Interventional instrument release control mechanism and interventional instrument delivery system
Patent Information
- Application Number
- CN202510936326.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Priority Date
- 2019-12-10
- Filing Date
- 2020-10-29
- Publication Date
- 2026-10-27
- Estimated Expiration
- 2040-10-29
AI Technical Summary
[0004]一些现有技术对介入器械的释放会回收进行了改进,采用线控的方式引入了更多的主动控制,但控制方式、程度以及相关动作方向性仍有改进需求
Smart Images

Figure CN121081176B_ABST
Abstract
Description
[0001] This application is a divisional application. The parent application information is international application number PCT / CN2020 / 124966, international application date 2020.10.29, titled "Interventional device release control mechanism, release method and interventional device delivery system", and national application number 202080071344.5. Technical Field
[0002] This application relates to the field of medical devices, and in particular to interventional device release control mechanisms, release methods, and interventional device delivery systems. Background Technology
[0003] An interventional device delivery system typically includes a control handle positioned proximally on the operator's side, and several slender, nested tubing pieces that slide within each other. The proximal end of each piece is the control end, connected to the control handle, while the distal end is the working end, which can be inserted into the body and, through their interaction, completes the delivery, release, or retrieval of the interventional device. The control handle usually has sliding or rotating components, which drive the relative axial movement between the tubing pieces. Currently, most control handles are mechanically controlled. However, with the development of interventional devices, more functional requirements are being placed on them.
[0004] Some existing technologies have improved the release and retrieval of interventional devices by using wired control to introduce more active control, but there is still room for improvement in the control method, degree, and directionality of related movements. Summary of the Invention
[0005] This application addresses existing interventional device delivery systems by further improving the release method of interventional devices, making them easier to operate.
[0006] This application provides an interventional device release control mechanism, comprising a first tube, an intermediate tube, and a second tube that slide and nest together sequentially from the inside out. The distal end of the first tube extends out of the intermediate tube, and an installation head for connecting an interventional device is provided on the extended portion. A flexible control element is connected to the intermediate tube, and the control element has:
[0007] In the held state, the control element penetrates the mounting head and restrains the interventional instrument to the mounting head;
[0008] In the open position, the interventional device can be completely detached from the mounting head;
[0009] The intermediate pipe is equipped with a locking member that cooperates with the control member. The locking member is slidably engaged with the intermediate pipe and switches different states of the control member when sliding.
[0010] Several alternative methods are provided below, but they are not intended as additional limitations on the overall solution above. They are merely further additions or optimizations. Provided there are no technical or logical contradictions, each alternative method can be combined individually with respect to the overall solution above, or multiple alternative methods can be combined with each other.
[0011] Optionally, the control element is a ligating suture, and the proximal end of the interventional device has multiple connecting ears. In the holding state, the ligating suture passes directly through and pulls each connecting ear; or a ring-shaped suture is passed between each connecting ear. In the holding state, the ligating suture bypasses the ring-shaped suture and indirectly pulls the connecting ear through the ring-shaped suture.
[0012] Optionally, the binding thread is multiple, and the pulling positions of each binding thread and the annular thread sleeve are evenly distributed along the circumference of the interventional device.
[0013] Optionally, when the intermediate pipe moves relative to the first pipe, the locking element is triggered by the mounting head and releases the control element to enter the open state.
[0014] Optionally, when the intermediate pipe moves relative to the first pipe, the direction of movement of the intermediate pipe is from the proximal end to the distal end.
[0015] Optionally, the locking element is triggered by the mounting head by direct contact or by indirect force application through a transmission component.
[0016] Optionally, when the lock is triggered by the mounting head, the direction of movement of the lock is from the far end to the near end.
[0017] Optionally, the intermediate tube is located on the proximal side of the mounting head, and the interventional device is located on the distal side of the mounting head. The mounting head has a convergence guide hole, through which the control component is passed to connect the interventional device, and in the holding state, the proximal side of the interventional device is restricted to the convergence guide hole.
[0018] Optionally, in the held state, the control element is guided forward and backward relative to the mounting head, and at least one of the forward and backward paths passes through the convergence guide hole.
[0019] Optionally, both the forward and reverse paths pass through the convergence guide hole.
[0020] Optionally, the control element may be one or more, and for the same control element, the forward and reverse paths pass through the same convergence guide hole.
[0021] Optionally, the mounting head is cylindrical and has an axial through hole, through which the first pipe penetrates.
[0022] Optionally, the mounting head and the first pipe fitting are fixed to each other by at least one of the following methods: welding, bonding, interference fit, and auxiliary connectors.
[0023] Optionally, there are multiple convergence guide holes, and the proximal side of the interventional device has connecting ears for passing through the control element. The connecting ears are divided into multiple groups, and before the interventional device is released, the connecting ears in the same group converge to a corresponding convergence guide hole.
[0024] Optionally, multiple convergence guide holes are evenly distributed along the circumference of the mounting head.
[0025] Optionally, the number of the convergence guide holes is 2 to 4.
[0026] Optionally, the convergence guide hole extends axially along the first tube and penetrates the mounting head.
[0027] Optionally, the convergence guide hole has a guide flare at the opening on the distal side.
[0028] Optionally, the intermediate tube is equipped with a fixed base and a slidable movable seat. The movable seat is fixed with a lock and an unlocking rod. The unlocking rod passes through the base and extends out of the base as a trigger end. The base is provided with a lock hole to receive the lock.
[0029] When the control component is in the holding state, it is sleeved on the lock component, and the end of the lock component is inserted into the lock hole. When the intermediate tube moves to the distal end relative to the first tube component, the trigger end of the unlocking rod abuts against the mounting head and drives the lock component to move to the proximal end and exit the lock hole, so that the control component enters the open state.
[0030] Optionally, the movable seat includes:
[0031] The annular portion is slidably sleeved on the intermediate tube and located on the proximal side of the base;
[0032] The locking element is rod-shaped and extends distally from the annular portion.
[0033] The unlocking lever extends from the annular portion to the distal end, and the extension length is greater than that of the lock.
[0034] Optionally, one end of the binding wire has a fixed loop and the other end has a movable loop;
[0035] In the holding state, the fixed loop is sleeved on the unlocking rod, and the movable loop is sleeved on the locking element;
[0036] In the open state, the fixed loop is fitted onto the unlocking rod, and the movable loop is disengaged from the locking element.
[0037] Optionally, the control element is a binding wire;
[0038] In the holding state, the ligating wire passes directly or indirectly around the interventional device, and both ends of the ligating wire are fixed relative to the locking device;
[0039] In the open state, at least one end of the ligature is separated from the locking member, releasing the restraint on the interventional device.
[0040] Optionally, in the held state, the base and the movable seat are tightly fitted together. When the intermediate tube moves to the distal end relative to the first tube, the movable seat follows the base until the trigger end of the unlocking rod abuts against the mounting head.
[0041] Optionally, the base is provided with a guide hole for the unlocking rod to pass through, and in the open state, at least a portion of the unlocking rod remains within the guide hole.
[0042] Optionally, the base has an axial channel, and the distal end of the intermediate pipe is inserted and fixed into the axial channel. The base includes:
[0043] The near end plate has clearance holes for the locking element and the unlocking rod to pass through respectively;
[0044] The distal end plate has a lock hole that mates with the lock and a guide hole through which the unlocking rod passes;
[0045] The transition section is fixedly connected between the proximal disk and the distal disk.
[0046] Optionally, the proximal disc has a receiving groove on the side facing the annular portion, the proximal ends of the lock and the unlocking rod are connected through the annular portion, and the annular portion is located in the receiving groove in the holding state, and the clearance hole is opened at the bottom of the receiving groove.
[0047] Optionally, the locking element and the unlocking lever are arranged alternately at intervals.
[0048] Optionally, the lock and the unlocking rod are two in number and are arranged alternately with uniform spacing.
[0049] Optionally, the periphery of the transition section is a mating area that is radially recessed relative to the proximal disc and the distal disc. In the held state, the connection points of the binding wire, the lock, and the unlocking rod are all located in the mating area.
[0050] Optionally, in the open state, the lock is withdrawn from the lock hole until the distal end of the lock is adjacent to the proximal disc.
[0051] Optionally, the outer periphery of the distal disk is provided with a wire-passing groove for the binding wire to pass through.
[0052] Optionally, the cable tray is open on the outer periphery of the distal disk.
[0053] Optionally, a support sleeve is fixed on the intermediate pipe, and the outer wall of the support sleeve is close to the inner wall of the second pipe.
[0054] Optionally, the support sleeve is located at the proximal end of the base and is spaced apart, and the sliding stroke of the movable seat is limited between the support sleeve and the base. The support sleeve has a first guide surface on the side facing the proximal end, which gradually narrows from the distal end to the proximal end.
[0055] Optionally, the support sleeve has a second guide surface on the side facing the distal end, which gradually narrows from the proximal end to the distal end, and the movable seat abuts against the second guide surface when it moves to its limit position towards the proximal end.
[0056] Of course, when combined with the aforementioned hydraulically driven control handles, this application also provides an interventional device delivery system, including a release control mechanism with the aforementioned structure, and a control handle that drives the release control mechanism. The proximal ends of each tube in the release control mechanism are connected to the control handle, and the tubes are hydraulically driven to move relative to each other at the control handle.
[0057] This application also provides a method for releasing an interventional device, wherein the interventional device is loaded into a release control mechanism, the release control mechanism comprising a first tube, an intermediate tube, and a second tube that are slidably nested together from the inside out, the distal end of the first tube extending out of the intermediate tube, and an installation head for connecting the interventional device is provided on the extended portion, the intermediate tube being connected to a flexible control element and a locking element that cooperates with the control element, the proximal end of the interventional device being bound to the installation head by the control element in a compressed state, and the interventional device being wrapped by the second tube;
[0058] The release method includes:
[0059] Slide the second tube proximally relative to the first tube until the interventional device is fully exposed;
[0060] Relative to the first tube, the intermediate tube is slid distally, causing the control element to follow distally and allowing the proximal end of the interventional device to gradually move away from the mounting head;
[0061] The locking mechanism is driven to move and release the control element, thereby fully releasing the interventional device.
[0062] The release method described in this application can be combined with the release control mechanism and the interventional device delivery system described in this application.
[0063] Optionally, the intermediate tube is equipped with a fixed base and a slidable movable seat. The movable seat is fixed with a lock and an unlocking rod. The unlocking rod passes through the base from the proximal end to the distal end and one end of the base serves as a trigger end. The base is provided with a lock hole for receiving the lock.
[0064] The control component is sleeved on the lock component in the holding state, and the end of the lock component is inserted into the lock hole;
[0065] The base and the movable seat are tightly fitted together. When the intermediate tube is slid to the distal end relative to the first tube, the movable seat follows the base, causing the control component to move to the distal end.
[0066] Optionally, the method of driving the lock to move and release the control member is to slide the intermediate tube distally relative to the first tube until the trigger end of the unlocking rod abuts against the mounting head;
[0067] Slide the intermediate tube further to the distal end, causing the unlocking rod to drive the movable seat away from the base under the obstruction of the mounting head, and drive the lock to exit the lock hole, thereby releasing the control component.
[0068] Optionally, a support sleeve is fixed on the intermediate pipe, the outer wall of the support sleeve is close to the inner wall of the second pipe, the support sleeve is located at the near end of the base and is spaced apart, and when the intermediate pipe is further slid to the far end, it continues until the movable seat abuts against the support sleeve, or until the base abuts against the mounting head.
[0069] Optionally, after the interventional device is fully released, the release control mechanism is retracted proximally.
[0070] Optionally, when retracting the release control mechanism proximally, the intermediate tube is first slid proximally relative to the first tube to separate the base from the mounting head;
[0071] Then, the first pipe fitting and the intermediate pipe fitting are put back into the second pipe fitting, and all pipe fittings are simultaneously withdrawn to the near end.
[0072] Optionally, the relative movement of each pipe fitting is driven by a control handle at the proximal end using a hydraulic method. Optionally, the control handle contains a first cylinder and a second cylinder that are sequentially connected along the axial direction, wherein a first piston is slidably installed in the first cylinder and a second piston is slidably installed in the second cylinder;
[0073] All tubes enter from the distal end of the first cylinder, wherein the first tube is fixed to the first piston, the intermediate tube extends out of the first piston, enters the second cylinder through the isolation seal and is fixed to the second piston, and the first tube extends out of the second piston and is fixed to the proximal end of the second cylinder.
[0074] A hydraulic drive circuit for driving the relative movement of the various pipe components via the piston is also provided at the control handle.
[0075] Optionally, before releasing the control element, adjustments are made to the interventional device, including:
[0076] Relative to the first tube, the intermediate tube is slid proximally, causing the control element to pull the interventional device until the proximal end of the interventional device is retracted;
[0077] The second tube is slid distally relative to the first tube, so that at least a portion of the interventional device is housed in the second tube.
[0078] Optionally, the control element is a binding wire;
[0079] Before release, the ligating wire passes directly or indirectly around the interventional device, and both ends of the ligating wire are fixed relative to the locking device;
[0080] After release, at least one end of the ligature separates from the locking element, releasing the restraint on the interventional device.
[0081] Optionally, one end of the binding wire has a fixed loop and the other end has a movable loop; the fixed loop is sleeved on the unlocking rod and the movable loop is sleeved on the lock.
[0082] Alternatively, one end of the binding wire is fixed to the base or mounting head, and the other end is a movable loop that is sleeved on the locking component.
[0083] Optionally, the mounting head is provided with a guide hole for the ligation suture to be threaded through to connect to the interventional device.
[0084] Optionally, the interventional device is a vena cava valve.
[0085] Optionally, the proximal end of the interventional device is provided with a ring-shaped suture that cooperates with the control element.
[0086] This application also provides an interventional device delivery system, including a release control mechanism with the aforementioned structure, and a control handle for driving the release control mechanism. The proximal ends of each tube in the release control mechanism are connected to the control handle, and the tubes are hydraulically driven to move relative to each other at the control handle.
[0087] This application also provides an interventional device delivery system, including a release control mechanism and a control handle for driving the release control mechanism. The proximal ends of each tube in the release control mechanism are connected to the control handle, and the tubes are hydraulically driven to move relative to each other at the control handle. The interventional device is loaded into the release control mechanism, which includes a first tube, an intermediate tube, and a second tube that slide and nest together sequentially from the inside to the outside. The distal end of the first tube extends out of the intermediate tube, and an installation head for connecting the interventional device is provided on the extended portion. A flexible control element and a locking element that cooperates with the control element are connected to the intermediate tube. The proximal end of the interventional device is bound to the installation head by the control element in a compressed state, and the interventional device is wrapped by the second tube.
[0088] When the interventional device is released:
[0089] Slide the second fitting proximally relative to the first fitting until the interventional device is fully exposed;
[0090] Relative to the first fitting, the intermediate fitting is slid distally, causing the control component to follow distally and allowing the proximal end of the interventional device to gradually move away from the mounting head;
[0091] The locking mechanism is driven to move and release the control element, allowing the interventional device to be completely released from the mounting head.
[0092] Optionally, the control handle is provided with one or more cylinders, the inside of which is a hydraulic chamber. A piston is slidably installed in each hydraulic chamber. Two radially adjacent pipes include an outer pipe and an inner pipe. The outer pipe enters the hydraulic chamber and is fixed to the piston in the hydraulic chamber. The inner pipe extends to connect to the piston of other hydraulic chambers or is fixed to the control handle.
[0093] Optionally, the multiple pipe fittings include a first pipe fitting, an intermediate pipe fitting, and a second pipe fitting arranged sequentially from the inside out. The proximal ends of each pipe fitting are movable relative to each other. The proximal end of the first pipe fitting is fixedly installed relative to the handle, and the proximal ends of the intermediate pipe fitting and the second pipe fitting are respectively fixed to the corresponding pistons.
[0094] Optionally, the distal end of the first fitting is used to connect an interventional device;
[0095] The distal end of the intermediate tube is fixedly connected to the first tube for traction and bending, or the distal end of the intermediate tube can move relative to the first tube and the distal end of the intermediate tube is provided with a locking device to restrict the interventional instrument to the first tube.
[0096] The distal end of the second tube is used to wrap or release the interventional device; the cylinder includes a first cylinder and a second cylinder connected sequentially along the axial direction, wherein a first piston is slidably installed in the first cylinder and a second piston is slidably installed in the second cylinder;
[0097] All tubes enter from the distal end of the first cylinder, wherein the first tube is fixed to the first piston, the intermediate tube extends out of the first piston, enters the second cylinder via an isolation seal and is fixed to the second piston, and the first tube extends out of the second piston and is fixed to the proximal end of the second cylinder.
[0098] Optionally, the distal end of the catheter system is provided with a distal hydraulic chamber for driving the release of the interventional device; a distal piston is slidably installed in the distal hydraulic chamber, and the interventional device is detachably connected to the distal piston.
[0099] Optionally, the control handle includes a working part for mounting the cylinder and a gripping part connected to the working part, the working part having opposing distal and proximal ends, and the gripping part being connected to the proximal end of the working part.
[0100] Optionally, a hydraulic drive circuit for driving relative movement of the various pipe components via the piston is also provided at the control handle; the hydraulic drive circuit includes:
[0101] Hydraulic lines are used to provide fluid passages connecting to various hydraulic chambers;
[0102] A drive pump is connected to the hydraulic lines to drive the flow of liquid.
[0103] A control valve, connected to the hydraulic pipeline, is used to control the flow direction of the liquid.
[0104] Optionally, the hydraulic drive circuit may further include a liquid storage tank connected to the hydraulic lines for temporary storage of liquid.
[0105] The control valve includes:
[0106] The multi-way switching valve has a drive-side interface connected to the inlet and outlet of the drive pump, and multiple working-side interfaces, wherein every two working-side interfaces are connected to one of the hydraulic chambers. The multi-way switching valve has multiple positions for switching the connection between the drive-side interface and different working-side interfaces to control the liquid flow direction.
[0107] Optionally, the control valve further includes:
[0108] Two check valves are provided. The outlet of the drive pump is connected to one of the drive-side interfaces via the first check valve. The inlet of the drive pump is connected to the other drive-side interface via the second check valve and the liquid storage tank.
[0109] The multi-way switching valve is embedded in the control handle, and the control handle is provided with an indicator indicating the position of the multi-way switching valve.
[0110] Optionally, a protective tube is fitted around the outermost periphery of the plurality of pipe fittings, the proximal end of the protective tube is connected to the fixed sleeve, the radial gap between the outermost pipe fitting and the protective tube is an exhaust gap, and the side wall of the fixed sleeve is provided with an exhaust hole communicating with the exhaust gap.
[0111] Optionally, the cylinder includes a first cylinder and a second cylinder connected sequentially from the distal end to the proximal end, wherein a first piston is slidably installed in the first cylinder and a second piston is slidably installed in the second cylinder, and the multiple pipes include a first pipe, an intermediate pipe, and a second pipe arranged coaxially from the inside to the outside;
[0112] All tubes enter from the distal end of the first cylinder, wherein the first tube is fixed to the first piston, the intermediate tube extends out of the first piston, enters the second cylinder and is fixed to the second piston, and the first tube extends out of the second piston and is fixed to the proximal end of the second cylinder.
[0113] Optionally, the protective tube is fixedly inserted into one axial end of the fixed sleeve, and the other axial end of the fixed sleeve is a connecting end. The connecting end is inserted into the distal end of the cylinder and fixed to the cylinder by a snap fastener. The outer periphery of the connecting end is fitted with a distal sealing plug that mates with the inner wall of the cylinder.
[0114] The distal sealing plug is provided with a clearance hole, and the outermost pipe among the multiple pipes slides and seals with the clearance hole.
[0115] Optionally, the connecting end has an outward flange, and the distal sealing plug is fitted onto the outward flange.
[0116] Optionally, the outer periphery of the distal sealing plug is provided with at least two convex rings arranged axially at intervals, and each convex ring is sealed to the inner wall of the cylinder.
[0117] Optionally, the outer periphery of the fixed sleeve is provided with a positioning groove, and the control handle has two interlocking half shells, the edges of which are engaged in the positioning groove.
[0118] Optionally, the inner wall of the fixing sleeve is provided with a blocking step, and the proximal end face of the protective tube abuts against the blocking step.
[0119] Optionally, the outer wall of the fixed sleeve is provided with a positioning plate, and the distal end face of the cylinder abuts against the positioning plate.
[0120] Optionally, the side wall of the cylinder is provided with a positioning hole, and the buckle includes an elastic arm extending from the positioning plate into the cylinder, and a hook at the end of the elastic arm that cooperates with the positioning hole.
[0121] Optionally, one side of the hook has a chamfered structure to guide the hook to rotate out of the positioning hole circumferentially.
[0122] Optionally, the side wall of the fixing sleeve has a thickened area, and the vent is opened in the thickened area.
[0123] Optionally, along the axial direction of the fixed sleeve, the vent is located between the blocking step and the positioning plate.
[0124] Optionally, the cylinder comprises a plurality of cylinders that are sequentially joined together along the axial direction, with adjacent cylinders connected by an isolation seal. One of the plurality of pipes slides through the isolation seal, and the isolation seal is detachably connected to the adjacent cylinders by a snap-fit mechanism.
[0125] Optionally, the cylinder includes a first cylinder and a second cylinder connected sequentially along the axial direction, wherein a first piston is slidably installed in the first cylinder and a second piston is slidably installed in the second cylinder, and the pipe includes a first pipe, an intermediate pipe and a second pipe arranged coaxially from the inside to the outside;
[0126] All tubes enter from the distal end of the first cylinder, wherein the first tube is fixed to the first piston, the intermediate tube extends out of the first piston, enters the second cylinder via the isolation seal and is fixed to the second piston, and the first tube extends out of the second piston and is fixed to the proximal end of the second cylinder.
[0127] Optionally, the isolation seal includes:
[0128] A cylindrical body, the cylindrical body having an axial direction, with cylinders on corresponding sides respectively inserted into the two ends of the cylindrical body along the axial direction;
[0129] Two sealing plugs are respectively fixed to one axial end of the cylinder and respectively seal with the inner wall of the cylinder on the corresponding side. Each sealing plug is provided with a clearance hole for the pipe to pass through.
[0130] Two sets of buckles are fixed to one axial end of the cylinder body and engage with the cylinder barrel on the corresponding side.
[0131] Optionally, the cylinder has outward flanges at both axial ends, and each sealing plug is fixedly sleeved on the corresponding outward flange.
[0132] Optionally, the outer periphery of the sealing plug is provided with at least two convex rings arranged axially at intervals, and each convex ring is sealed to the corresponding cylinder inner wall.
[0133] Optionally, a positioning disc is provided on the outer periphery of the cylinder, and the end faces of two adjacent cylinders abut against the two opposite sides of the positioning disc.
[0134] Optionally, reinforcing ribs are provided between the outer periphery of the cylinder and the two opposite sides of the positioning disk.
[0135] Optionally, in the radial direction of the cylinder, the outer edge of the reinforcing rib abuts against the inner wall of the cylinder.
[0136] Optionally, each cylinder has a positioning hole in its cylinder wall, and the two sets of buckles are fixed to the two opposite sides of the positioning plate. Each buckle includes an elastic arm extending from the positioning plate into the cylinder, and a hook at the end of the elastic arm that cooperates with the positioning hole.
[0137] Optionally, the reinforcing ribs and the buckles are arranged alternately and evenly along the circumference of the cylinder.
[0138] Optionally, the end of the hook has a guide slope that guides itself into the positioning hole along the axial direction of the cylinder.
[0139] Optionally, the hook has a chamfered structure on one side in the circumferential direction to guide itself to rotate out of the positioning hole along the circumferential direction of the cylinder.
[0140] Optionally, each cylinder is provided with a spare interface that communicates with the inside of the cylinder. The spare interface has a standby state where the cylinder is closed to maintain the internal pressure of the cylinder and an active state where the cylinder is open to connect to an external drive device.
[0141] Optionally, a hydraulic drive circuit for driving relative movement of the various pipes via the piston is provided at the control handle, and a communication port for connecting the hydraulic drive circuit is provided on the cylinder.
[0142] Optionally, each cylinder is provided with at least one of the aforementioned spare ports, and the spare ports and the connecting ports are independently or in conjunction with controllable valves.
[0143] Optionally, both the spare interface and the connecting port are located on the outer circumferential surface of the cylinder, and the positions of the spare interface and the connecting port correspond to each other.
[0144] Optionally, the control handle is provided with a cover for shielding at least a portion of the cylinder barrel, the cover being integral with or separate from the control handle.
[0145] Optionally, the shielding cover is engaged with the control handle by a snap fastener. The shielding cover is positioned in the extension direction of the pipe fitting and is provided with a first fitting that engages with the control handle in this direction. The first fitting is used to restrict the movement of the shielding cover in the radial direction of the pipe fitting.
[0146] Optionally, the shielding cover itself has a U-shaped cross-section, and the interior of the U-shape is used to accommodate the cylinder. The first fitting is opened at the U-shaped opening. Two first fittings are arranged opposite each other at the U-shaped opening of the shielding cover. The two first fittings have assembly positions that are close to each other and disassembly positions that are far apart from each other as the U-shaped opening of the shielding cover changes in amplitude.
[0147] Optionally, the shielding cover is provided with second fittings at both ends in the extension direction of the pipe fitting, and the second fittings cooperate with the control handle to restrict the movement of the shielding cover in the extension direction of the pipe fitting.
[0148] Optionally, the control handle is provided with a first assembly slot that mates with the first assembly part; the control handle is provided with a second assembly slot that mates with the second assembly part, the first assembly slot and the second assembly slot are not coplanar and are in space, and the first assembly slot and the second assembly slot are connected to each other or not connected.
[0149] Optionally, the shielding cover is configured as follows:
[0150] The length of the shielding cover is less than the length of the cylinder barrel and exposes part of the cylinder barrel;
[0151] The length of the shielding cover is greater than or equal to the length of the cylinder barrel, and the shielding cover exposes part of the cylinder barrel through partial perforation.
[0152] Optionally, the liquid storage tank includes:
[0153] The tank body has a tank opening and an inlet and outlet connected to a hydraulic drive circuit;
[0154] A buffer bladder is inserted into the tank body and sealed to the tank opening.
[0155] The pressure cap engages with the can body and clamps and secures the buffer bladder at the can opening.
[0156] Optionally, the tank body has a bottom wall on the side away from the tank opening, and the bottom wall has a liquid injection port, and a pipeline connector is installed at the liquid injection port.
[0157] Optionally, the tank is installed inside the control handle, with only the pipe fittings exposed to the control handle.
[0158] Optionally, both the inlet and outlet of the tank are adjacent to the bottom wall.
[0159] Optionally, the buffer bladder is made of an elastic material, which changes the internal volume of the tank through its own deformation.
[0160] Optionally, the buffer bladder has an open structure on the side facing the can opening, and the opening has an outward flange, which is clamped and fixed by the cap and the can opening.
[0161] Optionally, the outer flange has an annular protrusion that abuts against the pressure cap.
[0162] Optionally, the wall of the buffer bladder has a corrugated structure that can stretch and deform.
[0163] Optionally, the gland includes:
[0164] An annular frame that clamps and fixes the buffer bladder to the can opening;
[0165] An elastic hook that extends from the annular frame toward one side of the tank and cooperates with the tank.
[0166] Optionally, the can opening is turned outward to form an interface platform, the annular frame clamps and fixes the buffer bag with the top surface of the interface platform, and the elastic hook abuts against the bottom surface of the interface platform.
[0167] Optionally, the top surface of the interface platform is provided with a flange that abuts against the buffer bladder.
[0168] Optionally, the tank body includes a first tank body and a second tank body that are interconnected, and the first tank body is provided with the buffer bladder.
[0169] Optionally, the volume of the first tank is larger than the volume of the second tank.
[0170] Optionally, the top of the first tank has the opening, and the bottom shape of the first tank converges and transitions to the second tank.
[0171] Optionally, a hydraulic drive circuit for driving the relative movement of each pipe fitting is provided at the control handle. The hydraulic drive circuit includes at least one drive pump for driving liquid flow and a control valve for controlling the direction of liquid flow. The control handle has a grip portion, the operating component of the drive pump is disposed on the grip portion, and the operating component of the control valve is adjacent to the grip portion.
[0172] Optionally, the control valve is a multi-way switching valve, the multi-way switching valve comprising:
[0173] Two valve seats are arranged opposite each other, one of which has a drive-side interface for connecting to the hydraulic drive circuit, and the other valve seat has a working-side interface for the hydraulic drive circuit.
[0174] A valve core is sealed and rotatably mounted by two valve seats. The valve core has a connecting hole. When the valve core is rotated to different angles, the connecting hole connects the corresponding drive side interface and the working side interface.
[0175] A wrench linked to the valve core is used to change the rotation angle of the valve core, and the wrench serves as the operating component of the control valve.
[0176] Optionally, the wrench and the grip are located on the same side of the working part in the radial direction.
[0177] Optionally, the wrench is located on the proximal side of the grip, and the drive member faces the wrench.
[0178] Optionally, an anti-slip blocking element is provided at the end of the grip portion away from the working portion.
[0179] Optionally, the anti-dislodgement blocking element surrounds the wrench.
[0180] Optionally, the control handle includes a working part and a gripping part connected to the working part. The working part is equipped with a cylinder with an internal piston. The multiple pipes pass through the cylinder and are connected to the piston or fixed relative to the cylinder. The pipes are driven to move relative to each other in the cylinder by hydraulic means.
[0181] The cylinder is connected to corresponding working side interfaces on both sides of the piston. The hydraulic drive circuit also includes a drive pump that is connected to each drive side interface to drive the flow of liquid.
[0182] Optionally, the drive pump includes:
[0183] Pump housing fixed inside the control handle and connected to the hydraulic drive circuit;
[0184] An active working component installed within the pump casing to drive the flow of liquid;
[0185] A drive component is movably mounted on the gripping part and linked with the working part, and the drive component serves as the operating component of the drive pump;
[0186] A return spring acts between the control handle and the drive component.
[0187] Optionally, the cylinder includes a first cylinder and a second cylinder connected sequentially along the axial direction, wherein a first piston is slidably installed in the first cylinder and a second piston is slidably installed in the second cylinder, and the multiple pipes include a first pipe, an intermediate pipe, and a second pipe arranged coaxially from the inside to the outside;
[0188] All tubes enter from the distal end of the first cylinder, wherein the first tube is fixed to the first piston, the intermediate tube extends out of the first piston, enters the second cylinder via an isolation seal and is fixed to the second piston, and the first tube extends out of the second piston and is fixed to the proximal end of the second cylinder.
[0189] Optionally, each valve seat has a mounting groove on the side facing the valve core, and a sealing gasket is fixedly embedded in the mounting groove, and the sealing gasket abuts against the valve core to seal.
[0190] Optionally, the inner periphery of the mounting groove and the outer periphery of the sealing gasket are provided with interlocking positioning teeth.
[0191] Optionally, of the two valve seats, one valve seat is a first valve seat with the drive-side interface, and the other valve seat is a second valve seat with the working-side interface.
[0192] The first valve seat has a liquid inlet hole on the side facing the valve core that communicates with the drive side interface, and the first sealing gasket has a first liquid passage hole that corresponds to and communicates with the liquid inlet hole.
[0193] The second valve seat has a liquid outlet hole on the side facing the valve core that communicates with the working side interface, and the second sealing gasket has a second liquid passage hole that corresponds to and communicates with the liquid outlet hole.
[0194] When the valve core is rotated to different angles, the connecting hole on the valve core connects the corresponding first liquid passage hole and second liquid passage hole.
[0195] Optionally, there are two liquid inlet holes, each located at a different radial position relative to the rotation axis of the valve core; the first liquid passage hole matches the position of the corresponding liquid inlet hole.
[0196] The valve core has two annular grooves, inner and outer, on the side facing the first valve seat. Each annular groove is connected to one of the liquid inlet holes. There are two connecting holes, each connected to one of the annular grooves.
[0197] Optionally, the wrench includes an annular sleeve located on the outer periphery of the valve core, and a hook portion fixed to the annular sleeve and extending to the outside of the control handle; the inner edge of the annular sleeve and the outer periphery of the valve core are linked by a mutually cooperating one-way clutch mechanism.
[0198] Optionally, the one-way clutch mechanism includes:
[0199] Ratchets arranged around the outer periphery of the valve core;
[0200] Elastic claws fixed to the inner circumference of the annular sleeve;
[0201] The wrench has a relative forward and reverse rotation direction with respect to the valve core. When rotating forward, the elastic pawl engages with the ratchet and drives the valve core. When rotating in reverse, the elastic pawl deforms and slips off from the ratchet, and the wrench reset member drives the wrench to rotate in reverse.
[0202] Optionally, the elastic claw extends circumferentially along the annular sleeve and bends inward.
[0203] Optionally, 2 to 4 elastic claws are evenly distributed along the circumference of the annular sleeve.
[0204] Optionally, the multi-way switching valve includes a wrench reset element that acts between the wrench and at least one valve seat.
[0205] Optionally, the wrench includes an annular sleeve located on the outer periphery of the valve core, and a hook portion fixed to the annular sleeve and extending to the outside of the control handle; the inner edge of the annular sleeve and the outer periphery of the valve core are linked by a mutually cooperating one-way clutch mechanism.
[0206] The wrench reset component is a coil spring extending around the valve core axis, with one end of the coil spring connected to the valve seat and the other end connected to the annular sleeve.
[0207] Optionally, the coil spring consists of two coils arranged side by side. On the axial direction of the valve core, each coil spring is located on both sides of the annular sleeve. One end of each coil spring has a positioning bend for inserting into the corresponding side valve seat, and the other ends of each coil spring are connected to form a positioning crossbar. The outer periphery of the annular sleeve is provided with a groove for accommodating the positioning crossbar.
[0208] Optionally, each valve seat has an insertion hole for the positioning bend to be inserted.
[0209] Optionally, the one-way clutch mechanism includes:
[0210] Ratchets arranged around the outer periphery of the valve core;
[0211] Elastic claws fixed to the inner circumference of the annular sleeve;
[0212] The wrench has a relative forward and reverse rotation direction with respect to the valve core. When rotating forward, the elastic pawl engages with the ratchet and drives the valve core. When rotating in reverse, the elastic pawl deforms and slips off from the ratchet, and the wrench reset member drives the wrench to rotate in reverse.
[0213] Along the axial direction of the valve core, the outer periphery of the valve core includes three sections. The ratchet is fixedly distributed in the middle section, and the two sides are smooth sections. The two coil springs are respectively sleeved on the smooth sections on the corresponding sides.
[0214] The interventional device delivery system of this application uses a wired control method to control the release of interventional devices at the distal end, and can use a hydraulic drive method at the proximal end, making it convenient and quick to use. Attached Figure Description
[0215] Figure 1 This is a schematic diagram of an embodiment of the interventional device delivery system of this application;
[0216] Figure 2a This is a schematic diagram of the distal portion of the interventional device delivery system of this application;
[0217] Figure 2b This is a schematic diagram of the interventional device used in one embodiment of this application;
[0218] Figure 2c This is a schematic diagram of the interventional device used in another embodiment of this application;
[0219] Figure 2d This is a schematic diagram of the structure in the loaded state of the interventional device;
[0220] Figure 2e This is a schematic diagram of the interventional device in its semi-released state.
[0221] Figure 2f A schematic diagram of the structure of an interventional device in its released state;
[0222] Figure 3a This is a schematic diagram of the internal structure of an embodiment of the interventional device delivery system of this application;
[0223] Figure 3b for Figure 3a A schematic diagram of the structure of the interventional device delivery system after removing the movable cover and one half of its shell;
[0224] Figure 3c for Figure 3a Cross-sectional view of the interventional device delivery system;
[0225] Figure 3d This is a schematic diagram of the cylinder section in an interventional device delivery system;
[0226] Figure 3e for Figure 3d A schematic diagram of the disassembled cylinder and other components;
[0227] Figure 3f Enlarged view of the distal part of the control handle;
[0228] Figure 3g A schematic diagram showing the installation of a spare interface on the cylinder.
[0229] Figure 3h for Figure 3g A separate schematic diagram of the cylinder barrel from another perspective;
[0230] Figure 4 for Figure 3c Enlarged view of section C;
[0231] Figure 5 for Figure 3c Enlarged view of section B;
[0232] Figure 6a This is an exploded view of the fixing sleeve and distal sealing plug in one embodiment of the interventional device delivery system of this application;
[0233] Figure 6b for Figure 6a A schematic diagram of the structure after the middle fixed sleeve and the distal sealing plug are assembled;
[0234] Figure 6c for Figure 6a A structural diagram of the fixed sleeve from another angle;
[0235] Figure 6d This is a schematic diagram of the structure of the mating part between the fixing sleeve and the cylinder.
[0236] Figure 7a This is an exploded view of the isolation seal in one embodiment of the interventional device delivery system of this application;
[0237] Figure 7b for Figure 7a A schematic diagram of the assembled structure of the central isolation seal;
[0238] Figure 7c for Figure 7b A structural schematic diagram of the central isolation seal from another angle;
[0239] Figure 7d for Figure 3c Enlarged view of section D in the middle;
[0240] Figure 7e for Figure 7a A schematic diagram of the structure of the mating part between the central isolation seal and the two cylinder barrels;
[0241] Figure 8a This is a structural diagram of the near-end portion of the cylinder barrel;
[0242] Figure 8b This is a schematic diagram of the assembled pipe fitting and proximal sealing plug.
[0243] Figure 8c for Figure 8b Another angle structural diagram of the assembled central pipeline connector and proximal sealing plug;
[0244] Figure 8d for Figure 8b Exploded view of the central pipe joint and proximal sealing plug;
[0245] Figure 9a This is a schematic diagram of the structure of the reservoir in one embodiment of the interventional device delivery system of this application;
[0246] Figure 9b for Figure 3c Enlarged view of section E in the middle;
[0247] Figure 9c for Figure 9a Exploded view of the components of the intermediate liquid storage tank;
[0248] Figure 10 This is an exploded view of the pump drive components in one embodiment of the interventional device delivery system of this application;
[0249] Figure 11a This is a schematic diagram of the structure of a multi-port switching valve in one embodiment of the interventional device delivery system of this application;
[0250] Figure 11b for Figure 11a A schematic diagram of the valve core structure of a multi-way switching valve;
[0251] Figure 12a This is a schematic diagram of the structure of a multi-port switching valve in another embodiment of the interventional device delivery system of this application;
[0252] Figure 12b for Figure 12a A schematic diagram of the structure of a multi-way switching valve from another angle;
[0253] Figure 12c for Figure 12a Exploded view of components of a multi-way switching valve (valve seat remains engaged);
[0254] Figure 12d for Figure 12a Exploded view of components of a multi-way switching valve from another angle;
[0255] Figure 12e for Figure 12a Exploded view of components of a multi-way switching valve from another angle;
[0256] Figure 13a This is a schematic diagram of the hydraulic working principle in one embodiment of the interventional device delivery system of this application;
[0257] Figure 13b for Figure 13a Enlarged view of section D1 in the mid-range mode;
[0258] Figure 14a This is a schematic diagram of the distal portion of an embodiment of the interventional device delivery system of this application;
[0259] Figure 14b for Figure 14a Exploded view of the locking mechanism and related components;
[0260] Figure 14c for Figure 14a An exploded view of the locking mechanism and related components from another angle;
[0261] Figure 14d for Figure 3c Enlarged view of section A in the middle;
[0262] Figures 15a-15c This is a schematic diagram showing the changes of the lock components in different states;
[0263] Figures 16a-16d A schematic diagram showing the changes of the locking device and interventional instruments under different states;
[0264] Figure 17 A schematic diagram showing the connection method of the ligation wire on the stent of the interventional device;
[0265] Figure 18a for Figure 17 Schematic diagram of application scenarios for interventional devices;
[0266] Figure 18b for Figure 17 Schematic diagram of the structure of interventional devices after lining;
[0267] Figure 18c for Figure 17 A schematic diagram of stent segmentation in interventional devices;
[0268] Figures 19a-19e This is a schematic diagram illustrating the interaction between the binding wire and the annular wire sleeve on the bracket in different embodiments.
[0269] The annotations in the figure are explained as follows:
[0270] 1. Pipe fitting; 11. First pipe fitting; 11a. Distal section; 11b. Proximal section; 111. Guide head; 112. Mounting head; 1121. Retraction guide hole; 1122. Guide flare; 113. Pipe joint; 1131. Positioning plate; 1132. Hook; 12. Second pipe fitting; 121. Loading section; 13. Intermediate pipe fitting; 14. Protective pipe; 15. Base; 151. Proximal plate; 1511. Clearance hole; 1512. Container 152. Slot; 1521. Wire guide slot; 1522. Lock hole; 1523. Guide hole; 153. Transition section; 16. Movable seat; 161. Annular part; 162. Locking element; 163. Unlocking rod; 1631. Trigger end; 17. Support sleeve; 171. First guide surface; 172. Second guide surface; 18. Binding wire; 181. Fixed wire ring; 182. Movable wire ring; 19. Annular wire sleeve; 191. Transverse section;
[0271] 2. Control handle; 21. Working part; 211. Distal end; 212. Proximal end; 22. Grip part; 23. Positioning component; 24. First half-shell; 25. Second half-shell; 26. Positioning post; 27. Cover; 271. First assembly; 272. Second assembly; 273. First assembly slot; 274. Second assembly slot; 28. Anti-detachment blocking component;
[0272] 3. Cylinder; 31. First cylinder; 311. First hydraulic chamber; 312. First cavity; 313. Second cavity; 314. Connecting port; 315. Connecting port; 32. Second cylinder; 321. Second hydraulic chamber; 322. Third cavity; 323. Fourth cavity; 324. Connecting port; 325. Connecting port; 326. Spare port; 327. Spare port; 328. Spare port; 329. Spare port; 33. Hydraulic pipeline 331. First check valve; 332. Second check valve; 34. Isolation seal; 341. Cylinder; 342. Positioning disc; 343. Outward flange; 344. Reinforcing rib; 345. Snap fastener; 3451. Elastic arm; 3452. Hook; 3453. Guide slope; 3454. Chamfered structure; 346. Sealing plug; 3461. Raised ring; 35. Distal sealing plug; 351. Raised ring; 36. Proximal sealing plug; 361. Raised ring;
[0273] 4. First piston; 41. Support frame; 42. Sealing sleeve; 43. Through hole;
[0274] 5. Drive pump; 51. Pump casing; 52. Working parts; 53. Drive components; 531. Shaft hole; 54. Inlet; 55. Outlet; 56. Return spring; 57. Pump chamber;
[0275] 6. Multi-port switching valve; 61. Valve seat; 61a. First valve seat; 61b. Second valve seat; 611. First sealing gasket; 6111. First positioning tooth; 6112. First liquid passage hole; 613. Liquid inlet hole; 614. Second positioning tooth; 615. Third positioning tooth; 616. Liquid outlet hole; 617. Second sealing gasket; 6171. Fourth positioning tooth; 6172. Second liquid passage hole; 618. Cap; 619. Insert 62. Hole; 621. Valve core; 622. Shaft; 623. Rattle tooth; 624. Annular groove; 625. Connecting hole; 626. Smooth section; 63. Wrench; 631. Annular sleeve; 632. Elastic pawl; 633. Hook part; 634. Slot; 64. Mark; 65. Interface; 66. Flow channel; 67. Drive side interface; 68. Working side interface; 69. Wrench reset part; 691. Positioning crossbar; 692. Positioning bend;
[0276] 7. Storage tank; 71. Filling port; 72. Spare connector; 73. Inlet; 74. Outlet; 75. Tank body; 75a. First tank body; 75b. Second tank body; 751. Interface platform; 752. Flange; 76. Cap; 761. Elastic hook; 77. Buffer bladder; 771. Outward flange; 772. Annular protrusion;
[0277] 8. Fixing sleeve; 81. Through hole; 82. Vent hole; 83. Positioning groove; 84. Outward flange; 85. Blocking step; 86. Positioning plate; 861. Reinforcing rib; 87. Buckle; 871. Elastic arm; 872. Hook; 873. Chamfered structure; 88. Thickened area;
[0278] 9. Second piston;
[0279] 10. Support; 101. Connecting ear; 102. Leaflet; 103. Expanding mask; 104. Outflow section; 105. Waist section; 106. Inflow section;
[0280] 1000, Right atrium; 1100, Right ventricle; 1200, Inferior vena cava; 1300, Superior vena cava;
[0281] M1, connection point; M2, connection point. Detailed Implementation
[0282] The technical solutions of the embodiments of this application will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of this application, and not all embodiments. Based on the embodiments of this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.
[0283] It should be noted that when a component is said to be "connected" to another component, it can be directly connected to the other component or it can be connected to a component in between. When a component is said to be "set on" another component, it can be directly set on the other component or it may be set to a component in between.
[0284] It should be noted that the terms "proximal" and "distal" are relative to the operator. For example, in the catheters or sheaths mentioned herein, "proximal" refers to the end closer to the operator, i.e., the end that enters the body and is furthest from the lesion during use (e.g., the end of the catheter connected to the control handle), while "distal" refers to the end furthest from the operator, i.e., the end that enters the body and is closer to the lesion during use (e.g., the position at the catheter tip). Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the application. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.
[0285] This delivery system can be used to treat heart valves (e.g., mitral, aortic, tricuspid, vena cava, and pulmonary valves). For example, by loading a valve or stent distal to the delivery system, it can treat aortic stenosis, mitral or tricuspid regurgitation, or by loading a vena cava valve and implanting it in the superior or inferior vena cava, it can address right heart problems such as tricuspid regurgitation. This treatment can include, but is not limited to, valve replacement, valve repair, or other surgeries affecting valve function. This system and method can be used via catheterization, such as catheter systems delivered via a vein or femoral artery; or using other minimally invasive surgical methods, including but not limited to transapical catheter delivery.
[0286] See Figure 1 One embodiment of the interventional device delivery system of this application includes a catheter system, which includes multiple tubes 1 arranged coaxially from the inside to the outside, and a control handle 2 for driving the relative movement of the multiple tubes 1. The distal end of each tube is used to cooperate with each other to operate the interventional device, and the proximal end of each tube is connected to the control handle 2. The relative movement of each tube is driven by hydraulic means at the control handle 2.
[0287] This application uses hydraulic power to drive the various tubes at the control handle, enabling the operation of interventional instruments, such as release, cutting, rotation, grasping, or retrieval. The entire hydraulic system is configured at the proximal end, which is more convenient for on-site debugging or assembly. Even if unexpected situations occur, it is easier to resolve them externally. However, if the hydraulic mechanism is configured at the distal end, more stringent requirements are placed on the size and safety of the equipment, and the adjustable movement forms and directions are also limited due to equipment issues.
[0288] Multiple pipe fittings are understood as at least two. Specifically, any two pipe fittings can be in a sliding fit, meaning that all parts between the two pipe fittings have axial relative displacement during movement. Of course, if a deformable connector is additionally provided between the two pipe fittings, the relative movement relationship of the connector will be considered separately.
[0289] It can also be two pipe fittings, for example, two pipe fittings that are radially adjacent to each other and are locally fixed (for example, fixed to each other at the far end). Since these two are only fixed to each other at the far end, a small amount of relative displacement between them can be allowed at the near end. Of course, this relative movement will be transmitted to the far end and cause one of them to deform and bend. This feature can be used to adjust the bending at the far end of a pipe fitting.
[0290] The number of tubes 1 can be two, three, or more. The relative movement of different tubes 1 at the distal end (the end furthest from the operator, i.e., the end that enters the body closer to the lesion during use, and vice versa at the proximal end) enables corresponding operations on the interventional device, such as delivery, release, posture adjustment, and retrieval. The implementation of each tube 1 and its distal function can follow conventional techniques. However, improvements to the distal structure of the tubes are also provided below. One of the key points of this application is the use of a liquid-driven method at the operating handle to drive the relative movement of the different tubes.
[0291] See Figure 2a In one embodiment, the multiple pipe fittings include a first pipe fitting 11, an intermediate pipe fitting 13, and a second pipe fitting 12 that are sequentially slidably nested from the inside out, wherein:
[0292] The distal end of the first tube 11 is used to place an interventional device. The first tube 11 and the interventional device can be separated from each other in the body, that is, the interventional device remains in the body, or they can be connected to each other. After the operation is completed, the interventional device does not remain in the body, but is withdrawn to the outside of the body with the first tube 11.
[0293] The distal end of the first fitting 11 is the guide head 111. A mounting head 112 is fixed near the proximal end of the guide head 111. When the interventional device is loaded, it is positioned between the guide head 111 and the mounting head 112 and subjected to radial compression. Interventional devices generally have connecting lugs.
[0294] The connecting ear is the part where the interventional device connects to the delivery system. Relative to the stent, the connecting ear can be a mesh on the end of the stent, or a perforated connecting part extending outward from the stent body, for example... Figure 2b The connecting ear 101 shown;
[0295] In the prior art, the outer wall of the mounting head is usually provided with a groove or protrusion for engaging with the connecting ear of the interventional device. During loading, the connecting ear engages with the groove of the mounting head 112 or hangs on the protrusion to restrict the axial position of the interventional device. For more information on the fixing methods of the connecting ear and the mounting head, please refer to patent WO2019080857A1.
[0296] The distal end of the second tube 12 has a loading section for wrapping or releasing interventional instruments. In other embodiments, the proximal end of the second tube 12 may also be fitted with a protective tube 14 that is fixedly connected to the control handle.
[0297] The distal end of the intermediate tube 13 is provided with a locking member to restrict the interventional instrument to the first tube 11; the intermediate tube 13 can slide axially relative to the first tube 11, which can change the engagement relationship between the locking member and the mounting head on the first tube 11.
[0298] In other embodiments, the distal end of the intermediate tube 13 may be fixedly connected to the first tube 11 for traction and bending to change the posture of the interventional device in order to facilitate accurate positioning.
[0299] The connection points at the distal ends of the intermediate pipe fitting 13 and the first pipe fitting 11 can be adjacent to the mounting head on the first pipe fitting 11, for example, on the proximal side of the mounting head. Of course, the distal end of the intermediate pipe fitting 13 can also be directly fixed to the mounting head.
[0300] See Figure 2b , Figure 2c The interventional device involved in this application is not strictly limited in its specific shape. For example, it may include a stent 10 with a connecting ear 101 at one end of the stent 10 along its axial direction. The connecting ear 101 may have an expansion head at the end, or it may have an annular or C-shaped connecting part.
[0301] The scaffold 10 is made of nickel-titanium alloy or stainless steel and has a radially compressible or expandable structure. It is generally a mesh-like structure formed by laser cutting or weaving. The interior of the scaffold may or may not contain sutured biofilms.
[0302] Combination Figures 2d to 2f The distal end of the second tube 12 is a loading section 121. In the loaded state, the interventional device is radially compressed. The loading section 121 wraps around the periphery of the interventional device to restrict its radial expansion. After the interventional device is in place, the second tube 12 is driven to slide axially backward relative to the first tube 11 via the control handle, gradually exposing the interventional device in the blood vessels to allow for radial expansion. The interventional device enters a semi-release state from the distal expansion stage. As the second tube 12 further retracts, the interventional device is fully exposed. Finally, the connecting ear of the interventional device detaches from the mounting head and enters the release state, thus completing the release of the interventional device. Throughout the entire process, the axial relative sliding of the first tube 11 and the second tube 12 is driven by the control handle 2.
[0303] The first fitting 11 and the second fitting 12 are commonly used plastic or metal tubes in the field of interventional devices, such as cutting thiopanthematic tubes, metal braided tubes, or a mixture of metal braided tubes and thiopanthematic tubes, or a mixture of polymer and metal tubes. The first fitting 11 and / or the second fitting 12 can also be multilayer composite tubes.
[0304] See Figures 3a-3e The shape of the control handle 2 is not strictly limited. In order to facilitate the encapsulation of other components, a split structure can be adopted, that is, the housing of the control handle 2 includes a first half-shell 24 and a second half-shell 25 that are interlocked. Of course, in order to facilitate local maintenance or operation, it can also be divided into more parts.
[0305] To facilitate the mutual fixation between the first half-shell 24 and the second half-shell 25, various methods such as snap-fit and fasteners can be used. In this embodiment, at least one of the first half-shell 24 and the second half-shell 25 is provided with a positioning post 26, which has a screw hole. The other half is provided with a mounting hole for a bolt to pass through. The two are fixed by bolts.
[0306] Alternatively, both may have positioning posts 26 and be positioned in matching positions, with one positioning post having a positioning hole and the other positioning post directly engaging with the corresponding positioning hole.
[0307] In other embodiments, the first half-shell 24 and the second half-shell 25 may also be fixed by snap-fitting, bonding or welding.
[0308] In different embodiments, the hydraulic chamber is directly opened inside the control handle 2, or the control handle 2 is fixedly installed with a cylinder 3, and the inside of the cylinder 3 is a hydraulic chamber.
[0309] There are no strict restrictions on the cross-section of the cylinder 3. It is preferred that the outer periphery is surrounded by a smooth curve, such as a circle or an ellipse. Taking a circular cross-section as an example, it can be seen in the figure that the whole is cylindrical.
[0310] To protect the cylinder 3, the first half-shell 24 and the second half-shell 25 fasten and surround the cylinder 3. In a preferred embodiment, the control handle 2 is provided with a positioning component 23 that mates with the cylinder 3. The positioning component 23 is one or more positioning steps, the shape of which corresponds to the outer contour of the cylinder 3, to clamp and fix the cylinder 3. Although the shape of the control handle 2 is not strictly limited, for ease of operation, in a preferred embodiment, the control handle 2 includes a working part 21 and a gripping part 22 connected to the working part 21. The cylinder 3 is located within the working part 21, that is, the working part 21 as a whole is used to provide a hydraulic chamber, and the working part 21 has a distal end 211 and a proximal end 212.
[0311] The grip portion 22 is shaped for easy handling and operation. For example, it has a length direction. Since a cylinder is installed in the working part 21, with the direction of piston movement in the cylinder as the cylinder axis, the length direction of the grip portion 22 in this embodiment is approximately perpendicular to the cylinder axis, or slightly oblique. The working part 21 and the grip portion 22 are generally L-shaped. To further improve the grip feel and conform to the shape of the hand, the overall shape of the control handle 2 in this embodiment is similar to that of a pistol. Hydraulically driven control components, such as switches, can be provided in the grip portion 22 for easy one-handed operation.
[0312] In other embodiments, the length direction of the grip 22 can be approximately parallel to the cylinder axis, or even aligned with it. In this case, the overall shape of the control handle 2 is strip-shaped.
[0313] The working part 21 and the holding part 22 are integrated or detachably connected to each other, so as to facilitate storage with a smaller volume. The connection between the working part 21 and the holding part 22 can be made by means of snaps or threads for quick assembly.
[0314] In a preferred embodiment, the grip 22 is connected to the proximal end 212 of the working part 21. The tubes extend from the distal end 211 of the working part 21 through the control handle 2 and further distally.
[0315] In order to use hydraulically driven relative movement of the pipes, one embodiment of this application further improves the connection method of the pipes and pistons by directly inserting the pipes into the cylinder, making the structure more compact and improving the integration.
[0316] Of course, as a hydraulic drive, all pipes must be sealed at the points where they enter and exit the cylinder 3. Depending on the movement of the pipes relative to the cylinder 3, either a fixed seal or a sliding seal may be used.
[0317] Each connecting port is located in cylinder 3. The hydraulic drive circuit is used to drive the piston reciprocating within cylinder 3. The hydraulic drive circuit can be equipped with necessary control devices such as pumps and valves as needed. To further improve integration, in one embodiment, the hydraulic drive circuit is configured on control handle 2 to drive the piston and cause relative movement of the various tubes. The interior of the first tube 11 can be used for threading guide wires, etc. Therefore, the proximal end of the first tube 11 is fixed to control handle 2. In one embodiment, a pipe connector 113 is installed at the proximal end of the working part 21, and the first tube 11 extends and connects to the pipe connector 113. The pipe connector 113 can specifically be a Luer connector and connects to the first tube 11. Physiological saline can also be introduced into the first tube 11 through the pipe connector 113 to perform venting operations as needed. The proximal end of the first tube 11 can be directly fixed to the pipe connector 113, or connected to the pipe connector 113 through a fastening sleeve. The fastening sleeve can be filled between the outer wall of the first tube 11 and the inner wall of the pipe connector 113 to achieve fastening and sealing.
[0318] There are various ways to configure the relationship between the control handle 2 and the cylinder 3. For example, the control handle 2 can form a closed space to surround the cylinder 3; another example is that the control handle 2 exposes a part of the cylinder 3; yet another example is that the control handle 2 is only used to provide positioning for the cylinder 3 and exposes the cylinder 3 in the circumferential direction; and so on.
[0319] Reference Appendix Figure 3aIn the disclosed embodiments, the control handle 2 is provided with a shielding cover 27 for shielding at least a portion of the cylinder 3. The shielding cover 27 is integrally or separately provided with the control handle 2. In the embodiment shown in the accompanying drawings, the shielding cover 27 is an independent component. When the shielding cover 27 is installed on the control handle 2, the shielding cover 27 can surround the control handle 2 to achieve the closure of the external dimensions of the control handle 2, thereby achieving the shielding of the cylinder 3.
[0320] The shielding cover 27 and the control handle 2 can be installed in various ways, such as using clips or fasteners. (See reference) Figure 3f In the disclosed embodiment, the shielding cover 27 is engaged with the control handle 2 via a snap-fit. The shielding cover 27 is positioned along the extension direction of the pipe fitting 1, and a first fitting 271, which engages with the control handle 2, is provided in this direction. The first fitting 271 restricts the radial movement of the shielding cover 27 along the pipe fitting 1. The shielding cover 27 has a U-shaped cross-section, with the interior of the U-shape accommodating the cylinder 3. The first fitting 271 is located at the U-shaped opening. Two first fittings 271 are positioned opposite each other at the U-shaped opening of the shielding cover 27. The two first fittings 271 have positions that are close to each other and positions that are far apart as the width of the U-shaped opening of the shielding cover 27 changes. The two first fittings 271 are held in the assembled position by the elastic deformation of the shielding cover 27's material. Second fittings 272 are provided at both ends of the shielding cover 27 along the extension direction of the pipe fitting 1. The second fittings 272 engage with the control handle 2 to restrict the movement of the shielding cover 27 along the extension direction of the pipe fitting 1. The first assembly 271 and the second assembly 272 are raised ribs provided on the inner surface of the shielding cover 27. The control handle 2 has a first mounting groove 273 that mates with the first assembly 271. The control handle 2 has a second mounting groove 274 that mates with the second assembly 272. The first mounting groove 273 and the second mounting groove 274 are not coplanar. Specifically, the planes containing the first mounting groove 273 and the second mounting groove 274 are perpendicular to each other. Spatially, the first mounting groove 273 and the second mounting groove 274 may or may not be connected.
[0321] In the extending direction of pipe fitting 1, the length of the shielding cover 27 is greater than, equal to, or less than the length of cylinder 3. Different length relationships correspond to the shielding cover 27's coverage capability over the cylinder body. Besides dimensional variations, the shielding cover 27 can also expose part of the cylinder 3 through partial perforations. For example, in other embodiments, the shielding cover 27 can also be configured as a semi-open structure. For instance, the shielding cover 27 may completely cover the cylinder 3, but with partial openings for fittings to the cylinder 3. The shielding cover 27 is also provided with dust caps (not shown) corresponding to the interfaces. The dust caps can be an integral part of the shielding cover or a separate component.
[0322] refer to Figure 3dIn the illustrated embodiment, the first cylinder 31 also includes a connecting port 314 and a connecting port 315 for connecting to the hydraulic drive circuit. The proximal end of the second cylinder 32 is provided with a proximal sealing plug 36, and the second cylinder 32 also includes a connecting port 324 and a connecting port 325 for connecting to the hydraulic drive circuit. Each connecting port is used to achieve the driving effect of the cylinder on different pipelines; the specific connection effects will be explained in detail below. As described in the background art, the control handle has many components and complex mating relationships, posing a risk of failure.
[0323] refer to Figure 3g and Figure 3h In the embodiment shown, the interventional device delivery system includes multiple tubes arranged coaxially from the inside out, and a control handle 2 that drives the relative movement of the multiple tubes. The distal ends of each tube are used to cooperate with each other to operate the interventional device, and the proximal ends of each tube are connected to the control handle 2. The relative movement of each tube is driven by hydraulic means at the control handle 2.
[0324] The control handle contains one or more cylinders, and each cylinder 3 has a piston slidably installed inside. Two radially adjacent pipes include an outer pipe and an inner pipe. The outer pipe enters the cylinder and is fixed to the piston inside the cylinder. The inner pipe extends to connect to the piston of other cylinders or is fixed to the control handle.
[0325] The cylinder is provided with a spare port that communicates with the inside of the cylinder. The spare port has a standby state where the cylinder is closed to maintain the internal pressure of the cylinder, and an active state where the cylinder is open to connect to an external drive device.
[0326] Similar to connectors 314, 315, 324, and 325, multiple spare ports can also be provided. Referring to the attached diagram, the first cylinder 31 also has spare ports 326 and 327 for connecting to the hydraulic drive circuit. The second cylinder 32 also has spare ports 328 and 329 for connecting to the hydraulic drive circuit. These spare ports do not function when the cylinders and hydraulic lines are operating normally and are stored inside the operating handle, as described above regarding the cover. They can be used to connect to an external drive device in case of emergency. The external drive device provides power for the movement of the cylinders. The external drive device can be a piston pump, diaphragm pump, electromagnetic pump, or other commonly used fluid pumping devices in clinical settings.
[0327] The number of backup interfaces can also be varied. For example, in the embodiment disclosed in the attached drawings, four backup interfaces are provided corresponding to the connection ports to ensure that all functions of the hydraulic pipeline are realized under normal conditions and to improve stability.
[0328] For example, in another embodiment, the cylinder has three spare ports, but the spare port for pushing the second sheath distally is omitted. The main reason for this arrangement is that the actual function of the omitted spare port is to retrieve the interventional device. In actual treatment, retrieving the interventional device is a rare occurrence, so in some products, it is unnecessary to set up a spare port for this purpose to avoid excessive redundancy.
[0329] Regarding the setup of the spare ports, as described above regarding the shielding cover, the spare ports are positioned facing the shielding cover. This allows the shielding cover to easily cover or open the spare ports. The spare ports are spaced apart from each other. The spacing ensures effective cylinder drive. The positions of the spare ports correspond to those of the connecting ports. This setup ensures that the spare ports can perform all the functions of the cylinder under normal conditions as the connecting ports.
[0330] To facilitate observation of the hydraulic system's operation, the shielding cover 27 can be made of transparent material. Similarly, the parts of the control handle 2's housing corresponding to the areas requiring observation, such as the parts corresponding to the control valve or reservoir, can also be made of transparent material.
[0331] Correspondingly, controllable valves are independently or in conjunction with the backup interface and connection port. In the event of a problem in the pipeline, these valves can prevent unreliable pressure release of the fluid inside the cylinder, ensuring the stable operation of the operating handle.
[0332] The control handle 2 houses a first cylinder 31 and a second cylinder 32, which respectively provide a first hydraulic chamber 311 and a second hydraulic chamber 321. A first piston 4 is slidably mounted in the first hydraulic chamber 311, and a second piston 9 is slidably mounted in the second hydraulic chamber 321. The first cylinder 31 and the second cylinder 32 are coaxially arranged and connected to each other, with an isolation seal 34 provided at the connection point.
[0333] The proximal end of the second pipe 12 enters the first hydraulic chamber 311 and is fixedly connected to the first piston 4. The proximal end of the intermediate pipe 13 extends out of the first piston 4 and enters the second hydraulic chamber 321 through a sliding seal through the isolation seal 34. The proximal end of the intermediate pipe 13 is fixed to the second piston 9 inside the second hydraulic chamber 321. The proximal end of the first pipe 11 extends out of the second piston 9 and is fixedly connected to the control handle 2. The first piston 4 divides the first hydraulic chamber 311 into a first chamber 312 and a second chamber 313. The second piston 9 divides the second hydraulic chamber 321 into a third chamber 322 and a fourth chamber 323. Each chamber is connected to the hydraulic drive circuit through a corresponding connecting port.
[0334] The first chamber 312 and the second chamber 313 are divided according to the first piston 4, and the third chamber 322 and the fourth chamber 323 are divided according to the second piston 9. Since the positions of the two pistons are movable, the volume of each chamber also changes accordingly and is not fixed.
[0335] When only the first piston 4 moves to the distal end, it drives the second tube 12 to move to the distal end, while the positions of the first tube 11 and the intermediate tube 13 remain unchanged. The same applies when the first piston 4 moves to the proximal end.
[0336] When only the second piston 9 moves to the distal end, it drives the intermediate tube 13 to move to the distal end, while the positions of the first tube 11 and the second tube 12 remain unchanged. The same applies when the second piston 9 moves to the proximal end.
[0337] The first cylinder 31 and the second cylinder 32 are arranged coaxially and connected to each other through an isolation seal 34. The first cylinder 31 is provided with a distal sealing plug 35 at its distal end. The first cylinder 31 also has a connecting port 314 and a connecting port 315 on both sides of the first piston 4 for connecting the hydraulic drive circuit. The second cylinder 32 is provided with a proximal sealing plug 36 at its proximal end. The second cylinder 32 also has a connecting port 324 and a connecting port 325 on both sides of the second piston 9 for connecting the hydraulic drive circuit.
[0338] The second tube 12 has a sliding seal through the distal end sealing plug 35 connected to the first piston 4. The intermediate tube 13 and the first tube 11 extend from the second tube 12 to form the first piston 4. The intermediate tube 13 has a further sliding seal through the isolation seal 34 connected to the second piston 9. The first tube 11 extends from the intermediate tube 13 to form the second piston 9. The further fixed seal through the proximal end sealing plug 36 is connected to the pipe joint 113 of the control handle 2.
[0339] Each hydraulic chamber is equipped with a piston. Each piston can have the same structure, only its position and the pipes it passes through are different, but this does not affect its structural characteristics and working principle.
[0340] See Figure 4 In one embodiment, two radially adjacent pipe fittings include an outer pipe fitting, namely the second pipe fitting 12, and an inner pipe fitting, namely the middle pipe fitting 13. The first piston 4 includes a support frame 41. The two ends of the support frame 41 in the axial direction have outwardly turned flanges. Each flange is respectively fixedly provided with a sealing sleeve 42. According to the matching relationship with the pipe fitting, the two sealing sleeves 42 respectively serve as: a fixed sealing part, which is sleeved on the second pipe fitting 12 and fixedly and sealed with the outer wall of the second pipe fitting 12.
[0341] A sliding sealing part is sleeved on the intermediate pipe fitting 13 and slides and seals with the outer wall of the intermediate pipe fitting 13.
[0342] The support frame 41 and each sealing sleeve 42 have axial through holes 43 for pipe fittings to pass through. The sealing sleeve 42 can be made of elastic materials such as rubber to facilitate sealing.
[0343] The fixed sealing part and the sliding sealing part are fixedly connected relative to each other by the support frame 41, and the outer periphery of both are in sliding sealing cooperation with the inner wall of the first cylinder 31. The first piston 4 is fixedly connected to the second pipe 12, but in sliding cooperation with the intermediate pipe 13. Therefore, when the first piston 4 moves, it can drive the second pipe 12, but does not affect the position of the intermediate pipe 13. The second piston 9 is similar. For example, in one embodiment, the two pipes that are adjacent in the radial direction include the outer pipe, i.e., the intermediate pipe 13, and the inner pipe, i.e., the first pipe 11. The second piston 9 has a through hole extending along the axis. The proximal end of the intermediate pipe 13 is fixedly connected in the through hole. That is, the second piston 9 is fixedly connected to the intermediate pipe 13, but in sliding cooperation with the first pipe 11. Therefore, when the second piston 9 moves, it can drive the intermediate pipe 13, but does not affect the position of the first pipe 11. The proximal end of the first pipe 11 passes through the second hydraulic chamber and is fixedly connected to the pipe joint 113.
[0344] The radial gap between two adjacent pipe fittings is the venting gap. Each venting gap can be individually filled with saline solution for venting, or it can be connected to a unified hydraulic drive circuit for venting. This fully utilizes the auxiliary function of the hydraulic drive, venting through liquid filling and eliminating the need for additional venting equipment.
[0345] In order to establish a stable intervention channel, in one embodiment, a protective tube 14 is also sleeved on the outside of the second tube 12, and the proximal end of the protective tube 14 is fixed to the control handle 2.
[0346] The protective tube 14 is fixedly installed relative to the control handle and located on the outer periphery of the second tube 12. The intervention is performed through the channel established by the protective tube 14, which can prevent the second tube 12 from scratching the blood vessels when it moves back and forth. The length of the protective tube 14, i.e. the position of its distal end, can be determined according to the length of the intervention path. The proximal end of the protective tube 14 is fixed to the distal side of the control handle 2. The proximal end of the second tube 12 passes through the protective tube 14 and then enters the first cylinder.
[0347] To facilitate the installation of the proximal end of the protective tube 14, in one embodiment, a fixing sleeve 8 is installed on the control handle, and the proximal end of the protective tube 14 is sealed and connected to the distal end of the fixing sleeve 8. The proximal end of the second tube 12 extends further into the first hydraulic chamber after passing through the fixing sleeve 8 via the protective tube 14.
[0348] Since the protective tube 14 and the second fitting 12 need to slide relative to each other, a radial gap is sometimes reserved, and air needs to be vented from the radial gap during surgery.
[0349] Combination Figures 5-6d , Figures 3a-3eIn one embodiment, an interventional device delivery system is provided, including multiple tubes coaxially arranged from the inside out, and a control handle 2 for driving the relative movement of the multiple tubes. The distal ends of each tube are used to cooperate with each other to operate the interventional device, and the proximal ends of each tube are connected to the control handle 2. A cylinder 3 with an internal piston is disposed at the control handle 2. The distal end of the cylinder 3 is sealed and connected to a fixing sleeve 8. The multiple tubes pass through the fixing sleeve 8 into the cylinder 3 and are connected to the piston or fixed relative to the cylinder 3. The piston is driven hydraulically within the cylinder 3 to cause the relative movement of the tubes.
[0350] A protective tube 14 is fitted around the outermost periphery of multiple pipe fittings. The proximal end of the protective tube 14 is connected to the fixed sleeve 8. The radial gap between the outermost pipe fitting and the protective tube 14 is the exhaust gap. An exhaust hole 82 communicating with the exhaust gap is opened on the side wall of the fixed sleeve 8.
[0351] The above embodiments can be combined. For example, the cylinder 3 includes a first cylinder 31 and a second cylinder 32 connected sequentially from the far end to the near end. A first piston 4 is slidably installed in the first cylinder 31 and a second piston 9 is slidably installed in the second cylinder 32. The multiple pipes include a first pipe 11, an intermediate pipe 13 and a second pipe 12 arranged coaxially from the inside to the outside.
[0352] All pipes enter from the far end of the first cylinder 31, wherein the first pipe 11 is fixed to the first piston 4, the intermediate pipe 13 extends out of the first piston 4 and enters the second cylinder 32 and is fixed to the second piston 9, and the first pipe 11 extends out of the second piston 9 and is fixed to the proximal end of the second cylinder 32.
[0353] The fixing sleeve 8 has a through hole 81. The proximal end of the protective tube 14 extends into the through hole 81 and is sealed and fixedly connected to the hole wall by means of bonding, welding, interference fit, etc. The fixing sleeve 8 and the control handle 2 can be fixed by means of snap-fit or fasteners. In one embodiment, the outer periphery of the fixing sleeve 8 is provided with an annular positioning groove 83. The control handle 2 has two interlocking half shells, and the edges of the two half shells are engaged with the positioning groove 83. For example, as can be seen in the figure, the corresponding part of the first half shell 24 is engaged with the positioning groove 83 to limit the axial position of the fixing sleeve 8.
[0354] Since the second pipe fitting 12 needs to slide back and forth, the near end of the fixed sleeve 8 slides and seals with the outer wall of the second pipe fitting 12. This sliding and sealing fit can be either a direct contact fit between the inner wall of the through hole 81 and the outer wall of the second pipe fitting 12, or an indirect fit through other components.
[0355] The protective tube 14 is fixedly inserted into one axial end of the fixed sleeve 8. The other axial end of the fixed sleeve 8 is the connecting end. The connecting end is inserted into the far end of the first cylinder 31 and fixed to the first cylinder 31 by the buckle 87. The outer periphery of the connecting end is fitted with a far end sealing plug 35 that matches the inner wall of the first cylinder 31.
[0356] The distal sealing plug 35 has a clearance hole, and the outermost pipe fitting, namely the second pipe fitting 12, among the multiple pipe fittings slides and seals with the clearance hole.
[0357] To ensure a good connection and facilitate assembly, in one embodiment, the connecting end has an outward flange 84, and the distal sealing plug 35 is fitted onto the outward flange 84. The distal sealing plug 35 is made of an elastic material such as rubber, which facilitates installation and ensures a good seal. In a preferred embodiment, the outer periphery of the distal sealing plug 35 is provided with at least two axially spaced protruding rings 351, and each protruding ring 351 seals against the inner wall of the first cylinder 31.
[0358] In order to ensure accurate axial relative positioning between the protective tube 14 and the fixed sleeve 8, in one embodiment, the inner wall of the fixed sleeve 8 is provided with a blocking step 85, and the proximal end face of the protective tube 14 abuts against the blocking step 85.
[0359] In order to ensure accurate assembly between the fixed sleeve 8 and the first cylinder 31, while the fixed sleeve 87 is fixed to the first cylinder 31, in one embodiment, a positioning plate 86 is provided on the outer wall of the fixed sleeve 8, and the far end face of the first cylinder 31 abuts against the positioning plate 86.
[0360] The positioning disc 86 has a reinforcing rib 861 on the side facing the inside of the first cylinder 31. The reinforcing rib 861 can stabilize the positioning disc 86 and, after entering the first cylinder 31, abut against the inner wall of the first cylinder 31 to prevent radial wobbling of the fixing sleeve 8. The reinforcing rib 861 and the latch 87 can be arranged alternately and at intervals along the circumference of the fixing sleeve 8. For example, two reinforcing ribs 861 and two latches 87 can be provided and evenly alternated along the circumference.
[0361] After the buckle 87 and the first cylinder 31 are axially inserted, it can prevent accidental loosening. Of course, in order to facilitate the assembly of the buckle 87, in one embodiment, a positioning hole is provided on the side wall of the first cylinder 31. The buckle 87 includes an elastic arm 871 extending from the positioning plate 86 into the first cylinder 31, and a hook 872 located at the end of the elastic arm 871 and cooperating with the positioning hole.
[0362] At least two buckles 87 are distributed along the circumference of the fixing sleeve 8, and preferably evenly spaced. The axial ends of the hooks 872 are slightly chamfered. When inserted into the first cylinder 31, the elastic arm 871 can be guided to deform to allow each buckle 87 to enter the first cylinder 31 until the hooks 872 are located in the positioning hole. At this time, the elastic arm 871 is reset, locking the fixing sleeve 8 into the first cylinder 31.
[0363] Normally, during disassembly, tools are needed to push each clip radially inward to disengage the hook 872 from the positioning hole, and then pull it out axially. However, this operation is too cumbersome and requires the use of tools. In the preferred embodiment, one side of the hook 872 has a chamfered structure 873 to guide the hook 872 to rotate out of the positioning hole circumferentially.
[0364] When disassembly is required, the chamfered structure 873 rotates radially inward under the action of the inner edge of the positioning hole, thereby squeezing the hook 872 out of the positioning hole, and then pulling out the fixing sleeve 8 axially. The operation is simpler and does not require special tools.
[0365] In order to maintain the structural strength around the vent hole 82, in one embodiment, the side wall of the fixing sleeve 8 has a thickened area 88, and the vent hole 82 is opened in the thickened area 88.
[0366] In the axial direction, the venting gap between the protective tube 14 and the first tube 11 is open on the proximal side of the protective tube 14, so the venting hole 82 is located between the blocking step 85 and the positioning plate 86.
[0367] The vent 82 can be connected to a separate pipeline for venting. In order to make full use of the existing hydraulic drive circuit, the vent 82 can be connected to the hydraulic drive circuit. For example, one of the working side interfaces of the multi-way switching valve is connected to the vent 82. The multi-way switching valve has multiple positions, one of which is connected to the outlet of the drive pump and the vent 82, so that venting can be performed by liquid injection.
[0368] See Figures 7a-7e , combined Figures 3a-3e This embodiment provides an interventional device delivery system, including multiple tubes 1 arranged coaxially from the inside to the outside, and a control handle 2 that drives the relative movement of the multiple tubes 1. The distal ends of each tube are used to cooperate with each other to operate the interventional device, and the proximal ends of each tube are connected to the control handle 2. A cylinder 3 with an internal piston is arranged at the control handle 2. The multiple tubes 1 pass through the cylinder 3 and are connected to the piston or fixed relative to the cylinder 3. The relative movement of each tube is driven by hydraulic means within the cylinder 3.
[0369] The cylinder 3 comprises multiple cylinders that are sequentially joined together along the axial direction. Adjacent cylinders are connected by an isolation seal 34. One of the multiple pipes is a sliding seal that passes through the isolation seal 34. The isolation seal 34 is detachably connected to the adjacent cylinders by a snap-fit 345.
[0370] The relative movement of each pipe component is driven by hydraulic means. A cylinder with a piston can be used and a hydraulic pipeline can be configured accordingly. Of course, it can also be combined with the above embodiments. This embodiment makes improvements to the connection of multiple cylinders. The two ends of the isolation seal 34 are respectively sealed and matched with each cylinder. At the same time, the cylinder is positioned by snap-fit in both the axial and circumferential directions to facilitate quick disassembly and assembly.
[0371] In one embodiment, the cylinder includes a first cylinder 31 and a second cylinder 32 connected sequentially along the axial direction, wherein a first piston 4 is slidably installed in the first cylinder 31 and a second piston 9 is slidably installed in the second cylinder 32, and the pipe includes a first pipe 11, an intermediate pipe 13 and a second pipe 12 arranged coaxially from the inside to the outside.
[0372] All pipes enter from the far end of the first cylinder 31, wherein the first pipe 11 is fixed to the first piston 4, the intermediate pipe 13 extends out of the first piston 4 and enters the second cylinder 32 through the isolation seal 34 and is fixed to the second piston 9, and the first pipe 11 extends out of the second piston 9 and is fixed to the proximal end of the second cylinder 32.
[0373] In one embodiment, the isolation seal 34 includes:
[0374] The cylinder 341 has an axial direction, and the two ends of the cylinder 341 are respectively inserted into the corresponding cylinders.
[0375] Two sealing plugs 346 are fixed to one axial end of the cylinder and respectively seal with the inner wall of the cylinder on the corresponding side. Each sealing plug 346 is provided with a clearance hole for the pipe to pass through.
[0376] Two sets of clips 345 are fixed to one axial end of the cylinder 341 and respectively engage with the cylinder on the corresponding side.
[0377] The distal and proximal ends of the isolation seal 34 adopt a symmetrical structure, that is, they are connected with each cylinder using the same structural features. Therefore, the following description mainly takes one side as an example, and the other side is the same.
[0378] The sealing plug 346 is made of elastic material such as rubber to facilitate sealing. To facilitate the installation of the sealing plug 346, both axial ends of the cylinder 341 are respectively provided with outward flanges 343, and each sealing plug 346 is fixedly sleeved on the corresponding outward flange 343. At least two axially spaced convex rings 3461 are provided on the outer periphery of the sealing plug 346, and each convex ring 3461 seals against the corresponding cylinder inner wall. Each convex ring 3461 can form an independent seal, further ensuring the sealing effect.
[0379] In order to maintain relative stability, in one embodiment, a positioning disk 342 is provided on the outer periphery of the cylinder 341, and the end faces of two adjacent cylinders abut against the two opposite sides of the positioning disk 342.
[0380] As shown in the figure, the first cylinder 31 abuts against the far side of the positioning plate 342, and the second cylinder 32 abuts against the near side of the positioning plate 342. The positioning plate 342 supports and positions each cylinder on the one hand, and on the other hand, makes the structure between the two cylinders more compact.
[0381] Because the thickness of the positioning disk 342 is limited, in order to ensure structural strength, in one embodiment, reinforcing ribs 344 are provided between the outer periphery of the cylinder 341 and the two opposite sides of the positioning disk 342. The reinforcing ribs 344 can prevent the positioning disk 342 from deforming in the axial direction and improve the overall rigidity of the positioning disk 342.
[0382] In a preferred embodiment, the outer edge of the reinforcing rib 344 abuts against the inner wall of the cylinder in the radial direction of the cylinder body 341. The reinforcing rib 344 provides further radial stability to the two cylinders.
[0383] The reinforcing ribs 344 and the clips 345 can be arranged alternately. For example, on the same side of the positioning plate 342, two reinforcing ribs 344 and two clips 345 are provided and are evenly alternated along the circumference.
[0384] After the buckle 345 is axially inserted with each cylinder, it can prevent accidental loosening. Of course, in order to facilitate assembly, that is, to make it easy for the buckle 345 to be in place, in one embodiment, the cylinder wall of each cylinder is provided with a positioning hole. Two sets of buckles are fixed on two opposite sides of the positioning plate 342. Each buckle includes an elastic arm 3451 extending from the positioning plate 342 into the cylinder, and a hook 3452 located at the end of the elastic arm 3451 and cooperating with the positioning hole.
[0385] The end of the hook 3452 has a guide slope 3453 that guides itself into the positioning hole along the cylinder axial direction. When inserted into the cylinder, the elastic arm 3451 can be guided to deform to allow each buckle 345 to enter the corresponding cylinder until the hook 3452 is located in the positioning hole. At this time, the elastic arm 3451 resets and locks the isolation seal 34 into the connected cylinder.
[0386] Normally, during disassembly, tools are needed to push each clip radially inward to disengage the hook 3452 from the positioning hole, and then pull it out axially. However, this operation is too cumbersome. In the preferred embodiment, the hook 3452 has a chamfered structure 3454 on one side of its circumferential direction to guide the hook 3452 to rotate out of the positioning hole circumferentially.
[0387] When disassembly is required, the chamfered structure 3454, under the action of the inner edge of the positioning hole, radially pushes the hook 3452 out of the positioning hole, and then pulls it out axially to separate the isolation seal 34 and the cylinder. The operation is simpler and does not require special tools.
[0388] See Figures 8a-8d In one embodiment, a pipe connector 113 is provided. For example, a positioning hole is provided on the near-end wall of the second cylinder 32. The outer periphery of the pipe connector 113 is provided with a positioning plate 1131. The end face of the second cylinder 32 abuts against the positioning plate 1131. The positioning plate 1131 is also provided with a hook 1132 that extends into the second cylinder 32 and cooperates with the positioning hole. One side of the hook 1132 has a chamfered structure to guide the hook 1132 into and out of the positioning hole of the second cylinder 32.
[0389] The distal end of the pipe connector 113 has an outward flange, and the proximal sealing plug 36 is fitted on the outward flange. The proximal sealing plug 36 has two convex rings 361 on its outer periphery, and the two convex rings 361 seal with the inner wall of the second cylinder 32.
[0390] The proximal portion of the pipe connector 113 has a threaded or other quick-connect structure to facilitate connection with an external pipe, and the distal portion of the pipe connector 113 is fixed relative to and connected to the first pipe fitting 11.
[0391] The proximal sealing plug 36 has a clearance hole, into which the proximal end of the first pipe fitting 11 can extend and be fixed, or further extend and be fixed to the inner wall of the pipe joint 113.
[0392] See Figures 3a-3e In one embodiment of this application, to further improve integration, a hydraulic drive circuit for driving the relative movement of each pipe component via a piston is also configured at the control handle 2. Installing the hydraulic drive circuit on the control handle 2 avoids the use of lengthy external pipelines and reduces component interference during handheld operation.
[0393] In one embodiment, the hydraulic drive circuit includes:
[0394] Hydraulic lines are used to provide fluid passages connecting to various hydraulic chambers;
[0395] Drive pump 5, which is connected to the hydraulic pipeline to drive the flow of liquid;
[0396] Control valves are connected to hydraulic lines to control the flow of liquid.
[0397] Hydraulic lines generally refer to pipes used to connect various components in the hydraulic drive circuit. Since the hydraulic drive circuit is located inside the control handle 2, it is preferable that all or most of the hydraulic lines are housed inside the control handle 2. The hydraulic lines are omitted in the accompanying drawings of the specific structure in this application. Since the connection relationship of each component has been clearly explained, the hydraulic lines can be arranged as needed during implementation. Since hydraulic lines are generally made of flexible hoses, how to house them inside the control handle 2 can be implemented as needed.
[0398] When using hydraulic lines, they are filled with liquid. The direction of the liquid flow changes, which drives the piston to reciprocate. To improve safety, the liquid in the hydraulic drive circuit is saline solution.
[0399] By arranging corresponding control valves in the hydraulic drive circuit, the direction of liquid flow can be controlled, the direction of piston movement can be changed, or other auxiliary functions can be achieved. For example, the control valves may include check valves respectively configured at the inlet and outlet of the drive pump 5, and a multi-way switching valve 6 for switching the direction of piston movement.
[0400] See Figures 9a-9c In order to buffer and temporarily store liquid, in one embodiment the hydraulic drive circuit also includes a liquid storage tank 7 connected to the hydraulic pipeline for temporary liquid storage. The liquid storage tank 7 can also be integrated into the inside of the control handle 2. In order to add liquid in advance or on-site during use, the liquid storage tank 7 is provided with a liquid filling port 71.
[0401] The liquid storage tank 7 not only has inlet and outlet connected to the hydraulic pipeline, but can also be equipped with a separate liquid injection port 71. A valve can be separately configured at the liquid injection port 71 to connect to an external liquid filling device. In addition, in a preferred embodiment, liquid filling can also be achieved by using a drive pump 5.
[0402] Combination Figures 3a-3e In one embodiment, an interventional device delivery system is provided, including multiple tubes 1 arranged coaxially from the inside to the outside, and a control handle 2 that drives the relative movement of the multiple tubes 1. The distal ends of each tube are used to cooperate with each other to operate the interventional device, and the proximal ends of each tube are connected to the control handle 2. The control handle 2 is also equipped with a hydraulic drive circuit that drives the relative movement of each tube.
[0403] The hydraulic drive circuit includes at least a reservoir 7, which comprises:
[0404] Tank body 75, with a tank opening and an inlet 73 and an outlet 74 connected to a hydraulic drive circuit;
[0405] Buffer 77 is inserted into tank body 75 and sealed to the tank opening;
[0406] The pressure cap 76 is engaged with the tank body 75 and clamps and fixes the buffer bladder 77 at the tank opening.
[0407] In order to store liquid and act as a buffer for sudden changes in liquid pressure, a liquid storage tank 7 can be configured in the hydraulic drive circuit. The tank body 75 is connected to the inlet side of the drive pump 5 in the hydraulic drive circuit. When the liquid volume inside the tank body 75 changes, the pressure can be released by the deformation of the buffer bladder 77.
[0408] To facilitate the replenishment of bodily fluids from the outside, in one embodiment, the tank 75 has a bottom wall on the side away from the tank opening, and an injection port 71 is provided on the bottom wall, with a pipeline connector installed at the injection port 71.
[0409] The pipe fittings may have threads or other connection structures that facilitate disassembly and assembly. The tank body 75 is installed inside the control handle 2, with only the pipe fittings exposed to the control handle 2. To avoid interfering with the deformation of the buffer bladder 77, both the inlet 73 and outlet 74 of the tank body 75 are located near the bottom wall.
[0410] The tank 75 includes a first tank 75a and a second tank 75b that are interconnected, and the first tank 75a is provided with a buffer bladder 77.
[0411] The volume of the first tank 75a is larger than that of the second tank 75b. The top of the first tank 75a has a can opening, and the bottom shape of the first tank 75a converges and transitions to the second tank 75b.
[0412] The larger volume of the first tank 75a facilitates the configuration of a corresponding volume of buffer bladder 77, improving buffer adaptability. The bottom shape of the first tank 75a converges, forming a stepped structure. The bottom of the buffer bladder 77 can abut against the stepped structure when it expands to its maximum volume, playing an auxiliary phase role and avoiding excessive encroachment on the space of the second tank 75b.
[0413] The buffer bladder 77 is made of an elastic material and changes its internal volume of the tank 75 through its own deformation. In a preferred embodiment, the wall of the buffer bladder 77 has a corrugated structure that can stretch and deform. The stretching or compression of the corrugated structure can guide the volume change of the buffer bladder 77, further increasing the range of volume variation.
[0414] To avoid obstruction of increased internal pressure when the volume of the buffer bladder 77 decreases, in one embodiment, the buffer bladder 77 has an open structure on the side facing the can opening, and the opening has an outwardly flanged edge 771, which is clamped and fixed by the cap 76 and the can opening. When the volume of the buffer bladder 77 decreases, the internal air can be discharged from the opening, allowing the corrugated structure to fold flat.
[0415] In one embodiment, to ensure a sealing effect, the outer flange 771 has an annular protrusion 772 that abuts against the gland 76. The annular protrusion 772 can be considered as a thickened area with a larger deformation range. When the gland 76 abuts against the annular protrusion 772, the deformation of the annular protrusion 772 can compensate for local shape defects or processing errors, ensuring sealing. Of course, the corresponding part of the gland 76 can be slotted to accommodate the annular protrusion 772, which makes positioning and assembly easier. The slot depth is slightly smaller than that of the annular protrusion 772.
[0416] The buffer bladder 77 and the tank body 75 have formed a closed space for storing liquid. Therefore, the main function of the cap 76 is to fix the buffer bladder 77. In one embodiment, the cap 76 includes:
[0417] An annular frame that clamps and fixes the buffer bladder 77 at the can opening;
[0418] An elastic hook 761 extends from the annular frame toward one side of the tank 75 and cooperates with the tank 75.
[0419] In order to cooperate with the annular frame, the can opening is turned outward to form an interface platform 751. The annular frame and the top surface of the interface platform 751 clamp and fix the buffer bladder 77, and the elastic hook 761 abuts against the bottom surface of the interface platform.
[0420] The shape of the annular frame roughly matches that of the interface platform 751. The elastic hooks 761 are generally arranged in pairs to maintain balanced force application. The elastic hooks 761 have guide slopes that interact with the interface platform 751 to facilitate positioning during installation. To ensure a sealing effect, flanges 752 that abut against the buffer bladder 77 are arranged around the top surface of the interface platform 751.
[0421] See Figure 10 In one embodiment, the drive pump 5 includes:
[0422] Pump housing 51, which is fixed to the control handle and connected to the hydraulic drive circuit;
[0423] The working component 52 is installed inside the pump casing 51 to drive the flow of liquid;
[0424] A drive unit 53 is mounted on the control handle and is linked to the working component 52;
[0425] A return spring 56 acts between the control handle and the drive component 53.
[0426] The pump casing 51 is used to form a pump chamber 57. The pump casing 51 has an inlet 54 and an outlet 55 that communicate with the pump chamber 57, and the inlet 54 and outlet 55 are connected to the hydraulic drive circuit.
[0427] The control handle can also be equipped with a spare connector 72 for temporary liquid transfer or replacement of other parts.
[0428] The working component 52 performs linear reciprocating motion or circular motion within the pump casing 51 to drive the liquid flow. Common forms include impellers or plungers. In one embodiment, the working component 52 is a plunger, and the driving component 53 directly presses against the plunger or is linked to the plunger through a transmission mechanism.
[0429] The driving component 53 can be an electric component, a pneumatic component, or a manual component. The function of the driving component 53 is to drive the working component 52 to move. The driving component 53 and the working component 52 can be a single structure or separate linkage. Depending on the form of the power source, in order to simplify the structure, a manual component is preferred, that is, the working component 52 is driven by manual operation. Of course, the basic function can also be achieved by using electric or pneumatic power.
[0430] In one embodiment, the handpiece is an operating button that is slidably or rotatably mounted on the control handle.
[0431] In one embodiment, the drive member 53 has a shaft hole 531 and is mounted on a control handle via a rotating shaft. The control handle includes a working part for providing a hydraulic chamber and a gripping part 22 connected to the working part, with an operation button mounted on the gripping part 22. This allows for one-handed operation of the drive pump 5 while holding the handle.
[0432] In one embodiment, the drive pump 5 further includes a reset member acting between the operating button and the control handle. The drive member 53 and the working member 52 can abut against each other, and can also be connected by a limiting structure or a traction member, so that the drive member 53 simultaneously drives the working member 52 to reciprocate when it resets. A reset member can be provided between the drive member 53 and the control handle, such as a compression spring or tension spring acting on the drive member 53, or a coil spring installed on the rotating shaft, such as a reset spring 56. To enable the working member 52 to reciprocate, the reset member can also act directly on the working member 52, for example, a compression spring located in the pump chamber 57 directly abutting against the working member 52. During use, repeatedly pressing the drive member 53 drives the working member 52, causing the liquid to flow in the hydraulic drive circuit.
[0433] See Figures 11a-11b , Figures 12a-12d In one embodiment, the control valve is a multi-way switching valve 6. The multi-way switching valve 6 has a drive-side interface 67 connected to the inlet and outlet of the drive pump 5, and multiple working-side interfaces 68, wherein every two working-side interfaces are connected to one of the hydraulic chambers. The multi-way switching valve 6 has multiple positions for switching the connection between the drive-side interface and different working-side interfaces to control the liquid flow direction.
[0434] The multi-way switching valve 6 can switch the connection between the hydraulic chambers and the inlet / outlet of the drive pump 5 through different positions, thereby changing the direction of piston movement. A check valve can be configured as needed to prevent unnecessary backflow of liquid at the drive pump 5, ensuring efficient liquid delivery.
[0435] The drive-side interface and the working-side interface are only distinguished by different connecting components. For the multi-way switching valve 6 itself, they are just multiple different interfaces.
[0436] In one embodiment, the multi-port switching valve 6 includes a valve seat 61 and a valve core 62 that cooperate with each other. The valve seat 61 has a valve cavity, and the side wall of the valve cavity has multiple interfaces 65 for connecting the drive pump and each hydraulic cavity. The valve core 62 is placed in the valve cavity and rotates to cooperate. The outer peripheral wall of the valve core 62 is provided with multiple flow channels 66. When the valve core 62 rotates to different positions, there is a corresponding communication relationship between the multiple flow channels 66 and the multiple interfaces 65. In order to facilitate identification, in one embodiment, the multi-port switching valve 6 is embedded in the control handle 2, and the control handle 2 is provided with an indicator 64 indicating the position of the multi-port switching valve 6.
[0437] The valve core 62 is connected to a wrench 63. Rotating the wrench to different angles will point to the different gear indicators 64. In this embodiment, in order to match the functions of different gears, seven flow channels 66 (indicated by the arrows in the figure) are provided. Of course, the flow channels 66 can also be increased or decreased according to the functions to be achieved.
[0438] In one embodiment, the control valve further includes:
[0439] Two check valves are provided. The outlet of the drive pump 5 is connected to the storage tank 7 via the first check valve. The drive side interface of the multi-way switching valve is connected to the inlet of the drive pump 5 via the second check valve.
[0440] To further instruct the operation, the multi-way switching valve 6 is mounted on the control handle 2, and the control handle 2 is marked with an indicator indicating the position of the multi-way switching valve 6.
[0441] See Figure 3a , Figure 3b Although the shape of the control handle 2 is not strictly limited, for ease of operation, in some embodiments the control handle 2 includes a working part 21 and a gripping part 22 connected to the working part 21. The cylinder 3 is located within the working part 21, that is, the working part 21 as a whole is used to provide a hydraulic chamber. The working part 21 also has a distal end 211 and a proximal end 212, the relative orientation of which is described similarly to other components.
[0442] The grip 22 is shaped for easy handling and operation. For example, it has a length direction. Since a cylinder is installed in the working part 21, with the piston's movement direction in the cylinder as the cylinder axis, the length direction of the grip 22 is approximately perpendicular to or slightly oblique to the cylinder axis. The working part 21 and the grip 22 are generally L-shaped or T-shaped. To further improve the grip feel and conform to the shape of the hand, the overall shape of the control handle 2 is similar to that of a pistol. In the hydraulic drive circuit, some control components that require real-time operation, such as switches, can be located in the grip 22 for easy one-handed operation.
[0443] To facilitate one-handed operation, one embodiment of this application provides an interventional device delivery system, including multiple tubes coaxially arranged from the inside out, and a control handle 2 for driving the relative movement of the multiple tubes. The distal ends of each tube are used to cooperate with each other to operate the interventional device, and the proximal ends of each tube are connected to the control handle 2. A hydraulic drive circuit for driving the relative movement of each tube is configured at the control handle 2. The hydraulic drive circuit includes at least a drive pump 5 for driving the flow of liquid, and a control valve for controlling the direction of liquid flow.
[0444] The control handle 2 has a grip 22, the operating component of the drive pump 5 is disposed on the grip 22, and the operating component of the control valve is adjacent to the grip 22.
[0445] To enable the hydraulic drive circuit to work, the simplest and most direct method is to use manual operation. During operation, the components that need to be operated frequently are the drive pump 5 and the control valve. The operating components of both are located on or near the grip 22, which makes it easy to operate with one hand while also allowing the other hand to operate or support other equipment.
[0446] See Figure 3a , Figure 3b , Figures 12a-12e In one embodiment, the control valve is a multi-way switching valve 6. The interventional device delivery system in this embodiment includes multiple tubing components coaxially arranged from the inside out, and a control handle 2 that drives the relative movement of the multiple tubing components. The distal ends of each tubing component are used to cooperate in operating the interventional device, and the proximal ends of each tubing component are connected to the control handle 2. The control handle 2 is also equipped with a hydraulic drive circuit for driving the relative movement of each tubing component. The hydraulic drive circuit includes a multi-way switching valve 6 that switches the direction of fluid flow. The multi-way switching valve 6 includes:
[0447] Two valve seats are arranged opposite each other, one of which has a drive side interface 67 for connecting to the hydraulic drive circuit, and the other valve seat has a working side interface 68 for connecting to the hydraulic drive circuit.
[0448] The valve core 62 is sealed and rotatably mounted by two valve seats. The valve core 62 has a connecting hole 624. When the valve core 62 is rotated to different angles, the connecting hole 624 connects the corresponding drive side interface 67 and working side interface 68.
[0449] A wrench 63, which is linked to the valve core 62, is used to change the rotation angle of the valve core 62.
[0450] See Figure 3a , Figure 3b , Figures 12a-12eTo facilitate one-handed operation and mode switching (i.e., gear switching), one embodiment provides an interventional device delivery system, including multiple tubing components coaxially arranged from the inside out, and a control handle 2 for driving the relative movement of the multiple tubing components. The distal ends of each tubing component are used to cooperate in operating the interventional device, and the proximal ends of each tubing component are connected to the control handle 2. The control handle 2 is also equipped with a hydraulic drive circuit for driving the relative movement of the tubing components. The hydraulic drive circuit includes a multi-way switching valve 6 for switching the direction of fluid flow. The multi-way switching valve 6 includes:
[0451] Two valve seats are arranged opposite each other, one of which has a drive-side interface 67 for connecting to the hydraulic drive circuit, and the other valve seat has a working-side interface 68 for connecting to the hydraulic drive circuit.
[0452] The valve core 62 is sealed and rotatably mounted by two valve seats. The valve core 62 has a connecting hole 624. When the valve core 62 is rotated to different angles, the connecting hole 624 connects the corresponding drive side interface 67 and working side interface 68.
[0453] A wrench 63, which is linked to the valve core 62 via a one-way clutch mechanism, is used to change the rotation angle of the valve core 62.
[0454] A wrench reset member 69 that acts between a wrench 63 and at least one valve seat.
[0455] In this embodiment, the wrench 63 and the valve core 62 are driven by a one-way clutch mechanism, meaning that switching between different gears is achieved through the unidirectional rotation of the valve core 62, rather than bidirectional reciprocating rotation. This makes it easier to operate the wrench with a single finger, conforming to the physiological structure of the operator's fingers. In the hydraulic drive circuit, the power for the fluid flow can utilize existing technology or be combined with the drive pump 5 from other embodiments.
[0456] Combination Figures 3a-3e In one embodiment, the control handle 2 includes a working part 21 and a gripping part 22 connected to the working part 21. The working part 21 is equipped with a cylinder 3 with an internal piston. Multiple pipes are inserted into the cylinder 3 and connected to the piston or fixed relative to the cylinder 3. The pipes are driven to move relative to each other in the cylinder 3 by hydraulic means.
[0457] The cylinder 3 is connected to the corresponding working side interface 68 on both sides of the piston. The hydraulic drive circuit also includes a drive pump 5 connected to each drive side interface 67 to drive the flow of liquid.
[0458] In one embodiment, the cylinder 3 includes a first cylinder 31 and a second cylinder 32 connected sequentially along the axial direction, wherein a first piston 4 is slidably installed in the first cylinder 31 and a second piston 9 is slidably installed in the second cylinder 32, and the pipe includes a first pipe 11, an intermediate pipe 13 and a second pipe 12 arranged coaxially from the inside to the outside.
[0459] All pipes enter from the far end of the first cylinder 31, wherein the first pipe 11 is fixed to the first piston 4, the intermediate pipe 13 extends out of the first piston 4 and enters the second cylinder 32 through the isolation seal 34 and is fixed to the second piston 9, and the first pipe 11 extends out of the second piston 9 and is fixed to the proximal end of the second cylinder 32.
[0460] Combination Figure 10 In one embodiment, the drive pump 5 includes:
[0461] Pump housing 51, which is fixed inside the control handle 2 and connected to the hydraulic drive circuit;
[0462] The working component 52 is installed inside the pump casing 51 to drive the flow of liquid;
[0463] A drive component 53 is mounted on the grip 22 and linked to the working component 52;
[0464] A return spring 56 acts between the control handle 2 and the drive component 53.
[0465] The outlet 55 and inlet 54 of the drive pump 5 are both located on the pump housing 51. The multi-way switching valve 6 has two drive-side interfaces 67, which are connected to the outlet 55 and inlet 54 of the drive pump 5, respectively. In conjunction with the aforementioned related embodiments, necessary check valves and a liquid storage tank 7 connecting the inlet 54 and the corresponding drive-side interface 67 can also be configured.
[0466] The positional relationship between the wrench 63, the grip 22, and the working part 21 also affects the ease of operation. In one embodiment, the wrench 63 and the grip 22 are located on the same radial side of the working part 21. During operation, the wrench 63 and the grip 22 are generally closer to the operator, while the working part is relatively farther away from the operator.
[0467] In a preferred embodiment, the wrench 63 is located on the proximal side of the grip 22, and the drive member 53 faces the wrench 63. Operation is similar to that of a pistol; the index finger pulls the wrench 63, while the other four fingers grip the grip 22 and simultaneously press down on the drive member 53 to drive the drive pump 5. To shift gears, simply pull the wrench 63. The gripping of the control handle 2 and the operation of the hydraulic drive circuit can be completed with one hand, greatly reducing manpower and eliminating the inconvenience of multiple people cooperating.
[0468] To prevent slippage during gripping, an anti-slip stop 28 is provided at the end of the grip portion 22 (i.e., the end away from the working portion 21). The anti-slip stop 28 can extend further to other parts of the housing of the control handle 2. The anti-slip stop 28 is strip-shaped and extends along a smooth curve, which can further improve the feel.
[0469] To facilitate the operation of the wrench 63 and improve grip stability, in one embodiment, the anti-dislodgement stop 28 surrounds the wrench 63. That is, the wrench 63 is located within a closed area.
[0470] The valve core 62 and the wrench 63 can be separate components or integrated into one unit. The end of the wrench 63 is hook-shaped for easy hooking and operation.
[0471] Figures 12a-12e In a related embodiment, the multi-way switching valve 6 has multiple positions for switching the connection between the drive-side interface 67 and different working-side interfaces 68 to control the liquid flow direction. The valve seat 61 is made of two parts that snap together, and the valve core 62 rotates between the two parts. Different rotation angles correspond to different positions. Other details or improvements of the multi-way switching valve 6 will be further described below.
[0472] Since the valve core 62 and the valve seat 61 are rotatably engaged, it is necessary to ensure that they are sealed to each other. With sufficient machining accuracy, they can be tightly fitted together, but this undoubtedly places more stringent requirements on materials and processes. In order to reduce process requirements and facilitate machining, in one embodiment, each valve seat has an installation groove on the side facing the valve core 62, and a sealing gasket is fixedly embedded in the installation groove, and the sealing gasket abuts against the valve core 62 to seal.
[0473] In one embodiment, the gasket is positioned by having interlocking positioning teeth between the inner periphery of the mounting groove and the outer periphery of the gasket. Of course, other fixing methods can also be used for positioning. In this embodiment, the positioning teeth eliminate the need for other positioning components and adhesive bonding. During assembly, the gasket is simply aligned and pressed into the mounting groove, making the operation convenient.
[0474] The interlocking positioning teeth prevent the sealing gasket from rotating with the valve core 62. For example, the first valve seat 61a in the figure has a second positioning tooth 614 on the inner periphery of the mounting groove, and the first sealing gasket 611 in the mounting groove has a first positioning tooth 6111 on the outer periphery that meshes with the second positioning tooth 614. Similarly, the second valve seat 61b in the figure has a third positioning tooth 615 on the inner periphery of the mounting groove, and the second sealing gasket 617 in the mounting groove has a fourth positioning tooth 6171 on the outer periphery that meshes with the third positioning tooth 615.
[0475] The sealing gasket can be made of elastic materials such as rubber to maintain the necessary seal. In addition, the valve seat or other parts can be made of transparent materials to facilitate observation and verification of the positioning during assembly, as well as visual operation during use.
[0476] Of the two valve seats, one valve seat is a first valve seat 61a with a drive-side interface 67, and the other valve seat is a second valve seat 61b with a working-side interface 68.
[0477] The first valve seat 61a has an inlet hole 613 on the side facing the valve core, which communicates with the drive side interface 67. The first sealing gasket 611 embedded in the first valve seat 61a has a first liquid passage hole 6112 that corresponds to the position of the inlet hole 613 and communicates with it.
[0478] The second valve seat 61b has a liquid outlet hole 616 on the side facing the valve core, which communicates with the working side interface 68. The second sealing gasket 617 embedded in the second valve seat 61b has a second liquid passage hole 6172 that corresponds to the position of the liquid outlet hole 616 and communicates with it.
[0479] When the valve core is rotated to different angles, the connecting hole 624 on the valve core connects the corresponding first liquid passage hole 6112 and second liquid passage hole 6172.
[0480] There are two drive-side interfaces 67 on the first valve seat 61a, which are connected to the inlet and outlet of the drive pump 5 respectively. Correspondingly, two liquid inlet holes 613 and two connecting holes 624 are also configured one-to-one. A cap 618 can also be set on the side of the first valve seat 61a facing away from the other valve seat.
[0481] The working side interface 68 on the second valve seat 61b is configured according to the number of gears. For example, in the relevant figures of this embodiment, there are four working side interfaces 68, and four liquid outlet holes 616 are also configured accordingly. In order to facilitate gear switching, there are multiple second liquid passage holes 6172 of the second sealing gasket 617, for example, there are eight in this embodiment. Every two second liquid passage holes 6172 are connected to one of the liquid outlet holes 616. When the valve core 62 is rotated to different angles, the two connecting holes 624 correspond to the two second liquid passage holes 6172 at the corresponding positions, and the two second liquid passage holes 6172 at this position are connected to the two corresponding liquid outlet holes 616. In order to adapt to the distribution of the second liquid passage holes 6172, each liquid outlet hole 616 is extended into a strip shape, that is, the same liquid outlet hole 616 can connect to multiple second liquid passage holes 6172, so as to ensure that the position of the two connecting holes 624 changes while the position of the second sealing gasket 617 remains unchanged.
[0482] There are two liquid inlet holes 613, and each liquid inlet hole 613 is located at a different radial position relative to the rotation axis of the valve core; the first liquid passage hole 6112 is matched with the corresponding liquid inlet hole 613.
[0483] The valve core 62 has two annular grooves 623 on the side facing the first valve seat 61a. Each annular groove 623 is connected to one of the liquid inlet holes 613. There are two connecting holes 624, which are respectively connected to one of the annular grooves 623.
[0484] No matter what angle the valve core 62 rotates to, the inner and outer annular grooves 623 can ensure that they are connected to the liquid inlet hole 613 corresponding to the radial position.
[0485] The valve core 62 is rotatably mounted between two valve seats via a rotating shaft 621. The valve core 62 and the wrench 63 are linked by a one-way clutch mechanism, meaning that the wrench 63 can only drive the valve core 62 to rotate in one direction (circumferential direction). After the wrench 63 moves to the correct position, the wrench reset component 69 drives the wrench 63 to reset, while the valve core 62 remains stationary. This cycle repeats, which can drive the valve core 62 to switch to various gear positions.
[0486] In one embodiment, the wrench 63 includes an annular sleeve 631 located on the outer periphery of the valve core 62, and a hook portion 633 fixed to the annular sleeve 631 and extending to the outside of the control handle 2; the inner edge of the annular sleeve 631 and the outer periphery of the valve core 62 are linked by a mutually cooperating one-way clutch mechanism.
[0487] The hook portion 633 is used for finger-operated operation and is preferably hook-shaped and located on the proximal side of the grip portion 22. The two valve seats have interlocking positioning pins and are fixed with fasteners. To limit the extreme angle of each rotation of the wrench 63, a corresponding blocking element can be provided on the valve seat 61, or a limiting strip hole can be formed between the two valve seats. The hook portion 633 moves within this limiting strip hole, and the length of the limiting strip hole limits the travel stroke of the hook portion 633.
[0488] One-way clutch mechanisms include:
[0489] Ratchets 622 are arranged around the outer periphery of valve core 62;
[0490] Elastic claws 632 are fixed to the inner circumference of the annular sleeve 631;
[0491] The wrench 63 has a relative forward and reverse rotation direction with respect to the valve core 62. When rotating in the forward direction, the elastic pawl 632 engages with the ratchet 622 to drive the valve core 62. When rotating in the reverse direction, the elastic pawl 632 deforms and slips off from the ratchet 622, and the wrench reset member 69 drives the wrench 63 to rotate in the reverse direction.
[0492] The tooth surface of the ratchet 622 has a specific orientation. One side can engage with the elastic pawl 632, while the other side allows the elastic pawl 632 to slide off. The elastic pawl 632 extends roughly circumferentially, allowing the valve core to be radially retracted by the pressure of the ratchet 622 when it reverses, and then slide off each other. Afterward, it expands radially outward to reset under its own elasticity. If the valve core 62 rotates forward at this time, it will engage with the previously slipped ratchet 622 again.
[0493] To better engage with the ratchet 622, in one embodiment, the elastic claw 632 extends circumferentially along the annular sleeve 631 and curves inward. Two to four elastic claws 632 are evenly distributed circumferentially along the annular sleeve 631.
[0494] The wrench reset component 69 is a coil spring extending around the valve core axis. One end of the coil spring is connected to the valve seat 61, and the other end is connected to the annular sleeve 631.
[0495] When the wrench 63 drives the valve core 62 to rotate in the forward direction, it overcomes the spring force and allows the spring to store energy. When the wrench 63 is released, the spring drives the wrench to rotate in the reverse direction to reset. In order to balance the force, in one embodiment, the spring is two coils side by side. In the axial direction of the valve core 62, each coil spring is located on both sides of the annular sleeve 631. One end of each coil spring has a positioning bend 692 for inserting into the corresponding side valve seat. The other ends of each coil spring are connected to each other to form a positioning crossbar 691. The outer periphery of the annular sleeve 631 is provided with a groove 634 for accommodating the positioning crossbar 691.
[0496] Correspondingly, each valve seat is provided with an insertion hole 619 for the positioning bend 692 to be inserted.
[0497] To further stabilize the position of the coil spring before and after deformation, in one embodiment, the outer periphery of the valve core 62 includes three sections along the valve core axis. The ratchet 622 is fixedly distributed in the middle section, and the two sides are smooth sections 625. Two coil springs are respectively sleeved on the smooth sections 625 on the corresponding sides.
[0498] See Figures 13a-13b In one embodiment of the interventional device delivery system of this application, two cylinders are used, namely a first cylinder 31 and a second cylinder 32. A first piston 4 is installed in the first cylinder 31, and the first cylinder 31 has a connecting port 314 and a connecting port 315; a second piston 9 is installed in the second cylinder 32, and the second cylinder 32 has a connecting port 324 and a connecting port 325.
[0499] The axially relative moving pipe includes a second pipe fixedly connected to the first piston 4, an intermediate pipe fixedly connected to the second piston 9, and a first pipe fixedly connected to the control handle. In addition, a protective pipe located on the outer periphery of the second pipe is connected to the control handle via a fixing sleeve 8. The fixing sleeve 8 connected to the protective pipe has an exhaust hole 82.
[0500] The hydraulic drive circuit also includes a multi-way switching valve 6, a drive pump 5 with an inlet 54 and an outlet 55, and a storage tank 7 with an inlet 73 and an outlet 74. A first check valve 331 is connected to the inlet 54 of the drive pump 5; a second check valve 332 is connected to the outlet 55 of the drive pump 5. All components are connected through corresponding hydraulic lines 33.
[0501] In this embodiment, the multi-way switching valve 6 has seven ports, two of which are drive-side ports 67, which are connected to the inlet and outlet of the drive pump 5 respectively (indirectly connected through a check valve and a liquid storage tank). The other five ports of the multi-way switching valve 6 are working-side ports 68, two of which are connected to the two connecting ports of the first cylinder 31, two of which are connected to the two connecting ports of the second cylinder 32, and one of which is connected to the exhaust port 82.
[0502] If the exhaust is configured with a separate pipeline, a multi-port switching valve with six ports can also be used. Two of them are drive-side ports 67, which are connected to the inlet and outlet of the drive pump 5 respectively (indirectly connected through a check valve and a liquid storage tank). The other four ports of the multi-port switching valve are working-side ports 68, two of which are connected to the two connecting ports of the first cylinder 31, and the other two are connected to the two connecting ports of the second cylinder 32.
[0503] Inside the multi-way switching valve 6, multiple flow channels 66 on the valve core can connect the corresponding drive-side interface 67 and working-side interface 68. Taking the multi-way switching valve 6 as an example, it can be divided into five positions, D1 to D5, based on different connection relationships, and each position realizes a different function.
[0504] Specifically, the functions of each gear are as follows:
[0505]
[0506] Taking the multi-port switching valve 6, which has six ports, as an example, two are drive-side ports 67, connected to the inlet and outlet of the drive pump 5 respectively (indirectly connected via a check valve and a storage tank). The other four ports 68 are working-side ports, two of which connect to the two ports of the first cylinder 31, and the other two connect to the two ports of the second cylinder 32. Based on different connection relationships, they can be divided into four positions, D1 to D4, as shown in the table above, each position realizing a different function. For venting, a separate pipeline is configured. The vent hole 82 is connected to a connector via a pipeline. This connector can be embedded in the housing of the control handle to facilitate cooperation with external pipelines, allowing venting by adding saline solution.
[0507] See Figures 14a-17 In some of the following embodiments, an interventional device release control mechanism is provided, in which the mutually sliding and nested tubes cooperate to release or retrieve the interventional device at the distal end. The control method for the proximal end of each tube can be combined with the control handle of the aforementioned embodiments, or it can utilize a conventional mechanical or electric transmission control handle structure. Of course, when using the aforementioned hydraulically driven control handle, the liquid pressure can be detected by a sensing device, and then correspond to the force applied at the distal end or the relative stroke of the tube, which is more convenient for precise operation and provides the necessary hardware foundation for fully automatic mode or combined closed-loop control.
[0508] One embodiment provides an interventional device release control mechanism, including a first tube 11, an intermediate tube 13, and a second tube 12 that slide and nest together sequentially from the inside out. The distal end of the first tube 11 extends into the intermediate tube 13, and an installation head 112 for connecting an interventional device is provided on the extended portion. A flexible control element is connected to the intermediate tube 13, and the control element has:
[0509] In the holding state, the control element passes through the mounting head 112 and restrains the interventional instrument in the mounting head 112;
[0510] In the open position, the interventional device is allowed to be completely detached from the mounting head 112;
[0511] The intermediate pipe 13 is equipped with a locking element 162 that cooperates with the control element. The locking element 162 is slidably engaged with the intermediate pipe 13 and switches different states of the control element when sliding.
[0512] The "holding state" is understood as the locking element remaining in a locked state, such as when it is inserted into a keyhole. The control element binds the interventional device to the mounting head. It does not strictly require the interventional device to be in contact with the mounting head. Rather, it should be understood as the control element being pulled so that it cannot completely detach from the mounting head. Of course, if the interventional device is in contact with the mounting head or there is spatial interference, it is more conducive to the positioning of the interventional device. The release of the interventional device is a gradual process. However, as long as the locking element remains in a locked state, even if the interventional device and the mounting head become loose or even move away from each other, it is still in a holding state for the control element. That is, the interventional device cannot be completely detached from the mounting head and released.
[0513] Correspondingly, the open state of the control component is understood as the lock being unlocked, such as disengaging from the lock hole. At this time, the control component can disengage from the lock, which also means that the interventional device and the control component can be separated from each other. In actual operation, the control component needs to be retracted proximally after the interventional device is released and positioned. Therefore, before or at the initial stage of retraction, there is still contact or entanglement between the control component and the interventional device. However, since the lock has been unlocked, the emphasis here is on a state that allows the interventional device and the control component to be separated from each other, rather than emphasizing that the two are spatially far apart and without contact. Due to the loss of the restraint of the control component, the interventional device is also allowed to completely detach from the mounting head.
[0514] The first pipe fitting 11 in the figure is fixed by inserting both ends together, that is, it includes a distal section 11a and a proximal section 11b. One end of the distal section 11a has a guide head 111, and the other end is inserted into the proximal section 11b. The mounting head 112 is located at the end of the proximal section 11b. The segments of the first pipe fitting 11 and the mounting head 112 can be fixed to each other by welding or other means.
[0515] Taking stent 10 as an example, interventional devices generally have a connecting ear 101 on the proximal side. The connecting ear is provided with a connecting hole or hook for connecting to the control component. The flexible material of the control component is easy to bend, wrap and knot.
[0516] In one embodiment, the control element is a ligation line 18, and the proximal end of the interventional device has multiple connecting ears 101. In the holding state, the ligation line 18 passes directly through and pulls each connecting ear 101.
[0517] Alternatively, a ring-shaped cable sleeve 19 may be threaded between each connecting ear 101. In the holding state, the binding wire 18 passes around the ring-shaped cable sleeve 19 and indirectly pulls the connecting ear 101 through the ring-shaped cable sleeve 19.
[0518] After the interventional device is released, the annular sleeve 19 can remain on the interventional device and is not removed with the ligation line 18. Compared with the ligation line 18 directly pulling the connecting lug, the annular sleeve 19 can be pre-assembled on the interventional device. During use, it is easier to operate by wrapping around the ligation line 18 on site, and the stroke of the relatively moving tube is optimized.
[0519] The ligating suture 18 is used to restrain and pull the connecting ear, thereby controlling the release process and preventing the stent 10 from suddenly expanding radially and puncturing the tissue inside the body. The ligating suture 18 can be made of materials and strength commonly used in interventional procedures and can be directly or indirectly connected to the connecting ear 101.
[0520] Pulling the binding line 18 towards the proximal end can cause the connecting ear 101 to converge toward the distal end of the mounting head 112. As long as the binding line 18 remains in the holding state, the release of the bracket 10 can be restricted. Of course, the release and retraction of the bracket 10 are reverse processes, and the dynamic coordination between the components is similar.
[0521] In order to reasonably distribute the force application points when pulling the stent 10, multiple ligating wires 18 can be used, and the pulling positions of each ligating wire 18 and the ring sleeve 19 are evenly distributed along the circumference of the interventional device.
[0522] When the binding wire 18 directly pulls the connecting ear 101, the number of binding wires 18 should not be too many, otherwise it may affect the compressed size and loading. For example, the number should be slightly less than the number of connecting ears 101. In this way, the connecting ears 101 can be divided into multiple groups, with each group corresponding to one binding wire 18.
[0523] Lock 162 is installed on intermediate tube 13. The function of lock 162 is to limit at least one end of binding wire 18. For example, one end of binding wire 18 will never leave the intermediate tube, while the other end is connected to lock 162 after passing through connecting ear 101. This forms a restraint on bracket 10. Once lock releases binding wire 18, that end will no longer pull bracket 10, allowing bracket 10 to expand and release until finally that end is pulled out from connecting ear 101.
[0524] The binding wire 18 is knotted or meandered to form a loop. The locking member 162 is inserted into the loop to restrain the binding wire 18. When the locking member moves, the loop can be pulled out, that is, the corresponding permissible interventional device is completely detached from the installation head 112.
[0525] When the locking member 162 slides relative to the intermediate tube 13, a corresponding driving means can be adopted. For example, a transmission member can be set at the proximal end, or the locking member 162 can move relative to the intermediate tube 13 when it moves actively, or the intermediate tube 13 can carry the locking member 162 to a preset position, after which only the locking member 162 is blocked, forming relative movement with the intermediate tube 13. Of course, improved solutions are also provided in some embodiments below.
[0526] Configuring a separate transmission component could further complicate the structure of the control handle. To simplify the structure, in some embodiments, a scheme is provided in which the locking component and the intermediate tube follow each other and the binding wire 18 is released passively.
[0527] In one embodiment, an interventional device release control mechanism is provided, including a first tube 11, an intermediate tube 13, and a second tube 12 that slide and nest together from the inside out. The distal end of the first tube 11 extends into the intermediate tube 13, and an installation head 112 for connecting an interventional device is provided on the extended portion. A flexible control element is connected to the intermediate tube 13. The control element has a holding state that binds the interventional device to the installation head 112 and an open state that allows the interventional device to be completely detached from the installation head 112.
[0528] A locking element 162 is movably mounted on the intermediate pipe fitting 13. The locking element 162 is configured to restrict the control element to a holding state. When the intermediate pipe fitting 13 moves relative to the first pipe fitting 11, the locking element 162 is triggered by the mounting head 112 and releases the control element to enter the open state.
[0529] In this embodiment, when the intermediate tube 13 moves relative to the first tube 11, the locking member 162 moves accordingly. Although it is movably installed with the intermediate tube 13, it can maintain a certain friction or other separation resistance with the intermediate tube 13, thus allowing it to move with the intermediate tube 13. For example, in one embodiment, a fixed base 15 and a slidably installed movable seat 16 are installed on the intermediate tube 13. The locking member 162 is fixed to the movable seat 16. In the held state, the base 15 and the movable seat 16 are tightly fitted. When the intermediate tube 13 moves to the distal end relative to the first tube 11, the movable seat 16 moves with the base 15, and the locking member 162 is blocked, causing the base 15 and the movable seat 16 to move away from each other, that is, the release control enters the open state.
[0530] The locking element 162 can be blocked by direct contact or by indirect force applied through a transmission component to abut against the mounting head. Taking the indirect method as an example, an unlocking rod 163 is fixed on the movable seat 16. The near ends of the unlocking rod 163 and the locking element 162 can be connected through the annular part 161. The three together form the movable seat 16. The annular part 161 can be slidably sleeved on the outer periphery of the intermediate tube 13. When the intermediate tube 13 moves to the far end relative to the first tube 11, until the unlocking rod 163 abuts against the mounting head 112, if the intermediate tube 13 is pushed further, the movable seat 16 overcomes the tight fit resistance between itself and the base 15, moves away from the base 15, and releases the binding line 18 from the locking element 162.
[0531] The tight fit between the base 15 and the movable seat 16 can be achieved by the unlocking rod 163 passing through the base 15 and being tightly fitted at the passing part, or by at least one of the unlocking rod 163 and the locking piece 162 abutting against the base under the pull of the binding line 18 and having at least mutual frictional resistance.
[0532] When the intermediate pipe 13 moves relative to the first pipe 11, the direction of movement of the intermediate pipe 13 is from the proximal end to the distal end; when the locking member 162 is triggered to unlock by the mounting head 112, the direction of movement of the locking member 162 is from the distal end to the proximal end.
[0533] In this application, when the locking device 162 is unlocked, the operator pushes the intermediate tube distally, rather than pulling it directly proximally. Unlocking does not occur immediately during the distal push; the control unit also moves accordingly and maintains restraint on the interventional device. Therefore, the controllable phase during device release is longer, facilitating emergency retrieval during the release process. Conversely, if the locking device 162 is pulled proximally directly during unlocking, control over the interventional device will be lost prematurely.
[0534] The base 15 may be provided with a lock hole 1522 that cooperates with the lock 162. When the far end of the lock 162 is inserted into the lock hole 1522, the binding wire 18 is in a holding state because it is wrapped on the lock 162. If it comes out of the lock hole 1522, the binding wire 18 is allowed to detach from the lock 162 and switch to the open state.
[0535] The control unit restrains the interventional device to the mounting head 112, mainly to limit the interventional device from fully radially unfolding and completely detaching from the mounting head 112. In particular, when the interventional device is in a compressed state after loading, i.e., enclosed within the second tube 12, all the connecting ears 101 are pulled against the distal side of the mounting head 112 by the control unit. In order to guide each connecting ear into place and prevent them from interfering with each other, some of the following embodiments have made further improvements to the mounting head 112.
[0536] In one embodiment, an interventional device release control mechanism is provided, including a first tube 11, an intermediate tube 13, and a second tube 12 that slide and nest together from the inside out. The distal end of the first tube 11 extends into the intermediate tube 13, and an installation head 112 for connecting an interventional device is provided on the extended portion. A flexible control element is connected to the intermediate tube 13. The control element has a holding state that binds the interventional device to the installation head 112 and an open state that allows the interventional device to be completely detached from the installation head 112.
[0537] The intermediate tube 13 is located on the proximal side of the mounting head 112, and the interventional device is located on the distal side of the mounting head 112. The mounting head 112 is provided with a convergence guide hole 1121, which allows the control component to pass through and connect to the interventional device, and in the holding state, restricts the proximal side of the interventional device to the convergence guide hole 1121.
[0538] The retraction guide hole 1121 can guide and limit the extension path of the control component. In addition, under the pull of the control component, the connecting ears tend to converge towards each other and retract into the retraction guide hole 1121, which facilitates the loading of interventional instruments and keeping them in a compressed state. Its guiding role is particularly prominent during retrieval.
[0539] When the interventional device is released, the control component moves gradually to the distal end, and the outward expansion of each connecting ear 101 is also gradual. By controlling the release speed of the control component, the bouncing force of the sudden outward expansion of the connecting ear 101 can be prevented from puncturing the surrounding tissues inside the body.
[0540] The control unit extends distally from the intermediate tube 13 to connect to the interventional device and then returns proximally to the intermediate tube 13. In the holding state, the control unit is guided back and forth relative to the mounting head 112, and at least one of the forward and reverse paths passes through the convergence guide hole 1121.
[0541] In a preferred embodiment, the forward and reverse paths of the control element both pass through the convergence guide hole 1121. To minimize extension to the outer periphery of the mounting head 112 and reduce interference with other components, and to improve the convergence guide effect, in a further preferred embodiment, there are one or more control elements, and for the same control element, the forward and reverse paths pass through the same convergence guide hole 1121.
[0542] To facilitate assembly and achieve a regular outer peripheral shape, in one embodiment, the mounting head 112 is cylindrical and has an axial through hole, through which the first pipe 11 passes. The mounting head 112 and the first pipe 11 are fixed to each other by at least one of the following methods: welding, bonding, interference fit, or auxiliary connectors.
[0543] In other embodiments, the mounting head 112 may also be an annular component with a through hole in the middle, such as an annular plate.
[0544] In order to reasonably distribute the traction force in the circumferential direction and make the connecting ears have a suitable convergence tendency, in one embodiment, there are multiple convergence guide holes 1121, and the proximal side of the interventional device has a connecting ear 101 for inserting the control element. The connecting ear 101 is divided into multiple groups. Before the interventional device is released, the connecting ears in the same group converge to a corresponding convergence guide hole 1121.
[0545] To accommodate the grouping of the connecting ear 101, multiple convergence guide holes 1121 are evenly distributed along the circumference of the mounting head 112.
[0546] The number of convergence guide holes 1121 is 2 to 4, depending on the number of groups of connecting ears 101. While too many groups or no groups may result in a more even distribution of force points, it leads to an overly complex arrangement of locking and control components, which is detrimental to compression loading. The convergence guide holes 1121 extend axially along the first tube 11 and penetrate the mounting head 112. To avoid interference and friction between the control components and other parts (e.g., reducing friction with the inner wall of the second tube 12), the convergence guide holes 1121 extend inside the mounting head 112, opening only at the two axial end faces of the mounting head 112, i.e., not exposed on the outer periphery of the mounting head 112.
[0547] In a preferred embodiment, the retractable guide hole 1121 has a guide flare 1122 at the opening on the distal side. This makes it easier for the connecting ears 101 in the same group to be gathered and positioned at the retractable guide hole 1121.
[0548] To further optimize the unlocking method of the lock and make reasonable use of a limited number of tubes, in some embodiments, an interventional device release control mechanism is provided, including a first tube 11, an intermediate tube 13 and a second tube 12 that slide and nest together from the inside to the outside. The distal end of the first tube 11 extends into the intermediate tube 13, and an installation head 112 for connecting the interventional device is provided on the extended part. A flexible control element is connected to the intermediate tube 13. The control element has a holding state that binds the interventional device to the installation head 112 and an open state that allows the interventional device to be completely detached from the installation head 112.
[0549] A fixed base 15 and a sliding movable seat 16 are installed on the intermediate tube 13. A lock 162 and an unlocking rod 163 are fixed on the movable seat 16. The unlocking rod 163 passes through the base 15 and one end of the base 15 serves as a trigger end 1631. A lock hole 1522 for receiving the lock 162 is opened on the base 15.
[0550] When the control component is in the holding state, it is sleeved on the lock component 162, and the end of the lock component 162 is inserted into the lock hole 1522. When the intermediate tube 13 moves to the far end relative to the first tube 11, the trigger end 1631 of the unlocking rod 163 abuts against the mounting head 112 and drives the lock component 162 to move to the near end and exit the lock hole 1522, so that the control component enters the open state.
[0551] The following embodiments further improve the specific structure or cooperation relationship of each component in the release control mechanism. For example, the movable seat 16 includes:
[0552] The annular portion 161 is slidably sleeved on the intermediate tube 13 and located on the proximal side of the base 15;
[0553] The locking element 162 is rod-shaped and extends distally from the annular portion 161;
[0554] The unlocking lever 163 extends from the annular portion 161 to the distal end, and the extension length is greater than that of the lock 162.
[0555] The locking element 162 and the unlocking lever 163 need to move axially and slide in conjunction with the corresponding through-hole structures (such as the clearance hole 1511, the lock hole 1522, and the guide hole 1523). Therefore, they are generally rod-shaped and adapted to the diameter of the through hole. Since the movable seat 16 needs to move with the base 15 during unlocking, at least one of the locking element 162 and the unlocking lever 163 can be interference-fitted with the corresponding through-hole structure. However, the interference should not be too tight to avoid hindering unlocking.
[0556] If the length of the unlocking rod 163 is greater than that of the locking piece 162, the unlocking rod 163 will first abut against the mounting head 112 during movement. When the intermediate tube 13 (together with the base) moves further to the far end, the unlocking rod 163 will be blocked, and together with the locking piece 162, it will move relative to the intermediate tube 13 to achieve unlocking.
[0557] In one embodiment, the locking element 162 and the unlocking rod 163 are arranged alternately along the circumference of the annular portion 161, which can reasonably distribute the force. For example, there are two locking elements 162 and two unlocking rods 163, and they are arranged alternately with uniform spacing.
[0558] The control element in each embodiment is the binding wire 18;
[0559] In the holding state, the ligation line 18 passes directly or indirectly around the interventional device, and both ends of the ligation line 18 are fixed relative to the locking piece 162;
[0560] In the open state, at least one end of the ligature 18 separates from the locking member 162, releasing the restraint on the interventional device.
[0561] In order to fix the two ends of the binding wire 18 to the lock 162, in one embodiment, one end of the binding wire 18 has a fixed loop 181 and the other end has a movable loop 182.
[0562] In the holding state, the fixed wire loop 181 is sleeved on the unlocking rod 163, and the movable wire loop 182 is sleeved on the locking piece 162;
[0563] In the open state, the fixed wire ring 181 is fitted onto the unlocking rod 163, and the movable wire ring 182 is disengaged from the locking member 162.
[0564] The fixed suture ring 181 and the movable suture ring 182 are relative to the base 15 or the movable seat 16. The movable suture ring 182 needs to switch the state of the control component, so it can change the cooperation relationship with the locking component 162, which is equivalent to changing the cooperation relationship with the base 15 or the movable seat 16. The fixed suture ring 181 does not need to change the cooperation relationship, that is, it always remains relatively fixed, so as to facilitate the removal of the suture from the body after surgery.
[0565] In this embodiment, the fixed loop 181 is always sleeved or tied to the unlocking rod 163 of the movable seat 16, while the movable loop 182 can change its relationship with the locking member 162, which also allows the control member to switch between the holding state and the open state.
[0566] In the held state, both the fixed wire loop 181 and the movable wire loop 182 are connected to the movable seat 16, and the middle of the binding wire 18 is directly or indirectly wrapped around the interventional instrument, which can more effectively distribute the stroke of each component and improve the operation efficiency.
[0567] In other embodiments, the fixing loop 181 may not be used. Instead, other methods may be used to fix it relative to the base 15 or the movable seat 16. For example, the base 15 or the movable seat 16 may be drilled and one end of the binding wire 18 may be fixed in the hole. Alternatively, although the fixing loop 181 is used, it may not be sleeved on the unlocking rod 163, but connected to other parts of the base 15 or the movable seat 16, as long as they are not separated from each other.
[0568] In other embodiments, one end of the binding wire 18 is fixed to the mounting head 112, and the other end has a movable loop 182;
[0569] In the holding state, the movable loop 182 is fitted onto the locking element 162;
[0570] In the open state, the movable loop 182 disengages from the locking element 162.
[0571] The end fixed to the installation head 112 can be pulled out of the body as a whole after surgery by pulling the ligation line.
[0572] When the ligation suture is made of a suitable material, it can even remain in the body after surgery. In other embodiments, one end of the ligation suture 18 is fixed to the interventional device, and the other end has a movable suture loop 182.
[0573] In the holding state, the movable loop 182 is fitted onto the locking element 162;
[0574] In the open state, the movable loop 182 disengages from the locking element 162.
[0575] After the surgery, once the various tubes of the delivery system are removed from the body, the ligation suture will remain inside the body because one end is fixed to the interventional device.
[0576] The formation of each loop can be either a loop near the end of the wire or a looping motion, meaning it is not a local loop. For example, the binding wire can be formed into a loop and simultaneously fitted onto the unlocking rod 163 and the locking piece 162. The same principle applies when it is connected to the installation head 112 or interventional device.
[0577] The base 15 is fixedly mounted on the intermediate tube 13. The base 15 provides a lock hole 1522 that mates with the lock 162. When the movable seat 16 moves relative to the base 15, the lock 162 and the lock hole 1522 switch their mating relationship. When the lock 162 is inserted into the lock hole 1522, the fixing ring 181 cannot be disengaged. When the lock 162 is disengaged from the lock hole 1522, the fixing ring 181 is allowed to disengage from the lock 162.
[0578] In one embodiment, in order to guide the relative movement between the movable seat 16 and the base 15, the base 15 is provided with a guide hole 1523 through which the unlocking rod 163 passes. In the open state, at least a portion of the unlocking rod 163 is retained in the guide hole 1523.
[0579] Regarding the specific structure of the base, in one embodiment, the base 15 has an axial channel, and the distal end of the intermediate pipe 13 is inserted and fixed into the axial channel. Specifically, the base 15 includes:
[0580] The near end plate 151 has a clearance hole 1511 through which the locking element 162 and the unlocking rod 163 pass respectively;
[0581] The distal disc 152 has a lock hole 1522 that mates with the lock 162 and a guide hole 1523 through which the unlocking rod 163 passes.
[0582] Transition section 153 is fixedly connected between the proximal plate and the distal plate.
[0583] The outer periphery of the transition section 153 is a mating area that is radially recessed relative to the proximal plate 151 and the distal plate 152. In the held state, the connection points of the binding wire 18 with the lock 162 and the unlocking lever 163 are all located in the mating area. The radially recessed mating area can accommodate the loop or knot of the binding wire 18, and avoids occupying the space around the proximal plate 151 and the distal plate 152 as much as possible in the radial direction, making it easier to load.
[0584] In the open state, the locking element 162 retracts from the lock hole 1522 until the distal end of the locking element 162 is close to the proximal plate 151. That is, the locking element 162 is basically retracted into the corresponding clearance hole 1511, ensuring the unlocking of the movable ring 182.
[0585] The proximal plate 151 has a receiving groove 1512 on the side facing the annular portion 161. The proximal ends of the locking member 162 and the unlocking rod 163 are connected through the annular portion 161. In the holding state, the annular portion 161 is located in the receiving groove 1512. The clearance hole 1511 is opened at the bottom of the receiving groove 1512.
[0586] To prevent the binding wire 18 from becoming tangled and to further organize its extension path, in one embodiment, a wire-passing groove 1521 is provided on the outer periphery of the distal disc 152 for the binding wire 18 to pass through. In a further preferred embodiment, the wire-passing groove 1521 is open on the outer periphery of the distal disc 152. This makes it easier to extend and position the binding wire 18 and reduces the difficulty of threading. In some embodiments, a support sleeve 17 is fixed on the intermediate tube 13, and the outer wall of the support sleeve 17 is close to the inner wall of the second tube 12.
[0587] The support sleeve 17 prevents the second tube 12 from excessively constricting the movable seat 16 near it, thus avoiding unnecessary movement of the movable seat 16 when the second tube 12 moves. Additionally, the support sleeve 17 cooperates with the base 15 to restrict the movable seat 16. For example, the support sleeve 17 is located proximal to the base 15 and spaced apart, limiting the sliding stroke of the movable seat 16 between the support sleeve 17 and the base 15. When loading interventional instruments, the second tube 12 needs to be pushed distally. To allow for a smoother fit of the movable seat 16 and support sleeve 17 on the distal side of the second tube 12, in a preferred embodiment, the support sleeve 17 has a first guide surface 171 on the proximal side that gradually narrows from distal to proximal.
[0588] The distal end of the second pipe fitting 12 first contacts the first guide surface 171. Under the action of the first guide surface 171, it gradually centers itself and houses the support sleeve 17. After passing the support sleeve 17, it is also relatively easy to further house the movable seat 16 and the base 15.
[0589] To save axial space, in one embodiment, the support sleeve 17 has a second guide surface 172 on the side facing the distal end, which gradually narrows from the proximal end to the distal end. When the movable seat 16 moves to the extreme position towards the proximal end, it abuts against the second guide surface 172.
[0590] As the movable seat 16 moves toward the proximal end relative to the base 15, the annular portion 161 gradually fits onto the second guide surface 172. Similar to the function of the first guide surface 171, under the action of the second guide surface 172, the annular portion 161 self-aligns and, as it moves along the second guide surface 172, further increases its stroke, ensuring the unlocking effect.
[0591] Of course, in addition to the aforementioned hydraulically driven control handles, one embodiment also provides an interventional device delivery system, including a release control mechanism with the aforementioned structure, and a control handle that drives the release control mechanism. The proximal ends of each tube in the release control mechanism are connected to the control handle, and the tubes are hydraulically driven to move relative to each other at the control handle.
[0592] In addition to all the foregoing embodiments, in one embodiment, an interventional device delivery system is provided, including a release control mechanism and a control handle for driving the release control mechanism. The proximal ends of each tube in the release control mechanism are connected to the control handle, and the tubes are hydraulically driven to move relative to each other at the control handle.
[0593] The interventional device is loaded into the release control mechanism, which includes a first tube 11, an intermediate tube 13, and a second tube 12 that slide and nest together sequentially from the inside out. The distal end of the first tube 11 extends into the intermediate tube 13, and an installation head 112 for connecting the interventional device is provided on the extended portion.
[0594] The intermediate tube 13 is connected to a flexible control element and a locking element 162 that cooperates with the control element. The proximal end of the interventional device is bound to the installation head 112 by the control element in a compressed state, and the interventional device is wrapped by the second tube 12.
[0595] When the interventional device is released:
[0596] Slide the second tube 12 proximally relative to the first tube 11 until the interventional device is fully exposed;
[0597] Relative to the first fitting 11, the intermediate fitting 13 is slid distally, causing the control element to follow distally and allowing the proximal end of the interventional device to gradually move away from the mounting head 112;
[0598] The locking element 162 is driven to move and release the control element, so that the interventional device is completely released from the mounting head 112.
[0599] Combination Figures 15a-17In one embodiment, a method for releasing an interventional device is also provided, utilizing the above-mentioned release control mechanism and interventional device delivery system. The interventional device is loaded into the release control mechanism, which includes a first tube 11, an intermediate tube 13, and a second tube 12 that are slidably nested together from the inside out. The distal end of the first tube 11 extends into the intermediate tube 13, and an installation head 112 for connecting the interventional device is provided on the extended portion. The intermediate tube 13 is equipped with a locking member 162 that cooperates with the control member. The proximal end of the interventional device is bound to the installation head 112 by the control member in a compressed state, and the interventional device is wrapped by the second tube 12.
[0600] Release methods include:
[0601] Step S100: Slide the second tube 12 proximally relative to the first tube 11 until the interventional device is fully exposed;
[0602] Step S200: relative to the first tube 11, slide the intermediate tube 13 distally, so that the control element moves distally and allows the proximal end of the interventional device to gradually move away from the mounting head 112.
[0603] In step S300, the locking element 162 is driven to move and release the control element, so that the interventional device is completely released.
[0604] The proximal end of the bracket 10, namely the connecting ear 101, is divided into two groups in the compressed state. Each group is pulled together and positioned in the convergence guide hole 1121 of the mounting head 112. Each connecting ear 101 is wrapped with a ring-shaped wire sleeve 19.
[0605] There are two binding threads 18, each with a fixed loop 181 at one end and a movable loop 182 at the other end. The threading method is as follows:
[0606] One end of the fixed wire loop 181 is fitted onto the unlocking rod 163, and the other end extends through the wire groove 1521 to the coiling guide hole 1121, and after being wrapped around the annular wire sleeve 19, it returns to the near end. When returning to the near end, it still passes through the same wire groove 1521. After returning, it is fitted onto the lock 162 through the movable wire loop 182. The middle part of the binding wire 18 is hung on the annular wire sleeve 19 to achieve mutual pulling. Depending on the length of the annular wire sleeve 19, the position where the binding wire 18 and the annular wire sleeve 19 are wrapped around each other can be inside the coiling guide hole 1121 or on the near end side outside the coiling guide hole 1121.
[0607] After the ring-shaped cable sleeve 19 is pulled, it extends to the proximal end through the coiling guide hole 1121, while simultaneously causing the two sets of connecting ears to coil and converge. At this time, the locking piece 162 is inserted into the lock hole 1522, and the unlocking rod 163 is inserted into the guide hole 1523. Therefore, both ends of the binding wire 18 are locked and in a holding state, and the ring portion 161 is neatly housed in the receiving groove 1512.
[0608] In other embodiments, if the loop sleeve 19 is not provided, the binding wire 18 is threaded in the following manner:
[0609] One end of the fixed wire loop 181 is fitted onto the unlocking rod 163, and the other end extends through the wire groove 1521 to the convergence guide hole 1121. After entering the convergence guide hole 1121, it extends further to the distal end and passes through the connecting ears of the same group. After passing through the connecting ears, it returns to the proximal end through the same convergence guide hole 1121. When returning to the proximal end, it still passes through the same wire groove 1521. After returning, it is fitted onto the lock member 162 through the movable wire loop 182. The relative movement between the first tube 11, the intermediate tube 13, and the second tube 12 can be achieved using existing technology or by combining the control handles of the aforementioned embodiments. For example, the relative movement of each tube can be driven by hydraulic means using the control handle at the proximal end. When the tubes move relative to each other, the pressure of the hydraulic drive circuit can also be detected in real time as an operation reference or warning.
[0610] For example, in step S100, the multi-way switching valve is adjusted to the corresponding position, and the drive pump is operated to make the piston move the second tube 12 towards the proximal end. During the movement, the bracket 10 will gradually be exposed and expand radially outward. When the bracket 10 is fully exposed to the second tube 12, since the connecting ear 101 is still pulled and restricted by the annular sleeve 19, only the distal part of the bracket 10 expands and releases, while the proximal end remains in a compressed state.
[0611] In step S200, when the intermediate tube 13 is slid distally relative to the first tube 11, the binding line 18 gradually moves distally, relaxing the pull on the connecting ear 101. Under the elasticity of the bracket 10 itself, the connecting ear 101 gradually expands outward, detaches from the convergence guide hole 1121, and gradually moves away from the mounting head 112. Since the binding line 18 is always pulled, the speed and amplitude of the proximal expansion of the bracket are controllable. When the position or posture is improper and needs to be adjusted or retracted, the intermediate tube 13 can be slid distally relative to the first tube 11, that is, the connecting ear is pulled back to the convergence guide hole 1121 by the binding line 18, and the bracket 10 can be retracted by sliding the second tube 12 distally.
[0612] When the intermediate tube 13 slides at the far end, due to the mutual insertion between the base 15 and the movable seat 16 and the pull of the binding line 18, the base 15 and the movable seat 16 obtain sufficient frictional resistance, so that the movable seat 16 moves to the far end. That is, the locking piece 162 is always kept in the lock hole 1522, and the unlocking rod 163 is always kept in the guide hole 1523, preventing the movable loop 182 of the binding line 18 from loosening.
[0613] In step S300, the way to drive the lock to move and release the control member is to slide the intermediate tube 13 to the distal end relative to the first tube 11 until the trigger end 1631 of the unlocking rod 163 abuts against the proximal side of the mounting head 112.
[0614] When the intermediate tube 13 is slid further to the far end, the unlocking rod 163 is blocked, preventing the movable seat 16 from moving. It overcomes frictional resistance and separates from the base 15. The locking member 162 gradually exits the lock hole 1522. As the locking member 162 gradually retracts into the clearance hole 1511, it also separates from the movable wire ring 182, releasing the binding wire 18. This continues until the movable seat 16 abuts against the support sleeve 17, reaching its limit position, or the base 15 abuts against the mounting head 112. This can also be used as a way to limit the limit travel.
[0615] Since the movable loop 182 disengages from the locking piece 162 and is no longer binding the connecting ear 101, the bracket 10 can be completely released.
[0616] After the bracket 10 is fully released, the intermediate tube 13 is slid towards the proximal end relative to the first tube 11 to separate the base 15 from the mounting head 112, so as to avoid the two clamping the binding line 18 and ensure that the bracket is fully released. Then the first tube 11 and the intermediate tube 13 are put back into the second tube 12, and all tubes are simultaneously withdrawn towards the proximal end.
[0617] Figures 18a-18c The diagram further illustrates the structure and application scenarios of the vena cava valve. The vena cava is divided into the superior vena cava 1300 and the inferior vena cava 1200, both of which are connected to the right atrium 1000. The right atrium 1000 is connected to the right ventricle 1100 via the tricuspid valve. This embodiment also discloses a vena cava valve replacement system that implants a vena cava valve via the femoral vein into the superior or inferior vena cava, including the vena cava valve and the aforementioned interventional device delivery systems.
[0618] Depending on the need, vena cava valves can be placed either in the upper body vena cava (130°, adjacent to the right atrium) or the lower body vena cava (120°). Structurally, vena cava valves include:
[0619] The stent 10 has a mesh structure and an internal blood flow channel. The stent 10 has an inflow end and an outflow end in opposite directions in the axial direction.
[0620] For easier location, it may also include:
[0621] Leaflet 102, the leaflet is connected to the blood flow channel of the stent and can open or close the blood flow channel under the action of blood flow;
[0622] The expanded mask 103 is connected to the bracket 10 and surrounds the outer periphery of the outflow end. The expanded mask 103 has an flared structure facing away from the inflow end.
[0623] The inflow end of the bracket 10 is provided with multiple connecting ears 101. A ring-shaped wire sleeve 19 can be threaded through the connecting ears 101. In addition, the end of the expanding mask 103 and the outflow end of the bracket 10 are respectively provided with V-shaped parts. The ring-shaped wire sleeve 19 or the binding wire 18 can also be threaded through each V-shaped part for release control according to the release or pulling method.
[0624] The stent 10 includes, in sequence along the blood flow direction:
[0625] Inflow section 106 is located on one side of the inflow end;
[0626] The waist 105 is located in the middle of the axis of the support 10;
[0627] The outflow section 104 extends towards the outflow end from the part where the mask 103 is connected to the bracket 10;
[0628] Of course, each part of the stent 10 has a relative inflow side and an outflow side.
[0629] In some embodiments, not only the vena cava valve, but also interventional devices with connecting ears or similar structures can be threaded and connected to the ligation suture 18 in different ways when the loop suture 19 is set.
[0630] Figure 19a In the middle, there are two binding lines 18. Each binding line has a fixed loop 181 at one end and a movable loop 182 at the other end. One binding line passes around the connection point M1 to achieve pull with the ring loop 19, and the other binding line passes around the connection point M2 to achieve pull with the ring loop 19. The two connection points do not bisect the ring loop 19, that is, the corresponding central angle is less than 180 degrees. Taking six connecting ears as an example, there are four on one side of the line connecting the two connection points and two on the other side. Figure 19b In the middle, there are four binding lines 18. Each binding line has a fixed loop 181 at one end and a movable loop 182 at the other end. Each binding line passes around the corresponding connection point to achieve pulling with the ring loop 19, that is, there are four connection points.
[0631] Figure 19c In the middle, there are two binding lines 18. Each binding line has a fixed loop 181 at one end and a movable loop 182 at the other end. One binding line passes around the connection point M1 to achieve pull with the ring loop 19, and the other binding line passes around the connection point M2 to achieve pull with the ring loop 19. The two connection points bisect the ring loop 19, that is, the corresponding central angle is approximately 180 degrees. Taking six connecting ears as an example, there are three on one side of the line connecting the two connection points and three on the other side.
[0632] Figure 19dIn the middle, there are three binding lines 18. Each binding line has a fixed loop 181 at one end and a movable loop 182 at the other end. Each binding line passes around the corresponding connection point to achieve pulling with the ring loop 19, that is, there are three connection points.
[0633] Figure 19c In the middle, the ring-shaped cable sleeve 19 is also connected to two cross sections 191. There are two binding lines 18, each with a fixed loop 181 at one end and a movable loop 182 at the other end. One binding line passes around the connection point M1 to achieve pull with the cross section 191, and the other binding line passes around the connection point M2 to achieve pull with the cross section 191. The binding lines 18 indirectly pull the ring-shaped cable sleeve 19 through the cross sections 191. The cross sections 191 allow for more flexible configuration of the force application point, which is convenient for connecting ear grouping and for adjusting the turning point when the binding line extends to the far end. That is, the length of the binding line 18 can also be flexibly adjusted.
[0634] Figures 19a-19e The diagram mainly illustrates the connection method between the binding line 18 and the loop sleeve 19, and does not restrict the pulling direction of the binding line 18. The direction of the binding line 18 in the diagram is only for easy labeling and reading.
[0635] The technical features of the embodiments described above can be combined arbitrarily. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as the combination of these technical features does not contradict each other, it should be considered to be within the scope of this specification. When technical features of different embodiments are embodied in the same drawing, it can be regarded as the drawing also disclosing examples of combinations of the various embodiments involved.
[0636] The embodiments described above are merely examples of several implementation methods of this application, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the patent application. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of this application, and these modifications and improvements all fall within the protection scope of this application.
Claims
1. An interventional device release control mechanism, comprising a first tube, an intermediate tube, and a second tube that slide and nest together sequentially from the inside out, wherein the distal end of the first tube extends out of the intermediate tube, and a mounting head for connecting an interventional device is provided on the extended portion, characterized in that, A flexible control element is connected to the intermediate pipe, and the control element has the following characteristics: In the held state, the control element penetrates the mounting head and restrains the interventional instrument to the mounting head; In the open position, the interventional device can be completely detached from the mounting head; The intermediate pipe is equipped with a fixed base and a slidable movable seat. A locking element is fixed on the movable seat, and a lock hole for receiving the locking element is provided on the base. In the holding state, the base and the movable seat are tightly fitted together. When the intermediate tube moves to the distal end relative to the first tube, the movable seat moves with the base. When the locking element is obstructed, the base and the movable seat move away from each other, that is, the release control element enters the open state.
2. The interventional device release control mechanism as described in claim 1, characterized in that, An unlocking rod is also fixed on the movable base. The unlocking rod passes through the base from the proximal end to the distal end and one end of the base is used as a trigger end. When the intermediate tube moves to the distal end relative to the first tube, the trigger end of the unlocking rod abuts against the mounting head and drives the lock to move to the proximal end and exit the lock hole, so that the control component enters the open state.
3. The interventional device release control mechanism as described in claim 2, characterized in that, The control element is a ligating line. The proximal end of the interventional device has multiple connecting ears. In the holding state, the ligating line passes directly through and pulls each connecting ear. Alternatively, a ring-shaped wire sleeve may be threaded between each connecting ear. In the holding state, the binding wire passes around the ring-shaped wire sleeve and indirectly pulls the connecting ear through the ring-shaped wire sleeve.
4. The interventional device release control mechanism as described in claim 3, characterized in that, The base and the movable seat are tightly fitted in such a way that the unlocking rod passes through the base and is tightly fitted at the through part, or at least one of the unlocking rod and the locking member abuts against the base under the pull of the binding line and there is at least frictional resistance that allows them to move with each other.
5. The interventional device release control mechanism as described in claim 4, characterized in that, The base has an axial channel, and the distal end of the intermediate pipe is inserted and fixed into the axial channel. The base includes: The near end plate has clearance holes for the locking element and the unlocking rod to pass through respectively; The distal end plate has a lock hole that mates with the lock and a guide hole through which the unlocking rod passes; The transition section is fixedly connected between the proximal plate and the distal plate. The periphery of the transition section is a mating area that is radially recessed relative to the proximal plate and the distal plate. In the holding state, the connection parts of the binding wire, the lock, and the unlocking rod are all located in the mating area.
6. The interventional device release control mechanism as described in claim 1, characterized in that, The mounting head is provided with a convergence guide hole, through which the control element passes to connect to the interventional device, and in the holding state, the proximal side of the interventional device is restricted to the convergence guide hole; The proximal end of the interventional device has multiple connecting ears, which tend to converge towards each other and converge into the convergence guide hole under the traction of the control element.
7. An interventional instrument delivery system, characterized in that, include: The interventional device release control mechanism according to any one of claims 1 to 6; The control handle is used to control the relative movement of each pipe in the release control mechanism, with the proximal end of each pipe connected to the control handle.
8. The interventional device delivery system as described in claim 7, characterized in that, The control handle includes a working part and a gripping part connected to the working part. The working part is equipped with a cylinder with an internal piston. The cylinder includes a first cylinder and a second cylinder connected in sequence along the axial direction. A first piston is slidably installed in the first cylinder, and a second piston is slidably installed in the second cylinder. All tubes enter from the distal end of the first cylinder. The first tube is fixed to the first piston. The intermediate tube extends out of the first piston, enters the second cylinder through an isolation seal, and is fixed to the second piston. The first tube extends out of the second piston and is fixed to the proximal end of the second cylinder.
9. The interventional device delivery system according to claim 8, characterized in that, The first cylinder and the second cylinder are connected by an isolation seal, the isolation seal comprising: A cylindrical body, the cylindrical body having an axial direction, with cylinders on corresponding sides respectively inserted into the two ends of the cylindrical body along the axial direction; Two sealing plugs are fixed to one axial end of the cylinder and respectively seal against the inner wall of the cylinder on the corresponding side. Each sealing plug is provided with a clearance hole for the pipe to pass through. Two sets of buckles are fixed to one axial end of the cylinder body and engage with the cylinder barrel on the corresponding side.
10. The interventional device delivery system according to claim 9, characterized in that, The outer periphery of the cylinder is provided with a positioning plate, and the end faces of two adjacent cylinders abut against the two opposite sides of the positioning plate. Reinforcing ribs are provided between the outer periphery of the cylinder and the two opposite sides of the positioning plate. In the radial direction of the cylinder, the outer edge of the reinforcing rib abuts against the inner wall of the cylinder. Each cylinder has a positioning hole on its wall, and two sets of buckles are fixed to the two opposite sides of the positioning plate. Each buckle includes an elastic arm extending from the positioning plate into the cylinder, and a hook at the end of the elastic arm that cooperates with the positioning hole.
11. The interventional device delivery system according to claim 7, characterized in that, When the interventional device is released: Slide the second fitting proximally relative to the first fitting until the interventional device is fully exposed; Relative to the first fitting, the intermediate fitting is slid distally, causing the control component to follow distally and allowing the proximal end of the interventional device to gradually move away from the mounting head; The locking mechanism is driven to move and release the control element, allowing the interventional device to be completely released from the mounting head.
12. The interventional device delivery system according to claim 11, characterized in that, A hydraulic drive circuit for driving the relative movement of the various pipe components is also provided at the control handle, the hydraulic drive circuit including: Hydraulic lines are used to provide fluid passages connecting to various hydraulic chambers; A drive pump is connected to the hydraulic lines to drive the flow of liquid. A control valve, connected to the hydraulic lines, is used to control the flow direction of the liquid. A liquid storage tank is connected to the hydraulic pipeline to temporarily store liquid.
13. The interventional device delivery system according to claim 12, characterized in that, The liquid storage tank includes: The tank body has a tank opening and an inlet and outlet connected to a hydraulic drive circuit; A buffer bladder is inserted into the tank body and sealed to the tank opening. The pressure cap engages with the can body and clamps and secures the buffer bladder at the can opening.
14. The interventional device delivery system according to claim 12, characterized in that, The control valve is a multi-port switching valve, which includes: Two valve seats are arranged opposite each other, one of which has a drive-side interface for connecting to the hydraulic drive circuit, and the other valve seat has a working-side interface for the hydraulic drive circuit. A valve core is sealed and rotatably mounted by two valve seats. The valve core has a connecting hole. When the valve core is rotated to different angles, the connecting hole connects the corresponding drive side interface and the working side interface. A wrench linked to the valve core is used to change the rotation angle of the valve core, and the wrench serves as the operating component of the multi-way switching valve.
15. The interventional device delivery system according to claim 14, characterized in that, The wrench includes an annular sleeve located on the outer periphery of the valve core, and a hook portion fixed to the annular sleeve; the inner edge of the annular sleeve and the outer periphery of the valve core are linked by a mutually cooperating one-way clutch mechanism.
Citation Information
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