A pipe fitting for a leaflet capture ring and a leaflet capture ring

Abstract

The present invention belongs to the field of medical devices, and discloses a pipe fitting for a leaflet fishing ring and a leaflet fishing ring. The pipe fitting includes a pipe fitting body, and the pipe fitting body is a hollow structure. The pipe fitting body is a hollow structure, and a plurality of main cuts are longitudinally arranged on the pipe wall along the pipe fitting body; a protrusion and a groove adapted to the protrusion are provided in the main cut, the protrusion can extend into the groove, and the extension line of the protrusion of each main cut extending into the groove is the direction line of the main cut; the included angle between the direction line of at least one main cut and the longitudinal axis of the pipe fitting body is an acute angle, and this type of main cut is an inclined main cut. The protrusion and the groove on the pipe fitting limit the bending path, and the direction line of the main cut and the longitudinal axis of the pipe fitting body are acute angles. In addition, the curvature of the bending of the pipe fitting can be adjusted through the shaping wire, so as to realize the controllable bending shape of the pipe fitting.

Description

Technical Field

[0001] The present invention relates to the field of medical devices, and particularly to a pipe fitting for a leaflet capture ring and a leaflet capture ring. Background Art

[0002] Cardiac valvular disease is a common heart disease in China, which refers to the lesions of the mitral valve, tricuspid valve, aortic valve and pulmonary valve due to rheumatic fever, mucoid degeneration, degenerative changes, congenital malformations, ischemic necrosis, infection or trauma, etc., affecting the normal flow of blood, thus causing abnormal heart function and ultimately leading to single-valve or multi-valve lesions of heart failure. Valve regurgitation is a manifestation of cardiac valvular disease, usually caused by natural leaflet defects, chordae tendineae rupture, papillary muscle injury, etc. Surgical treatments such as artificial heart valve replacement or valvuloplasty are the radical treatment methods for cardiac valvular disease.

[0003] The mitral valve, aortic valve and tricuspid valve are relatively prone to diseases. With the aging of the population, there are more and more patients with valvular disease. Many elderly patients cannot tolerate conventional surgical operations. Transcatheter valve replacement and valvuloplasty use interventional catheter technology to deliver an artificial heart valve or annulus to the valve position, so as to efficiently complete artificial valve implantation, restore valve function, and solve the disadvantages of conventional surgical operations such as a large amount of bleeding and slow recovery. The present invention proposes a solution to the problem that the current transcatheter annulus of the interventional valve system is soft in texture, easy to change with the pulsation of the cardiac cycle, not easy to fix, and there is a problem of being unable to effectively anchor the valve, so as to facilitate the operation of doctors and save surgical time. Summary of the Invention

[0004] The purpose of the present invention is to provide a pipe fitting for a leaflet capture ring and a leaflet capture ring, which is not only easy to arrange the pipe fitting to a suitable position, but also the bending shape of the pipe fitting is controllable, which is beneficial to surgical operations under image guidance, reduces the difficulty of surgical operations. In addition, the formed capture ring can also provide a radial force to effectively anchor the artificial valve at the mitral valve leaflet.

[0005] The technical solution provided by the present invention is as follows:

[0006] On the one hand, a pipe fitting for a leaflet capture ring is provided, which has a pipe fitting body. The pipe fitting body is a hollow structure, and a plurality of main cuts are longitudinally arranged on the pipe wall along the pipe fitting body;

[0007] A protrusion and a groove adapted to the protrusion are provided in the main cut. The protrusion can extend into the groove, and the extension line of the protrusion extending into the groove of each main cut is the direction line of the main cut; the included angle between the direction line of at least one main cut and the longitudinal axis of the pipe fitting body is an acute angle, and the main cut with an acute included angle is an inclined main cut.

[0008] In this solution, a main incision is provided on the pipe fitting, which can provide a suitable radial deformation space for the bending of the pipe fitting. The protrusion extends into the groove, and the protrusion and the groove can limit the bending path of the pipe fitting. The path of the shaping wire does not need to be limited. During the operation, when the pipe fitting is delivered distally, it bends while being delivered, and the curvature of the front end of the pipe fitting can be adjusted, which not only facilitates the placement of the pipe fitting in place, but also improves the operation flexibility of the doctor during the operation and saves the operation time. The arrangement form of the protrusion and the groove will directly affect the mechanical properties of the pipe fitting at this position. Therefore, the design of the inclined main incision in this solution can adjust the coil pitch after the pipe fitting is bent and formed at the specified position, and further affect the curvature and coil diameter of the coiled part formed after the pipe fitting is bent by the action of the shaping wire.

[0009] Further preferably, at least two adjacent inclined main incisions are included on the pipe fitting body, and the direction lines of the adjacent inclined main incisions are spirally arranged along the longitudinal direction of the pipe fitting, and the helix angle of the spiral arrangement is a fixed value. The longitudinal region where the adjacent inclined main incisions are located is a pipe section.

[0010] In this technical solution, the direction lines of the adjacent inclined main incisions are spirally arranged along the longitudinal direction of the pipe fitting, and the concentrated arrangement of the inclined main incisions with the same helix angle of the direction line spiral arrangement, that is, when the direction line of the inclined main incision is on the same straight line (in the unfolded state of the pipe fitting), the longitudinal region where such adjacent inclined main incisions are located is defined as a pipe section. That is, the bending direction defined by the groove and the protrusion in this pipe section is more regular, and the pipe section can be bent along this bending direction, so as to more precisely control the mechanical parameters of the specified area of the pipe fitting, and then change the curvature and coil diameter of the corresponding position of the coiled part.

[0011] Specifically, a plurality of pipe sections are provided on the pipe fitting body;

[0012] Or, only one pipe section is provided on the pipe fitting body;

[0013] Or, a plurality of adjacent pipe sections are provided on the pipe fitting body.

[0014] Preferably, the adjacent main incisions have at least two longitudinal spacing values along the pipe fitting body.

[0015] In this technical solution, the softness and hardness of each section of the pipe fitting body can be controlled through the longitudinal spacing of the incision, and the smaller the spacing, the softer the pipe fitting, so as to control the size of each section after bending under the action of the same pulling force.

[0016] Preferably, the protrusion and the groove are located at the transverse center of the main incision, and the longitudinal dimension of the main incision gradually decreases from the center of the main incision to the edge of the main incision.

[0017] In this solution, the protrusions and grooves are located at the transverse center of the main incision, that is, the main incision is symmetric about both sides of the deformation path, and the width of the main incision gradually decreases from the symmetric center to both sides. This shape conforms to the deformation amounts of various parts of the pipe fitting during bending.

[0018] Furthermore, the pipe fitting further includes auxiliary incisions, and the main incision and the auxiliary incisions are not connected to each other; the auxiliary incisions are located between two adjacent main incisions, and the auxiliary incisions and the main incisions are oppositely arranged on the circumference of the pipe fitting body.

[0019] In this technical solution, by providing auxiliary incisions on the pipe fitting, the radial tension required when the pipe fitting is bent along the main incision can be reduced, making it easier for the pipe fitting as a whole to bend and deform.

[0020] Furthermore, the pipe fitting further includes auxiliary incisions, and the main incision and the auxiliary incisions are not connected to each other; the auxiliary incisions are located between two adjacent main incisions, and the auxiliary incisions and the main incisions are oppositely arranged on the circumference of the pipe fitting body; the arrangement direction of the auxiliary incisions is the same as the direction line of the main incision in the pipe section where the auxiliary incisions are located.

[0021] On the other hand, a leaflet capture ring is also provided, which includes a shaping wire, a fixing member, and the above-mentioned pipe fitting for the leaflet capture ring;

[0022] The pipe fitting includes a proximal end and a distal end;

[0023] The fixing member is arranged at the proximal end of the pipe fitting;

[0024] The shaping wire is arranged inside the pipe fitting, and one end of the shaping wire is fixed at the distal end of the pipe fitting, and a radial tension is applied to the pipe fitting, so that the pipe fitting is bent to form a fastening coil for surrounding the leaflet. When the pipe fitting is bent and formed, the other end of the shaping wire is fastened to the proximal end of the pipe fitting through the fixing member.

[0025] In this solution, the mitral valve leaflets are captured by the pipe fitting by delivering the pipe fitting to the distal end faster than the shaping wire. Alternatively, after the pipe fitting and the shaping wire are delivered to the distal end at the same speed for a short distance, the shaping wire is tightened towards the proximal end by a pulling wire to adjust the bending degree of the pipe fitting. The above actions are repeated multiple times to complete the arrangement of the capture ring at the mitral valve leaflets. Among them, the finally bent shape of the capture ring is related to the length difference between the shaping wire and the pipe fitting in the capture ring and the spacing between adjacent main incisions of the pipe fitting. The length difference between the shaping wire and the pipe fitting directly determines the radial force provided by the capture ring for the stent.

[0026] Further preferably, the fixing member is a barbed limiting member;

[0027] A shaping limiting member is connected to the end of the shaping wire far from the distal end of the pipe fitting, and the shaping limiting member moves inside the pipe fitting along with the shaping wire;

[0028] When the pipe fitting is bent and formed, the shaping and limiting member extends out of the proximal end of the pipe fitting and is clamped with the fixing member to fix the shaping wire.

[0029] Further preferably, a radially penetrating opening is provided at the distal end of the fixing member, which is used to reduce the diameter of the opening end of the fixing member when it is pressed and enable it to move within the pipe fitting. When the opening end of the fixing member is not pressed, the diameter of the opening end of the fixing member becomes larger, so that the opening end of the fixing member is clamped with the proximal end of the pipe fitting to fix the shaping wire.

[0030] In this solution, after the fishing ring is completely implanted, the distal end of the fixing member passes through the proximal end of the pipe fitting and finally is clamped on the end face of the proximal end of the pipe fitting to realize the fixation of the shaping wire.

[0031] Further preferably, it further includes a film layer, and the film layer covers the outer side wall of the pipe fitting and extends longitudinally along the pipe fitting to the distal end and the proximal end of the pipe fitting.

[0032] In this solution, the film layer can be made of a material with a relatively large friction force to increase the friction force between the fishing ring and the stent, prevent the fishing ring from unwinding, and maintain the relative position between the fishing ring and the stent.

[0033] Further preferably, the fastening coil includes multiple turns of coils, and the diameter of each turn of the coil is equal or increases sequentially in the direction from the proximal end to the distal end of the pipe fitting.

[0034] Further preferably, the maximum inner diameter of the fastening coil is smaller than the outer diameter of the leaflet.

[0035] Further preferably, when the pipe fitting is bent, a lower coil extending from the lower end of the fastening coil is also formed, and the diameter of the lower coil is larger than the maximum diameter of the fastening coil.

[0036] and / or,

[0037] When the pipe fitting is bent, an upper coil extending from the upper end of the fastening coil is also formed, and the diameter of the upper coil is larger than the maximum diameter of the fastening coil.

[0038] In this solution, in this solution, the diameter of the lower coil is set to be larger so as to more easily surround the leaflets and / or chordae tendineae in the mitral valve to navigate the fishing ring; the diameter of the upper coil is larger, and the upper coil can be positioned in the circulatory system (such as the left atrium) so that the fishing ring can be stabilized through the upper coil.

[0039] The technical effect of the present invention lies in:

[0040] 1. When the pipe fitting is delivered to the distal end, by applying an axial traction force to the shaping wire, the pipe fitting bends while being delivered. The protrusions and grooves on the pipe fitting limit the bending path, and the curvature of the front end of the pipe fitting can be adjusted through the shaping wire, so that the bending shape after the pipe fitting is bent and formed is controllable. This not only facilitates the placement of the pipe fitting in place, but also improves the operation flexibility of the doctor during the operation and saves the operation time.

[0041] 2. The design of the inclined main incision enables the protrusion of the main incision to extend to form an angle with the longitudinal axis of the pipe fitting body at the extension line of the groove, which can better and more precisely control the dimensional parameters of the coiled part formed by the pipe fitting.

[0042] 3. Design a region where the direction lines of adjacent inclined main incisions are spirally arranged longitudinally along the pipe body at the same rising angle to form a pipe section with a more regular bending direction. Through the arrangement of this pipe section and the setting of the rising angle, the coil pitch after the pipe fitting is bent and formed is adjusted according to actual needs to achieve different radial forces of the coil on the stent. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The present invention will be further described in detail below in conjunction with the drawings and specific embodiments:

[0044] Figure 1 is the unfolded structural schematic diagram of the pipe fitting for the leaflet capture ring of the present invention;

[0045] Figure 2A is the cutting programming diagram of a structure of the pipe fitting for the leaflet capture ring of the present invention;

[0046] Figure 2B is the cutting programming diagram of another structure of the pipe fitting for the leaflet capture ring of the present invention;

[0047] Figure 3 is the three-dimensional structural schematic diagram of the pipe fitting for the leaflet capture ring of the present invention;

[0048] Figure 4 is the cross-sectional view of an embodiment when the leaflet capture ring of the present invention is not bent;

[0049] Figure 5 is Figure 4 the cross-sectional view when the shaping limit member and the barb limit member in

[0050] Figure 6 is the structural schematic diagram of the shaping limit member of the present invention;

[0051] Figure 7 is the structural schematic diagram of an embodiment of the fixing member of the present invention;

[0052] Figure 8 is the cross-sectional view of another embodiment when the leaflet capture ring of the present invention is not bent;

[0053] Figure 9 It is a schematic structural view of another embodiment of the fixing member of the present invention;

[0054] Figure 10 It is a schematic structural view of a kind of the leaflet fishing ring of the present invention after bending;

[0055] Figure 11 It is another schematic structural view of the leaflet fishing ring of the present invention after bending;

[0056] Figure 12 It is a schematic view when the leaflet fishing ring of the present invention is arranged in place;

[0057] Figure 13 It is a schematic view after a stent is implanted in the leaflet fishing ring of the present invention.

[0058] Explanation of the reference numerals in the drawings:

[0059] 1. Pipe fitting; 11. Pipe fitting body; 111. Main incision; 112. Sub-incision; 113. Protrusion; 114. Groove; 12. Proximal end; 13. Distal end; 14. Fastening coil; 15. Lower coil; 16. Upper coil; 17. Transition section; 21. Shaping wire; 22. Pulling wire; 3. Fixing member; 31. Barbs; 32. Opening; 4. Shaping limiting member; 41. Round hole; 5. Stent; 6. Mitral valve; 61. Chordae tendineae; 7. Membrane layer. Detailed implementation manners

[0060] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the following will briefly introduce the drawings required for use in the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings.

[0061] For the sake of simplicity of the drawings, only the parts related to the present invention are schematically shown in each figure, and they do not represent the actual structure of the product as a whole. In addition, for the sake of simplicity and understanding of the drawings, in some figures, for the components with the same structure or function, only one of them is schematically shown, or only one of them is marked. In this document, "one" not only means "only one", but also means the situation of "more than one".

[0062] It should be further understood that the term "and / or" used in the description of the present application and the appended claims refers to any combination and all possible combinations of one or more of the associated listed items, and includes these combinations.

[0063] In this text, it should be noted that unless otherwise clearly stipulated and defined, the terms "installation", "connection", and "linkage" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, and it can be the communication inside two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0064] In addition, in the description of this application, the terms "first", "second", etc. are only used for differential description and cannot be understood as indicating or implying relative importance.

[0065] In order to more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the specific embodiments of the present invention will be described below with reference to the accompanying drawings. Obviously, the accompanying drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can be obtained based on these drawings, and other embodiments can also be obtained.

[0066] The present invention provides an embodiment of a pipe fitting for a leaflet capture ring. Figure 1 It is a schematic diagram of the unfolded structure of the pipe fitting for the leaflet capture ring of the present invention; Figure 2A and Figure 2B It is a cutting programming diagram of the pipe fitting for the leaflet capture ring of the present invention; Figure 3 It is a schematic perspective view of the pipe fitting for the leaflet capture ring of the present invention. The following will be combined with Figures 1-3 to describe in detail the pipe fitting for the leaflet capture ring involved in the embodiments of this application.

[0067] As Figures 1 to 3 shown, the pipe fitting 1 includes a pipe fitting body 11. The pipe fitting body 11 is a hollow structure, and a plurality of main cuts 111 are arranged longitudinally along the pipe fitting body 11 on the pipe wall, and the plurality of cuts are arranged longitudinally along the pipe fitting body 11. A protrusion 113 and a groove 114 adapted to the protrusion 113 are provided in the cut 111, and the protrusion 113 extends into the groove 114. The so-called longitudinal direction of the pipe fitting body 11 refers to the length direction of the pipe fitting body 11. Correspondingly, the transverse direction of the pipe fitting body 11 refers to the width direction of the pipe fitting body 11.

[0068] Define the extension line from the protrusion 113 to the groove 114 of each main cut 111 as the direction line of the main cut 111. The included angle between the direction line of the first type of main cut and the longitudinal axis of the pipe fitting body 11 is an acute angle. The main cut with such an acute angle is an inclined main cut. In the pipe fitting body 11 of this embodiment, at least one inclined main cut is provided. Refer to Figure 1 、 Figure 2A 、Figure 2B The main incisions shown are all inclined main incisions, and the state they present is the unfolded state of the pipe body 1, Figure 3 which is the three-dimensional structural form of the pipe body 1. The inclined main incision can change the mechanical properties at the corresponding position. Therefore, in this solution, the design of the inclined main incision can adjust the coil pitch after the pipe fitting 1 is bent and formed at a specified position, and further affect the curvature and coil diameter of the coiled part formed after the pipe fitting 1 is bent by the shaping wire. Correspondingly, the included angle between the direction line of the second type of main incision and the longitudinal axis is 0 degrees, and this type of main incision is defined as a flush main incision; in this embodiment, it is not restricted whether there is such a flush main incision on the pipe fitting body 11.

[0069] Preferably, the pipe fitting body 11 includes at least two adjacent inclined main incisions, and the direction lines of the inclined main incisions are located on the same straight line in the unfolded state of the pipe fitting 1; the longitudinal region where the adjacent inclined main incisions that meet the above conditions are located is defined as a pipe section. That is, the included angle between the direction line of the main incision in each pipe section and the longitudinal axis of the pipe fitting body 11 is equal, and the included angle is an acute angle. The foregoing shape characteristics are all described based on the unfolded state of the pipe fitting 1. Refer to Figure 3 as shown, its performance in the three-dimensional state of the pipe fitting 1 is: the direction lines of the adjacent inclined main incisions are arranged in a longitudinal helix along the pipe fitting 1, and the helix angle of the helix arrangement is a fixed value. The meaning of the helix arrangement is that the direction lines of the main incisions of the inclined main incisions in this pipe section should all be arranged on a helix. Of course, this helix does not actually exist, but the direction lines of the main incisions are arranged in the form of a helix.

[0070] The so-called helix angle is the included angle between the tangent line at any point on the direction line of the main incision 111 and the normal section of the pipe fitting body 11. The shape characteristics of the three-dimensional state and the unfolded state correspond to each other, that is, the helix after the three-dimensional state is unfolded should be a straight line. If the pipe fitting body 11 is a cylindrical pipe fitting, then this helix should be a cylindrical helix, and the inclination angle of the tangent line at each point on the helix to the normal section of the cylinder is equal, and this angle is called the helix angle of the cylindrical helix. Refer to Figure 1 and Figure 2A it can be known that the θ angle should be the complementary angle of the foregoing helix angle.

[0071] In addition, it should also be noted that in this embodiment, the direction lines of the adjacent inclined main incisions are arranged in a longitudinal helix along the pipe fitting 1, and it is not required that the direction lines of the inclined main incisions can be connected to form a helix that winds multiple turns, but as long as the direction lines of any two adjacent inclined main incisions are arranged along a certain part of a virtual helix.

[0072] There are the following several distribution forms of the pipe section.

[0073] Refer to Figure 2AAs shown, only one pipe section is provided on the pipe fitting body 11, that is, the inclined main incision direction lines on the pipe fitting body 11 are all on the same straight line in the unfolded state of the pipe fitting 1, the included angles between the inclined main incision direction lines and the longitudinal axis of the pipe fitting body 11 are equal, and the inclined main incisions are adjacent to each other to form a single pipe section. On the wall of the pipe fitting body 11, it can be cut according to Figure 2A the incision shape shown in the actual cutting programming diagram or a similar incision shape. As Figure 2A shown, "θ" refers to the included angle between the direction line of the main incision 111 and the longitudinal axis, "d" refers to the outer diameter of the pipe fitting body 11, and the unfolded view of the pipe fitting body shown in the figure. Since Figure 2A only includes one pipe section, the included angles between the direction lines of all the main incisions 111 in the pipe section and the longitudinal axis are equal, that is, the θ angle marked in the figure.

[0074] Referring to Figure 2B shown, at least three adjacent pipe sections are provided on the pipe fitting body 11, the included angles between the direction lines of the main incisions 111 of the adjacent pipe sections and the longitudinal axis of the pipe fitting body 11 are different, namely θ1, θ2, and θ3 respectively, and the pipe sections may also be arranged at intervals, that is, there are flush main incisions or irregularly arranged incisions arranged at intervals between two pipe sections. The number of pipe sections on the pipe fitting body 11 may also be 2, adjacent or not adjacent.

[0075] In summary, pipe sections with different or the same included angles of the inclined main incision direction lines can be set at different positions of the pipe fitting 1 as needed to adjust the coil diameter and pitch after the fishing ring is bent and formed to fit different brackets 5. The direction lines of the inclined main incisions 111 in the same pipe section are arranged along the same spiral line, which can make the pitches between the coils of the coiled parts formed after the pipe section in this area is bent equal; the direction line angles of the inclined main incisions 111 between different pipe sections are the same or different, which can make the coils of the coiled parts formed after different pipe sections are bent have different pitches.

[0076] Further preferably, referring to Figure 1 shown, the main pipe 1 further includes a secondary incision 112 that is not connected to the main incision 111. The secondary incision 112 is located between two adjacent main incisions 111, and the secondary incision 112 and the main incision 111 are oppositely arranged on the circumference of the pipe fitting body 11.

[0077] Specifically, the pipe fitting body 11 is a hollow pipe with a certain length, and the pipe fitting body 11 can be made of a metal biomaterial (such as nitinol, 316 stainless steel, etc.). Figure 1 shows a schematic structural view of the pipe fitting body 11 unfolded into a sheet. Figure 1The left-to-right direction in the figure is the longitudinal direction of the pipe fitting body 11. The pipe fitting body 11 can be a tubular structure formed by splicing the two long sides of a long strip-shaped sheet, or a directly integrally formed tubular structure.

[0078] The pipe fitting body 11 is provided with a plurality of incisions along the longitudinal direction. The incisions include main incisions 111 and secondary incisions 112. The main incisions 111 divide the pipe fitting body 11 into a plurality of connected regions. At each main incision 111, a protrusion 113 and a groove 114 adapted to the protrusion 113 are formed. The protrusion 113 extends into the groove 114 to limit the deformation path of the pipe fitting body 11 through the protrusion 113 and the groove 114. The secondary incisions 112 are located between two adjacent main incisions 111. Preferably, the secondary incisions 112 are located exactly in the middle between two adjacent main incisions 111. The setting of the secondary incisions 112 can reduce the hardness of the region between two main incisions 111, thereby reducing the radial tension required when the pipe fitting body 11 bends along the main incisions 111, making it easier for the pipe fitting body 11 to bend and deform. Optionally, the arrangement direction of the secondary incisions 112 is the same as the direction line of the main incisions 111 in the pipe section where they are located. The arrangement direction of the secondary incisions 112 can be represented by the connection line of the central positions on the secondary incisions 112.

[0079] As Figure 4 shown, when the pipe fitting 1 is used for the artificial valve capture ring, the capture ring is formed by bending the pipe fitting 1. When the pipe fitting 1 is bent into a capture ring, a shaping wire 21 can be arranged inside the pipe fitting 1. One end of the shaping wire 21 is fixed to the distal end 13 of the pipe fitting 1. The distal end 13 of the pipe fitting 1 refers to the end far from the external operation end. When the pipe fitting 1 is delivered through a catheter, the delivery speed of the pipe fitting 1 to the distal end 13 is faster than that of the shaping wire 21, or after the pipe fitting 1 and the shaping wire 21 are delivered to the distal end 13 at the same speed for a short section, the shaping wire 21 is tightened towards the proximal end 12 to adjust the bending degree of the pipe fitting 1 to form a capture ring. The above actions are repeated multiple times to complete the arrangement of the capture ring at the mitral valve leaflet. The capture ring bends while being delivered to the distal end 13, and the curvature of the front end of the capture ring is adjustable during the operation. When it needs to be retrieved during the pushing process, first deliver the shaping wire 21 a certain length towards the distal end, so that the bent part of the pipe body of the catheter is stretched, and then retrieve the capture ring. At this time, the retrieval resistance is very small. After the capture ring is successfully implanted in its entirety, the overall shape is controllable, which is conducive to the operation of the surgery under image guidance and provides flexibility for the doctor's operation during the surgery. As Figure 12 and Figure 13 shown, during the specific surgical process, the capture ring is pre-arranged at the mitral valve 6 in advance to reduce the opening cross-sectional size of the mitral valve leaflet. Subsequently, the stent 5 is implanted and fixed inside the arranged capture ring, and the inner diameter of the capture ring is smaller than the outer diameter of the stent 5. When the stent 5 is expanded, it will receive a radial force from the capture ring, making it not easy for the stent 5 to shift.

[0080] When the pipe fitting 1 is bent under the axial traction of the shaping wire 21, the main incision 111 provides a suitable radial deformation space for the bending of the pipe fitting 1, and the protrusion 113 on the pipe fitting 1 extends into the adjacent groove 114. When the pipe fitting 1 is bent, the protrusion 113 will only further enter the groove 114 and will not break out of the groove 114. Therefore, the protrusion 113 and the groove 114 on the pipe fitting 1 can limit the bending path of the pipe fitting 1, and there is no need for the shaping wire 21 inside the pipe fitting 1 to set a special path to guide the bending of the pipe fitting 1. The path of the shaping wire 21 does not need to be positioned. After the pipe fitting 1 is bent, the path of the shaping wire 21 will naturally follow the path of the protrusion 113 and the groove 114.

[0081] When the lengths of the pipe fitting 1 and the shaping wire 21 are fixed, pipe sections with different or the same inclination angles of the main incision direction lines can be set at different positions of the pipe fitting 1 as needed to adjust the pitch after the pipe fitting 1 is bent. Different pitches can affect the number of turns of the coil wound around the stent 5 and the length of a single turn of the functional coil, and further affect the radial force provided to the stent 5. For example, when the stent 5 is relatively small, the pitch between the coils after the pipe fitting 1 is bent can be reduced, and the pipe fitting 1 obtains a shorter unfolded length of a single turn of the functional coil after being bent. During the expansion process of the stent 5, a smaller deformation space is provided, so that the stent 5 receives sufficient radial force after expansion; if the pitch is set larger, the unfolded length of a single turn of the functional coil is longer, and the radial force received by the stent after expansion becomes smaller. When the stent 5 is relatively large, the pitch can be appropriately increased to form a suitable unfolded length of a single turn of the functional coil to ensure that sufficient radial force can be provided to the stent 5 to anchor the mitral valve leaflets.

[0082] Preferably, the adjacent main incisions 111 have at least two longitudinal spacing values along the pipe fitting body 11, that is, the main incisions 111 have different longitudinal spacings along the longitudinal direction of the key body and can be set as needed to adjust the softness and hardness of each section of the pipe fitting body 11 to control the dimensions of each section after bending under the action of the same tensile force. The protrusion 113 and the groove 114 are located at the transverse center of the main incision 111, and the longitudinal dimension of the main incision 111 gradually decreases from the center of the main incision 111 to the edge of the main incision 111. Here, the transverse and longitudinal directions still refer to the pipe fitting body 11, that is, the length direction of the pipe fitting body 11 is the longitudinal direction, and the width direction of the pipe fitting body 11 is the transverse direction. By adjusting the spacing between the adjacent main incisions 111, the softness and hardness of each section of the pipe fitting body 11 can be controlled to facilitate the bending and forming of the pipe fitting 1. The protrusion 113 and the groove 114 are located at the transverse center of the main incision 111, that is, the main incision 111 is symmetric about both sides of the deformation path, and the width of the main incision 111 gradually decreases from the symmetric center to both sides. This shape is more in line with the deformation amount of each part of the pipe fitting 1 during bending.

[0083] The present invention also provides an embodiment of a leaflet capture ring, such as Figure 4 、 Figure 8, Figure 10 and Figure 11 As shown, it includes a shaped wire 21, a fixing member 3, and the pipe member 1 for the leaflet capture loop in the above embodiment; the pipe member 1 includes a proximal end 12 and a distal end 13; the fixing member 3 is arranged at the proximal end 12 of the pipe member 1; the shaped wire 21 is arranged inside the pipe member 1, and one end is welded to the distal end 13 of the pipe member 1. By applying a radial tension to the pipe member 1, the pipe member 1 is bent to form a fastening coil 14 for surrounding the leaflet. When the pipe member 1 is bent and formed, the other end of the shaped wire 21 is fastened to the proximal end 12 of the pipe member 1 through the fixing member 3.

[0084] Specifically, the capture loop includes a pipe member 1, a shaped wire 21, and a fixing member 3. These parts are all made of biocompatible materials, and according to the stent material to be implanted later, materials with a low metal potential difference are preferably selected as much as possible. The pipe member 1 can be a nickel-titanium alloy, stainless steel, etc. The shaped wire 21 can be a suture, a tether, a wire, a strip, etc.; the shaped wire 21 can be made of a variety of materials, such as nickel-titanium, polymer, fiber, Dyneema wire or other biocompatible materials, etc.; the fixing member 3 can also be made of nickel-titanium material.

[0085] As Figures 4-6 shown, one end of the pipe member 1 is the proximal end 12, and the other end is the distal end 13. One end of the shaped wire 21 is fixed to the distal end 13 of the pipe member 1, and the other end of the shaped wire 21 is located at the proximal end 12 of the pipe member 1. And the length of the shaped wire 21 is less than the length of the pipe member 1. The end of the shaped wire 21 located at the proximal end 12 can be connected to the pulling wire 22 through the shaping limiting member 4. The shaped wire 21 and the shaping limiting member 4 can be welded or threadedly connected. The pulling wire 22 passes through the round hole 41 on the shaping limiting member 4, and both ends of the pulling wire 22 extend out of the pipe member 1 and are connected to the conveyor, which is convenient for delivering the shaped wire 21. In some other embodiments, the pulling wire 22 and the shaping limiting member 4 can also be threadedly connected. During the actual surgical process, when delivering the pipe member 1 and the shaped wire 21 in the catheter, the pipe member 1 can be bent to capture the mitral valve leaflet by delivering the pipe member 1 to the distal end 13 at a faster speed than the shaped wire 21, or after delivering a short section of the pipe member 1 and the shaped wire 21 to the distal end 13 at the same speed together, the shaped wire 21 is tightened to the proximal end 12 through the pulling wire 22 to adjust the bending degree of the pipe member 1. The above actions are repeated multiple times to make the pipe member 1 form a desired coil form or shape, and the inner diameter of the coil formed by the pipe member 1 is smaller than the outer diameter of the stent 5 to be implanted, so as to complete the arrangement of the capture loop at the mitral valve leaflet.

[0086] When the pipe fitting 1 bends under the action of the shaping wire 21, the main cut 111 on the pipe fitting 1 provides a suitable radial deformation space for the bending of the pipe fitting 1. The protrusions 113 and grooves 114 on the pipe fitting 1 limit the bending path, and there is no need for the shaping wire 21 inside the pipe fitting 1 to set a special path to guide the bending of the pipe fitting 1. After the pipe fitting 1 bends, the path of the shaping wire 21 will naturally follow the paths of the protrusions 113 and grooves 114. In addition, the setting of the main cut 111 on the pipe fitting 1 can also increase the friction coefficient when the fishing ring is arranged at the mitral valve leaf, and improve the retention force of the fishing ring on the stent 5.

[0087] As Figure 5 shown, after the fishing ring is arranged at the mitral valve leaf, in order to maintain the bent shape, the shaping wire 21 is fixed to the proximal end 12 of the pipe fitting 1 to complete the bending and shaping of the pipe fitting 1. There are two forms of the roughly shaped pipe fitting 1 after shaping, as Figure 10 and Figure 11 shown. The fastening coil 14 includes multiple turns of coils, and the multiple turns of coils are continuous and can extend in a roughly spiral shape. In Figure 10 , the fastening coil 14 has approximately three turns of coils, and the diameter of each turn of coil is basically equal. These three turns of coils are used to hold the stent 5 in the mitral valve 6 area. In Figure 11 , the fastening coil 14 has approximately three turns of coils, and the diameter of each turn of coil increases sequentially along the direction from the proximal end 12 to the distal end 13 of the pipe fitting 1, and the maximum inner diameter in the multiple turns of coils is smaller than the outer diameter of the valve leaf or the stent 5. Figure 11 In

[0088] In another embodiment, as Figures 4 to 7 shown, the fixing member 3 is a barbed limiting member. The barbed limiting member is a hollow structure, and there are multiple barbs 31 provided on its inner side wall; one end of the shaping wire 21 away from the distal end 13 of the pipe fitting 1 is connected with a shaping limiting member 4, and the shaping limiting member 4 moves in the pipe fitting 1 along with the shaping wire 21; when the pipe fitting 1 is bent and formed, the shaping limiting member 4 extends out of the proximal end 12 of the pipe fitting 1 and is clamped with the fixing member 3 to fix the shaping wire 21.

[0089] As Figure 4As shown, the distal end of the shaping wire 21 is welded to the distal end 13 of the pipe fitting 1. A shaping limit member 4 is welded to the proximal end of the shaping wire 21. The fixing member 3 is fixed to the proximal end 12 of the pipe fitting 1. When the shaping wire 21 moves within the pipe fitting 1, the shaping limit member 4 moves together with the shaping wire 21 within the pipe fitting 1. After the fishing loop is arranged at the mitral valve 6, in order to maintain the bent shape of the pipe fitting 1, the shaping limit member 4 is passed through the fixing member 3 from the distal end 13 to the proximal end 12 of the pipe fitting 1 through the pulling wire 22. When the traction force on the shaping wire 21 is released, the shaping limit member 4 retracts towards the distal end 13, as Figures 5-7 shown. At this time, the distal end face on the shaping limit member 4 just catches on the barbs 31 of the fixing member 3, completing the bending and shaping of the pipe fitting 1.

[0090] When the fishing loop is bent and formed, the length of the shaping wire 21 in the fishing loop affects the final bent shape of the fishing loop, that is, it affects the curvature of the fishing loop. Therefore, the length difference between the shaping wire 21 and the pipe fitting 1 can affect the radial force provided by the fishing loop to the stent 5. Figure 4 and Figure 8 In the figure, L1 is the length difference between the shaping wire 21 and the pipe fitting 1; when the number of turns of the fastening coil 14 around the stent 5 is fixed, the greater the length difference between the shaping wire 21 and the pipe fitting 1, and the greater the difference between the inner diameter of the fastening coil 14 and the outer diameter of the stent 5, the greater the radial fixing force of the fastening coil 14 on the stent 5. However, the difference between the two diameters cannot be too large, otherwise it is easy to cause the stent 5 not to be fully expanded, affecting the replacement function of the stent. In the actual application process, the pitch of the fastening coil 14 of the fishing loop and the length difference between the shaping wire 21 and the pipe fitting 1 can be comprehensively considered according to the required radial force of the stent 5 and the specifications of the stent 5 to ensure the radial force strength of the fishing loop on the stent 5.

[0091] In one embodiment, as Figure 8 and Figure 9 shown, the distal end of the fixing member 3 is provided with a radially penetrating opening 32. When the opening 32 of the fixing member 3 is pressed, its diameter becomes smaller and it can move within the pipe fitting 1 along with the shaping wire 21. When the opening end of the fixing member 3 is not pressed, the diameter of the opening end of the fixing member 3 becomes larger, so that the opening end of the fixing member 3 is clamped with the proximal end 12 of the pipe fitting 1 to fix the shaping wire 21.

[0092] As Figure 8 shown, one end of the shaping wire 21 is welded to the distal end 13 of the laser-cut pipe fitting 1, and the fixing member 3 is welded to the other end of the shaping wire 21. Before the pipe fitting 1 is bent, the opening end on the fixing member 3 can move freely inside the pipe fitting 1 through deformation compression. When the pipe fitting 1 is bent and formed and arranged in place, the fixing member 3 is migrated to the outside of the proximal end 12 of the pipe fitting 1 by the pulling wire 22, and the compressed opening end is released. When the traction force on the shaping wire 21 is released, the fixing member 3 retracts towards the distal end 13 of the pipe fitting 1, and the opening end just catches on the end face of the proximal end 12 of the pipe fitting 1, completing the bending and shaping of the pipe fitting 1.

[0093] In some embodiments of the present invention, as Figure 10 and Figure 11 shown, when the pipe fitting 1 is bent, a lower coil 15 extending from the lower end of the fastening coil 14 is also formed, and the diameter of the lower coil 15 is larger than the maximum diameter of the fastening coil 14. As Figure 10 shown, the diameter of the lower coil 15 is set to be larger so as to more easily surround the leaflets and / or chordae tendineae 61 in the mitral valve 6 for navigating the capture loop.

[0094] In some embodiments of the present invention, as Figure 10 and Figure 11 shown, when the pipe fitting 1 is bent, an upper coil 16 extending from the upper end of the fastening coil 14 is also formed, and the diameter of the upper coil 16 is larger than the maximum diameter of the fastening coil 14. The upper coil 16 has a larger diameter and can be positioned in the circulatory system (such as the left atrium) so that it can stably hold the capture loop. For example, the upper coil 16 is arranged to be close to the wall of the circulatory system to improve the ability of the capture loop to stay in its desired position before the implant stent 5.

[0095] In some embodiments of the present invention, as Figure 4 and Figure 8 shown, a film layer 7 is also coated on the outer side wall of the pipe fitting 1. The film layer 7 is a PET film and has a relatively high friction coefficient, so that after the stent 5 is expanded, a relatively large frictional force is generated between the stent 5 and the capture loop film layer 7 to prevent the capture loop from unwinding and maintain the relative position between the capture loop and the stent 5.

[0096] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A pipe fitting for a leaflet capture loop, having a pipe fitting body, characterized in that, the pipe fitting body is a hollow structure, and a plurality of main cuts are arranged longitudinally along the pipe fitting body on the pipe wall; a protrusion and a groove adapted to the protrusion are provided in the main cut, the protrusion can extend into the groove, and the extension line of the protrusion extending into the groove of each main cut is the direction line of the main cut; the included angle between the direction line of at least one main cut and the longitudinal axis of the pipe fitting body is an acute angle, and the main cut with an acute angle is an inclined main cut; a secondary cut is also provided on the pipe fitting body, and the main cut and the secondary cut are not connected to each other; the secondary cut is located between two adjacent main cuts, and the secondary cut is arranged opposite to the main cut on the circumference of the pipe fitting body; the pipe fitting body at least includes two adjacent inclined main cuts, and the direction lines of the adjacent inclined main cuts are arranged in a spiral pattern along the longitudinal direction of the pipe fitting, and the helix angle of the spiral arrangement is a fixed value, and the longitudinal region where the adjacent inclined main cuts are located is a pipe segment; a plurality of the pipe segments are provided on the pipe fitting body, and the included angles between the direction lines of the inclined main cuts of different pipe segments and the longitudinal axis of the pipe fitting body are different.

2. The pipe fitting for a leaflet capture loop according to claim 1, characterized in that, the adjacent main cuts have at least two longitudinal spacing values along the pipe fitting body.

3. The pipe fitting for a leaflet capture loop according to claim 1, characterized in that, the protrusion and the groove are located at the transverse center of the main cut, and the longitudinal dimension of the main cut gradually decreases from the center of the main cut to the edge of the main cut.

4. The pipe fitting for a leaflet capture loop according to claim 1, characterized in that, the arrangement direction of the secondary cut is the same as the direction line of the main cut in the pipe segment where it is located.

5. A leaflet capture loop, characterized in that, comprises a shaping wire, a fixing member and the pipe fitting for a leaflet capture loop according to any one of claims 1-4; the pipe fitting includes a proximal end and a distal end; the fixing member is arranged at the proximal end of the pipe fitting; the shaping wire is arranged inside the pipe fitting, and one end is fixed at the distal end of the pipe fitting, and a radial tension is applied to the pipe fitting to bend the pipe fitting into a fastening coil for surrounding the leaflet. When the pipe fitting is bent and formed, the other end of the shaping wire is fastened to the proximal end of the pipe fitting through the fixing member.

6. The leaflet capture loop according to claim 5, characterized in that, the fixing member is a barbed limiting member; a shaping limiting member is connected to the end of the shaping wire far from the distal end of the pipe fitting, and the shaping limiting member can move in the pipe fitting along with the shaping wire; when the pipe fitting is bent and formed, the shaping limiting member extends out of the proximal end of the pipe fitting and is clamped with the fixing member to fix the shaping wire.

7. The leaflet capture loop according to claim 5, characterized in that, The distal end of the fixing member is provided with an opening penetrating radially, which is used to make the diameter of the opening end of the fixing member decrease when the opening end of the fixing member is pressed and can move within the pipe fitting. When the opening end of the fixing member is not pressed, the diameter of the opening end of the fixing member increases, so that the opening end of the fixing member is clamped with the proximal end of the pipe fitting to fix the shaping wire.

8. A leaflet capture loop according to claim 5, wherein, it further comprises a film layer, and the film layer covers the outer sidewall of the pipe fitting and extends longitudinally along the pipe fitting to the distal end and the proximal end of the pipe fitting.

9. A leaflet capture loop according to any one of claims 5-8, wherein, the fastening coil comprises multiple turns of coils, and the diameter of each turn of coil is equal or increases sequentially in the direction from the proximal end to the distal end of the pipe fitting.

10. A leaflet capture loop according to claim 9, wherein, the maximum inner diameter of the fastening coil is smaller than the outer diameter of the leaflet.

11. A leaflet capture loop according to claim 5, wherein, when the pipe fitting is bent, a lower coil extending from the lower end of the fastening coil is further formed, and the diameter of the lower coil is larger than the maximum diameter of the fastening coil; and / or, when the pipe fitting is bent, an upper coil extending from the upper end of the fastening coil is further formed, and the diameter of the upper coil is larger than the maximum diameter of the fastening coil.

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