Tissue holder and valve repair device

Abstract

The invention discloses a tissue clamping piece which comprises a connecting base, a first driving part, a second driving part, a first elastic piece assembly and a second elastic piece assembly, and the first elastic piece assembly and the second elastic piece assembly integrally extend out of the two opposite side edges of the connecting base respectively. The first elastic piece assembly and the second elastic piece assembly each comprise a female elastic piece and a secondary elastic piece, and each secondary elastic piece is provided with a barb used for being connected with tissue. When the secondary elastic sheet is driven by the first driving part to reach the tissue or to be jointed with the tissue, the primary elastic sheet can be driven and controlled by the second driving part to move between a jointing state jointed with the tissue and a separating state separated from the tissue so as to detect whether the tissue is properly jointed by the secondary elastic sheet or not; after the tissue is properly jointed by the elastic piece, the female elastic piece and the elastic piece clamp the tissue at the same time. The invention also provides a valve repair device using the tissue holder.

Description

Technical Field

[0001] The present invention relates to the technical field of interventional medical devices, and in particular to a tissue clamp and a valve repair device. 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 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 problems or at least partially solve the above technical problems, the present invention provides a tissue clamp and a valve repair device.

[0008] A first aspect of the present invention provides a tissue clamp, comprising:

[0009] Connecting seat;

[0010] a first driving unit and a second driving unit;

[0011] A first spring fragment assembly and a second spring fragment assembly, wherein the first spring fragment assembly and the second spring fragment assembly are respectively extended integrally from two opposite sides of the connecting seat, and the first spring fragment assembly and the second spring fragment assembly both include a mother spring fragment and a bullet fragment, and the bullet fragment is provided with barbs for engaging tissue. When the bullet fragment is driven by the first driving part to reach the tissue or engage with the tissue, the mother spring fragment is driven and controlled by the second driving part to move between an engaged state with the tissue and a separated state with the tissue, so as to detect whether the tissue is properly engaged by the bullet fragment. After the tissue is properly engaged by the bullet fragment, the mother spring fragment and the bullet fragment simultaneously engage the tissue.

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

[0013] a first clamping member and a second clamping member that can be opened and closed relative to each other, and

[0014] A tissue clamp, comprising:

[0015] Connecting seat;

[0016] A first spring sheet assembly and a second spring sheet assembly, wherein the first spring sheet assembly and the second spring sheet assembly respectively cooperate 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 respectively extend integrally from two opposite sides of the connecting seat, and the first spring sheet assembly and the second spring sheet assembly both include a mother spring sheet and a bullet leaf, wherein the mother spring sheet and the bullet leaf respectively have barbs for engaging the leaflets, and the mother spring sheet can be controlled to move between an engaged state with the leaflet and a separated state with the leaflet to detect whether the leaflet is properly engaged by the bullet leaf, and when the leaflet is properly engaged by the bullet leaf, the mother spring sheet and the bullet leaf simultaneously engage the leaflet.

[0017] The tissue clamp and valve repair device provided by the present invention have at least the following beneficial effects:

[0018] The tissue clamp provided by the present invention has a mother shrapnel and a bullet shrapnel, the bullet shrapnel is used to pre-clamp or engage the tissue, the mother shrapnel can be controlled to move between an engagement state of engaging with the tissue and a separation state of separating from the tissue to detect whether the tissue is properly engaged by the bullet shrapnel, that is, when the mother shrapnel is separated from the tissue, if the tissue is separated from the bullet shrapnel, it indicates that the tissue is not properly engaged by the bullet shrapnel, that is, it is not clamped at the desired position. The situation of not being properly engaged includes the situation that the length of the clamped tissue is too short or the engagement area is too small, the tissue escapes as the tissue, such as the leaflet, beats, and the situation that the tissue is not clamped by the bullet shrapnel although the bullet shrapnel approaches or reaches the position of the engaged tissue; if the tissue is still clamped by the bullet shrapnel, it indicates that the tissue has been clamped at the desired position by the bullet shrapnel, and the mother shrapnel can assist the bullet shrapnel in clamping the tissue at the same time.

[0019] The valve repair device uses a tissue clamp to clamp the leaflets of the valve and detects whether the leaflets are properly engaged, that is, whether they are not clamped in the desired position. After detecting that the leaflets are properly engaged by the spring fragments, the mother spring fragments can clamp the leaflets together with the spring fragments to increase the clamping force of the leaflets. The valve repair device clamps the two leaflets that cannot be closed to repair the valve. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] 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.

[0021] 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.

[0022] Figure 1 This is a schematic diagram of the mitral valve and tricuspid valve in normal state;

[0023] Figure 2 yes Figure 1 Schematic diagram of a diseased tricuspid valve;

[0024] Figure 3 is a three-dimensional schematic diagram of a tissue clamp provided by a first embodiment of the present invention;

[0025] Figure 4 yes Figure 3 A schematic top view of a tissue clamp;

[0026] Figure 5 yes Figure 3 A front view of a tissue clamp;

[0027] Figure 6 yes Figure 3 A schematic diagram of a traction line setting of a tissue clamp;

[0028] Figure 7 yes Figure 6 An enlarged schematic diagram of a redundant portion of a traction line of a tissue clamp;

[0029] Figure 8 yes Figure 6 A schematic diagram of the traction line control when the parent shrapnel of the tissue clamp moves;

[0030] Fig. 9 yes Figure 7 A schematic diagram of the traction line control when the bullet fragment of the tissue clamp moves;

[0031] Fig.10 yes Figure 7 An enlarged schematic diagram of a tissue clamp when the first redundant portion of the traction line is eliminated;

[0032] Fig.11 yes Figure 3 A schematic diagram of another traction line setting of a tissue clamp;

[0033] Fig.12 is a three-dimensional schematic diagram of a valve repair device with a tissue clamp provided by an embodiment of the present invention, when the tissue clamp is in a natural state;

[0034] Fig.13 yes Fig.12 A schematic diagram of the cooperation between the tissue clamp and the fixing seat;

[0035] Fig.14 yes Fig.12 A three-dimensional schematic diagram of the valve repair device when the tissue clamp is in a second extreme position;

[0036] Fig.15 yes Fig.12 A three-dimensional schematic diagram of the valve repair device when the tissue clamp is in another second extreme position;

[0037] Fig.16 yes Fig.12 A schematic diagram of the first and second elastic leaf components of the tissue clamp engaging with the leaflets during the simulated detection of the leaflets by the valve repair device;

[0038] Fig.17 yes Fig.16 A schematic diagram of simulated detection in which the first spring piece assembly of the tissue clamp is used for detection, and the second spring piece assembly remains stationary;

[0039] Fig.18 yes Fig.16 A schematic diagram of a simulated detection in which the first spring piece assembly of the tissue clamping member remains stationary and the second spring piece assembly performs detection;

[0040] Fig.19 is a flow chart of a method for detecting a clamping state of a tissue clamping member provided by an embodiment of the present invention;

[0041] Fig. 20 is a flow chart of a method for a tissue clamping member to detect a leaflet clamping state provided by an embodiment of the present invention;

[0042] Fig.21 is a three-dimensional schematic diagram of a tissue clamping member in a natural state according to a second embodiment of the present invention;

[0043] Fig. 22 yes Fig.21 A three-dimensional schematic diagram of the tissue clamping member being in a second extreme position;

[0044] Fig.23 is a three-dimensional schematic diagram of a tissue clamping member of another deformable embodiment in a second extreme position;

[0045] Fig.24 is a three-dimensional schematic diagram of a tissue clamping member in a natural state according to a third embodiment of the present invention;

[0046] Fig.25 yes Fig.23 A three-dimensional schematic diagram of the tissue clamping member being in a second extreme position;

[0047] Fig.26 is a three-dimensional schematic diagram of a tissue clamping member of another deformable embodiment in a second extreme position;

[0048] Fig. 27 is a three-dimensional schematic diagram of a tissue clamp provided by a fourth embodiment of the present invention in a natural state;

[0049] Fig.28 yes Fig. 27 A front view of a tissue clamp;

[0050] Fig.29 is a front view of a tissue clamp provided by another deformable embodiment;

[0051] Fig.30 is a three-dimensional schematic diagram of a valve repair device provided by a fifth embodiment of the present invention;

[0052] Fig.31 is a schematic diagram of a valve repair device provided by an embodiment of the present invention;

[0053] Fig.32 yes Fig.31 Schematic diagram of the valve repair device when the traction wire is tensioned;

[0054] Fig.33 yes Fig.32 A schematic diagram of a valve repair device when the clamping assembly is closed;

[0055] Fig.34 It is a schematic diagram of a state in which a valve repair device with a detachable valve repair device provided by an embodiment of the present invention is extended into a treatment position when used for mitral regurgitation treatment;

[0056] Fig.35 yes Fig.34 A schematic diagram of a state in which a clamping assembly of a valve repair device is opened and is ready to capture anterior and posterior leaflets of a mitral valve;

[0057] Fig.36 yes Fig.35 A schematic diagram of a state in which a tissue clamp of a valve repair device engages with a valve leaflet;

[0058] Fig.37 yes Fig.36 A schematic diagram of a state in which a mother shrapnel of a tissue clamp of a valve repair device detects whether the shrapnel clamps the valve leaflet at a desired position;

[0059] Fig.38 yes Fig.37 A schematic diagram of a closed state of a valve repair device after the clamping assembly clamps the valve leaflet to a desired position;

[0060] Fig.39 yes Fig.38 Schematic diagram of the valve repair device being separated from the delivery device. DETAILED DESCRIPTION

[0061] 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.

[0062] In the description of the present invention, it should be noted that:

[0063] 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;

[0064] 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.

[0065] 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.

[0066] See also Figures 3 to 5 The tissue clamp 140 provided in the first embodiment of the present invention includes a first spring assembly 142 , a second spring assembly 144 and a connecting seat 146 , and the first spring assembly 142 and the second spring assembly 144 are connected as a whole through the connecting seat 146 .

[0067] The first spring fragment assembly 142 and the second spring fragment assembly 144 respectively include a mother spring fragment and a bullet spring fragment, which form a group extending from the same side of the connecting seat 146, that is, the mother spring fragment 142b and the bullet spring fragment 142a of the first spring fragment assembly 142 extend from one side of the connecting seat 146, and the mother spring fragment 144b and the bullet spring fragment 144a of the second spring fragment assembly 144 extend from the other side opposite to the connecting seat 146. The bullet spring fragments 142a, 144a and the mother spring fragments 142b, 144b are all connected to the connecting seat 146, and 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 bullet pieces 142a and 144a and the main body 146b of the corresponding mother bullet pieces 142b and 144b can be separated from each other. When subjected to external force, such as driving, the ends of the main body 146b of the bullet pieces 142a and 144a can be separated from each other in a direction away from the ends of the main body 146b of the mother bullet pieces 142b and 144b. Each mother bullet piece 142b and 144b is connected to the bullet piece 142a and 144a on the same side only at the connecting end 146a, and the other sides of each mother bullet piece 142b and 144b are not connected to the bullet piece 142a and 144a, so that the main body 146b of the bullet piece 142a and 144a and the main body 146b of the mother bullet piece 142b and 144b can be separated from each other.

[0068] The bullet pieces 142a, 144a and the mother bullet 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 transportation, and restore their original shape and position after release. The material of the bullet pieces 142a, 144a and the mother bullet pieces 142b, 144b is commonly nickel-titanium alloy.

[0069] The connecting end 146a has a certain pre-shaping, and the ends of the main body 146b of the bullet pieces 142a, 144a and the main body 146b of the mother bullet 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 bullet pieces 142a, 144a and the main body 146b, 144b can swing within a certain range. Due to the pre-shaping of the connecting end 146a or the limitation of the driving control, the extreme position where the bullet pieces 142a, 144a and the main body 142b, 144b can stand up and close toward the center of the connecting seat 146 is limited. When the bullet pieces 142a, 144a and the mother bullet pieces 142b, 144b are not subjected to driving force such as pulling force, and when no other elements apply clamping force, the bullet pieces 142a, 144a and the mother bullet pieces 142b, 144b are in a natural state, which is another extreme position.

[0070] For the convenience of description, when there is no other element applying clamping force and the bullet pieces 142a, 144a and the mother bullet pieces 142b, 144b are not driven, such as being pulled, the limit positions of the bullet pieces 142a, 144a and the mother bullet pieces 142b, 144b are defined as the first limit position; the limit positions of the bullet pieces 142a, 144a and the mother bullet pieces 142b, 144b approaching 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 tissue clamp 140, and the second limit position is conducive to maintaining the minimum volume of the entire tissue clamp 140 in the conveying state. The first limit position is a natural state, also a released state, that is, released from the second limit position to the first limit position.

[0071] The tissue clamp 140 of the present invention is used to clamp tissue, such as the leaflets of a valve, and the bullet pieces 142a and 144a are located below the parent bullet pieces 142b and 144b. When the tissue, such as the leaflets of a valve, is clamped below the tissue clamp 140 without being driven, such as being pulled, the bullet pieces 142a and 144a have a natural state of tending to the tissue. When clamping the leaflets of a valve, for example, the edges of the anterior leaflet and the posterior leaflet of the mitral valve are drooping, and even if the parent bullet pieces 142b and 144b are located above, the parent bullet pieces 142b and 144b can still be engaged with the leaflets, and the engagement includes contact and / or applying a certain clamping pressure based on the contact.

[0072] When clamping tissue, in order to make the tissue clamped more tightly and play a role in fixing the tissue, in one embodiment, at least the main body 146b of the bullet pieces 142a and 144a is provided with barbs 148 facing the tissue, and the bullet pieces 142a and 144a are used to clamp the tissue, and the mother bullet pieces 142b and 144b are mainly used to detect whether the tissue is clamped in an appropriate position by the bullet pieces 142a and 144a. In this embodiment, the main body 146b of the mother bullet pieces 142b and 144b is preferably also provided with barbs 148, so after the detection is completed, the mother bullet pieces 142b and 144b can also use the barbs 148 to clamp and fix the tissue like the bullet pieces 142a and 144a.

[0073] In the tissue clamping member 140 of the present invention, since the bullet pieces 142a, 144a and the corresponding mother bullet pieces 142b, 144b are connected into a group, if the bullet pieces 142a, 144a can keep clamping the tissue when the mother bullet pieces 142b, 144b are pulled, it means that the tissue is clamped in place, that is, the clamping depth is sufficient. Therefore, in addition to the function of helping the bullet pieces 142a, 144a to clamp the tissue, the mother bullet pieces 142b, 144b also have the function of detecting whether the tissue is clamped to the desired position by the bullet pieces 142a, 144a. After detecting that the tissue is properly clamped by the bullet pieces 142a, 144a, that is, clamped to the desired position, the mother bullet pieces 142b, 144b and the bullet pieces 142a, 144a clamp the tissue at the same time.

[0074] In this embodiment, the mother shrapnel 142b, 144b is provided with a through hole 145 from the connection end 146a toward the middle position of the mother shrapnel 142b, 144b, and the axial length of the bullet pieces 142a, 144a is less than or equal to the axial length of the through hole 145. Preferably, the axial length of the bullet pieces 142a, 144a is less than the axial length of the through hole 145, so as to avoid interference between the bullet pieces 142a, 144a and the mother shrapnel 142b, 144b when they move independently. The bullet pieces 142a, 144a can be formed by cutting from the through hole 145 of the mother shrapnel 142b, 144b, or directly molded to be separable from the mother shrapnel 142b, 144b. The bullet 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 bullet pieces 142a, 144a and the mother bullet pieces 142b, 144b when they are in the natural state.

[0075] The bullet pieces 142a and 144a extend downward from the through hole 145 relative to the mother bullet pieces 142b and 144b. When the bullet pieces 142a and 144a and the mother bullet pieces 142b and 144b are in the natural state, the ends of the bullet pieces 142a and 144a away from the connection seat 146 are lower than the ends of the mother bullet pieces 142b and 144b away from the connection seat 146. The axial length of the mother bullet pieces 142b and 144b is greater than the axial length of the bullet pieces 142a and 144a, and the axial length of the bullet pieces 142a and 144a is between 4 and 6 mm, and the axial length of the mother bullet pieces 142b and 144b is between 5 and 8 mm. In this embodiment, the angle A formed by the extension lines of the two mother bullet pieces 242b and 244 is about 120 degrees. The two spring pieces 242 a and 244 a are below the two mother spring pieces 242 b and 244 , so the angle formed by their extended lines is greater than the angle A formed by the extended lines of the two mother spring pieces 242 b and 244 .

[0076] In this embodiment, the width of the mother shrapnel 142b, 144b is greater than that of the bullet shrapnel 142a, 144a, and the number of barbs 148 on the mother shrapnel 142b, 144b may be greater than that on the bullet shrapnel 142a, 144a. The number and length of the barbs 148 of the mother shrapnel 142b and the number and length of the barbs 148 of the mother shrapnel 144b may be equal or unequal. The inclination angles of the barbs 148 relative to the bullet shrapnel 142a, 144a and the main body of the mother shrapnel 142b, 144b may be the same or different. In one embodiment, the number, length and inclination angle of the barbs 148 on the bullet shrapnel 142a and the barbs 148 on the bullet shrapnel 144a are the same; the number, length and inclination angle of the barbs 148 on the mother shrapnel 142b and the barbs 148 on the mother shrapnel 144b are the same. In another embodiment, according to the size of tissue, such as the leaflets of a valve, 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 achieve more targeted clamping, the number and length of the barbs 148 of the bullet clip 142a and the mother bullet clip 142b for clamping the anterior leaflet can be greater than the number and length of the barbs 148 of the bullet clip 144a and the mother bullet clip 144b for clamping the posterior leaflet.

[0077] In this embodiment, the areas of the mother shrapnel 142b and 144b are relatively large, the areas of the bullet shrapnel 142a and 144a are relatively small, and the lengths of the mother shrapnel 142b and 144b are also longer than the lengths of the bullet shrapnel 142a and 144a. In the case where the volume of the mother shrapnel 142b and 144b is relatively large, and the volume of the bullet shrapnel 142a and 144a is relatively small, since the mother shrapnel 142b and 144b are connected to the corresponding bullet shrapnel 142a and 144a at the connecting end 146a, when the mother shrapnel 142b and 144b are driven by the driving control device, the bullet shrapnel 142a and 144a on the same side will also be subjected to the associated force due to their relatively small volume, and have a tendency to move in the same direction. Under this setting, when the mother spring pieces 142b and 144b are driven by the drive control device, if the leaflets are not clamped to a sufficient depth by the spring pieces 142a and 144a, that is, if the spring pieces 142a and 144a are only clamped to the edge of the leaflets, the leaflets may escape. Therefore, the mother spring pieces 142b and 144b are driven to separate from the leaflets. If the leaflets are also separated from the spring pieces 142a and 144a, it indicates that the leaflets are not clamped at the desired position.

[0078] Since the bullet fragments 142a and 144a are relatively small in size, and the connecting seat 146 is fixed to the fixing seat 110, the mother bullet fragments 142b and 144b can be basically unrelated when the bullet fragments 142a and 144a are driven by the driving control device. The mother bullet fragments 142b and 144b have their own driving control devices, so that the mother bullet fragments 142b and 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 wire. The traction wire can be a metal wire that is easy to bend and straighten, such as a nickel-titanium wire, and the traction wire can be connected from a control handle and a delivery sheath (see Fig.31 )Stretch out.

[0079] In a preferred embodiment, the mother spring 142b and the bullet 142a of the first spring assembly 142 share a first traction line 149a to control movement, and the mother spring 144b and the bullet 144a of the second spring assembly 144 share a second traction line 149b to control movement. The two ends of each of the traction lines 149a and 149b constitute a first driving unit and a second driving unit, respectively. In other embodiments, the first driving unit and the second driving unit can be, for example, a driving wheel or an elastic control device (not shown) arranged in the connecting seat 146 to achieve the purpose of driving and controlling the mother spring and the bullet. In this embodiment, the first end 149c of the first traction line 149a and the second traction line 149b are respectively connected to the bullets 142a and 144a of the first spring assembly 142 and the second spring assembly 144, and the second end 149d of the first traction line 149a and the second traction line 149b are respectively connected to the mother spring 142b and 144b of the first spring assembly 142 and the second spring assembly 144. The first end 149c and the second end 149d can be wound around one of the elastic sheets to block the movement between the first end 149c and the second end 149d, so that the first end 149c and the second end 149d do not affect each other when they move, and the winding can be released from the elastic sheet under a certain pulling force. In this embodiment, the redundant part is provided so that the redundant part is consumed when the first end 149c and the second end 149d move, so that the movement between the first end 149c and the second end 149d does not affect each other is described.

[0080] See also Figure 6 and Figure 7In a preferred embodiment, the mother shrapnel 142b, 144b and the bullet shrapnel 142a, 144a of the first shrapnel assembly and the second shrapnel assembly are respectively coated with a coating 143, and the coating 143 of the mother shrapnel 142b, 144b and the bullet shrapnel 142a, 144a are respectively independent entities, that is, four coating sleeves are coated on the entire periphery of each shrapnel. The coating 143 is a biocompatible film. On the one hand, the coating 143 can be used as a flow-blocking membrane to improve the reflux treatment effect and prevent blood from entering the first shrapnel assembly 142 and the second shrapnel assembly 144 to form a thrombus. On the other hand, the coating 143 can make the entire tissue clamp have stronger biocompatibility. The material of the coating 143 can be, but not limited to, a biocompatible polymer such as PTFE, EPTFE, polyester, silicone resin, etc. In this embodiment, a redundant portion is provided between the first end 149c and the second end 149d of the first traction line 149a and the second traction line 149b, and the redundant portion includes a first redundant portion 149g and a second redundant portion 149h. The first redundant portion 149g is respectively crimped under the coating 143 of the mother shrapnel 142b and 144b, and the second redundant portion 149h is between the mother shrapnel 142b, 144b and the shrapnel 142a, 144a.

[0081] In this embodiment, the coating 143 is in the form of a woven net, and the first redundant part 149g can be vaguely seen from the outside under the coating 143. One end of the first redundant part 149g passes through the coating 143 of the mother elastic pieces 142b and 144b and is connected to the first end 149c, and the other end of the first redundant part 149g passes through the coating 143 of the mother elastic pieces 142b and 144b and is connected to the second redundant part 149h. The mother elastic pieces 142b and 144b of the first elastic piece assembly and the second elastic piece assembly may not be provided with threading holes. The design of the first redundant part 149g and the mesh density of the woven net of the coating 143 enable the two ends of the first redundant part 149g to be pulled out from the mesh of the woven net under a certain pulling force F, and can drive the mother elastic pieces 142b and 144b to move under a certain pulling force F1. The pulling force F is greater than the lifting force F1, so that when the lifting force F1 is small, the first pulling line 149a and the second pulling line 149b will not be pulled out from the coating 143 of the mother elastic pieces 142b and 144b, and the mother elastic pieces 142b and 144b can be pulled normally for repeated detection.

[0082] In this embodiment, the first redundant part 149g can be designed as a redundancy with a larger bending shape, so that a larger force is required to overcome the large bending shape. The second redundant part 149h can be designed as a redundancy with a longer length but a smaller bending, that is, the second redundant part 149h has a redundant length between the mother shrapnel 142b, 144b and the bullet pieces 142a, 144a on the same side. The force to overcome the first redundant part 149g to shorten or eliminate it is greater than the force to overcome the second redundant part 149h. The ends of the bullet pieces 142a, 144a of the first shrapnel assembly 142 and the second shrapnel assembly 144 are provided with a traction line hole 149f that penetrates the coating 143, and the first ends 149c of the first traction line 149a and the second traction line 149b can directly pass through the traction line hole 149f and connect to the first redundant part 149g.

[0083] See also Figure 8 , only the motion control of the mother-shrapnel group on the left side of the figure is used for explanation. Since the mother-shrapnel 142b is covered with the coating 143, when the second end 149d of the first traction line 149a is pulled, the pulling force F1 is applied to make the mother-shrapnel 142b be pulled up to the second extreme position of being erected. In the process of pulling up the mother-shrapnel 142b, due to the increase in the distance between the mother-shrapnel 142b and the shrapnel 142a, the second redundant part 149h can be involved and straightened. Due to the existence of the second redundant part 149h, the shrapnel 142a can be basically unaffected. The state of the motion control of the second traction line 149b on the mother-shrapnel group on the right side of the figure can be equivalent to the motion of the mother-shrapnel group on the left side.

[0084] Please continue reading Fig. 9 When the first end 149c of the first pulling line 149a is pulled, the pulling force F2 is applied to pull the bullet piece 142a to the second extreme position of being erected. During the pulling process, the movement resistance of the pulling line in the pulling line hole 149f can be overcome and the length of the second redundant part 149h can be shortened. In this embodiment, since the bullet piece 142a is shorter and farther away from the connecting seat 146 than the mother bullet piece 142b, the pulling force F2 that pulls the bullet piece 142a to the second extreme position of being erected can be greater than the above-mentioned pulling force F1.

[0085] See also Fig.10The first and second traction lines 149a and 149b of the present application can be released from the tissue clamp 140. The first and second traction lines 149a and 149b can be released by pulling. Taking the second end 149d of the traction line as an example, the pulling force F is applied to first overcome the redundancy of the larger bending shape of the first redundant part 149g, so that the redundancy of the first redundant part 149g is shortened or eliminated, and at the same time overcome the movement resistance in the coating 143, and then overcome the redundancy of the second redundant part 149h with a longer length but a smaller bending, and finally overcome the movement resistance in the traction line hole 149f, so that the first and second traction lines 149a and 149b can be separated from the sub-shrapnel on the same side. The pulling force F can be designed to be greater than a fixed value of the lifting force F1. Only when the pulling force F reaches the force value, the first pulling line 149a and the second pulling line 149b will be pulled out from the coating 143 of the mother shrapnel 142b and 144b, and separated from the shrapnel 142a and 144a.

[0086] In summary, due to the presence of the first redundant part 149g which requires a relatively large pulling force F to be pulled and released, when there is no threading hole under the coating 143, the first traction line 149a and the second traction line 149b can be pulled up by using a relatively small pulling force F1 to repeatedly detect the first and second traction lines 149a and 149b. The presence of the first redundant part 149g and the second redundant part 149h ensures that the movements of the first end 149c and the second end 149d do not affect each other in the same line.

[0087] See also Fig.11 In another traction line setting mode, the ends of the mother shrapnel 142b, 144b and the bullet shrapnel 142a, 144a of the first and second shrapnel assemblies are respectively provided with traction line holes 149f, and the first redundant parts 149g of the first and second traction lines 149a, 149b are arranged in a bent form near the traction line holes 149f of the mother shrapnel 142b, 144b. The second redundant part 149h is still located between the mother shrapnel 142b, 144b and the bullet shrapnel 142a, 144a with a longer length but a smaller bend.

[0088] In other embodiments, the first redundant portion 149g may also have a certain redundancy in the traction line hole 149f of the mother spring pieces 142b and 144b, and the need for repeatedly pulling up the mother spring pieces 142b and 144b for detection can be met only by a force that is smaller than the redundant force that overcomes the first redundant portion 149g.

[0089] In the above embodiment, the bullet pieces 142a, 144a are lower than the mother bullet pieces 142b, 144b in a natural state, and there is a certain space distance between the mother bullet pieces 142b, 144b and the bullet pieces 142a, 144a, so that the movement will not be interfered with, and the second redundant part 149h can be accommodated. In other embodiments, for example, if the bullet pieces 142a, 144a are flush with the mother bullet pieces 142b, 144b, there can also be a certain space distance between the bullet pieces 142a, 144a and the mother bullet pieces 142b, 144b, so that the movement will not be interfered with, and the second redundant part 149h can be accommodated so that the second redundant part 149h will not be excessively stacked.

[0090] Please also read Fig.12 and Fig.13 In an embodiment of the present invention, a tissue clamp 140 is used in a valve clamping device 100 for repairing heart valves, especially mitral valves and tricuspid valves. The valve clamping device 100 mainly includes a fixing seat 110, a clamping assembly 130, a driving unit 150, and the tissue clamp 140 mentioned above.

[0091] 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.31 )Removable connection.

[0092] 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.

[0093] The base 112 is relatively fixed to the connecting seat 146. In this embodiment, the hollow space of the connecting seat 146 of the tissue clamp 140 is used to accommodate the base 112. In other embodiments, the connecting seat 146 and the fixing seat 110 can be smaller in size, so that the connecting seat 146 is directly fixed to the fixing seat 110. 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 channel from the through hole 147 to the support rod 114.

[0094] The rotation of the first clamping member 130a and the second clamping member 130b is achieved by the driving unit 150. Fig.13 and Fig.14 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 tissue clamp 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.31 ) 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.

[0095] See also Fig.14 When the bullet fragments 142a, 144a and the mother bullet fragments 142b, 144b are pulled to the second extreme position, the bullet fragments 142a, 144a can be flush with the mother bullet fragments 142b, 144b, and this flush situation can make the bullet fragments 142a, 144a and the mother bullet fragments 142b, 144b smaller in size.

[0096] See also Fig.15 Due to the pre-shaping and / or driving force and limit of the connecting end 146a, the second limit position of the bullet pieces 142a and 144a may still be lower than the second limit position of the mother bullet pieces 142b and 144b.

[0097] See also Figures 16 to 18 , the simulation state of detecting and clamping the valve leaflets of the valve clamping device 100 with the tissue clamping assembly 140 applied is used for explanation. 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 spring sheets 142a, 144a and the mother spring sheets 142b, 144b are joined to the valve leaflets (see Fig.16 ), the engagement at this time may be that the bullet pieces 142a, 144a are engaged with the leaflets, or one of the bullet pieces 142a, 144a is not engaged with the leaflets. Since the mother bullet pieces 142b, 144b are longer in length or are at different positions from the bullet pieces 142a, 144a, the mother bullet pieces 142b, 144b shall prevail. Next, the first and second bullet piece assemblies 142, 144 can use the mother bullet pieces 142b, 144b to detect whether the leaflets are clamped by the bullet pieces 142a, 144a, respectively. Fig.17 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 spring element 142a is kept stationary, and the mother spring element 142b is pulled up. At this time, the left leaflet is still clamped by the spring element 142a, indicating that the leaflet is sufficiently captured. Fig.18 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 spring element 144a is kept stationary, and the main 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 can be understood that the engagement state of the main spring elements 142b, 144b of the tissue clamp 140 of the embodiment of the present invention with the leaflet during the detection process may also be between the first limit position and the second limit position of the main spring elements 142b, 144b, that is, it has not completely reached the natural state of release, but can be engaged with the leaflet for detection under partially controlled conditions. The above-mentioned Fig.17 and Fig.18 The detection of the clamping state of the front leaf 410 and the rear leaf 420 by the first spring piece assembly 142 and the female spring pieces 142b and 144b of the first spring piece assembly 144 can also be performed simultaneously.

[0098] It can be understood that the bullet clips 142a, 144a and the mother bullet clips 142b, 144b on the same side of the tissue clamping assembly 140 of the present invention are independently controlled. When the bullet clips 142a, 144a fail to clamp the tissue, such as the proper position of the leaflets, the mother bullet clips 142b, 144b can be lifted up, and the bullet clips 142a, 144a can be lifted up to re-engage the tissue. Under this operation, the bullet clips 142a, 144a can be independently moved and adjusted relative to the mother bullet clips 142b, 144b.

[0099] 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.19 The method for detecting the clamping state of the clamping assembly mainly includes the following steps:

[0100] S1: providing a clamping assembly, wherein the clamping assembly comprises a bullet fragment and a mother bullet fragment connected at one end;

[0101] S2: joining the bullet piece and the mother bullet piece to a sheet-like body; and

[0102] S3: Pulling the mother shrapnel of the shrapnel assembly to separate the mother shrapnel from the sheet body; if the shrapnel is separated from the sheet body, reengaging the shrapnel and the mother shrapnel of the shrapnel assembly with the sheet body until the mother shrapnel of the shrapnel assembly is pulled and the mother shrapnel is separated from the sheet body, and the shrapnel keeps clamping the sheet body.

[0103] See also Fig. 20 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:

[0104] S1: Joining the spring fragments and the mother spring fragment of the first spring fragment assembly and the second spring fragment assembly to the leaflets of the valve;

[0105] S2: driving the first spring sheet assembly and / or the second spring sheet assembly's mother spring sheet to separate the mother spring sheet from the leaflet; and

[0106] S3: Observe the information of 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 and / or the blood regurgitation volume of the valve increases, re-engage the bullet fragments and the mother bullet fragments of the first spring fragment assembly and / or the second spring fragment assembly to the valve leaflet until the mother bullet fragments of the first spring fragment assembly and / or the second spring fragment assembly are driven and the mother bullet fragments 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 compared with when the mother bullet fragments are engaged with the valve leaflet.

[0107] Fig. 20 The process of the method for detecting the clamping state of the valve leaflets can be understood as follows: since the implantation of the valve clamping device is performed under medical imaging, such as ultrasound, by observing and receiving information from medical imaging, such as an increase in the activity amplitude of the valve leaflets and / or an increase in the blood regurgitation volume of the valve, it is indicated that the spring fragments are separated from the valve leaflets, and the valve leaflets are not clamped or are clamped too short to cause separation. In this case, it is necessary to re-engage the spring fragments and the mother spring fragments of the first spring fragment assembly and / or the second spring fragment assembly with the valve leaflets until the mother spring fragments of the first spring fragment assembly and / or the second spring fragment assembly are driven and the activity amplitude of the valve leaflets and / or the blood regurgitation volume of the valve leaflets are separated from the valve leaflets, and the activity amplitude of the valve leaflets and / or the blood regurgitation volume of the valve leaflets do not increase relative to when the mother spring fragments are engaged with the valve leaflets.

[0108] Please also read Fig.21 and Fig. 22 , the bullet pieces 162a, 164a of the tissue clamp 160 provided in the second embodiment of the present invention are respectively arranged on the sides of the mother bullet pieces 162b, 164b. In this embodiment, the axial length of the bullet pieces 162a, 164a is shorter than the axial length of the mother bullet pieces 162b, 164b, and there is a certain distance between the ends of the bullet pieces 162a, 164a and the corresponding mother bullet pieces 162b, 164b, so that the driving movement of the bullet pieces 162a, 164a is not affected by the mother bullet pieces 162b, 164b. The second extreme position of the bullet pieces 162a, 164a is lower than the second extreme position of the mother bullet pieces 162b, 164b. At this extreme position, at least part of the bullet pieces 162a, 164a is lower than the mother bullet pieces 162b, 164b, so that it has better recognition under medical images. In this embodiment, the shape of the mother shrapnel 162b, 164b is quite different from that of the bullet shrapnel 162a, 164a. The mother shrapnel 162b, 164b extends from the connecting seat 166 by a thin strip portion 167a. The end of the mother shrapnel 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 bullet shrapnel 162a, 164a has a basically uniform width, and also has a barb 168a and a traction line hole 169a at the end. The thin strip portion 167a of the mother elastic fragments 162b and 164b makes it easier for the mother elastic fragments 162b and 164b to be pulled, and the mother elastic fragments 162b and 164b can be driven with a smaller force. The wide clamping 167b of the mother elastic fragments 162b and 164b enables the mother elastic fragments 162b and 164b to assist the spring fragments 162a and 164a in clamping a wider area of ​​the leaflet when the detection is completed. The axial length of the mother elastic fragments 162b and 164b is longer, and the mother elastic fragments 162b and 164b are closer to the valve ring of the heart when clamping.

[0109] See also Fig.23In a deformable embodiment, by changing the degree of pre-shaping of the ends connecting the bullet pieces 162a, 164a and the mother bullet pieces 162b, 164b and / or the driving of the driving control, the second extreme position of the bullet pieces 162a, 164a can also be flush with the second extreme position of the mother bullet pieces 162b, 164b.

[0110] Please also read Fig.24 and Fig.25 The bullet pieces 172a, 174a and the mother bullet pieces 172b, 174b of the tissue clamp 170 provided in the third embodiment of the present invention have the same length, and the bullet pieces 172a, 174a are arranged on the sides of the mother bullet pieces 172b, 174b. The number, length and inclination angle of the barbs on the bullet pieces 172a, 174a and the mother bullet 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 bullet pieces 172a, 174a are lower than the ends of the mother bullet pieces 172b, 174b (see Fig.24 ); The second limit position of the bullet pieces 172a, 174a is lower than the second limit position of the mother bullet pieces 172b, 174b (see Fig.25 ), that is, the positions of the mother shrapnel 172b, 174b are higher than the bullet shrapnel 172a, 174a, and the mother shrapnel 172b, 174b is designed to be easier to be pulled. In medical imaging, the bullet shrapnel 172a, 174a and the mother shrapnel 172b, 174b can also be better identified according to the height of the position.

[0111] See also Fig.26 In a deformable embodiment, the bullet fragments 172a, 174a can also be completely identical to the mother bullet fragments 172b, 174b. The bullet fragments 172a, 174a and the mother bullet fragments 172b, 174b play the role of double-row clamping arms to increase the clamping area, and the second extreme position of the bullet fragments 172a, 174a can be flush with the second extreme position of the mother bullet fragments 172b, 174b.

[0112] It is understandable that, in the case where the mother shrapnel 172b, 174b and the bullet shrapnel 172a, 174a are of equal length, the mother shrapnel 172b, 174b and the bullet shrapnel 172a, 174a are still connected at one end, so they can still be regarded as the mother shrapnel and the bullet shrapnel respectively, the bullet shrapnel, i.e., the bullet shrapnel 172a, 174a, is responsible for clamping, and the mother shrapnel, i.e., the mother shrapnel 172b, 174b, is responsible for detection, and after the detection is completed, the auxiliary bullet shrapnel 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 role for 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.

[0113] See also Figure 27 to Figure 28 The difference between the tissue clamp 240 provided in the fourth embodiment of the present invention and the tissue clamp 140 of the first embodiment is that when the tissue clamp 240 is in a natural state without being subjected to the pulling force of the traction line, the bullet pieces 242a, 244a are flush with the corresponding mother bullet pieces 242b, 244. In this embodiment, the natural state of the bullet pieces 242a, 244a, that is, the first limit position is flush with the first limit position of the mother bullet pieces 242b, 244, and the second limit position can also be flush with the second limit position of the mother bullet pieces 242b, 244. In this embodiment, the axial length of the bullet pieces 242a, 244a is less than the axial length of the through hole 245 of the mother bullet pieces 242b, 244, that is, the ends of the bullet pieces 242a, 244a have a certain space distance from the mother bullet pieces 242b, 244, so that the bullet pieces 242a, 244a and the mother bullet pieces 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 of the bullet fragments 242a, 244a may also have a certain space distance from the inner side of the through hole 245 of the mother bullet fragments 242b, 244 to further reduce motion interference. In this embodiment, the angle A between the two mother bullet fragments 242b, 244 is preferably slightly greater than 180 degrees, that is, the ends 246b of the two mother bullet fragments 242b, 244b are slightly lower than the connecting end 246a connected to the connecting seat 246. Since the two bullet fragments 242a, 244a are flush with the mother bullet fragments 242b, 244, the angle between the two bullet fragments 242a, 244a is also equal to the angle A between the two mother bullet fragments 242b, 244. The situation that the end 246b is slightly lower than the connecting end 246a helps the mother bullet fragments 242b, 244 and the bullet fragments 242a, 244a to be more inclined to the valve in the natural state.

[0114] In the above embodiment, since the leaflets of the heart valve are inclined, the mother elastic pieces 242b, 244b and the bullet pieces 242a, 244a can be joined to the leaflets in a natural state or in a partially controlled state. Theoretically, the angle between the two mother elastic pieces 242b, 244b in a natural state, or the angle between the two bullet pieces 242a, 244a between 90 degrees and 270 degrees can be joined to the leaflets. The mother elastic pieces 242b, 244b and the bullet pieces 242a, 244a are respectively provided with a row of barbs 248 in a transverse direction.

[0115] See also Fig.29 In a deformable embodiment, only the spring pieces 242a and 244a are provided with barbs 248, and the barbs 248 can be in two rows, while the mother spring pieces 242b and 244b are not provided with barbs. After completing the detection, the mother spring pieces 242b and 244b are also crimped onto the leaflets to play a certain auxiliary clamping role.

[0116] See also Fig.30 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 clamping assembly 230, the driving unit 250, and the bullet pieces 242a, 244a and the mother bullet pieces 242b, 244b included in the valve clamping device 200 have the same functions as those of the previous 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.31 ) connection, in other embodiments, the support rod 114 may also be inside the blocking net 210.

[0117] 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.

[0118] In summary, the tissue clamping member of the valve clamping device provided in an embodiment of the present invention has a spring clip and a mother spring clip. When the spring clip clamps the valve, the mother spring clip 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 a desired position by the spring clip, that is, when the mother spring clip is detached from the valve, if the valve is detached from the spring clip, it indicates that the valve is not clamped in the desired position, including situations where the clamping length is too short, the valve leaf escapes as it beats, and the valve leaf escapes without being clamped by the spring clip; if the valve is still clamped by the spring clip, it indicates that the valve is clamped in the desired position.

[0119] See also Figure 31 to Figure 33The 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.31 The traction line of the tissue clamping member 140 of the valve clamping device 100 is in a relaxed state and is in contact with the tissue clamping member 140 of the valve clamping device 100. Figure 8 The pulling line is consistent. Fig.32 and Fig.33 The traction line of the tissue clamping member of the valve clamping device 100 is in a tensioned state, and Fig.33 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.

[0120] Please also read Fig.31 , Figure 34 to Figure 39 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:

[0121] 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 in the fixing seat is unlocked (see Fig.13 ), the driving mandrel 320 is delivered to the distal end (see Fig.31 ), 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.35 ); at the same time, the traction line controlling the tissue clamp 140 is tensioned to close the tissue clamp 140. At this time, a leaflet accommodating space is formed between the tissue clamp 140 and the clamping assembly 130.

[0122] See also Fig.36 , release the tissue clamps 140 on both sides simultaneously or successively, the tissue clamps 140 engage the valve leaflets and cooperate with the clamping assembly 130 to capture the anterior leaflet and the posterior leaflet. Then, see Fig.37 The parent shrapnel 144b (or parent shrapnel 142b) of the tissue clamp 140 detects whether the shrapnel 144a (or parent shrapnel 142a) clamps the valve leaf to the desired position. The detection process is described in the above Figures 16 to 18 After detecting that the leaflet is clamped to the desired position, the female 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.38 ), so that the front leaf and the rear leaf are clamped between the clamping assembly 140 and the clamping assembly 130;

[0123] 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 200 and the delivery device is released, and then the delivery device is withdrawn from the body, and the following is obtained: Fig.39 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.

[0124] 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.

[0125] 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.

[0126] 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 tissue clamp, characterized in that: It includes: Connecting seat; a first driving unit and a second driving unit; A first spring fragment assembly and a second spring fragment assembly, wherein the first spring fragment assembly and the second spring fragment assembly are respectively extended integrally from two opposite sides of the connecting seat, and the first spring fragment assembly and the second spring fragment assembly both include a mother spring fragment and a bullet fragment, and the bullet fragment is provided with barbs for engaging tissue. When the bullet fragment is driven by the first driving part to reach the tissue or engage with the tissue, the mother spring fragment is driven and controlled by the second driving part to move between an engaged state with the tissue and a separated state with the tissue, so as to detect whether the tissue is properly engaged by the bullet fragment. After the tissue is properly engaged by the bullet fragment, the mother spring fragment and the bullet fragment simultaneously engage the tissue.

2. The tissue clamp according to claim 1, characterized in that: Each of the mother spring fragment and the bullet spring fragment of the first spring fragment assembly and the second spring fragment assembly extends outward from the connecting seat respectively, and the mother spring fragment and the bullet spring fragment each have 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 spring fragment can be separated from each other when subjected to the force of the first driving part and / or the second driving part.

3. The tissue clamp according to claim 2, characterized in that: The bullet fragment and the mother bullet fragment respectively have a natural state when not subjected to the force of the first driving part and the second driving part. When the bullet fragment and the mother bullet fragment are in the natural state, an end of the bullet fragment away from the connecting seat is lower than an end of the mother bullet fragment on the same side away from the connecting seat, or the bullet fragment is flush with the mother bullet fragment on the same side.

4. The tissue clamp according to claim 3, characterized in that: The mother shrapnel is provided with a through hole, and at least a part of the shrapnel is accommodated in the through hole. The shrapnel can move relative to the through hole when driven by the first driving part.

5. The tissue clamp according to claim 3, characterized in that: The bullet fragment is arranged on the side of the mother bullet fragment, the axial length of the bullet fragment is less than or equal to the axial length of the mother bullet fragment, and the bullet fragment can move relative to the mother bullet fragment when driven by the first driving part.

6. The tissue clamp according to claim 3, characterized in that: The bullet fragment is close to or engages with the tissue in the natural state, and when the mother bullet fragments of the first and second bullet fragment assemblies are driven and controlled by the second driving unit to separate from the tissue, the bullet fragments in the natural state are subjected to associated forces and have a tendency to separate from the tissue, and when the mother bullet fragment is driven and controlled to separate from the tissue, the bullet fragments clamp the tissue or separate from the tissue.

7. The tissue clamp according to claim 3, characterized in that: The mother spring fragment and the bullet fragment of the first spring fragment assembly and the second spring fragment assembly can move between a first extreme position and a second extreme position under the driving control of the corresponding first driving unit and the second driving unit. In the first extreme position or the second extreme position, the bullet fragment is flush with the mother spring fragment on the same side, or the bullet fragment is lower than the mother spring fragment on the same side.

8. The tissue clamp according to claim 7, characterized in that: The first driving part and the second driving part are both pulling wires. The mother spring fragment and the bullet fragment of the first spring fragment assembly share the first pulling wire to control movement. The mother spring fragment and the bullet fragment of the second spring fragment assembly share the second pulling wire to control movement. The first pulling wire and the second pulling wire respectively have a first end and a second end. The first end is connected to the bullet fragment, and the second end is connected to the mother spring fragment.

9. The tissue clamp according to claim 8, characterized in that: A redundant part is provided between the first end and the second end of the first pulling line and the second pulling line, and the redundant part includes a first redundant part provided on the mother spring of the first spring assembly and the second spring assembly, and the force for pulling the mother spring of the first spring assembly and the second spring assembly to the second extreme position is less than the force for overcoming the first redundant part.

10. The tissue clamp according to claim 9, characterized in that: The mother springs of the first spring assembly and the second spring assembly are both provided with a coating, the first redundant part is pressed in the coating of the mother spring, the redundant part also includes a second redundant part connected to the first redundant part, the second redundant part is arranged between the mother spring and the spring on the same side, one end of the first redundant part passes through the coating and is connected to the second ends of the first traction line and the second traction line, the other end of the first redundant part passes through the coating and is connected to the second redundant part, and the force to overcome the first redundant part is greater than the force to overcome the second redundant part.

11. The tissue clamp according to claim 10, characterized in that: The spring sheets of the first spring sheet assembly and the second spring sheet assembly are both provided with a coating, the coating of the spring sheet and the spring sheet are provided with a traction line hole, the first ends of the first traction line and the second traction line pass through the traction line holes of the spring sheets and are connected to the second redundant part.

12. The tissue clamp according to claim 10, characterized in that: The spring pieces of the first spring piece assembly and the second spring piece assembly have a spatial distance from the mother spring piece on the same side, and the second redundant part has a redundant length in the spatial distance.

13. The tissue clamp according to claim 1, characterized in that: The mother shrapnel is provided with barbs for engaging tissues, and the lengths and / or angles of the barbs of the mother shrapnel and the shrapnel are different.

14. A valve repair device, comprising a first clamping member and a second clamping member that can be opened and closed relative to each other, characterized in that: Also included is a tissue clamp, the tissue clamp comprising: Connecting seat; A first spring sheet assembly and a second spring sheet assembly, wherein the first spring sheet assembly and the second spring sheet assembly respectively cooperate 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 respectively extend integrally from two opposite sides of the connecting seat, and the first spring sheet assembly and the second spring sheet assembly both include a mother spring sheet and a bullet leaf, wherein the mother spring sheet and the bullet leaf respectively have barbs for engaging the leaflets, and the mother spring sheet can be controlled to move between an engaged state with the leaflet and a separated state with the leaflet to detect whether the leaflet is properly engaged by the bullet leaf, and when the leaflet is properly engaged by the bullet leaf, the mother spring sheet and the bullet leaf simultaneously engage the leaflet.

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