Valvulotome

Abstract

The present invention discloses a valvulotome. The valvulotome includes a blade assembly, and the blade assembly includes a connecting shaft, at least two blades, and a connecting rod mechanism connecting the blades and the connecting shaft. The blade edge of the blade faces away from the connecting shaft, and the blade edge is parallel to or inclined to the central axis of the connecting shaft. The connecting shaft drives the connecting rod mechanism to drive each blade to move radially by axial movement. In the valvulotome of the present invention, the connecting shaft drives the connecting rod mechanism to move axially to drive the blade to move radially, thereby opening or retracting the blade through the connecting rod mechanism. On the one hand, the blade edge is parallel to or inclined to the central axis of the connecting shaft, the contact area between the blade and the valve is small, and the required pulling force is small, which can effectively improve the cutting efficiency; on the other hand, the blade assembly can be fully extended into the valve opening, and the blade is slowly opened to cut the adhesion of the valve, thereby controlling the cutting range of the valve, and the cutting is accurate, avoiding the problem of incomplete cutting or excessive cutting.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and in particular, relates to a valvulotome. Background Art

[0002] Congenital aortic stenosis is caused by valve development disorder and thickening and adhesion of valve leaflets. About 20% of cases are combined with heart malformations such as patent ductus arteriosus and coarctation of aorta. The basic lesions are different degrees of thickening of valve tissue and junction adhesion, which can be divided into bicuspid valve malformation, tricuspid valve malformation and other malformations. Among them, bicuspid valve malformation is the most common, accounting for about 70%, and is mostly biased to the back.

[0003] In the prior art, a bileaflet percutaneous aortic valvulotome is used to treat valvular stenosis by cutting the adhesion site of the valve. The valvulotome includes a conveying device and a cutting device that can be received in the conveying device, and the cutting device includes two fixing frames and a blade mounted on the fixing frames. When the valve needs to be cut, the two fixing frames are unfolded to form a straight line perpendicular to the axis of the conveying device, and the blade on the fixing frame is aligned with the adhesion site of the valve under ultrasound guidance, and the blade is pulled from the left ventricle to the aortic valve with appropriate force, thereby cutting the adhesion valve. However, this structure has the following defects in actual use:

[0004] (1) Since the blade is in a straight line shape after opening and is parallel to the valve, the contact area between the blade and the valve is too large, and a large pulling force is required to cut the valve, resulting in low cutting efficiency.

[0005] (2) The length of the blade after opening is fixed and cannot change, so the length that the cutter can cut cannot change. However, valves with different physiological and anatomical structures, different degrees of calcification, and different degrees of adhesion should each require different cutting lengths. The structure of the cutter cannot effectively adjust and control the cutting length, which may lead to incomplete cutting or excessive cutting.

[0006] In view of this, there is an urgent need to improve the structure of the existing valvulotome to improve the cutting efficiency and adjust the cutting length as needed. Summary of the invention

[0007] A main purpose of the present invention is to overcome the defects of low cutting efficiency and inability to adjust the cutting length of the valvulotome in the above-mentioned prior art, and to provide a valvulotome, including a blade assembly, the blade assembly including a connecting shaft, at least two blades and a connecting rod mechanism connecting the blades and the connecting shaft, the blade edges of the blades face away from the connecting shaft, the blade edges are parallel to or inclined to the central axis of the connecting shaft, and the connecting shaft drives the connecting rod mechanism to move radially by axial movement.

[0008] The beneficial effect of the valve cutter of the present invention is that the connecting shaft drives the connecting rod mechanism to move axially and drives the blade to move radially, thereby opening or retracting the blade through the connecting rod mechanism. On the one hand, because the blade edge is parallel or inclined to the central axis of the connecting shaft, the blade and the valve are in a vertical or inclined state, and the contact between the blade and the valve is similar to point contact, the contact area is small, and the required pulling force is small. The blade can easily cut the valve, which can effectively improve the cutting efficiency; on the other hand, the blade assembly can be fully extended into the valve orifice, and the blade is slowly opened to cut the valve adhesion, thereby controlling the cutting range of the valve, cutting accurately, and avoiding the problem of incomplete cutting or excessive cutting. BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments consistent with the invention and, together with the description, serve to explain the principles of the invention.

[0010] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0011] Figure 1 This is a partial cross-sectional schematic diagram of the valvulotome according to the first embodiment of the present invention placed in the bending adjustment sheath.

[0012] Figure 2 This is a schematic diagram of the blade assembly of the valvulotome according to the first embodiment of the present invention extending out of the bending adjustment sheath.

[0013] Figure 3 This is a schematic diagram of the structure of the blade assembly according to the first embodiment of the present invention.

[0014] Figure 4 This is a schematic diagram of the exploded view of the blade assembly according to the first embodiment of the present invention.

[0015] Figure 5 This is a schematic structural diagram of the first support according to the first embodiment of the present invention.

[0016] Figure 6 It is a schematic structural diagram of the second support according to the first embodiment of the present invention.

[0017] Figure 7 It is a cross-sectional schematic diagram of an operating component according to the first embodiment of the present invention.

[0018] Figure 8 It is a partial cross-sectional schematic diagram of the valvulotome according to the first embodiment of the present invention.

[0019] Fig. 9It is an enlarged schematic diagram of part A of Example 1 of the present invention.

[0020] Fig.10 The figure is a schematic diagram of the movement of a single blade in the blade assembly according to the first embodiment of the present invention.

[0021] Fig.11 This is a schematic diagram of the structure of the handle of Embodiment 1 of the present invention.

[0022] Fig.12 This is a schematic diagram of an exploded view of the handle of the first embodiment of the present invention.

[0023] Fig.13 Schematic cross-sectional view of the bending adjustment sheath according to the first embodiment of the present invention.

[0024] Fig.14 Schematic diagram of the approach of the valvulotome according to the first embodiment of the present invention.

[0025] Fig.15 This is a schematic diagram of the blade assembly according to the first embodiment of the present invention entering the aortic valve.

[0026] Fig.16 This is a schematic diagram of the cutting process of the blade assembly according to the first embodiment of the present invention.

[0027] Fig.17 This is a schematic diagram of the cutting completion of the blade assembly according to the first embodiment of the present invention.

[0028] Fig.18 This is a schematic diagram of the incision process of the aortic valve with bicuspid valve deformity according to the first embodiment of the present invention.

[0029] Fig.19 It is a schematic top view of a blade assembly according to the second embodiment of the present invention.

[0030] Fig. 20 This is a schematic diagram of the structure of the blade assembly according to the second embodiment of the present invention.

[0031] Fig.21 It is a schematic structural diagram of the first support according to the second embodiment of the present invention.

[0032] Fig. 22 It is a schematic structural diagram of the second support according to the second embodiment of the present invention.

[0033] Fig.23 This is a schematic diagram of the blade assembly of the second embodiment of the present invention entering the aortic valve.

[0034] Fig.24 This is a schematic diagram of the cutting process of the blade assembly according to the second embodiment of the present invention.

[0035] Fig.25 This is a schematic diagram of the incision process of the aortic valve with tricuspid valve deformity according to the second embodiment of the present invention.

[0036] Fig.26 It is a cross-sectional schematic diagram of an operating component of Embodiment 3 of the present invention.

[0037] Fig. 27 It is a partial cross-sectional schematic diagram of the valvulotome according to the third embodiment of the present invention.

[0038] Fig.28 It is an enlarged schematic diagram of part B of embodiment 3 of the present invention.

[0039] Fig.29 The figure is a schematic diagram of the movement of a single blade in the blade assembly of the third embodiment of the present invention.

[0040] Fig.30 This is a schematic diagram of an exploded view of the handle of the third embodiment of the present invention.

[0041] Fig.31 It is a cross-sectional schematic diagram of the rotating knob of the third embodiment of the present invention.

[0042] Fig.32 This is a schematic structural diagram of a first sliding member and a second sliding member in accordance with a third embodiment of the present invention.

[0043] Fig.33 This is a cross-sectional schematic diagram of the handle of the third embodiment of the present invention. DETAILED DESCRIPTION

[0044] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0045] It should be noted that, unless otherwise clearly specified and limited, the terms such as "installed", "connected", "connected", "fixed", "set" and the like should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral one; it can be directly connected, or indirectly connected through an intermediate medium, and it can be the internal connection of two elements or the interaction relationship between two elements. When an element is referred to as being "on" or "under" another element, the element can be "directly" or "indirectly" located on the other element, or there may be one or more intervening elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to the specific circumstances.

[0046] In the description of the present invention, it still needs to be explained that the proximal end refers to the end of the instrument or component close to the operator, and the distal end refers to the end of the instrument or component away from the operator; the axial direction refers to the direction parallel to the line connecting the distal and proximal centers of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential direction refers to the direction surrounding the axial direction.

[0047] In order to overcome the defects of low cutting efficiency and inability to adjust cutting length of valvulotome in the prior art, the present invention discloses a valvulotome, which is described in detail below through specific embodiments and drawings.

[0048] Embodiment 1

[0049] See also Figure 1 and Figure 2 The first embodiment of the present invention discloses a valvulotome 1000, which can be used to treat aortic valve stenosis, such as dilatation of aortic valve with bicuspid valve malformation and dilatation of aortic valve with tricuspid valve malformation. Of course, it can also be used to dilate other valves, such as mitral valve, tricuspid valve, pulmonary valve, etc. Figure 3 and Figure 4 The valvulotome 1000 includes a blade assembly 100, which includes a connecting shaft 110, two blades 120, and a connecting rod mechanism 130 connecting the blades 120 and the connecting shaft 110. The blade edge 121 of the blade 120 is away from the connecting shaft 110, and the blade edge 121 is parallel to or inclined to the central axis of the connecting shaft 110. The connecting shaft 110 drives the connecting rod mechanism 130 to drive each blade 120 to move radially by axial movement.

[0050] In the valvulotome 1000 of the present invention, the connecting shaft 110 drives the link mechanism 130 to move axially and drives the blade 120 to move radially, so that the blade 120 is opened or retracted through the link mechanism 130. On the one hand, since the blade 121 of the blade 120 is parallel or inclined to the central axis of the connecting shaft 110, the blade 120 and the valve are in a vertical or inclined state, and the contact between the blade 121 and the valve is similar to point contact, with a small contact area and a small required pulling force. The blade 121 can easily cut the valve, which can effectively improve the cutting efficiency; on the other hand, the blade assembly 100 can be fully extended into the valve orifice, and the blade 120 can be slowly opened to cut the adhesion of the valve, thereby controlling the cutting range of the valve, and the cutting is accurate, avoiding the problem of incomplete cutting or excessive cutting.

[0051] It can be understood that the valvulotome 1000 of the present invention has a simple structure and is easy to use. It can greatly reduce the time of valve cutting and avoid excessive bleeding. During surgery, the axial movement of the connecting shaft 110 can be controlled to adjust the radial movement distance of the blade 120 as needed, thereby adjusting the radial opening size of the blade 120 to control the cutting length of the valve. The central axis of the connecting shaft 110 extends along the axial direction of the valvulotome 1000. The blade 121 of the blade 120 is away from the connecting shaft 110 and is parallel or inclined to the central axis of the connecting shaft 110, and the back of the blade 120 can be parallel to the central axis of the connecting shaft 110. The blade 120 is driven by the connecting shaft 110 to move radially through the connecting rod mechanism 130. Therefore, when cutting the valve adhesion, the blade 120 and the valve are kept in a substantially vertical state, which can avoid damaging the inner wall of the heart or other tissues.

[0052] The blade 121 is parallel to the central axis of the connecting shaft 110, that is, the overall radial size of the blade 120 is consistent. The blade 121 is inclined to the central axis of the connecting shaft 110, that is, the radial size of the blade 120 gradually increases or decreases from the distal end to the proximal end. Preferably, the radial size of the blade 120 gradually increases from the distal end to the proximal end, which facilitates the distal end of the blade assembly 100 to enter the valve orifice with a smaller size, and the valve can be gradually cut as the blade assembly 100 extends. In this embodiment, the blade 121 is parallel to the central axis of the connecting shaft 110. It should be pointed out that in the present invention, inclination does not include verticality, and the blade 121 is inclined to the central axis of the connecting shaft 110, which means that the blade 121 forms an acute angle or an obtuse angle with the central axis of the connecting shaft 110. The blade assembly 100 can be made of metal material as a whole, or the blade 120 is made of metal material, and other components can be made of polymer material.

[0053] It is worth mentioning that the valvulotome 1000 should be guided to the treatment site by external images, such as computed tomography (CT), fluoroscopy, intravascular ultrasound (IVUS), optical coherence tomography (OCT), intracardiac echocardiography (ICE), etc. Therefore, a developing portion should be provided on at least one blade 120, and the developing portion can be provided at the proximal end or the distal end of the blade 120, and the developing material is preferably a metal material such as platinum, platinum, and tantalum.

[0054] See also Figure 4-6 The connecting rod mechanism 130 includes a first support 131, a second support 132 and two groups of connecting rods. Each group of connecting rods includes at least two parallel first connecting rods 133 and one second connecting rod 134. Each blade 120 is rotatably connected to the first support 131 through the first connecting rod 133 and is rotatably connected to the second support 132 through the second connecting rod 134. The connecting shaft 110 is movably arranged in the first support 131, and the distal end of the connecting shaft 110 is fixed to the second support 132.

[0055] In this embodiment, with the axial movement of the connecting shaft 110 and the second support 132, in each group of connecting rods, the second connecting rod 134 performs synchronous action to drive the blade 120 to expand outward or retract inward in the radial direction, and the first support 131 moves axially relative to the connecting shaft 110. At least two parallel first connecting rods 133 perform synchronous action to make the blade 120 always parallel to the central axis of the connecting shaft 110, thereby ensuring that the overall radial displacement of the blade 120 is the same, thereby maintaining radial perpendicularity to the valve.

[0056] Specifically, the distal end of the connecting shaft 110 passes through the central hole 1321 of the second support 132 and is flush with the distal end surface of the second support 132, and the two can be fixedly connected by laser welding. The connecting shaft 110 passes through the inner hole 1312 of the first support 131, and the two can move axially relative to each other. At least two first connecting rods 133 are parallel to each other, and the number of the first connecting rods 133 can be two, three or other numbers. In this embodiment, in each group of connecting rods, the number of the first connecting rods 133 is two.

[0057] Further, the first connecting rod 133 includes a first connecting end 1331 rotatably connected to the blade 120 and a second connecting end 1332 rotatably connected to the first support 131, and the distance between the first connecting ends 1331 of the two first connecting rods 133 is equal to the distance between the two second connecting ends 1332. In this way, the two first connecting rods 133 of each group of connecting rods are parallel to each other. Specifically, there are four first connecting rods 133 in total in the two groups of connecting rods, the first support 131 is provided with four connecting holes, the second connecting ends 1332 of the four first connecting rods 133 are respectively connected to the four connecting holes of the first support 131 through a rotating shaft, and the first connecting ends 1331 of the two first connecting rods 133 of each group of connecting rods are respectively connected to the two connecting holes of each blade 120 through a rotating shaft. The distance between the centers of the two axially adjacent connecting holes of the first support 131 is the same as the distance between the centers of the two connecting holes of the blade 120, that is, in each group of connecting rods, the distance between the first connecting ends 1331 of the two first connecting rods 133 is the same as the distance between the two second connecting ends 1332. Therefore, the two first connecting rods 133 of each group of connecting rods connecting each blade 120 and the connecting shaft 110 are always in a parallel state.

[0058] In this embodiment, the blade 120, two mutually parallel first connecting rods 133 and the connecting shaft 110 form a movable parallelogram structure, and the two first connecting rods 133 of the parallelogram structure and the blade 120 and the connecting shaft 110 will also remain parallel during movement. Therefore, it can be ensured that the blade 120 always remains parallel to the connecting shaft 110, further improving the stability and movement accuracy of the connecting rod mechanism 130, so that the blade 120 is always parallel to the central axis of the connecting shaft 110 (i.e., the axial direction of the blood vessel), preventing the blade 120 from tilting and scratching the blood vessel.

[0059] Furthermore, the second connecting rod 134 includes a third connecting end 1341 rotatably connected to the blade 120 and a fourth connecting end 1342 rotatably connected to the second support 132. The third connecting end 1341 and the first connecting end 1331 of the first connecting rod 133 connected to the distal end of the first support 131 are rotatably connected to the blade 120 via a rotating shaft. In this way, each blade 120 can be radially moved by driving the first connecting rod 133 or the second connecting rod 134 to move. Specifically, the two groups of connecting rods have two second connecting rods 134, the second support 132 is provided with two connecting holes arranged in the radial direction, and the fourth connecting ends 1342 of the two second connecting rods 134 are respectively connected to the two connecting holes of the second support 132 via a rotating shaft. In each group of connecting rods, the third connecting end 1341 of the second connecting rod 134 and the first connecting end 1331 of the first connecting rod 133 connected to the distal end of the first support 131 are connected to the connecting hole at the distal end of the blade 120 via a rotating shaft.

[0060] In this embodiment, the first connecting rod 133 and the second connecting rod 134 have the same length. In each group of connecting rods, the second connecting rod 134 and the first connecting rod 133 connected to the distal end of the first support 131 are rotatably connected to the blade 120 via a rotating shaft. The movement of the second connecting rod 134 can drive the movement of the first connecting rod 133, and the movement of the first connecting rod 133 can also drive the movement of the second connecting rod 134. Therefore, only the first connecting rod 133 or the second connecting rod 134 can be driven to move to make each blade move radially. In the two groups of connecting rods, the two first connecting rods 133 and the two second connecting rods 134 form a movable parallelogram structure. During the movement, the first connecting rod 133 and the second connecting rod 134 in the parallelogram structure will also remain in a parallel state.

[0061] Of course, in other embodiments, the third connecting end 1341 and the first connecting end 1331 may be rotatably connected to the blade 120 via different rotating shafts. The second connecting rod 134 and the first connecting rod 133 may not share a rotating shaft, and the second connecting rod 134 may be set to the same length as the first connecting rod 133 to stabilize the parallel state of the blade 120. In the present invention, the rotating shaft may be a pin.

[0062] See also Figure 7-Figure 9 The valvulotome 1000 further includes an operating assembly 200. The operating assembly 200 includes a sheath tube 210 and a first shaft tube 230 axially movable in the sheath tube 210. The distal end of the sheath tube 210 is fixedly connected to the proximal end of the first support 131, and the distal end of the first shaft tube 230 is fixedly connected to the proximal end of the connecting shaft 110. In this way, the axial movement of the connecting shaft 110 and the second support 132 can be controlled by the axial movement of the first shaft tube 230, so that the first connecting rod 133 is driven to move through the second connecting rod 134, and then the blade 120 is radially moved.

[0063] In this embodiment, the sheath tube 210 is fixedly connected to the first support 131, and the first shaft tube 230 is fixedly connected to the connecting shaft 110. When the first shaft tube 230 drives the connecting shaft 110 to move axially, the second support 132 moves axially accordingly. The second support 132 moves toward the proximal end, so that the blade 120 opens radially outward, and the second support 132 moves toward the distal end, so that the blade 120 is retracted radially inward. The sheath tube 210 and the first shaft tube 230 are flexible at least at their distal ends, and can be bent, so as to facilitate the adjustment of the axial direction of the connecting shaft 110 so that the blade assembly 100 is aligned with the surgical site. In this embodiment, the first shaft tube 230 is made of a stainless steel tube, and the distal end of the stainless steel tube is cut to make it flexible. The sheath tube 210 is made of a flexible polymer sheath tube.

[0064] See also Fig.10 , the movement freedom degree of a single blade 120 in the blade assembly 100 is 1, and the moving component is the second connecting rod 134. The number of moving components is the same as the number of degrees of freedom, which is 1, so the movement trajectory of the blade assembly 100 is single and determined. Since the blade 120 remains parallel to the central axis of the connecting shaft 110, when the second support 132 is driven to move proximally, the second connecting rod 134 drives the first connecting rod 133 to move, thereby driving the blade 120 to move radially, and the movement trajectory of the blade 120 will also produce a displacement toward the proximal end. Therefore, the movement trajectory of the blade 120 is the vector sum of the movement directions of the two. The blade 120 will always remain open in a state parallel to the central axis of the connecting shaft 110, and will also be displaced along the axial direction of the connecting shaft 120. When the blade 120 is in this motion, it can achieve better results due to its own sawing action when cutting the leaflet.

[0065] See also Figure 5-Figure 9, the proximal end of the first support 131 is provided with an assembly cylinder 1313, the distal end of the sheath tube 210 is fixed to the outer circumferential surface of the assembly cylinder 1313, the first shaft tube 230 and the connecting shaft 110 are inserted into the inner cavity of the assembly cylinder 1313, and the wall thickness of the assembly cylinder 1313 is smaller than the gap between the sheath tube 210 and the first shaft tube 230. In this way, a gap is left between the first shaft tube 230 and the first support 131, so that the first shaft tube 230 can move in the assembly cylinder 1313 of the first support 131. Specifically, the outer circumferential surface of the assembly cylinder 1313 is a cylindrical surface, the sheath tube 210 is sleeved on the cylindrical surface, the cylindrical surface is fitted with the inner cavity surface of the sheath tube, and the two are fixedly connected by laser spot welding so that the distal end surface of the sheath tube 210 is in contact with the assembly cylinder 1313. The distal end of the sheath tube 210 may be provided with a connector 211, and the connector 211 is tightly connected to the distal end of the sheath tube 210, and the connection method may be adhesive bonding, welding, etc. The distal end of the sheath tube 210 may be fixedly connected to the assembly tube 1313 of the first support 131 through the connector 211, so that the connection is more secure. The connection shaft 110 and the first shaft tube 230 are fixed by sleeve- ing the proximal end of the connection shaft 110 in the distal end inner cavity of the first shaft tube 230, and the two are fixedly connected by laser spot welding.

[0066] The inner cavity of the assembly cylinder 1313 includes a blocking portion 1314, and the distal end of the first shaft tube 230 movably abuts against the blocking portion 1314. Specifically, the inner cavity of the assembly cylinder 1313 is provided with a blocking portion 1314 protruding radially inward. When the first shaft tube 230 drives the connecting shaft 110 to move axially toward the distal end, the distal end of the first shaft tube 230 can abut against the blocking portion 1314. In this way, the blocking portion 1314 is used to limit the moving distance of the first shaft tube 230 toward the distal end. In this embodiment, when the distance between the first support 131 and the second support 132 is the largest, the blade 120 is in a retracted state, at which time the first shaft tube 230 abuts against the blocking portion 1314 of the assembly cavity, and the first shaft tube 230 cannot continue to move toward the distal end.

[0067] Furthermore, the proximal end of the first support 131 may also be provided with an assembly platform 1311 connected to the assembly cylinder 1313, and the assembly platform 1311 is arranged around the assembly cylinder 1313. The assembly platform 1311 includes an assembly surface radially facing the proximal end, and the distal end of the sheath tube 210 is fixed to the outer peripheral surface of the assembly cylinder 1313 and fixedly connected to the assembly surface, which can enhance the connection stability between the sheath tube 210 and the first support 131.

[0068] See also Figure 1-Figure 12 The valvulotome 1000 further includes a handle 300 , and the handle 300 includes an operating member 310 . The operating member 310 is connected to the proximal end of the first shaft tube 230 , and the operating member 310 is used to drive the first shaft tube 230 to move axially.

[0069] Specifically, the sheath tube 210 is fixedly connected to the connecting end 320 of the handle 300, and the handle 300 is provided with a slide groove 330. The operating member 310 includes a rotating knob 311 and a sliding member 312 which are threadedly connected. The sliding member 312 is clamped in the slide groove 330 and is fixedly connected to the proximal end of the first shaft tube 230. The rotating knob 311 is a hollow cylinder with a threaded inner wall. Sector blocks are provided on both sides of the sliding member 312, and the outer periphery of the sector block is provided with a thread to connect to the inner cavity of the rotating knob 311. In this way, since the sliding member 312 is clamped in the slide groove 330, the slide groove 330 limits the rotation of the sliding member 312, and the sliding member 312 can only move along the axial direction. The sliding member 312 is driven to move axially in the slide groove 330 by rotating the rotating knob 311, thereby driving the first shaft tube 230 to move.

[0070] Furthermore, the sliding member 312 is connected to an identification member 350 for indicating the position of the sliding member 312. The handle 300 is provided with an indication housing 340, and the indication housing 340 is provided with a transparent window for indicating the position of the identification member 350 (i.e., the position of the sliding member 312), and the transparent window is marked with a scale reading. The operator can directly obtain the axial movement distance of the first shaft tube 230 from the reading of the transparent window, thereby determining the opening degree of the blade assembly 100. In this way, the operation accuracy is controlled through the transparent window, which is intuitive and improves the convenience of operation.

[0071] In practical applications, the valvulotome 1000 needs to pass through the intervention channel established by the bending sheath 2000 to reach the vicinity of the heart valve. Fig.13 The bending adjustment sheath 2000 is a multi-layer composite tube body, for example, including a polytetrafluoroethylene (PTFE) inner film layer, a metal braided reinforcement mesh as an intermediate layer, and a segmented polyetheramide resin (PEBAX) outer film layer. A traction ring 2300 is embedded in the distal end of the tube body, and a traction wire 2200 is provided in the tube wall. The distal end of the traction wire 2200 is fixedly connected to the traction ring 2300, and the proximal end of the traction wire 2200 extends along the proximal end of the tube body and is connected to the bending adjustment knob 2100. The operator drives the traction wire 2200 to move along the axial direction of the tube body by operating the bending adjustment knob 2100, thereby pulling the tube body to bend or restore straightness.

[0072] See also Figure 14-18 The following uses the bicuspid aortic valve 3000 deformity as an example to illustrate the use of the valvulotome 1000 of this embodiment to treat valvular stenosis:

[0073] S1: See Fig.14The blade assembly 100 and the operating assembly 200 in the valvulotome 1000 are inserted into the bending sheath 2000, and the blade assembly 100 reaches the vicinity of the aortic valve 3000 through the intervention channel (femoral artery-aorta-aortic valve 3000) established by the bending sheath 2000. During the delivery process of the valvulotome 1000, the blade assembly 100 remains in a closed and retracted state.

[0074] S2: See Fig.15 , push the blade assembly 100 out of the bending sheath 2000 (see Figure 2 ), the blade assembly 100 is extended as a whole into the narrow aortic valve opening and the middle portion of the blade assembly 100 is aligned with the aortic valve 3000.

[0075] S3: See Figure 16-18 By rotating the knob 311 to control the blade 120 to slowly expand outward in the radial direction, the blade 120 cuts the valve adhesion area until the ideal effect of aortic valve expansion is achieved.

[0076] S4, reversely rotate the knob 311 to control the blade 120 to retract radially inward (see Figure 1 ), and withdrawn into the bending sheath 2000, and finally the entire valvulotome 1000 and the bending sheath 2000 are withdrawn from the body.

[0077] Embodiment 2

[0078] See also Figure 19-22 The structure of the valvulotome provided in the second embodiment is similar to that in the first embodiment, except that: the number of blades 120 of the blade assembly 100 is three. Correspondingly, the connecting rod mechanism 130 includes a first support 131, a second support 132 and three groups of connecting rods. Each group of connecting rods includes two parallel first connecting rods 133 and one second connecting rod 134. The second support 132 is provided with three connecting holes arranged in the radial direction, and the first support 131 is provided with six connecting holes, which are respectively used for the rotational connection between the three groups of connecting rods and the blades 120. The angle between the three blades 120 can be set to 120 degrees. It can be understood that the angle between the blades 120 can also be set according to the common angle between the valve leaflets.

[0079] See also Figure 23-Figure 25 The use of the valvulotome of this embodiment to treat valvular stenosis is described by taking the trileaflet aortic valve 3000 malformation as an example.

[0080] S1. The blade assembly 100 and the operating assembly 200 in the valvulotome are inserted into the bending sheath, and the blade assembly 100 reaches the vicinity of the aortic valve 3000 through the intervention channel (femoral artery-aorta-aortic valve 3000) established by the bending sheath 2000. During the delivery process of the valvulotome, the blade assembly 100 remains in a closed and retracted state.

[0081] S2. See Fig.23 The blade assembly 100 of the valvulotome is pushed out of the bending sheath, and the blade assembly 100 is extended into the narrow aortic valve orifice as a whole, and the middle part of the blade is aligned with the aortic valve 3000.

[0082] S3. See Fig.24 and Fig.25 By rotating the knob 311, the blade 120 is controlled to slowly expand outward in the radial direction to cut the adhesion part of the valve until the ideal effect of aortic valve expansion is achieved.

[0083] S4. Reversely rotate the knob 311 to control the blade 120 to retract radially inward and withdraw into the bending sheath 2000. Finally, withdraw the entire valvulotome and the bending sheath 2000 out of the body.

[0084] Embodiment 3

[0085] See also Figure 26-Figure 33 The structure of the valvulotome provided in the third embodiment is similar to that of the first embodiment, except that the specific structures of the operating assembly 200 and the handle 300 are different.

[0086] See also Figure 26-Figure 28 The operating assembly 200 includes a sheath tube 210, a first shaft tube 230 axially movably disposed in the sheath tube 210, and a second shaft tube 220 axially movably disposed between the first shaft tube 230 and the sheath tube 210. The distal end of the first shaft tube 230 is fixedly connected to the proximal end of the connecting shaft 110, and the distal end of the second shaft tube 220 is fixedly connected to the proximal end of the first support 131. Compared with the first embodiment, the third embodiment adds a second shaft tube 220, and the axial movement of the first shaft tube 230 can control the axial movement of the connecting shaft 110 and the second support 132, and the axial movement of the second shaft tube 220 can control the axial movement of the first support 131 on the connecting shaft 110, so that the first shaft tube 230 and the second shaft tube 220 can move in the opposite direction along the axial direction, driving the second connecting rod 134 and the first connecting rod 133 to move in the opposite direction, thereby causing the blade 120 to move radially, thereby increasing the radial opening rate of the blade 120.

[0087] The second shaft tube 220 is fixedly connected to the first support 131, and the first shaft tube 230 is fixedly connected to the connecting shaft 110. When the first shaft tube 230 drives the connecting shaft 110 to move axially, the second support 132 moves axially accordingly; and the first support 131 can be movably penetrated through the connecting shaft 110, so that when the second shaft tube 220 moves axially, the first support 131 moves axially accordingly. The first support 131 moves toward the distal end, and the second support 132 moves toward the proximal end, so that the blade 120 opens radially outward; the first support 131 moves toward the proximal end, and the second support 132 moves toward the distal end, so that the blade 120 is radially retracted inward. The sheath tube 210, the first shaft tube 230, and the second shaft tube 220 are at least flexible at their distal ends, and can be bent, so as to facilitate the adjustment of the axial direction of the connecting shaft 110, so that the blade assembly 100 is aligned with the surgical site. In this embodiment, the first shaft tube 230 and the second shaft tube 220 are both made of stainless steel tubes, and the distal ends of the stainless steel tubes are cut to make them flexible. The sheath tube 210 is made of a flexible polymer sheath tube.

[0088] See also Fig.29 The single blade 120 in the blade assembly 100 has 3 degrees of freedom of movement, and the moving components are the second connecting rod 134 and the two first connecting rods 133. The number of moving components is the same as the number of degrees of freedom, which is 3, so the movement trajectory of the blade assembly 100 is single and determined. Since the blade 120 is parallel to the central axis of the connecting shaft 110, the first support 131 and the second support 132 are driven to move axially and keep the moving distances of the two the same, the second connecting rod 134 and the first connecting rod 133 move synchronously, thereby driving the blade 120 to move radially, and the movement direction of the blade 120 is perpendicular to the central axis of the connecting shaft 110.

[0089] See also Fig.28, the proximal end of the first support 131 is provided with an assembly cylinder 1313, the distal end of the second shaft tube 220 is fixed to the outer circumferential surface of the assembly cylinder 1313, the first shaft tube 230 and the connecting shaft 110 are inserted into the inner cavity of the assembly cylinder 1313, and the wall thickness of the assembly cylinder 1313 is smaller than the gap between the first shaft tube 230 and the second shaft tube 220. In this way, a gap is left between the first shaft tube 230 and the first support 131, so that the first shaft tube 230 can move in the assembly cylinder 1313 of the first support 131. Specifically, the outer circumferential surface of the assembly cylinder 1313 is a cylindrical surface, the second shaft tube 220 is sleeved on the cylindrical surface, the cylindrical surface is fitted with the inner cavity surface of the second shaft tube 220, and the two are fixedly connected by laser spot welding so that the distal end surface of the second shaft tube 220 is in contact with the assembly cylinder 1313. The connection shaft 110 and the first shaft tube 230 are fixed by inserting the proximal end of the connection shaft 110 into the distal inner cavity of the first shaft tube 230, and the two are fixedly connected by laser spot welding. The inner cavity of the assembly cylinder 1313 is also provided with a blocking portion 1314, which is used to abut the distal end of the first shaft tube 230, thereby limiting the moving distance of the first shaft tube 230 to the distal end, which will not be described in detail here.

[0090] Furthermore, the proximal end of the first support 131 may be provided with an assembly platform 1311 connected to the assembly cylinder 1313, and the assembly platform 1311 is arranged around the assembly cylinder 1313. The assembly platform 1311 includes an assembly surface radially facing the proximal end, and the distal end of the second shaft tube 220 is fixed to the outer peripheral surface of the assembly cylinder 1313 and fixedly connected to the assembly surface, which can enhance the connection stability between the second shaft tube 220 and the first support 131.

[0091] See also Fig.28 The outer periphery of the distal end of the second shaft tube 220 is provided with a limiting ring 221, and the limiting ring 221 is movably abutted against the distal end of the sheath tube 210. It can be understood that as the second shaft tube 220 moves axially, the limiting ring 221 abuts against the distal end of the sheath tube 210, or separates from the sheath tube 210. The limiting ring 221 is provided at the outer end of the second shaft tube 220 to limit the moving distance of the second shaft tube 220 to the proximal end. The limiting ring 221 can be welded to the second shaft tube 220, or can be directly formed by processing the second shaft tube 220.

[0092] See also Figure 30-Figure 33 In this embodiment, the handle 300 includes an operating member 310, which is respectively connected to the proximal end of the first shaft tube 230 and the proximal end of the second shaft tube 220, and the operating member 310 is used to drive the first shaft tube 230 and the second shaft tube 220 to move in opposite directions along the axial direction.

[0093] Specifically, see Fig.30The operating member 310 includes a rotating knob 311, a first sliding member 313 and a second sliding member 314. The first sliding member 313 and the second sliding member 314 are threadedly connected to the inner cavity of the rotating knob 311, and the threads of the first sliding member 313 and the second sliding member 314 are in opposite directions and have the same pitch. The first sliding member 313 is fixedly connected to the proximal end of the second shaft tube 220, and the second sliding member 314 is fixedly connected to the proximal end of the first shaft tube 230. In this way, the first sliding member 313 and the second sliding member 314 can be synchronously driven to move in opposite directions by rotating the knob 311, thereby driving the first shaft tube 230 and the second shaft tube 220 to move in opposite directions in the axial direction by the same distance, ensuring that the blade 120 is always parallel to the central axis of the connecting shaft 110.

[0094] Furthermore, the sheath tube 210 is fixedly connected to the connecting end 320 of the handle 300, and the handle 300 is provided with a slide groove 330, in which the first sliding member 313 and the second sliding member 314 are clamped. The rotating knob 311 is a hollow cylinder, and the inner wall is provided with two sections of threads, one section is a clockwise thread that matches the first sliding member 313, and the other section is a counterclockwise thread that matches the second sliding member 314. Both sides of the first sliding member 313 and the second sliding member 314 are provided with fan-shaped blocks, wherein the outer periphery of the fan-shaped block of the first sliding member 313 is provided with a clockwise thread, and the fan-shaped block of the second sliding member 314 is provided with a counterclockwise thread to be connected to the inner cavity of the rotating knob 311. In this way, since the first sliding member 313 and the second sliding member 314 are stuck in the sliding groove 330, the sliding groove 330 limits the rotation of the first sliding member 313 and the second sliding member 314, and the first sliding member 313 and the second sliding member 314 can only move axially. By rotating the knob 311, the first sliding member 313 and the second sliding member 314 are synchronously driven to move axially in the opposite direction in the sliding groove 330, thereby driving the first shaft tube 230 and the second shaft tube 220 to move in the opposite direction.

[0095] In addition, two different first knobs and second knobs may be provided to drive the first sliding member 313 and the second sliding member 314 respectively, and it is only necessary to ensure that the first sliding member 313 and the second sliding member 314 move the same distance and in opposite directions.

[0096] Embodiment 4

[0097] The structure of the valvulotome provided in the fourth embodiment is similar to that of the third embodiment, except that the number of blades 120 of the blade assembly 100 is three. The structural arrangement of the corresponding connecting rod mechanism 130 can refer to the second embodiment, so the valvulotome provided in the fourth embodiment is particularly suitable for treating tricuspid aortic valve malformation.

Claims

1. A valvulotome, characterized in that: The invention comprises a blade assembly, wherein the blade assembly comprises a connecting shaft, two blades and a connecting rod mechanism connecting the blades and the connecting shaft, wherein the blade edges of the blades face away from the connecting shaft, and the blade edges are parallel to or inclined to the central axis of the connecting shaft, and the connecting shaft drives the connecting rod mechanism to drive each blade to move radially by axial movement; The connecting rod mechanism comprises a first support, a second support and two groups of connecting rods, each group of connecting rods comprises two parallel first connecting rods and one second connecting rod, each of the blades is rotatably connected to the first support through the first connecting rod and is rotatably connected to the second support through the second connecting rod, the connecting shaft is movably arranged in the first support, and the distal end of the connecting shaft is fixed to the second support; The first connecting rod comprises a first connecting end rotatably connected to the blade and a second connecting end rotatably connected to the first support, and the distance between the two first connecting ends is equal to the distance between the two second connecting ends; The second connecting rod comprises a third connecting end rotatably connected to the blade and a fourth connecting end rotatably connected to the second support, the third connecting end and the first connecting end of the first connecting rod connected to the distal end of the first support are rotatably connected to the blade via a rotating shaft, so that the two first connecting rods connected to the distal end of the first support and the two second connecting rods form a movable parallelogram structure; In the two groups of connecting rods, the two first connecting rods in one group and the one second connecting rod in the other group remain parallel to each other during the movement.

2. The valvulotome according to claim 1, characterized in that: The valvulotome also includes an operating component, which includes a sheath and a first shaft tube axially movably disposed in the sheath, the distal end of the sheath is fixedly connected to the proximal end of the first support, and the distal end of the first shaft tube is fixedly connected to the proximal end of the connecting shaft.

3. The valvulotome according to claim 2, characterized in that: The proximal end of the first support is provided with an assembly tube, the distal end of the sheath tube is fixed to the outer circumferential surface of the assembly tube, the first shaft tube and the connecting shaft are inserted into the inner cavity of the assembly tube, and the wall thickness of the assembly tube is smaller than the gap between the sheath tube and the first shaft tube.

4. The valvulotome according to claim 1, characterized in that: The valvulotome also includes an operating component, which includes a sheath, a first shaft tube axially movably disposed in the sheath, and a second shaft tube axially movably disposed between the first shaft tube and the sheath, the distal end of the first shaft tube being fixedly connected to the proximal end of the connecting shaft, and the distal end of the second shaft tube being fixedly connected to the proximal end of the first support.

5. The valvulotome according to claim 4, characterized in that: A limiting ring is provided on the outer periphery of the distal end of the second shaft tube, and the limiting ring is movably abutted against the distal end of the sheath tube.

6. The valvulotome according to claim 4, characterized in that: The proximal end of the first support is provided with an assembly tube, the distal end of the second shaft tube is fixed to the outer circumferential surface of the assembly tube, the first shaft tube and the connecting shaft are inserted into the inner cavity of the assembly tube, and the wall thickness of the assembly tube is smaller than the gap between the first shaft tube and the second shaft tube.

7. The valvulotome according to claim 3 or 6, characterized in that: The inner cavity of the assembly cylinder includes a blocking portion, and the distal end of the first shaft tube movably abuts against the blocking portion.

8. The valvulotome according to claim 2 or 3, characterized in that: The valvulotome further includes a handle, wherein the handle includes an operating member, wherein the operating member is connected to the proximal end of the first shaft tube, and wherein the operating member is used to drive the first shaft tube to move axially.

9. The valvulotome according to any one of claims 4 to 6, characterized in that: The valvulotome further includes a handle, which includes an operating member, which is respectively connected to the proximal end of the first shaft tube and the proximal end of the second shaft tube, and is used to drive the first shaft tube and the second shaft tube to move in opposite directions along the axial direction.

10. The valvulotome according to claim 9, characterized in that: The operating member includes a rotating knob, a first sliding member and a second sliding member, the first sliding member and the second sliding member are respectively threadedly connected to the inner cavity of the rotating knob, the thread directions of the first sliding member and the second sliding member are opposite and the pitches are the same, the first sliding member is fixedly connected to the proximal end of the first shaft tube, and the second sliding member is fixedly connected to the proximal end of the second shaft tube.

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