connected with the middle tube 332.

The two blades 310 are respectively arranged on two opposite sides of the mounting seat 321, and the two blades 310 are rotatably connected with the mounting seat 321. The side of each blade 110 facing away from the other blade 110 is provided with a cutting edge 111, and when the two blades 310 rotate relative to the mounting seat 321, the distal ends of the two blades 310 move away from the central axis Y of the valvotomy device 300 in opposite directions. The rotational connection between the blade 310 and the mounting seat 321 may be hinged, screwed, riveted, etc. Preferably, two blades 310 are hinged to the mounting seat 321, and the blades 310 can rotate around the hinge point with the mounting seat 321, and the preferred hinge mode can be a pin-assisted welding mode.

Referring to fig. 20 and 21, control member 323 includes a bracket 325 having a proximal end fixedly coupled to mount 321. The shelf 325 is disposed between two blades 310, and the two blades 310 are symmetrically disposed on both sides of the shelf 325. The proximal end of the support 325 is fixedly connected to the distal end of the mounting seat 321, i.e., the proximal end of the support 325 cannot be separated from the mounting seat 321 to achieve relative movement therebetween. The distal end of the stent 325 is fixedly connected to the distal end of the driving rod 322, the stent 325 can be expanded or contracted in the radial direction, and the driving rod 322 drives the stent 325 to expand in the radial direction to push the two blades 310 open.

It will be appreciated that the bracket 325 is axially provided with a hollow passage through which the drive rod 322 extends. Since the driving rod 322 penetrates the mounting seat 321, the driving rod 322 can move axially 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 that the distal end of the bracket 325 can move axially along with the driving rod 322, and the proximal end of the bracket 325 is stationary relative to the mounting seat 321, so that the bracket 325 expands or contracts radially under the driving of the driving rod 322. The stent 325, when in a radially expanded state, may push the two blades 310 apart, such that the two blades 310 open at an angle, thereby controlling the extent to which the two blades 310 cut the valve. When the stent 325 is in the expanded state, there is local contact between the stent 325 and the two blades 310.

Drive assembly 320 also includes a spring 324, a sleeve 326, and a retaining head 327. The proximal ends of the two blades 310 are rotatably connected to opposite sides of the mounting seat 321, and both ends of the elastic member 324 are fixedly connected to the proximal ends of the two blades 310, respectively, so that the two blades 310 are connected to each other through the elastic member 324. The resilient member 324 is disposed proximate to the connection of the blade 310 and the mount 321. It will be appreciated that the central axis of the resilient member 324 is perpendicular to the central axis Y of the valvotomy device 300. The elastic force of the elastic member 324 in the radial direction will always make the two blades 310 to be subjected to a tensile force in the radial direction, so that the two blades 310 have a tendency to approach each other. Thus, when the two blades 310 are in the closed state, the central axis X of the blades 310 is parallel to the central axis Y of the valvotomy device 300. When the stent 325 changes from radial expansion to radial contraction, the elastic member 324 provides elasticity to enable the two blades 310 to be automatically closed, so that the failure of the instrument caused by the fact that the blades 310 cannot be closed in the using process is avoided. The elastic member 324 may be a spring.

The distal end of the carrier 325 is receivable within a sleeve 326 and is secured to the proximal end of the sleeve 326, and the distal end of the sleeve 326 is fixedly coupled to the distal end of the drive rod 322. It is understood that the bracket 325 may be fixedly connected to the driving rod 322 directly, or the bracket 325 may be fixedly connected to the driving rod 322 indirectly through the sleeve 326. Means of securing the connection include, but are not limited to, welding, gluing, or snap-fit. Further, the distal end of the sleeve 326 may be fixedly connected to a fixed head 327, and the fixed head 327 is fixedly connected to the driving rod 322, and the fixed connection includes, but is not limited to, welding or integral injection molding. The purpose of the fixation head 327 is to ensure that the valvulotomy device 300 has good passability through the body without damaging the inner wall of the vessel or other tissue. Fixed head 327 may be a TIP head.

When it is desired to open the two blades 310, and the driving rod 322 moves axially and proximally, the distal end of the support 325 moves axially and proximally under the driving of the fixing head 327 at the distal end of the driving rod 322, while the proximal end of the support 325 does not move axially relative to the mounting seat 321 because the proximal end of the support 325 is fixed to the mounting seat 321, so that the distance between the distal end and the proximal end of the support 325 is gradually reduced, and the support 325 is gradually expanded in the radial direction. At this time, the blade 310 is driven by the radially expanded bracket 325 to overcome the elastic force applied to the blade 310 by the elastic member 324, so as to rotate around the hinge point on the mounting seat 321, thereby opening the two blades 310. The two blades 310 assume a V-shape when opened.

When it is desired to close both blades 310, the driving rod 322 is controlled to move axially and distally, and the distal end of the holder 325 will follow the moving direction of the driving rod 322 simultaneously and axially and distally under the pull of the fixing head 327 at the distal end of the driving rod 322, so that the distance between the distal end and the proximal end of the holder 325 is gradually increased and the holder 325 is gradually contracted in the radial direction. Since the two blades 310 drive the elastic member 324 to be stretched during the opening process, the two blades 310 in the opened state are gradually increased by the elastic force of the elastic member 324. When the support 325 is contracted, the blade 310 will gradually close along with the radial contraction of the support 325 under the elastic force of the elastic member 324, until the radial diameter of the support 325 reaches the minimum value, and the blade 310 will be completely closed and return to the state before being opened.

The stent 325 is made of shape memory material, including shape memory materials such as nickel-titanium based shape memory alloy, copper-nickel based shape memory alloy, copper-aluminum based shape memory alloy, copper-zinc based shape memory alloy, and the like. This facilitates expansion or contraction of the stent 325 in the radial direction, with good deformability. The expanded proximal dimension of the stent 325, which is larger than the angle between the two blades 310, ensures that the stent 325 can push the two blades 310 apart, keeping the two blades 310 open.

Referring to fig. 25-29, stent 325 may expand or contract radially when subjected to an axial force. The carrier 325 in its contracted state is generally cylindrical in shape. Stent 325 assumes a balloon shape in the expanded state. Specifically, the scaffold 325 may be a wave structure, a rod structure, a mesh structure, or a combination thereof. The wave-shaped structure is formed by combining a plurality of layers of wave-shaped units which are connected end to end into a circle. Referring to fig. 25 to 27, the rod-shaped structure is a structure in which different support rods are connected to each other and distributed in multiple layers. Referring to fig. 28 and 29, the mesh structure refers to a structure formed by a plurality of individual cells being connected to each other in a staggered manner.

The stent 325 may be formed by cutting the entire tube or by weaving the entire tube. Of course, the stent 325 may also be processed by partially weaving and partially cutting, and the portions of the stent 325 processed in different manners may be fixed to each other by welding or by using a connecting member. In the third embodiment, the structure and the processing method of the holder 325 are not limited, and the above-listed structures and processing methods are all applicable. As long as the stent 325 can be expanded or contracted in the radial direction, and the stent 325 has a strength to overcome the elastic force of the elastic member 324 when being expanded in the radial direction so as to open the two blades 310, and can maintain the radially expanded state without being contracted when the blades 310 are subjected to the force for cutting the valve tissue.

It is to be understood that the foregoing examples, while indicating the preferred embodiments of the utility model, are given by way of illustration and description, and are not to be construed as limiting the scope of the utility model; it should be noted that, for those skilled in the art, the above technical features can be freely combined, and several changes and modifications can be made without departing from the concept of the present invention, which all belong to the protection scope of the present invention; therefore, all equivalent changes and modifications made within the scope of the claims of the present invention should be covered by the claims of the present invention.

Claims

1. The valve incision device is characterized by comprising a driving assembly and two blades, wherein the driving assembly comprises a mounting seat, a driving rod and a control piece, the near ends of the two blades are respectively connected with the far end of the mounting seat in a rotating mode, one side, deviating from the other blade, of each blade is provided with a cutting edge, the far end and/or the near end of each blade form a blunt port without cutting edges, the far end of each driving rod penetrates through the mounting seat and is connected with the control piece, the driving rod reaches the control piece, the control piece is located between the two blades, the driving rod drives the control piece to open the two blades and abut against the two blades, and when the two blades are in an opening state, the included angle between the two blades is smaller than 180 degrees.

2. The valvotomy device according to claim 1, wherein the mounting seat comprises a fixing part and a through groove axially penetrating the middle part of the fixing part, the driving rod is slidably arranged in the through groove, and the two blades are respectively and rotatably connected to two opposite sides of the fixing part.

3. The valvulotomy device according to claim 1 or 2, wherein when the two blades are in the closed state, the central axes of the two blades are parallel to the central axis of the valvulotomy device, the control member comprises a columnar structure fixedly connected with the distal end of the driving rod, the proximal end of the columnar structure has a V-shaped tangential surface, the side of the distal end of the blade, which is away from the cutting edge, is a bevel structure, and the driving rod drives the V-shaped tangential surface of the columnar structure to contact with the bevel structures of the two blades and push the two blades away.

4. The valvulotomy device of claim 3, wherein 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.

5. The valvulotomy device according to claim 2, wherein the fixing portion comprises a platform and projections arranged on opposite sides of a distal end of the platform, the through groove penetrates through the platform and is located between the two projections, grooves are respectively arranged on opposite sides of the two projections, and proximal ends of the two blades are respectively rotatably arranged in the two grooves.

6. The valvulotomy device according to claim 5, wherein a first stop is provided on a side of the proximal end of the blade facing away from the blade edge, and the first stop is in contact with the platform when the central axis of the blade is parallel to the central axis of the valvulotomy device.

7. The valvulotomy device according to claim 2, wherein the fixing part comprises a platform and a boss arranged in the middle of the platform, the through groove penetrates through the boss, and the proximal ends of the two blades are respectively rotatably connected to two opposite sides of the boss.

8. The valve incision device of claim 7, wherein a second stop is disposed on a side surface of the boss contacting the two blades, a third stop is axially disposed on a proximal end of the blades, and the third stop abuts against the second stop when a central axis of the blades is parallel to a central axis of the valve incision device.

9. The valvulotomy device according to claim 1 or 2, wherein the control member comprises a stent fixedly connected at a proximal end to the mounting block, and at a distal end to the drive rod, the stent being radially expandable or contractible, and the drive rod driving the stent to radially expand against the two blades.

10. The valvotomy device according to claim 9, wherein 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.

11. The valvulotomy device according to claim 9, wherein the drive assembly further comprises a sleeve, wherein the distal end of the stent is received in the sleeve and is fixed to the proximal end of the sleeve, and the distal end of the sleeve is fixedly connected to the distal end of the drive rod.

12. The valvulotomy device according to claim 9, wherein the driving assembly further comprises an elastic member, the proximal ends of the two blades are respectively rotatably connected to two opposite sides of the mounting seat, two ends of the elastic member are respectively fixedly connected with the proximal ends of the two blades, and the elastic member is disposed near the connection between the blades and the mounting seat.

13. The valve incision device of claim 1, further comprising a tube assembly, wherein the tube assembly comprises an outer tube, an intermediate tube movably disposed within the outer tube, and an inner tube movably disposed within the intermediate tube, wherein a distal end of the inner tube is fixedly connected to a proximal end of the drive rod, and a distal end of the intermediate tube is fixedly connected to a proximal end of the mounting base.

14. The valvulotomy device of claim 13, wherein the tube assembly further comprises a protection ring fixedly connected to the distal end of the outer tube.

15. The valvulotomy device of claim 13, further comprising an operating assembly, wherein the operating assembly comprises a handle and a first operating member and a second operating member disposed on the handle, the first operating member being connected to the proximal end of the inner tube, and the second operating member being connected to the proximal end of the intermediate tube or the outer tube.