Self-forming artificial valve ring conveying device

Abstract

An inner conveying catheter is movably arranged in an inner cavity of an outer conveying catheter in a penetrating mode, the inner conveying catheter comprises a first main body catheter section and a first bending adjusting catheter section in the axial direction of the inner conveying catheter, the far end of the first main body catheter section is connected with the near end of the first bending adjusting catheter section, and the first bending adjusting catheter section has the bendable function; the inner control silk thread is connected with the first bending adjusting pipe section and used for controlling the first bending adjusting pipe section to be bent actively, and the pushing inner core rod piece is movably arranged in an inner cavity of the inner conveying guide pipe in a penetrating mode. Therefore, the artificial valve ring has good regulation and delivery performance, the multi-angle space regulation performance of the artificial valve ring effectively improves the success rate of a mitral valve replacement operation, the mitral valve replacement operation can be carried out in various ways such as femoral artery, atrial septum (femoral vein) and cardiac apex, the release paths of the artificial valve ring are diversified, and the artificial valve ring has good application prospects. The operation range is greatly widened, the operation method is simple and easy to learn, and the learning curve and the operation duration of an operator can be effectively shortened.

Description

Technical Field

[0001] The present application relates to the technical field of medical devices, and in particular to a self-forming artificial valve ring delivery device. Background Art

[0002] Cardiovascular diseases include arteriosclerosis, myocardial infarction, stroke, arrhythmia and valvular disease. Valvular disease including aortic valve, pulmonary valve, mitral valve and tricuspid valve disease is one of the important causes of heart attacks such as heart failure and stroke. Among them, mitral valve disease is the most common of all valvular diseases.

[0003] Mitral valve disease mainly includes mitral regurgitation (MR) and mitral stenosis (MS). Mitral regurgitation refers to the phenomenon that the mitral valve orifice cannot be completely closed and blood flows back to the left atrium due to abnormalities or dysfunctions in any structure of the valve leaflets, valve rings, chordae tendineae, papillary muscles, and left ventricle. Regurgitation leads to increased left atrial blood flow, increased blood pressure, and increased pulmonary venous blood pressure. Severe cases can cause pulmonary edema, myocardial damage, heart failure, and even death. Mitral stenosis refers to the phenomenon that the mitral valve opening is narrowed and blood cannot flow from the left atrium to the left ventricle. Insufficient supply of oxygen-rich blood leads to fatigue and difficulty breathing. The increase in blood retained in the left atrium leads to increased left atrial pressure and enlargement of the left atrium, which can also cause pulmonary edema.

[0004] Considering that about half of mitral regurgitation patients do not undergo surgery due to factors such as poor heart function, multiple comorbidities, and advanced age, the large number of treatment needs are far from being met. One of the reasons for the high risk of surgery is that the accuracy of the delivery of the artificial valve ring to the lesion cannot be guaranteed. Summary of the invention

[0005] Based on this, it is necessary to provide a self-forming artificial valve ring delivery device to address the above-mentioned technical problems.

[0006] The present application provides a self-forming artificial valve ring delivery device, the self-forming artificial valve ring delivery device comprising:

[0007] an outer delivery sheath assembly, the outer delivery sheath assembly comprising an outer delivery catheter;

[0008] An inner delivery sheath assembly, the inner delivery sheath assembly comprising an inner delivery catheter and an inner control wire, the inner delivery catheter being movably arranged in the inner cavity of the outer delivery catheter, the inner delivery catheter comprising a first main body tube segment and a first bending adjustment tube segment along its axial direction, the distal end of the first main body tube segment being connected to the proximal end of the first bending adjustment tube segment, wherein the first bending adjustment tube segment has a bendable function, the inner control wire being connected to the first bending adjustment tube segment, and the inner control wire being used to control the active bending of the first bending adjustment tube segment;

[0009] A pushing inner core rod is movably arranged in the inner cavity of the inner delivery catheter, the distal end of the pushing inner core rod is used to connect to an artificial valve ring, and the inner cavity of the inner delivery catheter is used to accommodate the artificial valve ring.

[0010] In one embodiment, the first bending adjustment pipe segment includes a first unit pipe segment and a second unit pipe segment, the hardness of the first unit pipe segment is less than the hardness of the second unit pipe segment, the proximal end of the first unit pipe segment is connected to the distal end of the second unit pipe segment, and the proximal end of the second unit pipe segment is connected to the distal end of the first main body pipe segment;

[0011] The internal control wire includes a first unit wire and a second unit wire, the first unit wire is connected to the distal end of the first unit tube segment, the first unit wire is used to control the active bending of the first unit tube segment, the second unit wire is connected to the distal end of the second unit tube segment, and the second unit wire is used to control the active bending of the second unit tube segment.

[0012] In one embodiment, the inner delivery catheter further comprises:

[0013] A first transition pipe segment, the distal end of the first transition pipe segment is connected to the proximal end of the first bending adjustment pipe segment, the proximal end of the first transition pipe segment is connected to the distal end of the first main body pipe segment, the distal end of the first main body pipe segment is connected to the proximal end of the first bending adjustment pipe segment through the first transition pipe segment, wherein the hardness of the first transition pipe segment is greater than the hardness of the first bending adjustment pipe segment, and the hardness of the first transition pipe segment is less than the hardness of the first main body pipe segment.

[0014] In one embodiment, the inner delivery sheath assembly comprises:

[0015] A first delivery handle is connected to the inner delivery catheter, and the first delivery handle is controllably connected to the inner control wire, and is used to control the axial movement of the inner control wire along the inner delivery catheter.

[0016] In one embodiment, the first delivery handle comprises:

[0017] a first guide sleeve, the distal end of which is connected to the proximal end of the inner delivery catheter, and the first guide sleeve is provided with a first axial guide rail;

[0018] a first guide slide, the first guide slide is movably assembled on the first guide sleeve along the first axial guide rail, and the first guide slide is connected to the inner control wire;

[0019] A first control element is threadedly assembled on the first guide sleeve, wherein the first control element is connected to the first guide slide and is used to control the first guide slide to move relative to the first guide sleeve along the first axial guide rail.

[0020] In one embodiment, the outer delivery sheath assembly also includes an external control wire, and the outer delivery catheter includes a second main body tube segment and a second bending adjustment tube segment along its axial direction, and the distal end of the second main body tube segment is connected to the proximal end of the second bending adjustment tube segment, wherein the second bending adjustment tube segment has a bending function, and the external control wire is connected to the second bending adjustment tube segment, and the external control wire is used to control the active bending of the second bending adjustment tube segment.

[0021] In one embodiment, the outer delivery catheter further comprises:

[0022] A second transition pipe segment, the distal end of the second transition pipe segment is connected to the proximal end of the second bending adjustment pipe segment, the proximal end of the second transition pipe segment is connected to the distal end of the second main body pipe segment, the distal end of the second main body pipe segment is connected to the proximal end of the second bending adjustment pipe segment through the second transition pipe segment, wherein the hardness of the second transition pipe segment is greater than the hardness of the second bending adjustment pipe segment, and the hardness of the second transition pipe segment is less than the hardness of the second main body pipe segment.

[0023] In one embodiment, the outer delivery sheath assembly comprises:

[0024] A second delivery handle is connected to the outer delivery catheter, and the second delivery handle is controllably connected to the outer control wire, and is used to control the axial movement of the outer control wire along the outer delivery catheter.

[0025] In one embodiment, the second delivery handle comprises:

[0026] a second guide sleeve, the distal end of the second guide sleeve being connected to the proximal end of the inner delivery catheter, and the second guide sleeve being provided with a second axial guide rail;

[0027] a second guide slide, the second guide slide is movably assembled on the second guide sleeve along the second axial guide rail, and the second guide slide is connected to the inner control wire;

[0028] A second control element is threadedly assembled on the second guide sleeve, wherein the second control element is connected to the second guide slide and is used to control the second guide slide to move relative to the second guide sleeve along the second axial guide rail.

[0029] In one embodiment, the inner delivery catheter includes a first inner tube, a first middle tube and a first outer tube along its radial direction, the first inner tube is sleeved in the inner cavity of the first middle tube, and the first middle tube is sleeved in the inner cavity of the first outer tube; wherein the material of the first inner tube includes at least one of polytetrafluoroethylene and polyimide, the first middle tube is made of a stainless steel braided mesh tube or a hypo tube, and the first outer tube is made of a medical polymer tube; and / or,

[0030] The outer delivery catheter includes a second inner tube, a second middle tube and a second outer tube along its radial direction, the second inner tube is sleeved in the inner cavity of the second middle tube, and the second middle tube is sleeved in the inner cavity of the second outer tube; wherein the material of the second inner tube includes at least one of polytetrafluoroethylene and polyimide, the second middle tube is made of a stainless steel braided mesh tube or a hypo tube, and the second outer tube is made of a medical polymer tube.

[0031] The self-formable artificial valve ring delivery device provided above has good controllability and delivery performance. Its multi-angle spatial control performance effectively improves the success rate of mitral valve replacement surgery, and can simultaneously meet the needs of mitral valve replacement surgery through multiple routes such as transfemoral artery, transatrial septum (transfemoral vein) and transapical, making the release path of the artificial valve ring diverse, while meeting the needs of percutaneous or transapical routes, with the less difficult transapical route as the main route, greatly improving the scope of surgery. Its operation method is simple and easy to learn, which can effectively shorten the operator's learning curve and operation time.

[0032] Moreover, the release action is simple and easy to operate. After the delivery device reaches the target lesion, it only needs to push or withdraw to achieve the winding of the artificial valve ring on the chordae or leaflets, and can meet the requirements of more than 96% of the length of the artificial valve ring for recycle, and the number of recycling times is unlimited, which can effectively improve the success rate of the operation. (The length of the chordae varies, the shape of the valve ring is irregular, and the ventricular space is narrow; usually mitral valve replacement surgery is complicated and time-consuming, and the success rate is not high).

[0033] The operator can precisely adjust the bending shape of the distal end of the inner or outer delivery catheter according to the needs during the operation, which is conducive to the first bending section of the inner delivery catheter to effectively pass through the native mitral valve leaflets and the outer side of the chordae tendineae, thereby greatly improving the precise implantation of the self-forming artificial valve ring, and greatly improving the success rate of transcatheter mitral valve repair (TMVR). The operation does not affect the opening and closing of the mitral valve, which can greatly reduce the heart load and reduce the probability of postoperative complications such as atrial fibrillation. BRIEF DESCRIPTION OF THE DRAWINGS

[0034] Figure 1 A schematic diagram of the overall structure of a self-formable artificial valve ring delivery device provided in one embodiment of the present application.

[0035] Figure 2 For Figure 1 The schematic diagram of the structure of the inner delivery sheath assembly and the inner core pushing rod is shown.

[0036] Figure 3 For Figure 1 Schematic diagram of the structure of the outer delivery sheath assembly shown.

[0037] Figure 4 A schematic diagram of the structure of an inner delivery catheter provided in one embodiment of the present application.

[0038] Figure 5 A radial cross-sectional view of an inner delivery sheath assembly provided according to one embodiment of the present application.

[0039] Figure 6 An exploded schematic diagram of an inner delivery sheath assembly provided in accordance with one embodiment of the present application.

[0040] Figure 7 A schematic diagram of the structure of an external delivery catheter provided in one embodiment of the present application.

[0041] Figure 8 A radial cross-sectional view of an outer delivery sheath assembly provided according to one embodiment of the present application.

[0042] Fig. 9 An exploded schematic diagram of an outer delivery sheath assembly provided in accordance with one embodiment of the present application.

[0043] Fig.10 A schematic diagram of the implanted state of an artificial valve ring provided in one embodiment of the present application.

[0044] Figure Number:

[0045] 100, artificial valve ring; 200, left ventricle; 300, chordae tendineae; 400, aortic valve; 500, mitral valve;

[0046] 1000, inner delivery sheath assembly; 2000, outer delivery sheath assembly; 3000, inner core pushing rod;

[0047] 1100, inner delivery catheter; 1200, inner control wire; 1300, first delivery handle;

[0048] 1110, first main pipe section; 1120, first bending pipe section; 1130, first transition pipe section;

[0049] 1121, first unit pipe section; 1122, second unit pipe section; 1201, first unit silk thread; 1202, second unit silk thread;

[0050] 1310, first guide sleeve; 1320, first guide slide; 1330, first control element; 1340, end element; 1350, first regulating knob; 1360, second regulating knob; 1370, first flushing head; 1380, first sealing end cover; 1390, first handle housing;

[0051] 2100, external delivery catheter; 2200, external control wire; 2300, second delivery handle;

[0052] 2110, second main pipe section; 2120, second bending pipe section; 2130, second transition pipe section;

[0053] 2310, second guide sleeve; 2320, second guide slide; 2330, second control element; 2340, distal fixing nut; 2350, damping fixing knob; 2360, internal thread knob; 2370, second handle housing; 2380, second flushing head; 2390, second sealing end cover. DETAILED DESCRIPTION

[0054] In order to make the above-mentioned purposes, features and advantages of the present application more obvious and easy to understand, the specific implementation methods of the present application are described in detail below in conjunction with the accompanying drawings. In the following description, many specific details are set forth to facilitate a full understanding of the present application. However, the present application can be implemented in many other ways different from those described herein, and those skilled in the art can make similar improvements without violating the connotation of the present application, so the present application is not limited by the specific embodiments disclosed below.

[0055] In the description of the present application, it should be understood that if the terms "center", "longitudinal", "lateral", "length", "width", "thickness", "up", "down", "front", "back", "left", "right", "vertical", "horizontal", "top", "bottom", "inside", "outside", "clockwise", "counterclockwise", "axial", "radial", "circumferential", etc. appear, the orientation or position relationship indicated by these terms is based on the orientation or position relationship shown in the accompanying drawings, which is only for the convenience of describing the present application and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and therefore cannot be understood as a limitation on the present application.

[0056] In addition, if the terms "first" or "second" appear, these terms are used for descriptive purposes only and should not be understood as indicating or implying relative importance or implicitly indicating the number of technical features indicated. Therefore, a feature defined as "first" or "second" may explicitly or implicitly include at least one of the features. In the description of this application, if the term "plurality" appears, the meaning of "plurality" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0057] In this application, unless otherwise clearly specified and limited, if the terms "installed", "connected", "connected", "fixed" and the like appear, these terms should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integrated 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, it can be the internal connection of two elements or the interaction relationship between two elements, unless otherwise clearly defined. For ordinary technicians in this field, the specific meanings of the above terms in this application can be understood according to the specific circumstances.

[0058] In the present application, unless otherwise clearly specified and limited, if there is a description that a first feature is "above" or "below" a second feature, etc., or similar descriptions appear, it may mean that the first and second features are in direct contact, or that the first and second features are in indirect contact through an intermediate medium. Moreover, the first feature being "above", "above" and "above" the second feature may mean that the first feature is directly above or obliquely above the second feature, or simply means that the first feature is higher in level than the second feature. The first feature being "below", "below" and "below" the second feature may mean that the first feature is directly below or obliquely below the second feature, or simply means that the first feature is lower in level than the second feature.

[0059] It should be noted that if an element is referred to as being "fixed to" or "disposed on" another element, it may be directly on the other element or there may be a central element. If an element is considered to be "connected to" another element, it may be directly connected to the other element or there may be a central element at the same time. If any, the terms "vertical", "horizontal", "upper", "lower", "left", "right" and similar expressions used in this application are for illustrative purposes only and do not represent the only implementation method.

[0060] In order to more clearly describe the structure of the self-forming artificial valve ring delivery device, the term "distal end" is defined here to mean the end away from the operator during the surgical operation, and the "proximal end" is defined here to mean the end close to the operator during the surgical operation. Unless otherwise defined, all technical and scientific terms used in this application have the same meaning as those commonly understood by technicians in the technical field of this application. The terms used in the specification of this application are only for the purpose of describing specific embodiments and are not intended to limit this application.

[0061] See also Figures 1 to 3 As shown, the present application provides a self-forming artificial valve ring delivery device. The self-forming artificial valve ring delivery device includes an inner delivery sheath component 1000, an outer delivery sheath component 2000 and a pushing inner core rod 3000. Figure 2 and Figure 4 As shown, the inner delivery sheath assembly 1000 includes an inner delivery catheter 1100 and an inner control wire 1200, and the outer delivery sheath assembly 2000 includes an outer delivery catheter 2100. The outer diameter of the inner delivery catheter 1100 is slightly smaller than the inner diameter of the outer delivery catheter 2100, and the inner delivery catheter 1100 is movably arranged in the inner cavity of the outer delivery catheter 2100. The inner control wire 1200 can be made of stainless steel wire.

[0062] The push inner core rod 3000 is movably arranged in the inner cavity of the inner delivery catheter 1100, and the distal end of the push inner core rod 3000 is used to connect the artificial valve ring 100, and the inner cavity of the inner delivery catheter 1100 is used to receive the artificial valve ring 100. Among them, the distal end of the push inner core rod 3000 can be detachably connected to the artificial valve ring 100, and the connection method includes mechanical release, hydrolysis release, thermal release or electrical release and other release methods.

[0063] The artificial valve ring 100 has the ability to deform, and can be in a contracted state under stress, with its volume reduced, and in an expanded state under no stress, with its volume increased. Therefore, the artificial valve ring 100 can be loaded into the inner cavity of the inner delivery catheter 1100 in a contracted state, and then connected by pushing the inner core rod 3000, and the artificial valve ring 100 in a contracted state is controlled to move axially in the inner cavity of the inner delivery catheter 1100 by pushing the inner core rod 3000. After the artificial valve ring 100 is controlled to break away from the restraint of the inner delivery catheter 1100 by pushing the inner core rod 3000, the artificial valve ring 100 can be relieved of stress, presenting an expanded state, and implanted into the target position in the body, that is, the target lesion position.

[0064] In one embodiment, the inner delivery catheter 1100 includes a first inner tube, a first middle tube and a first outer tube along its radial direction, the first inner tube is sleeved in the inner cavity of the first middle tube, and the first middle tube is sleeved in the inner cavity of the first outer tube. The material of the first inner tube includes at least one of polytetrafluoroethylene and polyimide. For example, the first inner tube uses two tube bodies of polytetrafluoroethylene and polyimide and is formed by thermo-rheological composite processing. The first middle tube uses a stainless steel braided mesh tube or a hypotube. The first outer tube uses a medical polymer tube.

[0065] The outer delivery catheter 2100 includes a second inner tube, a second middle tube and a second outer tube along its radial direction. The second inner tube is sleeved in the inner cavity of the second middle tube, and the second middle tube is sleeved in the inner cavity of the second outer tube. The material of the second inner tube includes at least one of polytetrafluoroethylene and polyimide. For example, the second inner tube uses two tube bodies of polytetrafluoroethylene and polyimide and is processed by thermo-rheological composite. The second middle tube uses a stainless steel braided mesh tube or a hypotube. The second outer tube uses a medical polymer tube.

[0066] Continue reading Figure 4 As shown, the inner delivery catheter 1100 is arranged along its axial direction ( Figure 4 In the transverse direction), the first main tube segment 1110 and the first bending adjustment tube segment 1120 are included, and the distal end of the first main tube segment 1110 is connected to the proximal end of the first bending adjustment tube segment 1120, wherein the first bending adjustment tube segment 1120 has a bendable function, and the bendable function of the first bending adjustment tube segment 1120 can be achieved by specially designing the material and hardness of the first bending adjustment tube segment 1120, so that the first bending adjustment tube segment 1120 can bend when subjected to a force within a certain range.

[0067] Therefore, the inner control wire 1200 is connected to the first bending adjustment pipe segment 1120. When the inner control wire 1200 is pulled, the inner control wire 1200 can be used to control the first bending adjustment pipe segment 1120 to actively bend, and the bending degree of the first bending adjustment pipe segment 1120 is adjusted according to the control force of pulling the inner control wire 1200. In one embodiment, the inner control wire 1200 can be connected to different positions of the first bending adjustment pipe segment 1120 according to needs, for example, connected to different positions of the first bending adjustment pipe segment 1120 in the circumferential direction or in the axial direction, so that the pulling force of the inner control wire 1200 can be applied to different positions of the first bending adjustment pipe segment 1120, thereby controlling the first bending adjustment pipe segment 1120 to bend in different directions.

[0068] Continue reading Figure 4 As shown, in one embodiment, the first bending adjustment pipe segment 1120 may include a first unit pipe segment 1121 and a second unit pipe segment 1122, that is, the first bending adjustment pipe segment 1120 with a bendable function is further divided into two pipe segments with different hardnesses, and the hardness of the first unit pipe segment 1121 is limited to be less than the hardness of the second unit pipe segment 1122. Therefore, based on the different hardnesses, the first unit pipe segment 1121 can be bent more easily than the second unit pipe segment 1122, and has a more flexible bending ability. At this time, the proximal end of the first unit pipe segment 1121 is connected to the distal end of the second unit pipe segment 1122, and the proximal end of the second unit pipe segment 1122 is connected to the distal end of the first main body pipe segment 1110.

[0069] At this time, the internal control wire 1200 also includes a first unit wire 1201 and a second unit wire 1202. The first unit wire 1201 is connected to the distal end of the first unit tube segment 1121, and the first unit wire 1201 is used to control the active bending of the first unit tube segment 1121. The second unit wire 1202 is connected to the distal end of the second unit tube segment 1122, and the second unit wire 1202 is used to control the active bending of the second unit tube segment 1122.

[0070] In addition, those skilled in the art can also divide the first bending adjustment pipe section 1120 into two or more pipe sections with different hardnesses according to the needs, and equip it with two or more unit wires at the same time, and use each unit wire to control a pipe section to be bent independently to meet different bending needs. Among them, the connection position of the first unit wire 1201 or the second unit wire 1202 and the first unit pipe section 1121 or the second unit pipe section 1122 can be adjusted according to the needs, so that the first unit pipe section 1121 and the second unit pipe section 1122 can be bent in the same direction or different directions according to the needs, so as to achieve a more flexible bending effect and achieve the expected bending effect. Those skilled in the art can adjust according to the actual needs, which is not limited here.

[0071] In addition, in one embodiment, the inner delivery catheter 1100 also includes a first transition pipe segment 1130, the distal end of the first transition pipe segment 1130 is connected to the proximal end of the first bending adjustment pipe segment 1120, the proximal end of the first transition pipe segment 1130 is connected to the distal end of the first main body pipe segment 1110, and the distal end of the first main body pipe segment 1110 is connected to the proximal end of the first bending adjustment pipe segment 1120 through the first transition pipe segment 1130, wherein the hardness of the first transition pipe segment 1130 is greater than the hardness of the first bending adjustment pipe segment 1120, and the hardness of the first transition pipe segment 1130 is less than the hardness of the first main body pipe segment 1110.

[0072] If the first bending adjustment pipe section 1120 includes a first unit pipe section 1121 and a second unit pipe section 1122, the proximal end of the first transition pipe section 1130 is connected to the distal end of the first main pipe section 1110, and the distal end of the first main pipe section 1110 is connected to the proximal end of the second unit pipe section 1122 in the first bending adjustment pipe section 1120 through the first transition pipe section 1130. The hardness of the first unit pipe section 1121 is less than the hardness of the second unit pipe section 1122, the hardness of the first transition pipe section 1130 is greater than the hardness of the second unit pipe section 1122, and the hardness of the first transition pipe section 1130 is less than the hardness of the first main pipe section 1110.

[0073] In one embodiment, the inner delivery sheath assembly 1000 further includes a first delivery handle 1300, which is connected to the inner delivery catheter 1100 and is controllably connected to the inner control wire 1200, and is used to control the axial movement of the inner control wire 1200 along the inner delivery catheter 1100. Therefore, the operator can use the first delivery handle 1300 to control the inner control wire 1200, and by applying a force to the inner control wire 1200, the inner control wire 1200 moves axially, and then indirectly applies a force to the first bending adjustment tube segment 1120 through the inner control wire 1200, so as to control the first bending adjustment tube segment 1120 to actively bend.

[0074] Among them, if the first bending adjustment tube segment 1120 includes a first unit tube segment 1121 and a second unit tube segment 1122, the first conveying handle 1300 can also independently control the first unit wire 1201 or the second unit wire 1202, thereby independently controlling the first unit tube segment 1121 and the second unit tube segment 1122 to actively bend through the first unit wire 1201 or the second unit wire 1202.

[0075] The first delivery handle 1300 can adopt any feasible driving mechanism to realize the control of the internal control wire 1200. For example, in one embodiment, the first delivery handle 1300 may include a first guide sleeve 1310, a first guide slide 1320 and a first control element 1330. The distal end of the first guide sleeve 1310 is connected to the proximal end of the internal delivery catheter 1100. The first guide sleeve 1310 is provided with a first axial guide rail. The first guide slide 1320 is movably assembled on the first guide sleeve 1310 along the first axial guide rail. The first guide slide 1320 is connected to the internal control wire 1200, and the first control element 1330 is threadedly assembled on the first guide sleeve 1310.

[0076] Among them, the first control element 1330 is connected to the first guide slide 1320, and the first control element 1330 moves axially relative to the first guide sleeve 1310 through threaded movement. When the operator threadably rotates the first control element 1330 relative to the first guide sleeve 1310, the first control element 1330 can move axially at a small distance with high precision, which can be used to control the first guide slide 1320 to move relative to the first guide sleeve 1310 along the first axial guide rail and ensure the accuracy of the movement of the first guide slide 1320.

[0077] Continue reading Figure 5 and Figure 6 As shown, the first delivery handle 1300 may also include a terminal element 1340, a first regulating knob 1350, a second regulating knob 1360, a first flushing head 1370, a first sealing end cover 1380, a first handle housing 1390 and other matching structures, and all structures in the first delivery handle 1300 can be made of medical polymer injection molding such as ABS / PC / POM. In one embodiment, two first guide slides 1320 and two first control elements 1330 can be respectively provided, and the two first guide slides 1320 are respectively used to connect with the first unit wire 1201 or the second unit wire 1202, and the two first guide slides 1320 can be axially arranged at different axial positions of the first guide sleeve 1310.

[0078] At this time, the first regulating knob 1350 and the second regulating knob 1360 may be provided with a threaded structure inside, so that the first regulating knob 1350 and the second regulating knob 1360 can respectively cooperate with the two first control elements 1330 in a threaded manner, and are used to control the axial movement of the two first control elements 1330 on the first guide sleeve 1310 by threaded driving. The axial movement of the two first control elements 1330 on the first guide sleeve 1310 can be used to drive the two first guide slides 1320 to move axially on the first guide sleeve 1310.

[0079] The first axial guide rail may adopt a linear protrusion structure, the first regulating knob 1350 and the second regulating knob 1360 may adopt a sleeve structure with an internal thread structure, the first control element 1330 and the first guide slide 1320 may adopt a collar structure, and the first control element 1330 may have an external thread structure. Figure 5 and Figure 6 As shown, the end element 1340 can be set at the distal end of the first guide sleeve 1310, the first sealing end cover 1380 can be set at the proximal end of the first guide sleeve 1310, the first flushing head 1370 is assembled on the first guide sleeve 1310 and can be used for an external flushing component, and the first delivery handle 1300 can also include all the above structures through a detachable first handle shell 1390.

[0080] In one embodiment, the outer delivery sheath assembly 2000 further includes an outer control wire 2200, which can be made of stainless steel wire. Figure 7 The second main tube segment 2110 and the second bending adjustment tube segment 2120 are connected in the transverse direction, and the distal end of the second main tube segment 2110 is connected to the proximal end of the second bending adjustment tube segment 2120, wherein the second bending adjustment tube segment 2120 has a bendable function, and the bendable function of the second bending adjustment tube segment 2120 can be achieved by specially designing the material and hardness of the second bending adjustment tube segment 2120, so that the second bending adjustment tube segment 2120 can bend when subjected to a force within a certain range.

[0081] Therefore, the external control wire 2200 is connected to the second bending adjustment pipe segment 2120, and when the external control wire 2200 is pulled, the external control wire 2200 can be used to control the second bending adjustment pipe segment 2120 to actively bend, and the bending degree of the second bending adjustment pipe segment 2120 is adjusted according to the control force of pulling the external control wire 2200. In one embodiment, the external control wire 2200 can be connected to different positions of the second bending adjustment pipe segment 2120 according to needs, for example, connected to different positions of the circumference of the second bending adjustment pipe segment 2120, or different positions in the axial direction, so that the pulling force of the external control wire 2200 can be applied to different positions of the second bending adjustment pipe segment 2120, thereby controlling the second bending adjustment pipe segment 2120 to bend in different directions.

[0082] Among them, the connection position of the inner control wire 1200 and the first bending adjustment pipe segment 1120, as well as the connection position of the outer control wire 2200 and the second bending adjustment pipe segment 2120 can be adjusted according to needs, so that the first bending adjustment pipe segment 1120 and the second bending adjustment pipe segment 2120 can be bent in the same direction or different directions according to needs to achieve the expected bending effect. Technical personnel in this field can make adjustments according to actual needs and are not limited here.

[0083] In addition, in one embodiment, the outer delivery catheter 2100 also includes a second transition pipe segment 2130, the distal end of the second transition pipe segment 2130 is connected to the proximal end of the second bending adjustment pipe segment 2120, the proximal end of the second transition pipe segment 2130 is connected to the distal end of the second main body pipe segment 2110, and the distal end of the second main body pipe segment 2110 is connected to the proximal end of the second bending adjustment pipe segment 2120 through the second transition pipe segment 2130, wherein the hardness of the second transition pipe segment 2130 is greater than the hardness of the second bending adjustment pipe segment 2120, and the hardness of the second transition pipe segment 2130 is less than the hardness of the second main body pipe segment 2110.

[0084] In one embodiment, the outer delivery sheath assembly 2000 further includes a second delivery handle 2300, which is connected to the outer delivery catheter 2100 and is controllably connected to the outer control wire 2200, and is used to control the axial movement of the outer control wire 2200 along the outer delivery catheter 2100. Therefore, the operator can use the second delivery handle 2300 to control the outer control wire 2200, and by applying a force to the outer control wire 2200, the outer control wire 2200 moves axially, and then indirectly applies a force to the second bending adjustment tube segment 2120 through the outer control wire 2200, so as to control the second bending adjustment tube segment 2120 to actively bend.

[0085] The second delivery handle 2300 can adopt any feasible driving mechanism to realize the control of the external control wire 2200. For example, in one embodiment, the second delivery handle 2300 includes a second guide sleeve 2310, a second guide slide 2320 and a second control element 2330. The distal end of the second guide sleeve 2310 is connected to the proximal end of the inner delivery catheter 1100. The second guide sleeve 2310 is provided with a second axial guide rail. The second guide slide 2320 is movably assembled on the second guide sleeve 2310 along the second axial guide rail. The second guide slide 2320 is connected to the inner control wire 1200. The second control element 2330 is threadedly assembled on the second guide sleeve 2310.

[0086] Among them, the second control element 2330 is connected to the second guide slide 2320, and the second control element 2330 moves axially relative to the second guide sleeve 2310 through threaded movement. When the operator threadably rotates the second control element 2330 relative to the second guide sleeve 2310, the second control element 2330 can move axially at a small distance with high precision, and can be used to control the second guide slide 2320 to move relative to the second guide sleeve 2310 along the second axial guide rail, and ensure the accuracy of the movement of the second guide slide 2320.

[0087] Continue reading Figure 8 and Fig. 9As shown, the second delivery handle 2300 may also include a distal fixing nut 2340, a damping fixing knob 2350, an internal thread knob 2360, a second handle housing 2370, a second flushing head 2380, a second sealing end cap 2390 and other matching structures, and all structures in the second delivery handle 2300 may be formed by injection molding of medical polymers such as ABS / PC / POM. In one embodiment, a threaded structure may be provided inside the internal thread knob 2360, so that the internal thread knob 2360 may be threadedly matched with the second control element 2330, and is used to control the axial movement of the second control element 2330 on the second guide sleeve 2310 by thread drive. The axial movement of the second control element 2330 on the second guide sleeve 2310 may be used to drive the second guide slide 2320 to axially move on the second guide sleeve 2310.

[0088] Among them, the second axial guide rail can adopt a linear protrusion structure, the internal threaded knob 2360 can adopt a sleeve structure with an internal threaded structure, the second control element 2330 and the second guide slide 2320 can adopt a ring structure, and the outside of the second control element 2330 has a threaded structure.

[0089] In addition, continue to refer to Figure 8 and Fig. 9 As shown, the distal fixing nut 2340 can be arranged at the distal end of the second guide sleeve 2310, and is used to assemble the damping fixing knob 2350 at the distal end of the second guide sleeve 2310, and the damping fixing knob 2350 is assembled with the internal thread knob 2360. The distal fixing nut 2340 can tightly match the damping fixing knob 2350 with the second guide sleeve 2310, and the damping fixing knob 2350 contains multiple groups of stainless steel elastic pins, which can be used to correspond to the pin holes uniformly distributed on the second guide sleeve 2310. Therefore, when the damping knob is fixed, the outer delivery sheath assembly 2000 can be suspended at any angle along the axis by rotating the second delivery handle 2300. The second sealing end cap 2390 can be arranged at the proximal end of the second guide sleeve 2310, and the second flushing head 2380 is assembled on the second guide sleeve 2310, which can be used for external flushing components. The second delivery handle 2300 can also include all the above structures through a detachable second handle shell 2370.

[0090] Continue reading Fig.10 As shown, the state after the artificial valve ring 100 is delivered to the target position in the body by using the above-mentioned self-formable artificial valve ring delivery device, at which time the artificial valve ring 100 is in an expanded state and positioned at the target position in the body.

[0091] It can be seen that the self-formable artificial valve ring delivery device provided above has good controllability and delivery performance, and its multi-angle spatial control performance effectively improves the success rate of mitral valve 500 replacement surgery, and can simultaneously meet the needs of mitral valve 500 replacement surgery through multiple routes such as transfemoral artery, transatrial septum (transfemoral vein) and transapical, so that the release path of the artificial valve ring 100 is diverse, and it can meet the needs of percutaneous or transapical routes, with the less difficult transapical route as the main route, which greatly improves the scope of surgical application. The operation method is simple and easy to learn, which can effectively shorten the operator's learning curve and operation time.

[0092] Moreover, the release action is simple and easy to operate. After the delivery device reaches the target lesion, it only needs to push or withdraw to achieve the winding of the artificial valve ring 100 on the chordae 300 or the valve leaflets, and can meet the requirements of more than 96% of the length of the artificial valve ring 100 for recycling, and the number of recycling times is unlimited, which can effectively improve the success rate of the operation. (Note: The length of the chordae is uneven, the shape of the valve ring is irregular, and the ventricular space is narrow. Mitral valve replacement surgery is usually complicated and time-consuming, and the success rate is not high).

[0093] The operator can precisely adjust the bending shape of the distal end of the inner delivery catheter 1100 or the outer delivery catheter 2100 according to the needs during the operation, which is conducive to the first bending tube section 1120 of the inner delivery catheter 1100 to effectively pass through the leaflets of the native mitral valve 500 and the outer side of the chordae tendineae 300, thereby greatly improving the precise implantation of the self-forming artificial valve ring 100, and greatly improving the success rate of transcatheter mitral valve repair 500 (TMVR). The opening and closing of the mitral valve 500 is not affected during the operation, which can greatly reduce the heart load and reduce the probability of postoperative complications such as atrial fibrillation.

[0094] The technical features of the above embodiments may be combined arbitrarily. To make the description concise, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0095] The above-described embodiments only express several implementation methods of the present application, and the descriptions thereof are relatively specific and detailed, but they cannot be construed as limiting the scope of the patent application. It should be pointed out that, for a person of ordinary skill in the art, several variations and improvements can be made without departing from the concept of the present application, and these all belong to the protection scope of the present application. Therefore, the protection scope of the patent application shall be subject to the attached claims.

Claims

1. A self-forming artificial valve ring delivery device, characterized in that: The self-forming artificial valve ring delivery device comprises: an outer delivery sheath assembly, the outer delivery sheath assembly comprising an outer delivery catheter; An inner delivery sheath assembly, the inner delivery sheath assembly comprising an inner delivery catheter and an inner control wire, the inner delivery catheter being movably arranged in the inner cavity of the outer delivery catheter, the inner delivery catheter comprising a first main body tube segment and a first bending adjustment tube segment along its axial direction, the distal end of the first main body tube segment being connected to the proximal end of the first bending adjustment tube segment, wherein the first bending adjustment tube segment has a bendable function, the inner control wire being connected to the first bending adjustment tube segment, and the inner control wire being used to control the active bending of the first bending adjustment tube segment; A pushing inner core rod is movably arranged in the inner cavity of the inner delivery catheter, the distal end of the pushing inner core rod is used to connect to an artificial valve ring, and the inner cavity of the inner delivery catheter is used to accommodate the artificial valve ring.

2. The self-formable artificial valve ring delivery device according to claim 1, characterized in that: The first bending adjustment pipe segment includes a first unit pipe segment and a second unit pipe segment, the hardness of the first unit pipe segment is smaller than the hardness of the second unit pipe segment, the proximal end of the first unit pipe segment is connected to the distal end of the second unit pipe segment, and the proximal end of the second unit pipe segment is connected to the distal end of the first main body pipe segment; The internal control wire includes a first unit wire and a second unit wire, the first unit wire is connected to the distal end of the first unit tube segment, the first unit wire is used to control the active bending of the first unit tube segment, the second unit wire is connected to the distal end of the second unit tube segment, and the second unit wire is used to control the active bending of the second unit tube segment.

3. The self-formable artificial valve ring delivery device according to claim 1, characterized in that: The inner delivery catheter also includes: A first transition pipe segment, the distal end of the first transition pipe segment is connected to the proximal end of the first bending adjustment pipe segment, the proximal end of the first transition pipe segment is connected to the distal end of the first main body pipe segment, the distal end of the first main body pipe segment is connected to the proximal end of the first bending adjustment pipe segment through the first transition pipe segment, wherein the hardness of the first transition pipe segment is greater than the hardness of the first bending adjustment pipe segment, and the hardness of the first transition pipe segment is less than the hardness of the first main body pipe segment.

4. The self-formable artificial valve ring delivery device according to claim 1, characterized in that: The inner delivery sheath assembly comprises: A first delivery handle is connected to the inner delivery catheter, and the first delivery handle is controllably connected to the inner control wire, and is used to control the axial movement of the inner control wire along the inner delivery catheter.

5. The self-formable artificial valve ring delivery device according to claim 4, characterized in that: The first delivery handle comprises: a first guide sleeve, the distal end of which is connected to the proximal end of the inner delivery catheter, and the first guide sleeve is provided with a first axial guide rail; a first guide slide, the first guide slide is movably assembled on the first guide sleeve along the first axial guide rail, and the first guide slide is connected to the inner control wire; A first control element is threadedly assembled on the first guide sleeve, wherein the first control element is connected to the first guide slide and is used to control the first guide slide to move relative to the first guide sleeve along the first axial guide rail.

6. The self-formable artificial valve ring delivery device according to claim 1, characterized in that: The outer delivery sheath assembly also includes an external control wire, and the outer delivery catheter includes a second main body tube segment and a second bending adjustment tube segment along its axial direction, the distal end of the second main body tube segment is connected to the proximal end of the second bending adjustment tube segment, wherein the second bending adjustment tube segment has a bending function, and the external control wire is connected to the second bending adjustment tube segment, and the external control wire is used to control the active bending of the second bending adjustment tube segment.

7. The self-formable artificial valve ring delivery device according to claim 6, characterized in that: The outer delivery catheter further comprises: A second transition pipe segment, the distal end of the second transition pipe segment is connected to the proximal end of the second bending adjustment pipe segment, the proximal end of the second transition pipe segment is connected to the distal end of the second main body pipe segment, the distal end of the second main body pipe segment is connected to the proximal end of the second bending adjustment pipe segment through the second transition pipe segment, wherein the hardness of the second transition pipe segment is greater than the hardness of the second bending adjustment pipe segment, and the hardness of the second transition pipe segment is less than the hardness of the second main body pipe segment.

8. The self-formable artificial valve ring delivery device according to claim 6, characterized in that: The outer delivery sheath assembly comprises: A second delivery handle is connected to the outer delivery catheter, and the second delivery handle is controllably connected to the outer control wire, and is used to control the axial movement of the outer control wire along the outer delivery catheter.

9. The self-formable artificial valve ring delivery device according to claim 8, characterized in that: The second delivery handle comprises: a second guide sleeve, the distal end of the second guide sleeve being connected to the proximal end of the inner delivery catheter, and the second guide sleeve being provided with a second axial guide rail; a second guide slide, the second guide slide is movably assembled on the second guide sleeve along the second axial guide rail, and the second guide slide is connected to the inner control wire; A second control element is threadedly assembled on the second guide sleeve, wherein the second control element is connected to the second guide slide and is used to control the second guide slide to move relative to the second guide sleeve along the second axial guide rail.

10. The self-formable artificial valve ring delivery device according to claim 1, characterized in that: The inner delivery catheter includes a first inner tube, a first middle tube and a first outer tube along its radial direction, the first inner tube is sleeved in the inner cavity of the first middle tube, and the first middle tube is sleeved in the inner cavity of the first outer tube; wherein the material of the first inner tube includes at least one of polytetrafluoroethylene and polyimide, the first middle tube is made of a stainless steel braided mesh tube or a hypo tube, and the first outer tube is made of a medical polymer tube; and / or, The outer delivery catheter includes a second inner tube, a second middle tube and a second outer tube along its radial direction, the second inner tube is sleeved in the inner cavity of the second middle tube, and the second middle tube is sleeved in the inner cavity of the second outer tube; wherein the material of the second inner tube includes at least one of polytetrafluoroethylene and polyimide, the second middle tube is made of a stainless steel braided mesh tube or a hypo tube, and the second outer tube is made of a medical polymer tube.

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