Replacement system which avoids outflow obstruction

Abstract

The application relates to the field of medical devices, in particular to a replacement system capable of avoiding outflow tract obstruction, which comprises a valve stent, a valve clamping fixing device cooperatively operated with the valve stent, a valve clamping mechanism and a hoop element configured on the valve clamping mechanism, the hoop element is used for clamping the autologous valve leaflet, and the hoop element is used for moving the autologous valve leaflet upwards and clamping the valve stent after the valve stent is installed in place; the valve clamping mechanism comprises clamping arms, a control rod and a dismounting wire, the clamping arms comprise fixed arms and catching arms, the catching arms are hinged on the fixed arms, the control rod is detachably connected with the catching arms through the dismounting wire, and pulling back / pushing the control rod can make the catching arms open / close; the clamping arms in the application can accurately adjust the opening angle of the catching arms, the fault tolerance is higher, and the operation of a surgeon is facilitated.

Description

[0001] Cross-reference to related applications: This application claims priority to patent application CN202111164164.4, filed on September 30, 2021, the disclosure of which is incorporated herein by reference. Technical Field

[0002] This application relates to the field of medical devices, specifically to a replacement system that can avoid outflow tract obstruction. Background Technology

[0003] From a cardiac structural perspective, both the mitral and tricuspid valves have unique physiological structures, making accurate positioning and fixation of the replacement valve extremely difficult. In particular, the specific anatomical location and complex structure of the mitral valve within the heart pose a significant challenge to mitral valve replacement surgery.

[0004] In existing technologies, surgically locking the mitral / tricuspid valve prosthesis within the heart often utilizes the radial support force of the stent on the atrioventricular valve annulus. The disadvantages of this technique are that it can easily compress the tissues surrounding the valve annulus and can cause the stent and the compressed tissue to affect the outflow tract. From the perspective of the long-term effects of valve replacement, as patients use the replacement valve over time, regurgitation decreases, ventricular and atrial pressures drop, and the heart structure remodels. Larger stent sizes can lead to a reduction in valve annulus size, thus affecting the internal structure of the heart, which is clearly an undesirable outcome.

[0005] In addition, locking technology can also be achieved by pre-implanting a docking device at the leaflet, and then fixing it to the leaflet by a stent expanding inside the docking device. Patent CN109789019A describes a heart valve docking coil and system from Edwards Lifesciences. In this patent disclosure, the leaflet and stent are tightly clamped together by wrapping the docking device around the outside of the leaflet. This method of stent fixation is highly superior, but the large anterior leaflet clamped on the stent does not solve the problem of obstructing blood flow to the left outflow tract. While patent 202111164164.4 can use a clamp to lift the autologous leaflet upward to reduce obstruction of the outflow tract, the clamping mechanism with the clamp uses a pre-defined clamp shape to capture and anchor the leaflet. This means that the leaflet can only be captured once, and if the clamp hooks onto the chordae tendineae, the clamp cannot return to its straightened state, which can lead to surgical failure. This structural solution places very high demands on the surgeon.

[0006] In summary, mitral valve replacement prostheses currently suffer from at least the following technical challenges: 1. The leaflet clamping mechanism only has one chance to capture the leaflet, making it impossible to effectively adjust the angle of capture and resulting in a very low margin of error; 2. After replacement, the anterior leaflet can obstruct the left ventricular outflow tract; 3. Large-sized stents radially supporting the autologous valve annulus can affect the internal structure of the heart, leading to numerous complications. The industry urgently needs a new transcatheter heart valve replacement system to address these and other technical issues. Summary of the Invention

[0007] In view of the above and other concepts, this application is made. The main purpose of this application is to overcome some problems and shortcomings of the prior art.

[0008] According to one aspect of this application, a replacement system for avoiding outflow tract obstruction is disclosed, comprising: a valve stent, a valve clamping and fixing device cooperating with the valve stent, the valve clamping and fixing device being configured to clamp an autologous valve leaflet and a clamping member, the clamping member being at least partially disposed on the valve clamping mechanism, the clamping member being capable of driving the autologous valve leaflet upward and clamping it to the valve stent; the valve clamping mechanism including a clamping arm, a control rod, and a disassembly screw, wherein the clamping arm includes a fixed arm and a capturing arm, the capturing arm being hinged to the fixed arm, the control rod being detachably connected to the capturing arm via the disassembly screw, and pulling / pushing the control rod causing the capturing arm to open / close.

[0009] As a further improvement of the present invention, the capture arm is divided into a long arm and a short arm at the hinge point where it is hinged to the fixed arm, and the control rod is detachably connected to the short arm via the disassembly screw; when the capture arm captures the autologous leaflet, the valve stent enters the valve clamping mechanism and expands radially, and one end of the short arm abuts against the valve stent so that the long arm fits against the fixed arm.

[0010] As a further improvement of the present invention, after the capture arm captures the autologous leaflet, the valve stent enters the valve clamping mechanism along the control rod, and the disassembly screw is removed to separate it from the clamping arm. After the valve stent expands radially, the valve stent will abut against the short arm, and the long arm will abut against the fixed arm, while driving the clamping member, the autologous leaflet and the chordae tendineae to move together. The clamping member is at least partially moved upward and drives the autologous leaflet and the chordae tendineae to be pulled upward, and the clamping member tightens the valve stent.

[0011] As a further improvement of the present invention, the replacement system further includes a controllable release device, the distal end of which is detachably connected to the proximal end of the flap clamping mechanism. When capturing autologous flaps, the control lever is operated to move it distally relative to the controllable release device, and the capturing arm is opened to capture the autologous flaps.

[0012] As a further improvement of the present invention, when the valve stent expands radially, the clamp is positioned between the chordae tendineae and the autologous leaflet, and the radial expansion of the valve stent causes the clamp to be at least partially displaced upward and pulls the autologous leaflet and chordae tendineae upward.

[0013] As a further improvement of the present invention, the short arm is provided with a connecting hole, the distal end of the control rod has a U-shaped structure, and the short arm is at least partially disposed in the groove at the distal end of the control rod, and the detachment wire passes through the connecting hole and is detachably connected to the capture arm.

[0014] As a further improvement of the present invention, the fixed arm is provided with a groove, and the axial length of the groove is greater than the axial length of the short arm, so that the flip-out angle of the long arm is greater than 180°.

[0015] As a further improvement of the present invention, the clamping arm includes a first clamping arm and a second clamping arm, wherein the first clamping arm and the second clamping arm respectively capture and anchor adjacent autologous leaflets.

[0016] As a further improvement of the present invention, after the capture arm captures the autologous leaflet, the leaflet around the clamping arm can open and close autonomously. When the valve stent enters the valve clamping mechanism, the disassembly screw is removed from the connecting hole, the control rod is disassembled from the clamping arm, and the valve stent is in a radially expanded state. The radial expansion of the valve stent causes the clamping member to drive the autologous leaflet to move upward and clamp the valve stent.

[0017] As a further improvement of the present invention, after the valve clamping mechanism captures the autologous valve leaflet, the valve stent enters the valve clamping mechanism along the control rod.

[0018] As a further improvement of the present invention, the clamping mechanism further includes a spring for anchoring the autologous petal and a line for controlling the opening and closing of the spring. The spring is fixed on the capturing arm, and the line is detachably connected to the spring. Each spring is provided with teeth, which can define the relative position between the first clamping arm and the second clamping arm and the autologous petal. The teeth are configured to bite and fix the clamped autologous petal.

[0019] As a further improvement of the present invention, the proximal end of the valve clamping mechanism is provided with an atrial support section, the atrial support section including multiple support rods, and the length of the support rod in the anterior leaflet region is greater than the length of the support rod in the posterior leaflet region.

[0020] As a further improvement of the present invention, the number of support rods is three or four, which can provide strong support while avoiding excessive traction on the original valve annulus and reducing the implant size.

[0021] As a further improvement of the present invention, a method for operating a replacement system that avoids outflow tract obstruction is also provided, comprising: operating the outer sheath of the replacement system that avoids outflow tract obstruction into the surgical site; gradually retracting the outer sheath proximally relative to a control rod, progressively exposing the valve clamping mechanism under constraint within the outer sheath, and pulling back the control rod to open the capture arm and capture and clamp the corresponding autologous valve leaflet; completely withdrawing the outer sheath from the surgical site while retaining the control rod in place; and operating a valve stent delivery device to guide a tubular valve stent along the control rod into and to the media Between the first and second clamping arms of the valve clamping mechanism, the disassembly screw is pulled out to separate it from the capture arm, and the control lever is removed; the valve stent is radially expanded, the valve stent abuts against the short arm and the long arm abuts against the fixed arm, thereby unfolding and tensioning the clamp fastener attached to the outer periphery of the valve clamping mechanism, wherein the unfolding and tensioning of the clamp fastener gradually pulls the chordae tendineae and the autologous leaflets along the axial direction of the valve stent until the clamp fastens the valve stent and the valve clamping mechanism, and finally achieves the lifting and folding back of the autologous leaflets; and the valve stent delivery device is removed.

[0022] Compared with the prior art, the advantages and beneficial technical effects of this application include at least the following: 1. While existing replacement systems can clamp the leaflets using a clamping mechanism and, after radial expansion of the valve stent, allow the chordae tendineae and autologous leaflets to be lifted by the suture loops, thus avoiding obstruction of the outflow tract, the clamping mechanism, constructed of nickel-titanium metal, cannot adjust its opening angle when capturing autologous leaflets. Furthermore, it cannot be retracted after opening, resulting in a low tolerance for error. According to an embodiment of this application, the capture arm is hinged to the fixed arm. By pushing / pulling the control lever, the capture arm can be opened / closed, allowing for precise adjustment of its opening angle when capturing autologous leaflets. Additionally, if the capture arm hooks onto the chordae tendineae or its capture position is inappropriate, the control lever can be pushed to tilt the capture arm downwards, readjusting the capture position. After capturing the leaflets, the valve stent abuts against the short arm, causing the long arm to rest against the fixed arm. This mechanical locking method effectively avoids stress fatigue, is more conducive to long-term device implantation, and has significant clinical implications.

[0023] 2. Unlike existing technologies, according to one embodiment of this application, the clamp can both pull the chordae tendineae and lift the leaflets, and also allow the valve stent to be tightly clamped after radial expansion, thus avoiding obstruction of the left ventricular outflow tract. At the same time, it can also prevent the valve stent from radially supporting the autologous valve annulus, thus avoiding adverse effects on the morphology of the original valve. It solves two major technical pain points in the prior art regarding mitral valve replacement surgery, and has great clinical significance.

[0024] 3. In contrast to the prior art, according to an embodiment of this application, during pre-installation, the short arm portion is pre-installed in the groove at the distal end of the control rod, which can save the loading space of the sheath and is more conducive to transvascular access.

[0025] 4. Unlike the prior art, according to an embodiment of this application, the fixed arm is provided with a groove, and the axial length of the groove is greater than the axial length of the short arm, so that the flip angle of the long arm is greater than 180°. The advantage of this design is that when the clamping arm is hooked to the tendineae or the capture position is not suitable, the clamping arm can be flipped down and the capture position of the clamping arm can be readjusted, which can effectively improve the success rate of the operation.

[0026] 5. Unlike the prior art, in one embodiment of this application, the atrial support segment includes multiple support rods, and the length of the support rod in the anterior leaflet region is greater than the length of the support rod in the posterior leaflet region; this allows the valve stent to be more biased towards the posterior leaflet region after implantation, making room for the outflow tract as much as possible and avoiding obstruction of the outflow tract. Attached Figure Description

[0027] Figures 1a-1c This is a schematic diagram of the clamping and fixing device of the present invention.

[0028] Figure 2a and 2b This is a schematic diagram of the overall invention, wherein... Figure 2b This is a schematic diagram of the control lever.

[0029] Figures 3a-3e This is a schematic diagram of the working mechanism of the clamping flap of the present invention.

[0030] Figures 4a-4h This is a schematic diagram illustrating one operation of the present invention.

[0031] The feature names referred to by each number in the attached figure are as follows: 1-Valve stent; 2-Valve clamping and fixing device; 21-Valve clamping mechanism; 211-Clamping arm; 2111-Fixing arm; 21111-Groove; 2112-Catching arm; 21121-Long arm; 21122-Short arm; 2113-First clamping arm; 2114-Second clamping arm; 212-Control rod; 213-Removal thread; 214-Spring; 2141-Gear; 215-Wire; 22-Clamping component; 3-Controllable release device; 4-Atrial support segment; 41-Support rod. Detailed Implementation

[0032] In this application, "proximal end" refers to the end closer to the surgeon, and "distal end" refers to the end farther away from the surgeon.

[0033] Example 1: like Figures 1a-1cAs shown, a replacement system that avoids outflow tract obstruction includes: a valve stent 1, a valve clamping and fixing device 2 cooperating with the valve stent 1, the valve clamping and fixing device 2 being configured to clamp an autologous valve leaflet clamping mechanism 21 and a clamping member 22, the clamping member 22 being at least partially disposed on the valve clamping mechanism 21, the valve clamping mechanism 21 including a clamping arm 211, a control rod 212, and a disassembly wire 213, wherein the clamping arm 211 includes a fixing arm 2111 and a capturing arm 2112, the capturing arm 2112 being hinged to the fixing arm 2111, and the capturing arm 2112 being divided into a long arm 21121 and a short arm 21122 at the hinge point with the fixing arm 2111, the control rod 212 being connected via the disassembly wire 213. The short arm 21122 is detachably connected to the control rod 212; and pushing / pulling the control rod 212 can open / close the capture arm 2112 to capture the autologous leaflet. After the capture arm 2112 captures the autologous leaflet, the valve stent 1 enters the valve clamping mechanism 21 along the control rod 212, and the disassembly screw 213 is removed to separate it from the clamping arm 211. After the valve stent 1 expands radially, the valve stent 1 will abut against the short arm 21122, and the long arm 21121 will abut against the fixing arm 2111, while driving the clamping member 22, the autologous leaflet and the chordae tendineae to move together. The clamping member 22 is at least partially moved upward and drives the autologous leaflet and the chordae tendineae to be pulled upward, and the clamping member 22 clamps the valve stent 1.

[0034] In this embodiment, the replacement system further includes a controllable release device 3, such as... Figure 2a As shown, the distal end of the controllable release device 3 is detachably connected to the proximal end of the clamping mechanism 21. When capturing the autologous petal, the control rod 212 is operated to move it distally relative to the controllable release device 3, and the capturing arm 2112 is opened to capture the autologous petal.

[0035] In this embodiment, when the valve stent 1 expands radially, the clamp 22 is positioned between the chordae tendineae and the autologous leaflet, as shown below. Figure 4d As shown, the radial expansion of the valve stent 1 causes the clamp 22 to be at least partially displaced upwards, thereby pulling the autologous leaflet and chordae tendineae upwards.

[0036] In this embodiment, the short arm 21122 is provided with a connecting hole, the distal end of the control rod 212 has a U-shaped structure, and the short arm 21122 is at least partially disposed in the groove 21111 at the distal end of the control rod 212. The disassembly screw 213 passes through the connecting hole and is detachably connected to the capturing arm 2112. Figure 2a and 2b As shown.

[0037] In this embodiment, the fixed arm 2111 is provided with a groove 21111, and the axial length of the groove 21111 is greater than the axial length of the short arm 21122, so that the tilting angle of the long arm 21121 is greater than 180°. Figure 1b As shown.

[0038] In this embodiment, the clamping arm 211 includes a first clamping arm 2113 and a second clamping arm 2114, as shown below. Figure 1a and 4f As shown, the first clamping arm 2113 and the second clamping arm 2114 respectively capture and anchor adjacent autologous leaflets.

[0039] In this embodiment, after the capturing arm 2112 captures the autologous leaflet, the leaflet around the clamping arm 211 can open and close autonomously. When the valve stent 1 enters the valve clamping mechanism 21, the disassembly screw 213 is withdrawn from the connecting hole, and the control rod 212 is disassembled from the clamping arm 211. Figures 3a-3e As shown, the valve stent 1 is in a radially expanded state. The radial expansion of the valve stent 1 causes the clamp 22 to move the valve leaflet upward and clamp the valve stent 1.

[0040] In this embodiment, the clamping mechanism 21 further includes a spring piece 214 for anchoring the petal and a line 215 for controlling the opening and closing of the spring piece 214. The spring piece 214 is fixed to the capturing arm 2112, and the line 215 is detachably connected to the spring piece 214. Each spring piece 214 is provided with teeth 2141, such as... Figure 1b and 1c As shown, its teeth 2141 can define the relative position between the first clamping arm 2113 and the second clamping arm 2114 and the autologous leaflet, the teeth 2141 being configured to bite and fix the clamped autologous leaflet.

[0041] In this embodiment, the proximal end of the valve clamping mechanism 21 is provided with an atrial support section 4, which includes multiple support rods 41. Furthermore, the length of the support rods 41 in the anterior leaflet region is greater than the length of the support rods 41 in the posterior leaflet region.

[0042] In this embodiment, the number of support rods 41 is three or four, which can provide strong support while avoiding excessive traction on the original valve annulus and reducing the implant size.

[0043] In this embodiment, when the replacement system is used for mitral valve treatment, a method for operating the replacement system to avoid outflow tract obstruction is also provided, such as... Figures 4a-4hThe procedure includes: inserting the outer sheath of the replacement system designed to prevent outflow tract obstruction into the surgical site; gradually retracting the outer sheath proximally relative to the control lever 212, progressively exposing the valve clamping mechanism 21 within the outer sheath under constraint, and pushing the control lever 212 to open and capture the capture arm 2112, clamping the corresponding autologous valve leaflet; completely withdrawing the outer sheath from the surgical site while retaining the control lever 212 in place; operating the valve stent 1 delivery device to guide the tubular valve stent 1 along the control lever 212 into the space between the first clamping arm 2113 and the second clamping arm 2114 of the valve clamping mechanism 21, pulling out the disassembly thread 213 to separate it from the capture arm 2112, and withdrawing the control lever 212; radially expanding the valve stent 1, with the valve stent 1 abutting against the surgical site. The short arm 21122 is positioned so that the long arm 21121 is abutted against the fixed arm 2111, thereby unfolding and tensioning the clamp 22 fastened to the outer periphery of the valve clamping mechanism 21. The unfolding and tensioning of the clamp 22 gradually pulls the chordae tendineae and the autologous leaflets along the axial direction of the valve stent 1 until the clamp 22 clamps the valve stent 1 and the valve clamping mechanism 21, and finally achieves the lifting and folding back of the autologous leaflets; and the removal of the valve stent 1 delivery device.

[0044] The foregoing description of exemplary embodiments of this application has been provided for illustrative purposes. The foregoing description is not intended to be exhaustive, nor is it intended to limit this application to the precise configurations and / or constructions disclosed. Clearly, many modifications and variations can be made by those skilled in the art based on the teachings above without departing from this application. The scope and equivalents of this application are intended to be defined by the appended claims.

Claims

1. A displacement system that avoids outflow tract obstruction, comprising: A valve stent, and a valve clamping and fixing device cooperating with the valve stent, the valve clamping and fixing device being configured to clamp an autologous valve leaflet and a clamping member, the clamping member being at least partially disposed on the clamping mechanism, the clamping member being capable of driving the autologous valve leaflet upward and clamping the valve stent; characterized in that: the clamping mechanism includes a clamping arm, a control rod, and a disassembly screw, wherein the clamping arm includes a fixed arm and a capturing arm, the capturing arm being hinged to the fixed arm, the control rod being detachably connected to the capturing arm via the disassembly screw, and pulling / pushing the control rod can cause the capturing arm to open / close; the clamping member is fastened to the outer periphery of the clamping mechanism, the valve stent is in a radially expanded state, the radial expansion of the valve stent located within the clamping mechanism causes the clamping member to drive the autologous valve leaflet upward and clamp the valve stent.

2. The displacement system for avoiding outflow tract obstruction according to claim 1, characterized in that: The capture arm is divided into a long arm and a short arm at the hinge point where it is hinged to the fixed arm. The control rod is detachably connected to the short arm via the disassembly screw. When the capture arm captures the autologous leaflet, the valve stent enters the valve clamping mechanism and expands radially. One end of the short arm abuts against the valve stent, causing the long arm to fit against the fixed arm.

3. The displacement system for avoiding outflow tract obstruction according to claim 2, characterized in that: The replacement system also includes a controllable release device, the distal end of which is detachably connected to the proximal end of the flap clamping mechanism. When capturing autologous flaps, the control lever is operated to move it distally relative to the controllable release device, and the capture arm is opened to capture the autologous flaps.

4. The displacement system for avoiding outflow tract obstruction according to claim 2, characterized in that: The short arm is provided with a connection hole, the distal end of the control rod has a U-shaped structure, and the short arm is at least partially disposed in the groove at the distal end of the control rod. The detachment screw passes through the connection hole and is detachably connected to the capture arm.

5. The displacement system for avoiding outflow tract obstruction according to claim 2, characterized in that: The fixed arm is provided with a groove, and the axial length of the groove is greater than the axial length of the short arm, so that the flip angle of the long arm is greater than 180°.

6. The displacement system for avoiding outflow tract obstruction according to claim 4, characterized in that: The clamping arm includes a first clamping arm and a second clamping arm, which respectively capture and anchor adjacent autologous leaflets.

7. The displacement system for avoiding outflow tract obstruction according to claim 6, characterized in that: After the capture arm captures the autologous leaflet, the leaflet around the clamping arm can open and close autonomously. When the valve stent enters the valve clamping mechanism, the disassembly screw is withdrawn from the connection hole, and the control rod is disassembled from the clamping arm.

8. The displacement system for avoiding outflow tract obstruction according to claim 2, characterized in that: After the valve clamping mechanism captures the autologous valve leaflet, the valve stent enters the valve clamping mechanism along the control rod.

9. The displacement system for avoiding outflow tract obstruction according to claim 2, characterized in that: The clamping mechanism also includes a spring for anchoring the petal itself and a line for controlling the opening and closing of the spring. The spring is fixed on the capture arm, and the line is detachably connected to the spring.

10. The displacement system for avoiding outflow tract obstruction according to claim 1, characterized in that: The valve clamping mechanism has an atrial support section at its proximal end, which includes multiple support rods. The length of the support rods in the anterior leaflet region is greater than the length of the support rods in the posterior leaflet region.

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