Valve delivery system and method of operation

Abstract

The invention provides a valve conveying system and an operation method, the valve conveying system comprises a catheter assembly, a driving device and a rope locking assembly, the catheter assembly is connected to the driving device, the rope locking assembly is connected to the near end of the driving device, the valve conveying system is provided with a containing cavity, and the catheter assembly, the driving device and the rope locking assembly penetrate through the containing cavity; when the valve is loaded, a pull rope of the valve penetrates through the containing cavity, the rope locking assembly locks the end of the pull rope, and the driving device can drive the valve to move into the catheter assembly. When the valve is released, the driving device is driven to enable the valve to move out of the containing cavity and to be released at a designated position, and the rope locking assembly unlocks the end of the pull rope. According to the valve conveying system, the functions of loading, delivering, positioning, recycling and the like of the prosthetic valve can be achieved through active driving, the structure is simple, the response speed is high, operation is stable, the control precision is high, and the operation efficiency of an operator is improved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a valve delivery system and an operating method. Background Art

[0002] Mitral regurgitation is the most common heart valve disease in an aging population. If patients with severe mitral regurgitation do not receive effective treatment, the 5-year mortality rate is as high as 50%. For patients with mitral regurgitation, the current mainstream treatment is valve replacement through open-chest surgery. Due to the large trauma of traditional surgery and the poor basic condition of many patients, only 2% of patients with moderate to severe mitral regurgitation receive surgical treatment. With the progress of device development and clinical research, interventional treatment (such as transcatheter mitral valve replacement, TMVR) has become an emerging treatment for mitral regurgitation. Transcatheter mitral valve replacement uses a minimally invasive approach, without the need for cardiac arrest and extracorporeal circulation assistance, and can complete the treatment of mitral valve disease under the guidance of imaging technology.

[0003] Currently, most of the implantation devices for mitral valve prosthesis on the market are passive devices, that is, all the actions of loading, delivering and releasing the prosthetic valve are driven by manpower. Common transmission methods include screw pair transmission, gear meshing transmission, push rod transmission and spring transmission, etc. The overall efficiency is not high, the transmission accuracy is also limited, and it is more dependent on the operator's level and operating experience, and even tests the operator's strength and physical fitness. Summary of the invention

[0004] In view of this, an object of the present invention is to provide a valve delivery system, which can realize functions such as loading, delivery, positioning and recovery of prosthetic valves through active drive, has a simple structure, fast response speed, smooth operation and high control accuracy, and improves the operator's operating efficiency.

[0005] The present invention provides a device for delivering a prosthetic valve, comprising a catheter assembly, a drive device and a locking rope assembly, wherein the catheter assembly is connected to the drive device, and the locking rope assembly is connected to the proximal end of the drive device. The valve delivery system is provided with a receiving cavity, and the catheter assembly, the drive device and the locking rope assembly pass through the receiving cavity, and the drive device comprises at least one group of drive assemblies; when the valve is loaded, the pull rope of the valve is passed through the receiving cavity, the locking rope assembly locks the end of the pull rope, and the drive device can drive the valve to move into the catheter assembly; when the valve is released, the drive device is driven to move the valve out of the receiving cavity and released at a designated position, and the locking rope assembly unlocks the end of the pull rope; after the valve is released, if the valve release is abnormal, the drive device is driven to retract the valve into the receiving cavity.

[0006] In one embodiment, the catheter assembly includes a coaxially arranged delivery catheter and a catheter seat, the proximal end of the delivery catheter is arranged in the catheter seat, the delivery catheter is used to load and deliver the valve, and the catheter seat is fixedly connected to the driving device.

[0007] In one embodiment, the driving device includes an axially connected first driving component and a second driving component, the first driving component includes a first cylinder body and a first piston rod at least partially disposed in the first cylinder body, the catheter seat is fixedly connected to the first piston rod, and the first piston rod can drive the catheter seat and the delivery catheter to move along the length direction of the first cylinder body.

[0008] The second drive assembly includes a second cylinder body and a second piston rod at least partially disposed in the second cylinder body. When the second piston rod is extended, the second piston rod sequentially passes through the second cylinder body, the first piston rod, the catheter seat and the delivery catheter. The locking rope assembly is connected to one end of the second piston rod away from the catheter assembly.

[0009] In one embodiment, when the second piston rod is retracted and the first piston rod is extended, the valve is arranged in the catheter seat; when the first piston rod is retracted and the second piston rod is retracted, the valve is arranged in the delivery catheter; when the first piston rod is extended and the second piston rod is retracted, the valve is released.

[0010] In one embodiment, the driving device includes a third driving assembly, the third driving assembly includes a third cylinder and a third piston rod at least partially disposed in the third cylinder, the catheter assembly is fixedly connected to the third cylinder, and the locking rope assembly is connected to an end of the third piston rod away from the catheter assembly; the retraction and release of the valve are controlled by driving the third piston rod.

[0011] In one embodiment, the driving device is an active driving device.

[0012] In one embodiment, the driving assembly includes a cylinder body and a piston rod, and the piston rod is provided with a first plane and a second plane, and the first plane and the second plane are arranged opposite to each other.

[0013] In one embodiment, the valve delivery system further includes a loading assembly for compressing and storing the valve, wherein the loading assembly is connected to the catheter assembly, and the loading assembly includes a loading funnel, wherein a step structure is provided at the point where the loading funnel cooperates with the end surface of the delivery catheter.

[0014] In one embodiment, the rope locking assembly includes a rope locking screw and a fixing seat, and the rope locking screw cooperates with the fixing seat to lock the pull rope.

[0015] The present invention also relates to an operating method for the above-mentioned valve delivery system, the operating method comprising: connecting the loading assembly to the catheter assembly; emptying the valve delivery system, and passing the pull rope of the valve through the accommodating cavity, so that the rope locking device locks the end of the pull rope; driving the driving device to move the valve into the catheter assembly for loading, and when the valve loading is completed, removing the loading assembly from the catheter assembly; driving the driving device to move the valve outside the accommodating cavity and release it to a designated position, releasing the valve, and the rope locking assembly unlocks the end of the pull rope; if the valve release is abnormal after the valve is released, driving the driving device to retract the valve into the accommodating cavity.

[0016] The valve delivery system of the present invention locks and unlocks the draw rope of the valve through a locking rope assembly to achieve the release of the valve. The driving device is an active drive, which can drive the valve to be loaded and delivered. The active drive replaces the human drive, reduces the difficulty and physical strength of manual operation, and improves the efficiency of valve loading, delivery and release. The valve is driven to move by the driving device, and the delivery accuracy is high. A step structure is added at the matching point between the loading funnel and the end face of the delivery catheter, and the support of the compression point of the prosthetic valve loading is set on the loading funnel, which reduces the contact friction between the stent of the prosthetic valve and the distal end of the delivery catheter, making the installation of the stent of the prosthetic valve more convenient and preventing the end face of the delivery catheter from being torn, delaminated or severely deformed. A special-shaped seal is used to seal between the cylinder body and the piston rod of the driving device to prevent the piston rod from rotating relative to the cylinder body, thereby preventing the catheter assembly from rotating circumferentially and facilitating the axial movement of the catheter assembly.

[0017] In addition, according to the present invention, if the valve is in a bad position or abnormality after being released, the locking rope assembly has not unlocked the pull rope of the valve, and the valve can still be recovered into the catheter assembly by operating the driving device to release or replace the valve again. It is not only convenient to operate and has low requirements for the operator, but also has the characteristics of simple structure, fast response speed, stable operation and high control accuracy. The operator does not need to perform too many complicated operations during use, but only needs to control the driving device and observe the status of the valve. For the patient, the use of this valve delivery system makes the operation smoother and the operation time shorter. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for use in the embodiments are briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present invention and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without creative work.

[0019] Figure 1 It is a schematic structural diagram of the valve delivery system according to the first embodiment of the present invention.

[0020] Figure 2 It is a schematic structural diagram from another perspective of the valve delivery system of the first embodiment of the present invention.

[0021] Figure 3 yes Figure 1 Schematic diagram of the cross-sectional structure at AA in the middle.

[0022] Figure 4 yes Figure 2 Schematic diagram of the cross-sectional structure at BB in the middle.

[0023] Figure 5 It is a partial cross-sectional structural schematic diagram of the first driving assembly of the first embodiment of the present invention.

[0024] Figure 6 It is a schematic cross-sectional structural diagram of a lock rope assembly according to the first embodiment of the present invention.

[0025] Figure 7a-7c It is a structural schematic diagram of the valve loading process of the first embodiment of the present invention.

[0026] Figure 8a-8c It is a structural schematic diagram of the valve release process of the first embodiment of the present invention.

[0027] Fig. 9 It is a schematic structural diagram of a valve delivery system according to a second embodiment of the present invention.

[0028] Figure 10a-Figure 10b It is a structural schematic diagram of the valve loading process of the second embodiment of the present invention.

[0029] Figure 11a-Figure 11b 4 is a schematic structural diagram of the valve release process of the second embodiment of the present invention.

[0030] Fig.12 It is a schematic diagram of the active driving principle of the driving device of the first embodiment of the present invention.

[0031] Description of the accompanying drawings: accommodating chamber-101; loading assembly-11; loading funnel-111; funnel nut-112; catheter assembly-12; delivery catheter-121; catheter seat-122; first driving assembly-13; first cylinder-131; first plane-1311; second plane-1312; first piston rod-132; first gland-133; first end cover-134; second gland-135; second driving assembly-14; second cylinder-141; second piston rod-142; bracket top rod-143; third gland-144 ; second end cover -145; fourth pressure cover -146; third drive assembly -15; third cylinder body -151; third piston rod -152; rope locking assembly -16; rope locking screw -161; first tooth tip structure -1611; fixed seat -162; motor oil pump -171; first oil circuit -172; second oil circuit -1721; third oil circuit -1722; first overflow valve -173; second overflow valve -174; third overflow valve -175; first electromagnetic reversing valve -176; second electromagnetic reversing valve -177; valve -21; pull rope -22.

[0032] The realization of the purpose, functional features and advantages of the present invention will be further explained in conjunction with embodiments and with reference to the accompanying drawings. DETAILED DESCRIPTION

[0033] The specific embodiments of the present invention will be described in detail below in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, rather than all of the embodiments. Based on the description of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0034] In the description of the present invention, unless otherwise clearly specified and limited, the terms "set", "install", "connection" and the like should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium. For ordinary technicians in this field, the specific meanings of the above terms can be understood according to specific circumstances.

[0035] The directions or positional relationships indicated by terms such as “upper”, “lower”, “left”, “right”, “front”, “back”, “top”, “bottom”, “inside” and “outside” are based on the directions or positional relationships shown in the accompanying drawings, or are the directions or positional relationships in which the inventive product is usually placed when used. They are only for the convenience of description and simplified description, and do not indicate or imply that the device or element referred to must have a specific direction, be constructed and operated in a specific direction, and therefore should not be understood as a limitation on the present invention.

[0036] The terms "first", "second", "third" and the like are merely used to distinguish elements of similar nature, and do not indicate or imply relative importance or a particular order.

[0037] The terms "comprises," "comprising," or any other variations thereof, are intended to cover a non-exclusive inclusion of the elements listed and may also include additional elements not expressly listed.

[0038] In this embodiment, “pushing out” and “extending out”, “valve 21” and “prosthetic valve 21” have the same meaning.

[0039] First embodiment

[0040] like Figures 1 to 4 As shown, the valve delivery system is used to deliver the prosthetic valve 21, including a loading component 11, a catheter component 12, a driving device and a locking rope component 16. The valve 21 is compressed in the loading component 11, the catheter component 12 is connected to the driving device, and the locking rope component 16 is connected to the driving device. The valve delivery system is provided with a receiving chamber 101, and the receiving chamber 101 passes through the catheter component 12, the driving device and the locking rope component 16. When the valve 21 is loaded, the loading component 11 is connected to the catheter component 12, and the pull rope 22 of the valve 21 is passed through the catheter component 12. The accommodating chamber 101 is set, the locking rope assembly 16 locks the end of the pull rope 22, and the driving device can drive the valve 21 to move into the catheter assembly 12. When the valve 21 is loaded, the loading assembly 11 is removed from the catheter assembly 12; when the valve 21 is released, the driving device is driven to move the valve 21 to the outside of the accommodating chamber 101 and released at a specified position, and the locking rope assembly 16 unlocks the end of the pull rope 22; after the valve 21 is released, the valve 21 release is abnormal, and the driving device is driven to retract the valve 21 into the accommodating chamber 101. In this embodiment, the driving device is actively driven, and the driving device is also provided with at least one button, and the driving device is controlled by the button. The active drive is used to provide power for the driving device, and the preferred medium of the active drive is liquid. In addition, the distal end in this embodiment refers to the end close to the valve 21, and the proximal end refers to the end away from the valve 21.

[0041] The valve delivery system of the present invention locks and unlocks the pull rope 22 of the valve 21 through the lock rope assembly 16 to realize the release of the valve 21. The driving device is an active drive, which can drive the valve 21 to load and deliver, reducing the difficulty and physical strength of manual operation, and requiring no strength and physical fitness for the operator, thereby improving the efficiency of loading, delivering and releasing the valve 21. The valve 21 is driven by the drive device to move, and the delivery accuracy is high. In addition, if the valve 21 is in a bad position or abnormal after being released, the lock rope can be locked. Component 16 has not unlocked the pull rope 22 of the valve 21, and the valve 21 can still be retracted into the catheter component 12 by operating the driving device to release or replace the valve 21 again. It is not only easy to operate and has low requirements for the operator, but also has the advantages of simple structure, fast response speed, smooth operation and high control accuracy. The operator does not need to perform too many complicated operations during use, but only needs to control the driving device and observe the status of the valve 21; and for the patient, the use of this valve delivery system makes the operation smoother and the operation time shorter.

[0042] Preferably, the loading assembly 11 includes a loading funnel 111 and a funnel nut 112, one end of the funnel nut 112 is threadedly connected to the loading funnel 111, and the other end of the funnel nut 112 is threadedly connected to the catheter assembly 12. The funnel nut 112 is used to prevent leakage. The loading funnel 111 is provided with a conical cavity. Before compressing the valve 21, the valve 21 is placed in the conical cavity. The gap between the conical cavity and the valve 21 is 1mm to 2mm, so that the valve 21 remains uniform throughout the entire process of loading and compression. A through hole is provided in the middle of the funnel nut 112, and the through hole can be used for emptying during the loading process of the valve 21; to facilitate observation of the loading process, the loading assembly 11 is made of a transparent polymer material as a whole, preferably ABS, PC or PE. The loading funnel 111 is provided with a first pin, which passes through the loading funnel 111 and the catheter assembly 12 to prevent the loading funnel 111 and the catheter assembly 12 from rotating relative to each other. The loading funnel 111 and the catheter assembly 12 are sealed by a first seal, and a radial sealing method is adopted. The first seal is preferably rubber or silicone, and the shape of the first seal is preferably an O-ring.

[0043] Preferably, the catheter assembly 12 is a carrier for loading, transporting and recovering the valve 21. The catheter assembly 12 includes a coaxially arranged delivery catheter 121 and a catheter seat 122. The proximal end of the delivery catheter 121 is arranged in the catheter seat 122. The delivery catheter 121 is fixedly connected to the catheter seat 122 by means of glue, or the delivery catheter 121 and the catheter seat 122 are connected by a seal and a rubber ring. The delivery catheter 121 is used to load and transport the valve 21. The catheter seat 122 is fixedly connected to the driving device. In order to increase the radial strength and tube rigidity of the delivery catheter 121, the delivery catheter 121 is composed of an inner layer of PTFE, a metal braided layer and an outer layer of PA from the inside to the outside. The delivery catheter 121 is also provided with a distal developing ring. Specifically, the catheter assembly 12 also includes a hemostatic valve and a second seal. The hemostatic valve is connected to the side of the catheter seat 122. The hemostatic valve is the inlet and outlet of the balloon catheter access. The catheter seat 122 and the first piston rod 132 are fixedly connected by a second pin and a second seal. The second seal performs end face sealing, preferably a sealing pad. The body of the delivery catheter 121 in this embodiment is printed with a scale silk screen to facilitate observation of the depth and relative position mark of the delivery catheter 121 access; the catheter seat 122 is made of transparent polymer material, preferably ABS, PC or PE, etc. The inner wall of the catheter seat 122 is coated with PTFE coating, which serves as a loading and storage point for the prosthetic valve 21.

[0044] In this embodiment, the coordination between the loading funnel 111 and the delivery catheter 121 needs to control two points: first, reducing the gap between the loading funnel 111 and the delivery catheter 121 in the direction of the wall thickness, in order to increase the circumferential support for the delivery catheter 121 when the prosthetic valve 21 is loaded, and reduce the deformation of the tube body of the delivery catheter 121; second, adding a step structure at the coordination point between the loading funnel 111 and the end face of the delivery catheter 121, and setting the support at the loading compression point of the prosthetic valve 21 on the loading funnel 111, so as to reduce the contact friction between the stent of the prosthetic valve 21 and the distal end of the delivery catheter 121, and make the installation of the stent of the prosthetic valve more convenient, so as to protect the end face of the delivery catheter 121 and prevent the end face of the delivery catheter 121 from being torn, delaminated or severely deformed.

[0045] Preferably, the driving device includes a first driving assembly 13 and a second driving assembly 14 coaxially connected in sequence, the first driving assembly 13 includes a first cylinder 131 and a first piston rod 132 at least partially disposed in the first cylinder 131, the catheter seat 122 is fixedly connected to the first piston rod 132, and the first piston rod 132 can drive the catheter seat 122 and the delivery catheter 121 to move along the length direction of the first cylinder 131.

[0046] The second drive assembly 14 includes a second cylinder body 141 and a second piston rod 142 that is at least partially disposed in the second cylinder body 141. When the second piston rod 142 is extended, the second piston rod 142 sequentially passes through the second cylinder body 141, the first piston rod 132, the catheter seat 122 and the delivery catheter 121, and the locking rope assembly 16 is connected to the end of the second piston rod 142 away from the catheter assembly 12.

[0047] like Fig.12 As shown, the principle of active driving of the drive device is as follows: the motor oil pump 171 provides pressure liquid, so that the first overflow valve 173 on the first oil circuit 172 controls the output supply pressure, the first oil circuit 172 is divided into the second oil circuit 1721 and the third oil circuit 1722, the second overflow valve 174 is arranged in the second oil circuit 1721, the second overflow valve 174 controls the pressure flowing into the first electromagnetic reversing valve 176, the third overflow valve 175 is arranged in the third oil circuit 1722, the third overflow valve 175 controls the pressure flowing into the second electromagnetic reversing valve 177, the first electromagnetic reversing valve 176 controls the reciprocating motion of the first piston rod 132 of the first drive component 13, and the second electromagnetic reversing valve controls the reciprocating motion of the second piston rod 142 of the second drive component 14; the drive device can also be provided with continuous and electric (including forward and reverse) buttons as needed to realize the coarse and fine adjustment of the telescopic movement of the first piston rod 132 and the second piston rod 142.

[0048] Preferably, the first drive assembly 13 also includes a first pressure cap 133, a first end cap 134 and a second pressure cap 135. The cylinder body of the first drive assembly 13 is provided with a B port and a C port, the B port is connected to the small cavity of the first cylinder body 131, and the C port is connected to the large cavity of the first cylinder body 131. The active drive connects the B port and the C port through a quick-change connector, and the operation button can drive the catheter assembly 12 to perform axial reciprocating motion. End face seals are used at both ends of the first cylinder body 131, preferably O-rings and sealing gaskets; radial seals are used between the first end cap 134 and the first piston rod 132, preferably O-rings are used for sealing, and the first pressure cap 133 squeezes and fixes the first end cap 134; radial seals are used between the first piston rod 132 and the first cylinder body 131, preferably O-rings are used for sealing; Figure 5 As shown, the inner hole of the first cylinder body 131 is provided with a first plane 1311 and a second plane 1312 which are arranged opposite to each other, and a special-shaped seal is used between the first plane 1311, the second plane 1312 and the first piston rod 132, preferably a special-shaped silicone ring or a special-shaped rubber ring, etc., to prevent relative rotation between the first piston rod 132 and the first cylinder body 131; it can be understood that the points that need to be fastened in the first drive assembly 13 are all connected by screws.

[0049] Preferably, the second drive assembly 14 also includes a bracket push rod 143, a third pressure cover 144, a second end cover 145 and a fourth pressure cover 146, the bracket push rod 143 is connected to the distal end of the second piston rod 142, the lock rope assembly 16 is connected to the proximal end of the second piston rod 142, and the two ends of the second cylinder body 141 are sealed with end faces, preferably O-rings and sealing gaskets; the third pressure cover 144 is connected to one end of the second cylinder body 141, the second end cover 145 is connected to the other end of the second cylinder body 141, and the fourth pressure cover 146 squeezes and fixes the second end cover 145; the cylinder body of the second drive assembly 14 is provided with a D port and an E port, the D port is connected to the small cavity of the second cylinder body 141, and the E port is connected to the large cavity of the second cylinder body 141, the active drive connects the D port and the E port through a quick-change joint, and the operation button can drive the second piston rod 142, the bracket push rod 143 and the lock rope assembly 16 to perform axial reciprocating motion. The proximal rod outer circle of the second piston rod 142 is provided with a third plane and a fourth plane, a radial seal is used between the second piston rod 142 and the second cylinder body 141, preferably an O-ring, and a special-shaped seal is used between the second piston rod 142 and the second end cover 145, preferably a special-shaped silicone ring or a special-shaped rubber ring, etc., which can prevent the second piston rod 142 from rotating relative to the second cylinder body 141 during the reciprocating motion. It can be understood that the points that need to be fastened in the second drive assembly 14 are all connected by screws.

[0050] Preferably, since the overall driving force of the valve delivery system is small and the parts are not subjected to much force, the parts materials involved in the first drive component 13 and the second drive component 14 can be selected from ABS, PA or PC commonly used for injection molding to reduce the weight of the system and reduce production costs.

[0051] Preferably, both ends of the first cylinder body 131 are protected from cylinder collision by means of the protruding structures of the first end cover 134 and the second pressure cover 135 ; and both ends of the second cylinder body 141 are protected from cylinder collision by means of the protruding structures of the third pressure cover 144 and the second piston rod 142 .

[0052] Preferably, when the second piston rod 142 retracts and the first piston rod 132 extends, the valve 21 is set in the catheter seat 122; when the first piston rod 132 retracts and the second piston rod 142 retracts, the valve 21 is set in the delivery catheter 121; when the first piston rod 132 extends and the second piston rod 142 retracts, the valve 21 is released.

[0053] like Figure 3 , Figure 4 and Figure 6As shown, the rope locking assembly 16 includes a rope locking screw 161 and a fixing seat 162. The fixing seat 162 is fixedly connected to the second piston rod 142. The fixing seat 162 is provided with a fixing hole, which is arranged along the radial direction of the piston rod. The rope locking screw 161 cooperates with the fixing member to lock the pull rope 22. In this embodiment, the end face of the rope locking screw 161 is provided with a first tooth tip structure 1611, and the fixing seat 162 is provided with a second tooth tip structure that cooperates with the first tooth tip structure 1611. The second tooth tip structure is arranged in the fixing hole. The first tooth tip structure 1611 is made to bite or release the pull rope 22 by adjusting the tightness of the rope locking screw 161. Preferably, the rope locking screw 161 and the fixing seat 162 are sealed and matched through a sealing ring, and preferably, an O-ring is arranged on the screw; the rope locking assembly 16 and the second piston rod 142 are connected by gluing to ensure sealing and fixing.

[0054] like Figure 7a-Figure 8c Shown

[0055] The present invention also relates to an operating method for the above valve delivery system, the operating method comprising:

[0056] The loading assembly 11 is connected to the catheter assembly 12 ; specifically, the second piston rod 142 is first pushed out to the distal limit position, and the loading assembly 11 is installed on the catheter seat 122 .

[0057] The valve delivery system is emptied, and the pull rope 22 of the valve 21 is passed through the accommodating chamber 101 so that the locking rope assembly 16 locks the end of the pull rope 22; specifically, the valve delivery system is placed vertically, that is, the loading funnel 111 is facing upward, and liquid is injected through the F port to empty the system in the accommodating chamber 101 until the liquid level reaches more than 2 / 3 of the height of the funnel, and the pull rope 22 of the valve 21 is passed through the accommodating chamber 101 of the valve delivery system, and the pull rope 22 is pulled from the F port end until the pull rope 22 is straightened, that is, the proximal end of the stent of the valve 21 contacts the stent top rod 143, and the locking rope screw 161 is adjusted to make it bite the pull rope 22 for fixing.

[0058] The driving device is driven to move the valve 21 into the catheter assembly 12 for loading. When the loading of the valve 21 is completed, the loading assembly 11 is removed from the catheter assembly 12; specifically, the second piston rod 142 is retracted, that is, the second piston rod 142 is contracted to the proximal limit, and the first piston rod 132 remains in a retracted state. During this process, the valve 21 is evenly compressed by the loading assembly 11 to be completely set in the delivery catheter 121 and continues to move proximally, the first piston rod 132 is retracted, and the valve 21 is set in the delivery catheter 121.

[0059] The driving device is driven to move the valve 21 to the outside of the accommodating cavity 101 and release it at the designated position, the valve 21 is released, and the locking rope assembly 16 unlocks the end of the pull rope 22; specifically, a balloon catheter for the dilatation approach is inserted into the A port of the catheter seat 122, and after reaching the designated position, the balloon is filled to a specified pressure and then the apical dilatation approach is performed, and the balloon catheter is withdrawn after the approach is completed; then the first piston rod 132 of the first driving assembly 13 is withdrawn to the proximal limit, and the handle needs to be moved at a uniform speed during the withdrawal process to ensure that the position of the scale line during the approach is maintained at ±1 cm Within the range of meters, the second piston rod 142 is finally pushed out until a certain length of the distal end of the valve 21 leaks out of the delivery catheter 121, the position of the valve 21 bracket is identified by angiography or other means, the in and out of the second piston rod 142 and the circumferential position of the handle are slightly adjusted until the release requirements of the prosthetic valve 21 are met, and finally the second piston rod 142 is pushed out to the distal limit to deliver the valve 21 to the specified position outside the delivery catheter 121; the prosthetic valve 21 is released. If the release is determined to be successful, the rope locking screw 161 can be loosened to release the pull rope 22.

[0060] If the valve 21 is released abnormally, the driving device is driven to retract the valve 21 into the accommodating chamber 101. Specifically, the position and state of the valve 21 are judged, and if the position and state of the valve 21 are appropriate, the pull rope 22 of the valve 21 is unlocked by the rope locking device; or if the position and state of the valve 21 are not appropriate, the second piston rod 142 is retracted to retract the valve 21 into the delivery catheter 121 and finally withdrawn from the body; a new valve 21 and valve delivery system are selected for reoperation.

[0061] Second embodiment

[0062] like Fig. 9 and Fig.10b As shown, the valve delivery system of this embodiment is substantially the same in structure as the valve delivery system of the first embodiment, except that the structure of the driving device is different.

[0063] Specifically, the driving device includes a third driving assembly 15, which includes a third cylinder body 151 and a third piston rod 152 at least partially arranged in the third cylinder body 151, the catheter assembly 12 is fixedly connected to the third cylinder body 151, the bracket top rod 143 is connected to the third piston rod 152, the locking rope assembly 16 is connected to the end of the third piston rod 152 away from the catheter assembly 12, the fixing seat 162 of the locking rope assembly 16 is fixedly connected to the third piston rod 152, and the locking rope assembly 16 and the third piston rod 152 are fixed by adhesive; when the valve 21 is loaded, the pull rope 22 of the valve 21 is passed through the accommodating chamber 101, so that the locking rope assembly 16 locks the end of the pull rope 22, and drives the third piston rod 152 to retract so that the valve 21 moves into the catheter assembly 12; when the valve 21 is released, the third piston rod 152 is driven to extend so that the valve 21 moves to the outside of the catheter assembly 12 for release. The driving device in this embodiment has only one driving component, so only one set of power sources is needed to meet the requirements. It is not only simple in structure but also more convenient to operate.

[0064] like Figure 10a-Figure 10b As shown, the loading process of the valve 21 is as follows: first push the third piston rod 152 of the third drive assembly 15 to the distal limit, install the loading funnel 111 on the catheter seat 122, place the handle vertically, that is, the loading funnel 111 faces upward, and inject liquid through the K port to systematically empty the accommodating chamber 101 of the valve delivery system until the liquid level reaches more than 2 / 3 of the height of the loading funnel 111; pass the prepared prosthetic valve 21 pull rope 22 through the handle, pull the pull rope 22 from the F port end until it is straightened, so that the proximal end of the prosthetic valve 21 stent contacts the stent top rod 143, and then tighten the rope locking screw 161 to fix the pull rope 22. First, the third piston rod 152 is withdrawn to the proximal limit, and the withdrawal process can be observed through the transparent loading funnel 111. After reaching the limit, the prosthetic valve 21 is completely compressed into the catheter seat 122. At this point, the prosthetic valve 21 is loaded into place and completely placed in the inner cavity of the catheter seat 122 , and the loading assembly 11 is removed, completing the prosthetic valve 21 loading process.

[0065] like Figure 11a-Figure 11bThe delivery, positioning and release process of the valve 21 shown. The first step is the handle expansion approach: first, insert the unfilled balloon catheter with a guide wire (not shown) into the catheter assembly 12 through the hemostatic valve (A port), fill the balloon to the specified pressure and then slowly insert it through the apical opening. After confirming that the insertion is in place through angiography, release the balloon pressure and deflate it, withdraw the balloon catheter, and complete the handle expansion approach; the second step is delivery and release: push the third piston rod 152 out to a certain length of the delivery catheter 121 at the distal end of the valve 21, identify the position of the valve 21 stent through angiography or other means, slightly adjust the entry and exit of the third piston rod 152 and the circumferential position of the handle until the valve 21 release requirements are met, and finally push the third piston rod 152 to the distal limit to release the valve 21. If the relative circumferential position of the valve 21 still needs to be adjusted after complete release, the third piston rod 152 can be slightly withdrawn to the proximal end of the valve 21 stent, and the stent top rod 143 can be tightened and the handle can be rotated. After adjustment, the third piston rod 152 can be pushed to the distal limit. If the release is determined to be successful, the locking rope screw 161 can be loosened, the pull rope 22 can be released, and the handle can be completely withdrawn to proceed to the next step that is not related to the delivery system. If the effect is not good or the valve 21 is abnormal after release, the valve 21 needs to be withdrawn from the body. The third piston rod 152 can be withdrawn until it is confirmed that the prosthetic valve 21 is completely received in the inner cavity of the delivery catheter 121, and then it can be withdrawn from the body, and the valve 21 and the valve delivery system can be reselected for implantation.

[0066] The valve delivery system of the present invention has the following advantages:

[0067] 1. Active drive replaces human drive, and there is no strength or physical requirement for the operator;

[0068] 2. Few parts, compact structure, simple and reliable, easy to operate;

[0069] 3. A single handle can achieve loading, delivery, positioning, release and recovery of the prosthetic valve 21;

[0070] 4. Fine-tunable and recyclable, improving fault tolerance and release accuracy;

[0071] 5. Smooth operation, fast response, high control accuracy and short operation time.

[0072] The above are only specific embodiments of the present invention, but the protection scope of the present invention is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the present invention should be included in the protection scope of the present invention. Therefore, the protection scope of the present invention shall be subject to the attached claims.

Claims

1. A valve delivery system for delivering a prosthetic valve, characterized in that: The valve delivery system comprises a catheter assembly, a driving device and a locking rope assembly, wherein the catheter assembly is connected to the driving device, the locking rope assembly is connected to the proximal end of the driving device, the valve delivery system is provided with a receiving cavity, the catheter assembly, the driving device and the locking rope assembly pass through the receiving cavity, and the driving device comprises at least one set of driving assemblies; When the valve is loaded, the drawstring of the valve is passed through the accommodating cavity, the lock rope assembly locks the end of the drawstring, and the drive device can drive the valve to move into the catheter assembly; When the valve is released, the driving device is driven to move the valve outside the accommodating cavity and release it at a designated position, and the locking rope assembly unlocks the end of the pull rope; After the valve is released, an abnormality occurs in the valve release, driving the driving device to retract the valve into the accommodating cavity.

2. The valve delivery system according to claim 1, characterized in that: The catheter assembly comprises a coaxially arranged delivery catheter and a catheter seat, the proximal end of the delivery catheter is arranged in the catheter seat, the delivery catheter is used to load and deliver the valve, and the catheter seat is fixedly connected to the driving device.

3. The valve delivery system according to claim 2, characterized in that: The driving device comprises a first driving assembly and a second driving assembly connected axially, the first driving assembly comprises a first cylinder and a first piston rod at least partially disposed in the first cylinder, the catheter seat is fixedly connected to the first piston rod, and the first piston rod can drive the catheter seat and the delivery catheter to move along the length direction of the first cylinder; The second drive assembly includes a second cylinder body and a second piston rod at least partially disposed in the second cylinder body. When the second piston rod is extended, the second piston rod sequentially passes through the second cylinder body, the first piston rod, the catheter seat and the delivery catheter. The locking rope assembly is connected to one end of the second piston rod away from the catheter assembly.

4. The valve delivery system according to claim 3, characterized in that: When the second piston rod is retracted and the first piston rod is extended, the valve is disposed in the catheter seat; When the first piston rod is retracted and the second piston rod is retracted, the valve is disposed in the delivery catheter; When the first piston rod is extended and the second piston rod is retracted, the valve is released.

5. The valve delivery system according to claim 2, characterized in that: The driving device includes a third driving assembly, and the third driving assembly includes a third cylinder and a third piston rod at least partially disposed in the third cylinder. The catheter assembly is fixedly connected to the third cylinder, and the locking rope assembly is connected to an end of the third piston rod away from the catheter assembly; the retraction and release of the valve are controlled by driving the third piston rod.

6. The valve delivery system according to claim 1, characterized in that: The driving device is an active driving device.

7. The valve delivery system according to claim 1, characterized in that: The driving assembly comprises a cylinder body and a piston rod. The piston rod is provided with a first plane and a second plane. The first plane and the second plane are arranged opposite to each other.

8. The valve delivery system according to claim 1, wherein: The valve delivery system also includes a loading component for compressing and storing the valve. The loading component is connected to the catheter component. The loading component includes a loading funnel. A step structure is provided at the place where the loading funnel cooperates with the end surface of the delivery catheter.

9. The valve delivery system according to claim 1, wherein: The rope locking assembly comprises a rope locking screw and a fixing seat, and the rope locking screw cooperates with the fixing seat to lock the pull rope.

10. An operating method for the valve delivery system according to any one of claims 1 to 9, characterized in that: The operation method comprises: connecting a loading assembly to the catheter assembly; Emptying the valve delivery system, and passing the drawstring of the valve through the accommodating cavity, so that the drawstring locking device locks the end of the drawstring; Driving the driving device to move the valve into the catheter assembly for loading, and when the valve is loaded, removing the loading assembly from the catheter assembly; The driving device is driven to move the valve outside the accommodating cavity and release it at a designated position, thereby releasing the valve, and the locking rope assembly unlocks the end of the pull rope; If the valve release is abnormal after the valve is released, the driving device is driven to retract the valve into the accommodating cavity.

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