CN120203875A - Transcatheter Atrioventricular Valve Therapy System - Google Patents

Abstract

The present application discloses a transcatheter atrioventricular valve treatment system, which includes a valve repair device and a delivery device, wherein the delivery device includes a delivery catheter and an operating handle for controlling the delivery catheter, wherein the delivery catheter is used to deliver at least a portion of the valve repair device to the atrioventricular valve or near the atrioventricular valve, and wherein the delivery device also includes a fluid management system, wherein the fluid management system includes a pressure monitoring channel disposed inside the delivery catheter and extending from the proximal end to the distal end of the delivery catheter. The transcatheter atrioventricular valve treatment system of the present application can monitor the pressure of the ventricle through an external pressure sensor when the delivery catheter reaches the ventricle, and can also monitor the pressure of the atrium when the delivery catheter passes through a part of the heart, such as the atrium, and the pressure monitoring channel provides more independent and accurate monitoring to avoid being affected by other fluid channels.

Description

Transcatheter atrioventricular valve treatment system

Technical Field

The application relates to the technical field of medical instruments, in particular to a transcatheter atrioventricular valve treatment system.

Background

The atrioventricular valves, such as mitral valve, tricuspid valve, are one-way valves within the heart that allow normal healthy atrioventricular valves to control blood flow from the atrium to the ventricle while avoiding blood flow 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 that can control the flow of blood from the left atrium to the left ventricle while avoiding the flow of blood from the left ventricle to the left atrium. The mitral valve includes a pair of leaflets, anterior and posterior respectively. When the edges of the anterior and posterior leaflet align, the mitral valve may close completely, preventing blood from flowing from the left ventricle to the left atrium. When the leaflets of the mitral valve or their associated structures undergo an organic or functional change, the anterior and posterior leaflets of the mitral valve do not coapt properly, whereby the mitral valve does not close completely when the left ventricle of the heart contracts, resulting in regurgitation of blood from the left ventricle to the left atrium, causing a series of pathophysiological changes known as "mitral regurgitation".

Transcatheter atrioventricular valve treatment techniques refer to the delivery of various valve repair devices through a catheter to the mitral or tricuspid valve to treat mitral or tricuspid valve regurgitation by remote manipulation outside the patient's body to repair or replace the diseased mitral or tricuspid valve. Compared with the traditional valve treatment technology, the transcatheter treatment technology reduces the operation risk and time, and becomes one of the main stream treatment means of the atrioventricular valve.

For the transcatheter atrioventricular valve treatment technology, a doctor remotely operates the valve repair device outside the patient, the change of the internal structure of the heart of the patient cannot be visually seen, the treatment effect can be judged only by depending on medical imaging technologies such as ultrasound and the like, and the personal experience requirement of the doctor is high. It is found that, for example, by using a transcatheter mitral valve edge-to-edge repair, when the valve repair device acts on the anterior leaflet and the posterior leaflet of the mitral valve, and the blood reflux condition is improved, the pressure of the atrium and the ventricle is correspondingly changed, so that the pressure change and the transvalve pressure difference of the atrium and the ventricle before, during and after the operation can assist a doctor in judging the clamping condition of the anterior leaflet and the posterior leaflet, the improvement of the blood reflux quantity and the treatment effect of the operation. Therefore, monitoring of the atrial pressure, ventricular pressure, and transvalve pressure differential of the mitral or tricuspid valve during surgery remains a technical difficulty in the art to more accurately assess the effectiveness of surgical treatment, help doctors make decisions faster, further reduce the surgical time and improve the success rate of the surgery.

Disclosure of Invention

In view of the above, the present application provides a transcatheter atrioventricular valve treatment system that solves the problems of the prior art.

In one aspect, embodiments of the present application provide 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 the atrioventricular valve or to the vicinity of the atrioventricular valve, and an operating handle for controlling the delivery catheter, the delivery device further comprising a fluid management system comprising a pressure monitoring channel disposed within the delivery catheter and extending therethrough from a proximal end to a distal end of the delivery catheter.

In a preferred embodiment, the delivery catheter delivers a portion of the valve repair device to the ventricle via the atrium, the pressure monitoring channel being configured to monitor the pressure of the atrium when the distal end of the delivery catheter is located in the atrium, and the pressure monitoring channel being configured to monitor the pressure of the ventricle when the distal end of the delivery catheter is located in the ventricle.

In a preferred embodiment, the interior of the delivery catheter has a main lumen channel that houses a drive mandrel for driving the valve repair device and a plurality of secondary lumen channels surrounding the main lumen channel, one of the plurality of secondary lumen channels being hollow and the pressure monitoring channel, the remaining secondary lumen channels of the plurality of secondary lumen channels housing a control wire for controlling the valve repair device.

In a preferred embodiment, the fluid management system further comprises a first seal cavity pipeline assembly arranged in the operating handle, the first seal cavity pipeline assembly comprises a first seal cavity, a seal cavity pipeline connected with one end of the first seal cavity, the seal cavity pipeline is connected with the pressure monitoring channel, a pipeline opening and closing valve is externally connected with the first seal cavity, and the pipeline opening and closing valve can be connected with an external first pressure sensor.

In a preferred embodiment, the fluid management system further comprises a second seal cavity pipeline assembly arranged in the operating handle, the second seal cavity assembly comprises a second seal cavity, the seal cavity pipeline continuously penetrates through the second seal cavity to be connected with the pressure monitoring channel, the main cavity pipeline and the auxiliary cavity pipeline containing the control wire are in gas-liquid communication with the second seal cavity, and the second seal cavity is externally connected with the operating handle to open and close a valve.

In a preferred embodiment, the second seal cavity assembly further comprises 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 seal cavity, a plurality of through holes are formed in the side wall of the second seal cavity, the seal cavity pipeline sequentially penetrates through the second positioning member, the through holes in the side wall of the second seal cavity and the first positioning member to be connected with the pressure monitoring channel, the main cavity pipeline and the auxiliary cavity pipeline containing the control wire respectively extend into the second seal cavity and the first positioning member through first slender pipelines, and the first slender pipelines are opened between the first positioning member and the side wall of the second seal cavity to be in gas-liquid communication with the second seal cavity and penetrate out of the through holes in the side wall of the second seal cavity and the second positioning member through the second slender pipelines.

In a preferred embodiment, the second sealed cavity pipeline assembly further comprises a conduit locating piece provided with a plurality of cavity channels, the conduit locating piece is connected with the conveying conduit, the cavity channels of the conduit locating piece are respectively correspondingly communicated with the main cavity channel and the auxiliary cavity channel of the conveying conduit, the sealed cavity pipeline stretches into one cavity channel of the conduit locating piece to be connected with the pressure monitoring channel, the other cavity channels of the conduit locating piece stretch into the second sealed cavity through a plurality of first slender pipelines, the side wall of the second sealed cavity extends towards the end part of the operating handle through a plurality of second slender pipelines, and the driving mandrel and the control wire penetrate through the first slender pipelines and the second slender pipelines to reach the end part of the operating handle.

In a preferred embodiment, the delivery device further comprises 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 distal end of the delivery catheter, a gap is provided between the delivery sheath and the delivery catheter, and the fluid management system further comprises a second pressure sensor connected to the sheath handle on-off valve.

In a preferred embodiment, the delivery device further comprises an introducer sheath and an introducer sheath control handle for controlling the introducer sheath, the delivery sheath tube, the delivery catheter, and the valve repair device pass through the introducer sheath control handle and the introducer sheath, the introducer sheath control handle is in communication with an introducer sheath on-off valve, a gap is formed between the introducer sheath and the delivery sheath tube, and the fluid management system further comprises a third pressure sensor connected with the introducer sheath on-off valve.

In a preferred embodiment, the fluid management system further comprises a loader communicated with the delivery sheath, and a flushing head communicated with the loader, the valve repair device is accommodated in the loader, the flushing head is used for accessing exhaust liquid, the tail end of the loader is externally connected with a temporary opening and closing valve, and the opening or closing of the temporary opening and closing valve can be matched with the opening or closing of the pipeline opening and closing valve, the operating handle opening and closing valve and the sheath handle opening and closing valve to exhaust the pressure monitoring channel, the operating handle and the sheath handle.

In a preferred embodiment, the loader communicates with the introducer sheath control handle after removal of the temporary on-off valve.

In a preferred embodiment, the second sealing cavity is fixed in the operating handle along the axial direction of the operating handle, and the operating handle is provided with a visible window corresponding to the first sealing cavity and the second sealing cavity respectively.

In a preferred embodiment, the delivery catheter comprises a flexible tube body, the tail end of the flexible tube body is provided with a metal ring, the metal ring is provided with a plurality of cavity channels corresponding to the main cavity channel and the auxiliary cavity channel respectively, and the driving mandrel and the control wire extend out of the corresponding main cavity channel and auxiliary cavity channel to be detachably connected with the valve repair device.

Compared with the prior art, the transcatheter atrioventricular valve treatment system is provided with the pressure monitoring channel which extends through the delivery catheter, so that the pressure of the ventricle can be monitored through an external pressure sensor when the delivery catheter reaches the ventricle, the pressure of the atrium can also be monitored when the delivery catheter passes through other heart parts, such as the atrium, and the effect of treating reflux of the valve repair device is evaluated by a doctor through the change of the pressure of the ventricle or the atrium before and after the operation treatment and the transvalve pressure difference, and the transcatheter atrics treatment system is particularly suitable for evaluating the treatment effect of treating reflux of the mitral valve or the tricuspid valve. The transcatheter atrioventricular valve treatment system can solve the problem of monitoring the pressure of the ventricle and/or atrium without arranging a sensor at the far end of the conveying catheter, reduces the operation cost, avoids using active equipment, reduces the operation risk, is more independent and accurate, and can prevent the pressure monitoring process from being influenced by other fluid channels.

Drawings

In order to more clearly illustrate the embodiments of the application or the technical solutions of the prior art, the drawings which are used in the description of the embodiments or the prior art will be briefly described, it being obvious that the drawings in the description below are only some embodiments of the application, and that other drawings can be obtained from them without inventive faculty for a person skilled in the art.

Fig. 1 is a schematic diagram of a transcatheter atrioventricular valve treatment system according to an embodiment of the present application.

Fig. 2 is an enlarged schematic view of the distal region a of the transcatheter atrioventricular valve treatment system of fig. 1.

Fig. 3 is a schematic cross-sectional view of the delivery catheter of fig. 2 taken along the direction B-B.

Fig. 4 is an exploded view of the delivery catheter and the distal metal ring of fig. 1.

Fig. 5 is a partial internal schematic view of the operating handle of the transcatheter atrioventricular valve treatment system of fig. 1 coupled to a pressure sensor.

Fig. 6 is an exploded schematic view of the catheter mount, catheter positioning member, second seal lumen, etc. of the operating handle of fig. 5.

Fig. 7 is an enlarged schematic perspective view of the catheter positioning member of fig. 1.

Fig. 8 is a schematic view of the assembly of the catheter lock and catheter mount of fig. 6 with a delivery catheter.

Fig. 9 is an enlarged schematic view of portion a of fig. 6.

Fig. 10 is an assembled schematic view of the catheter mount, catheter positioning member, second seal lumen, etc. of fig. 6.

Fig. 11 is an enlarged schematic view of a portion B of fig. 10.

Fig. 12 is a schematic view of a partial explosion of the pressure monitoring channel connecting the first sealed chamber.

Fig. 13 is a schematic view of the transcatheter atrioventricular valve treatment system of fig. 1 in an exhaust state.

Fig. 14 is a schematic view of the assembly of the transcatheter atrioventricular valve treatment system of fig. 13 with an introducer sheath after venting.

Fig. 15 is a cross-sectional view of the introducer sheath, delivery sheath, and delivery catheter of fig. 13.

Fig. 16 is a cross-sectional view of another embodiment of an introducer sheath, delivery sheath, and delivery catheter.

Fig. 17 is a schematic view of a valve repair device provided in an embodiment of the present application.

FIG. 18 is a schematic view of a valve repair device according to an embodiment of the present invention as applied to mitral valve treatment;

FIG. 19 is a schematic view of the valve repair device of FIG. 18 in a closed, gripping position;

fig. 20 is a schematic view of the valve repair device of fig. 19 separated from the delivery device.

The application will be further described in the following detailed description in conjunction with the above-described figures.

Detailed Description

The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all embodiments of the application. All other embodiments, based on the embodiments of the application, which a person of ordinary skill in the art would achieve without inventive faculty, are within the scope of the application.

In the interventional medical field, the end of the instrument near the operator is generally referred to as a proximal end and the end of the instrument far from the operator is generally referred to as a distal end along the transport path of the instrument. In particular, for delivery devices used to deliver and release an implantable device into a patient, the distal end refers to the end of the delivery device that is free to be inserted into an animal or human body, and the proximal end refers to the end of the delivery device that is intended for manipulation by a user or machine. The direction of the rotation center axis of the column, the tube and the like is defined as the axial direction, the circumferential direction is the direction (perpendicular to the axis and the cross-section radius) around the axis of the column, the tube and the like, and the radial direction refers to the direction along the diameter or the radius. Wherein, the axial direction, the circumferential direction and the radial direction jointly form three orthogonal directions of the column object. It is noted that the term "end" as used in the terms of "proximal", "distal", "one end", "other end", "first end", "second end", "initial end", "terminal", "both ends", "free end", "upper end", "lower end", etc. is not limited to a tip, endpoint or end face, but includes a location extending an axial distance and/or a radial distance from the tip, endpoint or end face over the element to which the tip, endpoint or end face belongs. The above definitions are for convenience of description only and are not to be construed as limiting the application.

It is to be understood that the terminology used in the description and claims of the application and in the above description and drawings is for the purpose of describing particular embodiments only, and is not intended to be limiting of the application. The terms first, second and the like in the description and in the claims and in the above-described figures, are used for distinguishing between different objects and not necessarily for describing a sequential or chronological order. The singular forms "a," "an," and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The term "comprising" and any variations thereof is intended to cover a non-exclusive inclusion. Furthermore, the present application may be embodied in many different forms and is not limited to the embodiments described below. The following detailed description is provided to facilitate a more thorough understanding of the present disclosure, in which words of upper, lower, left, right, etc., indicating orientations are used solely for the illustrated structure in the corresponding figures.

It should be noted that all the foregoing drawings are exemplary illustrations of the present application, and do not represent actual sizes of products. And the dimensional relationships among the components in the drawings are not intended to limit the actual products of the application. The description hereinafter sets forth a preferred embodiment for practicing the application, but the above description is not intended to limit the scope of the application, as it is not intended to limit the general principles of the application. The scope of the application is defined by the appended claims.

Referring also to fig. 1-4, one embodiment of the present application provides a transcatheter atrioventricular valve treatment system 100 comprising a valve repair device 10 and a delivery device 20. Atrioventricular valve includes mitral and tricuspid valves, and valve repair device 10 refers to a permanent or temporary implant that acts directly or indirectly on the mitral or tricuspid valve or tissue in the vicinity thereof, including but not limited to, edge-to-edge clamping devices, annuloplasty rings, prosthetic valves, prosthetic chordae tendineae, leaflet coaptation edge enhancement devices, ventricular volume reduction devices, and the like, and can treat degenerative changes or functional insufficiency of the mitral or tricuspid valve.

The delivery device 20 is for delivering at least a portion of the valve repair device 10 to a ventricle of a mitral or tricuspid valve, the valve repair device 10 straddling between the ventricle and the atrium when the mitral or tricuspid valve is repaired, and thus at least a portion of the valve repair device 10 is located in the ventricle, the delivery device 20 basically comprising a delivery catheter 22, the delivery catheter 22 delivering at least a portion of the valve repair device 10 to the ventricle, e.g., a portion of the valve repair device 10 is located below the leaflet and a portion is located above the leaflet.

The delivery path may be, for example, an atrial to ventricular path or a transapical path.

The delivery device 20 includes a fluid management system for providing monitoring management of ventricular and/or atrial pressures at the surgical site, or transvalve differential pressure of the ventricular atria, and pre-venting management of the entire transcatheter atrioventricular valve treatment system.

The fluid management system includes a hollow pressure monitoring channel 224 disposed within the delivery catheter 22, with the pressure monitoring channel 224 extending through the proximal end to the distal end of the delivery catheter 22.

The delivery catheter 22 is a multi-lumen tube, and the multi-lumen tube includes a main lumen channel 222 and a plurality of auxiliary lumens surrounding the main lumen channel 221, the main lumen channel 221 accommodates a driving mandrel for driving the valve repair device 10, one of the plurality of auxiliary lumens is hollow and is the pressure monitoring channel 224, the remaining auxiliary lumens of the plurality of auxiliary lumens are control wire lumens 223, and the control wire lumens 223 accommodate control wires for controlling the valve repair device. The multiple lumens of the delivery catheter 22 may be embedded in the injection mold from individual tubing to form a delivery catheter with multiple lumens.

The delivery catheter 22 is essentially a flexible tube, in this embodiment, the distal end of the delivery catheter 22 has a metal ring 22a, which metal ring 22a may be welded to the distal end of the delivery catheter 22. The metal ring 22a has a plurality of channels corresponding to the main channel 222 and each of the auxiliary channels of the delivery conduit 22, respectively. A drive spindle 22b and a control wire 22c (see fig. 16) for driving the valve repair device 10 extend out of the corresponding lumen of the metal ring 22a, respectively, to be detachably connected with the valve repair device 10.

Referring to fig. 5-6, the delivery device 20 has an operating handle 24, the delivery catheter 22 is connected to the middle portion of the operating handle 24 at a position biased to the proximal end, and the delivery catheter 22 further extends 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 elongated channels 243, a second sealing cavity 244, a first positioning member 244a, a second positioning member 244b, and a plurality of second elongated channels 245. The conduit mount 241, conduit mount 242, first plurality of elongated conduits 243, second seal chamber 244, first mount 244a, second mount 244b, and second plurality of elongated conduits 245 form a second seal chamber assembly.

Specifically, referring to fig. 7 and 8, the catheter positioning member 242 has a plurality of channels 242a, 242b, 242c corresponding to the main channel 222 and each of the sub-channels of the delivery catheter 22, respectively, wherein the channel 242c corresponds to the pressure monitoring channel 224 in the sub-channel of the delivery catheter 22. Proximal ends of the plurality of lumens of the catheter positioning member 242 are correspondingly connected to the plurality of first elongate conduits 243. The catheter positioning member 242 and the delivery catheter 22 are fixedly connected by the catheter fixing member 241.

Referring to fig. 6 to 11 together, the catheter positioning member 242 is assembled into the second sealing cavity 244, the plurality of first elongated tubes 243 extend into the second sealing cavity 244, the first positioning member 244a is disposed at an end portion inside the second sealing cavity 244, and the plurality of first elongated tubes 243 are fixed on the first positioning member 244 a.

The first plurality of elongated conduits 243 secured to the catheter positioning member 242 include a drive mandrel conduit 243a, at least two control wire conduits 243b, and a seal lumen conduit 243c, or the seal lumen conduit 243c is secured to the catheter positioning member 242 in combination with the remaining first plurality of elongated conduits 243. The drive mandrel conduit 243a and at least two control wire conduits 243b are open, i.e., terminate, at the first positioning member 244a such that there is a gap between the sidewalls of the second seal chamber 244 and thereby in gas-liquid communication with the second seal chamber 244. The lumen conduit 243c continues within the second lumen 244 (see fig. 9 and 11), i.e., without breaking, and continues proximally directly through the second lumen 244.

The second sealing cavity 244 includes an upper housing 244c and a lower housing 244d, the upper housing 244c and the lower housing 244d together form a second sealing cavity, a sealing ring 244f may be disposed between the upper housing 244c and the lower housing 244d, and the plurality of first elongated pipes 243 and the first positioning members 244a are located in the second sealing cavity. The operating handle 24 may be provided with a transparent visual window 244a at a position corresponding to the second sealing chamber 244, so as to facilitate observation of the gas-liquid condition in the second sealing chamber 244, including the condition of gas and blood in the second sealing chamber 244.

The side wall of the second sealing cavity 244 is provided with a through hole 244e, the second positioning member 244b is disposed at the outer side of the second sealing cavity 244, and the plurality of second elongated pipes 245 are fixed to the second positioning member 244b and extend into the through hole 244e of the side wall of the second sealing cavity 244, so as to respectively correspond to the driving mandrel pipes 243a of the plurality of first elongated pipes 243 and at least two control wire pipes 243b. The drive spindle and control wire extend continuously from the first elongate conduit 243 to the corresponding second elongate conduit 245 to the proximal end of the operating handle. The proximal end of the operating handle is provided with a corresponding control knob for operating the movement of the driving mandrel and the control wire.

Referring to fig. 5, 6, 11 and 12, the lumen conduit 243c may continue proximally through the second positioning member 244 b. The capsule conduit 243c is further coupled to a first capsule 246. The first sealing chamber 246 also comprises an upper shell 246a, a lower shell 246b and a sealing ring 246c, the sealing chamber pipeline 243c is disconnected in the first sealing chamber 246, the other end of the first sealing chamber 246 is externally connected with a pipeline opening and closing valve 247, and the pipeline opening and closing valve 247 can be connected with the first sealing chamber 246 through a section of pipeline. The conduit opening/closing valve 247 may be externally connected to a pressure sensor 248. The pressure sensor 248 detects the pressure of the ventricle and/or atrium at the operation position or the pressure difference across the valve of the ventricle and atrium through the sealing cavity pipeline 243c and the pressure monitoring channel 224, so that the effect of the repair treatment of the valve repair device is judged through the pressure difference before and after the operation.

Referring again to fig. 1, the operating handle 24 may also be provided with a transparent visual window 246a at a position corresponding to the first sealing chamber 246, so as to facilitate observation of the gas-liquid condition in the first sealing chamber 246, including the condition of gas and blood in the first sealing chamber 246.

Referring to fig. 1 and 13 together, the delivery device 20 of the transcatheter atrioventricular valve treatment system 100 further comprises a delivery sheath 23 and a sheath handle 25 for controlling the delivery sheath 23, wherein the delivery catheter 22 passes through the sheath handle 25 and the delivery sheath 23, and wherein the delivery catheter 22 passes out of the delivery sheath 23. The sheath handle 25 has a bending adjusting function on the delivery sheath 23, and the delivery sheath 23 can drive the delivery catheter 22 to bend in the vascular path in the patient. The valve repair device 10 is fitted at the end of the delivery catheter 22.

The fluid management system further includes a loader 26, a flush head 27, a temporary on-off valve 28, a sheath handle on-off valve 29, and an operating handle on-off valve 30. The device is vented prior to entry into the patient via the catheter atrioventricular valve treatment system 100. The loader 26 has a hollow channel, and the delivery sheath 23 and the delivery catheter 22, together with the valve repair device 10, extend into the loader 26.

The rinse head 27 communicates with the loader 26. The sheath handle opening/closing valve 29 communicates with the sheath handle 25, and the operating handle opening/closing valve 30 communicates with the second seal chamber 244 of the operating handle 24. The flushing head 27, the temporary opening and closing valve 28, the sheath handle opening and closing valve 29, the operating handle opening and closing valve 30, and the pipe opening and closing valve 247 may be three-way cock, the three-way cock has a knob thereon, and may open or close a channel of the three-way cock, and the channel of the three-way cock may be externally connected with an external device, such as an external pressure sensor, or a physiological saline syringe, except for the delivery device 20 connected to the catheter atrioventricular valve treatment system 100.

Before the exhaust, the temporary closing valve 28 is mounted on the end of the delivery sheath 23, and the exhaust is performed in several steps:

(1) The knob of the flushing head 27 and the knob of the temporary on-off valve 28 are opened, and the sheath handle on-off valve 29, the operation handle on-off valve 30, and the pipe on-off valve 247 are closed, and then the temporary on-off valve 28 is appropriately raised, as slightly above the flushing head 27. Injecting heparin physiological saline into the loader 26 through the flushing head 27, discharging the gas in the whole loader 26 from the temporary opening and closing valve 28, and screwing the flushing head 27 and the temporary opening and closing valve 28 to a closed state after the gas in the loader 26 is discharged;

(2) The knob of the irrigation head 27 and the knob of the sheath handle opening/closing valve 29 are opened, and the temporary opening/closing valve 28, the operation handle opening/closing valve 30, and the tubing opening/closing valve 247 are closed, and then the sheath handle opening/closing valve 29 is appropriately lifted, as slightly above the irrigation head 27. Injecting heparin physiological saline into the delivery sheath 23 through the flushing head 27, discharging the gas in the whole delivery sheath 23 and the sheath handle 25 from the sheath handle 25 opening and closing valve 29, observing that the gas in the sheath handle 25 is discharged through a transparent window on the sheath handle 25, and screwing the flushing head 27 and the sheath handle opening and closing valve 29 to a closed state;

(3) The knob of the flushing head 27 and the knob of the operating handle opening/closing valve 30 are opened, and the temporary opening/closing valve 28, the sheath handle opening/closing valve 29 and the pipe opening/closing valve 247 are closed, and then the operating handle opening/closing valve 30 is appropriately raised, as slightly above the flushing head 27. The heparin physiological saline is injected into the delivery catheter 22 through the flushing head 27, the air in the unlocking wire cavity, the spring piece control wire cavity and the second sealing cavity 244 in the delivery catheter 22 is discharged from the operating handle opening and closing valve 30, and the flushing head 27 and the operating handle opening and closing valve 30 are screwed to the closed state after the air in the second sealing cavity 244 is completely discharged through the transparent window of the operating handle 24.

(4) The knob of the flushing head 27 and the knob of the pipe closing valve 247 are opened, and the temporary closing valve 28, the sheath handle closing valve 29 and the operating handle closing valve 30 are closed, and then the pipe closing valve 247 is appropriately lifted, as slightly above the flushing head 27. The heparin physiological saline is injected into the delivery catheter 22 through the flushing head 27, the pressure monitoring channel of the delivery catheter 22 and the gas in the operating handle 24 assembly are discharged from the pipeline opening and closing valve 247, the flushing head 27 and the pipeline opening and closing valve 247 are also screwed to the closed state after the gas in the operating handle 24 is completely discharged through the transparent window of the operating handle 24, and thus, the whole catheter atrioventricular valve treatment system 100 is completely discharged.

Referring to fig. 14, in mitral valve surgery, the delivery device 20 may further include an introducer sheath 31 and an introducer sheath control handle 32 for controlling the introducer sheath 31, the loader is in communication with the introducer sheath control handle 32 after removing the temporary closing valve 28, the delivery sheath 23, the delivery catheter 22 and the valve repair device 10 pass through the introducer sheath control handle 32 and the introducer sheath 31, and the introducer sheath 31 is more conveniently penetrated into the left atrium at the atrial septum of the heart under the control of the introducer sheath control handle 32, so that the treatment area of the mitral valve is reached via the atrial-ventricular path.

Referring to fig. 15, in the transcatheter atrioventricular valve system 100, if the gap D1 between the delivery sheath 23 and the delivery catheter 22 is suitable, for example, up to 0.3mm-1.5mm, the sheath handle closing valve 29 may be externally connected with a second pressure sensor (not shown) for sensing the atrial pressure of the delivery catheter 22 reaching the atrium through the gap between the delivery catheter 22 and the delivery sheath 23. In the present application, since the pressure monitoring channel is provided in the delivery catheter 22, the pressure of the atrium can be measured when the delivery catheter 22 is positioned in the atrium, and the pressure of the ventricle can be measured when the pressure reaches the ventricle, the sheath handle opening/closing valve 29 may not be externally connected to the second pressure sensor.

Referring to fig. 19, in the operation, since the delivery sheath 23 is always located in the atrium, the pressure of the atrium can be measured by the 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 of the delivery catheter 22 after entering the ventricle, and the pressure difference between the atrium and the ventricle measured by the two pressure sensors can be used as the pressure difference between the atria and the ventricle crossing valve at the same time.

Referring to fig. 16, if the inner diameter of the guiding sheath 31 is larger than the outer diameter of the delivering sheath 23, and the gap D2 between the guiding sheath 31 and the delivering sheath 23 is suitable, for example, 0.3mm-1.5mm, the guiding sheath control handle 32 may be connected to a guiding sheath opening/closing valve 33, and a third pressure sensor (not shown) may be connected to the interface of the guiding sheath opening/closing valve 33, and may be used to sense the pressure of the left atrium when the guiding sheath 31 reaches the left atrium. In the present application, since the pressure monitoring channel is provided in the delivery catheter 22, the pressure of the atrium can be measured when the delivery catheter 22 is positioned in the atrium, and the pressure of the ventricle can be measured when the pressure reaches the ventricle, the sheath control handle 32 may not be externally connected with the third pressure sensor.

Referring to fig. 19, in the operation, since the guiding sheath 31 only reaches the atrium, the third pressure sensor may be used to measure the pressure of the atrium, and the pressure sensor 248 connected to the pressure monitoring channel of the delivering catheter 22 may only measure the ventricular pressure of the delivering catheter 22 after entering the ventricle, and the pressure difference between the atrium and the ventricle measured by the two pressure sensors may be used as the pressure difference between the atrium and the ventricle at the same time.

In summary, the transcatheter atrioventricular valve treatment system 100 of the present invention provides a pressure monitoring passageway extending through the proximal end to the distal end of the delivery catheter 22 for delivering at least a portion of the valve repair device 10 to the ventricle of a heart, such that the pressure of the ventricle can be monitored by an external pressure sensor 248 when the delivery catheter 22 reaches the ventricle, and the pressure of the atrium can also be monitored when the delivery catheter 22 passes over a heart site, such as the atrium, and the pressure differential between the ventricle and the atrium, i.e., the transvalve pressure differential, facilitates evaluation of the effectiveness of the valve repair device treatment, particularly suitable for evaluation of the effectiveness of the mitral or tricuspid valve for treating regurgitation. The transcatheter atrioventricular valve treatment system 100 of the present invention solves the problem of ventricular and/or atrial pressure monitoring without requiring a built-in sensor to the distal end of the delivery catheter, and the transcatheter atrioventricular valve treatment system of the present invention is a more independent, accurate fluid management system, and pressure monitoring can be prevented from being affected by other fluid pathways.

Referring also to fig. 17, the valve repair device 10 of the present invention may be embodied as a clamp with a clamping function, which has a pair of openable or closable clamping members 12, clamping arms 14 located inside the clamping members 12, and a driving structure 15 for driving the clamping members 12 to open and close relatively. The clamping arm 14 can be opened by making a perforation through which a control wire extending from the delivery device can then be passed to control the relative opening and closing. The drive structure 15 is detachably connected to the delivery catheter 22. The clamp 12 cooperates with the clamping arms 14 to clamp the two leaflets of the valve (see fig. 20), thereby treating the problem of regurgitation of blood between the leaflets by clamping and pulling the two leaflets toward the center of the valve repair device 10.

Referring to fig. 17 and 18-20, taking as an example the anterior and posterior leaflet repair procedure of the mitral valve and taking as an example the transfemoral approach, the method of operation of the valve repair of the present invention generally comprises the steps of:

The method comprises the steps of penetrating the left atrium through the heart atrial septum by the guiding sheath 31 of the conveying device 20 through the inferior vena cava to enable the distal end of the conveying sheath tube 23 to extend out of the guiding sheath 31, extending the conveying catheter 22 out of the conveying sheath tube 23 and controlling the valve repairing device 10 to approach the front leaflet 80a and the rear leaflet 80b of the mitral valve, conveying the conveying catheter 22 to the distal end, enabling the conveying catheter 22 to drive the driving structure 15 of the valve repairing device 10, driving the clamping piece 12 to be unfolded through the driving structure 15, adjusting the direction of the clamping piece 12, observing the relative positions of the clamping piece 12 and the front leaflet and the rear leaflet of the mitral valve through medical developing or imaging equipment at the moment, enabling the clamping piece 12 to be approximately perpendicular to the free edges of the front leaflet and the rear leaflet, pushing the valve repairing device 10 to the left ventricle through the conveying catheter 22, enabling the valve repairing device 10 to be placed on the ventricular side of the front leaflet and the rear leaflet to enable the clamping piece to be opened to the capturing position, and simultaneously pulling the clamping piece 14 and the clamping piece 12 to form a leaflet accommodating space between the clamping piece 12 and the clamping piece 12;

simultaneously or sequentially releasing the clamping arms 14 at two sides, wherein the clamping arms 14 are matched with the clamping piece 12 to catch the front leaf and the rear leaf; when it is observed that the leaflet is not clamped in place, pulling proximally on the delivery catheter 22 brings the drive structure 15, thereby driving the clip 12 closed such that the anterior and posterior leaflets are clamped between the clamping arms 14 and the clip 12;

In the above steps, when the delivery catheter 22 reaches the atrium, the physician may monitor the pressure of the atrium by means of the pressure sensor 248 near the operating handle, and when the delivery catheter 22 reaches the ventricle, the physician may monitor the pressure of the ventricle by means of the pressure sensor 248, and by means of changes in the pressure of the ventricle or atrium before and after the surgical treatment, and the transvalve pressure difference between the ventricle and atrium may be beneficial for the physician to assess the effect of the valve repair device to treat regurgitation.

The connection between the delivery catheter 22 and the drive structure 15 is then released and the delivery catheter 22 is withdrawn, the valve clasper device 10 is further disconnected from the delivery catheter 22, and the entire delivery device 20 is then withdrawn from the body to achieve the implanted condition shown in fig. 20, the valve clasper device 10 pulls the anterior leaflet and the posterior leaflet of the mitral valve toward each other to clasp, completing the edge-to-edge repair of the anterior leaflet and the posterior leaflet.

The transcatheter atrioventricular valve treatment system 100 and the valve repair device 10 described above are suitable for use in mitral or tricuspid valve pinching procedures, other than the femoral vein-atrial septum-atrial ventricular path described above, which may also be a transapical approach. In application to the tricuspid valve, due to the presence of anterior, posterior and septal three leaflets, another or more valve repair devices 10 may be implanted as needed for treatment.

While the foregoing has been provided to illustrate the principles and embodiments of the present application, specific examples have been provided herein to assist in understanding the principles and embodiments of the present application, and are intended to be in no way limiting, for the purpose of illustrating the application, as long as the principles and embodiments of the present application are modified in accordance with the principles and embodiments of the present application.

Claims (13)

1. 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 the atrioventricular valve and an operating handle for controlling the delivery catheter, characterized in that the delivery device further comprises a fluid management system comprising a pressure monitoring channel disposed inside the delivery catheter and extending therethrough from a proximal end to a distal end of the delivery catheter.

2. The transcatheter atrioventricular valve therapy system of claim 1, wherein the delivery catheter delivers a portion of the valve repair device to the ventricle via the atrium, the pressure monitoring channel for monitoring pressure of the atrium when a distal end of the delivery catheter is positioned in the atrium, and the pressure monitoring channel for monitoring pressure of the ventricle when a distal end of the delivery catheter is positioned in the ventricle.

3. The transcatheter atrioventricular valve treatment system of claim 2, wherein an interior of said delivery catheter has a main lumen channel and a plurality of secondary lumen channels surrounding said main lumen channel, said main lumen channel housing a drive mandrel for driving said valve repair device, one of said plurality of secondary lumen channels being hollow and said pressure monitoring channel, a remaining of said plurality of secondary lumen channels housing a control wire for controlling said valve repair device.

4. The transcatheter atrioventricular valve treatment system of claim 3, wherein said fluid management system further comprises a first sealed-chamber conduit assembly disposed within said operating handle, said first sealed-chamber conduit assembly comprising a first sealed chamber, a sealed-chamber conduit connected to one end of said first sealed chamber, said sealed-chamber conduit connected to said pressure monitoring passageway, said first sealed chamber being externally connected with a conduit on-off valve connectable to an external first pressure sensor.

5. The transcatheter atrioventricular valve treatment system of claim 4, wherein said fluid management system further comprises a second sealed-chamber conduit assembly disposed within said operating handle, said second sealed-chamber assembly including a second sealed chamber through which said sealed-chamber conduit is continuously connected to said pressure monitoring passageway, said main chamber conduit and said secondary chamber conduit containing said control wire being in vapor-liquid communication with said second sealed chamber, said second sealed chamber circumscribing an operating handle on-off valve.

6. The transcatheter atrioventricular valve treatment system of claim 5, wherein said second seal chamber assembly further comprises a first positioning member and a second positioning member, said first positioning member and said second positioning member being secured to respective inner and outer sides of said second seal chamber, said second seal chamber side wall being provided with a plurality of through holes, said seal chamber conduit being connected to said pressure monitoring passageway in sequence through said second positioning member, said second seal chamber side wall through holes and said first positioning member, said main lumen and said control wire-containing auxiliary lumen extending into said second seal chamber and said first positioning member, respectively, through a first elongated conduit opening between said first positioning member and said second seal chamber side wall for gas-liquid communication with said second seal chamber and passing out of said second seal chamber side wall through said second elongated conduit.

7. The transcatheter atrioventricular valve treatment system of claim 6, wherein said second sealed lumen tubing assembly further comprises a catheter positioning member defining a plurality of lumens, said catheter positioning member being coupled to said delivery catheter, said plurality of lumens of said catheter positioning member being in respective communication with said main lumen and said auxiliary lumen of said delivery catheter, one of said sealed lumen tubing extending into said catheter positioning member being coupled to said pressure monitoring passageway, the remaining lumens of said catheter positioning member extending into said second sealed lumen through a plurality of said first elongated tubing, a sidewall of said second sealed lumen extending through a plurality of said second elongated tubing toward an end of said operating handle, said drive spindle and said control wire extending through said first elongated tubing and said second elongated tubing to an end of said operating handle.

8. The transcatheter atrioventricular valve treatment system of claim 5, wherein said delivery device further comprises a delivery sheath and a sheath handle for controlling said delivery sheath, said sheath handle in communication with a sheath handle on-off valve, said valve repair device removably attached to a distal end of said delivery catheter, said delivery sheath and said delivery catheter having a gap therebetween, said fluid management system further comprising a second pressure sensor attached to said sheath handle on-off valve.

9. The transcatheter atrioventricular valve treatment system of claim 8, wherein said delivery device further comprises an introducer sheath and an introducer sheath control handle for controlling said introducer sheath, said delivery catheter, and said valve repair device pass through said introducer sheath control handle and said introducer sheath, said introducer sheath control handle being in communication with an introducer sheath on-off valve, said introducer sheath and said delivery sheath having a gap therebetween, said fluid management system further comprising a third pressure sensor connected to said introducer sheath on-off valve.

10. The transcatheter atrioventricular valve treatment system of claim 9, wherein the fluid management system further comprises a loader in communication with the delivery sheath, and a flushing head in communication with the loader, the valve repair device being housed in the loader, the flushing head being adapted to access an exhaust fluid, the end of the loader being externally connected to a temporary on-off valve, the temporary on-off valve being opened or closed to allow for venting of the pressure monitoring passageway, the operating handle, and the sheath handle in coordination with the opening or closing of the conduit on-off valve, the operating handle on-off valve, and the sheath handle on-off valve.

11. The transcatheter atrioventricular valve treatment system of claim 10, wherein said loader communicates with said introducer sheath control handle after removal of said temporary closing valve.

12. The transcatheter atrioventricular valve treatment system of claim 5, wherein said second seal lumen is fixed within said operating handle in an axial direction of said operating handle, and wherein said operating handle has a visual window corresponding to each of said first seal lumen and second seal lumen.

13. The transcatheter atrioventricular valve treatment system of claim 3, wherein said delivery catheter comprises a flexible tube having a distal end provided with a metal ring having a plurality of lumens corresponding to said primary and secondary lumens, respectively, said drive mandrel and said control wire extending out of said corresponding primary and secondary lumens for detachable connection with said valve repair device.