Anchoring device implantation apparatus and transcatheter repair system

Abstract

The application provides an anchor implantation device and a transcatheter repair system, the anchor implantation device comprising a delivery sheath, a driving assembly, an anti-disengagement device and an anchor; the anti-disengagement device is movably accommodated in the delivery sheath, the anti-disengagement device has a lumen axially penetrating through a proximal end and a distal end thereof, the anti-disengagement device has elasticity, a distal end of the driving assembly penetrates through the proximal end of the anti-disengagement device and extends into the lumen, and the anchor is detachably connected to the distal end of the driving assembly and located in the lumen; when a distal end of the anti-disengagement device extends out of a distal end of the delivery sheath, the distal end of the anti-disengagement device expands along a radial direction thereof to separate a distal end face of the delivery sheath from target tissue. The anchor implantation device provided by the application separates the distal end face of the delivery sheath from the target tissue through the anti-disengagement device, so as to improve the accuracy and stability of the anchor implantation device in implanting the anchor on a target tissue implantation site.

Description

Technical Field

[0001] This application relates to the field of medical device technology, specifically to an anchor implantation device and a transcatheter repair system. Background Technology

[0002] Mitral regurgitation (MR) is a common valvular heart disease, including primary and secondary mitral regurgitation. Primary mitral regurgitation is caused by abnormalities in the mitral valve leaflets, rupture of the chordae tendineae, or papillary muscle insufficiency, leading to poor anastomosis of the anterior and posterior leaflets of the mitral valve. Secondary mitral regurgitation is caused by annular dilation, left atrial and left ventricular enlargement, resulting in poor anastomosis of the anterior and posterior leaflets of the mitral valve. In recent years, interventional treatment for mitral valve disease has developed rapidly, mainly including valve repair and valve replacement. Among them, mitral annulusop is a common repair procedure. Several spaced-apart anchors are implanted into the valve annulus via catheter. The anchors are connected by a suture, and tightening the suture reduces the size of the valve annulus to alleviate mitral regurgitation.

[0003] In existing technology, the anchor is detachably connected to the distal end of the anchoring device. The anchor is delivered to the valve annulus via a delivery sheath. Once the distal end of the delivery sheath is against the valve annulus, the anchoring device located within the delivery sheath inserts the distal end of the anchor into the valve annulus. However, there is a risk of slippage between the distal end of the delivery sheath and the valve annulus. This not only easily causes the anchor to deviate from the intended implantation site but also affects the stability of the anchor implantation, resulting in unstable anchor implantation and easy dislodgement. Summary of the Invention

[0004] To address the above technical problems, this application provides an anchor implantation device and a transcatheter repair system that improve the accuracy and stability of the anchor implantation site.

[0005] On one hand, this application provides an anchoring implantation device, including a delivery sheath, a drive assembly, an anti-slip element, and an anchoring element. The anti-slip element is movably housed within the delivery sheath, and has an internal cavity axially extending through its proximal and distal ends. The anti-slip element is elastic. The distal end of the drive assembly passes through the proximal end of the anti-slip element and extends into the internal cavity. The anchoring element is detachably connected to the distal end of the drive assembly and is located within the internal cavity. When the distal end of the anti-slip element protrudes from the distal end of the delivery sheath, the distal end of the anti-slip element expands radially to separate the distal end face of the delivery sheath from the target tissue.

[0006] In some embodiments, the anti-slip member includes a main body and an extended portion fixedly connected to the distal end of the main body. When the anti-slip member is integrally housed in the delivery sheath, the extended portion extends axially along the anti-slip member; when the main body is housed in the delivery sheath and the extended portion extends from the distal end of the delivery sheath, the extended portion expands radially along the anti-slip member so that the distal end face of the delivery sheath abuts against the proximal end face of the extended portion.

[0007] In some embodiments, the unfolded portion is annular, the main body portion has the inner cavity, and the unfolded portion is connected to the distal end of the outer peripheral wall of the main body portion.

[0008] In some embodiments, after the unfolding portion is radially unfolded along the anti-slip member, the outer diameter of the unfolding portion is larger than the outer diameter of the delivery sheath.

[0009] In some embodiments, the outer diameter of the unfolded portion is less than twice the outer diameter of the delivery sheath.

[0010] In some embodiments, the anti-slip element has a mesh structure.

[0011] In some embodiments, the distal surface of the unfolded portion is provided with at least one of a protrusion, a ridge, or a groove.

[0012] In some embodiments, the outer peripheral wall of the main body and the proximal end face of the unfolded portion are covered with a protective film.

[0013] In some embodiments, the anchoring element includes an anchor and a first connecting portion fixedly connected to the proximal end of the anchor. The driving assembly includes a driving tube, a connecting rod inserted into the driving tube, and a second connecting portion fixedly connected to the distal end of the driving tube. The first connecting portion and the second connecting portion are detachably connected. The connecting rod is axially inserted into the mating first connecting portion and the second connecting portion to maintain the connection between the driving tube and the anchoring element. The driving tube is used to drive the anchoring element to implant into the target tissue.

[0014] In some embodiments, the proximal end of the anti-slip element is fixedly connected to the outer peripheral wall of the drive tube.

[0015] In some embodiments, the first connecting portion, the second connecting portion, and the anchor are all located within the inner cavity.

[0016] In some embodiments, the anchoring element further includes a support portion and a threading structure, the support portion being connected between the distal end of the first connecting portion and the proximal end of the anchor, and the threading structure being movably connected to the support portion.

[0017] In some embodiments, the threading structure includes a connector and a threading ring, the support portion includes a support column and a limiting block disposed at the distal end of the support column, the connector is movably sleeved on the support column and located between the first connecting portion and the limiting block, and the threading ring is movably connected to the connector.

[0018] In some embodiments, the peripheral wall of the main body is provided with a through hole, which communicates with the inner cavity.

[0019] In some embodiments, the main body includes a proximal portion and a distal portion, the inner diameter of the proximal portion being smaller than the inner diameter of the distal portion, the through hole being provided in the proximal portion, and the thread loop at least partially passing through the through hole and extending out of the main body.

[0020] In some embodiments, the radial dimension of the through hole is greater than the maximum radial dimension of the anchor, and the axial dimension of the through hole is greater than the axial dimension of the anchor.

[0021] In some embodiments, the anchoring device further includes a control element fixedly connected to the proximal end of the anti-slip element, the control element being used to drive the anti-slip element to move.

[0022] On the other hand, this application also provides a transcatheter repair system, the transcatheter repair system including a tightening suture and the anchor implantation device, the anchor implantation device being used to implant a plurality of the anchors in the target tissue, and the tightening suture being used to connect the plurality of the anchors.

[0023] In some embodiments, the transcatheter repair system further includes a delivery line, the distal end of which is connected to the proximal end of the tightening line.

[0024] In the anchor implantation device provided in this application, during the process of driving the anchor to implant into the target tissue, the anti-slip element separates the distal end of the delivery sheath from the target tissue, which can avoid direct contact between the delivery sheath and the target tissue, reducing the possibility of the anchor deviating from the target implantation site due to slippage between the delivery sheath and the target tissue; since the anti-slip element is elastic, axial compression of the anti-slip element can increase the static friction between the anti-slip element and the target tissue, reducing the risk of slippage between the anti-slip element and the target tissue, which is beneficial to improving the accuracy of the anchor implantation site and the stability of the anchor implantation, preventing the anchor from falling off, and reducing surgical risks and difficulties. Attached Figure Description

[0025] To more clearly illustrate the technical solutions of the embodiments of this application, the drawings used in the embodiments will be briefly described below. Obviously, the drawings described below are only some embodiments provided by the embodiments of this application. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0026] Figure 1 This is a schematic diagram of the anchor implantation device provided in one embodiment of this application in its working state;

[0027] Figure 2 This is a schematic diagram of an anchor and tightening thread implanted in a target tissue according to one embodiment of this application;

[0028] Figure 3 yes Figure 2 A schematic diagram showing the tightened tension line;

[0029] Figure 4 This is a schematic diagram of the anchor implantation device provided in one embodiment of this application in the transport state;

[0030] Figure 5 This is an assembly cross-sectional view of the drive assembly, anti-slip component, and anchoring component provided in one embodiment of this application;

[0031] Figure 6 This is a schematic diagram showing the connection between the drive assembly and the anti-slip component according to one embodiment of this application;

[0032] Figure 7 This is a schematic diagram of the anti-slip component provided in one embodiment of this application;

[0033] Figure 8 This is a schematic diagram of the anti-slip component provided in another embodiment of this application;

[0034] Figure 9 This is a schematic diagram of the assembly structure of the drive assembly, anti-slip component and anchoring component provided in another embodiment of this application;

[0035] Figure 10 and Figure 11 This is a structural schematic diagram of an anti-slip component provided in another embodiment of this application;

[0036] Figure 12 This is a schematic diagram of the anchor implantation device provided in another embodiment of this application in the working state;

[0037] Figure 13 This is a schematic diagram of the anti-slip component provided in another embodiment of this application;

[0038] Figure 14This is a structural schematic diagram of the anchoring member provided in one embodiment of this application;

[0039] Figure 15 This is an assembly diagram of the first connecting part, the supporting part, and the threading structure provided in one embodiment of this application;

[0040] Figure 16 This is a schematic diagram of the structure of an anchoring member provided in another embodiment of this application;

[0041] Figure 17 This is a schematic diagram of the structure of the driving component provided in one embodiment of this application;

[0042] Figure 18 This is a schematic diagram of an anchor implantation device provided in one embodiment of this application inserted into a guide sheath;

[0043] Figure 19 This is a schematic diagram of a push rod push interval member provided in one embodiment of this application;

[0044] Figure 20 This is a schematic diagram showing the connection between the adjustment tool and the take-up device provided in one embodiment of this application;

[0045] Figure 21 This is a schematic diagram of the structure of a take-up device provided in one embodiment of this application;

[0046] Figure 22 This is a schematic diagram of the establishment of an intervention channel by a guide sheath provided in one embodiment of this application. Detailed Implementation

[0047] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this application, and not all of them. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0048] In the following description, numerous specific details are set forth for purposes of explanation in order to provide a thorough understanding of this application. However, it will be apparent to those skilled in the art that this application may be practiced without these specific details or with equivalent arrangements.

[0049] The word "and / or" in the text is merely a description of the relationship between related objects, indicating that three relationships can exist. For example, A and / or B can represent: A existing alone, A and B existing simultaneously, or B existing alone. Furthermore, in the description of the embodiments in this application, "multiple" refers to two or more.

[0050] It should be noted that, in the description of this application, in the field of interventional medical devices, "proximal" refers to the end closer to the operator, while "distal" refers to the end farther from the operator; "axial" refers to the direction parallel to the line connecting the center of the distal end and the center of the proximal end of the medical device, and "radial" refers to the direction perpendicular to the axial direction. It is important to note that the term "end" appearing in terms such as "proximal," "distal," "one end," "the other end," "first end," "second end," "initial end," "terminal end," "both ends," "free end," "upper end," and "lower end" is not limited to the tip, end point, or end wall, but also includes a portion extending axially and / or radially from the tip, end point, or end wall on the element to which the tip, end point, or end wall belongs. The above definitions are for convenience only and should not be construed as limiting this application.

[0051] Please see Figures 1-3 This application provides a transcatheter repair system, including an anchor implantation device 100 and a tightening line 200. The anchor implantation device 100 is used to implant multiple anchors 10 into target tissue 2000, and the tightening line 200 is used to connect the multiple anchors 10, that is, the multiple anchors 10 are passed through the tightening line 200 and tightened by the tightening line 200 to tighten or narrow the target tissue 2000 surrounded by the multiple anchors 10. In some embodiments, the target tissue 2000 includes cardiac tissues such as the mitral valve annulus, tricuspid valve annulus, left ventricular wall, and right ventricular wall, and the transcatheter repair system can be applied to annulus repair or ventricular volume reduction surgery. The anchor implantation device 100 implants multiple anchors 10 into the heart tissue. The distal end of a tightening suture 200 is fixedly connected to the first anchor 10 implanted in the heart tissue, while the proximal end of the tightening suture 200 can slide through the other anchors 10 implanted in the heart tissue. By tightening the tightening suture 200, the valve annulus can be directly reduced, or the ventricle can be narrowed to reduce ventricular volume, thereby treating mitral or tricuspid regurgitation. Additionally, reducing left ventricular volume can also treat ischemic heart failure. Of course, the target tissue 2000 can also be other tissues requiring anchor implantation 10 for treatment; in some applications of the anchor implantation device 100, the tightening suture 30 may be unnecessary. The following detailed explanation uses a transcatheter repair system applied to annulus repair surgery, with the valve annulus as the target tissue 2000.

[0052] Please refer to the following: Figure 1 , Figures 4 to 13The anchor implantation device 100 of this application includes a delivery sheath 20, a drive assembly 30, an anti-slip member 40, and an anchor 10. The anti-slip member 40 is movably housed within the delivery sheath 20, and its distal end extends beyond the distal end of the delivery sheath 20. The anti-slip member 40 has an inner cavity axially extending through its proximal and distal ends. The distal end of the drive assembly 30 passes through the proximal end of the anti-slip member 40 and extends into the inner cavity. The anchor 10 is located within the inner cavity of the anti-slip member 40, and its proximal end is detachably connected to the distal end of the drive assembly 30. The anchor 10, drive assembly 30, and anti-slip member 40 are all mounted within the delivery sheath 20. Through delivery via the delivery sheath 20, the anchor 10 can be delivered to the implantation site corresponding to the target tissue 2000. The drive assembly 30 drives the anchor 10 to implant into the target tissue 2000. The anti-slip component 40 is elastic. When the anchor implantation device 100 is in the delivery state, the distal end of the anti-slip component 40 extends along its axial direction, and the entire anti-slip component 40 is housed within the delivery sheath 20. When the anchor implantation device 100 is in the working state, the distal end of the anti-slip component 40 extends out of the distal end of the delivery sheath 20, and the distal end of the anti-slip component 40 expands radially to separate the distal end face of the delivery sheath 20 from the target tissue 2000.

[0053] In the aforementioned anchor implantation device 100, during the process of driving the anchor 10 to implant into the target tissue 200 by the driving component 30, the anti-slip member 40 separates the distal end of the delivery sheath 20 from the target tissue 2000, which can prevent direct contact between the delivery sheath 20 and the target tissue 2000, and reduce the possibility of the anchor 10 deviating from the target implantation site of the target tissue 2000 due to slippage between the delivery sheath 20 and the target tissue 2000. Since the anti-slip member 40 is elastic, the axial compression of the anti-slip member 40 can increase the static friction between the anti-slip member 40 and the target tissue 2000, reduce the risk of slippage between the anti-slip member 40 and the target tissue 2000, and help improve the accuracy of the anchor 10 implantation site and the stability of the anchor 10 implantation, prevent the anchor 10 from falling off, and reduce the surgical risk and difficulty.

[0054] Optionally, the anti-slip component 40 is made of an elastic material, including but not limited to nickel-titanium shape memory alloys, copper-based shape memory alloys, iron-based shape memory alloys, shape memory polymers, and other shape memory materials with superelasticity. This application does not limit this.

[0055] In some embodiments, the anti-slip member 40 includes a main body 41 and an extended portion 42 connected to the distal end of the main body 41. Specifically, the extended portion 42 is annular, the main body 41 has an inner cavity, and the extended portion 42 is connected to the distal end of the outer peripheral wall of the main body 41. It can be understood that the inner cavity of the anti-slip member 40 refers to the inner cavity of the main body 41, and the inner cavity axially extends through the proximal and distal ends of the main body 41, that is, both the proximal and distal ends of the main body 41 have openings. The anchoring member 10 can enter the inner cavity of the main body 41 through the distal opening to be detachably connected to the drive assembly 30, and the anchoring member can also detach from the inner cavity of the main body 41 through the distal opening.

[0056] When the anchor implantation device 100 is in the delivery state, the anti-slip member 40 is entirely housed within the delivery sheath 20, and the unfolding portion 42 extends axially along the anti-slip member 40. When the anchor implantation device 100 is in the working state, the main body 41 is housed within the delivery sheath 20, and the unfolding portion 42 extends from the distal end of the delivery sheath 20, unfolding radially along the anti-slip member 40 so that the distal end face of the delivery sheath 20 abuts against the proximal end face of the unfolding portion 42. Thus, the distal end face of the unfolding portion 42 adheres to the target tissue 2000, thereby separating the distal end face of the delivery sheath 20 from the target tissue 2000. Then, driven by the drive assembly 30, the distal end of the anchor 10 extends from the inner cavity of the main body 41, passing over the unfolding portion 42 to be implanted into the target tissue 2000.

[0057] In some examples, the expanding portion 42 extends from the distal end of the delivery sheath 20 and unfolds into a ring shape. The inner diameter of the expanding portion 42 is smaller than the inner diameter of the delivery sheath 20, and the outer diameter of the expanding portion 42 is larger than the outer diameter of the delivery sheath 20. Preferably, the outer diameter of the expanding portion 42 is larger than the outer diameter of the delivery sheath 20 but less than twice the outer diameter of the delivery sheath 20, to avoid the distal end of the expanding portion 42 being too large and obstructing the valve orifice of the mitral orifice orifice, thus affecting blood flow. In other examples, the expanding portion 42 may unfold into a regular polygonal ring shape, and the diagonal length of its outer polygon (i.e., its outer diameter) should be greater than the outer diameter of the delivery sheath 20, preferably less than twice the outer diameter of the delivery sheath 20. This application does not impose any limitation on this. Of course, the expanding portion 42 may also unfold into an irregular polygonal ring shape or other ring-shaped structures. The expansion section 42 increases the contact area between the anti-slip component 40 and the target tissue 2000, improves the adhesion between the anti-slip component 40 and the target tissue 2000, prevents the distal end of the delivery sheath 20 from slipping between the target tissue 2000 and the target tissue 2000, improves the stability and implantation effect of the anchor 10, and reduces the difficulty of surgical operation.

[0058] Please refer to the following: Figures 14-17In some embodiments, the anchoring member 10 includes an anchor 11 and a first connecting portion 12 fixedly connected to the proximal end of the anchor 11. In the illustrated example, the anchor 11 is a spiral nail with a pointed tip, which is easy to implant into the target tissue 2000, and the spiral nail has good stability when implanted into the target tissue 2000. In other embodiments, the anchor 11 includes, but is not limited to, barbs, hooks, teeth, etc., which have structures that enable the anchor 11 to engage with and be fixed to the target tissue 2000, and this application does not limit this.

[0059] The driving assembly 30 includes a driving tube 31, a connecting rod 32, and a second connecting portion 33. The second connecting portion 33 is located at the distal end of the driving tube 31, and the distal end of the second connecting portion 33 is detachably connected to the proximal end of the first connecting portion 12. The connecting rod 32 is inserted into the driving tube 31 and passes through the mating first connecting portion 12 and the second connecting portion 33, so that the anchor 10 is kept connected to the driving tube 31. The driving tube 31 is used to drive the anchor 10 to implant into the target tissue 2000.

[0060] Specifically, the first connecting part 12 and the second connecting part 33 are connecting seats with S-shaped interlocking surfaces respectively disposed at the proximal end of the anchor 11 and the distal end of the drive tube 31, each connecting seat having an inner cavity. When the first connecting part 12 and the second connecting part 33 are mated, the two connecting seats are correspondingly interlocked, and their inner cavities are connected. The distal end of the connecting rod 32, which is inserted into the drive tube 31, extends from the distal end of the drive tube 31 and inserts into the inner cavities of the two connecting seats, thereby restricting the separation of the first connecting part 12 and the second connecting part 33, so that the anchor 10 remains connected to the drive tube 31. In this way, by rotating the drive tube 31, the anchor 10 can be driven to rotate, thereby implanting the anchor 11 into the target tissue 2000. It can be understood that when the distal end of the connecting rod 32 is withdrawn from the mating and interlocking point of the first connecting part 12 and the second connecting part 33, the first connecting part 12 and the second connecting part 33 can be separated, thereby realizing the separation of the anchor 10 from the drive tube 31. The drive component 30 can be made of metal or polymer materials, preferably metal materials with high hardness such as stainless steel.

[0061] In other embodiments, the first connecting portion 12 and the second connecting portion 33 can be a locking block and a locking slot mating structure. The driving assembly 30 may also include a driving tube 31 and a connecting tube sleeved on the outside of the driving tube 31, with the distal end of the connecting tube sleeved on the outside of the mating first connecting portion 12 and the second connecting portion 33, which can also serve to restrict the separation of the first connecting portion 12 and the second connecting portion 33.

[0062] Please see Figure 6 and Figure 9In some embodiments, the proximal end of the anti-slip member 40 (i.e., the proximal end of the main body 41) is fixedly connected to the outer peripheral wall of the drive tube 31. Specifically, the proximal end of the main body 41 can be fixed to the outer peripheral wall of the drive tube 31 by welding or bonding, so that the anti-slip member 40 moves or rotates with the drive tube 31. In some examples, the main body 41 is cylindrical, which helps to reduce the friction of the anti-slip member 40 when moving in the delivery sheath 20, and makes the main body 41 move smoothly in the delivery sheath 20. The outer diameter of the main body 41 is smaller than the inner diameter of the delivery sheath 20, and the inner diameter of the main body 41 is larger than the maximum outer diameter of the anchor 10, so that the main body 41 can be installed as a whole in the delivery sheath 20, and the main body 41 will not interfere with the anchor 10 implantation into the target tissue 2000. The connection between the main body 41 and the drive tube 31 is located near the proximal end of the second connecting part 33. The anchor 10 can enter the inner cavity of the main body 41 through the distal opening of the main body 41, so that the first connecting part 12 and the second connecting part 33 can be connected. That is to say, the first connecting part 12, the second connecting part 33, and the anchor 11 are all located in the inner cavity of the main body 41. The anchor 10 is entirely located in the inner cavity of the main body 41, so that the anchor 10 contacts the target tissue 2000 before the unfolded part 42 of the anti-slip member 40.

[0063] During the implantation of the anchor 10, firstly, the moving drive tube 31 causes the unfolding portion 42 to extend and unfold from the distal end of the delivery sheath 20. The distal surface of the unfolding portion 42 attaches to the target tissue 2000 to support the delivery sheath 20. Then, the drive tube 31 is rotated so that it drives the anchor 11 to extend from the inner cavity of the main body 41 past the unfolding portion 42 to be implanted into the target tissue 2000. As the anchor 11 is implanted into the target tissue 2000, the main body 41 is continuously compressed axially. The elastic force generated by the main body 41 acts on the unfolding portion 42, increasing the friction between the unfolding portion 42 and the target tissue 2000, making it less prone to slippage. At the same time, because the main body 41 can be compressed axially, it avoids affecting the implantation depth and implantation stability of the anchor 11.

[0064] Please see Figures 14-16 In some embodiments, the anchoring member 10 further includes a support portion 13 connected between the proximal end of the anchor 11 and the distal end of the first connecting portion 12, and a threading structure 14 movably connected to the support portion 13. The threading structure 14 is used to connect the tightening line 200; that is, the tightening line 200 is connected to the anchoring member 10 through the threading structure 14.

[0065] Specifically, the support portion 13 includes a support column 131 and a limiting block 132 located at the distal end of the support column 131. The proximal end of the support column 131 is connected to the distal end of the first connecting portion 12, and the distal end of the first connecting portion 12 acts as another limiting block. The outer diameters of the two limiting blocks are equal and larger than the outer diameter of the support column 131. The support column 131 and the limiting blocks at both ends are roughly in the shape of an "I", forming a connecting groove 133 surrounding the support column 131. The threading structure 14 includes a connector 141 and a threading ring 142 movably connected to the connector 141. The connector 141 is movably sleeved on the support column 131 and located between the first connecting portion 12 and the limiting block 132. The connector 141 is partially received in the connecting groove 133. The connector 141 can rotate 360 ​​degrees around the central axis of the anchor 10. The threading ring 142 is used to connect the tightening line 200.

[0066] exist Figure 14 In the example, connector 141 can be a connecting ring, and threading ring 142 is directly fastened to the connecting ring. Figure 16 In the example, connector 141 has an assembly hole 1411 and a connection hole 1412, support post 131 is inserted into assembly hole 1411, and threading ring 142 is movably connected to connection hole 1412. In other embodiments, threading structure 14 can also be a threading ring 142 sleeved on support post 131. Of course, threading structure 14 can also be located near the end of anchor 11. Threading structure 14 can also be a threading hole on anchor 10, for example, on first connecting portion 12; this application does not limit this.

[0067] Please see Figures 5-11 In some embodiments, a through hole 43 is formed on the periphery of the main body 41, communicating with the inner cavity of the main body 41. The tightening line 200 can be connected to the threading structure 14 of the anchor 10 through the through hole 43. In this way, the anti-slip member 40 separates the tightening line 200 from the anchor 11, preventing the tightening line 200 from getting tangled in the anchor 11 and affecting the implantation of the anchor 11.

[0068] When the threading structure 14 includes a threading loop 142, the main body 41 may include a proximal portion and a distal portion. The inner diameter of the proximal portion is smaller than that of the distal portion. A through hole 43 is formed in the proximal portion. The threading loop 142 passes at least partially through the through hole 43 and extends out of the main body 41, facilitating the tightening wire 200 to pass through the threading loop 142 and connect with the anchor 10. Thus, during the implantation of the anchor 10, as the anchor 11 is embedded in the target tissue 2000, the threading loop 142 moves along the through hole 43 toward the distal portion of the main body 41. Since the inner diameter of the distal portion of the main body 41 is larger than that of the proximal portion, the movement of the threading loop 142 is not restricted and does not affect the anchor 10 from detaching from the inner cavity of the main body 41. Of course, the threading ring 142 can also be located in the inner cavity of the main body 41. The tightening wire 200 passes through the through hole 43 and is connected to the threading ring 142. The connection between the tightening wire 200 and the threading ring 142 is located in the inner cavity of the main body 41, while the other parts are located on the outside of the main body 41.

[0069] Preferably, the radial dimension of the through hole 43 is greater than the maximum radial dimension of the anchor 10, and the axial dimension of the through hole 43 is greater than the axial dimension of the anchor 10, so that the anchor 10 can enter the inner cavity of the main body 41 through the through hole 43, facilitating the assembly of the anchor 10 into the inner cavity of the anti-slip member 40. Optionally, the projection of the through hole 43 on the axial plane can be rectangular.

[0070] Please see Figures 9-11 In some embodiments, the anchoring device 100 further includes a steel pipe 50, and the proximal end of the main body 41 and the drive tube 31 can also be fixedly connected by crimping the steel pipe 50. The inner diameter of the steel pipe 50 is larger than the outer diameter of the drive tube 31, and its length can range from 3mm to 6mm. The proximal end of the main body 41 is provided with a connecting section 411, which is housed in the space between the steel pipe 50 and the drive tube 31. After the steel pipe 50 is crimped, the proximal end of the main body 41 can be fixed to the drive tube 31.

[0071] Please see Figure 7 and Figure 10 In some embodiments, the anti-slip element 40 may have a mesh structure. It is understood that the mesh-like anti-slip element 40 has excellent elastic properties and can increase the roughness of the distal surface of the unfolded portion 42, further increasing the friction between the distal surface of the unfolded portion 42 and the target tissue 2000. The anti-slip element 40 may be woven from shape-memory metal wires such as nickel-titanium wire. Please refer to... Figure 8 In other embodiments, the anti-slip component 40 may be a non-mesh structure, and the distal end face of its extended portion 42 may be provided with at least one of protrusions, ridges or grooves, which can also achieve the purpose of increasing roughness and increasing friction. This application does not limit this.

[0072] In some embodiments, the outer peripheral wall of the main body 41 and the proximal end face of the unfolding portion 42 are covered with a protective film to reduce friction between the anti-slip member 40 and the inner wall of the delivery sheath 20, prevent the anti-slip member 40 from damaging the target tissue 2000, and also avoid the risk of entanglement between the anti-slip member 40 and the anchoring member 10. The protective film can be made of a biocompatible polyester material, such as polyethylene terephthalate (PET) or polytetrafluoroethylene (PTFE). The distal end face of the unfolding portion 42 (the end face in contact with the target tissue 2000) is not covered with a protective film to ensure sufficient friction when the distal end face of the unfolding portion 42 contacts the target tissue 2000.

[0073] Please see Figure 12 and Figure 13 In some embodiments, the anchoring device 100 further includes a control element 60, which is fixedly connected to the proximal end of the anti-slip element 40. Specifically, the control element 60 is fixed to the proximal end of the main body 41 by welding, bonding, or other methods. The control element 60 is used to drive the anti-slip element 40 to move. It is understood that the anti-slip element 40 and the drive tube 31 can move relative to each other. The control element 60 can be a control wire, and one or more control wires can be used to control the movement of the anti-slip element 40. The control wire can be made of stainless steel wire, nickel-titanium wire, or multi-strand stainless steel wire; this application does not limit this.

[0074] Furthermore, a channel pipe can be embedded axially in the wall of the delivery sheath 20. This channel pipe serves as a moving channel for the control component 60, ensuring that the moving distance of the proximal end of the control component 60 is basically consistent with the moving distance of the distal end. To prevent the anti-slip component 40 from detaching from the delivery sheath 20, a travel limit mechanism can also be provided to restrict the moving distance of the control component 60.

[0075] Please refer to the following: Figure 18 The transcatheter repair system also includes a guide sheath 300 for establishing an interventional pathway from outside the patient to the patient's target tissue 2000. An anchor implantation device 100 can be inserted into the guide sheath 300 to allow the guide sheath 300 to move so that its distal end extends from the distal end of the guide sheath 300 and abuts against the patient's target tissue 2000, thereby implanting the anchor 10 into the patient's target tissue 2000. It is understood that the number of guide sheaths 300 includes, but is not limited to, one or more, and this application does not limit this.

[0076] Preferably, the guide sheath 300 is an adjustable bending sheath. During the process of establishing an interventional channel from outside the patient to the target tissue 2000, the bending angle of the distal end of the guide sheath 300 can be easily adjusted, facilitating the distal end of the guide sheath 300's approach to the target tissue 2000. Simultaneously, both the delivery sheath 20 and the drive assembly 30 have at least a flexible distal portion to adapt to the degree of curvature of the interventional channel established by the guide sheath 300. The anchor implantation device 100 (i.e., the delivery sheath 20 and drive assembly 30) is inserted into the guide sheath 300. By adjusting the bending angle of the distal end of the guide sheath 300, the distal end of the anchor implantation device 100 can be bent, causing the distal end of the anchor implantation device to abut against the target tissue.

[0077] Please refer to the following: Figure 19 The transcatheter repair system also includes a spacer 400 and a pusher 500. The spacer 400 is threaded onto the tightening line 200 and can be located between two adjacent anchors 10. Understandably, the spacer 400 is used to prevent the tightening line 200 from becoming too tight, causing the distance between two adjacent anchors 10 to be too short and damaging the target tissue 2000. Furthermore, the spacer 400 also has a buffering effect; when the tightening line 200 tightens, the spacer 400 can disperse the tightening force on the anchor 10 (the tightening force being the force exerted on the anchor 10 during the tightening process of the tightening line 200), preventing the anchor 10 from detaching from the target tissue 2000 due to excessive tightening force, thereby ensuring the stability of the anchor 10 implantation.

[0078] The spacer 400 is cylindrical. Preferably, the spacer 400 is made of a biocompatible material. A membrane may be wrapped around the spacer 400 to reduce the risk of damage to the target tissue 2000. Optionally, a spacer 400 may be provided between any two adjacent anchors 10, or a spacer 400 may be provided every two or more anchors 10; there is no limitation on this.

[0079] The distal end of the push rod 500 has a guide hole 501 for the proximal end of the tension line 200 to pass through. After the spacer 400 is inserted into the tension line 200, the tension line 200 passes through the guide hole 501 of the push rod 500, and the push rod 500 pushes the spacer 400 into the guide sheath 300 along the tension line 200. The delivery sheath 20 is inserted into the guide sheath 300 to push the spacer 400 in the guide sheath 300.

[0080] Understandably, after the first anchor 10 is implanted into the target tissue 2000, the anchor implantation device 100 is withdrawn, a spacer 400 is inserted through the proximal end of the tightening line 200, and the tightening line 200 is passed through the guide hole 501 of the push rod 500 in direction a (threading direction). The push rod 500 then pushes the spacer 400 into the guide sheath 300 along the tightening line 200 in direction b (pushing direction). Then, the push rod 500 is withdrawn, the second anchor 10 is assembled onto the drive assembly 30, the tightening line 200 passes through the second anchor 10, and the entire anchor implantation device 100 is inserted into the guide sheath 300, with the spacer 400 located on the distal side of the anchor implantation device 100. Thus, the anchor implantation device 100 moves axially within the guide sheath 300 to the distal end of the guide sheath 300, thereby pushing the spacer 400 to the target tissue 2000. Then, the anchor implantation device 100 implants a second anchor 10 into the target tissue 2000, positioning the spacer 400 between the two anchors 10. The same steps are repeated to implant multiple anchors 10 into the target tissue 2000 sequentially, with the spacer 400 interlaced between every two or more anchors 10. The distance between two adjacent anchors 10 must be greater than the axial length of the spacer 400.

[0081] Please see Figure 18 and Figure 19 The transcatheter repair system also includes a delivery line 600. The distal end of the tightening line 200 is fixedly connected to the first anchor 10 of the implanted target tissue 2000. The distal end of the delivery line 600 is connected to the proximal end of the tightening line 200, and the proximal end of the delivery line 600 extends outside the patient's body. Before the anchor 10 is implanted into the target tissue 2000, the anchor 10 is threaded onto the tightening line 200 via the delivery line 600. In this way, the anchor 10, spacer 400, etc., can be threaded onto the tightening line 200 via the delivery line 600, allowing the tightening line 200 to be implanted at an appropriate length. This eliminates the need for in-vivo trimming of the tightening line 200, avoids the shedding of filaments from the suture, and makes the circumduction procedure safer.

[0082] It should be noted that the distal end of the tightening line 200 is fixedly connected to the first anchor 10 for implanting the target tissue 2000. Other anchors 10 for implanting the target tissue 2000 are conveyed along the conveying line 600 and threaded onto the tightening line 200. Similarly, the spacer 400 is also conveyed along the conveying line 600 and threaded onto the tightening line 200. The tightening line 200 has a certain axial length and is flexible. The radial cross-sectional shape of the tightening line 200 can be circular, oval, rectangular, square, or other shapes. Similarly, the conveying line 600 also has a certain axial length and is flexible. The radial cross-sectional shape of the conveying line 600 can also be circular, oval, rectangular, square, or other shapes. This application does not specifically limit the radial cross-sectional shape of the tightening line 200 and the conveying line 600.

[0083] In some embodiments, the proximal end of the tightening line 200 is folded into a U-shape, and the conveyor line 600 passes through the fold of the tightening line 200, thereby achieving a detachable connection between the conveyor line 600 and the tightening line 200. In other embodiments, the conveyor line 600 can also be detachably connected to the tightening line 200 by means of threaded connection, snap-fit ​​connection, etc., which will not be described in detail.

[0084] Please refer to the following: Figure 20 and Figure 21 The conduit repair system also includes a take-up coil 700 and an adjustment tool 800 for conveying and controlling the take-up coil 700. It is understood that the conveyor line 600 is connected to the tensioning line 200, and the take-up coil 700 is conveyed along the conveyor line 600 onto the tensioning line 200. The take-up coil 700 is used to wind the tensioning line 200 to adjust the spacing between the plurality of anchors 10, and to lock the tensioning line 200 after the spacing between the plurality of anchors 10 has been adjusted.

[0085] It should be noted that the distal end of the delivery line 600 is connected to the proximal end of the tightening line 200, with the proximal end of the delivery line 600 extending outside the patient's body. The anchor 10, spacer 400, and retractor 700 can be delivered via the externally extending delivery line 600 and threaded onto the tightening line 200. After multiple anchors 10 and spacers 400 are implanted into the target tissue 2000, the retractor 700 is threaded onto the tightening line 200 along the delivery line 600. Then, the retractor 700 is used to wind the tightening line 200 to reduce the spacing between the multiple anchors 10 and lock the tightening line 200. The delivery line 600 can then be withdrawn and the tightening line 200 released, thereby narrowing the valve annulus and reducing the patient's blood reflux.

[0086] In other embodiments, the transcatheter repair system may omit the delivery line 600. The tightening line 200 is long enough to extend outside the patient's body. After implanting multiple anchors 10, the tightening line 200 is tightened to reduce the distance between the multiple anchors 10, thereby reducing the valve annulus and alleviating blood reflux. The tightening line 200 can then be locked using a conventional locking device, such as a knot lock or a pin lock, to keep the tightening line 200 in its tightened state. Excess portions of the tightening line 200 can be cut off. This application does not impose any limitations on this.

[0087] Please refer to the following: Figures 1-3 , Figure 18 and Figure 22 The following describes the usage process and principle of the transcatheter repair system according to the embodiments of this application, taking the application of the transcatheter repair system in mitral valve annulus repair as an example. The surgical path for mitral valve annulus repair is as follows: via femoral vein - inferior vena cava - right atrium (RA) - interatrial septum (AS) - left atrium (LA) - mitral valve (MV) annulus.

[0088] The first step involves puncturing the femoral vein and establishing a path from the femoral vein to the inferior vena cava, right atrium, interatrial septum, left atrium, and mitral valve annulus using a guidewire and a transatrial septal puncture device (the guidewire and transatrial septal puncture device are not shown in the figure).

[0089] The second step is to insert the guide sheath 300 along the guidewire until the distal end of the guide sheath 300 passes through the foramen ovale of the heart, reaches the left atrium, and is advanced to the vicinity of the valve annulus. At this point, the guidewire is withdrawn.

[0090] The third step involves first assembling the first anchor 10 (the thread loop 142 of the first anchor 10 is fixedly connected to the distal end of the tightening line 200, and the proximal end of the tightening line 200 is detachably connected to the distal end of the delivery line 600) with the drive assembly 30, and then threading it together with the tightening line 200 and the delivery line 600 into the delivery sheath 20. The delivery sheath 20 moves axially towards the distal end in the guide sheath 300 to the vicinity of its annulus. The drive assembly 30 is moved so that the unfolded portion 42 of the anti-slip member 40 extends from the distal end of the delivery sheath 20 and abuts against the annulus. Then, the first anchor 10 is implanted into the annulus of the mitral valve using the drive assembly 30.

[0091] In the fourth step, after implanting the first anchor 10, the drive assembly 30 and delivery sheath 20 are withdrawn. The spacer 400 is then introduced into the guide sheath 300 via the delivery line 600 and pusher 500. The proximal end of the delivery line 600 is then passed through the suture loop 142 of the second anchor 10 (the second anchor 10 is already assembled with the drive assembly 30 and inserted into the delivery sheath 20), and the delivery sheath 20 is pushed through the guide sheath 300. The forward pushing of the delivery sheath 20 transports the first spacer 400 and the second anchor 10 along the delivery line 600 to be inserted onto the tightening line 200 and delivered to the vicinity of the valve annulus. The spacer 400 is positioned between the first and second anchors 10. Under ultrasound and digital subtraction angiography (DSA) imaging, the position of the second anchor 10 is adjusted according to the size of the diseased valve annulus, and the guide sheath 300 and delivery sheath 20 are used for implantation. The distance between the second anchor 10 and the first anchor 10 needs to be greater than the axial length of the spacer 400.

[0092] Fifth, repeat step four, sequentially implanting multiple anchors 10 and spacers 400 from the anterior triangle of the mitral valve along the posterior valve annulus to the posterior triangle or in the opposite direction, so that the multiple anchors 10 and spacers 400 are evenly distributed on the valve annulus. After implanting a sufficient number of anchors 10, remove the drive assembly 30 and the delivery sheath 20.

[0093] Step 6: First, connect the take-up device 700 to the distal end of the adjustment tool 800. Then, pass the proximal end of the delivery line 600 through the take-up device 700 and deliver the take-up device 700 to the mitral valve annulus via the adjustment tool 800 and the guide sheath 300. Next, operate the adjustment tool 800 to wind the take-up device 700 around the tightening line 200 to shorten the length of the tightening line 200, thereby reducing the spacing between the multiple anchors 10 and achieving annulus reduction. After achieving a good annulus reduction effect, lock the tightening line 200. Then, control the adjustment tool 800 to disengage from the take-up device 700 to facilitate the removal of the adjustment tool 800. The tightening line 200, anchors 10, spacers 400, and take-up device 700 remain on the annulus, completing the annulus reduction surgery.

[0094] It should be noted that during the implantation of the anchor 10, there is a low probability of suture compression. In this case, digital subtraction angiography and ultrasound imaging can be used to reverse the rotation of the drive tube 31 of the drive assembly 30, loosen the anchor 10, and allow the tightening suture 200 to come out. Then, the anchor 10 can be tightened again before implantation.

[0095] It is understood that, in other embodiments, the transcatheter repair system provided in this application can also be applied to tricuspid valve annulus repair, and can also be applied to implanting multiple anchors 10 connected in series by tightening wires 200 in the left or right ventricular wall, thereby achieving ventricular volume reduction by tightening the tightening wires 200.

[0096] The above-disclosed embodiments are merely preferred embodiments of this application and should not be construed as limiting the scope of this application. Therefore, any equivalent variations made in accordance with the claims of this application are still within the scope of this application, and the specific solutions in the above embodiments can be applied to each other.

Claims

1. An anchoring component implantation device, characterized in that, Includes delivery sheath, drive assembly, anti-slip components, and anchoring components; The anti-slip element is movably housed in the delivery sheath. The anti-slip element has an inner cavity axially extending through its proximal and distal ends. The anti-slip element is elastic. The distal end of the drive assembly passes through the proximal end of the anti-slip element and extends into the inner cavity. The anchoring element is detachably connected to the distal end of the drive assembly and is located in the inner cavity. When the distal end of the anti-slip member extends beyond the distal end of the delivery sheath, the distal end of the anti-slip member expands radially to separate the distal end face of the delivery sheath from the target tissue.

2. The anchoring component implantation device as described in claim 1, characterized in that, The anti-slip component includes a main body and an unfolded part fixedly connected to the distal end of the main body; When the anti-slip component is entirely housed in the delivery sheath, the unfolded portion extends along the axial direction of the anti-slip component; When the main body is housed in the delivery sheath and the unfolded portion extends from the distal end of the delivery sheath, the unfolded portion unfolds radially along the anti-slip member so that the distal end face of the delivery sheath abuts against the proximal end face of the unfolded portion.

3. The anchoring component implantation device as described in claim 2, characterized in that, The unfolded portion is annular, the main body has the inner cavity, and the unfolded portion is connected to the distal end of the outer peripheral wall of the main body.

4. The anchoring component implantation device as described in claim 3, characterized in that, After the unfolding part is unfolded radially along the anti-slip member, the outer diameter of the unfolding part is larger than the outer diameter of the delivery sheath.

5. The anchoring component implantation device as described in claim 4, characterized in that, The outer diameter of the unfolded section is less than twice the outer diameter of the delivery sheath.

6. The anchoring device as described in any one of claims 1 to 5, characterized in that, The anti-slip component has a mesh structure.

7. The anchoring device as described in any one of claims 2 to 5, characterized in that, The distal surface of the unfolded portion is provided with at least one of a protrusion, a ridge, or a groove.

8. The anchoring component implantation device as described in any one of claims 2 to 5, characterized in that, The outer peripheral wall of the main body and the proximal end face of the unfolded part are covered with a protective film.

9. The anchoring component implantation device as described in claim 3, characterized in that, The anchoring element includes an anchor and a first connecting portion that is fixedly connected to the proximal end of the anchor. The driving assembly includes a driving tube, a connecting rod inserted into the driving tube, and a second connecting portion that is fixedly connected to the distal end of the driving tube. The first connecting portion and the second connecting portion are detachably connected. The connecting rod is axially inserted into the mating first connecting portion and the second connecting portion to maintain the connection between the driving tube and the anchoring element. The driving tube is used to drive the anchoring element to be implanted into the target tissue.

10. The anchoring component implantation device as described in claim 9, characterized in that, The proximal end of the anti-slip component is fixedly connected to the outer peripheral wall of the drive tube.

11. The anchoring component implantation device as claimed in claim 10, characterized in that, The first connecting part, the second connecting part, and the anchor are all located in the inner cavity.

12. The anchoring device as described in claim 9, characterized in that, The anchoring element further includes a support portion and a threading structure. The support portion is connected between the distal end of the first connecting portion and the proximal end of the anchor, and the threading structure is movably connected to the support portion.

13. The anchoring device as described in claim 12, characterized in that, The threading structure includes a connector and a threading ring. The support part includes a support column and a limiting block located at the far end of the support column. The connector is movably sleeved on the support column and located between the first connecting part and the limiting block. The threading ring is movably connected to the connector.

14. The anchoring component implantation device as described in claim 13, characterized in that, The peripheral wall of the main body is provided with a through hole, which communicates with the inner cavity.

15. The anchoring device as described in claim 14, characterized in that, The main body includes a proximal portion and a distal portion, the inner diameter of the proximal portion is smaller than the inner diameter of the distal portion, the through hole is provided in the proximal portion, and the thread loop at least partially passes through the through hole and extends out of the main body.

16. The anchoring device as described in claim 14 or 15, characterized in that, The radial dimension of the through hole is greater than the maximum radial dimension of the anchor, and the axial dimension of the through hole is greater than the axial dimension of the anchor.

17. The anchoring device as claimed in claim 1, characterized in that, The anchoring device further includes a control component, which is fixedly connected to the proximal end of the anti-slip component and is used to drive the anti-slip component to move.

18. A transcatheter repair system, characterized in that, The transcatheter repair system includes a tightening suture and an anchor implantation device as described in any one of claims 1 to 17, the anchor implantation device being used to implant a plurality of the anchors in the target tissue, and the tightening suture being used to connect the plurality of the anchors.

19. The transcatheter repair system as described in claim 18, characterized in that, The transcatheter repair system also includes a delivery line, the distal end of which is connected to the proximal end of the tightening line.

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