Detailed Description
The following description of the embodiments of the present invention will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without any inventive effort, are intended to be within the scope of the invention.
In describing the present invention, it should be noted that:
The terms "upper," "lower," "inner," "outer," and the like are used for convenience in describing and simplifying the description only, and do not denote or imply that the devices or elements in question must have a particular orientation, be constructed and operated in a particular orientation, and thus should not be construed as limiting the invention. Furthermore, the terms "first," "second," and the like, are used for descriptive purposes only and are not to be construed as indicating or implying relative importance;
When an element is referred to as being "fixed" or "disposed on" another element, it can be directly connected to the other element or be 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 can be directly connected to the other element or be connected to the other element by one or more connecting elements.
In the field of interventional medical devices, a proximal end refers to an end closer to an operator, and a distal end refers to an end farther from the operator, a direction of a rotation center axis of an object such as a cylinder, a tube, or the like is defined as an axial direction, a circumferential direction is a direction (perpendicular to the axis and perpendicular to a section radius) around an axis of the object such as the cylinder, the tube, or the like, and a radial direction refers to a direction along a wire diameter or a radius. It is noted that the term "end" as used in the terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc. is not limited to a tip, endpoint or end face, but includes a location extending an axial distance and/or a radial distance from the tip, endpoint or end face over the element to which the tip, endpoint or end face belongs. The above definitions are for convenience of description only and are not to be construed as limiting the invention.
The valve clamping device provided by the invention is used for repairing heart valves, in particular mitral valves and tricuspid valves.
Referring to fig. 3 to 7, a valve clamping device 100 according to a first embodiment of the present invention mainly includes a fixing base 110, a clamping assembly 130, a clamping assembly 140, and a driving unit 150.
The fixing base 110 mainly includes a base 112, the base 112 is provided with a hinge hole 112a, and the clamping assembly 130 is hinged to the fixing base 110. In this embodiment, the base 112 is further provided with a support rod 114, and the support rod 114 is fixedly connected with the base 112 or integrally formed. The support bar 114 may be adapted for detachable connection to a delivery sheath (see fig. 27) of a delivery device.
The clamping assembly 130 includes a first clamping member 130a and a second clamping member 130b, where each of the first clamping member 130a and the second clamping member 130b is configured to radiate and spread around the fixing base 110 in a paddle shape, and 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 hinge of the present application includes a pivot type, a hinge type, etc. to allow one member to rotate with respect to the other member, that is, the first and second clamping members 130a and 130b can rotate with respect to the fixing base 110.
The clamping assembly 140 includes a first spring assembly 142 and a second spring assembly 144, and the first spring assembly 142 and the second spring assembly 144 are connected together by a substantially U-shaped connection base 146. The base 112 and the connection seat 146 are relatively fixed, in this embodiment, the U-shaped hollow space of the connection seat 146 is used for accommodating the base 112, in other embodiments, the connection seat 146 may be smaller, the base 112 may also be smaller, and the connection seat 146 is directly fixed on the base 112. The center of the connecting seat 146 is provided with a through hole 147, the base 112 is also provided with a corresponding through hole, and the support rod 114 is hollow, so that a hollow channel is formed from the through hole 147 to the support rod 114.
The rotation of the first and second clamping members 130a, 130b is achieved by the drive unit 150. In this embodiment, referring to fig. 10 and 11 together, the driving unit 150 includes a base 152, a connecting rod 153 and a driving shaft 154, wherein one end of the driving shaft 154 is fixedly connected to the base 152, and the other end of the driving shaft passes through the through hole 147 of the clamping assembly 140 and the through hole of the base 112 to extend into the hollow channel of the supporting rod 114 for detachable connection with a driving device, such as a driving mandrel (see fig. 27) extending out of a delivery sheath. The base 112 is provided therein with a locking member 113, the locking member 113 can be engaged with the driving shaft 154 by elastic deformation to lock or disengaged to allow the driving shaft 154 to move forward and backward, and the locking member 113 can be controlled by a control wire (not shown). The locking element 113 also functions to re-unlock and re-clip when the leaflet is clipped in an improper position. The connecting rod 153 includes a pair of connecting rods, which are respectively pivoted to the base 152 and 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 130 b. The rotation of the link 153 may pull or push the first and second clamping members 130a and 130b to rotate relative to the fixed base 110, and when the driving shaft 154 is driven in the axial direction, the base 152 may move forward or backward along with the driving shaft 154, thereby driving the link 153 to rotate, and when the link 153 rotates, the first and second clamping members 130a and 130b are pulled or driven to be opened or closed.
The first spring assembly 142 and the second spring assembly 144 respectively include a clamping spring and a detecting spring, the detecting spring 142b and the clamping spring 142a of the first spring assembly 142 extend from one side of the connecting seat 146, and the detecting spring 144b and the clamping spring 144a of the second spring assembly 144 extend from the opposite side of the connecting seat 146. Since the detecting spring 142b and the clamping spring 142a of the first spring assembly 142 extend from the same side of the connecting seat 146, it may be called a mother-child spring set, and the detecting spring 144b and the clamping spring 144a of the second spring assembly 144 also extend from the same side of the connecting seat, it may be called another mother-child spring set.
The clamping spring plates 142a, 144a and the detecting spring plates 142b, 144b have a connecting end 146a connected to the connecting base 146, and a substantially elongated main body portion 146b extending from the connecting end 146 a. The main body 146b of the clamping spring 142a, 144a and the main body 146b of the detecting spring 142b, 144b are separable from each other, and are separable from each other when subjected to an external force, such as a driving force. Each of the detecting spring pieces 142b, 144b is connected to the holding spring piece 142a, 144a on the same side only at the connecting end 146a, and the other edge of each of the detecting spring pieces 142b, 144b is not connected to the holding spring piece 142a, 144a, so that the main body portion 146b of the holding spring piece 142a, 144a and the main body portion 146b of the detecting spring piece 142b, 144b can be separated from each other.
The clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b are made of elastic materials or materials with shape memory function, deform when being subjected to external force, tend to restore to the original shape and position due to elasticity or shape memory capability after the external force is eliminated, and can be tensioned and folded in the conveying process, and move towards the clamping piece after being released so as to clamp or detect the valve leaflet of the valve. The materials of the clamping spring plates 142a, 144a and the detecting spring plates 142b, 144b are commonly nickel-titanium alloy.
The ends of the clamping spring pieces 142a, 144a and the main body portion 146b of the detecting spring pieces 142b, 144b are far away from the connecting seat 146, so that they can be pulled when being subjected to a small pulling force, and when the ends are driven, for example, pulled, the connecting end 146a becomes a rotation point, so that the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b can be far away from the first clamping member 130a and the second clamping member 130b to a certain extent. Due to the limitation of the pre-shaping or driving control of the connecting end 146a, the limiting positions of the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b which can be folded towards the center of the connecting seat 146 are limited. The clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b are in a natural state, i.e., the other extreme position, when the clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b are not subjected to driving force such as pulling force, and when the clamping force is not applied by the first clamping member 130a and the second clamping member 130b. In this embodiment, the clamping elastic pieces 142a, 144a are located below the detecting elastic pieces 142b, 144b, and the clamping elastic pieces 142a, 144a are located in a natural state facing the first clamping member 130a and the second clamping member 130b when not driven, for example, pulled, so that the clamping elastic pieces 142a, 144a have a natural state tending toward the valve when the valve is clamped between the clamping assemblies 130 and 140. The edges of the valve, e.g., anterior and posterior leaflet of the mitral valve, are sagging and still engage the leaflet even if the probe tabs 142b, 144b are above, including contact and/or applying some clamping pressure upon contact.
For convenience of description, when the first clamping member 130a and the second clamping member 130b do not apply a clamping force and the clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b are not driven, for example, pulled, the limit positions of the clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b are defined as a first limit position, and the limit positions of the clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b closed toward the center of the connecting seat 146 are defined as a second limit position. The second extreme position is an extreme state in which the clamp assembly 140 is tightened, which facilitates maintaining a minimum volume of the entire valve clamping device 100 when the clamp assembly 130 is also closed in the delivery state, and the entire valve clamping device 100 is also in this state when implantation is complete. The first limit position is a natural state and is also a released state, i.e. released from the second limit position to the first limit position.
Referring to fig. 5 to fig. 7, through holes 145 are respectively formed in the detecting elastic pieces 142b, 144b from the connecting end 146a toward the middle of the detecting elastic pieces 142b, 144b, and the axial length of the clamping elastic pieces 142a, 144a is smaller than or equal to the axial length of the through holes 145, preferably, the axial length of the clamping elastic pieces 142a, 144a is smaller than the axial length of the through holes 145, so as to avoid interference between the clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b during independent movement. The clamping elastic pieces 142a, 144a may be formed by cutting from the through holes 145 of the detecting elastic pieces 142b, 144b, or may be directly molded to be in a separable state from the female elastic pieces 142b, 144 b. The bullet pieces 142a, 144a are movable relative to the through hole 145 when subjected to a drive control force. . The pre-shaping of the bent configuration of the connecting end 146a increases the fatigue resistance of the connecting end 146a during rotation, and also determines the relative positions of the clamping spring pieces 142a, 144a and the detecting spring pieces 142b, 144b in the natural state.
In this embodiment, the detecting elastic pieces 142b and 144b have larger areas, the clamping elastic pieces 142a and 144a have smaller areas, the detecting elastic pieces 142b and 144b have longer lengths than the clamping elastic pieces 142a and 144a, and the detecting elastic pieces 142b and 144b may be referred to as female elastic pieces, and the clamping elastic pieces 142a and 144a may be referred to as sub-elastic pieces due to the connection between the detecting elastic pieces 142b and 144b and the connection ends 146a of the clamping elastic pieces 142a and 144a corresponding to the same sides, and the difference between the areas and the lengths.
When the volumes of the detecting spring pieces 142b, 144b are larger and the volumes of the clamping spring pieces 142a, 144a are smaller, the detecting spring pieces 142b, 144b are connected with the corresponding clamping spring pieces 142a, 144a at the connecting ends 146a, and when the detecting spring pieces 142b, 144b are driven by the driving control device, the clamping spring pieces 142a, 144a on the same side are also subjected to the associated acting force due to the smaller volumes, and have the tendency of moving towards the same direction. In this arrangement, when the detection spring 142b, 144b is driven by the drive control means, if the leaflet is not clamped by the clamping spring 142a, 144a to a sufficient depth, i.e. if the clamping spring 142a, 144a is clamped only to the position of the leaflet at the more edge, the leaflet may escape, and thus by driving the detection spring 142b, 144b to separate from the leaflet, if the leaflet is also separated from the clamping spring 142a, 144a, this indicates that the leaflet is not clamped in the desired position.
Because the clamping spring pieces 142a, 144a have smaller volumes, and the connecting seat 146 is fixed to the fixing base 110, the detecting spring pieces 142b, 144b can be substantially not associated when the clamping spring pieces 142a, 144a are driven by the driving control device. The detecting spring piece 142b and the detecting spring piece 144b are respectively provided with a driving control device, so that the detecting spring pieces 142b and 144b can be independently driven and controlled to respectively detect the clamping condition of the heart valve, such as the anterior leaflet and the posterior leaflet of the mitral valve. The drive control device may be, for example, a traction wire, or a drive wheel or an elastic control device (not shown) may be disposed in the connection base 146, for example, to achieve the purpose of driving and controlling the detecting spring and the holding spring. In this embodiment, the clamping spring 142a and the clamping spring 144a may share one traction wire, or the clamping spring 142a and the clamping spring 144a may have respective traction wires. From the second extreme position in the delivery state (see fig. 28) to the first extreme position in the release state, the pull wire undergoes a relaxation (see fig. 27) process, and conversely, from the first extreme position in the release state to the second extreme position in the delivery state, the pull wire undergoes a tensioning process upon installation.
Referring to fig. 3 and 8, the detecting spring plates 142b, 144b and the clamping spring plates 142a, 144a have a pull wire hole 149 at their ends, and the clamping spring plates 142a and 144a share a pull wire 149a, i.e. two ends of the pull wire 149a respectively pass through the pull wire holes 149 at the ends of the clamping spring plates 142a, 144 a. The detecting spring piece 142b and the detecting spring piece 144b have respective traction wires 149b, 149c, however, the detecting spring piece 142b and the detecting spring piece 144b may also share a traction wire, and the detection can be performed simultaneously. Referring to fig. 9, in another embodiment, the clamping spring 142a and the clamping spring 144a have respective traction wires 149d, 149e, and the detecting spring 142b and the detecting spring 144b also have respective traction wires 149f, 149g. The pull wires of the present application are releasable from the pull wire holes 149, and the pull wires can be released by pulling, so that the valve clamping device 100 does not contain pull wires when implanted in a heart valve. The pull wire may be a nickel titanium wire that may be coupled to a control handle (see fig. 27) through the delivery sheath after extending from the pull wire hole 149.
Referring to fig. 10, when the clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b are pulled to the second limit positions, the clamping elastic pieces 142a, 144a may be flush with the detecting elastic pieces 142b, 144b, and the flush condition may make the clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b have smaller volumes. Referring to fig. 11, due to the pre-shaping and/or the limitation of the driving force and the limit of the connecting end 146a, the second limit position of the clamping elastic pieces 142a, 144a may still be lower than the second limit position of the detecting elastic pieces 142b, 144 b.
Referring to fig. 3 and 7 again, in the present embodiment, the clamping elastic pieces 142a, 144a extend downward from the through holes 145 relative to the detecting elastic pieces 142b, 144b, when the clamping elastic pieces 142a, 144a and the detecting elastic pieces 142b, 144b are in the natural state, the end of the clamping elastic pieces 142a, 144a away from the connecting seat 146 is lower than the end of the detecting elastic pieces 142b, 144b away from the connecting seat 146, i.e. the detecting elastic pieces 142b, 144b are farther from the first clamping member 130a and the second clamping member 130b than the clamping elastic pieces 142a, 144a, and the clamping elastic pieces 142a, 144a are also spaced from the detecting elastic pieces 142b, 144 b. The axial length of the detecting spring pieces 142b, 144b is greater than that of the clamping spring pieces 142a, 144a, the axial length of the clamping spring pieces 142a, 144a is between 4 mm and 6mm, and the axial length of the detecting spring pieces 142b, 144b is between 5mm and 8mm. In this embodiment, the angle a formed by the extension lines of the two detecting spring pieces 242b, 244 is about 120 degrees. The two clamping elastic pieces 242a and 244a are below the two detecting elastic pieces 242b and 244, so that an included angle formed by extension lines of the two clamping elastic pieces is larger than an included angle A formed by extension lines of the two detecting elastic pieces 242b and 244.
In this embodiment, the clamping spring plates 142a, 144a and the detecting spring plates 142b, 144b are respectively provided with barbs 148. The barbs 148 act to retain the heart valve leaflets toward and against the heart valve leaflets, thereby assisting in strengthening the anchoring valve tissue. In this embodiment, the width of the detecting spring plates 142b, 144b is greater than the width of the clamping spring plates 142a, 144a, and the number of barbs 148 on the detecting spring plates 142b, 144b may be greater than the number of barbs 148 on the clamping spring plates 142a, 144 a. The number and length of the barbs 148 of the detection dome 142b and the number and length of the barbs 148 of the detection dome 144b may be equal or unequal. The clip tabs 142a, 144a and the probe tabs 142b, 144b may each engage the leaflets of a valve that enters between the clip assembly 130 and the clip assembly 140 when the clip tabs 142a, 144a and the probe tabs 142b, 144b are in the natural state. The inclination angles of the barbs 148 relative to the bodies of the grip tabs 142a, 144a and the probe tabs 142b, 144b may be the same or different, and in one embodiment, the number, length, and inclination angles of the barbs 148 on the grip tab 142a and the barbs 148 on the grip tab 144a are the same, and the number, length, and inclination angles of the barbs 148 on the probe tab 142b and the barbs 148 on the probe tab 144b are the same. In another embodiment, depending on the size of the leaflet, e.g., the anterior leaflet of the mitral valve of the heart has a larger area than the posterior leaflet, so that the gripping is more targeted, the number and length of barbs 148 of the gripping and probing tabs 142a, 142b for the anterior leaflet of the grip may be greater and longer than the number and length of barbs 148 of the gripping and probing tabs 144a, 144b for the posterior leaflet of the grip.
Referring to fig. 12-14, a simulated state of probing and clamping the leaflet of the valve clamping device 100 having the tissue clamping assembly 140 of the present invention is illustrated, when the leaflet, such as the anterior leaflet 410 and the posterior leaflet 420 of the mitral valve, respectively enter the first clamping member 130a and the second clamping member 130b, the pull wires of the first elastic member 142 and the second elastic member 144 are loosened, so that the clamping elastic members 142a, 144a and the probing elastic members 142b, 144b are engaged to the leaflet (see fig. 12), and the engagement may be that the clamping elastic members 142a, 144a are engaged to the leaflet, or that one of the clamping elastic members 142a, 144a is not engaged to the leaflet. Because the length of the sensing tabs 142b, 144b is longer or different from the location of the gripping tabs 142a, 144a, the sensing tabs 142b, 144b are aligned with the engagement of the petals She Wei. Next, the first elastic sheet assembly 142 and the second elastic sheet assembly 144 may detect whether the valve leaflet is clamped by the clamping elastic sheets 142a and 144a respectively by using the detecting elastic sheets 142b and 144b, fig. 13 shows that the second elastic sheet assembly 144 is kept still, the first elastic sheet assembly 142 detects, and when the first elastic sheet assembly 142 detects, the clamping elastic sheet 142a is kept still, the detecting elastic sheet 142b is pulled up, and at this time, the left valve leaflet is still clamped by the clamping elastic sheet 142a, which indicates that the valve leaflet is sufficiently captured. Fig. 14 shows that the first elastic element 142 remains stationary, the second elastic element 144 detects, and when the second elastic element 144 detects, the clamping elastic element 144a is kept stationary, and the detecting elastic element 144b is pulled up, at this time, the right flap She Taotuo indicates that the leaflet is not clamped in the desired position. It will be appreciated that the sensing tabs 142b, 144b of the valve clasper device 100 of the present invention may also be positioned between a first extreme position and a second extreme position during sensing operation, i.e., not fully reached a released natural state, but may be engaged with the leaflet for sensing under partial control. The detection of the clamping state of the front leaf 410 and the rear leaf 420 by the detection spring 142b, 144b of the first spring assembly 142 and the first spring assembly 144 of fig. 13 and 14 may also be performed simultaneously.
It will be appreciated that the clamping tabs 142a, 144a and the probing tabs 142b, 144b on the same side of the tissue clamping assembly 140 of the present invention, due to independent control, can lift the probing tabs 142b, 144b when the clamping tabs 142a, 144a are not clamped to tissue, such as the leaflets are in place, and the clamping tabs 142a, 144a can be lifted to reengage the tissue, under which operation the clamping tabs 142a, 144a can be independently adjusted for movement relative to the probing tabs 142b, 144 b.
In summary, the clamping assembly provided by the embodiment of the present invention has a function of detecting the clamping state of the leaflet, and the leaflet is a sheet, so that the clamping assembly provided by the embodiment of the present invention has a function of detecting the clamping state of the sheet, referring to fig. 15, the method for detecting the clamping state of the clamping assembly mainly includes the following steps:
S1, providing a clamping assembly, wherein the clamping assembly comprises a clamping elastic sheet and a detection elastic sheet, and one end of the clamping elastic sheet is connected with the detection elastic sheet;
S2, jointing the clamping spring piece and the detecting spring piece with the sheet-shaped body and
And S3, lifting the detection spring piece of the spring piece assembly to separate the detection spring piece from the sheet-shaped body, and if the clamping spring piece is separated from the sheet-shaped body, re-jointing the clamping spring piece and the detection spring piece of the spring piece assembly with the sheet-shaped body until the detection spring piece of the spring piece assembly is lifted and the clamping spring piece keeps clamping the sheet-shaped body when the detection spring piece is separated from the sheet-shaped body.
Referring to fig. 16, if the sheet is a leaflet of a heart valve, the method for detecting the clamping state of the leaflet may include the following steps:
S1, jointing clamping elastic pieces and detection elastic pieces of the first elastic piece assembly and the second elastic piece assembly with valve leaflets of a valve;
s2, driving the detection spring piece of the first spring piece assembly and/or the second spring piece assembly to separate the detection spring piece from the valve leaflet, and
And S3, observing information of the activity amplitude of the valve leaflet and/or the blood reflux quantity of the valve receiving the medical image, and if the activity amplitude of the valve leaflet and/or the blood reflux quantity of the valve are increased, re-jointing the clamping elastic piece and the detection elastic piece of the first elastic piece assembly and/or the second elastic piece assembly with the valve leaflet until the detection elastic piece of the first elastic piece assembly and/or the second elastic piece assembly is driven and the activity amplitude of the valve leaflet and/or the blood reflux quantity of the valve are not increased relative to the activity amplitude of the valve leaflet and/or the blood reflux quantity of the valve when the detection elastic piece is jointed with the valve leaflet.
The flow of the method of detecting the leaflet clamped condition of fig. 16 can be understood as meaning that the leaflet is not clamped or too short to be detached due to the fact that the implantation of the valve clamping device is performed entirely under medical images, such as ultrasound, by observing information received from the medical images, such as an increase in the amplitude of the activity of the leaflet and/or an increase in the blood flow back of the valve, indicating detachment of the clamping flaps from the leaflet. In this case, the clamping spring and the detecting spring of the first spring assembly and/or the second spring assembly need to be combined with the valve leaflet again until the detecting spring of the first spring assembly and/or the second spring assembly is driven, and the activity amplitude of the valve leaflet and/or the blood reflux quantity of the valve when the detecting spring is separated from the valve leaflet are not increased relative to the activity amplitude of the valve leaflet and/or the blood reflux quantity of the valve when the detecting spring is combined with the valve leaflet.
Referring to fig. 17 and fig. 18 together, the clamping elastic pieces 162a and 164a of the clamping assembly 160 according to the second embodiment of the present invention are disposed at the sides of the detecting elastic pieces 162b and 164b, respectively. In this embodiment, the axial length of the clamping elastic pieces 162a, 164a is shorter than that of the detecting elastic pieces 162b, 164b, and a certain distance is provided between the ends of the clamping elastic pieces 162a, 164a and the corresponding detecting elastic pieces 162b, 164b, so that the driving motion of the clamping elastic pieces 162a, 164a is not affected by the detecting elastic pieces 162b, 164 b. The second limit position of the clamping spring 162a, 164a is lower than the second limit position of the detecting spring 162b, 164b, and at least part of the clamping spring 162a, 164a is lower than the detecting spring 162b, 164b in the limit position, so that the detection device has better identification under medical images. In this embodiment, the shape of the detecting spring plates 162b, 164b is greatly different from that of the clamping spring plates 162a, 164a, the detecting spring plates 162b, 164b extend from the connecting seat 166 from a thin strip portion 167a, the tail ends of the detecting spring plates 162b, 164b are wider clamping areas 167b, the clamping areas 167b are provided with barbs 168 and traction wire holes 169, and the clamping spring plates 162a, 164a are of substantially uniform width, and are also provided with barbs 168a and traction wire holes 169a at the tail ends. The thin strip 167a of the detecting spring 162b, 164b makes the detecting spring 162b, 164b easier to pull, the detecting spring 162b, 164b can be driven by smaller force, the wide clamping 167b of the detecting spring 162b, 164b makes the detecting spring 162b, 164b can assist the clamping spring 162a, 164a to clamp the valve leaflet for a wider area when the detecting is completed, the axial length of the detecting spring 162b, 164b is longer, and the detecting spring 162b, 164b is closer to the valve annulus of the heart when clamping.
Referring to fig. 19, in a deformable embodiment, by changing the pre-shaping degree and/or the driving of the driving control of the ends where the clamping elastic pieces 162a, 164a and the detecting elastic pieces 162b, 164b are connected, the second extreme positions of the clamping elastic pieces 162a, 164a can be flush with the second extreme positions of the detecting elastic pieces 162b, 164 b.
Referring to fig. 20 and 21 together, the clamping elastic pieces 172a, 174a and the detecting elastic pieces 172b, 174b of the clamping assembly 170 according to the third embodiment of the present invention have the same length, the clamping elastic pieces 172a, 174a are disposed at the sides of the detecting elastic pieces 172b, 174b, and the number, length and inclination angle of the barbs on the clamping elastic pieces 172a, 174a and the detecting elastic pieces 172b, 174b may be set to be the same. In a natural state, i.e., in a first limit position, the ends of the clamping elastic pieces 172a, 174a are lower than the ends of the detecting elastic pieces 172b, 174b (see fig. 20), and in a second limit position of the clamping elastic pieces 172a, 174a is lower than the second limit position of the detecting elastic pieces 172b, 174b (see fig. 21), i.e., the positions of the detecting elastic pieces 172b, 174b are higher than the positions of the clamping elastic pieces 172a, 174a, the detecting elastic pieces 172b, 174b are designed to be pulled more easily, and in a medical image, the clamping elastic pieces 172a, 174a and the detecting elastic pieces 172b, 174b can be recognized better according to the heights of the positions.
Referring to fig. 22, in a deformable embodiment, the clamping elastic pieces 172a, 174a may also be identical to the detecting elastic pieces 172b, 174b, where the clamping elastic pieces 172a, 174a and the detecting elastic pieces 172b, 174b function as double-row clamping arms to increase the clamping area, and the second extreme positions of the clamping elastic pieces 172a, 174a can be level with the second extreme positions of the detecting elastic pieces 172b, 174 b.
It will be appreciated that in the case of such detecting and clamping elastic pieces 172b, 174b, 172a, 174a of equal length, the detecting and clamping elastic pieces 172b, 174b, 172a, 174a may still be considered as a parent and a bullet piece, respectively, since they are still connected at one end, the child elastic piece, i.e. the clamping elastic piece 172a, 174a, is responsible for clamping, the parent elastic piece, i.e. the detecting elastic piece 172b, 174b, is responsible for detecting, and the auxiliary bullet piece, after detection, clamps the leaflet. The valve clamping device 100 of the embodiment of the present invention performs the function of edge-to-edge clamping on two leaflets that cannot be closed naturally after the clamping assembly 130 is closed, that is, the function of reducing the leakage of mitral valve or tricuspid valve regurgitation and reducing blood regurgitation, and the valve can still be normally opened and closed after the valve clamping device 100 is implanted.
Referring to fig. 23 to 24, the fourth embodiment of the present invention provides a clamping assembly 240 that is different from the clamping assembly 140 of the first embodiment in that the clamping assembly 240 is flush with the corresponding detecting spring 242b, 244 when the clamping assembly 240 is in a natural state without being pulled by the traction wire. In this embodiment, the axial length of the clamping elastic pieces 242a, 244a is smaller than the axial length of the through hole 245 of the detecting elastic pieces 242b, 244, i.e. the ends of the clamping elastic pieces 242a, 244a have a certain space distance from the detecting elastic pieces 242b, 244, so that the clamping elastic pieces 242a, 244a and the detecting elastic pieces 242b, 244 do not interfere when moving independently, and the traction wire redundant part can be accommodated. In this embodiment, the sides of the holding spring pieces 242a, 244a may also be spaced apart from the inner sides of the through holes 245 of the detecting spring pieces 242b, 244 to further reduce the interference of the movement. In this embodiment, the natural state of the clamping elastic pieces 242a, 244a, that is, the first limit position is flush with the first limit position of the detecting elastic pieces 242b, 244, and the second limit position may also be flush with the second limit position of the detecting elastic pieces 242b, 244. In a preferred embodiment, the angle a between the two detecting spring pieces 242b, 244 may be slightly larger than about 180 degrees, i.e. the end 246b of the two detecting spring pieces 242b, 244 is slightly lower than the connecting end 246a connected to the connecting base 246, and the angle a between the two clamping spring pieces 242a, 244a is equal to the angle a between the two detecting spring pieces 242b, 244 because the two clamping spring pieces 242a, 244a are flush with the detecting spring pieces 242b, 244. This condition of the tip 246b being slightly lower than the connecting end 246a helps to detect the tendency of the tabs 242b, 244 and the clip tabs 242a, 244a to be more biased toward the valve in the natural state.
In the above embodiment, since the leaflet of the heart valve is inclined, the detecting spring 242b, 244b and the holding spring 242a, 244a may be engaged to the leaflet in a natural state or in a partially controlled state, and theoretically, an angle between the two detecting spring 242b, 244b or an angle between the two holding spring 242a, 244a may be engaged to the leaflet in a natural state between 90 degrees and 270 degrees. The detecting spring plates 242b, 244b and the holding spring plates 242a, 244a are respectively and transversely provided with a row of barbs 248.
Referring to fig. 25, in a deformable embodiment, only the clamping elastic pieces 242a and 244a are provided with barbs 248, and the barbs 248 may be arranged in two rows, while the detecting elastic pieces 242b and 244b are not provided with barbs, and the detecting elastic pieces 242b and 244b are also pressed against the valve leaflet after the detection to play a role of auxiliary clamping.
Referring to fig. 26, the fixing seat of the valve clamping device 200 according to the fifth embodiment of the present invention is sleeved with a blocking net 210, the clamping assembly 230, the driving unit 250, and the clamping assembly including the clamping elastic pieces 242a, 244a and the detecting elastic pieces 242b, 244b have the same functions as those of the previous embodiments, and only difference is that after the clamping assembly 230 closes and clamps the leaflet that cannot be naturally closed, the blocking net 210 can block the gap between the clamped leaflets, so that the effect of treating the regurgitation is better. One end of the plugging screen 210 may be fixed to the fixing base by a fixing ring, and the supporting rod 114 of the fixing base may extend out of the other end of the plugging screen 210 to be connected to a delivery sheath (see fig. 27) of a delivery device, and in other embodiments, the supporting rod 114 may be located in the plugging screen 210.
The plugging net 210 is a three-dimensional net structure, preferably a three-dimensional net structure formed by weaving wires or cutting tubes with a shape memory function, for example, super-elastic materials such as nitinol wires, so that the plugging net 210 can adapt to gaps between different valve leaflets to adaptively deform under different clamping angles or different clamping forces of the clamping assembly 230, thereby adjusting the pulling degree of the valve clamping device 200 on the valve leaflets. For example, for larger, but thinner and fragile tricuspid adjacent leaflets (which may be anterior and posterior, anterior and septal, or posterior and septal) the clip assembly 230 may close at a larger clamping angle, avoiding excessive leaflet stress, preventing perforation or tearing, and for mitral adjacent leaflets (i.e., anterior and posterior mitral), the clip assembly 230 may close at a smaller clamping angle to provide a larger clamping force to the leaflets.
In summary, the clamping assembly of the valve clamping device provided by the embodiment of the invention is provided with the clamping spring and the detecting spring, when the clamping spring clamps the valve, the detecting spring can be controlled to move between a natural state of being jointed with the valve and a detecting state of being separated from the valve so as to detect whether the valve is clamped at a desired position by the clamping spring, namely, when the detecting spring is separated from the valve, if the valve is separated from the clamping spring, the valve is not clamped at the desired position, including the situation that the clamping length is too short, the valve escapes along with the jump of the valve leaflet and the valve is not clamped by the clamping spring, and if the valve is still clamped by the clamping spring, the valve is clamped at the desired position. After detecting that the leaflet is clamped to the desired position by the clamping spring, the detecting spring and the clamping spring can jointly clamp the leaflet. The clamping spring piece and the detection spring piece can be realized in a mode of a mother-child spring piece.
Referring to fig. 27 to 29, an embodiment of the present invention further provides a valve clamping system, which includes the valve clamping device 100 and a delivery device, wherein the delivery device includes a control handle 330, a delivery sheath 310 having a certain axial length, and a driving mandrel 320 movably penetrating the delivery sheath 310. The distal end of delivery sheath 310 is detachably connected to support shaft 114 of valve clasper device 100, and the distal end of drive mandrel 320 is detachably connected to drive shaft 154 for driving deployment and closure of clasper assembly 130. The connection between the drive mandrel 320 and the drive shaft 154 may be a threaded connection, the delivery sheath 310 may be engaged with the support shaft 114, the drive mandrel 320 may abut the drive shaft 154 against the delivery sheath 310 and the support shaft 114, such that the connection between the delivery sheath 310 and the support shaft 114 remains in place, and the delivery sheath 310 may automatically disengage from the support shaft 114 when the drive mandrel 320 is disengaged from the drive shaft 154. The drive mandrel 320 may be a wire and the valve clamping device 100 may be replaced with the valve clamping device 200 described above. The pull wire of the clamp assembly 140 of the valve clasping device 100 of fig. 27 is in a relaxed state and is identical to the pull wire of fig. 8. The pull wires of the clamping assembly of the valve clamping device 100 of fig. 28 and 29 are in tension and the clamping assembly 130 of the valve clamping device 100 of fig. 29 is closed, which may be in a delivery state or a closed state after clamping to the desired leaflet position.
Referring to fig. 10, 27 and 30-35, taking the repair process of the anterior leaflet and the posterior leaflet of the mitral valve as an example, the operation method of the valve clamping system using the valve clamping device of the present invention mainly comprises the following steps:
The distal end of the delivery sheath 310 and the valve clamping device 100 are delivered to the left atrium LA by way of transfemoral vein puncture, the valve clamping device 100 is controlled to approach the anterior leaflet 410 and the posterior leaflet 420 of the mitral valve, the locking element 113 (see fig. 10) in the fixed seat is unlocked, the driving mandrel 320 (see fig. 27) is delivered to the distal end, the driving mandrel 320 drives the driving shaft 154, the driving shaft 154 drives the clamping assembly 130 to open relatively, the direction of the clamping assembly 130 is adjusted, the relative positions of the clamping assembly 130 and the anterior leaflet and the posterior leaflet of the mitral valve can be observed through a medical developing or imaging device, the clamping assembly 130 is enabled to be approximately perpendicular to the free edges of the anterior leaflet and the septal leaflet, the valve clamping device 100 is pushed to the left ventricle through the delivery sheath 310, the valve clamping device 100 is placed under the anterior leaflet and the posterior leaflet, the clamping assembly 130 is continuously opened to the grasping position (see fig. 31), and simultaneously, the pulling wire tension of the clamping assembly 140 is controlled to close the clamping assembly 140, and a leaflet accommodating space is formed between the clamping assembly 140 and the clamping assembly 130.
Referring to fig. 32, the clamping assemblies 140 on both sides are released simultaneously or sequentially, and the clamping assemblies 140 engage the leaflet to capture the anterior leaflet and the posterior leaflet in cooperation with the clamping assembly 130. Then, referring to fig. 33, the detecting spring 144b (or the detecting spring 142 b) of the clamping assembly 140 detects whether the clamping spring 144a (or the detecting spring 142 a) clamps the valve leaflet to a desired position, and the detection process is described with reference to fig. 12 to 14. After detecting that the leaflet is clamped to the desired position, releasing the detection spring 144b of the clamping assembly 140 to clamp the leaflet together with the clamping assembly 140, and then proximally pulling the drive mandrel 320 and the drive shaft 154 to thereby drive the clamping assembly 130 closed (see fig. 34) such that the anterior leaflet and the posterior leaflet are clamped between the clamping assembly 140 and the clamping assembly 130;
The threaded connection between the drive mandrel 320 and the drive shaft 154 is disengaged and the drive mandrel 320 is withdrawn, the delivery sheath 310 is separated from the support rod 114, the connection between the valve clasping device 100 and the delivery device is released, after which the delivery device is withdrawn from the body to achieve the implanted condition shown in fig. 35, the valve clasping device 100 pulls the anterior leaflet and the posterior leaflet of the mitral valve toward each other, and the limbic repair of the anterior leaflet and the posterior leaflet is completed.
The valve repair apparatus and the valve clamping device are suitable for being applied to mitral valve clamping operation, and can be applied to tricuspid valve clamping operation, but the intervention paths are different, for example, the intervention paths of tricuspid valve clamping operation can be femoral vein-inferior vena cava-right atrium-right ventricle, and can also be transapical path.
It will be appreciated that the valve clasper systems provided by the present invention may include any of the valve clasper devices of the various embodiments described above and a delivery device capable of delivering the valve clasper device from outside the body to adjacent the tricuspid valve or mitral valve and for clasping the leaflets.
The foregoing is only a specific embodiment of the invention to enable those skilled in the art to understand or practice the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.