Transcatheter atrioventricular valve treatment system

Abstract

The application discloses a transcatheter atrioventricular valve treatment system comprising a valve repair device and a delivery device, the delivery device comprising a delivery catheter for delivering at least a portion of the valve repair device to or near an atrioventricular valve and an operating handle for controlling the delivery catheter, the delivery device also includes a fluid management system including a pressure monitoring channel disposed within the delivery catheter and extending therethrough from a proximal end to a distal end of the delivery catheter. According to the transcatheter atrioventricular valve treatment system, when the conveying catheter reaches the ventricle, the pressure of the ventricle can be monitored through the external pressure sensor, the pressure of the atrium can also be monitored when the conveying catheter passes through the heart part such as the atrium, more independent and accurate monitoring is provided through the pressure monitoring channel, and the treatment effect of the transcatheter atrioventricular valve treatment system is improved. And the influence of other fluid channels is avoided.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and in particular, to a transcatheter atrioventricular valve treatment system. Background Art

[0002] Atrioventricular valves such as the mitral valve and tricuspid valve are one-way valves in the heart. A normal and healthy atrioventricular valve can control the blood flow from the atrium to the ventricle, while preventing the blood from flowing from the ventricle to the atrium. For example, the mitral valve is a one-way valve located between the left atrium and the left ventricle of the heart, which can control the blood flow from the left atrium to the left ventricle, while preventing the blood from flowing from the left ventricle to the left atrium. The mitral valve includes a pair of valve leaflets, namely the anterior leaflet and the posterior leaflet. When the edges of the anterior leaflet and the posterior leaflet are aligned, the mitral valve can be completely closed, preventing the blood from flowing from the left ventricle to the left atrium. When there are organic or functional changes in the valve leaflets or their related structures of the mitral valve, the anterior leaflet and the posterior leaflet of the mitral valve do not align well. Therefore, when the left ventricle of the heart contracts, the mitral valve cannot be completely closed, resulting in blood reflux from the left ventricle to the left atrium, thus causing a series of pathophysiological changes, known as "mitral regurgitation".

[0003] Transcatheter atrioventricular valve treatment technology refers to delivering various valve repair devices to the mitral valve or tricuspid valve through a catheter, and repairing or replacing the diseased mitral valve or tricuspid valve through remote operation outside the patient's body, thereby treating mitral or tricuspid regurgitation. Compared with traditional valve treatment technology, transcatheter treatment technology reduces the surgical risk and time, and has gradually become one of the mainstream treatment methods for atrioventricular valves.

[0004] For transcatheter atrioventricular valve treatment technology, doctors remotely operate the valve repair device outside the patient's body and cannot directly observe the changes in the internal structure of the patient's heart. Usually, they can only rely on medical imaging technologies such as ultrasound to judge the treatment effect, which requires relatively high personal experience of doctors. Research has found that taking transcatheter mitral valve edge-to-edge repair as an example, when the valve repair device acts on the anterior leaflet and the posterior leaflet of the mitral valve and the blood reflux situation improves, the pressures in the atrium and ventricle will also change accordingly. Therefore, the pressure changes and transvalvular pressure gradients in the atrium and ventricle before, during, and after the operation can assist doctors in judging the clamping situation of the anterior leaflet and the posterior leaflet, the improvement of blood regurgitation volume, and the treatment effect of the operation. Therefore, in order to more accurately evaluate the surgical treatment effect, help doctors make judgments faster, further reduce the operation time, and improve the success rate of the operation, the monitoring of the atrial pressure, ventricular pressure, and transvalvular pressure gradient of the mitral valve or tricuspid valve during the operation is still a technical difficulty in this field. Summary of the Invention

[0005] In view of this, this application provides a transcatheter atrioventricular valve treatment system to solve the problems in the prior art.

[0006] On the one hand, an embodiment of the present application provides a transcatheter atrioventricular valve treatment system, which includes a valve repair device and a delivery device. The delivery device includes a delivery catheter and an operating handle for controlling the delivery catheter. The delivery catheter is used to deliver at least a part of the valve repair device to or near the atrioventricular valve. The delivery device further includes a fluid management system, and the fluid management system includes a pressure monitoring channel disposed inside the delivery catheter and extending through the proximal end to the distal end of the delivery catheter.

[0007] In a preferred embodiment, the delivery catheter delivers a part of the valve repair device to the ventricle via the atrium. When the distal end of the delivery catheter is located in the atrium, the pressure monitoring channel is used to monitor the pressure of the atrium. When the distal end of the delivery catheter is located in the ventricle, the pressure monitoring channel is used to monitor the pressure of the ventricle.

[0008] In a preferred embodiment, the interior of the delivery catheter has a main lumen and a plurality of sub-lumens surrounding the main lumen. The main lumen accommodates a drive mandrel for driving the valve repair device. One of the plurality of sub-lumens is hollow and is the pressure monitoring channel, and the remaining sub-lumens of the plurality of sub-lumens accommodate control wires for controlling the valve repair device.

[0009] In a preferred embodiment, the fluid management system further includes a first sealed cavity pipeline assembly disposed in the operating handle. The first sealed cavity pipeline assembly includes a first sealed cavity, a sealed cavity pipeline connected to one end of the first sealed cavity. The sealed cavity pipeline is connected to the pressure monitoring channel. An on-off valve is externally connected to the first sealed cavity, and the on-off valve can be connected to an external first pressure sensor.

[0010] In a preferred embodiment, the fluid management system further includes a second sealed cavity pipeline assembly disposed in the operating handle. The second sealed cavity assembly includes a second sealed cavity. The sealed cavity pipeline continuously passes through the second sealed cavity and is connected to the pressure monitoring channel. The main lumen and the sub-lumen accommodating the control wires are in gas-liquid communication with the second sealed cavity. An operating handle on-off valve is externally connected to the second sealed cavity.

[0011] In a preferred embodiment, the second sealing cavity assembly further includes a first positioning member and a second positioning member. The first positioning member and the second positioning member are respectively fixed on the inner side and the outer side of the second sealing cavity. A plurality of through holes are formed in the side wall of the second sealing cavity. The sealing cavity pipeline sequentially passes through the second positioning member, the through holes in the side wall of the second sealing cavity, and the first positioning member and is connected to the pressure monitoring channel. The main channel and the auxiliary channel accommodating the control wire respectively extend into the second sealing cavity and the first positioning member through a first slender pipeline. The first slender pipeline is open between the first positioning member and the side wall of the second sealing cavity to be in gas-liquid communication with the second sealing cavity, and passes out through the through holes in the side wall of the second sealing cavity and the second positioning member through a second slender pipeline.

[0012] In a preferred embodiment, the second sealing cavity pipeline assembly further includes a catheter positioning member provided with a plurality of channels. The catheter positioning member is connected to the delivery catheter. The plurality of channels of the catheter positioning member respectively communicate with the main channel and the auxiliary channel of the delivery catheter. The sealing cavity pipeline extends into one of the channels of the catheter positioning member and is connected to the pressure monitoring channel. The remaining channels of the catheter positioning member extend into the second sealing cavity through a plurality of the first slender pipelines. The side wall of the second sealing cavity extends towards the end of the operating handle through a plurality of the second slender pipelines. The drive mandrel and the control wire pass through the first slender pipeline and the second slender pipeline to reach the end of the operating handle.

[0013] In a preferred embodiment, the delivery device further includes a delivery sheath and a sheath handle for controlling the delivery sheath. The sheath handle is communicated with a sheath handle on-off valve. The valve repair device is detachably connected to the end of the delivery catheter. There is a gap between the delivery sheath and the delivery catheter. The fluid management system further includes a second pressure sensor connected to the sheath handle on-off valve.

[0014] In a preferred embodiment, the delivery device further includes a guiding sheath and a guiding sheath control handle for controlling the guiding sheath. The delivery sheath, the delivery catheter together with the valve repair device pass through the guiding sheath control handle and the guiding sheath. The guiding sheath control handle is communicated with a guiding sheath on-off valve. There is a gap between the guiding sheath and the delivery sheath. The fluid management system further includes a third pressure sensor connected to the guiding sheath on-off valve.

[0015] In a preferred embodiment, the fluid management system further includes a loader communicating with the delivery sheath, and a flush head communicating with the loader. The valve repair device is received in the loader. The flush head is used to access the exhaust liquid. The end of the loader is externally connected to a temporary on-off valve. The opening or closing of the temporary on-off valve, in cooperation with the opening or closing of the pipeline on-off valve, the operating handle on-off valve, and the sheath handle on-off valve, can exhaust the pressure monitoring channel, the operating handle, and the sheath handle.

[0016] In a preferred embodiment, after removing the temporary on-off valve, the loader communicates with the guiding sheath control handle.

[0017] In a preferred embodiment, the second sealing cavity is fixed axially along the operating handle within the operating handle, and the operating handle has visual windows corresponding to the first sealing cavity and the second sealing cavity respectively.

[0018] In a preferred embodiment, the delivery catheter includes a flexible tube body, and a metal ring is provided at the end of the flexible tube body. The metal ring has a plurality of channels corresponding to the main channel and the sub-channel respectively. The drive mandrel and the control wire extend out of the corresponding main channel and sub-channel and are detachably connected to the valve repair device.

[0019] Compared with the prior art, the transcatheter atrioventricular valve treatment system of the present invention is provided with a pressure monitoring channel extending through the delivery catheter, so that when the delivery catheter reaches the ventricle, the pressure of the ventricle can be monitored by an external pressure sensor. When the delivery catheter passes through other heart parts, such as the atrium, the pressure of the atrium can also be monitored. The change of the ventricle or atrium pressure and the transvalvular pressure difference before and after the surgical treatment are beneficial for doctors to evaluate the treatment effect of the valve repair device on regurgitation, and are particularly suitable for evaluating the treatment effect of mitral or tricuspid regurgitation. The transcatheter atrioventricular valve treatment system of the present invention can solve the problem of ventricle and / or atrium pressure monitoring without installing an internal sensor at the distal end of the delivery catheter, reduces the surgical cost, avoids the use of active devices, reduces the surgical risk, and the fluid management system is more independent and accurate. The pressure monitoring process can avoid being affected by other fluid channels. Description of the Drawings

[0020] In order to more clearly illustrate the technical solutions in the embodiments of the present application or the prior art, the following will briefly introduce the drawings required for the description of the embodiments or the prior art. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0021] Figure 1It is a schematic structural diagram of a transcatheter atrioventricular valve treatment system provided by an embodiment of the present application.

[0022] Figure 2 It is Figure 1 an enlarged schematic diagram of the distal A area of the transcatheter atrioventricular valve treatment system.

[0023] Figure 3 It is Figure 2 a sectional schematic diagram of the delivery catheter along the B-B direction.

[0024] Figure 4 It is Figure 1 an explosion schematic diagram of the delivery catheter and the metal ring at the end.

[0025] Figure 5 It is Figure 1 a partial internal schematic diagram of the operation handle of the transcatheter atrioventricular valve treatment system connected to the pressure sensor.

[0026] Figure 6 It is Figure 5 an explosion schematic diagram of the catheter fixing part, catheter positioning part, second sealing cavity, etc. of the operation handle.

[0027] Figure 7 It is Figure 1 a three-dimensional enlarged schematic diagram of the catheter positioning part.

[0028] Figure 8 It is Figure 6 an assembly schematic diagram of the catheter positioning part, catheter fixing part and delivery catheter.

[0029] Figure 9 It is Figure 6 an enlarged schematic diagram of part A.

[0030] Figure 10 It is Figure 6 an assembly schematic diagram of the catheter fixing part, catheter positioning part, second sealing cavity, etc.

[0031] Figure 11 It is Figure 10 an enlarged schematic diagram of part B.

[0032] Figure 12 It is a partial explosion schematic diagram of the pressure monitoring channel connected to the first sealing cavity.

[0033] Figure 13 It is Figure 1 a schematic diagram of the transcatheter atrioventricular valve treatment system in the exhaust state.

[0034] Figure 14 It is Figure 13 an assembly schematic diagram of the transcatheter atrioventricular valve treatment system after exhaust and the guiding sheath.

[0035] Figure 15 is Figure 13 A cross-sectional sectional view of the guiding sheath, the delivery sheath tube, and the delivery catheter.

[0036] Figure 16 A cross-sectional sectional view of the guiding sheath, the delivery sheath tube, and the delivery catheter of another embodiment.

[0037] Figure 17 A schematic diagram of the valve repair device provided by the embodiment of the present application.

[0038] Figure 18 A schematic diagram of the state when the valve repair device provided by the embodiment of the present invention is applied to the treatment of the mitral valve;

[0039] Figure 19 is Figure 18 A schematic diagram of the state when the valve repair device closes and clamps the valve leaf;

[0040] Figure 20 is Figure 19 A schematic diagram of the state when the valve repair device is separated from the delivery device.

[0041] The following specific embodiments will further illustrate the present application in conjunction with the above-mentioned drawings. Specific Embodiments

[0042] Next, the technical solutions in the embodiments of the present application will be clearly and completely described in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present application without creative efforts shall fall within the scope of protection of the present application.

[0043] First of all, it should be noted that in the field of interventional medicine, along the delivery path of the device, the end of the device closer to the operator is usually referred to as the proximal end, and the end of the device farther from the operator is referred to as the distal end. Specifically, for a delivery device used to deliver and release an implantable device into a patient's body, the distal end refers to the end where the delivery device can be freely inserted into an animal or human body, and the proximal end refers to the end where the delivery device is operated by a user or a machine. The direction of the rotation center axis of an object such as a cylinder or a tube is defined as the axial direction, the circumferential direction is the direction around the axis of a cylindrical object such as a cylinder or a tube (perpendicular to the axis and also perpendicular to the cross-sectional radius), and the radial direction refers to the direction along the diameter or radius. Among them, the axial direction, the circumferential direction, and the radial direction together constitute three orthogonal directions of the cylindrical object. It should be noted that no matter the "end" in words such as "proximal end", "distal end", "one end", "the other end", "the first end", "the second end", "the initial end", "the terminal end", "both ends", "the free end", "the upper end", "the lower end", etc., it is not limited to the end point, the end, or the end face, but also includes the part that extends an axial distance and / or a radial distance on the component to which the end point, the end, or the end face belongs from the end point, the end, or the end face. The above definitions are only for the convenience of expression and should not be construed as a limitation to this application.

[0044] It can be understood that the terms in the specification, claims, and the above-mentioned drawings of this application are only for describing specific embodiments and are not intended to limit this application. The terms "first", "second", etc. in the specification, claims, and the above-mentioned drawings of this application are used to distinguish different objects and are not used to describe a specific order. Unless otherwise clearly stated in the context, the singular forms "a" and "the" are also intended to include the plural forms. The term "comprising" and any of its variations are intended to cover non-exclusive inclusion. In addition, this application can be implemented in many different forms and is not limited to the embodiments described below. The purpose of providing the following specific embodiments is to facilitate a clearer and more thorough understanding of the disclosed content of this application. The words indicating directions such as up, down, left, and right are only for the positions of the shown structures in the corresponding drawings.

[0045] It should be noted that all the above-mentioned drawings are exemplary illustrations of this application and do not represent the actual size of the product. Also, the dimensional ratio relationship between components in the drawings is not a limitation to the actual product of this application. The subsequent description in the specification is the preferred embodiment for implementing this application. However, the above description is for the purpose of explaining the general principles of this application and is not intended to limit the scope of this application. The protection scope of this application shall be determined by what is defined in the appended claims.

[0046] Please refer to Figures 1 to 4, an embodiment of the present application provides a transcatheter atrioventricular valve treatment system 100, which includes a valve repair device 10 and a delivery device 20. The atrioventricular valve includes the mitral valve and the tricuspid valve. The valve repair device 10 refers to a permanent or temporary implant that directly or indirectly acts on the mitral valve, the tricuspid valve, or the tissue near them, including but not limited to edge-to-edge clamping devices, valve annuloplasty rings, artificial valves, artificial chordae tendineae, leaflet coaptation edge enhancement devices, ventricular volume reduction devices, etc., which can treat degenerative lesions or functional insufficiency of the mitral valve or the tricuspid valve.

[0047] The delivery device 20 is used to deliver at least a part of the valve repair device 10 to the ventricle of the mitral valve or the tricuspid valve. Since the leaflets of the mitral valve or the tricuspid valve are located between the ventricle and the atrium, when repairing the mitral valve or the tricuspid valve, the valve repair device 10 straddles between the ventricle and the atrium. Therefore, at least a part of the valve repair device 10 is located in the ventricle. The delivery device 20 basically includes a delivery catheter 22, and the delivery catheter 22 delivers at least a part of the valve repair device 10 to the ventricle. For example, a part of the valve repair device 10 is located below the leaflet and a part is located above the leaflet.

[0048] On the delivery path, it can be, for example, a path through the atrium to the ventricle, or a path through the apex of the heart, for example.

[0049] The delivery device 20 includes a fluid management system for monitoring and managing the ventricular and / or atrial pressures at the surgical site, or the transvalvular pressure difference between the ventricle and the atrium, and for pre-exhaust management of the entire transcatheter atrioventricular valve treatment system.

[0050] The fluid management system includes a hollow pressure monitoring channel 224 provided inside the delivery catheter 22, and the pressure monitoring channel 224 extends through the proximal end to the distal end of the delivery catheter 22.

[0051] The delivery catheter 22 is a multi-channel pipe fitting. The multi-channel includes a main channel 222 and a plurality of sub-channels surrounding the main channel 221. The main channel 221 accommodates a drive mandrel for driving the valve repair device 10. One of the plurality of sub-channels is hollow and is the pressure monitoring channel 224, and the remaining sub-channels of the plurality of sub-channels are control wire channels 223, and the control wire channels 223 accommodate control wires for controlling the valve repair device. The multi-channel of the delivery catheter 22 can be formed by embedding each pipe fitting into an injection mold to form a delivery catheter containing a multi-channel.

[0052] The delivery catheter 22 is basically a flexible tube body. In this embodiment, the end of the delivery catheter 22 has a metal ring 22a, and the metal ring 22a can be welded to the end of the delivery catheter 22. The metal ring 22a has a plurality of channels corresponding to the main channel 222 and each sub-channel of the delivery catheter 22. The drive mandrel 22b and the control wire 22c (see Figure 16 ) for driving the valve repair device 10 respectively extend out of the corresponding channels of the metal ring 22a and are detachably connected to the valve repair device 10.

[0053] Please refer to Figures 5 to 6 together. The delivery device 20 has an operating handle 24. The delivery catheter 22 is connected to a position near the proximal end in the middle of the operating handle 24, and the delivery catheter 22 further extends continuously to the proximal end of the operating handle 24 inside the operating handle 24 via a catheter fixing member 241, a catheter positioning member 242, a plurality of first slender pipes 243, a second sealing cavity 244, a first positioning member 244a, a second positioning member 244b, and a plurality of second slender pipes 245. The catheter fixing member 241, the catheter positioning member 242, the plurality of first slender pipes 243, the second sealing cavity 244, the first positioning member 244a, the second positioning member 244b, and the plurality of second slender pipes 245 form a second sealing cavity assembly.

[0054] Specifically, please refer to Figure 7 and Figure 8 together. The catheter positioning member 242 has a plurality of channels 242a, 242b, 242c corresponding to the main channel 222 and each sub-channel of the delivery catheter 22, wherein the channel 242c corresponds to the pressure monitoring channel 224 in the sub-channel of the delivery catheter 22. The proximal ends of the plurality of channels of the catheter positioning member 242 are correspondingly connected to the plurality of first slender pipes 243. The catheter positioning member 242 and the delivery catheter 22 are connected and fixed by the catheter fixing member 241.

[0055] Please refer to Figures 6 to 11 together. The catheter positioning member 242 is assembled into the second sealing cavity 244. The plurality of first slender pipes 243 extend into the second sealing cavity 244. The first positioning member 244a is arranged at the inner end of the second sealing cavity 244, and the plurality of first slender pipes 243 are fixed on the first positioning member 244a.

[0056] The multiple first elongated pipes 243 fixed to the catheter positioning member 242 described above include a drive mandrel pipe 243a, at least two control wire pipes 243b, and a sealing cavity pipe 243c. Alternatively, the sealing cavity pipe 243c and the remaining multiple first elongated pipes 243 are jointly fixed to the catheter positioning member 242. The drive mandrel pipe 243a and at least two control wire pipes 243b are open, i.e., terminate, at the first positioning member 244a, so there is a gap between them and the side wall of the second sealing cavity 244, thereby achieving gas-liquid communication with the second sealing cavity 244. The sealing cavity pipe 243c is continuous (see Figure 9 and Figure 11 ) within the second sealing cavity 244, that is, it does not disconnect and continues to extend proximally directly through the second sealing cavity 244.

[0057] The second sealing cavity 244 includes an upper housing 244c and a lower housing 244d. The upper housing 244c and the lower housing 244d jointly form a second sealing cavity chamber. A sealing ring 244f can be provided between the upper housing 244c and the lower housing 244d. The multiple first elongated pipes 243 and the first positioning member 244a are located within the second sealing cavity chamber. The operating handle 24 can be provided with a transparent visual window 244a at a position corresponding to the second sealing cavity 244, so as to facilitate observing the gas-liquid condition within the second sealing cavity 244, including the situation of gas and blood within the second sealing cavity 244.

[0058] A through hole 244e is provided in the side wall of the second sealing cavity 244. The second positioning member 244b is provided outside the second sealing cavity 244. The multiple second elongated pipes 245 are fixed to the second positioning member 244b and extend into the through hole 244e in the side wall of the second sealing cavity 244 to respectively correspond to the drive mandrel pipe 243a and at least two control wire pipes 243b of the multiple first elongated pipes 243. The drive mandrel and the control wires continuously extend from the first elongated pipes 243 to the corresponding second elongated pipes 245, thereby reaching the proximal end of the operating handle. There are corresponding control knobs at the proximal end of the operating handle to operate the movement of the drive mandrel and the control wires.

[0059] Please refer to Figure 5 、 Figure 6 、 Figure 11 and Figure 12, the sealed cavity conduit 243c can continue to extend proximally through the second positioning member 244b. The sealed cavity conduit 243c is further connected to a first sealed cavity 246. The first sealed cavity 246 also includes an upper shell 246a, a lower shell 246b, and a sealing ring 246c. The sealed cavity conduit 243c is disconnected within the first sealed cavity 246, and the other end of the first sealed cavity 246 is externally connected to a pipeline on-off valve 247. The pipeline on-off valve 247 can be connected to the first sealed cavity 246 through a section of pipeline. The pipeline on-off valve 247 can be externally connected to a pressure sensor 248. The pressure sensor 248 detects the pressure of the ventricle and / or atrium at the surgical position, or the transvalvular pressure difference between the ventricle and atrium, through the sealed cavity conduit 243c and the pressure monitoring channel 224, so as to judge the repair effect of the valve repair device before and after the operation through the pressure difference.

[0060] Please refer to again Figure 1 , a transparent visual window 246a can also be provided at the position of the operation handle 24 corresponding to the first sealed cavity 246, so as to facilitate observing the gas-liquid condition in the first sealed cavity 246, including the situation of gas and blood in the first sealed cavity 246.

[0061] Please refer to together Figure 1 and Figure 13 , the delivery device 20 of the transcatheter atrioventricular valve treatment system 100 further includes a delivery sheath 23 and a sheath handle 25 for controlling the delivery sheath 23. The delivery catheter 22 passes through the sheath handle 25 and the delivery sheath 23, and the delivery catheter 22 passes out of the delivery sheath 23. The sheath handle 25 has a function of bending the delivery sheath 23, and the delivery sheath 23 can drive the delivery catheter 22 to bend in the blood vessel path in the patient's body. The valve repair device 10 is assembled at the end of the delivery catheter 22.

[0062] The fluid management system further includes a loader 26, a flushing head 27, a temporary on-off valve 28, a sheath handle on-off valve 29, and an operation handle on-off valve 30. Before the transcatheter atrioventricular valve treatment system 100 enters the patient's body, the instruments are exhausted. The loader 26 has a hollow channel, and the delivery sheath 23, the delivery catheter 22, and the valve repair device 10 extend into the loader 26.

[0063] The flushing head 27 communicates with the loader 26. The sheath handle on-off valve 29 communicates with the sheath handle 25, and the operation handle on-off valve 30 communicates with the second sealing cavity 244 of the operation handle 24. The flushing head 27, the temporary on-off valve 28, the sheath handle on-off valve 29, the operation handle on-off valve 30, and the pipeline on-off valve 247 can all be three-way cocks. There is a knob on the three-way cock, which can open or close the channels of the three-way cock. In addition to connecting the delivery device 20 of the transcatheter atrioventricular valve treatment system 100, the redundant channels of the three-way cock can be externally connected to external devices, such as an external pressure sensor or a saline syringe.

[0064] Before exhausting the air, first load the temporary on-off valve 28 onto the end of the delivery sheath 23 and exhaust the air in several steps:

[0065] (1) Open the knob of the flushing head 27 and the knob of the temporary on-off valve 28, and close the sheath handle on-off valve 29, the operation handle on-off valve 30, and the pipeline on-off valve 247. Then, appropriately raise the temporary on-off valve 28, such as slightly higher than the position of the flushing head 27. Inject heparinized saline into the loader 26 through the flushing head 27 to discharge the gas in the entire loader 26 from the temporary on-off valve 28. After the gas in the loader 26 is exhausted, turn the flushing head 27 and the temporary on-off valve 28 to the closed state as well;

[0066] (2) Open the knob of the flushing head 27 and the knob of the sheath handle on-off valve 29, and close the temporary on-off valve 28, the operation handle on-off valve 30, and the pipeline on-off valve 247. Then, appropriately raise the sheath handle on-off valve 29, such as slightly higher than the position of the flushing head 27. Inject heparinized saline into the delivery sheath 23 through the flushing head 27 to discharge the gas in the entire delivery sheath 23 and the sheath handle 25 from the sheath handle 25 on-off valve 29. After observing through the transparent window on the sheath handle 25 that the gas in the sheath handle 25 is exhausted, turn the flushing head 27 and the sheath handle on-off valve 29 to the closed state as well;

[0067] (3) Open the knob of the irrigation head 27 and the knob of the operation handle on-off valve 30, and close the temporary on-off valve 28, the sheath handle on-off valve 29, and the pipeline on-off valve 247. Then, appropriately raise the operation handle on-off valve 30, such as to a position slightly higher than the irrigation head 27. Inject heparinized saline into the delivery catheter 22 through the irrigation head 27, and discharge the gas in the unlocking wire lumen, the shrapnel control wire lumen in the delivery catheter 22, and the second sealing cavity 244 assembly from the operation handle on-off valve 30. After observing through the transparent window of the operation handle 24 that the gas in the second sealing cavity 244 is completely discharged, turn the irrigation head 27 and the operation handle on-off valve 30 to the closed state as well.

[0068] (4) Open the knob of the irrigation head 27 and the knob of the pipeline on-off valve 247, and close the temporary on-off valve 28, the sheath handle on-off valve 29, and the operation handle on-off valve 30. Then, appropriately raise the pipeline on-off valve 247, such as to a position slightly higher than the irrigation head 27. Inject heparinized saline into the delivery catheter 22 through the irrigation head 27, and discharge the gas in the pressure monitoring channel of the delivery catheter 22 and the operation handle 24 assembly from the pipeline on-off valve 247. After observing through the transparent window of the operation handle 24 that the gas in the operation handle 24 is completely discharged, turn the irrigation head 27 and the pipeline on-off valve 247 to the closed state as well. Thus, all the gas in the entire transcatheter atrioventricular valve treatment system 100 is completely discharged.

[0069] Please refer to Figure 14 , during mitral valve surgery, the delivery device 20 may further include a guiding sheath 31 and a guiding sheath control handle 32 for controlling the guiding sheath 31. After removing the temporary on-off valve 28, the loader communicates with the guiding sheath control handle 32. The delivery sheath 23, and the delivery catheter 22 together with the valve repair device 10 pass through the guiding sheath control handle 32 and the guiding sheath 31. The guiding sheath 31 is more convenient to puncture the atrial septum of the heart into the left atrium under the control of the guiding sheath control handle 32, and thus reaches the treatment area of the mitral valve via the path from the atrium to the ventricle.

[0070] Please refer to Figure 15, in the above transcatheter atrioventricular valve treatment system 100, if the gap D1 between the delivery sheath 23 and the delivery catheter 22 is suitable, for example, reaching 0.3 mm - 1.5 mm, the sheath handle on-off valve 29 can be externally connected to a second pressure sensor (not shown in the figure) to sense the atrial pressure when the delivery catheter 22 reaches the atrium through the gap between the delivery catheter 22 and the delivery sheath 23. In this application, since there is a pressure monitoring channel in the delivery catheter 22, the atrial pressure can be measured when the delivery catheter 22 is located in the atrium, and the ventricular pressure can be measured when it reaches the ventricle. Therefore, the above sheath handle on-off valve 29 may not be externally connected to the second pressure sensor either.

[0071] Please refer to Figure 19 , during the operation, since the delivery sheath 23 is always located in the atrium, the atrial pressure can also be measured by the above second pressure sensor, and the pressure sensor 24 connected to the pressure monitoring channel of the delivery catheter 22 can only measure the ventricular pressure after the delivery catheter 22 enters the ventricle. The atrial and ventricular pressure differences measured by these two pressure sensors can be used as the atrial-ventricular transvalvular pressure difference at the same time.

[0072] Please refer to Figure 16 , the inner diameter of the above guiding sheath 31 is larger than the outer diameter of the delivery sheath 23. If the gap D2 between the guiding sheath 31 and the delivery sheath 23 is suitable, for example, reaching 0.3 mm - 1.5 mm, the guiding sheath control handle 32 can be connected to a guiding sheath on-off valve 33, and a third pressure sensor (not shown in the figure) can be connected through the interface on the guiding sheath on-off valve 33. This third pressure sensor can be used to sense the left atrial pressure when the guiding sheath 31 reaches the left atrium. In this application, since there is a pressure monitoring channel in the delivery catheter 22, the atrial pressure can be measured when the delivery catheter 22 is located in the atrium, and the ventricular pressure can be measured when it reaches the ventricle. Therefore, the guiding sheath control handle 32 may not be externally connected to the third pressure sensor either.

[0073] Please refer to Figure 19 , during the operation, since the guiding sheath 31 only reaches the atrium, the atrial pressure can also be measured by the above third pressure sensor, and the pressure sensor 248 connected to the pressure monitoring channel of the delivery catheter 22 can only measure the ventricular pressure after the delivery catheter 22 enters the ventricle. The atrial and ventricular pressure differences measured by these two pressure sensors can be used as the atrial-ventricular transvalvular pressure difference at the same time.

[0074] In summary, the transcatheter atrioventricular valve treatment system 100 of the present invention is provided with a pressure monitoring channel that extends through the proximal end to the distal end of the delivery catheter 22 for delivering at least a part of the valve repair device 10 to the ventricle. Thus, when the delivery catheter 22 reaches the ventricle, the pressure of the ventricle can be monitored by an external pressure sensor 248. When the delivery catheter 22 passes through a cardiac site, such as the atrium, the pressure of the atrium can also be monitored. The pressure difference between the ventricle and the atrium, that is, the transvalvular pressure gradient, helps to evaluate the treatment effect of the valve repair device, especially suitable for evaluating the treatment effect of mitral or tricuspid regurgitation. The transcatheter atrioventricular valve treatment system 100 of the present invention can solve the problem of ventricular and / or atrial pressure monitoring without an internal sensor at the distal end of the delivery catheter. The transcatheter atrioventricular valve treatment system of the present invention is a more independent and accurate fluid management system, and pressure monitoring can avoid being affected by other fluid channels.

[0075] Please refer to Figure 17 together. The valve repair device 10 of the present invention can specifically be a clamping forceps with a clamping function, which has a pair of clamping members 12 that can be deployed or closed, a clamping arm 14 located inside the clamping members 12, and a driving structure 15 for driving the relative opening and closing of the clamping members 12. The clamping arm 14 can be controlled to open and close relatively by opening a perforation and then passing a control wire extended from the delivery device through the perforation. The driving structure 15 is detachably connected to the delivery catheter 22. The clamping members 12 and the clamping arm 14 cooperate to clamp two leaflets of the valve (see Figure 20 ), and by clamping the two leaflets and pulling them towards the center of the valve repair device 10, the problem of blood reflux between the leaflets is treated.

[0076] The transcatheter atrioventricular valve treatment system 100 of the present invention delivers the valve repair device 10 to the cardiac valve, including the treatment of mitral or tricuspid valve regurgitation. Please refer to Figure 17 and Figures 18 to 20 together. Taking the repair process of the anterior and posterior leaflets of the mitral valve as an example and the trans-femoral vein path as an example, the operation method of the valve repair of the present invention mainly includes the following steps:

[0077] By means of trans-femoral vein puncture, the guiding sheath 31 of the delivery device 20 is passed through the inferior vena cava, through the atrial septum of the heart and into the left atrium, and the distal end of the delivery sheath tube 23 is extended out of the guiding sheath 31; then the delivery catheter 22 is extended out of the delivery sheath tube 23, and the valve repair device 10 is controlled to approach the anterior leaflet 80a and the posterior leaflet 80b of the mitral valve; the delivery catheter 22 is delivered distally, and the driving structure 15 of the valve repair device 10 is driven by the delivery catheter 22. The clamping member 12 is deployed through the driving structure 15, and the direction of the clamping member 12 is adjusted. At this time, the relative positions of the clamping member 12 and the anterior and posterior leaflets of the mitral valve can be observed through a medical imaging or imaging device, so that the clamping member 12 is substantially perpendicular to the free edges of the anterior and posterior leaflets; then the valve repair device 10 is pushed to the left ventricle through the delivery catheter 22, and the valve repair device 10 is placed on the ventricular side of the anterior and posterior leaflets, and the clamping member is continuously opened to the capture position; at the same time, the clamping member is pulled, and at this time, a leaflet accommodation space is formed between the clamping arm 14 and the clamping member 12;

[0078] At the same time or successively release the clamping arms 14 on both sides, and the clamping arms 14 cooperate with the clamping member 12 to capture the anterior and posterior leaflets; when it is observed that the leaflets are not clamped in the proper position, the delivery catheter 22 is pulled proximally to drive the driving structure 15, thereby driving the clamping member 12 to close, so that the anterior and posterior leaflets are clamped between the clamping arms 14 and the clamping member 12;

[0079] In the above steps, when the delivery catheter 22 reaches the atrium, the doctor can monitor the atrial pressure through the pressure sensor 248 near the operating handle. When the delivery catheter 22 reaches the ventricle, the ventricular pressure can be monitored through the pressure sensor 248. By the changes in the ventricular or atrial pressure before and after the surgical treatment, and the transvalvular pressure difference between the ventricle and the atrium, it is beneficial for the doctor to evaluate the effect of the valve repair device in treating regurgitation.

[0080] Then, the connection between the delivery catheter 22 and the driving structure 15 is released, and the delivery catheter 22 is retracted. The valve clamping device 10 is further disconnected from the delivery catheter 22, and then the entire delivery device 20 is withdrawn from the body, obtaining the Figure 20 implanted state as shown. The valve repair device 10 pulls the anterior and posterior leaflets of the mitral valve towards each other and clamps them, completing the edge-to-edge repair of the anterior and posterior leaflets.

[0081] The above-mentioned transcatheter atrioventricular valve treatment system 100 and valve repair device 10 are suitable for application in mitral or tricuspid valve clamping surgery. In addition to the above-mentioned femoral vein - atrial septum - atrium - ventricle path, it can also be the transapical approach. When applied to the tricuspid valve, since there are three leaflets, namely the anterior leaflet, the posterior leaflet and the septal leaflet, another or multiple valve repair devices 10 can be implanted when necessary.

[0082] The above has introduced the embodiments of the present application in detail. Specific examples are used herein to elaborate on the principle and embodiments of the present application. The description of the above embodiments is only used to help understand the method and its core idea of the present application; at the same time, for those of ordinary skill in the art, according to the idea of the present application, there will be changes in the specific embodiments and application scope. In summary, the content of this specification should not be construed as a limitation to the present application.

Claims

1. A transcatheter atrioventricular valve treatment system, comprising a valve repair device and a delivery device, the delivery device including a delivery catheter and an operating handle for controlling the delivery catheter, the delivery catheter being configured to deliver at least a portion of the valve repair device to or near the atrioventricular valve, wherein: The delivery device further includes a fluid management system, and the fluid management system includes a pressure monitoring channel disposed inside the delivery catheter and extending through the proximal end to the distal end of the delivery catheter.

2. The transcatheter atrioventricular valve treatment system according to claim 1, wherein The delivery catheter delivers a part of the valve repair device to the ventricle via the atrium. When the distal end of the delivery catheter is located in the atrium, the pressure monitoring channel is used to monitor the pressure of the atrium. When the distal end of the delivery catheter is located in the ventricle, the pressure monitoring channel is used to monitor the pressure of the ventricle.

3. The transcatheter atrioventricular valve treatment system according to claim 2, characterized in that, The interior of the delivery catheter has a main channel and a plurality of secondary channels surrounding the main channel. The main channel accommodates a drive mandrel for driving the valve repair device. One of the plurality of secondary channels is hollow and serves as the pressure monitoring channel, and the remaining secondary channels of the plurality of secondary channels accommodate control wires for controlling the valve repair device.

4. The transcatheter atrioventricular valve treatment system according to claim 3, wherein, The fluid management system further includes a first sealed cavity pipeline assembly disposed in the operation handle. The first sealed cavity pipeline assembly includes a first sealed cavity, a sealed cavity pipeline connected to one end of the first sealed cavity. The sealed cavity pipeline is connected to the pressure monitoring channel. An on-off valve is externally connected to the first sealed cavity, and the on-off valve can be connected to an external first pressure sensor.

5. The transcatheter atrioventricular valve treatment system according to claim 4, wherein, The fluid management system further includes a second sealed cavity pipeline assembly disposed in the operation handle. The second sealed cavity assembly includes a second sealed cavity. The sealed cavity pipeline continuously passes through the second sealed cavity and is connected to the pressure monitoring channel. The main channel and the secondary channels accommodating the control wires are in gas-liquid communication with the second sealed cavity. An operation handle on-off valve is externally connected to the second sealed cavity.

6. The transcatheter atrioventricular valve treatment system according to claim 5, wherein The second sealed cavity assembly further includes a first positioning member and a second positioning member. The first positioning member and the second positioning member are respectively fixed on the inner side and the outer side of the second sealed cavity. A plurality of through holes are formed in the side wall of the second sealed cavity. The sealed cavity pipeline sequentially passes through the second positioning member, the through holes in the side wall of the second sealed cavity, and the first positioning member and is connected to the pressure monitoring channel. The main channel and the secondary channels accommodating the control wires respectively extend into the second sealed cavity and the first positioning member through first slender pipelines. The first slender pipelines are open between the first positioning member and the side wall of the second sealed cavity to be in gas-liquid communication with the second sealed cavity, and pass through the through holes in the side wall of the second sealed cavity and the second positioning member through second slender pipelines.

7. The transcatheter atrioventricular valve treatment system according to claim 6, wherein, The second sealed cavity pipeline assembly further includes a catheter positioning member provided with a plurality of channels. The catheter positioning member is connected to the delivery catheter. The plurality of channels of the catheter positioning member are respectively correspondingly communicated with the main channel and the secondary channels of the delivery catheter. The sealed cavity pipeline extends into one of the channels of the catheter positioning member and is connected to the pressure monitoring channel. The remaining channels of the catheter positioning member extend into the second sealed cavity through a plurality of the first slender pipelines. The side wall of the second sealed cavity extends towards the end of the operation handle through a plurality of the second slender pipelines. The drive mandrel and the control wires pass through the first slender pipelines and the second slender pipelines to reach the end of the operation handle.

8. The transcatheter atrioventricular valve treatment system according to claim 5, wherein The delivery device further includes a delivery sheath and a sheath handle for controlling the delivery sheath. The sheath handle is in communication with a sheath handle on-off valve. The valve repair device is detachably connected to the end of the delivery catheter. There is a gap between the delivery sheath and the delivery catheter. The fluid management system further includes a second pressure sensor connected to the sheath handle on-off valve.

9. The transcatheter atrioventricular valve treatment system according to claim 8, wherein, The delivery device further includes a guiding sheath and a guiding sheath control handle for controlling the guiding sheath. The delivery sheath, the delivery catheter together with the valve repair device pass through the guiding sheath control handle and the guiding sheath. The guiding sheath control handle is in communication with a guiding sheath on-off valve. There is a gap between the guiding sheath and the delivery sheath. The fluid management system further includes a third pressure sensor connected to the guiding sheath on-off valve.

10. The transcatheter atrioventricular valve treatment system according to claim 9, wherein, The fluid management system further includes a loader in communication with the delivery sheath, and a flush head in communication with the loader. The valve repair device is received in the loader. The flush head is used to access the exhaust liquid. The end of the loader is externally connected to a temporary on-off valve. The opening or closing of the temporary on-off valve, in cooperation with the opening or closing of the pipeline on-off valve, the operating handle on-off valve, and the sheath handle on-off valve, can exhaust the pressure monitoring channel, the operating handle, and the sheath handle.

11. The transcatheter atrioventricular valve treatment system according to claim 10, wherein, After removing the temporary on-off valve, the loader is in communication with the guiding sheath control handle.

12. The transcatheter atrioventricular valve treatment system according to claim 5, characterized in that, The second sealing cavity is fixed axially in the operating handle, and the operating handle has visual windows corresponding to the first sealing cavity and the second sealing cavity respectively.

13. The transcatheter atrioventricular valve treatment system according to claim 3, wherein The delivery catheter includes a flexible tube body, and a metal ring is provided at the end of the flexible tube body. The metal ring has a plurality of channels corresponding to the main channel and the sub-channel respectively. The drive mandrel and the control wire extend out of the corresponding main channel and sub-channel and are detachably connected to the valve repair device.

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