CN114681125A - Valve clamping device for preventing valve leaflet from being damaged and valve clamping system - Google Patents

Abstract

The invention provides a valve clamping device for preventing damage of valve leaflets and a valve clamping system. The valve clamping device for preventing valve leaflet damage comprises a fixed base and a pair of clamp arms arranged on two opposite sides of the fixed base in an openable and closable manner, each clamp arm is provided with a connecting end connected with the fixed base, a free end opposite to the connecting end and a clamping section located between the connecting end and the free end, at least part of the clamping section is inwards sunken to form a capturing area, and the capturing area extends towards the free end and then extends towards the direction back to the capturing area of the other clamp arm to form a first flanging section. According to the valve clamping device and the valve clamping system for preventing the valve leaflets from being damaged, the first flanging section is arranged at the tail end of the clamp arm, so that the valve leaflets and the first flanging section form a joint structure after entering the capturing area, the contact area between the valve leaflets and the valve leaflets is increased, the valve leaflets are prevented from being locally stressed and concentrated, the damage of the edges of the clamp arm to the valve leaflets due to repeated friction between the valve leaflets and the beating of the heart is effectively reduced, and the surgical complications are reduced.

Description

A valve clamp and valve clamp system for preventing valve leaflet damage

technical field

The invention belongs to the technical field of medical devices, and in particular relates to a valve clamp and a valve clamp system for preventing valve leaflet damage.

Background technique

The mitral valve is a one-way valve between the left atrium and left ventricle of the heart. A normal, healthy mitral valve controls the flow of blood from the left atrium to the left ventricle, while preventing blood from flowing from the left ventricle to the left atrium. The mitral valve consists of a pair of leaflets called anterior and posterior leaflets. When the edges of the anterior and posterior leaflets meet, the mitral valve can be completely closed, preventing blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or their related structures are qualitatively or functionally altered, the anterior and posterior leaflets of the mitral valve are misaligned, so that when the left ventricle of the heart contracts, the mitral valve cannot It closes completely, causing blood to flow back from the left ventricle to the left atrium, causing a series of pathophysiological changes known as "mitral regurgitation."

There is a minimally invasive treatment device, which is based on the principle of edge-to-edge operation of the valve, and delivers a valve clamp to the mitral valve through an interventional catheter, and then simultaneously grasps the front of the mitral valve through the relative opening of the clamp. Leaflets and posterior leaflets, so as to achieve the purpose of fixing the valve leaflets and reducing mitral regurgitation.

The prior art discloses a valve clamping system, which includes a clamping device and a conveying device. The clamping device includes a clamp arm and a clamp arm. The clamp arm is driven to open and close by a mandrel connected to it, and the core is driven to the distal end. The shaft drives the clamp arms to open to capture the anterior and posterior leaflets of the mitral valve, then releases the clamp arms, clamps the valve through the cooperation of the clamp arms and the clamp arms, and then drives the mandrel proximally to close the clamp arms It also draws the anterior and posterior leaflets toward each other, thereby reducing the leaflet gap and treating mitral regurgitation. However, due to the small contact area between the edge of the forceps arm and the valve leaflets, it not only has a poor fit with the valve leaflets, but also the local force of the valve leaflets is concentrated. Damage to the valve leaflets leads to inflammation, and in severe cases, it can lead to valve leaflet perforation, endangering the safety of patients.

SUMMARY OF THE INVENTION

One of the main purposes of the present invention is to overcome the above-mentioned defects of the prior art, and provide a valve clamp for preventing valve leaflet damage, comprising a fixed base and an openable and closable one on opposite sides of the fixed base. For the clamp arms, each of the clamp arms has a connection end connected to the fixed base, a free end opposite to the connection end, and a clamping segment located between the connection end and the free end , the clamping section is at least partially recessed inward to form a capture area, and after the capture area extends to the free end, it extends in a direction away from the capture area of the other clamp arm to form a first flip edge segment.

The present invention also provides a valve clamping system, comprising a drive assembly and a valve clamp for preventing valve leaflet damage as described above, wherein the drive assembly includes:

a drive shaft, the drive shaft passes through the fixed base;

a connecting seat located at the distal end of the drive shaft and a pair of connecting rods pivotally connected to both sides of the connecting seat, and one end of the connecting rods is connected to one of the clamp arms;

The drive shaft slides axially relative to the fixed base, so as to rotate through the connecting rod and drive the clamp arm to open and close relative to the fixed base.

Compared with the prior art, the valve clamp and valve clamp system for preventing valve leaflet damage of the present invention have at least the following beneficial effects: the end of the clamp arm is provided with a first flanging segment, which can make the valve leaflet enter the capture area, The valve leaflet and the first flanging segment form a fitting structure, which increases the contact area with the valve leaflet, avoids local force concentration on the valve leaflet, and effectively reduces the repeated friction between the edge of the clamp arm and the valve leaflet as the heart beats. injury and reduce surgical complications.

Description of drawings

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.

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the following briefly introduces the accompanying drawings that need to be used in the description of the embodiments or the prior art. In other words, on the premise of no creative labor, other drawings can also be obtained from these drawings.

FIG. 1 is a front view of a valve clamping system shown according to an exemplary embodiment when it is opened.

FIG. 2 is an oblique view of a valve clamping system when opened, according to an exemplary embodiment.

FIG. 3 is a front view of a valve clamping system slightly opened according to an exemplary embodiment.

FIG. 4 is an oblique view of a valve clamping system slightly opened according to an exemplary embodiment.

FIG. 5 is a front view of a valve clamping system when closed, according to an exemplary embodiment.

FIG. 6 is a front view of a valve clamping system when closed, according to an exemplary embodiment.

7 is an oblique view of a clamp arm shown according to an exemplary embodiment.

FIG. 8 is an oblique view from another angle of the clamp arm shown in accordance with an exemplary embodiment.

9 is a top view of a clamp arm shown according to an exemplary embodiment.

10 is a front view of a clamp arm shown according to an exemplary embodiment.

11 is a right side view of a clamp arm shown according to an exemplary embodiment.

FIG. 12 is a right side view of the leaflet resting on the forceps arm, shown according to an exemplary embodiment.

13 is a front view of a valve clamping system showing preliminary clamping of the valve leaflets, according to an exemplary embodiment.

Figure 14 is a front view of the valve clamping system after leaflet clamping is completed, according to an exemplary embodiment.

15 is an oblique view of a valve clamping system with the fixation base and clamping arms removed, according to an exemplary embodiment.

16 is an exploded view of a rotating pin shown in accordance with an exemplary embodiment.

FIG. 17 is an assembled view of two clamp arms in a top view according to an exemplary embodiment.

FIG. 18 is a diagram showing the structural parameters of the valve clamping system when it is closed, according to an exemplary embodiment.

FIG. 19 is a structural parameter diagram of the valve clamping system when the valve clamping system is opened to the maximum angle according to an exemplary embodiment.

FIG. 20 is a schematic structural diagram of a fixing base according to an exemplary embodiment.

FIG. 21 is a schematic view of the assembly of a fixing member and a fixing base according to an exemplary embodiment.

Fig. 22 is a schematic structural diagram of a valve clamping system and an adjustment part according to an exemplary embodiment.

FIG. 23 is a schematic diagram showing the structure of the valve clamping system reaching the valve leaflets according to an exemplary embodiment.

Figure 24 is a schematic diagram showing the structure of the valve clamping system open and ready to clamp the valve leaflets, according to an exemplary embodiment.

FIG. 25 is a schematic structural diagram of a clamp arm of a valve clamping system fitted with a valve leaflet according to an exemplary embodiment.

Fig. 26 is a schematic diagram showing the structure of clamping the valve leaflets by the clamp arm of the valve clamping system according to an exemplary embodiment.

FIG. 27 is a schematic structural diagram of a mitral valve edge-to-edge repair performed by a valve clamping system according to an exemplary embodiment.

Detailed ways

In order to make the purposes, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments These are some embodiments of the present invention, but not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present invention.

It should be understood that "front", "rear", "up", "down", "left", "right", "vertical", "horizontal", "vertical", "horizontal", "top", The orientation or positional relationship indicated by "bottom", "inner", "outer", "head", "tail", etc. is based on the orientation or positional relationship shown in the drawings, constructed and operated in a specific orientation, only for convenience The technical solution is described instead of indicating that the indicated device or element must have a specific orientation, so it should not be construed as a limitation on the present invention.

It should also be noted that, unless otherwise expressly specified and limited, terms such as "installation", "connection", "connection", "fixation" and "setup" should be understood in a broad sense, for example, it may be a fixed connection, or a It is a detachable connection or an integral body; it can be directly connected or indirectly connected through an intermediate medium, and it can be the internal communication of two elements or the interaction relationship between the two elements. When an element is referred to as being "on" or "under" another element, it can be "directly" or "indirectly" on the other element, or one or more intervening elements may also be present. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific situations.

In the description of the present invention, it should be noted that, unless otherwise specified, the proximal end refers to the end of the instrument or component close to the operator, the distal end refers to the end of the instrument or component away from the operator; the axial direction refers to the end parallel to the instrument Or the direction of the connection between the distal end and the proximal center of the 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.

Referring to FIGS. 1 to 6, a valve clamp for preventing valve leaflet damage of the present invention, the valve clamp is delivered to the vicinity of the patient's mitral valve in a transcatheter or transapical manner through a delivery assembly, and the valve clamp The proximal end of the valve is releasably connected to the delivery assembly, the operator remotely manipulates the valve clamp, clamps the anterior and posterior leaflets of the mitral valve together, and then releases the connection between the delivery assembly and the valve clamp, Thereby, the valve clamp is implanted in the patient's body, and the anterior and posterior leaflets of the mitral valve are fixed together to achieve "edge-to-edge repair" of the mitral valve.

Referring to FIGS. 7-12 , the valve clamp of the present invention includes a fixed base 200 and a pair of clamp arms 100 that can be opened and closed on opposite sides of the fixed base 200 . The connecting end connected to the seat 200, the free end opposite to the connecting end, and the clamping section between the connecting end and the free end, the clamping section is at least partially recessed inward to form a capturing area, and after the capturing area extends toward the free end, The first flange segment 110 is formed by extending in a direction away from the capture area of the other clamp arm 100 . A first flanging section 110 is provided at the end of the forceps arm 100, so that the valve leaflet 700 and the first flanging section 110 form a fitting structure, increase the contact area with the valve leaflet 700, and avoid the partial force concentration of the valve leaflet 700, thereby It overcomes the defect that the forceps arm of the valve clamp and the valve leaflet 700 in the prior art have a low degree of fit, which easily leads to damage to the valve leaflet 700 .

In the technical solution of the present invention, the clamping section of the forceps arm 100 is the main force-bearing area for clamping the valve leaflet 700, the surface of the clamping section is concave inward, and is provided with the first flange section 110, so that the different The following beneficial effects are achieved in the use state: first, referring to FIG. 5 and FIG. 6 , in the delivery state, the clamping arm 300 is at least partially accommodated in the inner surface of the forceps arm 100 , reducing the outer diameter of the valve clamp and facilitating delivery; 13 and 14, after the clamp arm 100 cooperates with the clamp arm 300 to clamp the valve leaflet 700, the concave inner surface can increase the contact area between the clamp arm 100 and the valve leaflet 700, and make the clamp arm 300 The valve leaflet 700 is pressed into the inner surface of the forceps arm 100 to increase the clamping force; and the first flanging section 110 is provided at the end of the forceps arm 100, so that after the valve leaflet 700 enters the capture area, the valve leaflet 700 and the first The flanging section 110 forms a fitting structure, increases the contact area with the valve leaflet 700, avoids local force concentration of the valve leaflet 700, and reduces the valve leaflet damage caused by repeated friction between the edge of the forceps arm 100 and the valve leaflet 700 with the beating of the heart , reduce surgical complications.

In a preferred embodiment, the valve clamp further includes a pair of clamping arms 300, each clamping arm 300 is disposed between the fixed base 200 and the forceps arm 100, and the clamping arms 300 are at least partially in a natural state Contained on the inner wall of the capture area. When the clamping arm 300 is released, it moves closer to the forceps arm 100 and cooperates with the forceps arm 100 to clamp the tissue of the leaflet 700 therebetween. The clamping arm 300 is accommodated in the capture area in a natural state, which can reduce the overall size of the valve clamp, and can protect the clamping arm 300 during the delivery of the valve clamp, preventing the clamping arm 300 Causes damage to cardiac tissue.

It can be understood that, in order to increase the biocompatibility between the valve clamp and the valve leaflets, and to facilitate the climbing of endothelial cells, the clamping surface of the clamp arm 100 (that is, the surface facing the clamp arm 300 ) and the clamp arm The clamping surface of 300 (that is, the surface facing the clamp arm 100 ) can also be coated with a biocompatible polymer coating, and the polymer coating is selected from PET, PTFE and other materials. The material of the coating may be the same or different.

It can also be understood that, in order to increase the clamping force of the clamping arm 300 and the forceps arm 100 on the valve leaflet 700 , at least one row of barbs may be provided on the surface of the clamping arm 300 facing the forceps arm 100 , thereby preventing the valve leaflet 700 slip out of the inner surface of the clamp arm 100 .

Referring to FIGS. 2 and 4 , the clamping section of the forceps arm 100 is further provided with at least one opening 160 penetrating the surface of the clamping section, which has the following advantages: (1) To reduce the weight of the forceps arm 100 and reduce the impact of the forceps arm 100 on the valve leaflets (2) When a polymer coating is applied on the surface of the forceps arm 100 by suture, it is beneficial to fix the suture, improve the connection strength of the coating, and prevent the coating from moving during the movement of the valve leaflet 700. (3) It is conducive to the crawling of endothelial cells; (4) In the delivery state, both the clamping arm 300 and the clamping arm 100 are attached to the outside of the fixed base 200, and the top of the clamping arm 300 is inverted at this time. The barb is at least partially received or pressed into the opening 160 of the forceps arm 100, but the two are not clamped, thereby reducing the outer diameter of the valve clamp and facilitating delivery.

In a preferred embodiment, referring to FIG. 14 , an included angle A is formed between the tangent of the end of the first flanging segment 110 and the axial direction of the clamping segment, and the value of the included angle A ranges from 90° to 150°. When the valve leaflet 700 is placed inside the forceps arm 100, a part of the valve leaflet 700 is placed in the capture area, and the part placed on the outside of the forceps arm 100 is placed on the first flange section 110, and the angle of the included angle A determines the valve leaflet 700 The lap joint shape of 90°-150° can provide good support for the valve leaflet 700, and at the same time prevent the valve leaflet 700 from being damaged due to excessively concentrated force.

Further, in the above embodiment, after the pair of clamp arms 100 are closed relative to the fixed base 200, an included angle B is formed between the axial directions of the two clamping segments, and the value of the included angle B ranges from 20° to 60° °. The size of the angle B is related to the effect of treating regurgitation. The smaller the angle B is, the better the coaptation effect of the two valve leaflets 700 after the forceps arm 100 is closed, and the more obvious the effect of reducing the regurgitation. The tensile stress will also increase, and if the angle B is too large, the valve leaflets 700 will not be well aligned, so that the effect of effectively reducing regurgitation cannot be achieved. Therefore, the value of the included angle B ranges from 20° to 60° .

Further, in the above embodiment, an angle C is formed between the extension line of the first flanging segment 110 and the vertical line of the central axis of the valve clamp, and the value of the angle C ranges from -30° to 10°. °. The angle C is a direction angle and has a direction regulation. In the present invention, it is defined as a negative angle above the vertical line, and a positive angle below the vertical line; The larger the negative angle, the better the fitting effect, but the corresponding stress will also increase, increasing the risk of damaging the valve leaflets 700; the larger the positive angle, the worse the fitting effect, so The value range of the included angle C is -30° to 10°.

Still further, in the above embodiment, B/2+90°=A+C. The size of the angle A is related to the angle C. The larger the angle A, the larger the negative angle of the angle C, which will increase the risk of damaging the valve leaflet 700; the smaller the angle A, the larger the positive angle of the angle C. It will lead to poor bonding effect. To sum up, the value range of the included angle A should be set at 90°～150°, preferably 95°～120°.

In a preferred embodiment, referring to FIG. 10 , a detachment prevention part 111 is further provided between the capture area and the first flange section 110 , and the depth of the detachment prevention part 111 is smaller than that of the capture area. The depth here refers to the depth along the radial direction of the clamping segment, where the depth of the capture zone determines the containment effect of the leaflets. The disengagement prevention portion 111 can be set to a smooth transition shape such as an arc surface or a curved surface with varying curvature, and the disengagement prevention portion 111 has a limiting effect on the valve leaflet 700 placed on the clamping section, preventing the valve leaflet 700 from falling out of the capture area.

In a preferred embodiment, referring to FIG. 11 and FIG. 12 , the clamp arm 100 further includes a pair of second flanging segments 120 , each of which is formed by extending from the capturing area to two sides respectively. The second flanging sections 120 are respectively connected to one side of the first flanging section 110 smoothly. The second flanging section 120 of the clamp arm 100 is located at the transition position from the clamping section to the end of the clamp arm 100 . In this position, the bottom is first closed to the center line of the clamping section of the clamp arm 100, and then gradually expanded upwards and outwards. The advantages are: (1) The second flange section 120 can increase the area of the flange developed at the upper part. , on the premise of not increasing the size, the contact area between the valve leaflet 700 and the clamp arm 100 is increased; (2) the second flanging segment 120 does not need to additionally increase the overall size of the valve clamp, which is conducive to reducing the delivery component size of. Specifically, in order to achieve a smooth connection between the second flanging section 120 and the first flanging section 110 , the second flanging section 120 has a circular arc transition area for reducing the bending stress of the valve leaflet 700 .

Further, in the above-mentioned embodiment, referring to FIG. 9 , the clamp arm 100 further includes a pair of third flanging segments 130 , each of which is formed by extending outward from both sides of the capturing area, each The third flanging segments 130 are respectively connected smoothly with the second flanging segments 120 on the same side. Since the leaflet 700 is pressed into the inner surface of the forceps arm 100, there is a certain pulling force between the leaflet 700 and the edge of the forceps arm 100, and the third flange section 130 can increase the force-bearing area of the capture area, preventing the forceps arm Stress damage to leaflet 700 caused by the edge of 100 . The third flanging section 130 is smoothly connected with the second flanging section 120, so that the position that may contact the valve leaflet 700 is kept smooth, and the valve leaflet 700 is prevented from being damaged. Specifically, the shape of the third flanging segment 130 may be a parallel and equal-width structure, or may be a non-equal-width structure with a smooth transition through a curve.

Specifically, in the above embodiment, referring to FIG. 9 , the third flanging section 130 sequentially includes, from the distal end to the proximal end: a first part 131 , a second part 132 , and a third part 133 , and the lateral dimension of the first part 131 is from The distal end gradually increases proximally to be substantially equal to the lateral dimension of the second portion 132 , and the lateral dimension of the second portion 132 gradually decreases from the distal end to the proximal end to be substantially equal to the lateral dimension of the third portion 133 .

Or further, in the above embodiment, referring to FIGS. 7 to 9 , the clamp arm 100 further includes a pair of fourth flanging segments 140 , and each fourth flanging segment 140 consists of a third flanging segment on the same side respectively. 130 extends proximally. The fourth flange section 140 of the clamp arm 100 is located at the proximal end of the clamp arm 100 , close to the installation position of the fixed base 200 . The function of the fourth flanging section 140 is to increase the contact area between the forceps arm 100 and the valve leaflet 700 on the one hand, so as to prevent the edge of the forceps arm 100 from scratching the valve leaflet 700; proximal deformation.

Specifically, referring to FIG. 9 and FIG. 10 , the clamp arm 100 is provided with a hole 150 for assembly, the fourth flanging section 140 is disposed on one side of the hole 150 and the axial dimension of the fourth flanging section 140 is larger than that of the hole 150 diameter of. The hole position 150 here is used for rotatably connecting other components, for example, as a pin hole, and a pincer arm pin is arranged in the pin hole, see FIGS. 15 and 16 . After the valve clamp clamps the valve leaflet 700, the pulling force of the valve leaflet 700 will be applied to the forceps arm 100, and then transmitted to the pin of the forceps arm 100, so the pin hole needs to bear a large load. For example, the fourth flange section 140 of the clamp arm 100 is used as a reinforcing rib, so that the boundary of the clamp arm 100 covers the pin hole 150 in the projection direction, which effectively improves the strength of the hole 150, thereby preventing the clamp arm 100 from failing due to insufficient strength , enhance the strength of the forceps arm 100 itself, and ensure the fatigue resistance of the valve clamp.

In a preferred embodiment, referring to FIG. 17 , the legs of the clamp arm 100 can be bent inward or outward to form a bent portion 170 , and the two clamp arms 100 after bending are in a central axis Rotational symmetry, that is, the structures of the clamp arms 100 on both sides of the valve clamp are exactly the same, which not only makes the structure simple and reliable, but also saves the material cost, and also ensures that the center of mass of the valve clamp is in the middle position, preventing the valve clamp. The clip is displaced during delivery and after implantation.

The clamping arm 300 is disposed between the fixed base 200 and the forceps arm 100 for cooperating with the forceps arm 100 to clamp the tissue of the valve leaflet 700 therebetween. It can be understood that, in order to ensure that the clamping arm 300 can actively approach the clamping arm 100 to press the valve leaflet 700 to the clamping arm 100, the clamping arm 300 is at least partially made of an elastic material with a shape memory function, and has undergone heat setting treatment. , and has a natural state and a delivery state that can be compressed or stretched for delivery in small-sized sheaths. Wherein, in the natural state, the two sides of the clamping arm 300 radially extend outward relative to the fixed base 200, and preferably extend toward the proximal end so as to cooperate with the clamp arm 100 to clamp the tissue of the valve leaflet 700, preferably, naturally The angle between the two clamp arms 300 in the unfolded state should be slightly larger than the angle between the two clamp arms 100 , that is, the angle between the length direction of the clamp arms 300 and the axial direction of the fixed base 200 . The angle is greater than or equal to the angle between the clamp arm 100 and the fixed base 200 when the clamp arm 100 corresponding to the side is fully opened relative to the fixed base 200, so that the free end of each clamp arm 300 is connected to the corresponding clamp arm 300. The arms 100 are close to each other and have a certain clamping force to provide a more stable clamping force. Specifically, in this embodiment, the angle between the length direction of the clamping arm 300 and the axial direction of the fixing base 200 ranges from 0° to 150°, that is, in a natural state, the two clamping arms 300 The included angle between them can be up to 300° at most, preferably 160° to 200°.

It should be noted that the free end of the clamping arm 300 is provided with a control wire hole for connecting the control wire (not shown in the figure) of the pushing device, and the free end of the clamping arm 300 can be controlled by a control wire extending outside the patient's body . In the conveying state, the free end of the clamping arm 300 is pulled tightly by the control wire and adheres to the surface of the fixing base 200; and after the control wire on the free end is released, the clamping arm 300 is released, and the clamping arm The 300 restores its natural state due to its own elastic memory performance, and presses the leaflet 700 against the forceps arm 100 .

The present invention also discloses a valve clamping system, including a drive assembly and a valve clamp with the above-mentioned structure for preventing valve leaflet damage. The drive shaft 400 passes through the fixed base 200 . The connecting base 500 is disposed at the distal end of the drive shaft 400 , a pair of connecting rods 510 are pivotally connected to both sides of the connecting base 500 , and one end of the connecting rods 510 is connected to a clamp arm 100 . The drive shaft 400 slides axially relative to the fixed base 200 to rotate through the connecting rod 510 and drive the clamp arm 100 to open and close relative to the fixed base 200 .

Specifically, one end of each link 510 is connected to a clamp arm 100, and the other end is pivotally connected to the connecting base 500, that is, each clamp arm 100 is rotatably connected to the drive shaft 400 through the link 510 on the corresponding side. The distal end of the connection base 500 . The drive shaft 400 movably passes through the fixed base 200 . When the drive shaft 400 slides axially relative to the fixed base 200 , the connecting rod 510 rotates and drives the clamp arm 100 to open and close relative to the fixed base 200 . Specifically, one end of the connecting section of each clamp arm 100 away from the clamping section is rotatably connected to the same position on the fixed base 200 , and the connecting section of each clamp arm 100 is rotatably connected to the corresponding side of the clamping section at the position close to the clamping section. The proximal end of the connecting rod 510 and the distal end of the connecting rod 510 are rotatably connected to the connecting seat 500 at the distal end of the drive shaft 400 by means of rotating pins 610 or bolts. When the drive shaft 400 slides toward the distal end relative to the fixed base 200 in the axial direction, the connecting rod 510 is driven to move. When the drive shaft 400 slides toward the proximal end relative to the fixed base 200 in the axial direction, the link 510 pulls the clamp arm 100 to rotate around the pin hole to close relative to the fixed base 200 .

Specifically, the connecting section of the pliers arm 100 has two pairs of pin holes, each pair of pin holes overlaps in the projection direction, and the pin holes close to the clamping section are hingedly connected to the connecting rod 510 through the pin, so that the pliers arm 100 and the connecting rod are hinged. 510 The two can be rotated relative to each other without separation. Specifically, referring to FIG. 16 , the connection between the pincer arm 100 and the pin can be that the smaller end face of the pin is directly welded on the pincer arm 100 , or it can be welded by adding a collar. The pin hole away from the clamping section is the fixing hole, and the fixing pin 620 is inserted into the fixing hole, so that the fixing pin 620 is relatively fixed with the clamp arm 100 , but can rotate around the pin hole on the fixing base 200 . Specifically, the larger end of the fixing pin 620 is directly welded to the connecting section of the clamp arm 100 .

In a preferred embodiment, referring to FIG. 15 , the connecting base 500 is fixedly connected to the distal end of the drive shaft 400 , the connecting base 500 is symmetrically provided with two pairs of connecting holes penetrating each other, and one end of each connecting rod 510 is rotatably connected thereinto. inside a pair of connecting holes. It can be understood that a pair of pins pass through a pair of connecting holes, so the connecting holes are not shown in the drawings. Specifically, the connection seat 500 is fixedly disposed at the distal end of the drive shaft 400 by welding or other means. The connection seat 500 includes two opposite first planes and two connection surfaces connecting the two first planes. The ends are respectively provided with a pair of pin holes penetrating the two first planes. The pin holes are used to connect the clamp arms 100 through a pin hinge, that is, the clamp arms 100 can be rotated relative to each other through the hinge connection, so as to realize the opening and closing of the clamp arms 100 relative to the fixed base 200 . The cross-sectional dimension of the connection seat 500 parallel to the second plane direction gradually decreases from the proximal end to the distal end, that is, the shape of the connection seat 500 is any structure such as a hemisphere, a spherical cap or a bullet shape, so that the valve clamp is Easier to push in the body. The drive shaft 400 and the connecting base 500 may be of an integral structure or a non-integrated structure. In order to ensure the safety after implantation, the drive shaft 400 and the connecting seat 500 are made of biocompatible materials such as polyester, silicone resin, stainless steel, cobalt alloy, cobalt-chromium alloy or titanium alloy, preferably stainless steel with higher hardness or cobalt-chromium alloys.

In a preferred embodiment, referring to FIG. 18 , when the valve clamp is in the closed state, after the pair of clamp arms 100 is closed relative to the fixed base 200 , between the two clamp arms 100 and the rotation center of the connecting rod 510 The range of the distance is 2.4 ~ 4mm. The distance between the rotation centers of the two clamp arms 100 and the connecting rod 510 is represented by L ₁ . When L ₁ is too large, the outer diameter of the delivery sheath will be larger, which will cause greater trauma to the delivery path; L ₁ If it is too small, the valve leaflet 700 will be clamped too tightly, which may easily cause clamping damage to the valve leaflet 700 . The distance between the central holes of the two pins on the connection base 500 is L ₂ , and L ₂ =(0.8˜1.6)*L ₁ . The reason for this setting is: the difference between the hole distance of the two pins of the connection seat 500 and the hole distance of the pins will affect the closing effect of the valve clamp. The wider it is, the smaller the driving force required to close the valve clamp is, the easier it is to cause the valve leaflet 700 to be clamped too tightly, resulting in excessive pulling stress on the valve leaflet 700 by the forceps arm 100, which is prone to damage to the valve leaflet 700. Or perforation; the smaller the gap between the two, the smaller the distance between the two pin holes of the connecting seat 500, the greater the driving force required to close the valve clamp, the greater the load required by the delivery system, and the easier it is to cause the mandrel to break. or equipment failure.

In a preferred embodiment, referring to FIG. 19 , when the valve clamp is opened, and the pair of forceps arms 100 are opened to the inverted state relative to the fixed base 200 , the range of the eversion angle between the two forceps arms 100 is as follows: 260°～300°; the span of the ends of the two clamp arms 100 ranges from 14 to 18 mm. Specifically, after the valve clamper clamps the valve leaflet 700, if it is found that the clamping position is unreasonable or the effect is not satisfactory, it is necessary to release the valve leaflet 700 and then re-capture the valve leaflet 700 or adjust the position or angle. When releasing, the bilateral clamping arms 300 are first pulled up by the control wire, and then the connecting rods 510 are used to drive the clamping arms 100 on both sides to turn down, so that the leaflets 700 jump out of the clamping arms 100 and pass through the clamping arms 100. The inversion of the valve achieves the disengagement of the valve clamp from the entangled chordae tendineae.

Referring to FIG. 19 , when the pair of clamp arms 100 is opened to the inverted state relative to the fixed base 200 , the distance between the abutting positions of the clamp arms 100 on each side and the side link 510 ranges from 3.6 to 4.4 mm. During the process of inverting the clamp arm 100, the outer side of the connecting rod 510 abuts against the outer side of the clamp arm 100, preventing the clamp arm 100 from turning further. Therefore, the angle _RA between the clamp arms 100 on both sides after the clamp arm 100 is everted and the clamp arm 100 on each side It is related to the distance D ₁ between the positions where the side link 510 abuts. _The smaller D1, the larger the angle _RA between the two sides of the clamp arms ₁₀₀ after eversion, and the smaller the span W1 between the ends of the two clamp arms 100, which is more favorable for the valve clamp to be pulled back from the ventricle side to the The operation on the atrial side prevents the distal end of the forceps arm 100 from hooking on the leaflets 700 or the chordae tendineae. The larger D ₁ is, the smaller the angle _RA between the two sides of the forceps arm 100 after eversion is turned, which is not conducive to the valve leaflet 700 jumping off and releasing from the inner surface of the forceps arm 100 . In the present embodiment, in the inverted state, the eversion angle _RA of the clamp arms 100 on both sides ranges from 260° to 300°, preferably 265° to 275°. The span W ₁ of the ends of the clamp arms 100 on both sides ranges from 14 to 18 mm. The distance D ₁ between the position where each side clamp arm 100 abuts against the side link 510 ranges from 3.6 mm to 4.4 mm.

In a preferred embodiment, the valve clamping system further includes a delivery assembly 800 . The delivery assembly 800 includes an outer sheath tube and a mandrel movably passed through the outer sheath tube, the distal end of the mandrel and the proximal end of the drive shaft 400 Detachable connection between.

Specifically, referring to FIGS. 20 and 21 , the proximal outer wall of the fixing base 200 is symmetrically provided with at least one latching position 210 that communicates with the lumen of the fixing base 200 , and the distal end of the outer sheath is provided with a fixing piece 810 , and the fixing piece 810 includes two branches 811, each branch 811 has a boss at the end. In the natural state, the two branches 811 both point to the central axis of the fixing member 810 . During assembly, insert the fixing member 810 into the fixing base 200, and then insert the mandrel of the delivery assembly 800 into the outer sheath until the mandrel is inserted into the fixing member 810, and push the two branches 811 of the fixing member 810 outward. , the boss at the end of the branch 811 is snapped into the two locking positions 210 of the fixed base 200 , so as to connect the fixed base 200 with the fixed piece 810 , that is, connect the valve clamp and the delivery assembly 800 . When the mandrel is withdrawn from the fixing member and the outer sheath, the two branches 811 return to their natural inward state and are disengaged from the clamping position 210 of the fixing base 200 , so that the valve clamp and the delivery assembly 800 are released from each other. connect. The fixing member 810 is made of a material with certain hardness and elasticity, such as nickel titanium. The outer sheath can be a multi-layer composite tube. The mandrel is made of stainless steel.

The inside of the fixing base 200 is provided with a circular through hole as a passage for the driving shaft 400 , and the driving shaft 400 is slidably inserted through the passage of the fixing base 200 along the axial direction. The proximal end of the drive shaft 400 is provided with external threads for connecting with the mandrel of the delivery assembly 800 so as to control the axial movement of the drive shaft 400 through the mandrel. After the clamping arm 300 and the forceps arm 100 clamp the valve leaflet 700 tissue, the mandrel drives the drive shaft 400 to move proximally in the axial direction, the drive shaft 400 drives the connecting rod 510 to rotate, and the connecting rod 510 drives the forceps arm 100 relative to the The fixed base 200 is closed until the forceps arm 100 is completely closed relative to the fixed base 200 , so that the clamp is in a collapsed state and falls below the valve leaflet 700 .

Referring again to FIG. 1 , in order to effectively treat "mitral regurgitation" in different patients with differences in the spacing of the leaflets 700 , the valve clamp is provided with an adjustment portion 900 . The adjusting part 900 is located inside the valve clamp and abuts against the forceps arm 100 to adjust the degree of pulling the valve clamp to the tissue of the valve leaflet 700 . The adjusting part 900 includes a first end 901 and a second end 902 opposite to the first end 901 . The first end 901 is an open end, and the second end 902 is a closed end formed by closing the heads together. The head of the second end 902 and the fixing base 200 are fixed together by common detachable or non-detachable connection methods such as welding, bonding, screw connection, crimping, bolt locking, etc. The welding connection is adopted in this embodiment. The inner diameter of the head should be at least 0.01 mm larger than the outer diameter of the fixed base 200 , preferably 0.05-2 mm, so that the adjusting portion 900 can be welded on the fixed base 200 . The interior of the adjusting portion 900 is hollow, the fixing base 200 , the driving shaft 400 and the fixing member 810 at the distal end of the conveying assembly 800 are located inside the adjusting portion 900 , and the mandrel and the driving shaft 400 can move relative to the fixing base 200 along the opening of the adjusting portion .

Referring to FIG. 22 , the adjusting part 900 includes an elastic body. When the adjusting part 900 is filled between the anterior leaflet and the posterior leaflet of the clamped mitral valve and abuts against the forceps arm 100 , it has the following advantages: (1) Elasticity The main body has a buffering effect on the pulsating valve leaflet 700, so that the degree of pulling of the valve leaflet 700 by the clamp can be adjusted to avoid damage to the valve leaflet 700; (2) the elastic body can be squeezed following the pulsation of the valve leaflet 700 Deformation, the generated elastic force pushes the part of the valve leaflet 700 close to the elastic body away from the fixed base 200 , so that the clamping angle between the anterior leaflet and the posterior leaflet of the mitral valve is smaller than the opening angle between the forceps arms 100 , which can reduce the pulling of the valve leaflet 700 by the clamp, so that the pulling degree of the valve leaflet 700 by the clamp is always kept within a reasonable range; (3) the elastic body can buffer the direct scouring of the inside of the clamp by the blood flow , to prevent the clamp from falling off due to the continuous scouring of blood, and also to prevent blood from accumulating and forming thrombus at the dead angle (E in the figure) between the clamping parts of the clamp; (4) the elastic body is affected by the valve leaflet 700 When the pressure is applied, a certain degree of deformation will occur, and the degree of deformation increases with the increase of pressure, so as to prevent the elastic body from being squeezed by the forceps arm 100 after grasping the leaflet 700 and acting on the forceps arm 100 in turn above, it is ensured that the grasping effect of the valve clamp on the valve leaflet 700 after the release is the same as that before the release.

The following takes the antegrade approach and repair of the mitral valve through the interatrial septum as an example to illustrate the use process of the valve clamp provided in this embodiment:

S1: Referring to FIG. 23, the drive shaft 400 and the valve clamp connected to it are advanced from the left atrium through the delivery assembly 800, through the mitral valve to the left ventricle;

S2: Adjust the valve clamp close to the valve leaflets 700, that is, the anterior and posterior leaflets of the mitral valve;

S3: Referring to FIG. 24, pull the mandrel and the drive shaft 400 toward the proximal end, drive the forceps arm 100 to open relative to the fixed base 200, and adjust the direction of the forceps arm 100. At this time, the forceps arm 100 and the mitral tip can be observed through X-ray equipment. The relative position of the anterior and posterior leaflets of the valve such that the forceps arm 100 is perpendicular to the mitral valve coaptation line;

S4: Referring to Fig. 25, retract the entire valve clamp proximally, so that the clamp arm 100 supports the valve leaflet 700 on the left ventricle side;

S5: Referring to FIG. 26 , loosen the control wire to release the clamping arms 300 on both sides. The clamping arms 300 on each side press the valve leaflet 700 on the atrial side and cooperate with the clamp arm 100 on the side to fix the valve leaflet 700 to achieve Complete clamping of the leaflets 700;

S6: when the anterior leaflet and the posterior leaflet of the mitral valve are respectively clamped between the pair of clamp arms 100 and the clamp arms 300, the mandrel and the drive shaft 400 are pushed distally, thereby driving the clamp arms 100 to close;

S7: Release the threaded connection between the mandrel and the drive shaft 400, and withdraw the mandrel, the two branches 811 of the fixing member 810 return to the state of being close to the central axis, and the boss is separated from the clamping position of the fixing base 200, The connection between the valve clamp and delivery assembly 800 is released, after which the delivery assembly 800 is withdrawn from the body, resulting in the implanted state of Figure 27, where the valve clamp pulls the anterior and posterior leaflets of the mitral valve toward each other , to obtain a bi-ported mitral valve, and complete the edge-to-edge repair of the mitral valve.

Claims (18)

1. The valve clamping device for preventing valve leaflets from being damaged is characterized by comprising a fixing base and a pair of clamp arms which are arranged on two opposite sides of the fixing base in an openable and closable manner, wherein each clamp arm is provided with a connecting end connected with the fixing base, a free end opposite to the connecting end and a clamping section positioned between the connecting end and the free end, at least part of the clamping section is inwards recessed to form a capturing area, and the capturing area extends towards the free end and then extends towards the direction away from the capturing area of the other clamp arm to form a first flanging section.

2. The valve clamping device for preventing the damage of the valve leaflets according to claim 1, characterized in that an included angle A is formed between the tangent line of the tail end of the first flanging section and the axial direction of the clamping section, and the value range of the included angle A is 90-150 °.

3. The valve clamping device for preventing valve leaflet damage according to claim 2, wherein an included angle B is formed between the axial directions of the two clamping sections after the pair of forceps arms are closed relative to the fixed base, and the included angle B ranges from 20 degrees to 60 degrees.

4. The valve binder of claim 3, wherein an angle C is formed between the extension line of the first flanging section and the vertical line of the central axis of the valve binder, and the angle C ranges from-30 ° to 10 °.

5. The valve binder of claim 4 for protecting against leaflet injury, wherein B/2+90 ° -A + C.

6. The valve binder of claim 1 for preventing damage to valve leaflets, wherein a retaining portion is further disposed between the capturing region and the first cuff section, and the depth of the retaining portion is smaller than the depth of the capturing region.

7. The valve clip according to any one of claims 1 to 6, wherein the pair of arms further comprises a pair of second flange sections, each of the second flange sections extends from the capturing region to both sides, and each of the second flange sections is smoothly connected to one side of the first flange section.

8. The valve binder of claim 7, wherein the clamp arms further comprise a pair of third flange sections, each third flange section extends outwardly from both sides of the capturing area, and each third flange section is connected to the second flange section on the same side of the third flange section.

9. The valve binder of claim 8 for protecting against leaflet injury, wherein the third flanging section comprises, in order from the distal end to the proximal end: a first portion, a second portion, and a third portion, the first portion gradually increasing in transverse dimension from the distal end to the proximal end to be substantially equal to the transverse dimension of the second portion, the second portion gradually decreasing in transverse dimension from the distal end to the proximal end to be substantially equal to the transverse dimension of the third portion.

10. The valve binder of claim 8 wherein said arms further comprise a pair of fourth flange segments, each of said fourth flange segments being formed by said third flange segment extending proximally from the same side of said fourth flange segment.

11. The valve binder of claim 10, wherein the arms are provided with holes for assembly, the fourth flanged segment is disposed on one side of the holes and has an axial dimension greater than a diameter of the holes.

12. The valve binder of claim 1 further comprising a pair of gripping arms, each gripping arm disposed between the fixation base and the clamp arm, the gripping arms being at least partially received in an inner wall of the capture zone in a natural state.

13. A valve coaptation system, comprising an actuation assembly and the valve coaptation device of any of claims 1-12 for protecting valve leaflets from damage, the actuation assembly comprising:

the driving shaft penetrates through the fixed base;

the connecting seat is arranged at the far end of the driving shaft, and the connecting rods are pivotally connected with two sides of the connecting seat;

the driving shaft slides axially relative to the fixed base so as to rotate through the connecting rod and drive the clamp arms to open and close relative to the fixed base.

14. The valve clamping system of claim 13, wherein the connecting seat is fixedly connected to the distal end of the driving shaft, the connecting seat is symmetrically provided with two pairs of connecting holes penetrating through each other, and one end of each connecting rod is rotatably connected to one of the pairs of connecting holes.

15. The valve clamping system of claim 13, wherein a distance between the pair of clamp arms and a center of rotation of the link is in a range of 2.4-4 mm when the pair of clamp arms are closed relative to the stationary base.

16. The valve clamping system of claim 13, wherein the eversion angle between the pair of clamp arms ranges from 260 ° to 300 ° when the clamp arms are expanded to an inverted state relative to the fixation base; the span range of the tail ends of the two clamp arms is 14-18 mm.

17. The valve clamping system of claim 13, wherein the distance between each of the pair of clamp arms and the position where the clamp arm abuts the link ranges from 3.6 mm to 4.4mm when the clamp arms are opened to the inverted state relative to the fixed base.

18. The valve clamping system of any one of claims 13-17, further comprising a delivery assembly, the delivery assembly comprising a sheath and a mandrel movably disposed within the sheath, wherein a distal end of the mandrel is removably coupled to a proximal end of the drive shaft.

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