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

Abstract

The present invention discloses a valve clamping device, comprising a fixing seat; a first clamping member and a second clamping member hinged on the fixing seat; and a clamping assembly, wherein the clamping assembly comprises a connecting seat and a first elastic sheet assembly and a second elastic sheet assembly extending from opposite sides of the connecting seat, wherein the fixing seat is accommodated in the connecting seat, wherein the first elastic sheet assembly and the second elastic sheet assembly respectively cooperate with the first clamping member and the second clamping member to clamp the leaflets of the valve, and wherein the first elastic sheet assembly and the second elastic sheet assembly each comprise a clamping leaflet and a detection leaflet. When the clamping leaflet cooperates with the first clamping member or the second clamping member to clamp the leaflet, the detection leaflet on the same side can be controlled to move between an engaged state with the leaflet and a detection state disengaged from the leaflet to detect whether the leaflet is clamped in a desired position by the clamping leaflet and the first clamping member or the second clamping member. The present invention also 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 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 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 leaflet, posterior leaflet and septal leaflet. Under normal circumstances, when the left ventricle 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 ventricle 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 currently a minimally invasive treatment device that is based on the principle of edge-to-edge valve surgery. It delivers a valve clamp to the mitral valve or tricuspid valve through an interventional catheter, and then simultaneously clamps the anterior and posterior leaflets of the mitral valve, or any two leaflets of the anterior, septal, and posterior leaflets of the tricuspid valve, through the relative opening of the clamp, thereby achieving the purpose of reducing the interleaflet 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 has to be repeated.

[0005] There is another type of minimally invasive mitral or tricuspid valve clamp that detects the clamping state of the 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 judged by ultrasound to confirm the clamping state of the leaflets. However, since most of the parts of the clamp are metal parts, they will interfere with the judgment of the position of the detection element 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 the 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 problems or at least partially solve the above technical problems, 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 clipping device, comprising:

[0009] Fixed seat;

[0010] a first clamping member and a second clamping member hingedly connected to the fixing seat; and

[0011] An integrated clamping assembly, which 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 leaflet of the valve, the first spring assembly and the second spring assembly both include a clamping spring and a detection spring, when the clamping spring and the first clamp or the second clamp cooperate to clamp the leaflet, the detection spring 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 the desired position by the clamping spring and the first clamp or the second clamp.

[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 hingedly connected to the fixing seat; and

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

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

[0020] The present invention further provides another method for detecting a leaflet clamping state, comprising:

[0021] Engaging 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 received in the 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 spring and the detection spring of the first spring assembly and / or the second spring assembly with the valve leaflet until the detection spring of the first spring assembly and / or the second spring assembly is driven and the detection spring is 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 relative to the movement amplitude of the valve leaflet and / or the blood regurgitation volume of the valve when the detection spring is engaged with the valve leaflet.

[0024] A fourth aspect of the present invention provides a valve clamping system comprising the aforementioned valve clamping device and a delivery device. The delivery device comprises a delivery sheath having a predetermined axial length, a drive mandrel movably mounted within the delivery sheath, and a pull wire. The drive mandrel is configured to drive the first and second clamping members to expand and close, and the pull wire is configured to control the clamping and detection springs of the first and second spring leaf assemblies.

[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 comprises 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 in which it engages with the leaflet of the valve and a detection state in which it disengages from the leaflet, so as to detect whether the leaflet is clamped in the desired position by the clamping spring. That is, when the detection spring is disengaged from the leaflet, if the leaflet is disengaged from the clamping spring, it indicates that the leaflet is not clamped in the desired position. Situations in which the leaflet is not clamped in the desired position include situations in which the clamping length is too short, the leaflet escapes as it beats, and the leaflet escapes without being clamped by the clamping spring even though 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 in the desired position. After detecting that the leaflet is clamped in the desired position by the clamping spring, the detection spring can clamp the leaflet simultaneously with the clamping spring. The clamping spring and the detection spring can be implemented 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 the desired position. After detecting that the leaflets are clamped in the 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 the role of repairing the valve by clamping the two leaflets that cannot close naturally.

[0028] The present invention provides a method for detecting the clamping state of the clamping assembly. Taking the clamping leaflets as an example, after the clamping shrapnel and the detection shrapnel engage the leaflets of the valve, the detection shrapnel is driven to separate the detection shrapnel from the leaflets. At this time, if the leaflets are not clamped in the desired position by the clamping shrapnel, for example, the clamping length is too short and the leaflets will escape as the leaflets beat, or although the clamping shrapnel is close to the leaflets, the leaflets are not clamped by the clamping shrapnel 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 shrapnel. 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 invention and, together with the description, serve to explain the principles of the invention.

[0030] 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 drawings required for use in the embodiments or the description of the prior art. 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 and tricuspid valves in their normal state;

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

[0033] Figure 3 is a three-dimensional schematic diagram of the valve clamping device provided by the first embodiment of the present invention, with the clamping assembly 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 the 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] Figure 9 yes Figure 3 A schematic diagram of another traction line control of the clamping assembly of the valve clamping device;

[0040] Figure 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] Figure 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] Figure 12 yes Figure 3 A schematic diagram of the first and second elastic leaflet assemblies of the clamping assembly engaging with the leaflet during simulated detection of the leaflet by the valve clamping device;

[0043] Figure 13 yes Figure 12 A schematic diagram of a simulated detection in which the first spring element assembly of the clamping assembly is used for detection and the second spring element assembly remains stationary;

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

[0045] Figure 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] Figure 16 is a flow chart of a method for detecting a leaflet clamping state provided by an embodiment of the present invention;

[0047] Figure 17 is a perspective schematic diagram of a clamping assembly in a natural state according to a second embodiment of the present invention;

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

[0049] Figure 19 is a perspective schematic diagram of a clamping assembly in another deformable embodiment in a second extreme position;

[0050] Figure 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] Figure 21 yes Figure 20 A three-dimensional schematic diagram of the clamping assembly being in a second extreme position;

[0052] Figure 22 is a perspective schematic diagram of a clamping assembly in another deformable embodiment in a second extreme position;

[0053] Figure 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] Figure 24 yes Figure 23 A front view of the clamping assembly;

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

[0056] Figure 26 is a perspective schematic diagram of a valve clamping device provided in a fifth embodiment of the present invention;

[0057] Figure 27 is a schematic diagram of a valve clipping system provided by an embodiment of the present invention;

[0058] Figure 28 yes Figure 27 Schematic diagram of the valve clipping system when the traction wire is tensioned;

[0059] Figure 29 yes Figure 28 A schematic diagram of a valve clipping system when the clipping components are closed;

[0060] Figure 30 1 is a schematic diagram of a valve clipping system with a detachable valve clipping device provided by an embodiment of the present invention, when applied to mitral valve treatment and extended into a mitral valve treatment position;

[0061] Figure 31 yes Figure 30 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] Figure 32 yes Figure 31 A schematic diagram of a state in which the clamping assembly of the valve clamping device engages with the valve leaflet;

[0063] Figure 33 yes Figure 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] Figure 34 yes Figure 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] Figure 35 yes Figure 34 Schematic diagram of the valve clamping device being separated from the delivery device. DETAILED DESCRIPTION

[0066] The following will clearly and completely describe the technical solutions in the embodiments of the present invention 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] Terms such as "upper," "lower," "inner," and "outer" indicate positions or relationships based on those shown in the accompanying drawings. These terms are intended solely to facilitate and simplify the description of the present invention and are not intended to indicate or imply that the devices or components referred to must have, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limitations of the present invention. Furthermore, terms such as "first" and "second" are used for descriptive purposes only and should not be construed 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 objects such as cylinders and tubes is defined as axial; the circumferential direction is the direction around the axis of objects such as cylinders and tubes (perpendicular to the axis and also perpendicular to the cross-sectional radius); and the radial direction refers to the direction along the wire diameter or radius. It is worth noting that the "end" that appears 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 the part extending an axial distance and / or radial distance from the end, endpoint, or end face on the component to which the end, endpoint, or end face belongs. The above definitions are only for convenience of expression and should not 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, the base 112 is further provided with a support rod 114, 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 of a delivery device (see Figure 27 ) Detachable connection.

[0074] The clamping assembly 130 includes a first clamping member 130a and a second clamping member 130b. Each of the first clamping member 130a and the second clamping member 130b is paddle-shaped and radiates outward from the fixing base 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 base 110. The term "hinged" herein and in this application includes hinges, pivots, and the like, which allow one element to rotate relative to another. Specifically, the first clamping member 130a and the second clamping member 130b can rotate relative to the fixing base 110.

[0075] The clamping assembly 140 includes a first spring assembly 142 and a second spring assembly 144, which are connected integrally via a substantially U-shaped connecting seat 146. The base 112 and the connecting seat 146 are relatively fixed. 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 and the base 112 may be smaller, and the connecting seat 146 may be directly fixed to the base 112. A through hole 147 is defined in the center of the connecting seat 146, and a corresponding through hole is also defined in the base 112. The support rod 114 is hollow inside, forming 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. In this embodiment, please refer to Figure 10 and Figure 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 for connecting with a driving device, such as a driving core shaft extending from the delivery sheath (see Figure 27) is detachably connected. A locking element 113 is provided 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 function of the locking element 113 is also to unlock and re-clamp the leaflet when it is 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 be rotated 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 fragment assembly 142 and the second spring fragment assembly 144 respectively include a clamping spring fragment and a detecting spring fragment. The detecting spring fragment 142b and the clamping spring fragment 142a of the first spring fragment assembly 142 extend from one side of the connecting base 146, while the detecting spring fragment 144b and the clamping spring fragment 144a of the second spring fragment assembly 144 extend from the opposite side of the connecting base 146. Since the detecting spring fragment 142b and the clamping spring fragment 142a of the first spring fragment assembly 142 extend from the same side of the connecting base 146, they can be referred to as a primary spring fragment group. The detecting spring fragment 144b and the clamping spring fragment 144a of the second spring fragment assembly 144 also extend from the same side of the connecting base and can be referred to as another primary spring fragment group.

[0078] The clamping springs 142a, 144a and the detecting springs 142b, 144b each have a connecting end 146a connected to the connecting base 146 and a substantially elongated main body 146b extending from the connecting end 146a. The main body 146b of the clamping springs 142a, 144a and the main body 146b of the corresponding detecting springs 142b, 144b are separable from each other and can be separated from each other when subjected to an external force, such as actuation. Each of the detection spring pieces 142b, 144b is connected to the clamping spring piece 142a, 144a on the same side only at the connection 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 piece 142a, 144a and the main body 146b of the detection spring piece 142b, 144b can be separated from each other.

[0079] The clamping springs 142a, 144a and the detecting springs 142b, 144b are made of an elastic material or a material with shape memory. They deform when subjected to an external force and tend to return to their original shape and position after the external force disappears due to their elasticity or shape memory. Therefore, they can be tightened and gathered during delivery and then move toward the clamping member after release to perform the clamping or detection of the valve leaflets of the present application. The clamping springs 142a, 144a and the detecting springs 142b, 144b are commonly made of nickel-titanium alloy.

[0080] The ends of the main bodies 146b of the clamping springs 142a, 144a and the detecting springs 142b, 144b are positioned away from the connecting base 146. Therefore, they can be pulled when subjected to a relatively small pulling force. When the ends are driven, such as when pulled, the connecting end 146a becomes a pivot point, allowing the clamping springs 142a, 144a and the detecting springs 142b, 144b to move away from the first clamping member 130a and the second clamping member 130b to a certain extent. Due to the pre-shaping or drive control limitations of the connecting end 146a, the extreme position at which the clamping springs 142a, 144a and the detecting springs 142b, 144b can close toward the center of the connecting base 146 is limited. When the clamping springs 142a, 144a and the detecting springs 142b, 144b are not subjected to a driving force, such as a pulling force, and when no clamping force is applied by the first clamping member 130a and the second clamping member 130b, the clamping springs 142a, 144a and the detecting springs 142b, 144b are in a natural state, which is another extreme position. In this embodiment, the clamping springs 142a, 144a are located below the detecting springs 142b, 144b. When not driven, such as pulled, the clamping springs 142a, 144a are in a natural state facing the first clamping member 130a and the second clamping member 130b. When the valve is clamped between the clamping assembly 130 and the clamping assembly 140, the clamping springs 142a, 144a are in a natural state facing 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 springs 142b, 144b are at the top, they can still be engaged with the leaflets, and the engagement includes contact and / or applying a certain clamping pressure based on the contact.

[0081] For ease of description, when no clamping force is applied to the first and second clamping members 130a, 130b, and the clamping springs 142a, 144a and the detecting springs 142b, 144b are not driven, such as by being pulled, the limit positions of the clamping springs 142a, 144a and the detecting springs 142b, 144b are defined as the first limit position. The limit positions of the clamping springs 142a, 144a and the detecting springs 142b, 144b, which are closed toward the center of the connecting seat 146, are defined as the second limit position. This second limit position is the limit state in which the clamping assembly 140 is tightened. This second limit position facilitates maintaining the minimum volume of the entire valve clamping device 100 when the clamping assembly 130 is also closed during transport, and also maintains this position when the entire valve clamping device 100 is implanted. The first limit position is the natural state, also known as the released state, i.e., the state released from the second limit position to the first limit position.

[0082] See also Figures 5 to 7 The detection springs 142b and 144b each have a through-hole 145 extending from the connection end 146a toward the center of the detection springs 142b and 144b. The axial length of the clamping springs 142a and 144a is less than or equal to the axial length of the through-hole 145. Preferably, the axial length of the clamping springs 142a and 144a is less than the axial length of the through-hole 145 to prevent interference between the clamping springs 142a and 144a and the detection springs 142b and 144b during independent movement. The clamping springs 142a and 144a can be formed by cutting through the through-hole 145 of the detection springs 142b and 144b, or directly molded to be separable from the parent springs 142b and 144b. The springs 142a and 144a can move relative to the through-hole 145 when subjected to a driving control force. The pre-shaping of the bent shape of the connecting end 146a increases the fatigue strength of the connecting end 146a during rotation, 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, and due to 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 large and the volume of the clamping spring pieces 142a, 144a is 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 drive control device, the clamping spring pieces 142a, 144a on the same side will also be subject to the associated force due to their smaller volume, and have a tendency to move in the same direction. Under this setting, when the detection springs 142b and 144b are driven by the drive control device, if the leaflet is not clamped to a sufficient depth by the clamping springs 142a and 144a, that is, if the clamping springs 142a and 144a are only clamped to the edge of the leaflet, the leaflet may escape. Therefore, the detection springs 142b and 144b are driven to separate from the leaflet. If the leaflet is also separated from the clamping springs 142a and 144a, it indicates that the leaflet is not clamped at the desired position.

[0085] Since the volume of the clamping shrapnel 142a, 144a is relatively small, and the connecting seat 146 is fixed to the fixing seat 110, the detecting shrapnel 142b, 144b can be basically unrelated when the clamping shrapnel 142a, 144a is driven by the driving control device. The detecting shrapnel 142b and the detecting shrapnel 144b respectively have their own driving control devices, so that the detecting shrapnel 142b, 144b can be driven and controlled separately to respectively detect the clamping conditions of the heart valve, 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 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 shrapnel and the clamping shrapnel. In this embodiment, the clamping shrapnel 142a and the clamping shrapnel 144a can share a traction line, or the clamping shrapnel 142a and the clamping shrapnel 144a have their own traction lines. From the second extreme position in the conveying state (see Figure 28 ) to the first limit position when it reaches the released state, the traction line experiences a relaxation (see Figure 27 ) process; on the contrary, when installed, the traction line undergoes a tensioning process from the first limit position when in the released state to the second limit position when in the conveying state.

[0086] Please also refer to 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 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 achieve the present invention. Please refer to Figure 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 are all releasable from the traction line hole 149. 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. After the traction line extends from the traction line hole 149, it can pass through the delivery sheath and the control handle (see Figure 27 )connect.

[0087] See also Figure 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. This flushing can make the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b smaller in size. Figure 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 and 144a extend downward from the through holes 145 relative to the detection springs 142b and 144b. When the clamping springs 142a and 144a and the detection springs 142b and 144b are in the natural state, the ends of the clamping springs 142a and 144a away from the connecting seat 146 are lower than the ends of the detection springs 142b and 144b away from the connecting seat 146, that is, the detection springs 142b and 144b are relatively farther away from the first clamping member 130a and the second clamping member 130b than the clamping springs 142a and 144a. Therefore, the clamping springs 142a and 144a have a certain spatial distance from the detection springs 142b and 144b. The axial length of the detection springs 142b and 144b is greater than the axial length of the clamping springs 142a and 144a. The axial length of the clamping springs 142a and 144a is between 4 and 6 mm, while the axial length of the detection springs 142b and 144b is between 5 and 8 mm. In this embodiment, the angle A formed by the extension lines of the two detection springs 242b and 244 is approximately 120 degrees. The two clamping springs 242a and 244a are located below the two detection springs 242b and 244, so the angle formed by their extension lines is greater than the angle A formed by the extension lines of the two detection springs 242b and 244.

[0089] In this embodiment, the clamping spring pieces 142a, 144a and the detection spring pieces 142b, 144b are respectively provided with barbs 148. The barbs 148 face toward and abut against the heart valve leaflets to limit the heart valve leaflets, thereby helping to strengthen and fix the valve tissue. In this embodiment, the width of the detection spring pieces 142b, 144b is greater than the width of the clamping spring pieces 142a, 144a, and the number of barbs 148 on the detection spring pieces 142b, 144b can be greater than the number of barbs 148 on the clamping spring pieces 142a, 144a. The number and length of the barbs 148 on the detection spring piece 142b and the number and length of the barbs 148 on the detection spring piece 144b can be equal or unequal. When the clamping springs 142a, 144a and the detecting springs 142b, 144b are in the natural state, the barbs 148 on the clamping springs 142a, 144a and the detecting springs 142b, 144b can engage with the leaflets of the valve inserted 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 springs 142a, 144a and the detecting springs 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 142a and the barbs 148 on the clamping spring 144a are the same; the number, length, and inclination angle of the barbs 148 on the detecting spring 142b and the barbs 148 on the detecting spring 144b are the same. In another embodiment, according to the size of the leaflet, 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 piece 142a and the detection spring piece 142b for clamping the anterior leaflet can be greater than the number and length of the barbs 148 of the clamping spring piece 144a and the detection spring piece 144b for clamping the posterior leaflet.

[0090] See also Figures 12 to 14 , the following description is made of a simulated state of detecting and clamping leaflets of the valve clamping device 100 having the tissue clamping assembly 140 of the present invention. When the 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 assembly 142 and the second spring assembly 144 are loosened, so that the clamping springs 142a, 144a and the detecting springs 142b, 144b are engaged with the leaflets (see Figure 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, whether the detection spring pieces 142b, 144b are engaged with the leaflets 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 respectively detect whether the leaflets are clamped by the clamping spring pieces 142a, 144a. Figure 13 As shown, the second spring element assembly 144 remains stationary, and the first spring element assembly 142 performs detection. When the first spring element assembly 142 performs detection, the clamping spring element 142a is kept stationary, and the detection spring element 142b is pulled up. At this time, the left leaflet is still clamped by the clamping spring element 142a, indicating that the leaflet is sufficiently captured. Figure 14 As shown, the first spring element assembly 142 remains stationary, while the second spring element assembly 144 performs detection. When the second spring element assembly 144 performs detection, the clamping spring element 144a is kept stationary, and the detection spring element 144b is pulled up. At this time, the right leaflet escapes, indicating that the leaflet is not clamped in the desired position. It is understandable that the detection spring elements 142b, 144b of the valve clamping device 100 of the embodiment of the present invention may also be engaged with the leaflet in the process of detection between the first limit position and the second limit position, that is, they have not fully reached the natural state of release, but can be engaged with the leaflet under partial control for detection. The above-mentioned Figure 13 and Figure 14 The detection springs 142b and 144b 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 springs 142a, 144a and the detection springs 142b, 144b on the same side of the tissue clamping assembly 140 of the present invention are independently controlled. When the clamping springs 142a, 144a do not clamp the tissue, such as when the leaflets are in the appropriate position, the detection springs 142b, 144b can be lifted up, and the clamping springs 142a, 144a can be lifted up to re-engage the tissue. Under this operation, the clamping springs 142a, 144a can be independently moved and adjusted relative to the detection springs 142b, 144b.

[0092] In summary, the clamping assembly provided by 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 by the embodiment of the present invention has the function of detecting the clamping state of the sheet-like body. Figure 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 includes a clamping spring and a detection spring 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 the detection spring of the spring assembly to separate the detection spring from the sheet body. If the clamping spring is separated 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 pulled and the detection spring is separated from the sheet body, and the clamping spring keeps clamping the sheet body.

[0096] See also Figure 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 and 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 leaflet and / or the blood regurgitation volume of the valve received in the medical image. If the movement amplitude of the leaflet increases and / or the blood regurgitation volume of the valve increases, re-engage the clamping spring and the detection spring of the first spring assembly and / or the second spring assembly to the leaflet until the detection spring of the first spring assembly and / or the second spring assembly is driven and the detection spring is separated from the leaflet, and the movement amplitude of the leaflet and / or the blood regurgitation volume of the valve do not increase relative to when the detection spring is engaged with the leaflet.

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

[0101] Please also refer to Figure 17 and Figure 18 The clamping springs 162a and 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 and 164b. In this embodiment, the axial length of the clamping springs 162a and 164a is shorter than the axial length of the detection springs 162b and 164b, and a certain distance is maintained between the ends of the clamping springs 162a and 164a and the corresponding detection springs 162b and 164b, so that the driving movement of the clamping springs 162a and 164a is not affected by the detection springs 162b and 164b. The second extreme position of the clamping springs 162a and 164a is lower than the second extreme position of the detection springs 162b and 164b. In this extreme position, at least part of the clamping springs 162a and 164a is lower than the detection springs 162b and 164b, thereby achieving better recognition in 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 by 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 a barb 168 and a traction line hole 169; the clamping spring pieces 162a, 164a are of basically uniform width, and are also provided with a barb 168a and a traction line hole 169a at the end. The thin strip portion 167a of the detection spring pieces 162b and 164b makes it easier to pull the detection spring pieces 162b and 164b, and the detection spring pieces 162b and 164b can be driven with less force. The wide clamping 167b of the detection spring pieces 162b and 164b enables the detection spring pieces 162b and 164b to assist the clamping spring pieces 162a and 164a in clamping a wider area of ​​the leaflet when the detection is completed. The axial length of the detection spring pieces 162b and 164b is longer, and the detection spring pieces 162b and 164b are closer to the valve ring of the heart when clamped.

[0102] See also Figure 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 detection spring pieces 162b, 164b and / or the drive of the drive control, the second limit position of the clamping spring pieces 162a, 164a can also be flush with the second limit position of the detection spring pieces 162b, 164b.

[0103] Please also refer to Figure 20 and Figure 21The clamping springs 172a, 174a and the detecting springs 172b, 174b of the clamping assembly 170 provided in the third embodiment of the present invention have the same length. The clamping springs 172a, 174a are arranged on the sides of the detecting springs 172b, 174b. The number, length and inclination angle of the barbs on the clamping springs 172a, 174a and the detecting springs 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 springs 172a, 174a are lower than the ends of the detecting springs 172b, 174b (see Figure 20 ); The second limit position of the clamping spring 172a, 174a is lower than the second limit position of the detection spring 172b, 174b (see Figure 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 pull. In medical imaging, the clamping spring pieces 172a, 174a and the detection spring pieces 172b, 174b can also be better identified based on the height of the position.

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

[0105] It is understood that when the detection springs 172b, 174b and the clamping springs 172a, 174a are of equal length, the detection springs 172b, 174b and the clamping springs 172a, 174a are still connected at one end and can therefore still be considered as the main spring and the auxiliary spring, respectively. The spring, i.e., the clamping spring 172a, 174a, is responsible for clamping, while the main spring, i.e., the detection spring 172b, 174b, is responsible for detection, and after detection, the auxiliary spring clamps the valve leaflets. The valve clamping device 100 of the embodiment of the present invention, after the clamping assembly 130 is closed, clamps the two leaflets that cannot close naturally, thereby reducing the leakage of mitral or tricuspid regurgitation and reducing blood reflux. The valve can still open and close normally after the valve clamping device 100 is implanted.

[0106] See also Figures 23 to 24The clamping assembly 240 provided in the fourth embodiment of the present invention differs from the clamping assembly 140 of the first embodiment in that, when the clamping assembly 240 is in its natural state, free from the tension of the pull line, the clamping springs 242a, 244a are flush with the corresponding detection springs 242b, 244. In this embodiment, the axial length of the clamping springs 242a, 244a is less than the axial length of the through-holes 245 of the detection springs 242b, 244. That is, the ends of the clamping springs 242a, 244a are spaced a certain distance from the detection springs 242b, 244. This ensures that the clamping springs 242a, 244a and the detection springs 242b, 244 do not interfere with each other during independent movement and allows for the traction line to be redundant. In this embodiment, the sides of the clamping springs 242a, 244a may also be spaced a certain distance from the inside of the through-holes 245 of the detection springs 242b, 244 to further reduce motion interference. In this embodiment, the natural state of the clamping springs 242a, 244a, i.e., the first extreme position, is flush with the first extreme position of the detecting springs 242b, 244, and the second extreme position may also be flush with the second extreme position of the detecting springs 242b, 244. In a preferred embodiment, the included angle A between the two detecting springs 242b, 244 may be slightly greater than approximately 180 degrees, i.e., the ends 246b of the two detecting springs 242b, 244 are slightly lower than the connecting end 246a connected to the connecting seat 246. Since the two clamping springs 242a, 244a are flush with the detecting springs 242b, 244, the included angle between the two clamping springs 242a, 244a is also equal to the included angle A between the two detecting springs 242b, 244. The fact that the end 246b is slightly lower than the connecting end 246a helps the detecting spring pieces 242b and 244 and the clamping spring pieces 242a and 244a to be closer to the valve in a natural state.

[0107] In the above embodiment, since the leaflets of the heart valve are tilted, the detection springs 242b, 244b and the clamping springs 242a, 244a can engage with the leaflets in a natural state or in a partially controlled state. Theoretically, in a natural state, the angle between the two detection springs 242b, 244b, or the angle between the two clamping springs 242a, 244a, can engage with the leaflets if it is between 90 degrees and 270 degrees. The detection springs 242b, 244b and the clamping springs 242a, 244a are each laterally provided with a row of barbs 248.

[0108] See also Figure 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 pressed against the leaflet to play a certain auxiliary clamping role.

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

[0110] The occluding mesh 210 is a three-dimensional mesh structure, preferably a three-dimensional mesh structure formed by weaving wire or cutting tubular material with shape memory function, such as superelastic materials such as nickel-titanium alloy wire. Therefore, under different clamping angles or different clamping forces of the clamping assembly 230, the occluding mesh 210 can adapt to the gaps between different leaflets and undergo adaptive deformation, thereby adjusting the degree of traction on the leaflets by the valve clamping device 200. For example, for adjacent leaflets of the tricuspid valve with large gaps but relatively thin and fragile (such as the anterior and posterior leaflets, 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 leaflet perforation or tearing. For adjacent leaflets of the mitral valve (i.e., the anterior and posterior leaflets of the mitral valve), the clamping assembly 230 can be closed at a smaller clamping angle to provide a greater clamping force on the leaflets.

[0111] In summary, the clamping assembly of the valve clamping device provided by 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 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 situations where the clamping length is too short, the valve leaflet escapes as the leaflet beats, and the valve leaflet 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 leaflet is clamped in 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 implemented in the form of a mother spring.

[0112] See also Figures 27 to 29Embodiments of the present invention further provide a valve clipping system comprising the aforementioned valve clipping device 100 and a delivery device, wherein the delivery device comprises a control handle 330, a delivery sheath 310 having a predetermined axial length, and a drive mandrel 320 movably mounted within the delivery sheath 310. The distal end of the delivery sheath 310 is detachably connected to the support rod 114 of the valve clipping device 100, and the distal end of the drive mandrel 320 is detachably connected to the drive shaft 154 for driving the expansion and closure of the clipping assembly 130. The connection between the drive mandrel 320 and the drive shaft 154 may be a threaded connection, and the delivery sheath 310 and the support rod 114 may be snap-fitted. The drive mandrel 320 and the drive shaft 154 abut against the delivery sheath 310 and the support rod 114, maintaining the connection between the delivery sheath 310 and the support rod 114. When the drive mandrel 320 and the drive shaft 154 are separated, the delivery sheath 310 may automatically separate from the support rod 114. The driving core shaft 320 may be a metal wire, and the valve clipping device 100 may also be replaced by the aforementioned valve clipping device 200 . Figure 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. Figure 28 and Figure 29 The traction line of the clamping assembly of the valve clamping device 100 is in a tensioned state, and Figure 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 refer to Figure 10 、 Figure 27 、 Figures 30 to 35 Taking the repair process of the anterior and posterior leaflets of the mitral valve as an example, the operation method of the valve clipping system using the valve clipping 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 clipping device 100 are delivered to the left atrium LA through the inferior vena cava; the valve clipping device 100 is then 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 Figure 10 ), the driving mandrel 320 is delivered to the distal end (see Figure 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 and posterior leaflets 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 into the left ventricle through the delivery sheath 310, and the valve clamping device 100 is placed under the anterior and posterior leaflets, and the clamping assembly 130 is continued to open to the capture position (see Figure 31 ); at the same time, the traction line controlling the clamping assembly 140 is tightened 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 Figure 32 , release the clamping components 140 on both sides simultaneously or successively, the clamping components 140 engage the leaflets and cooperate with the clamping components 130 to capture the anterior leaflet and the posterior leaflet. Then, see Figure 33 The detection spring 144b (or detection spring 142b) of the clamping assembly 140 detects whether the clamping spring 144a (or detection spring 142a) clamps the leaflet to the desired position. The detection process is described in the aforementioned Figures 12 to 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 and the clamping assembly 140 can clamp the leaflet together, and then the driving core shaft 320 and the driving shaft 154 are pulled proximally to drive the clamping assembly 130 to close (see Figure 34 ), so that the front leaflet and the rear leaflet are clamped between the clamping assembly 140 and the clamping assembly 130;

[0116] Release the threaded connection between the drive core shaft 320 and the drive shaft 154, and withdraw the drive core shaft 320, separate the delivery sheath 310 from the support rod 114, and release the connection between the valve clipping device 100 and the delivery device. Then, withdraw the delivery device from the body, and obtain the following: Figure 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 for 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 mitral valve and clamping the valve leaflets.

[0119] The foregoing description is intended only to provide specific embodiments of the present invention, intended to enable those skilled in the art to understand and implement the present invention. Various modifications to these embodiments will be readily 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 is not intended to be limited to the embodiments shown herein, but is intended to be accorded 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 to the fixing seat; as well as an integrated clamping assembly, the clamping assembly comprising a connecting seat and a first elastic sheet assembly and a second elastic sheet assembly extending from opposite sides of the connecting seat, the connecting seat being fixed to the fixing seat, the first elastic sheet assembly and the second elastic sheet assembly respectively cooperating with the first clamping piece and the second clamping piece to clamp the leaflet of the valve, and the first elastic sheet assembly and the second elastic sheet assembly each comprising a clamping elastic sheet and a detection elastic sheet, when the clamping elastic sheet cooperates with the first clamping piece or the second clamping piece to clamp the leaflet, the detection elastic sheet on the same side can be controlled to move between an engaged 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 elastic sheet and the first clamping piece or the second clamping piece; Each of the clamping spring piece and the detecting spring piece extends outward from the connecting seat, and each of the clamping spring piece and the detecting spring piece has 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 piece and the main body of the detecting spring piece are separable from each other; Each of the clamping springs is adjacently arranged on the outside of the detection spring, and the length of the clamping spring is equal to the length of the detection spring; Each of the detection springs 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 separate 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 separate from the leaflet, the clamping spring on the same side clamps the leaflet or separates from the leaflet.

2. The valve clipping device according to claim 1, characterized in that: One end of the clamping spring piece away from the connecting seat is lower than one end of the detecting spring piece on the same side away from the connecting seat.

3. The valve clipping device according to claim 1, characterized in that: When the clamping elastic piece clamps the leaflet and the detecting elastic piece is in the engaged state, the clamping elastic piece is flush with the corresponding detecting elastic piece.

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

5. The valve clipping device according to claim 1, characterized in that: Each clamping spring of the first spring assembly and the second spring assembly is connected to a drive control device. When each clamping spring and detection spring is driven and controlled, it can move between a first extreme position and a second extreme position. 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.

6. The valve clipping device according to claim 5, characterized in that: The drive control device for the detection spring and the clamping spring includes a traction line. The detection springs of the first spring assembly and the second spring assembly are respectively driven and controlled by separate traction lines. The clamping springs of the first spring assembly and the second spring assembly are colinearly driven and controlled, or driven and controlled by separate traction lines.

7. The valve clipping device according to claim 1, characterized in that: When the main body of the clamping spring piece and the main body of the detection spring piece are in a natural state without being subjected to external force, the angle between the clamping spring piece of the first spring piece assembly and the clamping spring piece of the second spring piece assembly is between 90 degrees and 270 degrees, and the angle between the detection spring piece of the first spring piece assembly and the detection spring piece of the second spring piece assembly is between 90 degrees and 270 degrees.

8. The valve clipping device according to claim 1, characterized in that: It also includes a drive shaft, the fixing seat and the connecting seat are provided with aligned through holes, the drive shaft passes through the through holes, and the drive 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.

9. The valve clipping device according to claim 8, 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 elastic sheet assembly and the second elastic sheet assembly, and the drive shaft extends into the blocking net and is connected to a drive core shaft.

10. A valve clamping device, characterized in that: It includes: Fixed seat; A first clamping member and a second clamping member hinged to the fixing seat; as well as The clamping assembly comprises a connecting seat and a first elastic sheet assembly and a second elastic sheet assembly extending from opposite sides of the connecting seat, the connecting seat being fixed to the fixing seat, the first elastic sheet assembly and the second elastic sheet assembly being respectively used to cooperate with the first clamping piece and the second clamping piece to clamp the leaflet of the valve, and the first elastic sheet assembly and the second elastic sheet assembly both comprise a mother elastic sheet and a spring sheet, the mother elastic sheet having a detection state and a release state, the mother elastic sheet being able to 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 spring sheet on the same side, and the mother elastic sheet and the spring sheet on the same side simultaneously clamp the leaflet in the release state; Each of the bullet fragments and the mother bullet fragment extends outward from the connecting seat, and each of the bullet fragments and the mother bullet fragment has a connecting end connected to the connecting seat and a main body extending from the connecting end, and the main body of the bullet fragment and the main body of the mother bullet fragment are separable from each other; Each of the bullet fragments is adjacently arranged on the outside of the mother bullet fragment, and the length of the bullet fragment is equal to the length of the mother bullet fragment; Each of the mother springs of the first spring assembly and the second spring assembly is connected to a drive control device. When the mother spring is driven and controlled to separate from the leaflet, the springs on the same side are subjected to an associated force and have a tendency to separate from the leaflet. When the mother spring is driven and controlled to separate from the leaflet, the springs on the same side clamp the leaflet or separate from the leaflet.

11. 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 an axial length and a driving core shaft and a traction line movably installed in the delivery sheath, the driving core shaft being used to drive the first clamping member and the second clamping member to expand and close, and the traction line being used to control the clamping springs and detection springs of the first spring assembly and the second spring assembly.

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