Valve clamping device, valve clamping system and method for detecting clamping state of clamping assembly

Abstract

The invention discloses a valve clamping device. The valve clamping device comprises a fixed seat; the first clamping piece and the second clamping piece are hinged to the fixed seat; the clamping assembly comprises a connecting base, a first elastic piece assembly and a second elastic piece assembly, the first elastic piece assembly and the second elastic piece assembly extend out of the two opposite sides of the connecting base, and the fixing base is contained in the connecting base; the first elastic piece assembly and the second elastic piece assembly are matched with the first clamping piece and the second clamping piece respectively to clamp a valve leaflet of a valve, the first elastic piece assembly and the second elastic piece assembly each comprise a clamping elastic piece and a detection elastic piece, and when the clamping elastic pieces are matched with the first clamping piece or the second clamping piece to clamp the valve leaflet, the detection elastic pieces are arranged on the clamping elastic pieces. The detection elastic pieces on the same side can be controlled to move between the joint state where the detection elastic pieces are jointed with the valve leaflet and the detection state where the detection elastic pieces are separated from the valve leaflet so as to detect whether the valve leaflet is clamped at the expected position or not by the clamping elastic pieces and the first clamping piece or the second clamping piece in a matched mode. The invention further provides a valve clamping system using the valve clamping device and a method for detecting the clamping state of the clamping assembly.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a valve clamping device, a valve clamping system and a method for detecting the clamping state of a clamping assembly. Background Art

[0002] The atrioventricular valves such as the mitral valve and tricuspid valve are one-way valves in the heart. Normal and healthy atrioventricular valves can control the flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. Figure 1 As shown, the mitral valve MV is a one-way valve located between the left atrium LA and the left ventricle LV of the heart, which can control the blood flow from the left atrium LA to the left ventricle LV, and prevent the blood from flowing from the left ventricle LV to the left atrium LA; the tricuspid valve TV is a one-way valve located between the right atrium RA and the right ventricle RV of the heart, which can control the blood flow from the right atrium RA to the right ventricle RV, and prevent the blood from flowing from the right ventricle RV to the right atrium RA.

[0003] The mitral valve consists of anterior and posterior leaflets, and the tricuspid valve consists of anterior leaflets, posterior leaflets, and septal leaflets. Under normal circumstances, when the left or right ventricle contracts, the edges of any two adjacent leaflets of the mitral valve or tricuspid valve should be completely aligned to prevent blood from flowing from the ventricle to the atrium. If the adjacent leaflets of the mitral valve or tricuspid valve are not aligned properly, when the left or right ventricle contracts, the mitral valve or tricuspid valve cannot be completely closed, causing blood to flow back from the ventricle to the atrium, thereby causing a series of pathophysiological changes, known as "mitral regurgitation" or "tricuspid regurgitation". Figure 2 The example shown is tricuspid regurgitation.

[0004] There is a minimally invasive treatment device based on the principle of edge-to-edge surgery of the valve. The valve clamp is delivered to the mitral valve or tricuspid valve through an interventional catheter, and then the anterior and posterior leaflets of the mitral valve, or any two leaflets of the anterior, septal and posterior leaflets of the tricuspid valve, are clamped simultaneously through the relative opening of the clamp, thereby achieving the purpose of reducing the leaflet gap and alleviating mitral regurgitation. Since there are many causes of mitral or tricuspid regurgitation, and the leaflets of the mitral or tricuspid valve are always in a state of large-scale and strong opening and closing activities, the leaflets themselves are difficult to grasp, and even if they are grasped, the grasping position may not be secure. For example, the leaflets may only be partially grasped, rather than fully contacting the grasping element. This may lead to less than ideal closure or eventual leaflet slippage, and the surgical operation can only be repeated.

[0005] There is another type of minimally invasive mitral or tricuspid valve clamp that detects the clamping state of the valve leaflets based on the developability of the detection element or with the help of sensors and circuit principles. For example, before the fixing device is clamped, a detection element made of a developing material such as metal is pushed toward the grasping element, and the position or shape of the detection element is determined by ultrasound to confirm the clamping state of the valve leaflets. However, since most of the parts of the clamp are metal parts, the position judgment of the detection element will be interfered with under ultrasound, and the doctor cannot intuitively evaluate the grasping effect of the valve. In addition, the detection element is very small and the amplitude of position or shape change is also small, so the actual development effect is not ideal.

[0006] In summary, reducing the repeated grasping and fixation of the valve leaflets by the implantable instruments of the mitral valve or tricuspid valve, reducing the operation time, and lowering the surgical risks are technical difficulties in this field. Summary of the invention

[0007] In order to solve the above technical problem or at least partially solve the above technical problem, the present invention provides a valve clamping device, a valve clamping system and a method for detecting the clamping state of a clamping assembly.

[0008] A first aspect of the present invention provides a valve clamping device, comprising:

[0009] Fixed seat;

[0010] A first clamping member and a second clamping member hinged on the fixing seat; and

[0011] An integrated clamping assembly, which includes a connecting seat and a first spring sheet assembly and a second spring sheet assembly extending from opposite sides of the connecting seat, the connecting seat being fixed to the fixing seat, the first spring sheet assembly and the second spring sheet assembly respectively cooperating with the first clamping piece and the second clamping piece to clamp the leaflets of the valve, the first spring sheet assembly and the second spring sheet assembly both including a clamping spring sheet and a detection spring sheet, when the clamping spring sheet and the first clamping piece or the second clamping piece cooperate to clamp the leaflets, the detection spring sheet on the same side can be controlled to move between an engagement state with the leaflet and a detection state disengaged from the leaflet, so as to detect whether the leaflet is clamped in a desired position by the clamping spring sheet and the first clamping piece or the second clamping piece.

[0012] A second aspect of the present invention provides a valve clamping device, comprising:

[0013] Fixed seat;

[0014] A first clamping member and a second clamping member hinged on the fixing seat; and

[0015] A clamping assembly, the clamping assembly includes a connecting seat and a first spring assembly and a second spring assembly extending from opposite sides of the connecting seat, the connecting seat is fixed to the fixing seat, the first spring assembly and the second spring assembly respectively cooperate with the first clamping piece and the second clamping piece to clamp the valve, and the first spring assembly and the second spring assembly both include a mother spring and a spring piece, the mother spring has a detection state and a release state, the mother spring can move between an engagement state with the valve and a separation state with the valve in the detection state to detect whether the valve is clamped in a desired position by the spring piece on the same side, and the mother spring and the spring piece on the same side clamp the valve at the same time in the release state.

[0016] A third aspect of the present invention provides a method for detecting a clamping state of a clamping assembly, comprising:

[0017] A clamping assembly is provided, wherein the clamping assembly includes a clamping spring piece and a detection spring piece connected at one end;

[0018] Joining the clamping spring piece and the detecting spring piece to the sheet-like body; and

[0019] The detection spring piece is pulled to separate the detection spring piece from the sheet body. If the clamping spring piece is separated from the sheet body, the clamping spring piece and the detection spring piece are re-engaged with the sheet body until the detection spring piece is pulled and the detection spring piece is separated from the sheet body, and the clamping spring piece keeps clamping the sheet body.

[0020] The present invention further provides another method for detecting the clamping state of a valve leaflet, which comprises:

[0021] Engage the clamping springs and the detection springs of the first spring assembly and the second spring assembly with the leaflets of the valve;

[0022] driving the detection spring of the first spring assembly and / or the second spring assembly to separate the detection spring from the leaflet; and

[0023] Observe the information on the movement amplitude of the valve leaflet and / or the blood regurgitation volume of the valve in the received medical image. If the movement amplitude of the valve leaflet increases and / or the blood regurgitation volume of the valve increases, re-engage the clamping springs and the detection springs of the first spring assembly and / or the second spring assembly to the valve leaflet until the detection springs of the first spring assembly and / or the second spring assembly are driven and the detection springs are separated from the valve leaflet, and the movement amplitude of the valve leaflet and / or the blood regurgitation volume of the valve do not increase relative to when the detection springs are engaged with the valve leaflet.

[0024] In a fourth aspect of the present invention, a valve clamping system is provided, comprising the above-mentioned valve clamping device and a delivery device. The delivery device comprises a delivery sheath having a certain axial length, a driving mandrel and a traction line movably installed in the delivery sheath, the driving mandrel is used to drive the first clamping member and the second clamping member to expand and close, and the traction line is used to control the clamping springs and the detection springs of the first spring assembly and the second spring assembly.

[0025] The valve clamping device, valve clamping system, and clamping state detection method of the clamping assembly provided by the present invention have at least the following beneficial effects:

[0026] The clamping assembly of the valve clamping device provided by the present invention has a clamping spring and a detection spring. When the clamping spring clamps the valve, the detection spring can be controlled to move between an engagement state with the leaflet of the valve and a detection state detached from the leaflet, so as to detect whether the leaflet is clamped at a desired position by the clamping spring, that is, when the detection spring is detached from the leaflet, if the leaflet is detached from the clamping spring, it indicates that the leaflet is not clamped at the desired position. The situation of not being clamped at the desired position includes the situation that the clamping length is too short, the leaflet escapes with the beating of the leaflet, and the situation that the leaflet is not clamped by the clamping spring although the clamping spring is close to the leaflet; if the leaflet is still clamped by the clamping spring, it indicates that the leaflet is clamped at the desired position. After detecting that the leaflet is clamped to the desired position by the clamping spring, the detection spring can clamp the leaflet together with the clamping spring. The clamping spring and the detection spring can be realized in the form of a mother spring.

[0027] The valve clamping system utilizes a clamping assembly to clamp the leaflets of the valve and detects whether the leaflets are clamped in a desired position. After detecting that the leaflets are clamped in a desired position by the clamping springs, the detection springs can clamp the leaflets together with the clamping springs so that the leaflets are better clamped. The valve clamping system plays a role in repairing the valve by clamping two leaflets that cannot close naturally.

[0028] The method for detecting the clamping state of the clamping assembly provided by the present invention takes the clamping leaflets as an example. After the clamping spring and the detection spring are engaged with the leaflets of the valve, the detection spring is driven to separate the detection spring from the leaflets. At this time, if the leaflets are not clamped in the desired position by the clamping spring, for example, the clamping length is too short and the leaflets will escape as the leaflets beat, or although the clamping spring is close to the leaflets, the leaflets are not clamped by the clamping spring and escape. Under medical imaging, the leaflets will beat more significantly, or the blood reflux volume between the valves will increase abnormally. Therefore, it can be judged that the leaflets are not clamped in the desired position by the clamping spring. At this time, the clamping assembly can be readjusted to clamp the leaflets until the leaflets are kept clamped, that is, the activity amplitude of the leaflets and / or the blood reflux volume of the valve do not increase. BRIEF DESCRIPTION OF THE DRAWINGS

[0029] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments of the present invention and, together with the description, serve to explain the principles of the present invention.

[0030] 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.

[0031] Figure 1 This is a schematic diagram of the mitral valve and tricuspid valve in normal state;

[0032] Figure 2 yes Figure 1 Schematic diagram of a diseased tricuspid valve;

[0033] Figure 3 is a three-dimensional schematic diagram of the valve clamping device provided by the first embodiment of the present invention when the clamping assembly is in a natural state;

[0034] Figure 4 yes Figure 3 A schematic diagram of the cooperation between the clamping assembly and the fixing seat;

[0035] Figure 5 yes Figure 3 A three-dimensional schematic diagram of a clamping assembly;

[0036] Figure 6 yes Figure 5 A schematic top view of a clamping assembly;

[0037] Figure 7 yes Figure 5 A front view of a clamping assembly;

[0038] Figure 8 yes Figure 3 A schematic diagram of a traction line control of a clamping assembly of a valve clamping device;

[0039] Fig. 9 yes Figure 3 A schematic diagram of another traction line control of a clamping assembly of a valve clamping device;

[0040] Fig.10 yes Figure 3 A three-dimensional schematic diagram of the valve clamping device when the clamping assembly is in a second extreme position;

[0041] Fig.11 yes Figure 3 A three-dimensional schematic diagram of the valve clamping device when the clamping assembly is in another second extreme position;

[0042] Fig.12 yes Figure 3 A schematic diagram of the first spring sheet assembly and the second spring sheet assembly of the clamping assembly engaging the valve leaflet during the simulated detection of the valve leaflet by the valve clamping device;

[0043] Fig.13 yes Fig.12 A schematic diagram of a simulated detection in which the first spring piece component of the clamping component is used for detection, and the second spring piece component remains stationary;

[0044] Fig.14 yes Fig.12 A schematic diagram of a simulated detection in which the first spring piece assembly of the clamping assembly remains stationary and the second spring piece assembly performs detection;

[0045] Fig.15 is a flow chart of a method for detecting a clamping state of a clamping assembly provided by an embodiment of the present invention;

[0046] Fig.16 is a flow chart of a method for detecting a leaflet clamping state provided by an embodiment of the present invention;

[0047] Fig.17 is a three-dimensional schematic diagram of a clamping assembly in a natural state according to a second embodiment of the present invention;

[0048] Fig.18 yes Fig.17 A three-dimensional schematic diagram of the clamping assembly being in a second extreme position;

[0049] Fig.19 is a three-dimensional schematic diagram of another deformable embodiment of a clamping assembly in a second extreme position;

[0050] Fig. 20 is a three-dimensional schematic diagram of a clamping assembly in a natural state according to a third embodiment of the present invention;

[0051] Fig.21 yes Fig. 20 A three-dimensional schematic diagram of the clamping assembly being in a second extreme position;

[0052] Fig. 22 is a three-dimensional schematic diagram of another deformable embodiment of a clamping assembly in a second extreme position;

[0053] Fig.23 is a three-dimensional schematic diagram of a clamping assembly provided by a fourth embodiment of the present invention in a natural state;

[0054] Fig.24 yes Fig.23 A front view of a clamping assembly;

[0055] Fig.25is a front view of a clamping assembly of another deformable embodiment;

[0056] Fig.26 is a three-dimensional schematic diagram of a valve clamping device provided in a fifth embodiment of the present invention;

[0057] Fig. 27 is a schematic diagram of a valve clamping system provided by an embodiment of the present invention;

[0058] Fig.28 yes Fig. 27 Schematic diagram of the valve clipping system when the traction line is tensioned;

[0059] Fig.29 yes Fig.28 A schematic diagram of a valve clamping system when the clamping components are in a closed state;

[0060] Fig.30 It is a schematic diagram of a state in which a valve clamping system with a detachable valve clamping device provided by an embodiment of the present invention is applied to mitral valve treatment and is extended into a mitral valve treatment position;

[0061] Fig.31 yes Fig.30 A schematic diagram of a state in which the clamping assembly of the valve clamping device is opened and is ready to capture the anterior leaflet and the posterior leaflet of the mitral valve;

[0062] Fig.32 yes Fig.31 A schematic diagram of a state in which a clamping assembly of a valve clamping device engages a valve leaflet;

[0063] Fig.33 yes Fig.32 A schematic diagram of a state in which a detection spring of a clamping assembly of a valve clamping device detects whether the clamping spring clamps the valve leaflet at a desired position;

[0064] Fig.34 yes Fig.33 A schematic diagram of a closed state of the valve clamping device after the clamping assembly clamps the valve leaflet to a desired position;

[0065] Fig.35 yes Fig.34 Schematic diagram of the valve clamping device being separated from the delivery device. DETAILED DESCRIPTION

[0066] The technical solutions in the embodiments of the present invention will be described clearly and completely below in conjunction with the accompanying drawings. Obviously, the described embodiments are only 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.

[0067] In the description of the present invention, it should be noted that:

[0068] The directions or positional relationships indicated by the terms "upper", "lower", "inner", "outer", etc. are based on the directions or positional relationships shown in the drawings, and are only for the convenience of describing the present invention and simplifying the description, and do not indicate or imply that the devices or elements referred to must have a specific direction, be constructed and operated in a specific direction, and therefore cannot be understood as limitations of the present invention. In addition, the terms "first", "second", etc. are only used for descriptive purposes and cannot be understood as indicating or implying relative importance;

[0069] When an element is referred to as being "fixed to" or "disposed on" another element, the element may be directly connected to the other element or indirectly connected to the other element through one or more connecting elements. When an element is referred to as being "connected to" another element, it may be directly connected to the other element or connected to the other element through one or more connecting elements.

[0070] It should also be noted that in the field of interventional medical devices, the proximal end refers to the end closer to the operator, while the distal end refers to the end farther from the operator; the direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial direction; the circumferential direction refers to the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius); the radial direction refers to the direction along the wire diameter or radius. It is worth noting that the "end" in the terms "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end", "lower end", etc. is not limited to the end, endpoint or end face, but also includes a portion extending from the end, endpoint, or end face on the element to which the end, endpoint, or end face belongs for an axial distance and / or radial distance. The above definitions are only for the convenience of expression and cannot be understood as the limit of the present invention.

[0071] The valve clamping device provided by the present invention is used for repairing heart valves, especially mitral valves and tricuspid valves.

[0072] See also Figures 3 to 7 The valve clamping device 100 provided in the first embodiment of the present invention mainly includes a fixing seat 110, a clamping assembly 130, a clamping assembly 140, and a driving unit 150.

[0073] The fixing seat 110 mainly includes a base 112, and the base 112 is provided with a hinge hole 112a. The clamping assembly 130 is hinged on the fixing seat 110. In this embodiment, a support rod 114 is also provided on the base 112, and the support rod 114 is fixedly connected to the base 112 or integrally formed. The support rod 114 can be used to connect with a delivery sheath tube of a delivery device (see Fig. 27 )Removable connection.

[0074] The clamping assembly 130 includes a first clamping member 130a and a second clamping member 130b, each of which is in a paddle shape and radiates from the fixing seat 110. In this embodiment, each of the first clamping member 130a and the second clamping member 130b shares a hinge point 110a on the fixing seat 110. The hinges herein and in this application include a rotating shaft type, a hinge type, etc., so that one element can rotate relative to another element, that is, the first clamping member 130a and the second clamping member 130b can rotate relative to the fixing seat 110.

[0075] The clamping assembly 140 includes a first spring assembly 142 and a second spring assembly 144, which are connected as a whole through a substantially U-shaped connecting seat 146. The base 112 is relatively fixed to the connecting seat 146. In this embodiment, the U-shaped hollow space of the connecting seat 146 is used to accommodate the base 112. In other embodiments, the connecting seat 146 can be smaller in size, and the base 112 can also be smaller. The connecting seat 146 is directly fixed to the base 112. A through hole 147 is provided at the center of the connecting seat 146, and a corresponding through hole is also provided at the base 112. The support rod 114 is hollow inside to form a hollow passage from the through hole 147 to the support rod 114.

[0076] The rotation of the first clamping member 130a and the second clamping member 130b is achieved by the driving unit 150. Fig.10 and Fig.11 The driving unit 150 includes a base 152, a connecting rod 153 and a driving shaft 154. One end of the driving shaft 154 is fixedly connected to the base 152, and the other end passes through the through hole 147 of the clamping assembly 140 and the through hole of the base 112 and extends into the hollow channel of the support rod 114, so as to be connected with a driving device, such as a driving core shaft extending from the delivery sheath (see Fig. 27) is detachably connected. A locking element 113 is arranged in the base 112. The locking element 113 can engage the drive shaft 154 to lock it through elastic deformation, or release the engagement so that the drive shaft 154 can move forward and backward. The locking element 113 can be controlled by a control wire (not shown). The locking element 113 also functions to unlock and re-clamp the leaflets when they are clamped in an inappropriate position. The connecting rod 153 includes a pair, which are respectively pivotally connected to the base 152 and are respectively connected to the first clamping member 130a and the second clamping member 130b, that is, the connecting rod 153 can rotate relative to the base 152, and the connecting rod 153 can be fixedly connected to the first clamping member 130a and the second clamping member 130b. The rotation of the connecting rod 153 can pull or push the first clamping member 130a and the second clamping member 130b to rotate relative to the fixed base 110. When the driving shaft 154 is driven in the axial direction, the base 152 can move forward or backward following the driving shaft 154, thereby prompting the connecting rod 153 to rotate. When the connecting rod 153 rotates, it pulls or drives the first clamping member 130a and the second clamping member 130b to expand or close.

[0077] The first spring sheet assembly 142 and the second spring sheet assembly 144 respectively include a clamping spring sheet and a detecting spring sheet, wherein the detecting spring sheet 142b and the clamping spring sheet 142a of the first spring sheet assembly 142 extend from one side of the connecting seat 146, and the detecting spring sheet 144b and the clamping spring sheet 144a of the second spring sheet assembly 144 extend from the other side opposite to the connecting seat 146. Since the detecting spring sheet 142b and the clamping spring sheet 142a of the first spring sheet assembly 142 extend from the same side of the connecting seat 146, they can be referred to as a mother spring sheet group, and the detecting spring sheet 144b and the clamping spring sheet 144a of the second spring sheet assembly 144 also extend from the same side of the connecting seat, they can be referred to as another mother spring sheet group.

[0078] The clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b respectively have a connecting end 146a connected to the connecting seat 146, and a substantially long strip-shaped main body 146b extending from the connecting end 146a. The main body 146b of the clamping spring pieces 142a, 144a and the main body 146b of the corresponding detecting spring pieces 142b, 144b can be separated from each other, and can be separated from each other under external force, such as driving. Each of the detection spring pieces 142b, 144b is connected to the clamping spring pieces 142a, 144a on the same side only at the connecting end 146a, and the other sides of each of the detection spring pieces 142b, 144b are not connected to the clamping spring pieces 142a, 144a, so that the main body 146b of the clamping spring pieces 142a, 144a and the main body 146b of the detection spring pieces 142b, 144b can be separated from each other.

[0079] The clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b are made of elastic materials or materials with shape memory function, and deform when subjected to external force. After the external force disappears, they tend to restore their original shape and position due to elasticity or shape memory ability, so they can be tightened and gathered during the transportation process, and move toward the clamping piece after release to clamp or detect the leaflets of the valve in the present application. The material of the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b is commonly nickel-titanium alloy.

[0080] The ends of the main body 146b of the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b are far away from the connecting seat 146, so they can be pulled when subjected to a small pulling force, and when the ends are driven, such as pulled, the connecting end 146a becomes a rotation point, so that the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b can be away from the first clamping member 130a and the second clamping member 130b within a certain range. Due to the pre-shaping or drive control limitations of the connecting end 146a, the extreme position at which the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b can be closed toward the center of the connecting seat 146 is limited to a certain extent. When the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b are not subjected to a driving force such as a pulling force, and when the first clamping member 130a and the second clamping member 130b do not apply a clamping force, the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b are in a natural state, which is another extreme position. In this embodiment, the clamping spring pieces 142a, 144a are below the detecting spring pieces 142b, 144b, and when they are not driven such as pulled, the clamping spring pieces 142a, 144a are in a natural state facing the first clamping member 130a and the second clamping member 130b, and when the valve is clamped between the clamping assembly 130 and the clamping assembly 140, the clamping spring pieces 142a, 144a have a natural state tending to the valve. The edges of the anterior and posterior leaflets of a valve, such as a mitral valve, are drooping, and even if the detection spring pieces 142b, 144b are at the top, they can still engage with the leaflets, and the engagement includes contact and / or applying a certain clamping pressure based on the contact.

[0081] For the convenience of description, when the first clamping member 130a and the second clamping member 130b do not apply clamping force, and the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b are not driven, such as being pulled, the limit positions of the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b are defined as the first limit position; the limit positions of the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b that are closed toward the center of the connecting seat 146 are defined as the second limit position. The second limit position is the limit state for tightening the clamping assembly 140, and the second limit position is conducive to maintaining the minimum volume of the entire valve clamping device 100 when the clamping assembly 130 is also closed in the transport state, and the entire valve clamping device 100 is also in this state when the implantation is completed. The first limit position is a natural state, and is also a released state, that is, released from the second limit position to the first limit position.

[0082] See also Figures 5 to 7 , the detection spring pieces 142b, 144b are respectively provided with through holes 145 from the connection end 146a toward the middle of the detection spring pieces 142b, 144b, and the axial length of the clamping spring pieces 142a, 144a is less than or equal to the axial length of the through hole 145. Preferably, the axial length of the clamping spring pieces 142a, 144a is less than the axial length of the through hole 145, so as to avoid interference between the clamping spring pieces 142a, 144a and the detection spring pieces 142b, 144b when they move independently. The clamping spring pieces 142a, 144a can be formed by cutting from the through holes 145 of the detection spring pieces 142b, 144b, or directly molded to be separable from the mother spring pieces 142b, 144b. The spring pieces 142a, 144a can move relative to the through hole 145 when subjected to a driving control force. . The pre-shaping of the bending shape of the connecting end 146a increases the fatigue strength of the connecting end 146a when it rotates, and also determines the relative positions of the clamping springs 142a, 144a and the detecting springs 142b, 144b when they are in the natural state.

[0083] In this embodiment, the area of ​​the detection spring pieces 142b and 144b is larger, and the area of ​​the clamping spring pieces 142a and 144a is smaller. The length of the detection spring pieces 142b and 144b is also longer than the length of the clamping spring pieces 142a and 144a. Since the detection spring pieces 142b and 144b are connected to the connecting ends 146a of the clamping spring pieces 142a and 144a corresponding to the same side, as well as the difference in area and length, the detection spring pieces 142b and 144b can be called mother spring pieces, and the clamping spring pieces 142a and 144a can be called spring pieces.

[0084] When the volume of the detection spring pieces 142b, 144b is relatively large and the volume of the clamping spring pieces 142a, 144a is relatively small, since the detection spring pieces 142b, 144b are connected to the corresponding clamping spring pieces 142a, 144a at the connecting end 146a, when the detection spring pieces 142b, 144b are driven by the driving control device, the clamping spring pieces 142a, 144a on the same side will also be affected by the associated force due to their smaller volume and tend to move in the same direction. Under this setting, when the detection spring pieces 142b and 144b are driven by the drive control device, if the leaflets are not clamped to a sufficient depth by the clamping spring pieces 142a and 144a, that is, if the clamping spring pieces 142a and 144a are only clamped to the edge of the leaflets, the leaflets may escape. Therefore, the detection spring pieces 142b and 144b are driven to separate from the leaflets. If the leaflets are also separated from the clamping spring pieces 142a and 144a, it indicates that the leaflets are not clamped at the desired position.

[0085] Since the clamping spring pieces 142a and 144a are relatively small in size, and the connecting seat 146 is fixed to the fixing seat 110, the detecting spring pieces 142b and 144b can be basically unrelated when the clamping spring pieces 142a and 144a are driven by the driving control device. The detecting spring pieces 142b and the detecting spring pieces 144b have their own driving control devices, respectively, so that the detecting spring pieces 142b and 144b can be driven and controlled separately to respectively detect the clamping conditions of the heart valves, such as the anterior leaflet and the posterior leaflet of the mitral valve. The driving control device can be, for example, a traction line, or, for example, a driving wheel or an elastic control device (not shown) can be provided in the connecting seat 146 to achieve the purpose of driving and controlling the detecting spring pieces and the clamping spring pieces. In this embodiment, the clamping spring pieces 142a and the clamping spring pieces 144a can share a traction line, or the clamping spring pieces 142a and the clamping spring pieces 144a have their own traction lines. From the second extreme position in the conveying state (see Fig.28 ) to the first limit position when released, the traction line experiences a relaxation (see Fig. 27 ) process; on the contrary, during installation, the traction line undergoes a tensioning process from the first extreme position when in the released state to the second extreme position when in the conveying state.

[0086] Please also read Figure 3 and Figure 8The ends of the detection spring pieces 142b, 144b and the clamping spring pieces 142a, 144a have a traction line hole 149. The clamping spring piece 142a and the clamping spring piece 144a share a traction line 149a, that is, the two ends of the traction line 149a pass through the traction line holes 149 at the ends of the clamping spring pieces 142a, 144a respectively. The detection spring piece 142b and the detection spring piece 144b have their own traction lines 149b, 149c. Of course, the detection spring piece 142b and the detection spring piece 144b can also share a traction line, and simultaneous detection can also realize the present invention. Please refer to Fig. 9 In another embodiment, the clamping spring piece 142a and the clamping spring piece 144a have respective traction lines 149d and 149e, and the detection spring piece 142b and the detection spring piece 144b also have respective traction lines 149f and 149g. The traction lines of the present application can be released from the traction line hole 149, and the traction lines can be released by pulling, so that the valve clamping device 100 does not contain traction lines when implanted in the heart valve. The traction line can be a nickel-titanium wire, and after the traction line extends out of the traction line hole 149, it can pass through the delivery sheath and the control handle (see Fig. 27 )connect.

[0087] See also Fig.10 When the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b are pulled to the second extreme position, the clamping spring pieces 142a, 144a can be flush with the detecting spring pieces 142b, 144b, and this flushing can make the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b smaller in size. Fig.11 Due to the pre-shaping and / or driving force and limit of the connecting end 146a, the second limit position of the clamping spring pieces 142a and 144a may still be lower than the second limit position of the detecting spring pieces 142b and 144b.

[0088] Please refer again Figure 3 and Figure 7In this embodiment, the clamping springs 142a, 144a extend downward from the through hole 145 relative to the detection springs 142b, 144b. When the clamping springs 142a, 144a and the detection springs 142b, 144b are in the natural state, the end of the clamping springs 142a, 144a away from the connecting seat 146 is lower than the end of the detection springs 142b, 144b away from the connecting seat 146, that is, the detection springs 142b, 144b are relatively farther away from the first clamping member 130a and the second clamping member 130b than the clamping springs 142a, 144a. Therefore, the clamping springs 142a, 144a have a certain spatial distance from the detection springs 142b, 144b. The axial length of the detection spring pieces 142b, 144b is greater than the axial length of the clamping spring pieces 142a, 144a, and the axial length of the clamping spring pieces 142a, 144a is between 4-6mm, and the axial length of the detection spring pieces 142b, 144b is between 5-8mm. In this embodiment, the angle A formed by the extension lines of the two detection spring pieces 242b, 244 is about 120 degrees. The two clamping spring pieces 242a, 244a are below the two detection spring pieces 242b, 244, so the angle formed by their extension lines will be greater than the angle A formed by the extension lines of the two detection spring pieces 242b, 244.

[0089] In this embodiment, the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b are respectively provided with barbs 148. The barbs 148 face and abut against the heart valve leaflets to limit the heart valve leaflets, thereby playing a role in assisting in strengthening and fixing the valve tissue. In this embodiment, the width of the detecting spring pieces 142b, 144b is larger than the width of the clamping spring pieces 142a, 144a, and the number of barbs 148 on the detecting spring pieces 142b, 144b can be more than the number of barbs 148 on the clamping spring pieces 142a, 144a. The number and length of the barbs 148 of the detecting spring piece 142b and the number and length of the barbs 148 of the detecting spring piece 144b can be equal or unequal. When the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b are in the natural state, the barbs 148 on the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b can be engaged with the leaflets of the valve entering between the clamping assembly 130 and the clamping assembly 140. The inclination angles of the barbs 148 relative to the main bodies of the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b can be the same or different. In one embodiment, the number, length and inclination angle of the barbs 148 on the clamping spring piece 142a are the same as those of the barbs 148 on the clamping spring piece 144a; the number, length and inclination angle of the barbs 148 on the detecting spring piece 142b are the same as those of the barbs 148 on the detecting spring piece 144b. In another embodiment, according to the size of the leaflets, for example, the area of ​​the anterior leaflet of the mitral valve of the heart is larger than the area of ​​the posterior leaflet, so as to clamp more specifically, the number and length of the barbs 148 of the clamping spring clip 142a and the detection spring clip 142b used for clamping the anterior leaflet can be greater than the number and length of the barbs 148 of the clamping spring clip 144a and the detection spring clip 144b used for clamping the posterior leaflet.

[0090] See also Figure 12 to Figure 14 , the simulated state of detecting and clamping the valve leaflets of the valve clamping device 100 with the tissue clamping assembly 140 of the present invention is described. When the valve leaflets, such as the anterior leaflet 410 and the posterior leaflet 420 of the mitral valve, enter the first clamping member 130a and the second clamping member 130b respectively, the traction lines of the first spring sheet assembly 142 and the second spring sheet assembly 144 are relaxed, so that the clamping spring sheets 142a, 144a and the detecting spring sheets 142b, 144b are engaged with the valve leaflets (see Fig.12), the engagement at this time may be that the clamping spring pieces 142a, 144a are engaged with the leaflets, or one of the clamping spring pieces 142a, 144a is not engaged with the leaflets. Since the detection spring pieces 142b, 144b are longer or are at different positions from the clamping spring pieces 142a, 144a, the detection spring pieces 142b, 144b shall prevail. Next, the first spring piece assembly 142 and the second spring piece assembly 144 can use the detection spring pieces 142b, 144b to detect whether the leaflets are clamped by the clamping spring pieces 142a, 144a, respectively. Fig.13 As shown, the second spring sheet assembly 144 remains stationary, and the first spring sheet assembly 142 performs detection. When the first spring sheet assembly 142 performs detection, the clamping spring sheet 142a is kept stationary, and the detection spring sheet 142b is pulled up. At this time, the left leaflet is still clamped by the clamping spring sheet 142a, indicating that the leaflet is sufficiently captured. Fig.14 As shown, the first spring sheet assembly 142 remains stationary, and the second spring sheet assembly 144 performs detection. When the second spring sheet assembly 144 performs detection, the clamping spring sheet 144a is kept stationary, and the detection spring sheet 144b is pulled up. At this time, the right leaflet escapes, indicating that the leaflet is not clamped in the desired position. It can be understood that the detection spring sheets 142b, 144b of the valve clamping device 100 of the embodiment of the present invention may also be engaged with the leaflet in the detection process. The state may be between the first limit position and the second limit position, that is, it has not completely reached the natural state of release, but can be engaged with the leaflet for detection under partial control. The above-mentioned Fig.13 and Fig.14 The detection springs 142 b and 144 b of the first spring assembly 142 and the first spring assembly 144 can also detect the clamping state of the front leaf 410 and the rear leaf 420 at the same time.

[0091] It can be understood that the clamping spring pieces 142a, 144a and the detection spring pieces 142b, 144b on the same side of the tissue clamping assembly 140 of the present invention are independently controlled. When the clamping spring pieces 142a, 144a fail to clamp the tissue, such as when the leaflets are in the proper position, the detection spring pieces 142b, 144b can be lifted up, and the clamping spring pieces 142a, 144a can be lifted up to re-engage the tissue. Under this operation, the clamping spring pieces 142a, 144a can be independently moved and adjusted relative to the detection spring pieces 142b, 144b.

[0092] In summary, the clamping assembly provided in the embodiment of the present invention has the function of detecting the clamping state of the leaflet. The leaflet is a sheet-like body, so the clamping assembly provided in the embodiment of the present invention has the function of detecting the clamping state of the sheet-like body. Fig.15 The method for detecting the clamping state of the clamping assembly mainly includes the following steps:

[0093] S1: providing a clamping assembly, wherein the clamping assembly comprises a clamping spring piece and a detection spring piece connected at one end;

[0094] S2: joining the clamping spring piece and the detecting spring piece to a sheet-like body; and

[0095] S3: Pull up the detection spring of the spring assembly to separate the detection spring from the sheet body. If the clamping spring separates from the sheet body, re-engage the clamping spring and the detection spring of the spring assembly with the sheet body until the detection spring of the spring assembly is lifted and the detection spring separates from the sheet body, and the clamping spring keeps clamping the sheet body.

[0096] See also Fig.16 If the sheet-like body is a leaflet of a heart valve, the method for detecting the clamping state thereof may include the following steps:

[0097] S1: engaging the clamping springs and the detection springs of the first spring assembly and the second spring assembly with the leaflets of the valve;

[0098] S2: driving the detection spring of the first spring assembly and / or the second spring assembly to separate the detection spring from the leaflet; and

[0099] S3: Observe the information on the movement amplitude of the valve leaflet and / or the blood regurgitation volume of the valve in the received medical image. If the movement amplitude of the valve leaflet increases and / or the blood regurgitation volume of the valve increases, re-engage the clamping springs and the detection springs of the first spring assembly and / or the second spring assembly to the valve leaflet until the detection springs of the first spring assembly and / or the second spring assembly are driven and the detection springs are separated from the valve leaflet, and the movement amplitude of the valve leaflet and / or the blood regurgitation volume of the valve leaflet do not increase compared to when the detection springs are engaged with the valve leaflet.

[0100] Fig.16 The process of the method for detecting the clamping state of the leaflets can be understood as that since the implantation of the valve clamping device is carried out under medical imaging, such as ultrasound, by observing and receiving information from medical imaging, such as an increase in the activity amplitude of the leaflets and / or an increase in the blood regurgitation volume of the valve, it is indicated that the clamping springs are detached from the leaflets, and the leaflets are not clamped or are clamped too short to cause detachment. In this case, it is necessary to re-engage the clamping springs and the detection springs of the first leaflet assembly and / or the second leaflet assembly with the leaflets until the detection springs of the first leaflet assembly and / or the second leaflet assembly are driven and the activity amplitude of the leaflets and / or the blood regurgitation volume of the leaflets are separated from the leaflets, and the activity amplitude of the leaflets and / or the blood regurgitation volume of the leaflets do not increase relative to when the detection springs are engaged with the leaflets.

[0101] Please also read Fig.17 and Fig.18 , the clamping springs 162a, 164a of the clamping assembly 160 provided in the second embodiment of the present invention are respectively arranged on the sides of the detection springs 162b, 164b. In this embodiment, the axial length of the clamping springs 162a, 164a is shorter than the axial length of the detection springs 162b, 164b, and there is a certain distance between the ends of the clamping springs 162a, 164a and the corresponding detection springs 162b, 164b, so that the driving movement of the clamping springs 162a, 164a is not affected by the detection springs 162b, 164b. The second limit position of the clamping springs 162a, 164a is lower than the second limit position of the detection springs 162b, 164b. At this limit position, at least part of the clamping springs 162a, 164a is lower than the detection springs 162b, 164b, so that it has better recognition under medical images. In this embodiment, the shape of the detection spring pieces 162b, 164b is quite different from that of the clamping spring pieces 162a, 164a. The detection spring pieces 162b, 164b extend from the connecting seat 166 through a thin strip portion 167a. The end of the detection spring pieces 162b, 164b is a wider clamping area 167b, and the clamping area 167b is provided with barbs 168 and traction line holes 169; the clamping spring pieces 162a, 164a are of basically uniform width, and barbs 168a and traction line holes 169a are also provided at the ends. The thin strip portion 167a of the detection spring pieces 162b, 164b makes it easier to pull the detection spring pieces 162b, 164b, and a smaller force is required to drive the detection spring pieces 162b, 164b. The wide clamping 167b of the detection spring pieces 162b, 164b enables the detection spring pieces 162b, 164b to assist the clamping spring pieces 162a, 164a in clamping a wider area of ​​the leaflets when the detection is completed. The axial length of the detection spring pieces 162b, 164b is longer, and the detection spring pieces 162b, 164b are closer to the valve ring of the heart when clamped.

[0102] See also Fig.19 In a deformable embodiment, by changing the degree of pre-shaping of the ends connected to the clamping spring pieces 162a, 164a and the detecting spring pieces 162b, 164b and / or the drive of the drive control, the second extreme position of the clamping spring pieces 162a, 164a can also be flush with the second extreme position of the detecting spring pieces 162b, 164b.

[0103] Please also read Fig. 20 and Fig.21The clamping spring pieces 172a, 174a and the detecting spring pieces 172b, 174b of the clamping assembly 170 provided in the third embodiment of the present invention have the same length. The clamping spring pieces 172a, 174a are arranged on the sides of the detecting spring pieces 172b, 174b. The number, length and inclination angle of the barbs on the clamping spring pieces 172a, 174a and the detecting spring pieces 172b, 174b can be set to be the same. In the natural state, that is, in the first extreme position, the ends of the clamping spring pieces 172a, 174a are lower than the ends of the detecting spring pieces 172b, 174b (see Fig. 20 ); The second limit position of the clamping spring pieces 172a, 174a is lower than the second limit position of the detection spring pieces 172b, 174b (see Fig.21 ), that is, the position of the detection spring pieces 172b, 174b is higher than that of the clamping spring pieces 172a, 174a, and the detection spring pieces 172b, 174b are designed to be easier to be pulled. Under medical imaging, the clamping spring pieces 172a, 174a and the detection spring pieces 172b, 174b can also be better identified according to the height of the position.

[0104] See also Fig. 22 In a deformable embodiment, the clamping spring pieces 172a, 174a can also be exactly the same as the detection spring pieces 172b, 174b. The clamping spring pieces 172a, 174a and the detection spring pieces 172b, 174b play the role of double-row clamping arms to increase the clamping area, and the second extreme position of the clamping spring pieces 172a, 174a can be flush with the second extreme position of the detection spring pieces 172b, 174b.

[0105] It can be understood that, in the case where the detection spring pieces 172b, 174b and the clamping spring pieces 172a, 174a are of equal length, the detection spring pieces 172b, 174b and the clamping spring pieces 172a, 174a are still connected at one end, so they can still be regarded as the mother spring piece and the spring piece respectively, the spring piece, i.e. the clamping spring piece 172a, 174a, is responsible for clamping, the mother spring piece, i.e. the detection spring piece 172b, 174b, is responsible for detection, and after the detection is completed, the auxiliary spring piece clamps the leaflet. After the clamping assembly 130 is closed, the valve clamping device 100 of the embodiment of the present invention plays an edge-to-edge clamping effect on the two leaflets that cannot be naturally closed, that is, plays a role in reducing the leakage of mitral valve or tricuspid valve regurgitation and reducing blood regurgitation, and the valve can still open and close normally after the valve clamping device 100 is implanted.

[0106] See also Figure 23 to Figure 24The difference between the clamping assembly 240 provided in the fourth embodiment of the present invention and the clamping assembly 140 of the first embodiment is that: when the clamping assembly 240 is in a natural state without being subjected to the pulling force of the traction line, the clamping springs 242a, 244a and the corresponding detection springs 242b, 244 are flush. In this embodiment, the axial length of the clamping springs 242a, 244a is less than the axial length of the through hole 245 of the detection springs 242b, 244, that is, the ends of the clamping springs 242a, 244a have a certain spatial distance from the detection springs 242b, 244, so that the clamping springs 242a, 244a and the detection springs 242b, 244 do not interfere with each other when they move independently, and can accommodate the redundant part of the traction line. In this embodiment, the side edges of the clamping springs 242a, 244a can also have a certain spatial distance from the inner side of the through hole 245 of the detection springs 242b, 244 to further reduce motion interference. In this embodiment, the natural state of the clamping spring pieces 242a, 244a, that is, the first limit position is flush with the first limit position of the detection spring pieces 242b, 244, and the second limit position can also be flush with the second limit position of the detection spring pieces 242b, 244. In a preferred embodiment, the angle A between the two detection spring pieces 242b, 244 can be slightly greater than about 180 degrees, that is, the ends 246b of the two detection spring pieces 242b, 244 are slightly lower than the connection end 246a connected to the connection seat 246, and the two clamping spring pieces 242a, 244a are flush with the detection spring pieces 242b, 244, so the angle between the two clamping spring pieces 242a, 244a is also equal to the angle A between the two detection spring pieces 242b, 244. The situation that the end 246b is slightly lower than the connecting end 246a helps the detecting spring pieces 242b, 244 and the clamping spring pieces 242a, 244a to be closer to the valve in the natural state.

[0107] In the above embodiment, since the leaflets of the heart valve are inclined, the detection spring pieces 242b, 244b and the clamping spring pieces 242a, 244a can be engaged with the leaflets in a natural state or in a partially controlled state. Theoretically, the angle between the two detection spring pieces 242b, 244b in a natural state or the angle between the two clamping spring pieces 242a, 244a between 90 degrees and 270 degrees can be engaged with the leaflets. The detection spring pieces 242b, 244b and the clamping spring pieces 242a, 244a are respectively provided with a row of barbs 248 in a transverse direction.

[0108] See also Fig.25 In a deformable embodiment, only the clamping spring pieces 242a and 244a are provided with barbs 248, and the barbs 248 can be in two rows, while the detection spring pieces 242b and 244b are not provided with barbs. After completing the detection, the detection spring pieces 242b and 244b are also crimped on the leaflets to play a certain auxiliary clamping role.

[0109] See also Fig.26 The fifth embodiment of the present invention provides a valve clamping device 200 whose fixed seat outer cover is provided with a blocking net 210. The functions of the clamping assembly 230, the driving unit 250, and the clamping spring pieces 242a, 244a and the detection spring pieces 242b, 244b included in the clamping assembly of the valve clamping device 200 are the same as those of the aforementioned embodiments, and the only difference is that after the clamping assembly 230 closes and clamps the leaflets that cannot be closed naturally, the blocking net 210 can block the gaps between the clamped leaflets, so that the effect of treating reflux is better. One end of the blocking net 210 can be fixed to the fixed seat by a fixing ring, and the support rod 114 of the fixed seat can extend out of the other end of the blocking net 210 and connect with a delivery sheath of a delivery device (see Fig. 27 ) connection, in other embodiments, the support rod 114 may also be inside the blocking net 210.

[0110] The occluding net 210 is a three-dimensional mesh structure, preferably a three-dimensional mesh structure made of woven wire or cut tube with shape memory function, such as superelastic materials such as nickel-titanium alloy wire, so that under different clamping angles or different clamping forces of the clamping assembly 230, the occluding net 210 can adapt to the gaps between different leaflets and undergo adaptive deformation, thereby adjusting the pulling degree of the leaflets by the valve clamping device 200. For example, for the adjacent leaflets of the tricuspid valve with a large gap but thin and fragile (it can be the anterior leaflet and the posterior leaflet, the anterior leaflet and the septal leaflet, or the posterior leaflet and the septal leaflet of the tricuspid valve), the clamping assembly 230 can be closed at a larger clamping angle to prevent the leaflets from being subjected to excessive stress and prevent the leaflets from being perforated or torn; for the adjacent leaflets of the mitral valve (i.e., the anterior leaflet and the posterior leaflet of the mitral valve), the clamping assembly 230 can be closed at a smaller clamping angle to provide a larger clamping force to the leaflets.

[0111] In summary, the clamping assembly of the valve clamping device provided in the embodiment of the present invention has a clamping spring and a detection spring. When the clamping spring clamps the valve, the detection spring can be controlled to move between a natural state of engagement with the valve and a detection state of detachment from the valve, so as to detect whether the valve is clamped in the desired position by the clamping spring, that is, when the detection spring is detached from the valve, if the valve is detached from the clamping spring, it indicates that the valve is not clamped in the desired position, including the situation that the clamping length is too short, the valve leaf escapes with the beating of the valve leaf, and the valve leaf is not clamped by the clamping spring; if the valve is still clamped by the clamping spring, it indicates that the valve is clamped in the desired position. After detecting that the valve leaf is clamped to the desired position by the clamping spring, the detection spring can clamp the valve leaf together with the clamping spring. The clamping spring and the detection spring can be realized in the form of a mother spring.

[0112] See also Figure 27 to Figure 29The embodiment of the present invention further provides a valve clamping system, which includes the above-mentioned valve clamping device 100 and a delivery device, wherein the delivery device includes: a control handle 330, a delivery sheath 310 with a certain axial length, and a driving core shaft 320 movably installed in the delivery sheath 310. The distal end of the delivery sheath 310 is detachably connected to the support rod 114 of the valve clamping device 100, and the distal end of the driving core shaft 320 is detachably connected to the driving shaft 154, which is used to drive the expansion and closure of the clamping assembly 130. The connection between the driving core shaft 320 and the driving shaft 154 can be a threaded connection, the delivery sheath 310 and the support rod 114 can be clamped, the driving core shaft 320 and the driving shaft 154 abut the delivery sheath 310 and the support rod 114, so that the connection between the delivery sheath 310 and the support rod 114 is maintained in position, and when the driving core shaft 320 is separated from the driving shaft 154, the delivery sheath 310 can be automatically separated from the support rod 114. The driving core shaft 320 may be a metal wire, and the valve clamping device 100 may also be replaced by the aforementioned valve clamping device 200 . Fig. 27 The traction line of the clamping assembly 140 of the valve clamping device 100 is in a relaxed state and is in contact with the Figure 8 The pulling line is consistent. Fig.28 and Fig.29 The traction line of the clamping assembly of the valve clamping device 100 is in a tensioned state, and Fig.29 The clamping assembly 130 of the valve clamping device 100 is closed, and this closed state can be a delivery state or a closed state after the leaflet is clamped to a desired position.

[0113] Please also read Fig.10 , Fig. 27 , Figure 30 to Figure 35 Taking the repair process of the anterior leaflet and the posterior leaflet of the mitral valve as an example, the operation method of the valve clamping system using the valve clamping device of the present invention mainly includes the following steps:

[0114] By puncturing the femoral vein, the distal end of the delivery sheath 310 and the valve clamping device 100 are delivered to the left atrium LA through the inferior vena cava; then the valve clamping device 100 is controlled to approach the anterior leaflet 410 and the posterior leaflet 420 of the mitral valve; the locking element 113 in the fixing seat is unlocked (see Fig.10 ), the driving mandrel 320 is delivered to the distal end (see Fig. 27), the driving core shaft 320 drives the driving shaft 154, and the driving shaft 154 drives the clamping assembly 130 to open relatively, and adjusts the direction of the clamping assembly 130. At this time, the relative position of the clamping assembly 130 and the anterior leaflet and the posterior leaflet of the mitral valve can be observed by medical imaging or imaging equipment, so that the clamping assembly 130 is roughly perpendicular to the free edges of the anterior leaflet and the septal leaflet; then the valve clamping device 100 is pushed to the left ventricle through the delivery sheath 310, and the valve clamping device 100 is placed under the anterior leaflet and the posterior leaflet, and the clamping assembly 130 is continued to be opened to the capture position (see Fig.31 ); at the same time, the traction line controlling the clamping assembly 140 is tensioned to close the clamping assembly 140. At this time, a leaflet accommodating space is formed between the clamping assembly 140 and the clamping assembly 130.

[0115] See also Fig.32 , release the clamping assemblies 140 on both sides simultaneously or successively, the clamping assemblies 140 engage the leaflets and cooperate with the clamping assembly 130 to capture the anterior leaflet and the posterior leaflet. Then, see Fig.33 The detection spring piece 144b (or the detection spring piece 142b) of the clamping assembly 140 detects whether the clamping spring piece 144a (or the detection spring piece 142a) clamps the leaflet to the desired position. The detection process is described in the above Figure 12 to Figure 14 After detecting that the leaflet is clamped to the desired position, the detection spring 144b of the clamping assembly 140 is released so that it clamps the leaflet together with the clamping assembly 140, and then the driving core shaft 320 and the driving shaft 154 are pulled toward the proximal end, thereby driving the clamping assembly 130 to close (see Fig.34 ), so that the front leaf and the rear leaf are clamped between the clamping assembly 140 and the clamping assembly 130;

[0116] The threaded connection between the drive core shaft 320 and the drive shaft 154 is released, and the drive core shaft 320 is withdrawn, the delivery sheath 310 is separated from the support rod 114, and the connection between the valve clamping device 100 and the delivery device is released, and then the delivery device is withdrawn from the body, and the following is obtained: Fig.35 In the implanted state shown, the valve clipping device 100 pulls the anterior and posterior leaflets of the mitral valve toward each other, completing an edge-to-edge repair of the anterior and posterior leaflets.

[0117] The valve repair device and valve clipping device are suitable for use in mitral valve clipping, and of course can also be used in tricuspid valve clipping, but the interventional pathways are different. For example, the interventional pathway of tricuspid valve clipping can be femoral vein-inferior vena cava-right atrium-right ventricle, or it can be a transapical approach.

[0118] It can be understood that the valve clamping system provided by the present invention may include any valve clamping device of the above-mentioned embodiments and a delivery device capable of delivering the valve clamping device from outside the body to the vicinity of the tricuspid valve or the mitral valve and clamping the valve leaflets.

[0119] The foregoing is merely a specific embodiment of the present invention, which enables those skilled in the art to understand or implement the present invention. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but will conform to the widest scope consistent with the principles and novel features claimed herein.

Claims

1. A valve clamping device, characterized in that: It includes: Fixed seat; A first clamping member and a second clamping member hinged on the fixing seat; as well as An integrated clamping assembly, which includes a connecting seat and a first spring sheet assembly and a second spring sheet assembly extending from opposite sides of the connecting seat, the connecting seat being fixed to the fixing seat, the first spring sheet assembly and the second spring sheet assembly respectively cooperating with the first clamping piece and the second clamping piece to clamp the leaflets of the valve, and the first spring sheet assembly and the second spring sheet assembly both include a clamping spring sheet and a detection spring sheet, when the clamping spring sheet and the first clamping piece or the second clamping piece cooperate to clamp the leaflets, the detection spring sheet on the same side can be controlled to move between an engagement state with the leaflet and a detection state disengaged from the leaflet, so as to detect whether the leaflet is clamped in a desired position by the clamping spring sheet and the first clamping piece or the second clamping piece.

2. The valve clamping device according to claim 1, characterized in that: Each clamping spring sheet and detecting spring sheet respectively extends outward from the connecting seat, and both the clamping spring sheet and the detecting spring sheet have a connecting end connected to the connecting seat and a main body extending from the connecting end, and the main body of the clamping spring sheet and the main body of the detecting spring sheet can be separated from each other.

3. The valve clamping device according to claim 2, characterized in that: One end of the clamping spring sheet away from the connecting seat is lower than one end of the detecting spring sheet on the same side away from the connecting seat.

4. The valve clamping device according to claim 2, characterized in that: When the clamping spring piece clamps the leaflet and the detecting spring piece is in the engaged state, the clamping spring piece is flush with the corresponding detecting spring piece.

5. The valve clamping device according to claim 1, characterized in that: There is a spatial distance between the clamping spring piece and the detecting spring piece, and the clamping spring piece is provided with barbs.

6. The valve clamping device according to claim 1, characterized in that: Each detection spring of the first spring assembly and the second spring assembly is connected to a drive control device. When the detection spring is driven and controlled to be separated from the leaflet, the clamping spring on the same side is subjected to an associated force and has a tendency to separate from the leaflet. When the detection spring is driven and controlled to be separated from the leaflet, the clamping spring on the same side clamps the leaflet or separates from the leaflet.

7. The valve clamping device according to claim 6, characterized in that: Each clamping spring of the first spring assembly and the second spring assembly is connected to a drive control device, and each clamping spring and detection spring can move between a first extreme position and a second extreme position when driven and controlled. In the first extreme position or the second extreme position, the clamping spring is flush with the detection spring on the same side, or the clamping spring is lower than the detection spring on the same side.

8. The valve clamping device according to claim 7, characterized in that: The drive control device for the detection spring piece and the clamping spring piece includes a traction line. The detection spring pieces of the first spring piece assembly and the second spring piece assembly are respectively driven and controlled by separate traction lines. The clamping spring pieces of the first spring piece assembly and the second spring piece assembly are colinearly driven and controlled, or driven and controlled by separate traction lines.

9. The valve clamping device according to claim 2, characterized in that: Each of the detection springs is provided with a through hole, and the axial length of each of the clamping springs is less than or equal to the axial length of the through hole.

10. The valve clamping device according to claim 2, characterized in that: Each of the clamping spring pieces is adjacently arranged on the outer side of the detection spring piece, and the length of the clamping spring piece is less than or equal to the length of the detection spring piece.

11. The valve clamping device according to claim 2, characterized in that: When the main body of the clamping spring and the main body of the detecting spring are in a natural state without being subjected to external force, the angle between the clamping spring of the first spring assembly and the clamping spring of the second spring assembly is between 90 degrees and 270 degrees, and the angle between the detecting spring of the first spring assembly and the detecting spring of the second spring assembly is between 90 degrees and 270 degrees.

12. The valve clamping device according to claim 1, characterized in that: It also includes a driving shaft, the fixing seat and the connecting seat are provided with aligned through holes, the driving shaft passes through the through holes, and the driving shaft is connected to the first clamping member and the second clamping member through a connecting rod to drive the first clamping member and the second clamping member to expand or close relative to each other.

13. The valve clamping device according to claim 12, characterized in that: It also includes a blocking net, the fixing seat is provided with a support rod, the blocking net is sleeved on the support rod and is located between the first spring sheet assembly and the second spring sheet assembly, and the driving shaft extends into the blocking net and is connected to a driving core shaft.

14. A valve clamping device, characterized in that: It includes: Fixed seat; A first clamping member and a second clamping member hinged on the fixing seat; as well as A clamping assembly, the clamping assembly includes a connecting seat and a first spring assembly and a second spring assembly extending from opposite sides of the connecting seat, the connecting seat is fixed to the fixing seat, the first spring assembly and the second spring assembly are respectively used to cooperate with the first clamping piece and the second clamping piece to clamp the leaflets of the valve, and the first spring assembly and the second spring assembly both include a mother spring and a bullet leaf, the mother spring has a detection state and a release state, the mother spring can move between an engagement state with the leaflet and a separation state with the leaflet in the detection state to detect whether the leaflet is clamped in a desired position by the bullet leaf on the same side, and the mother spring and the bullet leaf on the same side clamp the leaflet at the same time in the release state.

15. A method for detecting a clamping state of a clamping assembly, comprising: A clamping assembly is provided, wherein the clamping assembly includes a clamping spring piece and a detection spring piece connected at one end; Joining the clamping spring piece and the detecting spring piece to the sheet-like body; and The detection spring piece is pulled to separate the detection spring piece from the sheet body. If the clamping spring piece is separated from the sheet body, the clamping spring piece and the detection spring piece are re-engaged with the sheet body until the detection spring piece is pulled and the detection spring piece is separated from the sheet body, and the clamping spring piece keeps clamping the sheet body.

16. A valve clamping system, comprising a valve clamping device as described in claim 1, and a delivery device, wherein the delivery device comprises a delivery sheath having a certain axial length and a driving core shaft and a traction wire movably installed in the delivery sheath, the driving core shaft is used to drive the first clamping member and the second clamping member to expand and close, and the traction wire is used to control the clamping springs and detection springs of the first spring assembly and the second spring assembly.

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