Transcatheter repair system

Abstract

The application provides a transcatheter repair system. A transcatheter repair system includes a sheath and an implant. The implant includes a flexible elongate member. The sheath includes a proximal portion and a distal portion. And the flexible slender piece is movably arranged in the sheath tube in a penetrating manner. At least the distal portion of the sheath tube has a developing strength that is less than a developing strength of the flexible elongate member. The optical density of the developed image of the distal portion of the sheath tube is configured to be 0.5-1.2. An optical density of a developed image of the flexible elongate member is configured to 1.5-2.5. By simultaneously adjusting the optical densities of the developed images of the sheath tube and the flexible elongated member, it is ensured that the flexible elongated member has a desired developing effect throughout the system.

Description

Technical Field

[0001] The present application belongs to the field of medical devices, and relates to cardiac interventional treatment devices, and in particular to a transcatheter repair system. Background Art

[0002] Mitral regurgitation (abbreviated as: MR) is a common heart valve disease, including primary mitral regurgitation and secondary mitral regurgitation. Among them, primary mitral regurgitation is due to abnormal mitral valve leaflets, rupture of chordae tendineae or papillary muscle insufficiency, resulting in poor anastomosis of the anterior and posterior leaflets of the mitral valve. Secondary mitral regurgitation is due to the dilation of the valve ring, enlargement of the left atrium and left ventricle, resulting in poor anastomosis of the anterior and posterior leaflets of the mitral valve.

[0003] For secondary mitral regurgitation, surgical thoracotomy and implantation of an artificial ring are generally used for valve repair. However, thoracotomy is more harmful to patients and has poor postoperative recovery, especially for elderly patients. In recent years, mitral valve interventional treatment technology has begun to emerge and has developed rapidly due to its minimally invasive and safe characteristics.

[0004] Mitral valve interventional treatment techniques mainly include valve repair and valve replacement. Among them, mitral annuloplasty is a common valve repair procedure. In mitral annuloplasty, the anchor is connected to the ring closing wire, and the anchor is implanted in the mitral valve ring through a transcatheter path. Multiple anchors are implanted in different positions of the mitral valve ring in sequence, and the multiple anchors at different positions of the valve ring are tightened through the ring closing wire, which can reduce the patient's valve ring size to reduce mitral valve regurgitation.

[0005] However, during the operation, since the anchor is connected to the loop wire, there is a risk of the anchor and the loop wire intertwining during the implantation of the anchor. During the operation, it is difficult to determine the specific position and real-time status of the loop wire in the heart, which can easily affect the quality of the operation, increase the difficulty of the operation and increase the operation time.

[0006] Therefore, how to improve the developability of the loop line has become a problem that needs to be solved urgently. Summary of the invention

[0007] The purpose of the present application is to provide a transcatheter repair system to overcome the above-mentioned defects in the prior art.

[0008] A transcatheter repair system includes a sheath and an implant, wherein the implant includes a flexible slender member, the sheath includes a proximal portion and a distal portion, the flexible slender member is movably installed in the sheath, at least the development intensity of the distal portion of the sheath is less than the development intensity of the flexible slender member, the optical density of the development image of the distal portion of the sheath is configured to be 0.5-1.2, and the optical density of the development image of the flexible slender member is configured to be 1.5-2.5.

[0009] Compared with the prior art, the transcatheter repair system provided by the present application has at least the following advantages:

[0010] On the one hand, by adjusting the optical density of the development image of at least the distal part of the sheath and reducing its development properties, the interference with the development effect of the flexible slender member can be improved, the real-time judgment of the position and state of the flexible slender member during the operation can be improved, and the surgical risk can be reduced.

[0011] On the other hand, by adjusting the optical density of the development image of the flexible slender member, the development effect of the flexible slender member itself is improved, so that it can be clearly identified under the DSA image during the operation, thereby judging the real-time status of the flexible slender member and its position relative to tissues and other components, so as to make better judgments and better reduce surgical risks.

[0012] In summary, it is ensured that the flexible elongated member has the desired development effect in the entire system.

[0013] Figures and Description of Figures

[0014] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate some embodiments consistent with the present application and, together with the description, serve to explain the principles of the present application.

[0015] In order to more clearly illustrate the embodiments of the present application or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without paying any creative labor.

[0016] Figure 1 is a schematic diagram of the overall structure of a transcatheter repair system in some embodiments;

[0017] Figure 2 A schematic diagram of the operation of a transcatheter repair system in some embodiments;

[0018] Figure 3 A schematic diagram showing a partial detail of a transcatheter repair system in some embodiments.

[0019] Figure 4 It is a schematic diagram of the implantation effect of the implant in the transcatheter repair system in some embodiments;

[0020] Figure 5 is a schematic diagram of the structure of a single anchoring member in some embodiments;

[0021] Figure 6 Schematic diagram of the structure of the sheath tube in some embodiments

[0022] Figure 7 Schematic diagram of the structure of the flexible elongated member in some embodiments;

[0023] Figure 8 Schematic diagram of the structure of the main wire in the flexible elongated member in some embodiments;

[0024] Fig. 9 Schematic diagram of the structure of the developing wire in the flexible elongated member in some embodiments;

[0025] Fig.10 is a schematic structural diagram of a developing section of a flexible elongated member in some embodiments;

[0026] Fig.11 Schematic diagrams of various structures of the developing section of the flexible elongated member in some embodiments;

[0027] Fig.12 Schematic diagram of the marking effect of the developing section of the flexible elongated member in some embodiments;

[0028] Fig.13 A schematic diagram of the working process of a transcatheter repair system in some embodiments;

[0029] Fig.14 Schematic diagram of some working processes of the transcatheter repair system in some embodiments;

[0030] Fig.15 It is a schematic diagram of enlarged local details of the transcatheter repair system in some embodiments. DETAILED DESCRIPTION

[0031] For the convenience of description, the following definition is used: In the field of interventional medical devices, the proximal end refers to the end of the device or component that is closer to the operator, while the distal end refers to the end that is farther from the operator.

[0032] Development intensity: The clarity of the development image is defined by the optical density D (which can be measured by an optical density meter), and the development intensity of the part is reflected by the value of the optical density D. The optical density D ranges from 0.0 to 3.0. The larger the optical density value, the stronger the development intensity of the part and the better the image development effect.

[0033] Among them, the optical density range corresponding to development level 1 is 0<D≤0.8, the optical density range corresponding to development level 2 is 0.8<D≤1.6, the optical density range corresponding to development level 3 is 1.6<D≤2.0, the optical density range corresponding to development level 4 is 2.0<D≤2.4, and the optical density range corresponding to development level 5 is 2.4<D≤3.0.

[0034] In order to make the purpose, technical solution and advantages of the embodiments of the present application clearer, the technical solution in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, not all of the embodiments. Based on certain embodiments in the present application, all other embodiments obtained by ordinary technicians in this field without making creative work are within the scope of protection of this application.

[0035] References to "one embodiment", "an embodiment", "in another embodiment" or "in some embodiments" throughout the specification are intended to include in at least one embodiment the specific referenced elements, structures or features described in relation to that embodiment. Thus, the phrases "in some embodiments" or "in an embodiment" or "in other embodiments" or "in some embodiments" appearing in different places throughout the specification do not necessarily all refer to the same embodiment. Furthermore, specific elements, structures or features may be combined in any appropriate manner in one or more embodiments.

[0036] It should be noted that, in this article, relational terms such as "first" and "second" are only used to distinguish one entity or operation from another entity or operation, and do not necessarily require or imply any such actual relationship or order between these entities or operations. Moreover, the terms "include", "comprise" or any other variants thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device including a series of elements includes not only those elements, but also other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of further restrictions, the elements defined by the sentence "comprise a ..." do not exclude the existence of other identical elements in the process, method, article or device including the elements.

[0037] The transcatheter repair system 1 of the present application can implant implants in cardiac tissues such as the mitral valve annulus, tricuspid valve annulus, left ventricular wall or right ventricular wall to reshape the annulus, thereby reducing or eliminating blood reflux. When the implant is implanted in the annulus, the size of the annulus is directly reduced to reshape the annulus. When the implant is implanted in the ventricular wall below the annulus, such as the ventricular wall 0.5cm-2cm below the annulus, the purpose of reducing the size of the annulus can be achieved by narrowing the ventricle to reduce the volume of the ventricle. It should be noted that reducing the volume of the left ventricle can also treat ischemic heart failure. The transcatheter repair system 1 can also perform other applicable repair operations. Transcatheter repair system

[0038] See also Figure 1-4As shown, a transcatheter repair system 1 includes a sheath 10 and an implant 20. The implant 20 includes a flexible elongated member 22 and a plurality of anchors 24 mounted on the flexible elongated member 22. The flexible elongated member 22 is movably mounted in the sheath 10. Through the cooperation of the sheath 10, a plurality of anchors 24 can be implanted in cardiac tissue (such as the mitral valve annulus, the tricuspid valve annulus, the left ventricular wall, and the right ventricular wall), and then the distance between the plurality of anchors 24 can be adjusted and tightened, thereby achieving the purpose of reducing the size of the diseased valve ring B to reduce regurgitation. The following description takes the catheter repair system 1 performing annuloplasty on the mitral valve ring B as an example.

[0039] In some embodiments, the implant 20 further includes a locker 26. The flexible elongated member 22 is configured to adjust the distance between the plurality of anchors 24. The locker 26 is configured to lock the length of the flexible elongated member 22 on the valve ring B to maintain the tension of the flexible elongated member 22, thereby maintaining the effect of annuloplasty. In addition, in other embodiments, the locker 26 can also be driven to adjust the length of the flexible elongated member 22 on the valve ring and lock the length of the flexible elongated member 22 after the length of the flexible elongated member 22 is adjusted.

[0040] In some embodiments, the sheath 10 includes a proximal portion J and a distal portion Y. When the implant 20 is delivered, the flexible elongated member 22 is movably mounted in the sheath 10. At least the developing intensity of the distal portion Y of the sheath 10 is less than the developing intensity of the flexible elongated member 22. When the optical density of the developing image of the sheath 10, especially the distal portion Y of the sheath 10, is configured to be 0.5 to 1.2, and the optical density of the developing image of the flexible elongated member 22 is configured to be 1.5 to 2.5, the developing effect of the flexible elongated member 22 in the entire system is the best.

[0041] It should be emphasized that the present application focuses on explaining in detail that during the operation, in order to improve the visualization of the flexible slender member 22 under DSA (Digital subtraction angiography) images, so that its real-time status and specific relative position with the valve ring B can be clearly and intuitively identified, thereby greatly reducing the risk of the operation and shortening the operation time, specific improvements are made to the sheath 10 surrounding the flexible slender member 22 and the structure of the flexible slender member 22 itself.

[0042] On the one hand, by adjusting the optical density of the development image of at least the distal part Y of the sheath 10 and reducing its development properties, the interference with the development effect of the flexible slender member 22 can be improved, thereby improving the real-time judgment of the position and state of the flexible slender member 22 during the operation and reducing the surgical risk.

[0043] On the other hand, by adjusting the optical density of the development image of the flexible slender member 22, the development effect of the flexible slender member 22 itself is improved, so that it can be clearly identified under the DSA image during the operation, thereby judging the real-time status of the flexible slender member 22 and its position relative to tissues and other components, so as to make better judgments and better reduce surgical risks.

[0044] It is emphasized that, since the flexible elongated member 22 implanted in the heart is usually overlapped with the distal portion Y of the sheath 10, the imaging effect of the sheath 10 will interfere with the imaging effect of the flexible elongated member 22 movably installed in the inner cavity thereof, especially the distal portion Y of the sheath 10. In different embodiments, as long as the flexible elongated member 22 is installed in the inner cavity of the sheath 10, it is necessary to ensure that at least the imaging strength of the distal portion Y of the sheath 10 is less than the imaging strength of the flexible elongated member 22, so as to achieve a good imaging effect without affecting the flexible elongated member 22.

[0045] In some embodiments, the transcatheter repair system 1 further includes a delivery line 32. The distal end of the flexible elongated member 22 is connected to the first anchor 24, and the proximal end of the flexible elongated member 22 is connected to the distal end of the delivery line 32. It can be understood that the distal end of the flexible elongated member 22 is pre-connected with the first anchor 24. The flexible elongated member 22 and the delivery line 32 enter the patient's body along with the delivery of the first anchor 24, and the proximal end of the delivery line 32 extends outside the body. In this way, the remaining anchors 24, the lock 26, etc. can be worn on the flexible elongated member 22 through the delivery of the delivery line 32, so that the flexible elongated member 22 can select a suitable implantation length, so that the flexible elongated member 22 does not need to be cut in the body, which avoids the shedding of particles on the wire and makes the operation safer.

[0046] In some embodiments, the proximal end of the flexible elongated member 22 is connected to the distal end of the conveying line 32 in a U-shape. The conveying line 32 can be separated from the flexible elongated member 22 by pulling the conveying line 32 outside the body, which is easy to operate. In other embodiments, the conveying line 32 can also be detachably connected to the flexible elongated member 22 by means of threaded connection, snap connection, etc., which will not be described in detail.

[0047] In other embodiments, the transcatheter repair system 1 can omit the delivery line 32, and the length of the flexible elongated member 22 is long enough. After the flexible elongated member 22 enters the heart with the first anchoring member 24, the proximal end of the flexible elongated member 22 can extend outside the patient's body. In this way, the distal portion of the flexible elongated member 22 is locked by the locker 26 and remains in the heart, and the proximal excess portion of the flexible elongated member 22 can be cut off by a wire cutter. In this embodiment, the optical density of the development image of the distal portion of the flexible elongated member 22 (i.e., the portion remaining in the heart) is configured to be 1.5-2.5. The optical density of the development image of the proximal excess portion of the flexible elongated member 22 does not need to be specifically limited, and is preferably less than the optical density of the development image of the distal portion of the flexible elongated member 22.

[0048] The following description will be continued in detail by taking the example that the transcatheter repair system 1 includes a delivery wire 32, the distal end of the flexible slender member 22 is connected to the first anchoring member 24, and the proximal end of the flexible slender member 22 is connected to the distal end of the delivery wire 32.

[0049] In some embodiments, the transcatheter repair system 1 includes a first guide sheath 12 and a second guide sheath 14 movably mounted in the inner cavity of the first guide sheath 12. The first guide sheath 12 can reach the left atrium along the guide wire through the femoral vein-inferior vena cava-right atrium-atrial septum. The second guide sheath 14 is movably mounted in the inner cavity of the first guide sheath 12, and can reach the distal end and extend and adjust to the vicinity of the mitral valve ring B.

[0050] Optionally, the first guide sheath tube 12 and the second guide sheath tube 14 are both adjustable curved sheath tubes, so that the distal ends of the first guide sheath tube 12 and the second guide sheath tube 14 can be accurately adjusted to a suitable angle. Using two adjustable curved sheath tubes together can have a larger adjustment space and better adjust the bending angle and direction of the distal end.

[0051] In other embodiments, the transcatheter repair system 1 may also use only one bendable guide sheath, so that it has the bending functions of both the first guide sheath 12 and the second guide sheath 14 .

[0052] In some embodiments, the transcatheter repair system 1 further comprises a delivery sheath 16. At least the distal portion of the delivery sheath 16 is flexible. The delivery sheath 16 can be movably installed in the inner cavity of the second guide sheath 14. The anchor 24 is installed in the delivery sheath 16, and the delivery sheath 16 is pushed distally in the second guide sheath 14 to deliver the anchor 24 to the desired position in the patient's body.

[0053] In some embodiments, the sheath 10 includes a first guide sheath 12 and a second guide sheath 14. The second guide sheath 14 is movably mounted in the inner cavity of the first guide sheath 12. The tube wall of the delivery sheath 16 is provided with a narrow groove 162 extending from the distal end to the proximal end, and the narrow groove 162 is connected to the inner cavity of the delivery sheath 16. The anchor 24 includes an anchor 242 and a threading structure 244 movably sleeved on the anchor 242. The anchor 24 is loaded into the delivery sheath 16 from the distal tube opening of the delivery sheath 16, wherein the anchor 242 enters the inner cavity of the delivery sheath 16, and the threading structure 244 can enter the narrow groove 162 so that the threading ring 2440 of the threading structure 244 is at least partially located outside the delivery sheath 16. The flexible slender member 22 is connected to the anchor 24 through the threading ring 2440. During the process of the delivery sheath 16 pushing the anchor 24, the flexible elongated member 22 and the delivery wire 32 are located outside the delivery sheath 16 and in the inner cavity of the second guide sheath 14. In this embodiment, the optical density of the development image of at least the distal portion of the first guide sheath 12 and the second guide sheath 14 is configured to be 0.5-1.2.

[0054] In other embodiments, the sheath 10 includes a first guide sheath 12, a second guide sheath 14, and a delivery sheath 16. The second guide sheath 14 is movably installed in the inner cavity of the first guide sheath 12. The anchor 24 is loaded in the inner cavity of the delivery sheath 16, and the flexible elongated member 22 and the delivery line 32 connected to the flexible elongated member 22 are located in the inner cavity of the delivery sheath 16. In the process of the delivery sheath 16 pushing the anchor 24, the delivery sheath 16 moves toward the distal end in the inner cavity of the second guide sheath 14, and the flexible elongated member 22 and the delivery line 32 are located in the inner cavity of the delivery sheath 16. In this embodiment, the optical density of the development image of at least the distal portion of the first guide sheath 12, the second guide sheath 14, and the delivery sheath 16 is configured to be 0.5 to 1.2.

[0055] In some embodiments, the implant 20 further comprises at least one spacer 28. The spacer 28 is movably connected to the flexible elongated member 22. The spacer 28 is inserted between two adjacent anchoring members 24. The spacer 28 acts as a spacer between the anchoring members 24 to prevent the two adjacent anchoring members 24 from being squeezed too close to each other during the tightening process of the flexible elongated member 22, thereby affecting the annuloplasty effect.

[0056] Optionally, a spacer 28 may be provided between any two adjacent anchors 24 among the plurality of anchors 24, that is, the anchors 24 and the spacers 28 are staggered. Of course, a spacer 28 may also be provided every two or more anchors 24, that is, a spacer 28 may be provided between some adjacent two anchors 24, and no spacer 28 may be provided between some adjacent two anchors 24, and the present invention is not limited thereto.

[0057] It should be noted that the various deformation settings of the sheath tube 10 described below can be generally applied to any sheath tube used in the transcatheter repair system 1 if necessary.

[0058] The sheath 10 includes an inner layer 102, an intermediate layer 104 and an outer layer 106, and the three layers are composed of different materials. Among them, the inner layer 102 is used to establish a channel, and is generally made of PTFE (polytetrafluoroethylene). The intermediate layer 104 is a metal wire braided mesh sleeved outside the inner layer 102, which can improve the overall support performance and torsional performance of the sheath 10. The outer layer 106 is sleeved outside the metal wire braided mesh 104. The outer layer 106 is a polymer material layer, generally made of polymer materials such as pebax (block polyetheramide resin) or TPU (Thermoplastic polyurethanes). During shaping, the sheath 10 is hot-melted as a whole, and the polymer outer layer 106 is melted and deformed after being heated, so that the three layers of material can be completely welded into a whole to form a composite tube.

[0059] In some embodiments, the metal wire braided mesh 104 is made of stainless steel wire with weaker developability. Among them, the wire diameter of the stainless steel wire cannot be too small. Although the small wire diameter can effectively reduce the developability of the braided mesh, it is easy to break the wire during the braiding process, affecting the production efficiency. At the same time, the overall support performance of the sheath 10 is weak, and it is easy to bend and deform. The wire diameter of the stainless steel wire cannot be too large. Too large a wire diameter will increase the developability of the braided mesh, resulting in an increase in the optical density of the developed image of the sheath 10, especially the distal part Y of the sheath 10, which is not conducive to observing the state and specific position of the flexible slender member 22. At the same time, the weaving difficulty of the braided mesh will also increase, the flexibility of the sheath 10 will decrease, and the overall outer diameter will also increase. In particular, when the sheath 10 is an adjustable bending sheath, it will seriously affect the bending performance of the sheath 10, increase the required bending force, and make it difficult to reach the specified position when conveying the instrument, thereby affecting the surgical operation and success rate.

[0060]

[0061] Table 1 Correspondence between braided mesh diameter and sheath tube 10 performance

[0062] See Table 1, which shows the corresponding relationship between the wire diameter of the braided mesh 104 and the performance of the sheath tube 10 within a certain range. Preferably, the metal wire of the metal wire braided mesh 104 is a stainless steel wire, and the wire diameter of the stainless steel wire is 0.10 mm to 0.15 mm. On the one hand, the physical properties of the sheath tube 10 can meet clinical needs; on the other hand, the optical density value of the developed image of the sheath tube 10 woven by the stainless steel wire within this size range can be stabilized in the range of 0.8 to 1.2.

[0063] In some embodiments, the developability of the sheath 10 is changed by adjusting the weaving density of the weaving mesh 104. Weaving density refers to the number of meshes per unit length, usually expressed in PPI. In this application, the number of meshes within a one-inch length range is defined as the weaving mesh density PPI.

[0064] It should be noted that the metal wire braided mesh 104 is usually braided by a mesh braiding machine with braiding mandrels of different outer diameters. During the braiding process, the braided mesh 104 is wrapped around the outer surface of the braiding mandrel, and the braiding density can be adjusted by adjusting the wire diameter of the braiding wire, the outer diameter of the braiding mandrel and the rotation speed of the mesh braiding machine.

[0065] In some embodiments, based on the selection of metal wires with appropriate wire diameters, the smaller the outer diameter of the braided mandrel, the smaller the braiding density that can be braided. The outer diameter of the mandrel can be selected according to the inner diameter size requirements of different sheath tubes 10, preferably in the range of 3F to 25F. This can avoid the situation where the braided mesh 104 is easy to spread out and difficult to form due to too high a braiding density.

[0066] In some embodiments, the rotation speed of the network tube braiding machine is set corresponding to the appropriate wire diameter of the braiding wire and the outer diameter of the braiding mandrel. Usually, the speed of the braiding machine is set at 100-500r / min, which can be adjusted according to the specific wire diameter and mandrel size.

[0067] In some embodiments, in order to make the braided mesh 104 easy to shape, convenient for production and use, and not easy to deform, the braiding density range of the braided mesh 104 of the optional sheath 10 is set to be 5 to 100 PPI. When the braiding density of the braided mesh 104 is greater, the proportion of braided wires per unit length will be greater, the optical density value of the developed image corresponding to the sheath 10 will be higher, and the development intensity will be higher.

[0068] Table 2 shows the corresponding relationship between the braiding density and the performance of the sheath tube 10 when the wire diameter of the braided mesh 104 is constant. Preferably, the braiding density is 20-60 PPI, and the optical density of the developed image corresponding to the sheath tube 10 within the braiding density range is less than 1.2. Thus, it is possible to effectively reduce the developability of the sheath tube 10 while ensuring the physical properties of the sheath tube 10. It is possible to well reduce the interference of the development of the sheath tube 10 on the development of the flexible elongated member 22, so that the developed image of the flexible elongated member 22 is easy to distinguish.

[0069]

[0070] Table 2 Correspondence between braiding density and sheath 10 performance

[0071] It is particularly emphasized that, in some embodiments, the wire braided mesh 104 includes a distal segment 101, a middle segment 103 and a proximal segment 105. In order to make the flexible elongated member 22 more visible in the distal portion Y of the sheath 10, combined with the data in Table 2, the braiding density of the distal segment 101 is set to 20-35 PPI, the braiding density of the middle segment 103 is set to 35-45 PPI, and the braiding density of the proximal segment 105 is set to 45-60 PPI, as shown in FIG. Figure 6 As shown. It can be understood that the distal segment corresponds to the distal portion Y of the sheath 10. By reducing the developability of the sheath 10, especially the developability of the distal portion Y of the sheath 10, the developability of the flexible elongated member 22 can be made more obvious while ensuring the support performance and bending force of the sheath 10, thereby better improving the safety of the operation.

[0072] In addition, in some embodiments, for the polymer material outer layer 106 of the sheath tube 10, before the tube body is hot-melt molded, the proportion of barium sulfate doped in the polymer material outer layer 106 is adjusted, which can also achieve the purpose of reducing the developability of the sheath tube 10. Specifically, the corresponding relationship between the doping ratio of barium sulfate and the optical density of the developed image of the sheath tube 10 is shown in Table 3. Preferably, the doping amount of barium sulfate is 20% to 30%.

[0073]

[0074] Table 3 Corresponding relationship between the doping ratio of barium sulfate in the sheath tube 10 and the optical density value

[0075] In some embodiments, the flexible elongated member 22 includes a main wire 222 and a plurality of additional wires 224 surrounding the main wire 222, such as an additional wire 224. Figure 7 The development strength of the main thread 222 is greater than the development strength of the additional thread 224.

[0076] Exemplarily, the material of the main wire 222 includes at least one of tantalum, gold, platinum and tungsten with excellent developability. The material of the additional wire 224 includes at least one of stainless steel and nickel titanium. In this way, the develop strength of the main wire 222 is greater than the develop strength of the additional wire 224.

[0077] It is additionally explained that, since the flexible elongated member 22 is made of multiple strands of silk, when the overall outer diameter of the flexible elongated member is the same, the more strands there are, the smaller the diameter of the single strand of silk will be. The overall development of the flexible elongated member 22 will also be enhanced, and the compliance of the flexible elongated member 22 will be better.

[0078] When the optical density value of the development image of the distal portion Y of the sheath 10 is adjusted to be in the range of 0.5 to 1.2 at the same time, the optical density difference between the two is at least greater than 0.3 (medical imaging stipulates that when the optical density difference is within the range of 0 to 0.2, it is weak development, and when the optical density difference is greater than 0.2, it is strong development), the relative position and state of the flexible elongated member 22 can be clearly identified during surgery. In other words, even if the flexible elongated member 22 is located in the sheath 10, the position and state of the flexible elongated member 22 can be clearly identified.

[0079] In some embodiments, Figure 7 As shown in FIG. 4 , the flexible elongated member 22 is made of multiple strands of silk thread, the center of which is a main silk thread 222, and the periphery is surrounded by multiple strands of additional silk threads 224. The main silk thread 222 can be a strand of woven silk thread formed by multiple strands of filaments 2220. Each strand of additional silk thread 224 can also be a strand of woven silk thread formed by multiple strands of filaments 2220. The main silk thread 222 can also be composed of a single strand of filaments 2220. The additional silk thread 224 can also be composed of a single strand of filaments 2220.

[0080] In some embodiments, the outer diameter of the flexible elongated member 22 is 0.25 mm-0.3 mm. Under this outer diameter range, the diameter of the single filament 2220 can be 0.025 mm-0.03 mm, thereby ensuring that the flexible elongated member 22 has good flexibility, and the optical density value of the developed image of the flexible elongated member 22 is ≥1.5 and stable, so that the development performance is very good.

[0081] In some embodiments, in combination Figure 8 As shown, the main wire 222 includes a developing filament 2220, and the developing filament 2220 is used to adjust the developing strength of the main wire 222. When the outer diameter of the flexible elongated member 22 is the same, the developing strength of the flexible elongated member 22 is adjusted by comparing the size of the cross-sectional area ratio of the developing filament 2220 within the unit cross-sectional area. The larger the cross-sectional area ratio of the developing filament 2220, the stronger the optical density of the corresponding developed image. The developing filament 2220 refers to a filament made of at least one developing material selected from tantalum, gold, platinum and tungsten.

[0082] Specifically, if the total outer diameter of the main filament 222 is set to 0.1 mm, when the main filament 222 is made of 1, 3, 5 and 7 strands of developing filaments 2220, the cross-sectional area ratios of the developing filaments 2220 are 100%, 64%, 68% and 77% respectively. In order to ensure the developing property and flexibility of the developing filaments 2220 at the same time, it is preferred that the main filament 222 is made of 7 strands of developing filaments 2220, that is, the cross-sectional area ratio of the developing filaments 2220 is 77%.

[0083] In other embodiments, the flexible elongated member 22 includes at least one main wire 222 and a plurality of additional wires 224. Fig. 9 As shown, the main wire 222 is distributed in a spiral shape and appears in the flexible elongated member 22. The developing strength of the main wire is greater than the developing strength of the additional wire. Exemplarily, the material of the main wire 222 includes at least one of tantalum, gold, platinum and tungsten with excellent developing properties. The material of the additional wire 224 includes at least one of stainless steel and nickel titanium. In this way, the developing strength of the main wire 222 is greater than the developing strength of the additional wire 224.

[0084] Optionally, the flexible elongated member 22 is twisted by a main thread 222 and an additional thread 224. The main thread 222 can be a strand of woven thread formed by a plurality of filaments 2220. The additional thread 224 can be a strand of woven thread formed by a plurality of filaments 2220. The main thread 222 can also be composed of a single filament 2220. The additional thread 224 can also be composed of a single filament 2220.

[0085] In some embodiments, the developability of the flexible elongated member 22 is different due to the different weaving pitches L. The weaving pitch L generally refers to the distance between two adjacent wave crests or wave troughs that appear repeatedly in the same strand of silk. The weaving pitch L of the flexible elongated member 22 is generally an integer multiple of the wire diameter of a single strand of silk (the silk refers to the main silk or the additional silk). For example, the wire diameter of a single strand of silk of the flexible elongated member 22 is 0.2 mm, and the flexible elongated member is woven from a total of 7 strands of silk, then the weaving pitch L of the flexible elongated member 22 is 1.4 mm.

[0086] It should be noted that the braiding pitch L of the flexible elongated member 22 is inversely proportional to its developability. That is to say, the smaller the braiding pitch L, the higher the frequency of the single strand of silk (referring to the main silk or the additional silk) in the unit length H, the higher the volume ratio of the main silk 222 (the volume ratio refers to the percentage of the volume of the main silk 222 in the unit length H to the volume of all silks constituting the flexible elongated member 22), the greater the optical density of the corresponding developed image, and the more obvious the developing effect.

[0087] In some embodiments, in combination Fig. 9 As shown, there are three flexible elongated members 22 with different weaving pitches L, and the weaving pitches L decrease from left to right. The main wire 222 of the flexible elongated member 22 on the far right has the largest volume ratio per unit length H, and the greater the optical density of the developed image of the flexible elongated member 22, the better the developing performance.

[0088]

[0089] Table 4 Corresponding relationship between weaving pitch L and development performance of flexible elongated member 22

[0090] Combined with Table 4, in order to ensure both good flexibility of the flexible elongated member 22 and the optical density of the developed image under DSA to be greater than 1.5, so that its development performance is excellent and the surgical risk is greatly reduced, the braiding pitch L of the flexible elongated member 22 is preferably 1.6 mm to 3.0 mm. The volume proportion of the main wire 222 in the unit length H is 17.7% to 24.3%.

[0091] In other embodiments, since the single strands of the flexible elongated member 22 have the same structure and usually have multiple strands, the developability of the flexible elongated member 22 can be adjusted by controlling the number of main strands 222 that appear in the spiral. The more main strands 222 that appear in the spiral, the better the developability of the flexible elongated member 22. However, since the tensile strength of the main strands 222 is weaker than that of the additional strands, in order to simultaneously ensure the tensile strength and developability requirements of the flexible elongated member 22, the number of strands of the main strands 222 distributed in the spiral can be set to be less than or equal to 3, and the spacing between the spirals can be distributed in increasing order from near to far.

[0092] In some other embodiments, the flexible elongated member 22 includes a plurality of developing sections 221. Fig.10 As shown, segments A1, A2, and An are imaging segments 221. The imaging segment 221 is used as an identification mark to identify whether each anchor 24 mounted on the flexible elongated member 22 is implanted in the expected corresponding position of the patient's valve ring. For example, before the implant is implanted in the body, combined with imaging methods such as ultrasound images, each anchor 24 is preset to correspond to a specific position in a certain imaging segment 221 in sequence. During the implantation process, the relative position of each anchor 24 and the corresponding imaging segment 221 is observed in real time for judgment.

[0093] Preferably, the length of each developing section 221 ranges from 5 mm to 12 mm. The spacing X between each two developing sections 221 is from 3 mm to 12 mm. The smaller the spacing between two adjacent developing sections, the more developing sections 221 there are. The multiple developing sections 221 are equidistant or distributed in increasing order from the far end to the near end.

[0094] In some embodiments, if the length of the patient's valve ring B is 90 mm to 100 mm, the 90 mm to 100 mm from the distal end to the proximal end of the flexible elongated member 22 can be evenly set to be segmented for development. To ensure a good development effect of the flexible elongated member 22. Preferably, the length A of each development segment 221 is 8 mm to 12 mm, and the spacing X between two adjacent development segments is 3 mm to 5 mm. In addition, in order to reserve enough space for the locker 26 to collect the wire, the total length of the flexible elongated member 22 is set to 140 to 150 mm.

[0095] In some embodiments, when multiple anchors 24 are implanted, the relative position relationship between each anchor 24 and the developing segment 221 can be observed through DSA to determine whether the implantation position of each anchor 24 and the distance between it and the previous anchor 24 are consistent with the preoperative plan, so that the implantation position of each anchor 24 can be adjusted in real time to improve the surgical effect.

[0096] In some embodiments, the implant 20 includes a plurality of spacers 28, each of which is mounted on the flexible elongated member 22. The implantation position of each spacer 28 and the anchor 24 can be determined by determining whether the spacer 28 mounted on the flexible elongated member 22 is at the position of the corresponding developing segment 221 expected to be set on the flexible elongated member 22. When it is found that the position of the spacer 28 and the developing segment 221 on the flexible elongated member 22 is offset, it can be known that the implantation position of the previous anchor 24 is deviated. When this deviation is identified, timely adjustments can be made during the subsequent implantation of the spacer 28 and the anchor 24 to avoid the accumulation of errors and the resulting poor surgical effect.

[0097] In some other embodiments, by setting the length of the flexible elongated member 22 and the length and spacing of the imaging segments 221, and comparing them with the length of the patient's valve ring B measured before the operation, the imaging segments 221 can also be used as an identification mark of the annuloplasty ratio. The length between the first and last imaging segments 221 of the flexible elongated member 22 is substantially equal to the length of the patient's valve ring B measured before the operation.

[0098] Optionally, the 90 mm to 100 mm from the distal end to the proximal end of the flexible elongated member 22 is evenly arranged as segmented development, the spacing X between two adjacent development segments 221 is 1 mm to 5 mm, and the length A of each development segment 221 is 5 mm to 12 mm. The flexible elongated member is provided with 7 to 11 development segments 221 in total.

[0099] Define the total number of developing segments 221 on the flexible elongated member 22 as M, when the locker 26 is used to perform the wire-retracting operation, the number of developing segments 221 remaining on the flexible elongated member 22 on the valve ring B (i.e., the number of developing segments 221 located outside the locker 26) is N, the patient's posterior valve ring length is C, and the posterior valve ring length contraction rate is β, then β=[(MN)×(A+X)]÷C×100%. By comparing the calculation with the preoperatively planned valve ring shaping ratio, it can be known whether the expected valve ring shaping effect has been achieved.

[0100] Combined with Table 5, the doctor can plan the number of developing segments 221 on the flexible slender member 22 before and after the annulus contracts before the operation. According to the patient's posterior annulus length C, after the annulus contracts, the shrinkage rate of the patient's annulus can be quickly determined by comparing the preoperatively planned value. For example, if the patient's posterior annulus length is 110 mm, the total number M of developing segments 221 is set to 11, the number N of the remaining external developing segments 221 of the flexible slender member 22 is 7, the spacing X between two adjacent developing segments 221 is 1 mm to 5 mm, and the length A of each developing segment 221 is 5 mm to 12 mm, corresponding to a shrinkage rate of 38%. During the actual implantation process, when the shrinkage rate is not reached or the shrinkage is excessive, it can be adjusted in real time to improve the success rate of the operation.

[0101]

[0102] Table 5 Corresponding relationship between the number of imaging segments 221 and the annular contraction rate β

[0103] In some embodiments, Fig.12 As shown in FIG. 1 , multiple strands of additional threads 224 are arranged around the outside of the main thread 222, and the additional threads 224 have no developing property or have a developing strength that is inferior to that of the main thread 222 and the difference is relatively large. Among them, developing sections 221 are arranged in sections on the main thread 222, and the developing sections 221 are evenly distributed inside the flexible elongated member 22. In this way, the developing sections 221 can be effectively prevented from being ineffective due to long-term contact and wear with multiple anchors 24 or spacers 28, thereby protecting the developing sections 221.

[0104] In some embodiments, Fig.12 As shown in FIG. 2 , a tantalum wire, gold wire, platinum wire, etc. with strong developing property is wound on the outer surface of the flexible elongated member 22 in sections to form a developing section 221. Alternatively, a heavy metal material with good developing property such as gold, platinum, tantalum, iridium, etc. is electroplated on the outer surface of the flexible elongated member 22 in sections to form the developing section 221.

[0105] In other embodiments, Fig.12 As shown in c, developing ink is sprayed in sections or cloth with developing properties is sewn on the flexible elongated member 22 at the position where development is required to form a developing section 221.

[0106] In some other embodiments, Fig.13 As shown in FIG. 13a-13b, a developing section 221 is integrally provided on the flexible elongated member 22. For example, a tantalum wire is integrally wound around the flexible elongated member 22, or a cloth with developing properties is sewn on the flexible elongated member 22, or developing ink is applied, or a coating is performed on the flexible elongated member 22, so as to achieve the effect that the flexible elongated member 22 has developing properties as a whole. Such an arrangement can achieve developing properties while also increasing friction, so that the anchoring member 24 cannot slide easily on the flexible elongated member 22, so as to prevent the relative distance between the multiple anchoring members 24 from changing.

[0107] In some embodiments, a sleeve (not shown) can also be sewn on the flexible elongated member 22. The sleeve material can be PET (polyethylene terephthalate) with good biocompatibility. Before suturing, the PET sleeve can be coated with ink with developing properties to make it developable as a whole. In this way, it can be ensured that after the sleeve is sewn to the flexible elongated member 22, not only the flexible elongated member 22 has developing properties, but also the wear resistance of the flexible elongated member 22 can be increased, making its fatigue cycle longer. At the same time, due to the good biocompatibility of the PET sleeve, the flexible elongated member 22 can also achieve endothelialization faster and better integrate with the tissue.

[0108] The following briefly describes the application process of the transcatheter repair system 1 of the present application in mitral annuloplasty, and the surgical path is: femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-mitral valve ring.

[0109] Step 1: Puncture the femoral vein and establish a track of femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-mitral valve ring through a guide wire and an atrial septal puncture device (not shown);

[0110] Step 2: Push the first guiding sheath tube 12 along the guide wire until its distal end passes through the oval foramen to reach the left atrium, withdraw the guide wire, and freely install the second guiding sheath tube 14 in the first guiding sheath tube 12 to establish an in vitro-in vivo passage and adjust the first guiding sheath tube 12 and the second guiding sheath tube 14 so that the distal end of the second guiding sheath tube 14 faces the appropriate expected position of the valve ring B;

[0111] Step 3: Use the delivery sheath 16 to push the first anchor 24 in the second guide sheath 14 to the vicinity of the patient's mitral valve annulus B. Then, implant the first anchor 24. The distal end of the flexible slender member 22 is pre-connected with the first anchor 24, and the delivery line 32 is connected to the proximal end of the flexible slender member 22. When delivering the anchor 24, the flexible slender member 22 and the delivery line 32 are located in the inner cavity of the second guide sheath 14 and outside the delivery sheath 16. When implanting the anchor 24, the distal end of the delivery sheath 16 abuts against the predetermined treatment site of the valve annulus B, which can ensure that the anchor 24 is implanted stably and accurately.

[0112] The fourth step is Figure 2-3 and Figure 14-15As shown, after the implantation of the first anchor 24 is completed, the spacer 28 is passed through the proximal end of the delivery wire 32, and the spacer 28 is pushed into the second guide sheath 14. Then, the second anchor 24 is passed through the proximal end of the delivery wire 32, and the spacer 28 and the second anchor 24 are passed through the flexible elongated member 22 and delivered to the vicinity of the valve ring B by the delivery sheath 16, and then the second anchor 24 is implanted into the valve ring B.

[0113] In the fifth step, step 4 is repeated, and multiple anchors 24 are implanted in the valve ring B from the anterior triangular area of ​​the mitral valve along the posterior valve ring B to the posterior triangular area or in the reverse direction. At the same time, the spacers 28 are sequentially inserted between every two anchors 24, so that the multiple anchors 24 and the multiple spacers 28 are staggered on the valve ring B. It should be emphasized that under ultrasound and DSA, the position of the next anchor 24 is adjusted according to the size of the diseased valve ring B, and the distance from the previous anchor 24 needs to be greater than the axial length of the spacer 28.

[0114] In step 6, after implanting a sufficient number of anchors 24 and spacers 28, the delivery sheath 16 is withdrawn, and then the locker 26 is delivered along the delivery line 32 to the vicinity of the last anchor 24 on the flexible elongated member 22, and finally the flexible elongated member 22 is tightened and locked by the locker 26, so that the spacing between the multiple anchors 24 is reduced, thereby reducing the size of the valve ring B. Finally, the locker 26 is released, the delivery line 32 is withdrawn, and the annuloplasty is completed to reduce mitral regurgitation, such as Figure 4 shown.

[0115] The above description is only a specific implementation of the present application, so that those skilled in the art can understand or implement the present application. Various modifications to these embodiments will be apparent to those skilled in the art, and the general principles defined herein can be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application will not be limited to the embodiments shown herein, but will conform to the widest range consistent with the principles and novel features applied for herein.

Claims

1. A transcatheter repair system, comprising a sheath and an implant, wherein the implant comprises a flexible slender member, the sheath comprises a proximal portion and a distal portion, the flexible slender member is movably installed in the sheath, at least the developing intensity of the distal portion of the sheath is less than the developing intensity of the flexible slender member, the optical density of the developing image of the distal portion of the sheath is configured to be 0.5-1.2, and the optical density of the developing image of the flexible slender member is configured to be 1.5-2.

5.

2. The transcatheter repair system according to claim 1, characterized in that: The sheath tube comprises a first guiding sheath tube and a second guiding sheath tube, and the second guiding sheath tube is movably installed in the inner cavity of the first guiding sheath tube.

3. The transcatheter repair system according to claim 1, characterized in that: The sheath tube comprises an inner layer and a metal wire braided mesh sleeved outside the inner layer. The metal wire is a stainless steel wire with a wire diameter of 0.10 mm-0.15 mm.

4. The transcatheter repair system according to claim 3, characterized in that: The braided mesh includes a distal segment, a middle segment and a proximal segment; the braiding density of the distal segment is 20-35 PPI, the braiding density of the middle segment is 35-45 PPI, and the braiding density of the proximal segment is 45-60 PPI.

5. The transcatheter repair system according to claim 3, characterized in that: The sheath tube further comprises an outer layer sleeved outside the braided mesh, the outer layer is a polymer material layer, and the doping amount of barium sulfate in the polymer material layer is 20% to 30%.

6. The transcatheter repair system according to claim 1, characterized in that: The flexible elongated member comprises a main wire and a plurality of additional wires surrounding the main wire, wherein the main wire has a development strength greater than that of the additional wires.

7. The transcatheter repair system according to claim 6, characterized in that: The main filaments include developer filaments, wherein the cross-sectional area ratio of the developer filaments is 77%.

8. The transcatheter repair system according to claim 1, wherein: The flexible elongated member comprises at least one main thread and a plurality of additional threads, the main thread is distributed in a spiral shape, and the developing strength of the main thread is greater than the developing strength of the additional threads.

9. The transcatheter repair system according to claim 8, characterized in that: The braiding pitch of the flexible elongated member is 1.6 mm to 3.0 mm, and the volume proportion of the main filament per unit length is 17.7% to 24.3%.

10. The transcatheter repair system according to claim 6 or 8, characterized in that: The material of the main wire includes at least one of tantalum, gold, platinum and tungsten, and the material of the additional wire includes at least one of stainless steel and nickel titanium.

11. The transcatheter repair system according to claim 1, characterized in that: The flexible elongated member comprises a plurality of developing segments, and the plurality of developing segments are equidistantly distributed or distributed in increasing order from the distal end to the proximal end.

12. The transcatheter repair system according to claim 11, characterized in that: The implant further comprises a plurality of anchors connected to the flexible elongated member, and the developing section is constructed to determine whether each of the anchors is implanted in the expected position of the patient's valve ring and an identification mark of the annuloplasty ratio.

Images