Transcatheter repair system

Abstract

The present application provides a transcatheter repair system. The transcatheter repair system includes a sheath and an implant. The implant includes a flexible, slender member. The sheath includes a proximal portion and a distal portion. The flexible, slender member is movably mounted within 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. The optical density of the developing image of the flexible, slender member is configured to be 1.5-2.5. By simultaneously adjusting the optical density of the developing images of the sheath and the flexible, slender member, it is ensured that the flexible, slender member has the desired developing effect in the entire system.

Description

Technical Field

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

[0002] Mitral regurgitation (MR) is a common heart valve disease that includes primary MR and secondary MR. Primary MR is caused by mitral valve leaflet abnormalities, chordae tendineae rupture, or papillary muscle insufficiency, leading to poor anastomosis of the anterior and posterior mitral leaflets. Secondary MR is caused by annular dilatation, left atrial and ventricular enlargement, and poor anastomosis of the anterior and posterior mitral leaflets.

[0003] For secondary mitral regurgitation, valvular repair is typically performed through surgical thoracotomy with the implantation of an artificial ring. However, thoracotomy is particularly intrusive and can lead to poor postoperative recovery, making it unsuitable, particularly for elderly patients. In recent years, interventional mitral valve treatment has gained popularity and is rapidly gaining popularity due to its minimally invasive and safe nature.

[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, an anchor is connected to a ring closure wire and implanted into the mitral valve annulus via a transcatheter route. Multiple anchors are implanted sequentially at different locations of the mitral valve annulus. The multiple anchors at different locations of the annulus are tightened using the ring closure wire, which can reduce the patient's annulus size and alleviate mitral regurgitation.

[0005] However, during surgery, the anchor is connected to the retraction wire, creating a risk of entanglement and interference during implantation. Furthermore, it's difficult to determine the retraction wire's exact position and real-time status within the heart during surgery, which can affect surgical quality, increase surgical difficulty, and increase operative time.

[0006] Therefore, how to improve the developability of the loop line has become an urgent problem to be solved. Summary of the Invention

[0007] The purpose of this 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 this 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 status 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 part, the development effect of the flexible slender part 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 part 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 following briefly introduces the drawings required for use in the embodiments or the description of the prior art. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without any creative work.

[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 Schematic diagram of enlarged details of a transcatheter repair system in some embodiments

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

[0020] Figure 5 is a schematic structural diagram 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] Figure 9 Schematic diagram of the structure of the developing wire in the flexible elongated member in some embodiments;

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

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

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

[0028] Figure 13 A schematic diagram of the working process of a transcatheter repair system according to some embodiments;

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

[0030] Figure 15 This is a schematic diagram of enlarged details of a transcatheter repair system in some embodiments. DETAILED DESCRIPTION

[0031] For the sake of convenience, 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 Strength: Optical density D (measured by an optical densitometer) is used to define the clarity of the developed image. The optical density D value reflects the development strength of the part. The optical density D ranges from 0.0 to 3.0. A higher optical density value indicates a stronger development strength and better image development.

[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] To make the purpose, technical solutions, and advantages of the embodiments of this application more clear, the technical solutions in the embodiments of this application will be clearly and completely described below in conjunction with the drawings in the embodiments of this application. Obviously, the described embodiments are part of the embodiments of this application, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on certain embodiments of this application without making creative efforts are within the scope of protection of this application.

[0035] References throughout this specification to "one embodiment," "an embodiment," "in another embodiment," or "in certain embodiments" mean that at least one embodiment includes the particular referenced elements, structures, or features described in connection with that embodiment. Thus, appearances of the phrases "in some embodiments," "in an embodiment," "in other embodiments," or "in certain embodiments" in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular elements, structures, or features may be combined in any suitable manner in one or more embodiments.

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

[0037] The transcatheter repair system 1 of the present application can implant an implant 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 also 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 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. By cooperating with the sheath 10, a plurality of anchors 24 can be implanted in cardiac tissue (such as the mitral valve annulus, tricuspid valve annulus, left ventricular wall, and 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 annulus B to alleviate regurgitation. The following description will take the annuloplasty operation performed on the mitral valve annulus B by the catheter repair system 1 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 annulus B to maintain tension on the flexible elongated member 22, thereby maintaining the annuloplasty effect. Furthermore, in other embodiments, the locker 26 can be actuated to adjust the length of the flexible elongated member 22 on the annulus 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. During delivery of the implant 20, the flexible elongated member 22 is movably mounted within the sheath 10. The imaging intensity of at least the distal portion Y of the sheath 10 is less than that of the flexible elongated member 22. When the optical density of the developed image of the sheath 10, particularly the distal portion Y of the sheath 10, is configured to be 0.5 to 1.2, and the optical density of the developed image of the flexible elongated member 22 is configured to be 1.5 to 2.5, the optimal imaging effect of the flexible elongated member 22 in the entire system is achieved.

[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 status 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 the tissue and other components, so as to make better judgments and better reduce surgical risks.

[0044] It is important to emphasize that because the flexible elongated member 22 implanted in the heart typically overlaps with the distal portion Y of the sheath 10, the visualization effect of the sheath 10 can interfere with the visualization effect of the flexible elongated member 22 movably installed within its lumen, particularly the distal portion Y of the sheath 10. In various embodiments, whenever the flexible elongated member 22 is installed within the lumen of the sheath 10, it is necessary to ensure that the visualization strength of at least the distal portion Y of the sheath 10 is less than that of the flexible elongated member 22, so as to effectively achieve the visualization effect of the flexible elongated member 22 without affecting it.

[0045] In some embodiments, the transcatheter repair system 1 further includes a delivery wire 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 wire 32. It can be understood that the distal end of the flexible elongated member 22 is pre-connected to the first anchor 24. The flexible elongated member 22 and the delivery wire 32 are delivered into the patient's body along with the first anchor 24, and the proximal end of the delivery wire 32 extends outside the body. In this way, the remaining anchors 24, the lock 26, etc. can be installed on the flexible elongated member 22 through the delivery of the delivery wire 32, so that the flexible elongated member 22 can be selected to a suitable implantation length, thereby eliminating the need to cut the flexible elongated member 22 in the body, avoiding the shedding of particles on the wire, and making the operation safer.

[0046] In some embodiments, the proximal end of the flexible elongated member 22 forms a U-shaped connection with the distal end of the delivery line 32. The delivery line 32 can be easily separated from the flexible elongated member 22 by pulling the delivery line 32 outside the body. In other embodiments, the delivery line 32 can also be detachably connected to the flexible elongated member 22 by a threaded connection, a snap-fit ​​connection, or other means, which will not be described in detail.

[0047] In other embodiments, the transcatheter repair system 1 can omit the delivery wire 32, and the length of the flexible elongated member 22 is sufficiently long. After the flexible elongated member 22 enters the heart along 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 of the transcatheter repair system 1 including the delivery wire 32, the distal end of the flexible elongated member 22 connected to the first anchoring member 24, and the proximal end of the flexible elongated member 22 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 within the lumen of the first guide sheath 12. The first guide sheath 12 can be guided along a guidewire through the femoral vein, inferior vena cava, right atrium, and atrial septum to the left atrium. The second guide sheath 14 movably mounts within the lumen of the first guide sheath 12 and can be extended distally and adjusted to the vicinity of the mitral valve annulus B.

[0050] Optionally, the first guide sheath 12 and the second guide sheath 14 are both adjustable bend sheaths, so that the distal ends of the first guide sheath 12 and the second guide sheath 14 can be precisely adjusted to a suitable angle. Using two adjustable bend sheaths together can provide 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 a distal portion of the delivery sheath 16 is flexible. The delivery sheath 16 is movably mounted within the lumen of the second guide sheath 14. The anchor 24 is mounted within the delivery sheath 16 and is distally advanced within the second guide sheath 14 to deliver the anchor 24 to a desired location within 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 installed 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 mounted on the anchor 242. The anchor 24 is loaded into the delivery sheath 16 from the distal tube mouth 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 within the lumen of the second guide sheath 14. In this embodiment, the optical density of the developed 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 mounted within the lumen of the first guide sheath 12. The anchor 24 is loaded within the lumen of the delivery sheath 16, and the flexible elongated member 22 and the delivery wire 32 connected to the flexible elongated member 22 are located within the lumen of the delivery sheath 16. During the process of the delivery sheath 16 pushing the anchor 24, the delivery sheath 16 moves distally within the lumen of the second guide sheath 14, and the flexible elongated member 22 and the delivery wire 32 are located within the lumen of the delivery sheath 16. In this embodiment, the optical density of the developed 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 includes 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 serves to separate the anchoring members 24, thereby preventing the adjacent anchoring members 24 from being too closely pressed against each other during the tightening 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, i.e., the anchors 24 and the spacers 28 are staggered. Of course, a spacer 28 may also be provided between every two or more anchors 24, i.e., a spacer 28 may be provided between some adjacent anchors 24, while no spacer 28 may be provided between some adjacent anchors 24. The present invention is not limited to this.

[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 that is sheathed outside the inner layer 102, which can improve the overall support performance and torsional performance of the sheath 10. The outer layer 106 is sheathed 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, thermoplastic polyurethane elastomer rubber). During shaping, the sheath 10 is hot-melted as a whole, and the outer layer 106 of the polymer material melts and deforms 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 woven mesh 104 is made of stainless steel wire with weaker developability. The wire diameter of the stainless steel wire cannot be too small. Although a small wire diameter can effectively reduce the developability of the woven mesh, it is easy for the wire to break during the weaving process, affecting 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. An excessively large wire diameter will increase the developability of the woven 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 woven 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 bend sheath, it will seriously affect the bending performance of the sheath 10, increase the required bending force, and make it difficult to reach the designated 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] Table 1 shows the relationship between the wire diameter of the woven mesh 104 and the performance of the sheath 10 within a certain range. Preferably, the wires of the woven mesh 104 are stainless steel wires with a diameter of 0.10 mm to 0.15 mm. This ensures that the physical properties of the sheath 10 meet clinical requirements. Furthermore, the optical density of the developed image of the sheath 10 woven with stainless steel wire within this size range remains stable within the range of 0.8 to 1.2.

[0063] In some embodiments, the visualization properties of the sheath 10 are modified by adjusting the weave density of the weave mesh 104. Weave density refers to the number of meshes per unit length, typically expressed in PPI. In this application, the number of meshes per one inch is defined as the weave density PPI.

[0064] It should be noted that the metal wire braided mesh 104 is typically braided using a braiding machine with braiding mandrels of varying outer diameters. During the braiding process, the braided mesh 104 is wrapped around the outer surface of the braiding mandrel. The braiding density can be adjusted not only by the diameter of the braiding wires but also by varying the outer diameter of the braiding mandrel and the rotational speed of the braiding machine.

[0065] In some embodiments, based on the selection of metal wires of appropriate diameter, the smaller the outer diameter of the braiding mandrel, the smaller the braid density that can be achieved. The mandrel outer diameter can be selected to suit the inner diameter of the sheath 10, preferably within a range of 3F to 25F. This can prevent the braided mesh 104 from unraveling and becoming difficult to form due to excessive braid density.

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

[0067] In some embodiments, to facilitate the shaping of the braided mesh 104, facilitate production and use, and prevent deformation, the braided mesh 104 of the sheath tube 10 can be configured to have a braid density ranging from 5 to 100 PPI. A higher braided mesh 104 has a higher proportion of braided filaments per unit length, resulting in a higher optical density value of the developed image corresponding to the sheath tube 10 and a higher development intensity.

[0068] Table 2 shows the relationship between the braid density and the performance of the sheath tube 10, given a constant wire diameter for the braided mesh 104. Preferably, a braid density of 20 to 60 PPI is used. Within this range, the optical density of the developed image of the sheath tube 10 is less than 1.2. This effectively reduces the developability of the sheath tube 10 while maintaining its physical properties. This effectively reduces interference between the development of the sheath tube 10 and the development of the flexible elongated member 22, making the developed image of the flexible elongated member 22 easier to distinguish.

[0069]

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

[0071] It is particularly emphasized that, in some embodiments, the wire mesh 104 includes a distal segment 101, an intermediate 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, the braiding density of the distal segment 101 is set to 20-35 PPI, the braiding density of the intermediate 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 Table 2. Figure 6 As shown, the distal segment corresponds to the distal portion Y of the sheath 10. By reducing the visibility of the sheath 10, especially the visibility of the distal portion Y of the sheath 10, the visibility of the flexible elongated member 22 can be made more obvious while ensuring the support performance and bending force of the sheath 10, thereby further improving the safety of the operation.

[0072] Furthermore, in some embodiments, the ratio of barium sulfate doped into the polymer outer layer 106 of the sheath tube 10 can be adjusted before the tube body is hot-melt-formed to reduce the developability of the sheath tube 10. Specifically, the relationship between the barium sulfate doping ratio and the optical density of the developed image of the sheath tube 10 is shown in Table 3. Preferably, the barium sulfate doping level is 20% to 30%.

[0073]

[0074] Table 3 Corresponding relationship between the doping ratio of barium sulfate in 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 the additional wires 224. Figure 7 The development strength of the main wire 222 is greater than the development strength of the additional wire 224.

[0076] For example, the material of the main wire 222 includes at least one of tantalum, gold, platinum, and tungsten, all of which have excellent developability. The material of the additional wire 224 includes at least one of stainless steel and nickel titanium. This allows the main wire 222 to have a greater developability than the additional wire 224.

[0077] It should be noted 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. This will enhance the overall development of the flexible elongated member 22 and improve the compliance of the flexible elongated member 22.

[0078] When the optical density values ​​of the developed image of the distal portion Y of the sheath 10 are simultaneously adjusted to be within the range of 0.5 to 1.2, and the optical density difference between the two values ​​is at least greater than 0.3 (medical imaging regulations stipulate that an optical density difference between 0 and 0.2 indicates weak development, and an optical density difference greater than 0.2 indicates strong development), the relative position and state of the flexible elongated member 22 can be clearly identified during surgery. In other words, even when the flexible elongated member 22 is within the sheath 10, the position and state of the flexible elongated member 22 can be clearly identified.

[0079] In some embodiments, as Figure 7 As shown in Figures ad, the flexible elongated member 22 is made of multiple strands of silk, with a main strand 222 at its center and multiple strands of additional strands 224 surrounding the periphery. The main strand 222 can be a stranded strand braided from multiple strands of filaments 2220. Each additional strand 224 can also be a stranded strand braided from multiple strands of filaments 2220. The main strand 222 can also be composed of a single strand of filament 2220. The additional strands 224 can also be composed of a single strand of filament 2220.

[0080] In some embodiments, the outer diameter of the flexible elongated member 22 is 0.25 mm to 0.3 mm. Within this outer diameter range, the diameter of the single filament 2220 can be in the range of 0.025 mm to 0.03 mm, thereby ensuring good flexibility of the flexible elongated member 22 and a stable optical density value of the developed image of the flexible elongated member 22 of ≥ 1.5, resulting in excellent development performance.

[0081] In some embodiments, combined Figure 8 As shown, the main filament 222 includes a developing filament 2220, which is used to adjust the developing intensity of the main filament 222. Given the same outer diameter of the flexible elongated member 22, the developing intensity of the flexible elongated member 22 is adjusted by comparing the cross-sectional area ratio of the developing filament 2220 per unit cross-sectional area. A greater cross-sectional area ratio of the developing filament 2220 corresponds to a higher optical density of the corresponding developed image. The developing filament 2220 is made of at least one developing material selected from tantalum, gold, platinum, and tungsten.

[0082] Specifically, if the total outer diameter of the main thread 222 is set to 0.1 mm, when the main thread 222 is made of 1, 3, 5, and 7 strands of developing filament 2220, the cross-sectional area ratios of the developing filament 2220 are 100%, 64%, 68%, and 77%, respectively. To ensure both the developing properties and the flexibility of the developing filament 2220, the main thread 222 is preferably made of 7 strands of developing filament 2220, that is, the cross-sectional area ratio of the developing filament 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. Figure 9 As shown, the main thread 222 is spirally distributed within the flexible elongated member 22. The main thread has a greater development strength than the additional threads. For example, the main thread 222 is made of at least one of tantalum, gold, platinum, and tungsten, all of which have excellent development properties. The additional threads 224 are made of at least one of stainless steel and nickel-titanium. This ensures that the main thread 222 has a greater development strength than the additional threads 224.

[0084] Optionally, the flexible elongated member 22 is twisted together by a main thread 222 and an additional thread 224. The main thread 222 can be a twisted thread braided from multiple strands of filaments 2220. The additional thread 224 can be a twisted thread braided from multiple strands of filaments 2220. The main thread 222 can also be composed of a single strand of filament 2220. The additional thread 224 can also be composed of a single strand of 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 crests or troughs of 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, the smaller the braiding pitch L, the higher the frequency of single strands (referring to the main strands or additional strands) appearing per unit length H. Consequently, the higher the volume fraction of the main strands 222 (the volume fraction refers to the percentage of the volume of the main strands 222 per unit length H to the volume of all strands comprising the flexible elongated member 22) is, the higher the optical density of the corresponding developed image is, and the more pronounced the developing effect is.

[0087] In some embodiments, combined Figure 9 As shown, three flexible elongated members 22 have different braiding pitches L, with the braiding pitch L decreasing from left to right. The rightmost flexible elongated member 22 has the largest volume ratio of the main filament 222 per unit length H. The higher 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] In conjunction with Table 4, to ensure both good flexibility of the flexible elongated member 22 and an optical density greater than 1.5 for the developed image under DSA, thereby achieving excellent development performance and significantly reducing surgical risks, the braiding pitch L of the flexible elongated member 22 is preferably 1.6 mm to 3.0 mm. The volume ratio of the main filament 222 per 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 typically 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, to ensure both the tensile strength and developability of the flexible elongated member 22, the number of strands of the spirally distributed main strands 222 can be set to be less than or equal to 3, and the spacing between the spirals can be increased from near to far.

[0092] In some other embodiments, the flexible elongated member 22 includes a plurality of developing segments 221. Figure 10 As shown, segments A1, A2, and An represent imaging segments 221. These segments 221 serve as identification markers, confirming whether each anchor 24, mounted on the flexible elongated member 22, is implanted in the intended corresponding position within the patient's annulus. For example, prior to implantation, each anchor 24 is pre-assigned to a specific position within imaging segment 221, using imaging modalities such as ultrasound. During implantation, the relative position of each anchor 24 to its corresponding imaging segment 221 is determined in real time.

[0093] Preferably, the length of each developing segment 221 ranges from 5 mm to 12 mm. The spacing X between each two developing segments 221 ranges from 3 mm to 12 mm. The smaller the spacing between two adjacent developing segments, the greater the number of developing segments 221. The multiple developing segments 221 are equidistant or distributed in increasing order from the distal end to the proximal end.

[0094] In some embodiments, if the patient's annulus B is 90 mm to 100 mm long, the flexible elongated member 22 can be evenly arranged for segmented imaging, with the 90 mm to 100 mm interval from the distal end to the proximal end. To ensure optimal imaging of the flexible elongated member 22, preferably, the length A of each imaging segment 221 is 8 mm to 12 mm, and the spacing X between adjacent imaging segments is 3 mm to 5 mm. Furthermore, to allow sufficient space for the lock 26 to be retracted, 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, so as 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 as to be able to make real-time adjustments to the implantation position of each anchor 24 and improve the surgical effect.

[0096] In some embodiments, the implant 20 includes a plurality of spacers 28, each of which is mounted on a flexible, elongated member 22. The implant position of each spacer 28 and anchor 24 can be determined by determining whether the spacer 28 mounted on the flexible, elongated member 22 is located at the corresponding imaging segment 221 of the flexible, elongated member 22 as intended. If a deviation is detected between the position of the spacer 28 and the imaging segment 221 on the flexible, elongated member 22, it is determined that the implant position of the previous anchor 24 has deviated. When this deviation is identified, timely adjustments can be made during the subsequent implantation of the spacer 28 and anchor 24 to avoid cumulative errors that could result in a poor surgical outcome.

[0097] In other embodiments, by adjusting the length of the flexible elongated member 22 and the length and spacing of the imaging segments 221 and comparing them with the preoperatively measured length of the patient's annulus B, the imaging segments 221 can also serve as an indicator of the annuloplasty ratio. The length between the first and last imaging segments 221 of the flexible elongated member 22 is approximately equal to the preoperatively measured length of the patient's annulus B.

[0098] Optionally, the flexible elongated member 22 is evenly arranged as segmented development from the distal end to the proximal end for 90 mm to 100 mm, with the spacing X between two adjacent development segments 221 being 1 mm to 5 mm, and the length A of each development segment 221 being 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 imaging segments 221 on the flexible elongated member 22 as M. After the locker 26 is used for retraction, the number of imaging segments 221 remaining on the flexible elongated member 22 on the annulus B (i.e., the number of imaging segments 221 located outside the locker 26) is N. The patient's posterior annular length is C, and the posterior annular length contraction rate is β. Thus, β = [(MN) × (A + X)] ÷ C × 100%. This calculation can be compared with the preoperatively planned annuloplasty ratio to determine whether the desired annuloplasty 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 it with the preoperative 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, timely and real-time adjustments can be made, thereby improving 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, as Figure 12 As shown in Figure a, multiple additional strands of thread 224 are arranged around the outside of the main thread 222. The additional threads 224 either have no developing properties or have significantly lower developing strength than the main thread 222. The developing segments 221 are arranged in sections on the main thread 222 and are evenly distributed within the flexible elongated member 22. This effectively prevents the developing segments 221 from long-term contact and wear with the multiple anchors 24 or spacers 28, thus protecting the developing segments 221.

[0104] In some embodiments, as Figure 12 As shown in FIG. 2 , a highly developable tantalum wire, gold wire, platinum wire, or the like is wound segmentally around the outer surface of the flexible elongated member 22 to form a developing section 221. Alternatively, the outer surface of the flexible elongated member 22 is electroplated with a highly developable heavy metal material such as gold, platinum, tantalum, or iridium to form the developing section 221.

[0105] In other embodiments, Figure 12 As shown in c, developing ink is sprayed in sections or developing cloth 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, Figure 13 As shown in FIG. 13 a-13b , a developing section 221 is integrally provided on the flexible elongated member 22. For example, the flexible elongated member 22 may be entirely wrapped with tantalum wire, sewn with developing fabric, coated with developing ink, or otherwise coated, thereby imparting developing properties to the entire flexible elongated member 22. This arrangement not only achieves development but also increases friction, preventing the anchor members 24 from sliding easily on the flexible elongated member 22, thereby preventing variations in the relative distances between the multiple anchor members 24.

[0107] In some embodiments, a sleeve (not shown) can also be sewn onto 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 the entire sleeve have developing properties. 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 become better integrated with the tissue.

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

[0109] Step 1: Through femoral vein puncture, a trajectory of femoral vein-inferior vena cava-right atrium-atrial septum-left atrium-mitral valve annulus is established using a guidewire and an atrial septal puncture device (not shown).

[0110] Step 2: The first guide sheath 12 is advanced along the guide wire until its distal end passes through the foramen ovale and reaches the left atrium. The guide wire is withdrawn, and the second guide sheath 14 is freely inserted into the first guide sheath 12 to establish an in vitro-in vivo passage. The first guide sheath 12 and the second guide sheath 14 are adjusted so that the distal end of the second guide sheath 14 faces the appropriate expected position of the valve annulus B.

[0111] Step 3: Use the delivery sheath 16 to advance 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 elongated member 22 is pre-connected with the first anchor 24, and the delivery line 32 is connected to the proximal end of the flexible elongated member 22. When delivering the anchor 24, the flexible elongated 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 rests against the predetermined treatment site of the annulus B, which can ensure that the anchor 24 is implanted stably and accurately.

[0112] The fourth step is as follows 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 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 annulus B by pushing the delivery sheath 16. Then, the second anchor 24 is implanted into the annulus B.

[0113] In the fifth step, step four is repeated, starting from the anterior trigone of the mitral valve and moving along the posterior annulus B to the posterior trigone or vice versa, sequentially implanting multiple anchors 24 into the annulus B. Meanwhile, spacers 28 are sequentially inserted between every two anchors 24, so that multiple anchors 24 and multiple spacers 28 are staggeredly distributed on the annulus 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 annulus B, and the distance from the previous anchor 24 needs to be greater than the axial length of the spacer 28.

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

[0115] The foregoing is merely a list of specific embodiments of the present application, intended to enable those skilled in the art to understand or implement the present application. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present application. Therefore, the present application is not limited to the embodiments shown herein, but is intended to conform to the broadest scope consistent with the principles and novel features of the present application.

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 mounted within 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, wherein: The sheath tube includes 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, wherein: 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 to 0.15 mm.

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

5. The transcatheter repair system according to claim 3, wherein: 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, wherein: The flexible elongated member includes a main wire and a plurality of additional wires surrounding the main wire, wherein the main wire has a greater developing strength than the additional wires.

7. The transcatheter repair system according to claim 6, wherein: The main filament includes a developing filament, wherein the cross-sectional area ratio of the developing filament is 77%.

8. The transcatheter repair system according to claim 1, wherein: The flexible elongated member includes at least one main thread and multiple 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, wherein: 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, wherein: The flexible elongated member includes a plurality of developing segments, and the plurality of developing segments are equidistant or distributed in increasing order from the distal end to the proximal end.

12. The transcatheter repair system according to claim 11, wherein: The implant further comprises a plurality of anchors connected to the flexible elongated member, and the imaging section is configured to determine whether each of the anchors is implanted at a desired position of the patient's valve annulus and an identification mark of annuloplasty ratio.

Images