Locking retention device
By designing a locking and holding device with a self-locking function, the problem of difficulty in ensuring stability and effectiveness of the locking device in the prior art when it resists cardiac beating for a long time is solved, and the long-term maintenance of the locking state is achieved and the treatment effect of the surgery is improved.
Patent Information
- Application Number
- CN202311202108.4
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2023-09-15
- Publication Date
- 2025-03-18
- Estimated Expiration
- 2043-09-15
AI Technical Summary
When the locking device in the prior art resists the heartbeat for a long time, it is difficult to maintain stability and effectiveness, and there is a risk of locking failure, which affects the treatment effect of the surgery.
A locking and holding device with a self-locking function is designed, including a base body, a rotatably connected locking member, a movable retaining member and an elastic member located between the retaining member and the base body. The locking member achieves a long-term locking state through the self-locking section and the self-locking slope, combining the elastic member and friction.
Through the self-locking function, the locking and holding device can remain locked for a long time under continuous heartbeat, improving the stability and effectiveness of the device and helping to maintain the therapeutic effect of the surgery.
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Figure CN119632727A_ABST
Abstract
Description
Technical Field
[0001] The present invention relates to the technical field of medical devices, and in particular to a locking and retaining device. Background Art
[0002] The heart is the driving organ of blood circulation. It relies on rhythmic beating to push blood to continuously flow in the blood vessels. The atrioventricular valves (mitral valve and tricuspid valve) of the heart are one-way valves between the atria and ventricles, which are used to control the directional and efficient flow of blood from the atria to the ventricles, while preventing blood from flowing from the ventricles to the atria. When the atria contract, the atrioventricular valve opens, and blood flows from the atria to the ventricles; when the ventricles contract, the atrioventricular valve closes to prevent blood from flowing back to the atria. However, when the leaflets, chordae tendineae, or valve rings of the atrioventricular valve and other related structures are diseased, the atrioventricular valve will not be able to close completely, causing blood to flow back to the atria, thereby causing a series of pathological and physiological diseases.
[0003] Clinically, the repair techniques for heart valve disease include surgical operations and minimally invasive interventional operations, and these operations generally require implants to be implanted into the heart and maintained in a certain state for a long time. Taking chord repair surgery as an example, generally, one end of the suture needs to be fixed to the leaflets of the heart valve, and the other end of the suture needs to be fixed to the ventricular tissue to serve as an artificial chord; at this time, a locking device can be used to lock one end of the suture for long-term fixation. However, when the locking device in the prior art is in a locked state, in order to resist long-term heart beating, it is extremely difficult for the locking device to remain in a locked state for a long time, and there is a risk of locking failure. That is, in the prior art, the long-term stability and effectiveness of the locking device are extremely difficult to guarantee, so it is difficult to maintain the therapeutic effect of the surgery. Summary of the invention
[0004] The purpose of the present invention is to provide a locking and holding device with a self-locking function to ensure the long-term stability and effectiveness of the locking and holding device under continuous heart beating, which helps to maintain the therapeutic effect of the operation.
[0005] In order to achieve the above object, the present invention provides a locking and holding device, comprising:
[0006] matrix;
[0007] A locking member, the locking member is rotatably connected to the base, and the locking member has a self-locking section;
[0008] A retaining member, the retaining member is movably disposed on the base, and the retaining member has a self-locking inclined surface cooperating with the self-locking section; and
[0009] an elastic member, the elastic member being located between the retaining member and the base;
[0010] The locking member is actuated to rotate relative to the base in a direction away from the self-locking inclined surface to a locked state, and the first position of the self-locking section is disengaged from the abutment of the self-locking inclined surface; under the action of the elastic member, the retaining member moves on the base until the self-locking inclined surface abuts and remains in the second position of the self-locking section; wherein the curvature radius of the first position is greater than the curvature radius of the second position.
[0011] The locking and holding device provided by the present invention, in the locked state, the second position of the self-locking section of the locking member abuts against the self-locking inclined surface of the holding member, and under the dual action of the elastic thrust of the elastic member and the friction between the holding member and the base, the holding member can be prevented from moving toward the elastic member on the base, thereby ensuring that the self-locking inclined surface and the second position of the self-locking section can maintain abutment for a long time, and finally ensuring that the locking member can be maintained in the locked state for a long time. That is, the self-locking function of the locking and holding device provides long-term resistance to the reverse rotation of the locking member, thereby resisting long-term heart beats, thereby ensuring the long-term stability and effectiveness of the locking and holding device, and helping to maintain the therapeutic effect of the operation. BRIEF DESCRIPTION OF THE DRAWINGS
[0012] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are some implementation methods of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.
[0013] Figure 1 It is a schematic diagram of the three-dimensional structure of the locking and holding device provided in the first embodiment of the present invention.
[0014] Figure 2 yes Figure 1 A partially exploded schematic diagram of the locking and retaining device shown.
[0015] Figure 3 yes Figure 2 The locking and holding device shown is an exploded schematic diagram from another perspective after omitting the anchoring member.
[0016] Figure 4 yes Figure 1 The locking and holding device shown is a cross-sectional view when a suture is passed through the device and the first position of the self-locking section abuts against the self-locking inclined surface.
[0017] Figure 5 yes Figure 1 The locking protection device shown is a cross-sectional view when a suture is passed through the locking protection device and the second position of the self-locking section abuts against the self-locking inclined surface.
[0018] Fig. 6A yes Figure 4 The schematic diagram of the forces between the locking member, the retaining member and the base body when the locking and retaining device is in the initial state is shown.
[0019] Figure 6B yes Figure 5 The schematic diagram of the forces between the locking member, the retaining member and the base when the locking and retaining device is in a locked state is shown.
[0020] Figure 7 yes Figure 3 Schematic diagram of the three-dimensional structure of the substrate shown.
[0021] Figure 8 yes Figure 7 A schematic diagram of the three-dimensional structure of the substrate shown in another viewing angle.
[0022] Fig. 9 yes Figure 3 A schematic diagram of the three-dimensional structure of the locking member is shown.
[0023] Fig.10 yes Figure 3 A schematic diagram of the three-dimensional structure of the retaining member shown.
[0024] Fig.11 It is a schematic diagram of the three-dimensional structure of the retaining member in another embodiment.
[0025] Fig.12 yes Figure 4 A schematic diagram of a locking and retaining device shown having sutures threaded therethrough and movably connected to an actuator and a driver.
[0026] Fig.13 It is a schematic diagram of the three-dimensional structure of the anchoring member in another embodiment.
[0027] Figures 14 to 18 1 is a schematic diagram of the use of the locking and retaining device of the first embodiment for locking sutures in artificial chordal implantation, wherein: Fig.15 yes Fig.14 An enlarged schematic diagram of section XV is shown.
[0028] Fig.19 It is a schematic diagram of the three-dimensional structure of the locking and holding device provided in the second embodiment of the present invention.
[0029] Fig. 20 yes Fig.19 A perspective exploded schematic diagram of the locking and retaining device shown.
[0030] Fig.21 yes Fig. 20 A schematic diagram of the three-dimensional structure of the base shown.
[0031] Fig. 22 yes Fig.21A schematic diagram of the three-dimensional structure of the base shown in another viewing angle.
[0032] Fig.23 yes Fig. 20 A schematic diagram of the three-dimensional structure of the shell shown.
[0033] Fig.24 yes Fig. 20 A schematic diagram of the three-dimensional structure of the locking member is shown.
[0034] Fig.25 yes Fig.19 The locking and holding device shown is a cross-sectional view when a suture is passed through the device and the first position of the self-locking section abuts against the self-locking inclined surface.
[0035] Fig.26 yes Fig.19 The locking protection device shown is a cross-sectional view when a suture is passed through the locking protection device and the second position of the self-locking section abuts against the self-locking inclined surface.
[0036] Figure 27 to Figure 29 1 is a schematic diagram of the use of the locking and retaining device of the second embodiment for locking sutures in transcatheter mitral valve edge-to-edge repair, wherein: Fig.28 yes Fig. 27 An enlarged schematic diagram of portion XXVIII is shown.
[0037] Description of main reference numerals:
[0038] Locking and holding device-1000; suture-2000; conveying device-3000; base-1; main body-11; guide sliding surface-111; protrusion-112; plug-in hole-113; first end plate-12; guide groove-121; guide hole-122; positioning groove-123; support part-13; first through hole-131; extension part-14; second thread hole-141; joint part-15; base-16; base body-161; second end plate-162; third end plate-163; second traction hole-164; third traction hole-165; first positioning structure-166; shell- 17; avoidance groove-171; second positioning structure-172; third through hole-173; locking member-2; self-locking section-21; second through hole-22; first wire hole-23; first traction hole-24; retaining member-3; self-locking inclined surface-31; wedge block-32; guide column-33; elastic member-4; open end-41; bent end-42; insertion hole-421; connecting shaft-5; anchor member-6; plug-in part-63; push rod-3100; release rod-3200; anchor sheath tube-3300; traction rope-3400; delivery sheath tube-3500; first position-A; second position-B.
[0039] The following specific implementation manner will further illustrate the present invention in conjunction with the above-mentioned drawings. DETAILED DESCRIPTION
[0040] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. 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.
[0041] In addition, the following descriptions of the embodiments are made with reference to the attached diagrams to illustrate specific embodiments in which the present invention may be implemented. The directional terms mentioned in the present invention, such as "upper", "lower", "front", "back", "left", "right", "inner", "outer", "side", etc., are only with reference to the directions of the attached diagrams. Therefore, the directional terms used are for better and clearer description and understanding of the present invention, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention.
[0042] It should be noted that, in order to more clearly describe the structure of the locking and retaining device provided by the present invention, the limiting terms "proximal end" and "distal end" described in the specification of the present invention are all conventional terms in the field of interventional medicine. Specifically, "distal end" refers to the end away from the operator during the surgical operation, and "proximal end" refers to the end close to the operator during the surgical operation; the direction of the central axis of rotation of an object such as a cylinder or a tube is defined as the axial direction; the circumferential direction is the direction around the axis of an object such as a cylinder or a tube (perpendicular to the axis and perpendicular to the cross-sectional radius); the radial direction is the direction along the diameter or radius. It is worth noting that the "end" in the terms such as "proximal end", "distal end", "one end", "the other end", "first end", "second end", "initial end", "end", "two ends", "free end", "upper end" and "lower end" is not limited to the end, end point or end face, but also includes a portion extending from the end, end point or end face on the element to which the end, end point or end face belongs for an axial distance and / or radial distance. Unless otherwise defined, all technical and scientific terms used in the present invention have the same meaning as those generally understood by technicians in the technical field of the present invention. The conventional terms used in the specification of the present invention are only for the purpose of describing specific embodiments and are not to be construed as limiting the present invention.
[0043] Please combine Figures 1 to 5 An embodiment of the present invention provides a locking and holding device 1000 with a self-locking function to ensure the long-term stability and effectiveness of the locking and holding device 1000 under continuous heart beating, which helps to maintain the therapeutic effect of the surgery.
[0044] Specifically, Figures 1 to 3As shown, in the embodiment of the present invention, the locking and holding device 1000 comprises a base 1, a locking member 2 rotatably connected to the base 1, a holding member 3 movably arranged on the base 1, and an elastic member 4 located between the holding member 3 and the base 1. Figure 4 and Figure 5 As shown, the locking member 2 has a self-locking section 21 (i.e., the arc-shaped outer surface of the locking member 2 that is rotatably connected to one end of the base 1), and the retaining member 3 has a self-locking inclined surface 31 that cooperates with the self-locking section 21 (i.e., the inclined surface of the retaining member 3 that faces and abuts against the locking member 2). The elastic member 4 is compressed and arranged between the retaining member 3 and the base 1, and is used to provide an elastic thrust to push the retaining member 3, so that the self-locking inclined surface 31 of the retaining member 3 is always in abutment with the self-locking section 21 of the locking member 2, and the self-locking inclined surface 31 abuts against different positions of the self-locking section 21 when the locking member 2 is in different states. Specifically, as Figure 4 As shown, the locking member 2 is in the initial state, and the self-locking inclined surface 31 abuts against the first position A of the self-locking section 21; Figure 5 As shown, the locking member 2 is in a locked state, and the self-locking inclined surface 31 abuts against the second position B of the self-locking section 21 , wherein the curvature radius of the self-locking section 21 at the first position A is greater than the curvature radius at the second position B.
[0045] Please combine again Figure 4 and Figure 5 In the embodiment of the present invention, the locking member 2 can be in the actuator (not limited to Figure 4 The push rod 3100 shown in the figure rotates relative to the base 1, and the locking member 2 in the initial state is actuated to rotate relative to the base 1 in the direction away from the self-locking inclined surface 31, and the first position A of the self-locking section 21 is disengaged from the abutment of the self-locking inclined surface 31. Under the action of the elastic member 4, the retaining member 3 moves on the base 1 until the self-locking inclined surface 31 abuts and is maintained at the second position B of the self-locking section 21. At this time, the locking member 2 is switched from the initial state to the locked state. It is not difficult to understand that the rotation axis of the locking member 2 is fixed relative to the position of the base 1, and the curvature radius of the self-locking section 21 in the first position A is greater than the curvature radius in the second position B. Therefore, after the self-locking inclined surface 31 is separated from the first position A of the self-locking section 21, a gap is formed between the self-locking section 21 and the self-locking inclined surface 31, and the elastic member 4 pushes the retaining member 3 on the base 1 to move toward the locking member 2, thereby causing the self-locking inclined surface 31 to abut against the second position B of the self-locking section 21, which means that when the locking member 2 is in different states, the self-locking inclined surface 31 abuts against different positions of the self-locking section 21, and the self-locking section 21 also abuts against different positions of the self-locking inclined surface 31. In some embodiments, the curvature radius of the self-locking section 21 in the first position A is the distance from the rotation axis of the locking member 2 to the first position A, and the curvature radius of the self-locking section 21 in the second position B is the distance from the rotation axis of the locking member 2 to the second position B.
[0046] like Figure 4 and Figure 5 As shown, when the locking and holding device 1000 provided by the embodiment of the present invention is applied to the locking of the suture 2000, the operator can first pass the suture 2000 between the base 1 and the locking member 2 in the initial state, and then actuate the locking member 2 to rotate to the locked state relative to the base 1. The locking member 2 in the locked state is configured to compress the suture 2000 located between the base 1 and the locking member 2, so as to achieve the locking of the suture 2000; furthermore, the second position B of the self-locking section 21 of the locking member 2 in the locked state abuts against the self-locking inclined surface 31 of the retaining member 3, and the elastic thrust of the elastic member 4 is Under the dual action of the friction force between the retaining member 3 and the base 1, the retaining member 3 can be prevented from moving on the base 1 in the direction away from the locking member 2, thereby ensuring that the self-locking bevel 31 remains in contact with the second position B of the self-locking section 21, and preventing the locking member 2 from rotating in the opposite direction relative to the base 1, such as rotating in the direction close to the self-locking bevel 31, thereby realizing the self-locking function of the locking member 2, so that the locking member 2 in the locked state can always press the suture 2000, thereby resisting long-term heart beating, preventing the suture 2000 from loosening, and helping to maintain the therapeutic effect of the surgery using the suture 2000.
[0047] Preferably, Figure 4 and Figure 5 As shown, in some embodiments of the present invention, the self-locking section 21 of the locking member 2 is an arc-shaped outer surface with a curvature radius gradually decreasing from the first position A to the second position B, and the contour line of the self-locking section 21 can be a section of an Archimedean spiral or a section of an involute. In this way, when the heart beats and drives the suture 2000 to react on the locking piece 2 in the locked state, the locking piece 2 tends to reverse in the direction close to the self-locking bevel 31. However, since the curvature radius of the self-locking segment 21 gradually increases from the second position B to the first position A, the locking piece 2 with a reversal tendency will produce a greater squeezing force on the retaining piece 3. The squeezing force further causes the retaining piece 3 to exert a greater force on the base 1, thereby increasing the friction between the base 1 and the retaining piece 3, and helping to prevent the retaining piece 3 from moving in the opposite direction on the base 1, so as to ensure that the self-locking bevel 31 continues to abut against the second position B of the self-locking segment 21, and prevent the locking piece 2 from rotating relative to the base 1 in the direction close to the self-locking bevel 31, thereby improving the reliability of the self-locking function of the locking piece 2 and preventing the suture 2000 from loosening.
[0048] See also Fig. 6A and Figure 6B , Fig. 6A FIG. 1 shows a schematic diagram of the forces between the locking member 2, the retaining member 3 and the base 1 of the locking and retaining device 1000 when the locking member 2 is in the initial state. Figure 6BFIG. 1 shows a schematic diagram of the forces between the locking member 2, the retaining member 3 and the base 1 of the locking and retaining device 1000 when the locking member 2 is in a locked state. Fig. 6A as well as Figure 6B As shown, the base 1 has a guide sliding surface 111, the retaining member 3 is slidably arranged on the guide sliding surface 111, and the contour line of the self-locking section 21 of the locking member 2 is schematically illustrated by an Archimedean spiral. It should be noted that in the embodiment of the present invention, the friction coefficient of the self-locking inclined surface 31 is defined as μ1, the friction coefficient of the guide sliding surface 111 is defined as μ2, the angle between the self-locking inclined surface 31 and the guide sliding surface 111 is θ, and the gravity of the locking member 2 and the retaining member 3 is ignored.
[0049] like Fig. 6A As shown, when the locking member 2 is in the initial state, the first position A of the self-locking section 21 is maintained at the first position of the self-locking inclined surface 31. At this time, the retaining member 3 is subjected to the elastic force F1 of the elastic member 4 and has a tendency to move horizontally to the left. The retaining member 3 generates an initial pre-tightening force and squeezes the outer contour of the self-locking section 21 of the locking member 2, but cannot move relative to each other under the joint support of the base 1 and the locking member 2. The outer contour of the self-locking section 21 is in line contact with the self-locking inclined surface 31 of the retaining member 3. The locking member 2 is subjected to a static analysis. Due to the action of the elastic member 4, the locking member 2 is subjected to a pressure F provided by the retaining member 3 along the normal direction of the self-locking inclined surface 31. N , F N = F1*sinθ. The direction of the line between the rotation axis of the locking member 2 and the first position A and the pressure F N The angle between the directions is α. In fact, the angle α is small. In this process, it is considered that F N When the operator switches the locking member 2 from the initial state to the locked state, the retaining member 3 generates a force F' that is tangential to the outer contour of the self-locking section 21 of the locking member 2. At this time, a friction force f is generated between the retaining member 3 and the locking member 2 to prevent the locking member 2 from rotating, wherein f = F N *μ1. It is not difficult to understand that when F'<f, the locking member 2 cannot rotate, and when the operator increases the force F' until F'>f, that is, F'>F1*sinθ*μ1, the locking member 2 is subjected to unbalanced force and rotates. During the rotation, because the outer contour of the self-locking section 21 of the locking member 2 is an arc-shaped outer surface with a gradually decreasing curvature, the retaining member 3 will move to the left under the push of the elastic member 4, and the elastic force F1 of the elastic member 4 will gradually decrease. The force F' exerted on the locking member 2 will cause the locking member 2 to rotate to a locked state of squeezing the suture 2000. At this time, the second position B of the self-locking section 21 abuts against the second position of the self-locking inclined surface 31 (see Figure 6B ).
[0050] like Figure 6BAs shown, after the locking member 2 is in the locked state, in order to ensure that the suture 2000 does not loosen, that is, it is necessary to ensure that the locking member 2 does not rotate, and the clockwise rotation direction of the locking member 2 is the thread loosening process, at this time, the retaining member 3 will hinder the clockwise rotation of the locking member 2 to achieve static balance. Because it is necessary to ensure that the locking member 2 does not rotate, that is, equivalent to the retaining member 3 not being displaced in the left and right directions shown in the figure, the retaining member 3 is subjected to a static analysis, and the total forces acting on the retaining member 3 include: the force (i.e. elastic force) F1 of the elastic member 4 on the retaining member 3, the force (i.e. pressure) F2 of the locking member 2 on the retaining member 3, the friction force f1 of the guide sliding surface 111 on the retaining member 3, and the friction force f2 of the locking member 2 on the retaining member 3. Assuming that the direction of the friction force is positive when it is horizontally facing left, when the self-locking inclined surface 31 abuts against the second position B of the self-locking section 21, the angle between the direction of the line between the rotation axis of the locking member 2 and the second position B and the normal direction of the self-locking inclined surface 31 is α, and the retaining member 3 does not move in the left and right directions as shown in the figure, that is, the sum of the component forces in the horizontal direction is zero, that is, the horizontal resultant force to the right is equal to the horizontal resultant force to the left. At this time, the above-mentioned various forces satisfy the following relationship:
[0051] Formula 1: F2*cosα*sinθ+F2*sinα*cosθ-f2*cosθ-f1-F1=0; that is, F2*cosα*sinθ+F2*sinα*cosθ(horizontal resultant force to the right)=f2*cosθ+f1+F1(horizontal resultant force to the left)
[0052] Formula 2: f2=F2*μ1*cosα
[0053] Formula 3: f1=F2*μ2*cosθ*cosα
[0054] According to the above formula, we can obtain: tanθ+tanα=μ1+μ2+F1 / (F2*cosθ*cosα). Therefore, in order to prevent the holding member 3 from moving horizontally, the resultant force to the right must be less than or equal to the resultant force to the left, that is:
[0055] tanθ+tanα≤μ1+μ2+F1 / (F2*cosθ*cosα)
[0056] Under actual conditions, the angle α is very small, that is, tanα≈0, cosα≈1; and the friction coefficients μ1 and μ2 are related to the material and surface conditions. Substituting them into the above inequality, the final inequality is:
[0057] tanθ≤μ1+μ2+F1 / (F2*cosθ)
[0058] In the embodiment of the present invention, it is assumed that the materials used are all ideal rigid bodies, the friction coefficient μ1 of the self-locking inclined surface 31, the friction coefficient μ2 of the guide sliding surface 111, the elastic force F1 of the elastic member 4, the pressure F2 of the locking member 2 on the retaining member 3, and the value of the angle θ satisfy the above-mentioned final inequality, and the locking member 2 forms a self-locking function. In order to make the locking member 2 self-lock after locking the wire, it is more appropriate to have a smaller angle θ according to the above-mentioned final inequality, but considering that the materials used are not ideal rigid bodies, the smaller the angle θ, the easier it is for the retaining member 3 to deform, which is more likely to cause the self-locking failure of the locking member 2. Therefore, preferably, in the embodiment of the present invention, the angle θ between the self-locking inclined surface 31 and the guide sliding surface 111 is less than or equal to 45 degrees, and more preferably 30 degrees.
[0059] It should be noted that, in the embodiment of the present invention, the locking and holding device 1000 also includes other components. For example, in some embodiments, the locking and holding device 1000 also includes a connecting shaft 5 for rotatably connecting the locking member 2 to the base 1, and an anchoring member 6 for engaging the target tissue (not limited to the ventricular tissue), etc. The specific structure of the locking and holding device 1000 provided by the embodiment of the present invention will be described in detail below in conjunction with the accompanying drawings.
[0060] Please combine Figure 1 , Figure 7 and Figure 8 In the first embodiment of the present invention, the base 1 includes a main body 11 of a substantially rectangular parallelepiped structure, a first end plate 12 connected to one end of the main body 11 close to the elastic member 4, and a pair of support portions 13 connected to the outer peripheral wall of the first end plate 12 and extending along the length direction of the main body 11 toward the direction close to the locking member 2. Figure 1 , Figure 7 and Figure 8 As shown, the side of the main body 11 facing the locking member 2 has a guide sliding surface 111 for movably setting the retaining member 3, the first end plate 12 includes a first plate body that is roughly semicircular, and a second plate body that is rectangular and connected to one side of the first plate body, the first plate body covers the end of the main body 11 and the outer peripheral wall exceeds the end of the main body 11, the second plate body is connected to the side of the first plate body adjacent to the guide sliding surface 111, a pair of support portions 13 are connected to the outer peripheral wall of the first plate body and are spaced apart on opposite sides of the width direction of the main body 11, and each support portion 13 exceeds the guide sliding surface 111 of the main body 11. Among them, the main body 11, the first end plate 12 and the pair of support portions 13 jointly define a receiving space located on one side of the guide sliding surface 111, and the locking member 2, the retaining member 3 and the elastic member 4 are all arranged in the receiving space (see Figure 1 ).
[0061] See also Fig. 9In the first embodiment of the present invention, the locking member 2 is roughly in a rectangular block structure, and its two opposite ends in the length direction are respectively a free end and a transfer end, and the transfer end is provided with a self-locking section 21 and is used to be rotatably connected to the base 1. Figure 1 , Figure 3 and Fig. 9 In the first embodiment of the present invention, a first through hole 131 is formed at one end of each support portion 13 away from the first end plate 12 along the width direction of the main body 11, a second through hole 22 is formed at the adapter end of the locking member 2, and the locking and holding device 1000 further includes a connecting shaft 5, which is inserted into the corresponding first through hole 131 and the second through hole 22, so that the locking member 2 is rotatably connected to a pair of support portions 13 of the base 1 around the connecting shaft 5. The connecting shaft 5 can be fixed to the support portion 13 by threaded connection, welding, bonding, etc., and welding is preferred for reliability considerations.
[0062] In other embodiments, the locking member 2 may also be provided with a pair of connecting shafts protruding on opposite sides of the adapter end, and the pair of connecting shafts are correspondingly installed in the pair of first through holes 131 of the pair of supporting parts 13, so that the locking member 2 is rotatably connected to the pair of supporting parts 13 of the base 1 around the pair of connecting shafts, thereby eliminating the connecting shaft 5 of a separate component, and simplifying the structure of the locking and holding device 1000. Of course, in other embodiments, each supporting part 13 may also be provided with a connecting shaft protruding toward the other supporting part 13, and the two connecting shafts of the pair of supporting parts 13 are installed in the second through holes 22 of the locking member 2, and the locking member 2 may also be rotatably connected to the pair of supporting parts 13 of the base 1 around the pair of connecting shafts, thereby eliminating the connecting shaft 5 of a separate component, and simplifying the structure of the locking and holding device 1000.
[0063] Please combine Figure 1 , Figure 3 , Fig.10 and Fig.11 In the first embodiment of the present invention, the retaining member 3 includes a wedge block 32 and a guide post 33 connected to one end of the wedge block 32, the self-locking inclined surface 31 is arranged on the wedge block 32 and faces away from the guide post 33, and the elastic member 4 is sleeved on the guide post 33 and axially compressed between the wedge block 32 and the base 1. Specifically, in the first embodiment of the present invention, the elastic member 4 includes a spring with a U-shaped structure, the spring includes an open end 41 and a bent end 42 connected to the open end 41, the open end 41 abuts against the first end plate 12 of the base 1, the bent end 42 abuts against the wedge block 32, and the bent end 42 is provided with a through hole 421 for the guide post 33 to be inserted. In other embodiments, the elastic member 4 can also be a spring, which is sleeved on the guide post 33 and compressed between the wedge block 32 and the first end plate 12 of the base 1, and can also push the retaining member 3.
[0064] Optional, such as Fig.10As shown, in one embodiment, the wedge block 32 is a block with a generally L-shaped structure, and the self-locking inclined surface 31 extends a certain distance from the side of the wedge block 32 away from the guide column 33 to the side close to the guide column 33, and the end of the wedge block 32 close to the guide column 33 has a rectangular protrusion, such as Figure 4 As shown, the bent end 42 of the elastic member 4 abuts against the rectangular protrusion of the wedge block 32, and the abutment area between the bent end 42 and the wedge block 32 is large, which helps to improve the stability of the elastic push effect of the elastic member 4 on the retaining member 3. Fig.11 As shown, in another embodiment, the wedge block 32 is a block with a roughly triangular prism structure, and the self-locking slope 31 extends from the side of the wedge block 32 away from the guide column 33 to the side close to the guide column 33. The wedge block 32 is small in size, which helps to reduce the overall mass of the locking and retaining device 1000.
[0065] Preferably, Figure 1 , Figure 3 and Figure 8 As shown, in the first embodiment of the present invention, the base 1 is provided with a guide groove 121 extending axially (i.e., in the length direction of the main body 11), and the end of the guide post 33 away from the wedge block 32 is at least partially received in the guide groove 121 and can move axially relative to the guide groove 121. In this embodiment, the guide post 33 is at least partially received in the guide groove 121 and can move axially relative to the guide groove 121, which can limit the elastic member 4 to push the retaining member 3 to move axially along the guide sliding surface 111 of the base 1. Specifically, in Figure 1 , Figure 3 and Figure 8 In the example, the guide groove 121 is provided on the side surface of the second plate body of the first end plate 12 facing the elastic member 4. Preferably, the guide groove 121 penetrates the second plate body, which reduces the difficulty of machining the guide groove 121 on the second plate body. The end of the guide column 33 away from the wedge block 32 is exposed to the first end plate 12 through the guide groove 121. The shape of the axial cross section of the guide column 33, the shape of the through hole 421 and the shape of the guide groove 121 are mutually adapted, and can be, but not limited to, oval, circular, cross-shaped, etc. Figure 3 and Figure 8 In the example, the shape of the axial cross-section of the guide column 33, the shape of the insertion hole 421 and the shape of the guide groove 121 are preferably oval, and the long axis direction of the oval extends along the width direction of the main body 11. In this way, it can be limited that when the retaining member 3 moves on the guide sliding surface 111, it will not move in the radial direction of the base 1 (i.e., the direction perpendicular to the guide sliding surface 111), which helps to improve the movement stability of the retaining member 3.
[0066] Preferably, Figure 1 and Figure 8As shown, in the first embodiment of the present invention, the base 1 is further provided with a positioning groove 123 for accommodating one end of the elastic member 4 that abuts against the base 1. Figure 1 and Figure 8 In the example, a positioning groove 123 is respectively provided at the intersection of the second plate body of the first end plate 12 facing the retaining member 3 and the pair of supporting portions 13, and the open end 41 of the elastic member 4 is correspondingly received in the two positioning grooves 123. In this embodiment, by providing the positioning groove 123 on the base body 1 to receive the open end 41 of the elastic member 4, the elastic member 4 can be positioned, which helps to improve the stability of the elastic member 4 disposed between the base body 1 and the retaining member 3, thereby also improving the stability of the elastic member 4 pushing the retaining member 3.
[0067] Further, please combine Figure 3 , Figure 4 and Figure 8 In the first embodiment of the present invention, the proximal end of the base 1 is further provided with a guide hole 122, the locking member 2 is provided with a driving surface (i.e., the surface of the free end of the locking member 2 close to the self-locking inclined surface 31), an actuator (i.e. Figure 4 The distal end of the push rod 3100 shown in the figure passes through the guide hole 122 and engages with the driving surface of the locking member 2 to actuate the locking member 2, so that the locking member 2 can rotate relative to the base body 1 in a direction away from the self-locking inclined surface 31. Figure 3 , Figure 4 and Figure 8 In the example, the guide hole 122 is formed on the second plate body of the first end plate 12 and is located on the side of the guide groove 121 away from the guide sliding surface 111. The shape of the guide hole 122 may be, but is not limited to, circular or elliptical, preferably circular. It is understood that the push rod 3100 is movably arranged in the circular guide hole 122 and its distal end abuts against the driving surface of the locking member 2. By moving the push rod 3100 axially toward the distal end, the locking member 2 can be pushed to rotate around the connecting shaft 5 in a direction away from the self-locking inclined surface 31.
[0068] Preferably, Figure 4 and Fig. 9 As shown, in the first embodiment of the present invention, the side surface of the locking member 2 close to the self-locking inclined surface 31 is a concave arc surface, which helps to increase the abutment area between the distal end of the push rod 3100 and the driving surface of the locking member 2, thereby ensuring that the push rod 3100 can push the locking member 2 to rotate from the initial state to the locked state.
[0069] Please refer again Figure 4 and Fig. 9In the first embodiment of the present invention, the locking member 2 is provided with a first thread hole 23 for passing the suture 2000. After passing through the first thread hole 23, the suture 2000 is located between the base 1 and the locking member 2, and can move toward the base 1 driven by the locking member 2 until it is pressed against the base 1 by the locking member 2. Specifically, in Figure 4 and Fig. 9 In the example, the first thread hole 23 is provided between the free end and the adapter end of the locking member 2, and the inner diameter of the first thread hole 23 is larger than the diameter of the suture 2000 so as to allow the suture 2000 to move freely. In this embodiment, by providing the first thread hole 23 for passing the suture 2000 on the locking member 2, the movement of the suture 2000 along the radial direction of the substrate 1 can be restricted. When the suture 2000 is pressed between the locking member 2 and the substrate 1, the movement of the suture 2000 along the axial direction of the substrate 1 can be restricted, thereby achieving the locking of the suture 2000.
[0070] Preferably, Figure 4 and Figure 8 As shown, in the first embodiment of the present invention, an extension portion 14 is extended radially (i.e., perpendicular to the guide sliding surface 111) from one end of the base 1 (specifically, the main body 11) away from the elastic member 4, and the extension portion 14 and the locking member 2 are located on the same side of the base 1. The extension portion 14 is provided with a second thread hole 141, and the suture 2000 axially passes through the connected second thread hole 141 and the first thread hole 23 and then passes through the locking and holding device 1000. In this embodiment, by providing the second thread hole 141 connected to the first thread hole 23 on the extension portion 14 of the base 1, the movement of the suture 2000 along the radial direction of the base 1 can be further restricted. At the same time, under the dual restrictions of the second thread hole 141 and the first thread hole 23, it can be ensured that the suture 2000 is partially located between the base 1 and the locking member 2, and it is ensured that the locking member 2 can compress the suture 2000 after rotation. The first thread hole 23 and the second thread hole 141 can be, but not limited to, circular holes or elliptical holes, and this is not limited to this.
[0071] Preferably, Figure 5 and Figure 8 As shown, in the first embodiment of the present invention, the main body 11 of the base 1 may further be provided with a protrusion 112 at one end away from the elastic member 4. When the locking member 2 presses the suture 2000, the protrusion 112 is at least partially received in the first thread hole 23, and the protrusion 112 squeezes the suture 2000 passing through the first thread hole 23. In this embodiment, by providing the protrusion 112 on the main body 11 to squeeze the suture 2000 passing through the first thread hole 23, the squeezing area of the locking and holding device 1000 on the suture 2000 is increased, thereby helping to improve the locking reliability of the suture 2000.
[0072] Please refer again Figure 5 and Figure 8 In the first embodiment of the present invention, the extension portion 14 of the base 1, the protrusion 112 on the main body 11, and the portion of the main body 11 between the extension portion 14 and the protrusion 112 together constitute a bearing structure that is roughly in the shape of a U-shaped groove, and the bearing structure has a first bearing surface located at the bottom of the U-shaped groove, a second bearing surface located at the side of the extension portion 14 facing the protrusion 112, and a third bearing surface located at the side of the protrusion 112 facing the extension portion 14. Among them, the first bearing surface, the second bearing surface, and the third bearing surface extend in three different directions, and the angle between the first bearing surface and the second bearing surface is an acute angle, ranging from 30 degrees to 90 degrees, and preferably 60 degrees in the present invention; the angle between the first bearing surface and the third bearing surface is an obtuse angle, and preferably 120 degrees in the present invention. The end of the locking member 2 and the part away from the first wire-passing hole 23 constitute a roughly U-shaped block-shaped wire pressing structure, which has a first wire pressing surface, a second wire pressing surface and a third wire pressing surface extending in three different directions. When the locking member 2 is in a locked state and the protrusion 112 is at least partially accommodated in the first wire-passing hole 23, the first wire pressing surface, the second wire pressing surface and the third wire pressing surface of the wire pressing structure correspond to the first bearing surface, the second bearing surface and the third bearing surface of the bearing structure respectively. Under the joint action of the wire pressing structure and the bearing structure, the suture 2000 is compressed between the locking member 2 and the substrate 1 in a U shape, and the suture 2000 forms a U-shaped locking wire length, which can provide a larger locking force. Among them, the suture 2000 is compressed and deformed between the aforementioned wire pressing structure and the bearing structure. In order to ensure that the suture 2000 is compressed, preferably, the compression deformation amount L of the suture 2000 satisfies the relationship: 1 / 2*D<L<3 / 4*D, D is the diameter of the suture 2000.
[0073] Please combine Figure 1 and Fig.12 In the first embodiment of the present invention, the proximal end of the base body 1 is provided with a joint portion 15, and the joint portion 15 is used to detachably connect a driver (for example Fig.12 The release lever 3200 shown in the figure is used to drive the locking and holding device 1000 to move. Figure 1 and Fig.12 In the example of , the joint portion 15 is a connection hole opened in the first end plate 12 of the base 1, and the driver is a release rod 3200, and the distal end of the release rod 3200 is engaged in the connection hole, thereby driving the locking and holding device 1000 to move. In other embodiments, the joint portion 15 can also be an internal thread or an external thread extending along the axial direction of the base 1, and the joint portion 15 is threadedly connected to the release rod 3200. Of course, the joint portion 15 can also be detachably connected to the release rod 3200 by other engaging connection methods, which is not limited to this.
[0074] Further, please combine Figure 1 , Figure 2 and Fig.13 In the first embodiment of the present invention, the locking and holding device 1000 further comprises an anchor 6 connected to the distal end of the base 1, and the anchor 6 is used to engage the target tissue (not limited to the ventricular tissue). Figure 1 and Figure 2 As shown, in one embodiment, the anchor 6 may be a spiral anchor; Fig.13 As shown, the anchor 6 can be a barbed spring. The spiral anchor and the barbed spring can be spiral anchors and barbed springs in the prior art, which will not be described in detail. Figure 1 and Figure 2 In the example, the anchor 6 adopts a spiral anchor, and the proximal end of the spiral anchor is provided with a plug-in portion 63, and the distal end of the main body 11 of the substrate 1 is provided with a plug-in hole 113, and the plug-in portion 63 of the spiral anchor is correspondingly plugged into the plug-in hole 113 of the main body 11, thereby fixing the anchor 6 to the distal end of the substrate 1. It is not difficult to understand that by driving the locking and retaining device 1000 to rotate, the spiral anchor (i.e., the anchor 6) can be driven to anchor and engage with the target tissue.
[0075] It should be noted that the materials for the components of the locking and holding device 1000 can be stainless steel, pure titanium, titanium alloy, etc., and 316LVM stainless steel is preferably used for the sake of processing difficulty and biocompatibility. Figures 14 to 17 The delivery device 3000 shown is delivered into the patient's body, and the delivery device 3000 includes the aforementioned push rod 3100, release rod 3200, anchor sheath 3300 and a proximal control handle, wherein the control handle can be used to control the movement and rotation of the push rod 3100, the release rod 3200 and the anchor sheath 3300, and the push rod 3100, the release rod 3200 and the anchor sheath 3300 are all configured to have a bending adjustment function to achieve the delivery of the locking and retaining device 1000 to the target position in the patient's body through the complex human vascular system. Among them, when the locking and holding device 1000 is loaded into the conveying device 3000, the locking and holding device 1000 is in an initial state and is located at the distal end of the inner cavity of the anchor sheath 3300, the push rod 3100 is inserted into the anchor sheath 3300 and the distal end of the push rod 3100 abuts against the driving surface of the locking member 2, and the release rod 3200 is also inserted into the anchor sheath 3300 and the distal end of the release rod 3200 is detachably connected to the joint 15 of the locking and holding device 1000.
[0076] The following will be combined Figure 4 , Figure 5 , Figures 14 to 18 , taking the application of suture 2000 in artificial chord implantation as an example, the use process of the locking and retaining device 1000 provided in the first embodiment of the present invention is explained.
[0077] In the first step, a suturing device (not shown) is delivered through the delivery sheath 3500 to fix the distal end of the inner suture 2000 to the leaflet. After completing the leaflet suturing operation at the leaflet end, the suturing device is withdrawn to leave the suture 2000. At this time, the proximal end of the suture 2000 extends from the leaflet and extends through the delivery sheath 3500 to the outside of the body.
[0078] The second step is, Figure 4 and Fig.16 As shown, the suture 2000 extending outside the body is introduced into the delivery device 3000. Specifically, the proximal end of the suture 2000 is passed from the distal end of the anchor sheath tube 3300 and through the thread holes of the base 1 and the locking member 2 (i.e., the second thread hole 141 and the first thread hole 23), and then further passed out from the proximal end of the anchor sheath tube 3300 and the control handle. At this time, the suture 2000, the push rod 3100 and the release rod 3200 are carried in parallel in the anchor sheath tube 3300. Keep the suture 2000 appropriately tensioned, and according to the following Fig.16 The method shown is to deliver the delivery device 3000 to the vicinity of ventricular tissue such as the papillary muscle through the delivery sheath 3500.
[0079] The third step is Fig.17 As shown, after the locking and holding device 1000 is delivered to the vicinity of the papillary muscle through the anchor sheath 3300, the bending direction of the anchor sheath 3300 is adjusted so that its distal opening points to the desired anchoring position, and the control handle of the conveying device 3000 is rotated, for example, the driving mechanism of the control handle is rotated to spirally advance the release rod 3200 (it can also be manually driven), so that the locking and holding device 1000 is spirally advanced as a whole to the distal end, thereby rotating the anchor 6 to be embedded in the papillary muscle.
[0080] The fourth step is Figure 4 and Figure 5 As shown, after adjusting the tension of the suture 2000 in vitro, the control handle of the delivery device 3000 is pushed, for example, the actuating mechanism of the control handle is pushed to axially drive the push rod 3100 (it can also be manually driven) to actuate the locking member 2 to rotate around the connecting axis 5 to a locked state, thereby compressing the suture 2000 to complete the locking thread, thereby completing the anchoring of the suture 2000 on the papillary muscle.
[0081] Step 5: Fig.18 As shown, after the locking is completed, the push rod 3100 and the release rod 3200 are separated from the locking and holding device 1000 and the delivery device 3000 is withdrawn, and then the cutting device is delivered through the delivery sheath 3500 and enters the body along the path of the suture 2000 to cut the suture 2000 near the locking and holding device 1000. The remaining suture 2000, the cutting device and the delivery sheath 3500 are withdrawn, and the locking and holding device 1000 is retained in the patient's body, thereby completing the anchoring operation to complete the implantation of the artificial tendon cord.
[0082] Please combine Fig.19 and Fig. 20 The locking and retaining device 1000 provided in the second embodiment of the present invention has a structure that is basically the same as the locking and retaining device 1000 in the first embodiment, except that: in the second embodiment of the present invention, the base 1 includes a base 16 and a shell 17 with two ends passing through, the base 16 is fixedly installed in the shell 17, the locking member 2 is rotatably connected to the shell 17, the retaining member 3 is movably arranged on the base 16, and the elastic member 4 is compressed between the retaining member 3 and the base 16.
[0083] For details, please combine Fig.21 and Fig. 22 In the second embodiment of the present invention, the base 16 includes a base body 161 and a second end plate 162 and a third end plate 163 located at opposite ends of the base body 161, wherein the second end plate 162 is a circular end plate and connected to one end of the base body 161 close to the elastic member 4, and the third end plate 163 is a semicircular end plate and connected to one end of the base body 161 away from the elastic member 4. It should be noted that the base body 161 is provided with the guide sliding surface 111 in the first embodiment, and the second end plate 162 is provided with the guide groove 121, the positioning groove 123 and the joint portion 15 in the first embodiment, which will not be described in detail.
[0084] Please combine Fig.19 and Fig.23 In the second embodiment of the present invention, the housing 17 is a cylindrical housing. When the base 16 is fixedly installed in the housing 17, the second end plate 162 covers the opening of the housing 17 at one end close to the elastic member 4, and the third end plate 163 covers the opening of the housing 17 at one end away from the elastic member 4 and leaves an entrance for the suture 2000 to pass through. The second end plate 162 and the third end plate 163 can be fixed to the housing 17 by welding, snap connection, etc., preferably welding.
[0085] Preferably, Fig. 22 and Fig.23 As shown, in the second embodiment of the present invention, the outer peripheral wall of the third end plate 163 is provided with a first positioning structure 166, and the opening edge of the shell 17 is provided with a second positioning structure 172 corresponding to the first positioning structure 166. The first positioning structure 166 cooperates with the second positioning structure 172, which is conducive to quickly sealing the third end plate 163 at the opening of the shell 17 away from the elastic member 4, thereby improving the convenience and stability of the base 16 installed in the shell 17. Among them, the first positioning structure 166 and the second positioning structure 172 can be but not limited to the cooperation of a protrusion and a groove, which is not limited to this.
[0086] like Fig.19 and Fig.23As shown, in the second embodiment of the present invention, the housing 17 is provided with a pair of third through holes 173, and the connecting shaft 5 is inserted into the corresponding communicating third through holes 173 and the second through hole 22, so that the locking member 2 is rotatably connected to the housing 17 around the connecting shaft 5. Fig.19 and Fig.23 As shown, in the second embodiment of the present invention, the housing 17 is provided with an axially extending avoidance groove 171, so that at least a portion (specifically at least a portion of the free end) of the locking member 2 can extend out of or enter the housing 17. The avoidance groove 171 can extend a portion of the distance from the edge of the opening at one end of the housing 17 covered with the third end plate 163 toward the direction of the other end opening, or can extend a portion of the distance from the position adjacent to the edge of the opening at one end of the housing 17 covered with the third end plate 163 toward the direction of the other end opening, preferably extending from the edge of the opening, so as to reduce the difficulty of processing the avoidance groove 171.
[0087] The locking and holding device 1000 provided in the second embodiment of the present invention is different from the locking and holding device 1000 in the first embodiment in that the actuation method of the locking member 2 is different. Fig.21 , Figure 24 to Figure 26 In the second embodiment of the present invention, the locking member 2 is provided with a first traction hole 24, and the first traction hole 24 is arranged on the locking member 2 adjacent to the first wire hole 23 for the actuator ( Fig.25 and Fig.26 The base 1 (specifically, the base body 161) is provided with a radially extending second traction hole 164 at a position adjacent to the locking member 2, and the proximal end of the base 1 (specifically, the second end plate 162) is provided with a third traction hole 165. The distal end of the actuator (i.e., the traction rope 3400) is removably connected to the first traction hole 24, and the proximal end of the actuator passes through the second traction hole 164 and the third traction hole 165 and then passes through the locking and holding device 1000 until it extends outside the body. Fig.25 and Fig.26As shown, in the second embodiment, by pulling the traction rope 3400 toward the proximal end, the traction rope 3400 can drive the locking member 2 to rotate around the connecting shaft 5 in a direction away from the self-locking inclined surface 31, thereby pressing the suture 2000 to achieve thread locking. It can be understood that in order to avoid the risk of entanglement between the suture 2000 and the traction rope 3400 during the process of locking the suture 2000, the first traction hole 24 is arranged on the side of the first wire hole 23 away from the free end of the locking member 2. In this way, the wire pressing structure of the locking member 2 and the first traction hole 24 are located on opposite sides of the first wire hole 23, which can prevent the suture 2000 from being entangled with the traction rope 3400. Furthermore, in order to ensure that the locking member 2 can effectively rotate under the drive of the traction rope 3400, the first traction hole 24 is located between the first wire hole 23 and the second through hole 22 of the locking member 2, and is spaced a certain distance from the second through hole 22. Figure 24 to Figure 26 In the example, the number of the first traction holes 24 is two, and they are arranged side by side along the extension direction parallel to the second through hole 22. The axial center of the first traction hole 24 is parallel to the axial center of the first wire hole 23, and perpendicular to the axial center of the second through hole 22. In this embodiment, the traction rope 3400 can be looped back and passed through the two first traction holes 24 so that its distal end can be detachably connected to the locking piece 2. When the proximal end of the traction rope 3400 is pulled to drive the locking piece 2 to rotate to the locked state and complete the locking line, one of the proximal ends of the traction rope 3400 is pulled to withdraw the traction rope 3400 from the patient's body.
[0088] It is understandable that the locking and holding device 1000 in the first embodiment can also be provided with a corresponding traction hole so as to actuate the locking member 2 to rotate by pulling the traction rope 3400, which is not described in detail. Similarly, each component of the locking and holding device 1000 in the second embodiment can also have the features of the corresponding components in the first embodiment, which is not described in detail.
[0089] Please combine Figure 22 to Figure 26 In the second embodiment of the present invention, one end of the suture 2000 passes through the housing 17 from the entrance formed by the opening of the end of the third end plate 163 covering the housing 17 away from the elastic member 4, and then passes through the first thread hole 23 of the locking member 2 to penetrate the locking and holding device 1000 as a whole, and the suture 2000 is located between the locking member 2 and the base 1. Fig.26As shown, when the proximal end of the traction rope 3400 is pulled to drive the locking member 2 to rotate to the locking state and complete the thread locking, the suture 2000 is compressed between the locking member 2 and the base 16. The side of the base body 161 facing the locking member 2 constitutes a bearing surface, and the free end of the locking member 2 has a thread pressing surface. The suture 2000 is compressed and deformed between the bearing surface and the thread pressing surface. Similarly, in order to ensure that the suture 2000 is compressed, preferably, the compression deformation amount L of the suture 2000 satisfies the relationship: 1 / 2*D<L<3 / 4*D, D is the diameter of the suture 2000.
[0090] It should be noted that the locking and holding device 1000 provided in the second embodiment of the present invention is different from the locking and holding device 1000 in the first embodiment in that no anchoring member 6 is provided at the distal end of the locking and holding device 1000 .
[0091] It should also be noted that the locking and retaining device 1000 provided in the second embodiment of the present invention can also be delivered into the patient's body through the aforementioned delivery device 3000. The locking and retaining device 1000 in the initial state is placed at the distal end of the inner cavity of the anchor sheath 3300, the traction rope 3400 is inserted into the anchor sheath 3300 and the distal end of the traction rope 3400 is detachably connected to the locking member 2, and the release rod 3200 is also inserted into the anchor sheath 3300 and the distal end of the release rod 3200 is detachably connected to the joint 15 of the locking and retaining device 1000.
[0092] The following will be combined Figure 25 to Figure 29 The use of the locking and retaining device 1000 provided in the second embodiment of the present invention is described by taking the application of the suture 2000 in the edge-to-edge repair of the mitral valve as an example.
[0093] The first step, such as Fig. 27 As shown, a suturing device (not shown) is delivered through a delivery sheath 3500 to implant two sets of sutures 2000 in the anterior and posterior leaflets of the mitral valve, respectively. After completing the leaflet suturing operation at the leaflet ends, the suturing device is withdrawn to leave the sutures 2000. At this time, the proximal end of each set of sutures 2000 is extended from the leaflet and extended through the delivery sheath 3500 to the outside of the body.
[0094] The second step is, Fig.25 and Fig.28As shown, the suture 2000 extending outside the body is introduced into the delivery device 3000. Specifically, the proximal end of the suture 2000 is inserted from the distal end of the anchor sheath 3300, and then passes through the entrance formed between the third end plate 163 and the shell 17 and the first thread hole 23 of the locking member 2. The suture 2000 further passes through the proximal end of the anchor sheath 3300 and the control handle. At this time, the suture 2000, the release rod 3200 and the traction rope 3400 are carried in parallel in the anchor sheath 3300, and the traction rope 3400 is engaged with the first traction hole 24 of the locking member 2. The proximal end of the traction rope 3400 passes through the second traction hole 164 and the third traction hole 165 and then passes through the locking and holding device 1000. The distal end of the release rod 3200 is connected to the joint 15 of the base 1. Keep the suture 2000 appropriately tensioned, and according to the following example, Fig.28 In the manner shown, the delivery device 3000 is delivered to the apposition edge of the mitral valve through the delivery sheath 3500 , with its distal opening pointing toward the mitral valve, and the locking and retaining device 1000 is located at the distal end of the inner cavity of the anchor sheath 3300 .
[0095] The third step is Fig.26 As shown, after adjusting the tension of the suture 2000 in vitro, the locking member 2 is actuated by controlling the actuating mechanism of the handle or manually pulling the traction rope 3400 toward the proximal end to rotate around the connecting axis 5 to a locked state, thereby compressing the suture 2000 to complete the thread locking.
[0096] The fourth step is Fig.28 As shown, after the locking is completed, the release rod 3200 and the traction rope 3400 are detached from the locking and holding device 1000 and the delivery device 3000 is withdrawn, and then the cutting device is delivered through the delivery sheath 3500 and enters the body along the path of the suture 2000 to cut the suture 2000 near the locking and holding device 1000, and the remaining cut suture 2000, the cutting device and the delivery sheath 3500 are withdrawn, and the locking and holding device 1000 is retained in the patient's body, thereby completing the edge-to-edge repair of the mitral valve, as shown in FIG. Fig.29 shown.
[0097] It can be understood that, in the embodiment of the present invention, the suture 2000 can be one suture or multiple sutures, and the locking and retaining device 1000 can also be used to lock the suture 2000 in other surgeries, without limitation thereto.
[0098] The above is an implementation method of the embodiment of the present invention. It should be noted that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention. The above is an implementation method of the embodiment of the present invention. It should be noted that, for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principles of the embodiment of the present invention, and these improvements and modifications are also considered to be within the scope of protection of the present invention.
Claims
1. A locking and holding device, characterized in that: include: matrix; A locking member, the locking member is rotatably connected to the base, and the locking member has a self-locking section; A retaining member, the retaining member is movably disposed on the base, and the retaining member has a self-locking inclined surface cooperating with the self-locking section; and an elastic member, wherein the elastic member is located between the retaining member and the base; The locking member is actuated to rotate relative to the base in a direction away from the self-locking inclined surface to a locked state, and the first position of the self-locking section is disengaged from the abutment of the self-locking inclined surface; under the action of the elastic member, the retaining member moves on the base until the self-locking inclined surface abuts and remains in the second position of the self-locking section; wherein the curvature radius of the first position is greater than the curvature radius of the second position.
2. The locking and holding device according to claim 1, characterized in that: The base has a sliding surface, and the retaining member is slidably arranged on the sliding surface, wherein the friction coefficient of the self-locking inclined surface is μ1, the friction coefficient of the sliding surface is μ2, and the angle between the self-locking inclined surface and the sliding surface is θ; when the self-locking inclined surface abuts at the second position, the force exerted by the elastic member on the retaining member is F1, the force exerted by the locking member on the retaining member is F2, and the angle θ satisfies the relationship: tanθ≤μ1+μ2+F1 / (F2*cosθ).
3. The locking and holding device according to claim 2, characterized in that: An included angle θ between the self-locking inclined surface and the guide sliding surface is less than or equal to 45 degrees.
4. The locking and holding device according to claim 1, characterized in that: The locking and holding device further comprises a connecting shaft, and the locking member is rotatably connected to the base body around the connecting shaft.
5. The locking and holding device according to claim 1, characterized in that: The self-locking section is an arc-shaped outer surface with a curvature radius gradually decreasing from the first position to the second position.
6. The locking and holding device according to claim 1, characterized in that: The retaining member includes a wedge block and a guide column connected to one end of the wedge block, the self-locking inclined surface is arranged on the wedge block and faces away from the guide column, and the elastic member is sleeved on the guide column and axially compressed between the wedge block and the base.
7. The locking and holding device according to claim 6, characterized in that: The elastic member includes a spring sheet, which includes an open end and a bent end connected to the open end, the open end abuts against the base, the bent end abuts against the wedge block, and the bent end is provided with a through hole for the guide column to pass through.
8. The locking and holding device according to claim 6, characterized in that: The base is provided with an axially extending guide groove, and one end of the guide post away from the wedge block is at least partially accommodated in the guide groove and can move axially relative to the guide groove.
9. The locking and holding device according to claim 1, characterized in that: A guide hole is opened at the proximal end of the base, and the locking member is provided with a driving surface. After the distal end of an actuator passes through the guide hole, it engages with the driving surface to actuate the locking member.
10. The locking and holding device according to claim 1, characterized in that: The locking member is provided with a first traction hole, the base is provided with a radially extending second traction hole at a position adjacent to the locking member, the proximal end of the base is provided with a third traction hole, the distal end of an actuator is removably engaged with the first traction hole, and the proximal end of the actuator passes through the second traction hole and the third traction hole and then out of the locking and retaining device.
11. The locking and holding device according to claim 1, characterized in that: The locking member is provided with a first thread hole for passing a suture, and the suture moves toward the base body under the drive of the locking member until it is pressed against the base body by the locking member.
12. The locking and holding device according to claim 11, characterized in that: An extension portion radially extends from one end of the base away from the elastic member, and the extension portion and the locking member are located on the same side of the base; the extension portion is provided with a second thread hole, and the suture axially passes through the second thread hole and the first thread hole and then passes through the locking and retaining device.
13. The locking and holding device according to claim 11, characterized in that: The base body is provided with a protrusion at one end away from the elastic member. When the locking member presses the suture, the protrusion is at least partially received in the first thread passing hole, and the protrusion squeezes the suture passing through the first thread passing hole.
14. The locking and holding device according to claim 1, characterized in that: The base comprises a base and a shell with two ends penetrating therethrough, and the base is fixedly installed in the shell; The locking member is rotatably connected to the shell, the retaining member is movably arranged on the base, and the elastic member is compressed between the retaining member and the base; the shell is provided with an axially extending avoidance groove to allow at least part of the locking member to extend out of or enter the shell.
15. The locking and holding device according to claim 1, characterized in that: A coupling portion is disposed at the proximal end of the base body, and the coupling portion is used for detachably connecting a driver, and the driver is used for driving the locking and holding device to move.
16. The locking and holding device according to claim 1, characterized in that: The lock-and-hold device further includes an anchor connected to the distal end of the base, the anchor being adapted to engage a target tissue.
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