Tissue clamp and valve repair device

Abstract

The present invention discloses a tissue clamp, which includes a connecting seat, a first driving portion, a second driving portion, a first elastic fragment assembly, and a second elastic fragment assembly. The first elastic fragment assembly and the second elastic fragment assembly respectively extend integrally from two opposite sides of the connecting seat. The first elastic fragment assembly and the second elastic fragment assembly each include a mother elastic fragment and a spring fragment. The spring fragment has barbs for engaging tissue. When the spring fragment is driven by the first driving portion to reach the tissue or engage the tissue, the mother elastic fragment can be driven and controlled by the second driving portion to move between an engaged state with the tissue and a separated state with the tissue to detect whether the tissue is properly engaged by the spring fragment. After the tissue is properly engaged by the spring fragment, the mother elastic fragment and the spring fragment simultaneously clamp the tissue. The present invention also provides a valve repair device using the tissue clamp.

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 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 tricuspid valve, 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 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 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 portion and a second driving portion;

[0011] A first spring fragment assembly and a second spring fragment assembly, the first spring fragment assembly and the second spring fragment assembly respectively extend integrally from two opposite sides of the connecting seat, the first spring fragment assembly and the second spring fragment assembly both include a mother spring fragment and a spring fragment, the spring fragment is provided with a barb for engaging tissue, when the spring fragment is driven by the first driving part to reach the tissue or engage 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 spring fragment, and after the tissue is properly engaged by the spring fragment, the mother spring fragment and the spring 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] The first spring piece assembly and the second spring piece assembly respectively cooperate with the first clamping piece and the second clamping piece to clamp the leaflet of the valve, the first spring piece assembly and the second spring piece assembly respectively extend integrally from the two opposite sides of the connecting seat, and the first spring piece assembly and the second spring piece assembly both include a mother spring piece and a bullet leaf, the mother spring piece and the bullet leaf respectively have barbs for engaging the leaflet, the mother spring piece 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 piece 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 comprises a primary shrapnel and a secondary shrapnel, wherein the secondary shrapnel is used to pre-clamp or engage tissue. The primary shrapnel can be controlled to move between an engaged state in which the shrapnel engages with the tissue and a disengaged state in which the shrapnel separates from the tissue to detect whether the tissue is properly engaged by the secondary shrapnel. That is, when the primary shrapnel disengages from the tissue, if the tissue disengages from the secondary shrapnel, it indicates that the tissue is not properly engaged by the secondary shrapnel, that is, it is not clamped in the desired position. Situations in which the tissue is not properly engaged include situations in which the length of the clamped tissue is too short or the engagement area is too small, the tissue escapes due to the beating of the tissue, such as a leaflet, and situations in which the tissue is not clamped by the secondary shrapnel even though the secondary shrapnel approaches or reaches the position for engaging the tissue. If the tissue is still clamped by the secondary shrapnel, it indicates that the tissue has been clamped in the desired position by the secondary shrapnel, and the primary shrapnel can assist the secondary 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 shrapnel, the mother shrapnel can clamp the leaflets at the same time as the shrapnel 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 invention and, together with the description, serve to explain the principles of the invention.

[0021] 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.

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

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

[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 Schematic diagram of traction line control when the mother shrapnel of the tissue clamp moves;

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

[0031] Figure 10 yes Figure 7 An enlarged schematic diagram of a tissue clamping member when the first redundant portion of the pulling line is eliminated;

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

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

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

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

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

[0037] Figure 16 yes Figure 12 A schematic diagram of the first and second elastic leaflet assemblies of the tissue clamp engaging with the leaflet during simulated detection of the leaflet by the valve repair device;

[0038] Figure 17 yes Figure 16 A schematic diagram of a simulated detection in which the first elastic fragment assembly of the tissue clamping member performs detection and the second elastic fragment assembly remains stationary;

[0039] Figure 18 yes Figure 16 A schematic diagram of a simulated detection in which the first elastic fragment assembly of the tissue clamping member remains stationary and the second elastic fragment assembly performs detection;

[0040] Figure 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] Figure 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] Figure 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] Figure 22 yes Figure 21 A three-dimensional schematic diagram of the tissue clamping member in the second extreme position;

[0044] Figure 23 is a perspective schematic diagram of a tissue clamping member of another deformable embodiment in a second extreme position;

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

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

[0047] Figure 26 is a perspective schematic diagram of a tissue clamping member of another deformable embodiment in a second extreme position;

[0048] Figure 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] Figure 28 yes Figure 27 A front view of a tissue clamp;

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

[0051] Figure 30 is a perspective schematic diagram of a valve repair device provided by a fifth embodiment of the present invention;

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

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

[0054] Figure 33 yes Figure 32 A schematic diagram of the valve repair device with the clip assembly in a closed state;

[0055] Figure 34 This is a schematic diagram of a valve repair device with a detachable valve repair device provided by an embodiment of the present invention, when applied to treat mitral regurgitation and extended into a treatment position;

[0056] Figure 35 yes Figure 34 Schematic diagram of a state in which the clamping assembly of the valve repair device is opened and is ready to capture the anterior leaflet and the posterior leaflet of the mitral valve;

[0057] Figure 36 yes Figure 35 A schematic diagram of a state in which a tissue clamp of a valve repair device is engaged with a valve leaflet;

[0058] Figure 37 yes Figure 36 A schematic diagram of a state in which a mother shrapnel of a tissue clamping member of a valve repair device detects whether the shrapnel is clamping the valve leaflet in a desired position;

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

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

[0061] 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.

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

[0063] 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.

[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 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.

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

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

[0068] The bullet fragments 142a, 144a and the primary bullet fragments 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 stretched and gathered during transportation and return to their original shape and position after release. The material of the bullet fragments 142a, 144a and the primary bullet fragments 142b, 144b is commonly nickel-titanium alloy.

[0069] The connecting end 146a has a certain pre-shaped structure, and the ends of the main bodies 146b of the shrapnel 142a, 144a and the main bodies 146b of the main bodies 142b, 144b are all away from the connecting base 146. Therefore, they can be pulled when subjected to a small pulling force. When the ends are driven, such as when pulled, the connecting end 146a becomes a rotation point, allowing the shrapnel 142a, 144a and the main bodies 142b, 144b to swing within a certain range. Due to the pre-shaped structure of the connecting end 146a or the limitations of the driving control, the extreme positions at which the shrapnel 142a, 144a and the main bodies 142b, 144b can stand upright and close toward the center of the connecting base 146 are limited. When the spring clips 142a, 144a and the mother spring clips 142b, 144b are not subjected to a driving force such as a pulling force, and when no other components apply a clamping force, the spring clips 142a, 144a and the mother spring clips 142b, 144b are in a natural state, which is another extreme position.

[0070] For ease of description, the limit positions of the spring clips 142a, 144a and the primary spring clips 142b, 144b when no other elements apply a clamping force and when the spring clips 142a, 144a and primary spring clips 142b, 144b are not being driven, such as by pulling, are defined as the first limit position. The limit positions of the spring clips 142a, 144a and primary spring clips 142b, 144b, which are aligned 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 tissue clamp 140 is tightened, and this second limit position helps to minimize the volume of the entire tissue clamp 140 during transport. The first limit position is the natural state, also known as the released state, i.e., the state in which the tissue clamp 140 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. The spring clips 142a and 144a are positioned below the primary spring clips 142b and 144b. When not being driven, such as pulled, when tissue, such as the leaflets of a valve, is clamped below the tissue clamp 140, the spring clips 142a and 144a naturally tend to the tissue. When clamping the leaflets of a valve, for example, if the edges of the anterior and posterior leaflets of a mitral valve are drooping, the primary spring clips 142b and 144b can still engage with the leaflets even when the primary spring clips 142b and 144b are positioned above. This engagement includes contact and / or application of a certain clamping pressure based on the contact.

[0072] When clamping tissue, to more tightly clamp the tissue and secure it, in one embodiment, at least the main body 146b of the shrapnel 142a, 144a is provided with barbs 148 directed toward the tissue. The shrapnel 142a, 144a is used to clamp the tissue, and the primary shrapnel 142b, 144b is primarily used to detect whether the tissue is properly clamped by the shrapnel 142a, 144a. In this embodiment, the main body 146b of the primary shrapnel 142b, 144b is preferably also provided with barbs 148. Therefore, after detection is completed, the primary shrapnel 142b, 144b can also use the barbs 148 to clamp and secure the tissue, similar to the shrapnel 142a, 144a.

[0073] In the tissue clamping member 140 of the present invention, since the spring clips 142a, 144a and the corresponding mother spring clips 142b, 144b are connected as a group, if the spring clips 142a, 144a can maintain their grip on the tissue when the mother spring clips 142b, 144b are pulled, it indicates that the tissue is properly gripped, i.e., the grip depth is sufficient. Therefore, in addition to assisting the spring clips 142a, 144a in gripping the tissue, the mother spring clips 142b, 144b also have the function of detecting whether the tissue has been gripped to a desired position by the spring clips 142a, 144a. After detecting that the tissue has been properly gripped, i.e., gripped to the desired position, the mother spring clips 142b, 144b and the spring clips 142a, 144a simultaneously grip the tissue.

[0074] In this embodiment, the primary shrapnel 142b, 144b is provided with a through hole 145 extending from the connection end 146a toward the center of the primary shrapnel 142b, 144b. The axial length of the shrapnel 142a, 144a is less than or equal to the axial length of the through hole 145. Preferably, the axial length of the shrapnel 142a, 144a is less than the axial length of the through hole 145 to prevent interference between the shrapnel 142a, 144a and the primary shrapnel 142b, 144b during independent movement. The shrapnel 142a, 144a can be formed by cutting from the through hole 145 of the primary shrapnel 142b, 144b, or directly molded to be separable from the primary shrapnel 142b, 144b. The shrapnel 142a, 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 spring pieces 142a, 144a and the mother spring pieces 142b, 144b in the natural state.

[0075] The shrapnel 142a, 144a extends downward from the through hole 145 relative to the mother shrapnel 142b, 144b. When the shrapnel 142a, 144a and the mother shrapnel 142b, 144b are in the natural state, the ends of the shrapnel 142a, 144a away from the connecting seat 146 are lower than the ends of the mother shrapnel 142b, 144b away from the connecting seat 146. The axial length of the mother shrapnel 142b, 144b is greater than the axial length of the shrapnel 142a, 144a. The axial length of the shrapnel 142a, 144a is between 4-6 mm, while the axial length of the mother shrapnel 142b, 144b is between 5-8 mm. In this embodiment, the angle A formed by the extension lines of the two mother shrapnel 242b, 244 is approximately 120 degrees. The two spring clips 242 a and 244 a are below the two mother spring clips 242 b and 244 , so the angle formed by their extension lines is larger than the angle A formed by the extension lines of the two mother spring clips 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. 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 on the mother shrapnel 142b and the number and length of the barbs 148 on the mother shrapnel 144b may be equal or unequal. The angles of inclination of the barbs 148 relative to the main bodies of the bullet shrapnel 142a, 144a and 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; and the number, length, and inclination angle of the barbs 148 on the mother shrapnel 142b and the mother shrapnel 144b are the same. In another embodiment, according to the size of the tissue, such as the leaflets of the 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 fragment 142a and the mother bullet fragment 142b used for clamping the anterior leaflet can be greater than the number and length of the barbs 148 of the bullet fragment 144a and the mother bullet fragment 144b used for clamping the posterior leaflet.

[0077] In this embodiment, the areas of the primary shrapnel 142b, 144b are larger, while the areas of the shrapnel 142a, 144a are smaller, and the lengths of the primary shrapnel 142b, 144b are also longer than the lengths of the shrapnel 142a, 144a. When the primary shrapnel 142b, 144b is larger and the shrapnel 142a, 144a is smaller, since the primary shrapnel 142b, 144b is connected to the corresponding shrapnel 142a, 144a at the connecting end 146a, when the primary shrapnel 142b, 144b is driven by the drive control device, the shrapnel 142a, 144a on the same side, due to their smaller volumes, will also be subject to the associated force and tend 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 drive control device. The mother bullet fragment 142b and the mother bullet fragment 144b each have their own drive control device, 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 drive 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. The traction wire can be connected from a control handle and a delivery sheath (see Figure 31 )Stretch out.

[0079] In a preferred embodiment, the primary spring 142b and the secondary spring 142a of the first spring assembly 142 share a first pull line 149a for control of movement, while the primary spring 144b and the secondary spring 144a of the second spring assembly 144 share a second pull line 149b for control of movement. The ends of each pull line 149a and 149b constitute a first drive unit and a second drive unit, respectively. In other embodiments, the first and second drive units may be, for example, drive wheels or elastic control devices (not shown) disposed within the connector 146 to achieve the purpose of driving and controlling the primary spring and secondary springs. In this embodiment, the first ends 149c of the first and second pull lines 149a and 149b are connected to the secondary springs 142a and 144a of the first and second spring assemblies 142 and 144, respectively, and the second ends 149d of the first and second pull lines 149a and 149b are connected to the primary springs 142b and 144b of the first and second spring assemblies 142 and 144, respectively. The first end 149c and the second end 149d can be wrapped around one of the elastic sheets to isolate 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 during movement. The wrapping can be released from the elastic sheet by applying a certain pulling force. In this embodiment, the redundant portion is provided so that the redundant portion is consumed during movement of the first end 149c and the second end 149d, thereby preventing the first end 149c and the second end 149d from affecting each other.

[0080] See also Figure 6 and Figure 7In a preferred embodiment, the primary shrapnel 142b, 144b and the shrapnel 142a, 144a of the first and second shrapnel assemblies are each covered with a coating 143. The coatings 143 of the primary shrapnel 142b, 144b and the shrapnel 142a, 144a are each independent, integral units, i.e., four coatings are sleeve-shaped and cover the entire periphery of each shrapnel. The coating 143 is a biocompatible film. On the one hand, the coating 143 can serve as a flow barrier to enhance the efficacy of reflux treatment and prevent blood from entering the first and second shrapnel assemblies 142, 144 and forming thrombi. On the other hand, the coating 143 can enhance the biocompatibility of the entire tissue clamp. The material of the coating 143 can be, but is not limited to, a biocompatible polymer such as PTFE, EPTFE, polyester, or silicone. In this embodiment, a redundant portion is provided between the first end 149c and the second end 149d of the first pulling line 149a and the second pulling 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 elastic fragments 142b and 144b, and the second redundant portion 149h is between the mother elastic fragments 142b and 144b and the bullet fragments 142a and 144a.

[0081] In this embodiment, the coating 143 is a woven mesh. The first redundant portion 149g is faintly visible from the outside beneath the coating 143. One end of the first redundant portion 149g passes through the coating 143 of the primary elastic pieces 142b and 144b and connects to the first end 149c. The other end of the first redundant portion 149g passes through the coating 143 of the primary elastic pieces 142b and 144b and connects to the second redundant portion 149h. The primary elastic pieces 142b and 144b of the first and second elastic pieces assemblies do not need threading holes. The design of the first redundant portion 149g and the mesh density of the coating 143 allow both ends of the first redundant portion 149g to be pulled out of the mesh under a certain pulling force F, while driving the primary 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 portion 149g can be designed to be redundant with a larger bend, requiring greater force to overcome the larger bend. The second redundant portion 149h can be designed to be redundant with a longer length but a smaller bend, i.e., the second redundant portion 149h has a redundant length between the primary springs 142b, 144b and the spring clips 142a, 144a on the same side. The force required to shorten or eliminate the first redundant portion 149g is greater than the force required to overcome the second redundant portion 149h. The ends of the spring clips 142a, 144a of the first and second spring clip assemblies 142, 144 are provided with a pull line hole 149f that extends through the coating 143. The first ends 149c of the first and second pull lines 149a, 149b can pass directly through the pull line hole 149f and connect to the first redundant portion 149g.

[0083] See also Figure 8 The motion control of the left-hand parent and shrapnel assembly will be described below. Because the parent shrapnel 142b is encased in the coating 143, when the second end 149d of the first pull line 149a is pulled, the applied pulling force F1 causes the parent shrapnel 142b to be lifted toward its second, upright, extreme position. During the lifting process, the distance between the parent shrapnel 142b and the shrapnel 142a increases, causing the second redundant portion 149h to be drawn in and straightened. Due to the presence of this second redundant portion 149h, the shrapnel 142a remains largely unaffected. The motion control of the right-hand parent and shrapnel assembly under the second pull line 149b is equivalent to that of the left-hand parent and shrapnel assembly.

[0084] Please continue reading Figure 9 When the first end 149c of the first pull line 149a is pulled, the pulling force F2 applied causes the spring clip 142a to be pulled upward toward the second, upright, limit position. This pulling process overcomes the resistance of the pull line in the pull line hole 149f and shortens the length of the second redundant portion 149h. In this embodiment, because the spring clip 142a is shorter and farther from the connecting seat 146 than the primary spring clip 142b, the pulling force F2 required to pull the spring clip 142a toward the second, upright, limit position can be greater than the pulling force F1.

[0085] See also Figure 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 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 is reached, 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 portion 149g, which requires a relatively large pulling force F to release, when no threading holes are provided under the cover 143, a relatively small pulling force F1 can be used to pull the second ends 149d of the first and second pull lines 149a, 149b to lift the female elastic pieces 142b, 144b for repeated probing. Furthermore, the presence of the first redundant portion 149g and the second redundant portion 149h prevents the movement of the first end 149c and the second end 149d from interfering with each other when the first and second ends 149c, 149d are connected by the same thread.

[0087] See also Figure 11 In another pull line arrangement, the ends of the primary springs 142b and 144b and the secondary springs 142a and 144a of the first and second spring fragment assemblies are each provided with a pull line hole 149f. The first redundant portion 149g of the first and second pull lines 149a and 149b is bent and positioned near the pull line hole 149f of the primary springs 142b and 144b. The second redundant portion 149h, also longer but with a smaller bend, is positioned between the primary springs 142b and 144b and the secondary springs 142a and 144a.

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

[0089] In the above embodiment, the spring clips 142a, 144a are naturally lower than the mother spring clips 142b, 144b. A certain distance exists between the mother spring clips 142b, 144b and the spring clips 142a, 144a to prevent interference with movement and to accommodate the second redundant portion 149h. In other embodiments, for example, if the spring clips 142a, 144a are flush with the mother spring clips 142b, 144b, a certain distance may also exist between the spring clips 142a, 144a and the mother spring clips 142b, 144b to prevent interference with movement and to accommodate the second redundant portion 149h so that the second redundant portion 149h does not over-accumulate.

[0090] Please also refer to Figure 12 and Figure 13 In an embodiment of the present invention, a tissue clamp 140 is used in a valve clamping device 100 for repairing heart valves, particularly the mitral and tricuspid valves. The valve clamping device 100 primarily includes a fixing base 110, a clamping assembly 130, a drive unit 150, and the aforementioned tissue clamp 140.

[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, 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 31 ) Detachable connection.

[0092] 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.

[0093] The base 112 is fixed relative 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 formed in the center of the connecting seat 146, and a corresponding through hole is also formed in the base 112. The support rod 114 is hollow inside, forming 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. In this embodiment, please refer to Figure 13 and Figure 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 for connecting with a driving device, such as a driving core shaft extending from the delivery sheath (see Figure 31 ) 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.

[0095] See also Figure 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. This flush situation can make the bullet fragments 142a, 144a and the mother bullet fragments 142b, 144b smaller in size.

[0096] See also Figure 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 following description is made using a simulated state of the valve clamping device 100 detecting and clamping the valve leaflets with the tissue clamping assembly 140 already applied. 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 assembly 142 and the second spring assembly 144 are loosened, so that the spring fragments 142a, 144a and the mother spring fragments 142b, 144b are joined to the valve leaflets (see Figure 16 ), the engagement at this time may be that the spring pieces 142a, 144a are engaged with the leaflets, or one of the spring pieces 142a, 144a is not engaged with the leaflets. Since the mother spring pieces 142b, 144b are longer or are located at different positions from the spring pieces 142a, 144a, the engagement of the mother spring pieces 142b, 144b with the leaflets shall prevail. Next, the first spring piece assembly 142 and the second spring piece assembly 144 can use the mother spring pieces 142b, 144b to detect whether the leaflets are clamped by the spring pieces 142a, 144a respectively. Figure 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. Figure 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 mother 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 mother spring elements 142b, 144b of the tissue clamp 140 of the embodiment of the present invention may also be in the state of engagement with the leaflet during the detection process between the first limit position and the second limit position of the mother spring elements 142b, 144b, 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 17 and Figure 18 The detection of the clamping status of the front leaf 410 and the rear leaf 420 by the first elastic leaf assembly 142 and the female elastic leaves 142b and 144b of the first elastic leaf assembly 144 can also be performed simultaneously.

[0098] It can be understood that the shrapnel 142a, 144a and the mother shrapnel 142b, 144b on the same side of the tissue clamping assembly 140 of the present invention are independently controlled. When the shrapnel 142a, 144a does not clamp the tissue, such as when the leaflets are in the appropriate position, the mother shrapnel 142b, 144b can be lifted up, and the shrapnel 142a, 144a can be lifted up to re-engage the tissue. Under this operation, the shrapnel 142a, 144a can be independently moved and adjusted relative to the mother shrapnel 142b, 144b.

[0099] 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 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 includes a bullet fragment and a mother bullet fragment connected at one end;

[0101] S2: joining the bullet fragment and the mother bullet fragment 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 Figure 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 elastic fragment assembly and / or the second elastic fragment assembly's mother elastic fragment to separate the mother elastic fragment 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 spring fragments and the mother spring fragments of the first spring fragment assembly and / or the second spring fragment assembly with the valve leaflet until the mother spring fragments of the first spring fragment assembly and / or the second spring fragment assembly are driven and the mother spring fragments are separated from the valve leaflet, and the movement amplitude of the valve leaflet and / or the blood regurgitation volume of the valve leaflet do not increase compared with the movement amplitude of the valve leaflet and / or the blood regurgitation volume of the valve when the mother spring fragments are engaged with the valve leaflet.

[0107] Figure 20 The process of the method for detecting the leaflet clamping state can be understood as follows: since the entire implantation process of the valve clamping device is performed under medical imaging, such as ultrasound, by observing the received medical imaging information, such as an increase in the leaflet movement amplitude and / or an increase in the valve blood regurgitation volume, it is indicated that the spring fragments are detached from the leaflets, and the leaflets are not clamped or are clamped too short, resulting in detachment. In this case, the spring fragments and the mother spring fragments of the first spring fragment assembly and / or the second spring fragment assembly need to be re-engaged with the leaflets until the mother spring fragments of the first spring fragment assembly and / or the second spring fragment assembly are driven and the leaflet movement amplitude and / or the valve blood regurgitation volume are not increased when the mother spring fragments are separated from the leaflets compared to when the mother spring fragments are engaged with the leaflets.

[0108] Please also refer to Figure 21 and Figure 22 The second embodiment of the present invention provides a tissue clamp 160 with spring clips 162a and 164a disposed on the sides of respective primary spring clips 162b and 164b. In this embodiment, the axial length of the spring clips 162a and 164a is shorter than that of the primary spring clips 162b and 164b, and a certain distance exists between the distal ends of the spring clips 162a and 164a and the corresponding primary spring clips 162b and 164b, so that the driving motion of the spring clips 162a and 164a is not affected by the primary spring clips 162b and 164b. The second extreme position of the spring clips 162a and 164a is lower than the second extreme position of the primary spring clips 162b and 164b. In this extreme position, at least a portion of the spring clips 162a and 164a is positioned lower than the primary spring clips 162b and 164b, thereby providing better recognition in medical imaging. In this embodiment, the shape of the female elastic fragments 162b, 164b is quite different from that of the bullet fragments 162a, 164a. The female elastic fragments 162b, 164b extend from the connecting seat 166 by a thin strip portion 167a. The end of the female elastic fragments 162b, 164b is a relatively wide clamping area 167b, and the clamping area 167b is provided with a barb 168 and a traction line hole 169; the bullet fragments 162a, 164a have a 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 mother elastic fragments 162b and 164b makes it easier to pull the mother elastic fragments 162b and 164b, and the mother elastic fragments 162b and 164b can be driven with less 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 Figure 23In a deformable embodiment, by changing the degree of pre-shaping of the ends connecting the shrapnel 162a, 164a and the mother shrapnel 162b, 164b and / or the driving of the driving control, the second extreme position of the shrapnel 162a, 164a can also be flush with the second extreme position of the mother shrapnel 162b, 164b.

[0110] Please also refer to Figure 24 and Figure 25 The third embodiment of the present invention provides a tissue clamp 170 in which the bullet fragments 172a, 174a and the mother bullet fragments 172b, 174b have the same length. The bullet fragments 172a, 174a are arranged on the sides of the mother bullet fragments 172b, 174b. The number, length and inclination angle of the barbs on the bullet fragments 172a, 174a and the mother bullet fragments 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 fragments 172a, 174a are lower than the ends of the mother bullet fragments 172b, 174b (see Figure 24 ) The second limit position of the shrapnel 172a, 174a is lower than the second limit position of the female shrapnel 172b, 174b (see Figure 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 pull. In medical imaging, the bullet shrapnel 172a, 174a and the mother shrapnel 172b, 174b can be better identified based on the height of the position.

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

[0112] It is understood that in the case where the mother springs 172b, 174b and the springs 172a, 174a are of equal length, the mother springs 172b, 174b and the springs 172a, 174a are still connected at one end and can therefore still be considered as the mother spring and the spring, respectively. The springs 172a, 174a are responsible for clamping, while the mother springs 172b, 174b are responsible for detection and, after detection, assist the springs in clamping the leaflets. The valve clamping device 100 of the embodiment of the present invention, after the clamping assembly 130 is closed, clamps the two leaflets edge to edge, thereby reducing the leakage of mitral or tricuspid regurgitation and reducing blood reflux. The valve can still open and close normally after implantation of the valve clamping device 100.

[0113] See also Figures 27 and 28 The tissue clamp 240 provided in the fourth embodiment of the present invention differs from the tissue clamp 140 of the first embodiment in that, in its natural state, free from the tension of the pull line, the spring segments 242a, 244a are flush with the corresponding mother segments 242b, 244. In this embodiment, the spring segments 242a, 244a in their natural state, i.e., their first extreme position, are flush with the first extreme position of the mother segments 242b, 244. Their second extreme position can also be flush with the second extreme position of the mother segments 242b, 244. In this embodiment, the axial length of the spring segments 242a, 244a is less than the axial length of the through-holes 245 of the mother segments 242b, 244. Specifically, the distal ends of the spring segments 242a, 244a are spaced a certain distance from the mother segments 242b, 244. This ensures that the spring segments 242a, 244a and the mother segments 242b, 244 do not interfere with each other during independent movement and accommodates redundant portions of the pull line. In this embodiment, the sides of the spring clips 242a and 244a may also be spaced a certain distance from the inner sides of the through-holes 245 of the mother spring clips 242b and 244 to further reduce motion interference. In this embodiment, the angle A between the two mother spring clips 242b and 244 is preferably slightly greater than 180 degrees, that is, the ends 246b of the two mother spring clips 242b and 244b are slightly lower than the connecting end 246a connected to the connecting seat 246. Because the two spring clips 242a and 244a are flush with the mother spring clips 242b and 244, the angle between the two spring clips 242a and 244a is also equal to the angle A between the two mother spring clips 242b and 244. This slightly lowering of the ends 246b relative to the connecting end 246a helps the mother spring clips 242b and 244 and the spring clips 242a and 244a to be more inclined toward the valve in their natural state.

[0114] In the above embodiment, since the leaflets of the heart valve are tilted, the primary elastic fragments 242b, 244b and the shrapnel fragments 242a, 244a can be engaged with the leaflets in a natural state or under partially controlled conditions. Theoretically, in a natural state, the angle between the two primary elastic fragments 242b, 244b, or the angle between the two shrapnel fragments 242a, 244a, can be engaged with the leaflets if it is between 90 degrees and 270 degrees. The primary elastic fragments 242b, 244b and the shrapnel fragments 242a, 244a are each laterally provided with a row of barbs 248.

[0115] See also Figure 29 In a deformable embodiment, only the spring clips 242a and 244a are provided with barbs 248, and the barbs 248 can be two rows, while the mother spring clips 242b and 244b are not provided with barbs. After completing the detection, the mother spring clips 242b and 244b are also pressed against the leaflet to play a certain auxiliary clamping role.

[0116] See also Figure 30 The fifth embodiment of the present invention provides a valve clamping device 200 with a fixing seat outer shell provided with a blocking net 210. The functions of the clamping assembly 230, the driving unit 250, and the bullet clips 242a, 244a and the mother bullet clips 242b, 244b included in the valve clamping device 200 are the same as those of the previous embodiment, 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 31 ) connection, in other embodiments, the support rod 114 can also be inside the blocking net 210.

[0117] 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.

[0118] In summary, the tissue clamping piece 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 the 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 the situation that the clamping length is too short, the valve leaflet escapes as it beats, and the valve leaflet 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 Figures 31 to 33Embodiments 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 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. Figure 8 The pulling line is consistent. Figure 32 and Figure 33 The traction line of the tissue clamping member of the valve clamping device 100 is in a tensioned state, and Figure 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 refer to Figure 31 、 Figures 34 to 39 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:

[0121] 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 in the fixing seat is unlocked (see Figure 13 ), the driving mandrel 320 is delivered to the distal end (see Figure 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 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 35 ); at the same time, the traction line controlling the tissue clamp 140 is tightened 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 Figure 36 , release the tissue clamps 140 on both sides simultaneously or successively, the tissue clamps 140 engage the leaflets and cooperate with the clamping assembly 130 to capture the anterior leaflet and the posterior leaflet. Then, see Figure 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 leaflet to the desired position. The detection process is described in the aforementioned 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 and the clamping assembly 140 can clamp the leaflet together, 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 Figure 38 ), so that the front leaflet and the rear leaflet are clamped between the clamping assembly 140 and the clamping assembly 130;

[0123] 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 clamping device 200 and the delivery device. Then, withdraw the delivery device from the body, and obtain the following: Figure 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 for 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 mitral valve and clamping the valve leaflets.

[0126] 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 tissue clamp for valve repair, characterized in that: It includes: Connecting seat; a first driving portion and a second driving portion; a first spring fragment assembly and a second spring fragment assembly, wherein the first spring fragment assembly and the second spring fragment assembly are integrally extended from two opposite side edges of the connecting seat respectively, and each of the first spring fragment assembly and the second spring fragment assembly includes a mother spring fragment and a spring fragment, and the spring fragment is provided with barbs for engaging tissue. When the spring fragment is driven by the first driving part to reach the tissue or engage 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 spring fragment. After the tissue is properly engaged by the spring fragment, the mother spring fragment and the spring fragment simultaneously engage the tissue; The first driving portion and the second driving portion are both pull lines. The mother spring and the spring of the first spring assembly share the first pull line to control their movement. The mother spring and the spring of the second spring assembly share the second pull line to control their movement. The first pull line and the second pull line respectively have a first end and a second end. The first end is connected to the spring, and the second end is connected to the mother spring. A redundant portion is provided between the first and second ends of the first and second pulling lines, the redundant portion including a first redundant portion provided on the female springs of the first and second spring assemblies, and the force required to pull the female springs of the first and second spring assemblies to the second limit position is less than the force required to overcome the first redundant portion; The second limit position is the limit position of the bullet fragment and the mother bullet fragment moving toward the center of the connecting seat.

2. The tissue clamp according to claim 1, wherein: Each of the mother spring fragment and the bullet fragment of the first spring fragment assembly and the second spring fragment assembly extends outward from the connecting seat respectively, and each of the mother spring fragment and the bullet fragment has a connecting end connected to the connecting seat and a main body extending from the connecting end. 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, wherein: The bullet fragment and the mother bullet fragment are in 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, the end of the bullet fragment away from the connecting seat is lower than the 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 portion 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 shrapnel is close to or engages with the tissue in the natural state. When the mother shrapnel of the first shrapnel assembly and the second shrapnel assembly is driven and controlled by the second driving part to separate from the tissue, the shrapnel in the natural state is subjected to an associated force and has a tendency to separate from the tissue. When the mother shrapnel is driven and controlled to separate from the tissue, the shrapnel clamps the tissue or separates 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 part and the second driving part. 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 1, wherein: 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 within the coating of the mother spring, the redundant part further 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 and second pull lines, 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.

9. The tissue clamp according to claim 8, characterized in that: The spring sheets of the first spring sheet assembly and the second spring sheet assembly are both provided with a coating, and the coating and the spring sheet are provided with a traction line hole, and the first ends of the first traction line and the second traction line pass through the traction line holes of the spring sheet and are connected to the second redundant part.

10. The tissue clamp according to claim 8, wherein: There is a spatial distance between the spring fragments of the first spring fragment assembly and the second spring fragment assembly and the mother spring fragment on the same side, and the second redundant portion has a redundant length in the spatial distance.

11. The tissue clamp according to claim 1, wherein: 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.

12. A valve repair device comprising a first clamping member and a second clamping member that can open and close relative to each other, characterized in that: Also included is a tissue clamp, the tissue clamp comprising: Connecting seat; The first spring piece assembly and the second spring piece assembly respectively cooperate with the first clamping piece and the second clamping piece to clamp the leaflet of the valve, the first spring piece assembly and the second spring piece assembly respectively extend integrally from the two opposite sides of the connecting seat, and the first spring piece assembly and the second spring piece assembly both include a mother spring piece and a bullet leaf, the mother spring piece and the bullet leaf respectively have barbs for engaging the leaflet, the mother spring piece 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 piece and the bullet leaf simultaneously engage the leaflet.

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