Delivery system for an implantable medical device, and control handle thereof, implantable medical device, and method for securing, loading and releasing thereof

Abstract

The application discloses a delivery system of implantable medical device, including a balloon catheter, a sheath, an adjusting wire and a locking wire. The sheath is slidingly fitted on the outer periphery of the balloon catheter and is used for wrapping the implantable medical device; the adjusting wire is used for releasably fixing the implantable medical device on the balloon catheter, one end of the adjusting wire can be kept fixed with the balloon catheter, and the other end can pass through the implantable medical device and is provided with a locking hole; the locking wire has opposite locking and unlocking states, in the locking state, the locking wire is inserted into each locking hole to limit the implantable medical device, and in the unlocking state, the locking wire is separated from each locking hole to release the implantable medical device. The application effectively fixes the implantable medical device to the delivery system to be delivered to a lesion position, adjusts or limits the relative position of the implantable medical device in the axial direction of the balloon body through the locking between the locking wire, the adjusting wire and the implantable medical device, and prevents accidental expansion of the implantable medical device through the wrapping of the controllable sliding sheath, thereby improving the safety of the operation.

Description

TECHNICAL FIELD

[0001] The present application relates to the field of medical devices, in particular to a delivery system of an implantable medical device and a control handle thereof, an implantable medical device and a fixing method, a loading method and a releasing method thereof. BACKGROUND

[0002] Invasive deployment of certain implantable medical devices has become a routine method for treating certain diseases. For example, stents and prosthetic heart valves are now delivered to treatment sites within blood vessels and the heart by a catheter-based procedure that avoids invasive surgery.

[0003] In order to facilitate delivery to the desired treatment location, the implantable medical device (such as a stent and a prosthetic heart valve) needs to be loaded in a compressed state on a balloon catheter, and then passed through a catheter or sheath inserted into the vascular system to reach the target location. Then, the implantable medical device is inflated to its intended size by a balloon body in the balloon catheter, and fixed at the desired treatment location, and finally the balloon body is deflated to a collapsed state and the balloon catheter is pulled out of the body.

[0004] The fixation of the implantable medical device on the balloon body is usually completed by friction, or a shoulder is provided on the balloon catheter to prevent the implantable medical device from moving during insertion and delivery. When the balloon body is inflated / liquidized, it is usually inflated / liquidized at both ends of the balloon body to act as a barrier to prevent the implantable medical device from moving on the balloon body.

[0005] Although the above loading method is more practical, there are still several problems.

[0006] Firstly, the implantable medical device in a compressed state is exposed to the surrounding environment (e.g. conventional sheath, blood vessels, etc.), which can cause the implantable medical device to experience movement during insertion. When passing through the aortic arch, the implantable medical device exposed to the outside tends to expand outwardly on the outer surface of its distal end, which can cause harm to the artery.

[0007] Secondly, the shoulder for fixing the implantable medical device on the balloon body can fix the implantable medical device in place, but the implantable medical device will move and press against the shoulder, so the shoulder has the risk of piercing the balloon body.

[0008] Therefore, in order to avoid the above-mentioned shortcomings, it is still necessary to further improve the delivery system or method for fixing the implantable medical device to the delivery system for delivery to the treatment location, and for deploying the implantable medical device at the treatment location. SUMMARY

[0009] In order to solve the above technical problems, the present application discloses a delivery system of an implantable medical device, comprising a balloon catheter, further comprising:

[0010] a sheath, which is slidingly fitted on the outer periphery of the balloon catheter, for wrapping the implantable medical device;

[0011] an adjustment wire, which is used for releasably fixing the implantable medical device on the balloon catheter, one end of the adjustment wire being capable of being held fixed with the balloon catheter, and the other end being capable of passing through the implantable medical device and being provided with a locking hole;

[0012] a locking wire, which has opposite locking and unlocking states, in the locking state, the locking wire penetrates into each locking hole to restrict the implantable medical device, and in the unlocking state, the locking wire is disengaged from each locking hole to release the implantable medical device.

[0013] The following also provides several optional modes, but not as an additional limitation to the above general scheme, just a further supplement or preferred, without technical or logical contradiction, each optional mode can be combined alone for the above general scheme, but also can be combined between multiple optional modes.

[0014] Optionally, the delivery system further comprises a control handle, the balloon catheter, the sheath and the locking wire all extending to the control handle, and the balloon catheter, the sheath and the locking wire being capable of relative movement.

[0015] Optionally, the balloon catheter comprises:

[0016] a guide head, which is provided with a socket, and the end part of the locking wire in the locking state extends into the socket;

[0017] a balloon body, which is adjacent to the guide head and located on the proximal end side of the guide head, and the outer periphery of the balloon body is a loading area of the implantable medical device;

[0018] a catheter body, which is in communication with the balloon body and extends to the proximal end side of the delivery system.

[0019] Optionally, the balloon catheter further comprises:

[0020] a central tube, which is provided in the catheter body, one end of the central tube extending to the proximal end side of the delivery system, and the other end penetrating through the balloon body and being connected with the guide head.

[0021] Optionally, the locking wire extends to the proximal end side of the delivery system from a lumen defined between the sheath and the catheter body.

[0022] Optionally, the locking wire extends to the proximal end side of the delivery system from a lumen defined inside the catheter body.

[0023] Optionally, the catheter body is provided with a through hole, and the distal end of the locking wire extends to the outside of the catheter body through the through hole, so as to cooperate with the adjustment wire.

[0024] Optionally, the tube wall of the catheter body has a radially inwardly concave region, and the through hole is formed in a proximal end side of the radially inwardly concave region.

[0025] Optionally, there is only one joint between the adjustment wire and the locking wire.

[0026] Optionally, there are at least two joints between the adjustment wire and the locking wire, at least one of which limits the movement of the implantable medical device in the distal direction, and at least one of which limits the movement of the implantable medical device in the proximal direction.

[0027] Optionally, the adjustment wire is one or more, and the same adjustment wire can provide one or more locking holes.

[0028] Optionally, the locking holes are arranged in pairs, and in the same pair of locking holes, one is close to the distal end of the balloon catheter, and the other is close to the proximal end of the balloon catheter.

[0029] Optionally, the end of the adjustment wire is wound into a wire loop structure, and the inside of the wire loop structure is the locking hole.

[0030] Optionally, the adjustment wire comprises:

[0031] a first adjustment wire having a first locking hole, the first adjustment wire being connected to the balloon catheter and adjacent to the distal end of the balloon catheter;

[0032] a second adjustment wire having a second locking hole, the second adjustment wire being connected to the balloon catheter and adjacent to the proximal end of the balloon catheter;

[0033] In the locked state, the locking wire passes through the first locking hole and the second locking hole at the same time.

[0034] Optionally, in the locked state, the distance between the end of the locking wire and the size of the first locking hole ranges from at least 5mm, for example, 8-30mm.

[0035] Optionally, the first adjustment wire and the second adjustment wire are fixedly connected to the balloon catheter, respectively.

[0036] Optionally, the first adjustment wire is fixed to the guide head.

[0037] Optionally, the second adjustment wire is fixedly sleeved on the outer periphery of the catheter body.

[0038] Optionally, the outer periphery of the catheter body has a limiting step, and the second adjustment wire is limited by the limiting step.

[0039] Optionally, the first adjustment wire and the second adjustment wire are movably connected to the balloon catheter.

[0040] Optionally, the first adjustment line and the second adjustment line are connected by a connecting line.

[0041] Optionally, at least one of the first adjustment line and the second adjustment line is an integral structure with the connecting line.

[0042] Optionally, the connecting line extends towards the proximal end side of the delivery system.

[0043] Optionally, the connecting line extends within the central tube towards the proximal end side of the delivery system and is pullably movable relative to the balloon catheter.

[0044] Optionally, one of the first adjustment line and the second adjustment line is a fixed adjustment line fixedly connected to the balloon catheter, and the other is a movable adjustment line pullably movable relative to the balloon catheter, and an intermediate sheath is movably arranged in the lumen defined between the sheath and the catheter body, and the movable adjustment line is connected to the intermediate sheath.

[0045] Optionally, the central tube has a plurality of lumens, and the movable adjustment line extends along one of the lumens.

[0046] Optionally, of the plurality of lumens, one is a central lumen, and at least one other is a second lumen arranged eccentrically, and the movable adjustment line extends through the second lumen.

[0047] Optionally, the lumen wall of the second lumen is provided with two openings, and the first adjustment line and the second adjustment line extend out of the central tube through the corresponding openings.

[0048] Optionally, the implantable medical device is provided with a ring body, and in the locked state, the end of the adjustment line with the locking hole passes through the corresponding ring body and cooperates with the locking line.

[0049] Optionally, the ring body is at least two, respectively at the two opposite ends of the implantable medical device.

[0050] Optionally, the ring body is formed in at least one of the following ways:

[0051] a. using independent components and fixedly connected to the implantable medical device;

[0052] b. by punching holes in the implantable medical device;

[0053] c. directly using the structural gap of the implantable medical device itself.

[0054] Optionally, the implantable medical device has a tubular device body, and the end of the adjustment line with the locking hole is guided from the inside of the device body to the outside of the device body in the radial direction.

[0055] Optionally, the ring body is at least two, respectively at the axial ends of the instrument body.

[0056] Optionally, the locking wire is a metal rod.

[0057] Optionally, the delivery system further comprises a bending adjuster, which is inside, outside or sandwiched in the wall of the catheter body, and interacts with the distal end of the catheter body to bend the balloon catheter at the distal end.

[0058] Optionally, the proximal end of the bending adjuster is connected to and controlled by the control handle.

[0059] Optionally, the bending adjuster is a bending wire or a bending tube, which is fixed at the distal end and slidably connected at the proximal end to bend the balloon catheter at the distal end.

[0060] Optionally, the bending adjuster comprises an inner bending tube and an outer bending tube, which are fixed at the distal end and slidably connected at the proximal end to bend the bending adjuster at the distal end and act on the catheter body.

[0061] Optionally, the bending adjuster is fixedly connected or movably connected with the distal end of the catheter body.

[0062] Optionally, at least one of the inner bending tube and the outer bending tube is movably connected with the control handle.

[0063] Optionally, a control handle for operating an implantable medical instrument comprises a support body and a first drive assembly mounted on the support body, the first drive assembly comprising:

[0064] a first mounting seat slidably arranged on the support body;

[0065] a first drive member movably mounted on the support body and in transmission cooperation with the first mounting seat;

[0066] wherein the first mounting seat comprises a body with an inner cavity, and a distal interface, a drive interface, a limiting interface and a proximal interface are opened in the body and in communication with the inner cavity.

[0067] the distal interface is used to connect a balloon catheter

[0068] the drive interface is used to inject fluid into the balloon catheter,

[0069] the limiting interface is used to pass a locking wire.

[0070] the proximal interface is used to pass a guide wire.

[0071] Optionally, the control handle further comprises a second driving assembly mounted on the support body, the second driving assembly being located at the proximal side of the first driving assembly, the second driving assembly comprising:

[0072] a second mounting seat slidingly arranged on the support body;

[0073] a second driving member movably mounted on the support body and in transmission cooperation with the second mounting seat.

[0074] Optionally, the control handle further comprises a third driving assembly mounted on the support body, the third driving assembly being located between the first and second driving assemblies, the third driving assembly comprising:

[0075] a fixed mounting seat;

[0076] a third mounting seat slidingly arranged on the support body;

[0077] a third driving member movably mounted on the support body and in transmission cooperation with the third mounting seat.

[0078] Optionally, the support body has an axial direction in space, the support body is provided with a guide groove extending along the axial direction thereof, and each mounting seat is slidingly arranged in a corresponding guide groove; and each driving member is rotatably sleeved on the outer periphery of the support body and in threaded cooperation with the corresponding mounting seat.

[0079] Optionally, the support body has an axial direction in space, the first mounting seat has a four-way structure with four branch pipes, and the distal end interface, the driving interface, the limiting interface and the proximal end interface are respectively a pipe opening of a corresponding branch pipe.

[0080] Along the axial direction of the support body, the distal end interface and the proximal end interface are aligned with each other.

[0081] Optionally, the axes of the four branch pipes are substantially coplanar.

[0082] Optionally, the proximal end and the distal end interface of the catheter body are in sealed connection, the proximal end of the central pipe extends out of the catheter body and extends in the inner cavity of the first mounting seat and is in sealed connection to the proximal end interface.

[0083] The driving interface is communicated to the radial gap of both the catheter body and the central pipe.

[0084] Optionally, the proximal end of the locking wire extends into the inner cavity of the first mounting seat and then directly passes out of the first mounting seat through the limiting interface or passes out of the first mounting seat through the side wall of the branch pipe where the limiting interface is located.

[0085] Optionally, the branch pipe where the limiting interface is located extends obliquely towards the proximal end of the support body and the included angle α between the branch pipe and the axis of the support body satisfies 0°<α<60°. For example, 10°<α<45°, and for example, 15°<α<30°.

[0086] The present application discloses a delivery system of an implantable medical device, including a balloon catheter, further comprising:

[0087] A sheath is slidably fitted on the outer periphery of the balloon catheter, and is used to wrap the implantable medical device;

[0088] An adjusting wire is used to releasably fix the implantable medical device on the balloon catheter, one end of the adjusting wire can be kept fixed with the balloon catheter, and the other end is provided with a locking hole and is passed through by the implantable medical device;

[0089] A locking wire has opposite locking and unlocking states, in the locking state, the locking wire is passed through the implantable medical device to limit the implantable medical device from being separated from the adjusting wire, and in the unlocking state, the locking wire is separated from the implantable medical device, so that the locking hole is allowed to be separated and the implantable medical device is released.

[0090] Optionally, a ring is arranged on the implantable medical device, in the locking state, the ring is passed through the end of the corresponding adjusting wire provided with the locking hole, and cooperates with the locking wire.

[0091] The present application further discloses an implantable medical device, including a stent and a valve connected to the stent, the stent has opposite compressed and expanded states and is radially deformable, and the implantable medical device further includes a bundle-shaped ring arranged around the stent in the circumferential direction and connected to the stent, the bundle-shaped ring limits the radial deformation amplitude of the stent during the process that the stent enters the expanded state.

[0092] Optionally, the bundle-shaped ring is arranged around the outer periphery of the stent or the inner wall of the stent or is arranged on the inner and outer sides of the stent in a wavy manner.

[0093] Optionally, in the axial direction of the stent, the bundle-shaped ring is arranged at the middle part of the stent or adjacent to the inflow side of the stent.

[0094] Optionally, in the axial direction of the stent, the position of the bundle-shaped ring is adjacent to the position of the inflow side of the valve.

[0095] Optionally, in the axial direction of the stent, the width of the bundle-shaped ring is 2-30 mm. For example, 5-20 mm, and for example, 5-15 mm. For example, 8 mm.

[0096] Optionally, the bundle-shaped ring is made of flexible material and can be compressed with the stent.

[0097] Optionally, the bundle-shaped ring is sewn to the stent.

[0098] Optionally, the material of the bundle-shaped ring is PTFE.

[0099] Optionally, the bundle-shaped ring is a metal wire.

[0100] Optionally, along the axial direction of the stent, the stent comprises bundle-shaped segments corresponding to the positions of the bundle-shaped rings, and free segments on both sides of the bundle-shaped segments, and in the expanded state, the bundle-shaped segments have a smaller outer diameter than the free segments.

[0101] Optionally, the stent is a mesh tube with a hollow structure and has a spatial axial direction, and according to the direction of blood flow, one end of the axial direction of the stent is the inflow side and the other end is the outflow side, the inside of the stent is a blood flow channel that penetrates in the axial direction, and the leaflets are 2, 3 or 4 leaflets, each leaflet cooperates with each other to open or close the blood flow channel.

[0102] Optionally, the implantable medical device further comprises a first covering connected to the inside of the stent, and the first covering is connected to the inflow side of the leaflets.

[0103] Optionally, the implantable medical device further comprises a second covering connected to the outside of the stent, and the second covering is connected to the inflow side of the bundle-shaped ring.

[0104] Optionally, the first covering and the second covering are an integral structure.

[0105] Optionally, the first covering and the second covering both extend to the inflow side of the stent, and both abut each other to wrap the inflow side edge of the stent.

[0106] Optionally, one of the first covering and the second covering extends to the inflow side of the stent and is folded to wrap the inflow side edge of the stent, and after folding, it further extends to the outflow side of the other.

[0107] Optionally, the first covering and / or the second covering has a cut at the edge part adjacent to the inflow side of the stent, and the position of the cut matches the shape of the inflow side edge of the stent.

[0108] Optionally, the inflow side of the stent comprises a plurality of unit cells arranged in the circumferential direction, and the adjacent unit cells have a structural gap towards the inflow side, and the cut matches the position of the corresponding structural gap.

[0109] Optionally, the first covering and / or the second covering is serrated at the edge part adjacent to the inflow side of the stent, and the cut is between adjacent teeth, and the positions on both sides of the cut are connected to the corresponding positions of the stent.

[0110] The present application provides an implantable system comprising an implantable medical device and a delivery system cooperating with the implantable medical device.

[0111] The present application discloses a method for releasing an implantable medical device, the implantable medical device being previously fixed on a delivery system, the method comprising:

[0112] driving the sheath to move towards the proximal end of the delivery system to expose the implantable medical device;

[0113] pulling the locking wire out of the locking hole of the adjustment wire;

[0114] driving the balloon to expand and deform the implantable medical device to an expanded state, and also pulling the adjustment wire out of the implantable medical device;

[0115] shrinking the balloon and moving the balloon catheter towards the proximal end of the delivery system to separate the balloon catheter from the implantable medical device.

[0116] The present application provides a method for loading an implantable medical device, the method comprising:

[0117] placing the implantable medical device in an expanded state around the balloon in a shrunk state;

[0118] radially compressing the implantable medical device to a compressed state;

[0119] threading the end of the adjustment wire with the locking hole through the implantable medical device;

[0120] threading the locking wire through the locking hole;

[0121] sliding the sheath towards the distal end of the delivery system until the implantable medical device is wrapped.

[0122] The present application provides a method for fixing an implantable medical device on a balloon catheter, comprising the following steps:

[0123] An implantable medical device, the implantable medical device having a tubular device body, the tubular device body having a first end and a second end, the first end being provided with a first ring body, and the second end being provided with a second ring body;

[0124] A balloon catheter is provided, the balloon catheter comprising:

[0125] a catheter body having a guide head;

[0126] a balloon body adjacent to the guide head and located at the proximal end of the guide head, the balloon body having opposite distal and proximal ends;

[0127] a first adjustment wire having a first locking hole, the first adjustment wire being located adjacent to the distal end of the balloon catheter and fixed to the balloon catheter; and

[0128] a second adjustment line having a second locking hole, the second adjustment line being positioned proximally adjacent to the balloon catheter and being fixed to the balloon catheter;

[0129] a sheath is provided for sliding movement over the catheter body and the balloon, the sheath having a distal end;

[0130] implantable medical device in an expanded state is placed over a balloon body in a deflated state;

[0131] implantable medical device is radially deformed over the balloon body in a deflated state to a compressed state;

[0132] a first locking hole on a first adjustment line is threaded through a first ring body and a second locking hole on a second adjustment line is threaded through a second ring body;

[0133] a locking line is threaded through the first and second locking holes and into a guide head; and

[0134] the sheath is slid over the implantable medical device in a compressed state until advanced to the guide head to completely cover the implantable medical device.

[0135] wherein the step of advancing the locking line includes the step of advancing the locking line through a lumen defined between the sheath and the catheter body to extend out of the distal end of the sheath.

[0136] optionally, wherein the step of threading the first and second locking holes includes the step of locking the first and second locking holes in the first and second ring bodies, respectively.

[0137] optionally, wherein each of the first and second ring bodies is provided as a separate ring body and is connected to a first and second end of the implantable medical device, respectively.

[0138] optionally, wherein each of the first and second ring bodies is provided as a rounded tip at the first and second end of the implantable medical device, respectively.

[0139] optionally, wherein each of the first and second ring bodies is provided as an opening in an apex of the first and second end of the implantable medical device, respectively.

[0140] optionally, further comprising a connecting line connecting the first and second adjustment lines.

[0141] optionally, further comprising providing a central lumen extending through the balloon body, wherein the connecting line extends through the central lumen.

[0142] optionally, further comprising providing an intermediate sheath extending through a lumen defined between the sheath and the catheter body, wherein the second adjustment line is connected to a distal end of the intermediate sheath.

[0143] Optionally, a method for implanting an implantable medical device into a human organ, the method for securing the implantable medical device on a balloon catheter, comprising the steps of:

[0144] directly withdrawing the sheath at the proximal end to expose the implantable medical device;

[0145] withdrawing the locking wire in the proximal direction;

[0146] driving the balloon to expand in vitro, causing the first and second adjustment wires to be withdrawn from the first and second ring bodies, respectively;

[0147] causing the balloon body to contract; and directly withdrawing the balloon catheter at the proximal end.

[0148] When the implantable medical device is preferably an artificial heart valve, the present application accordingly provides an implantable artificial heart valve, a delivery system for the implantable artificial heart valve, and an implantable system for the artificial heart valve.

[0149] The related methods are also a method for releasing the implantable artificial heart valve, a method for loading the implantable artificial heart valve, and a method for securing the implantable artificial heart valve on the balloon catheter.

[0150] The present application effectively secures the implantable medical device to the delivery system for delivery to the treatment site, and for deployment at the treatment site, the improved locking method can lock the medical device on the contracted balloon body to avoid displacement; further, the end of the implantable medical device is prevented from expanding by the sheath, thereby minimizing the risk of piercing the balloon body. BRIEF DESCRIPTION OF DRAWINGS

[0151] Figure 1A An exploded view of the implantable medical device and the balloon catheter according to an embodiment of the present application;

[0152] Figure 1B An implantable medical device according to an embodiment of the present application positioned around the balloon body; Figure 1A

[0153] An implantable medical device according to an embodiment of the present application in a compressed state and around the balloon body; Figure 2 Figure 1A

[0154] Figure 3A An implantable medical device according to an embodiment of the present application positioned around the balloon body;

[0155] Figure 3B An implantable medical device according to an embodiment of the present application positioned around the balloon body;

[0156] Figure 4 An implantable medical device according to an embodiment of the present application positioned around the balloon body; ​​

[0157] Figure 5 Extraction of the sheath to expose the implantable medical device;

[0158] Figure 6 Extraction of the sheath to expose the implantable medical device;

[0159] Figure 7 Extraction of the sheath to expose the implantable medical device;

[0160] Figure 8 Extraction of the sheath to expose the implantable medical device;

[0161] Figure 9 Extraction of the sheath to expose the implantable medical device;

[0162] Figures 10-12B Extraction of the sheath to expose the implantable medical device; Figure 1A Extraction of the sheath to expose the implantable medical device;

[0163] Figure 13A Extraction of the sheath to expose the implantable medical device;

[0164] Figure 13B Extraction of the sheath to expose the implantable medical device; Figure 13A Extraction of the sheath to expose the implantable medical device;

[0165] Figure 14A Extraction of the sheath to expose the implantable medical device; Figure 13A Extraction of the sheath to expose the implantable medical device;

[0166] Figure 14B Extraction of the sheath to expose the implantable medical device; Figure 14A Extraction of the sheath to expose the implantable medical device;

[0167] Figure 15A Extraction of the sheath to expose the implantable medical device;

[0168] Figure 15B Extraction of the sheath to expose the implantable medical device; Figure 15A Extraction of the sheath to expose the implantable medical device.

[0169] Figure 16 Extraction of the sheath to expose the implantable medical device;

[0170] Figure 17 Extraction of the sheath to expose the implantable medical device;

[0171] Figure 18 Extraction of the sheath to expose the implantable medical device;

[0172] Figure 19 Extraction of the sheath to expose the implantable medical device; Figure 18 Extraction of the sheath to expose the implantable medical device;

[0173] Figure 20 This is a schematic diagram showing the connection between the bending member and the distal portion of the guide tube in one embodiment of this application;

[0174] Figure 21 for Figure 20 Enlarged view of section K with the central adjustment bend and the guide tube fixedly connected;

[0175] Figure 22 for Figure 21 Schematic diagram of the guiding body's effect on the bending of the mid-bending component after its movement;

[0176] Figure 23 for Figure 20 Enlarged view of section K in the movable connection state between the central adjustment bend and the guide tube;

[0177] Figure 24 for Figure 23 Schematic diagram of the guiding body's effect on the bending of the mid-bending component after its movement;

[0178] Figure 25 This is a schematic diagram of the balloon catheter portion structure in one embodiment of this application;

[0179] Figure 26 for Figure 25 Enlarged view of the middle J section;

[0180] Figure 27 This is a schematic diagram of the matching structure between the second adjustment line and the limiting step of the guide tube in one embodiment of this application;

[0181] Figure 28 for Figure 16 Exploded view;

[0182] Figure 29 for Figure 16 A cross-sectional view of the central control handle;

[0183] Figure 30 for Figure 16 Cross-sectional view of the central balloon catheter;

[0184] Figure 31 for Figure 28 Enlarged view of section A in the middle;

[0185] Figure 32 for Figure 28 Enlarged view of section B;

[0186] Figure 33 for Figure 29 Enlarged view of section G in the middle;

[0187] Figure 34 for Figure 28 Enlarged view of section C;

[0188] Figure 35 for Figure 28 Enlarged view of section D;

[0189] Figure 36 for Figure 29 Enlarged view of the middle H section;

[0190] Figure 37 for Figure 28 Enlarged view of section E in the middle;

[0191] Figure 38 for Figure 28 Enlarged view of section F in the middle;

[0192] Figure 39 for Figure 29 Enlarged view of the middle section (I);

[0193] Figure 40 for Figure 30 A magnified view of a portion of the guide head;

[0194] Figure 41 for Figure 28 A schematic diagram of the structure of the first mounting base;

[0195] Figure 42 for Figure 16 A cross-sectional view of the first driving component;

[0196] Figure 43 This is a schematic diagram of an implantable medical device according to an embodiment of this application in a compressed state after being loaded with a bundle ring;

[0197] Figure 44 This is a schematic diagram of an implantable medical device according to an embodiment of this application in its expanded state after being loaded with a bandgap ring;

[0198] Figure 45 This is a perspective view of an implantable medical device according to an embodiment of this application in its expanded state after being loaded with a bandgap ring;

[0199] Figure 46 This is a partial structural diagram of the first covering membrane in an implantable medical device according to an embodiment of this application;

[0200] Figure 47 This is a partial structural diagram of the first and second coverslips in an implantable medical device according to an embodiment of this application;

[0201] Figure 48 This is a partial structural diagram of the first and second coverslips in an implantable medical device according to another embodiment of this application;

[0202] Figure 49 This is a schematic diagram of the exhaust assembly in the control handle according to an embodiment of this application.

[0203] The reference signs in the drawings are explained as follows:

[0204] 100, implantable medical device; 102, cell; 103, stent; 104, heart valve assembly; 105, ring body; 105a, ring body; 105b, tip; 105c, tip; 105d, ring body; 105e, ring body; 106, distal end; 107, proximal end; 108, leaflet; 109, bundle ring; 111, first covering; 112, second covering; 113, inflow side; 114, outflow side; 115, through hole;

[0205] 120, balloon catheter; 121, first adjusting wire; 122, balloon body; 123, sheath; 124, catheter body; 126, locking wire; 127, guide head; 128, proximal end; 129, connector; 131, second adjusting wire; 132, distal end; 133, central tube; 135, first locking hole; 136, second locking hole; 137, lumen; 138, insertion hole; 139, limiting step;

[0206] 140, connecting wire; 8a, locking area; 8b, locking area; LK, locking area; 11a, lock; 11b, lock; 141, central lumen; 142, second cavity; 143, second opening; 144, first opening; 150, intermediate sheath;

[0207] 160, concave area; 161, through hole;

[0208] 200, control handle; 210, support body; 211, guide groove; 212, guide surface; 220, first driving assembly; 221, first mounting seat; 222, first driving piece; 230, second driving assembly; 231, second mounting seat; 232, second driving piece; 240, exhaust assembly; 241, connecting head; 242, liquid injection pipe; 250, third driving assembly; 251, third mounting seat; 252, third driving piece; 253, fixed mounting seat; 261, distal end interface; 262, driving interface; 263, limiting interface; 264, proximal end interface; 265, operating piece;

[0209] 300, bending member; 301, inner bending tube; 302, outer bending tube. DETAILED DESCRIPTION

[0210] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only part of the embodiments of the present application, rather than all the embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those skilled in the art without creative labor fall within the scope of protection of the present application.

[0211] It should be noted that when a component is referred to as being "connected" to another component, it can be directly connected to the other component or intervening components can be present. When a component is referred to as being "disposed on" another component, it can be directly disposed on the other component or intervening components can be present.

[0212] 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 in the description herein is for describing particular embodiments only and is not intended to be limiting of the application. As used herein, the term "and / or" includes any and all combinations of one or more of the associated listed items.

[0213] Referring to Figure 1A The present application provides a delivery system for an implantable medical device 100, which can be any implantable medical device implanted in a human body, such as a stent, a transcatheter heart valve, a stent-graft assembly, a closure device, a plug, etc. The present application is illustrated in conjunction with a transcatheter heart valve assembly 104 of an expandable stent or a stent frame for a transcatheter heart valve. By way of example of a heart valve, it can be applied to an aortic valve, a mitral valve, a tricuspid valve, a pulmonary valve, etc.

[0214] The heart valve assembly 104 has a tubular device body, such as a hollow cylindrical stent 103, which is woven or sculpted with a frame structure, such as being woven from a single wire or multiple wires or being laser cut from a metal (such as nickel-titanium) tube. A plurality of cells 102 are defined by the frame structure.

[0215] Referring to Figures 1A-15B The delivery system for an implantable medical device of the present application includes a balloon catheter 120, and further includes:

[0216] A sheath 123 is slidably fitted on the outer periphery of the balloon catheter 120 for wrapping the implantable medical device 100;

[0217] An adjustment wire is used to releasably secure the implantable medical device 100 on the balloon catheter 120, one end of the adjustment wire being capable of being held in fixed connection with the balloon catheter 120 and the other end being capable of passing through the implantable medical device 100 and having a locking hole;

[0218] A locking wire 126 has opposite locking and unlocking states, in the locking state, the locking wire 126 penetrates into each locking hole to restrict the implantable medical device, and in the unlocking state, the locking wire 126 is disengaged from each locking hole to release the implantable medical device 100.

[0219] Balloon catheter 120 has an axial length and has a proximal end 132 and a distal end 128, the distal end 128 is the end of balloon catheter 120 that is first inserted into the human body, the proximal end 132 is the end opposite to the distal end 128, the delivery system has the same direction of the proximal end and the distal end of balloon catheter 120, that is, the remaining components in the delivery system, such as sheath 123, locking wire 126, etc. have the same direction of the distal end 128 and the proximal end 132 of balloon catheter 120.

[0220] Implantable medical device 100 can be separated from the delivery system, for the convenience of description, implantable medical device 100 has a distal end 106 and a proximal end 107.

[0221] Balloon catheter 120 is made of elastic material and is arranged at the distal end of the delivery system, which can be bent and enable implantable medical device 100 arranged thereon to reach the lesion site. Referring to FIGS. 1B and Figure 6 , balloon catheter 120 can also be inflated / liquid, so as to expand itself and drive implantable medical device 100 to switch to the expanded state, and of course after deflation / liquid, balloon catheter 120 switches to the contracted state.

[0222] Implantable medical device 100 has a compressed state and an expanded state, and can switch between the expanded and compressed states.

[0223] Referring to FIGS. 1B and Figure 4 , sheath 123 is a hollow tube, which is slidably mounted on the delivery system and slides along the balloon catheter in the axial direction, thereby changing the constraint state of implantable medical device 100, when sheath 123 is arranged at the outer periphery of balloon catheter 120, implantable medical device 100 can be constrained inside it, limiting the expansion of implantable medical device 100, when sheath 123 slides relative to balloon catheter 120 and completely exits the expansion path of implantable medical device 100, implantable medical device 100 is exposed, allowing implantable medical device 100 to expand.

[0224] The adjustment wire is used to limit the misalignment between implantable medical device 100 and balloon catheter 120 during the operation (especially in the axial direction of balloon catheter 120), the misalignment between the two may affect the three-dimensional shape of implantable medical device 100 after entering the expanded state, and even have safety hazards, the releasable fixation of implantable medical device 100 on balloon catheter 120 by the adjustment wire can be understood as not affecting the release of implantable medical device 100 under the premise of avoiding axial misalignment as much as possible.

[0225] In order to ensure the limit, one end of the adjustment wire can be kept fixed with balloon catheter 120, in some cases, this end can also move controllably relative to balloon catheter 120, which can not only flexibly adjust the position of implantable medical device 100, but also avoid interference with its release.

[0226] Controllable motion can be achieved by utilizing the elasticity of the adjustment line itself within a predictable range of deformation, or by using transmission components to operate the adjustment line, etc.

[0227] After the other end of the adjustment line passes through the implantable medical device 100, it is bound by the locking line 126. There is no strict restriction on the specific way the adjustment line and the implantable medical device 100 are threaded. The junction of the locking hole and the locking line on the adjustment line can be regarded as a limiting point. With regard to a certain limiting point, at least the movement of the implantable medical device in a certain direction along the balloon catheter axis can be restricted or interfered with to reduce misalignment.

[0228] The main purpose of the locking suture is to maintain the threaded state between the adjustment suture and the implantable medical device, and to prevent the adjustment suture from being pulled out of the implantable medical device. The locking suture itself can have appropriate rigidity, and can at least withstand the shear force at the locking hole of the adjustment suture in a localized area.

[0229] In one embodiment, there is only one connection point between the adjustment line and the locking line. When the adjustment line itself is a rigid component, even a single connection point can limit the misalignment of the implantable medical device in two directions. If the adjustment line is flexible and the deformable portion is relatively short, the above requirements can also be basically met.

[0230] In another embodiment, there are at least two engagement points between the adjustment wire and the locking wire, wherein at least one engagement point restricts the movement of the implantable medical device in a distal direction, and at least one engagement point restricts the movement of the implantable medical device in a proximal direction.

[0231] Of course, if the focus is only on the misalignment restriction in a certain direction, the above structure can be further simplified.

[0232] The adjustment line can be one or more, and the same adjustment line can provide one or more keyholes. In one embodiment, the keyholes are arranged in pairs, such as one or more pairs, with one keyhole in the same pair located near the distal end of the balloon catheter (in use) and the other near the proximal end of the balloon catheter.

[0233] Using adjustment lines to traction and limit the implantable medical device, the adjustment lines as a whole (when there are multiple adjustment lines, they are considered as a single unit) and the balloon catheter must withstand mutual traction in two directions:

[0234] The junction of the locking hole and the locking wire near the distal end of the balloon catheter can restrict the movement of the implantable medical device proximally.

[0235] The junction of the locking hole and the locking wire near the proximal end of the balloon catheter can restrict the distal movement of the implantable medical device.

[0236] The separation between the locking line and the adjustment line can be actively controlled or driven by the deformation of the balloon catheter and the implanted medical device, thereby achieving automatic separation at a specific stage of the operation.

[0237] In this embodiment, the implanted medical device 100 is provided with a ring body 105. In the locked state, the ring body 105 passes through the end of the adjustment line with the lock hole and cooperates with the locking line 126.

[0238] After the end of the adjustment line with the lock hole passes through the ring body 105, the adjustment line is restricted from detaching from the ring body 105 by the locking line 126, so that the adjustment line and the implanted medical device 100 cannot be detached. This is mainly reflected in that when the implanted medical device 100 slides on the balloon catheter 120 and is finally restricted from further sliding at the lock hole. The sliding of the implanted medical device 100 in the compressed / expanded state relative to the balloon catheter in the axial direction is restricted. Of course, the ring body 105 can also pass through the lock hole, and the ring body 105 is restricted from detaching from the adjustment line by the locking line 126.

[0239] The lock hole passes through the ring body 105 or the ring body 105 passes through the lock hole, and the operation of the locking line passing through the lock hole or the ring body 105 can be manually threaded or other threading methods.

[0240] The locking line 126 is movably threaded in the delivery system. In the locked state, the locking line 126 is sequentially threaded through all the lock holes or the ring body 105, and the two ends are fixed, so that the adjustment line and the implanted medical device 100 are restricted from being separated by the mutual action among the three. The locking line 126 can be separated from the delivery system at the distal end thereof. After the locking line 126 is separated and completely exits all the lock holes or the ring body 105, the corresponding switching to the unlocked state is realized.

[0241] In one embodiment, the delivery system further includes a control handle 200, and the balloon catheter 120, the sheath 123, and the locking line 126 all extend to the control handle 200. The balloon catheter 120, the sheath 123, and the locking line 126 can relatively move.

[0242] The three can also move relative to the control handle 200. The movement control can be realized by the control of the proximal end of the tube or line after the tube or line extends to the control handle 200. The movement of the balloon catheter 120 can realize the adjustment of the balloon catheter itself and the implanted medical device at the lesion position. The sheath 123 can slide along the balloon catheter in the axial direction to wrap or expose the implanted medical device 100. The movement of the locking line 126 can realize the separation from the adjustment line.

[0243] Referring to Figures 1A-3B In some embodiments, the balloon catheter 120 includes:

[0244] The guide head 127 is provided with a receptacle 138, and the end part of the locking line 126 in the locked state extends into the receptacle.

[0245] a balloon body 122, adjacent to and proximal of the guide head 127, the balloon body 122 having an outer circumference that is a loading zone of the implantable medical device 100;

[0246] a catheter body 124, in communication with the balloon body 122 and extending proximally of the delivery system.

[0247] wherein the distal end of the balloon catheter 120 is the guide head 127, and the locking wire 126 extends into the receptacle to secure the adjustment wire from unintended release.

[0248] The balloon body 122 is disposed adjacent to and proximal of the guide head 127. The guide head 127 can have a tapered configuration that tapers in diameter from a proximal end 128 thereof to a distal-most end thereof to facilitate guiding the balloon body 122 and the catheter body 124 proximally within the body, and can provide a cylindrical connector 129 at the proximal end 128 that is of a smaller diameter than the proximal end 128, the connector 129 further extending proximally.

[0249] The distal end of the balloon body 122 is secured to a proximal end surface of the connector 129, and the proximal end of the balloon body 122 is secured to a distal end 132 of the catheter body 124. The balloon body 122 is hollow to allow inflation / deflation and passage of other components.

[0250] The catheter body 124 is a hollow tube that extends proximally into the control handle 200, and is in addition to the tube, wire, etc. for distal control, a fluid passageway in communication with the balloon body 122 to deliver inflation / deflation fluid for expanding the balloon body 122. A sheath 123 can be used to slide over the catheter body 124 and the balloon body 122 along the length of the catheter body 124 to provide some protection. The balloon body 122 and the catheter body 124 are both made of a resilient material to facilitate deformation.

[0251] Referring to Figure 1A In one embodiment, the balloon catheter 120 further comprises:

[0252] a central tube 133 that is disposed within the catheter body 124, the central tube 133 extending proximally of the delivery system and connected to the control handle 200 at one end, and extending through the balloon body 122 and connected to the guide head 127 at the other end.

[0253] wherein the central tube 133 is a hollow tube and is made of a resilient material to facilitate bending with the balloon catheter 120. The central tube 133 is open at both ends and provides a guidewire passageway therethrough.

[0254] With respect to the materials of the above components, it is noted herein that the catheter body 124 can be made of Pebax, PTFE, Nylon or any other known material used for catheter bodies; the sheath 123 can be made of Pebax, PTFE, Nylon or any other known material used for similar slidable sheaths; the adjustment wire can be a polypropylene wire, a braided PET wire, a PTFE wire or any conventional wire. The balloon body 122 can be made of any conventional balloon body material, such as Nylon and Pebax TM .

[0255] Referring to Figures 1A-7 , the locking wire 126 can be arranged as follows:

[0256] In one embodiment, the locking wire 126 extends from the lumen 137 defined between the sheath 123 and the catheter body 124 towards the proximal side of the delivery system.

[0257] The sheath 123 is slidably arranged on the outer circumference of the catheter body 124, and a lumen 137 is formed between the two for accommodating the locking wire 126.

[0258] In another embodiment, the locking wire 126 extends from the lumen 137 defined inside the catheter body 124 towards the proximal side of the delivery system.

[0259] In another embodiment, the catheter body 124 has a through hole 161 formed in the wall thereof, and the distal end of the locking wire 126 extends to the outside of the catheter body 124 through the through hole 161 for cooperating with the adjustment wire. In this embodiment, the wall of the catheter body 124 has a radially inwardly recessed area 160, and the through hole 161 is formed in the proximal side of the radially inwardly recessed area 160.

[0260] The radially inwardly recessed area 160 reduces the bending change of the locking wire 126 at the through hole 161, so that the movement of the locking wire 126 is smoother. In other embodiments, the through hole is a strip-shaped hole, and the length direction of the strip-shaped hole is consistent with the axial direction of the catheter body.

[0261] In one embodiment, the locking wire is a metal rod.

[0262] The locking wire 126 can be made of 304 or 316 stainless steel (the diameter of the locking wire is generally about 0.5 mm), so as to provide a strong axial pushing force and facilitate the threading of the locking hole or the ring body. The outer surface of the locking wire 126 is coated with PTFE, so as to reduce the friction with other tubes and wires and to have no stickiness, thereby ensuring the smooth sliding of the locking wire 126.

[0263] In one embodiment, the end of the adjustment wire is wound into a wire ring structure, and the inside of the wire ring structure is a locking hole.

[0264] The lock hole can also be a ring structure formed by another wire, and the end of the adjusting wire is fixed to the ring structure. The material of the wire can be the same as that of the adjusting wire or other materials. Of course, the formation of the lock hole is not limited to this.

[0265] The lock hole is generally a closed structure in the circumferential direction, but can also be a non-closed structure in the circumferential direction under the condition of limiting the lock wire from being pulled out.

[0266] In an embodiment, the adjusting wire comprises:

[0267] The first adjusting wire 121 has a first lock hole 135, and the first adjusting wire 121 is connected to the balloon catheter 120 and is adjacent to the distal end 106 of the balloon catheter 120.

[0268] The second adjusting wire 131 has a second lock hole 136, and the second adjusting wire 131 is connected to the balloon catheter 120 and is adjacent to the proximal end 107 of the balloon catheter 120.

[0269] In the locked state, the lock wire 126 passes through the first lock hole 135 and the second lock hole 136 at the same time.

[0270] The specific connection mode of the two ends of the two adjusting wires is as described above. The two adjusting wires are respectively located at the proximal end and the distal end of the balloon catheter 120, and function to limit the axial direction of the implantable medical device 100 in two directions.

[0271] The first adjusting wire 121 and the second adjusting wire 131 can be one or more, and when there are multiple, they are arranged at intervals in the circumferential direction of the balloon catheter 120. The connection positions (circumferential positions) of the first adjusting wire 121 and the second adjusting wire 131 to the balloon catheter 120 can be aligned with each other or arranged in a staggered manner.

[0272] The lock wire can be one or more. Taking the first adjusting wire 121 as an example, if the number of lock wires is less than the number of first adjusting wires 121, the first lock holes 135 on the multiple first adjusting wires 121 can share one of the lock wires. When multiple lock wires are provided, each lock wire can be independently controlled or linked with each other, and preferably moves synchronously.

[0273] According to the extension distance of the first lock hole 135 and the second lock hole 136 relative to the implantable medical device 100, the movement range of the implantable medical device 100 on the balloon catheter 120 is controlled. As shown in Figure 3B 、 Figure 30 and Figure 40 The lock wire 126 passes through the first lock hole 135 and the second lock hole 136 and enters the insertion hole 138 in the guide head 127. Figure 3BThe locking region LK in the figure illustrates the locking relationship, where the locking wire 126 passes through each locking hole after passing through the corresponding ring body 105, and then sequentially through each locking hole. The hole in the guide head 127 should have a certain depth so that the locking wire 126 can be securely locked in the guide head 127. In this embodiment, the heart valve assembly 104 is securely restrained on the balloon body 122 by the constraints provided by the first adjustment line 121, the second adjustment line 131, and the locking wire 126 to prevent any lateral (in the figure, i.e., the length direction of the catheter body 124) movement.

[0274] In the locked state, the distance between the end of the locking wire 126 and the first lock hole 135 is at least 5 mm, for example, 8 to 30 mm.

[0275] In some embodiments, the connection of each adjustment line to the balloon catheter may be configured in different ways.

[0276] In one embodiment, one of the first adjustment line 121 and the second adjustment line 131 is a fixed adjustment line fixedly connected to the balloon catheter 120, and the other is a movable adjustment line that can be pulled relative to the balloon catheter 120.

[0277] In one embodiment, the first adjustment line 121 and the second adjustment line 131 are respectively fixedly connected to the balloon catheter 120.

[0278] Regarding the first adjustment line 121, it can be directly fixed to at least one of the guide head 127, connector 129, or balloon body, and the specific fixing method can be at least one of various methods such as binding or bonding.

[0279] For example, the end of the adjustment line can be tied to the corresponding component (at least one of the guide head, connector, or balloon body). To ensure connection strength, at least one of the following methods can be further used:

[0280] The end of the adjusting line is wound into a loop;

[0281] The corresponding component has a through hole for the adjustment line to pass through;

[0282] The ends of the adjustment lines are heat-fused to the corresponding components.

[0283] In one embodiment, a first adjustment line 121 is fixed to a connector 129 and extends from the connector 129 toward the proximal end of the balloon body 122. Similarly, a second adjustment line 131 is fixed to the distal end 132 of the catheter body 124 and has a locking hole, extending from the distal end 132 toward the distal end of the balloon body 122.

[0284] In another embodiment, the first adjustment line 121 is fixed to the guide head 127.

[0285] As for the second adjustment line 131, it can be directly fixed to at least one of the catheter body or the balloon body, and the fixing manner is specifically referred to the connection manner of the first adjustment line 121.

[0286] In an embodiment, the second adjustment line 131 is fixedly sleeved on the outer periphery of the catheter body 124.

[0287] For example, the outer periphery of the catheter body 124 is provided with a limiting step 139, and the second adjustment line 131 is limited by the limiting step.

[0288] Referring to Figure 27 , the connection end of the second adjustment line 131 is tied to form a ring structure around the outer periphery of the catheter body 124 and at the proximal end of the limiting step 139. The limiting groove can also be used, that is, the end of the second adjustment line 131 is placed in the limiting groove.

[0289] In another embodiment, the first adjustment line 121 and the second adjustment line 131 are both movably connected to the balloon catheter 120.

[0290] One end of the two adjustment lines is provided with a locking hole, and the other end can be regarded as a movable end. The two adjustment lines can be controlled to stretch and contract relative to the balloon catheter 120, control the length of the exposed part of the two adjustment lines outside the balloon catheter 120, and further limit the sliding range of the implantable medical device 100.

[0291] In Figure 14B , in an embodiment, the first adjustment line 121 and the second adjustment line 131 are connected through a connecting line 140. Operating the connecting line 140 can simultaneously drive the first adjustment line 121 and the second adjustment line 131.

[0292] As Figure 13A and 13B shown, the connecting line 140 is in a relaxed state, so that the exposed parts of the first adjustment line 121 and the second adjustment line 131 are too long. As Figure 13A shown, when the exposed parts of the first adjustment line 121 and the second adjustment line 131 are too long, the implantable medical device 100 in a compressed state has a space for forward and backward sliding (see the adjustable locking 11a), so that the fixing effect is not good. When the connecting line 140 is pulled tight, the first adjustment line 121 and the second adjustment line 131 are also pulled, so that the exposed parts of the first adjustment line 121 and the second adjustment line 131 become shorter. As Figure 14A shown, the first locking hole 135 and the second locking hole 136 respectively located at the ends of the first adjustment line 121 and the second adjustment line 131 are aligned with the ring body 105 on the implantable medical device 100 (see the adjustable locking 11b), so that the implantable medical device 100 is tightly fixed.

[0293] Preferably, at least one of the first adjustment line 121 and the second adjustment line 131 is integrally formed with the connecting line 140.

[0294] Combining two types of wire (such as bonding or binding) will thicken the connection point, while a one-piece structure will reduce one connection point.

[0295] In one embodiment, the connecting line 140 extends toward the proximal side of the conveying system.

[0296] The connecting cable 140 extends to the control handle 200 on the proximal side for easy control.

[0297] The specific extension path of the connecting line 140 is not strictly limited. For example, it can extend radially inside the central tube, outside the catheter body, between the central tube and the catheter body, on the wall of the central tube, or on the wall of the catheter body.

[0298] In one embodiment, the connecting line 140 extends within the central tube 133 toward the proximal side of the delivery system and is capable of traction relative to the balloon catheter 120.

[0299] For example, when the connecting wire 140 moves proximally, it causes the exposed portions of the two adjustment wires to shorten, restricting the relative movement of the implantable medical device 100. When the implantable medical device 100 is released, the connecting wire 140 may move slightly distally to accommodate size changes.

[0300] Similarly, when the two adjustment lines are fixedly set, an appropriate margin can be left after passing through the implantable medical device 100 to accommodate the release of the implantable medical device 100. Of course, this margin can at least prevent excessive misalignment of the implantable medical device 100. If the axial length of the balloon catheter 120 is sufficient, this margin can also be relaxed.

[0301] like Figures 13A-14B To facilitate the installation and arrangement of wires (e.g., guide wires, connecting wires, adjusting wires), in one embodiment, the central tube 133 has multiple cavities, along which the movable adjusting wire extends. The remaining cavities can accommodate guide wires or other wires, each with its own independent channel to prevent interference and entanglement.

[0302] In this embodiment, among the multiple lumens, one is a central lumen 141, and at least another is an eccentrically arranged second lumen 142, through which the movable adjustment line extends. In use, the guidewire extends through the central lumen 141.

[0303] In one embodiment, the cavity wall of the second cavity 142 is provided with two openings, and the first adjustment line 121 and the second adjustment line 131 extend out of the central tube 133 through the corresponding openings.

[0304] The two openings are spaced apart and are respectively a first opening 144 at the distal end and a second opening 143 at the proximal end, which allow the second cavity 142 to communicate with the outside of the central tube 133, allowing the two adjustment lines to extend and be exposed. The first adjustment line 121 extends through the first opening 144, and the second adjustment line 131 extends through the second opening 143. The connecting line 140 extends through the second cavity 142 between the two openings, so that the first end of the connecting line 140 is connected to the first adjustment line 121, and the opposite second end of the connecting line 140 is connected to the second adjustment line 131.

[0305] In an embodiment, an intermediate sheath 150 is movably arranged in the lumen defined between the sheath 123 and the catheter body 124, and the intermediate sheath 150 is connected to the adjustment lines. The intermediate sheath 150 acts as a transmission member, which is more convenient to extend proximally and be connected to the control handle. The second adjustment line 131 can be fixed to the distal end of the intermediate sheath 150, and the first adjustment line 121 can be directly fixed to the connector 129 or a fixed position adjacent to the connector 129.

[0306] In Figure 15A , the intermediate sheath 150 is pushed towards the distal side of the balloon body 122, and the distal end of the intermediate sheath 150 extends out of the sheath 123 and is exposed, so that the first lock hole 135 and the second lock hole 136 can extend through the corresponding ring body 105.

[0307] In Figure 15B , the intermediate sheath 150 moves away from the proximal end of the balloon body 122, which causes the first adjustment line 121 and the second adjustment line 131 to be tightened, and the first lock hole 135 and the second lock hole 136 to be locked by the corresponding ring body 105. This embodiment Figure 15A and Figure 15B work on the same principle as the above-mentioned embodiments, the main difference being that the intermediate sheath 150 is provided instead of a longer adjustment line or connecting line.

[0308] In combination with the above, in one embodiment, the ring body 105 on the implantable medical device has at least two, at least one of which is arranged adjacent to the opposite end of the implantable medical device 100, or is respectively at the two opposite ends of the implantable medical device 100. For example, respectively at the two ends of the implantable medical device in the axial direction.

[0309] The two ring bodies 105 are respectively provided for the first lock hole 135 and the second lock hole 136, and the end of the lock wire 126 is fixed after the lock wire 126 is sequentially arranged through the two lock holes, thereby completing the locking.

[0310] Conversely, the two ring bodies 105 can also correspond to the first lock hole 135 and the second lock hole 136, and the lock wire 126 is sequentially arranged through the two ring bodies 105 and then fixed to the opposite guide head, thereby completing the locking.

[0311] The rings can be aligned or misaligned circumferentially with respect to the implantable medical device. By aligned, it is meant that the line connecting the two rings 105 is parallel to the axis of the implantable medical device (the overall shape of the implantable medical device is approximately a straight cylinder), and by misaligned, it is meant that the line connecting the two rings 105 is not parallel.

[0312] In some embodiments, the rings 105 are formed in at least one of the following ways:

[0313] a. Using separate components and fixed to the implantable medical device 100, such as Figure 10 As mentioned, the rings 105a can be made of the same material as the implantable medical device 100 or a different material, and in the assembly process, the rings 105a are manually installed to the stent 103. The rings 105a can be made of any conventional suture material (e.g., polypropylene, polytetrafluoroethylene) or the same material as the stent 103.

[0314] b. Formed by punching holes in the implantable medical device 100.

[0315] Figure 12A A through hole 115 is shown in the tip 105c of the cell 102, in which the first adjustment line 121 and the second adjustment line 131 can pass through the corresponding through hole 115, or be passed through by the corresponding through hole 115.

[0316] c. Directly using the structural gap of the implantable medical device 100 itself.

[0317] Figure 11 Another case is shown, in which the ring 105 is the tip 105b of the cell 102, and the ring 105 is formed by the frame strip surrounding the cell itself. The tip 105b can adopt an arc shape to avoid cutting the adjustment line. The first adjustment line 121 and the second adjustment line 131 are adapted to extend into the space defined by the tip 105b in the same way. The tip 105b is open to the inside of the cell, which facilitates the entry of the adjustment line into the ring 105.

[0318] In which, a single implantable medical device 100 allows the existence of multiple forms of rings 105, such as Figure 12B As shown, the implantable medical device 100 has a pair of rings 105 aligned circumferentially with respect to each other, which are the ring 105d and the ring 105e. The ring 105d is a structural gap of the implantable medical device 100, and the ring 105e is formed by punching. As for the axial position of the ring on the implantable medical device 100, there can be multiple configurations, such as the ring 105d being at one axial end of the implantable medical device 100, and the ring 105e not being at the axial end but only being adjacent.

[0319] In one embodiment, the implantable medical device 100 has a tubular device body, and the adjustment wire has one end with a locking hole, which is guided from the inside of the device body to the outside of the device body in a radial direction.

[0320] First, the side of the device body facing the balloon catheter 120 is defined as the inside, and the corresponding outside is the side facing away from the balloon catheter.

[0321] The locking hole passes through the corresponding ring body 105 from the inside to the outside, and finally reaches the outside of the implantable medical device 100. The locking wire 126 is sequentially threaded through the locking hole on the outside of the device body. For example, the threading direction is consistent with the axial direction of the balloon catheter 120. The locking wire 126 can be threaded without obstruction on the outside, facilitating assembly.

[0322] The adjustment wire and the implantable medical device are mutually threaded, and the locking wire limits mutual disengagement of the two, which can achieve positioning. For details, please refer to Figures 17-19 An embodiment of the present application discloses a delivery system of an implantable medical device, which comprises a balloon catheter, and further comprises:

[0323] A sheath 123 is slidably fitted on the outer periphery of the balloon catheter 120, and is used to wrap the implantable medical device 100;

[0324] An adjustment wire is used to releasably fix the implantable medical device 100 on the balloon catheter 120. One end of the adjustment wire can be kept fixed with the balloon catheter 120, and the other end has a locking hole and is threaded through the implantable medical device 100;

[0325] A locking wire 126 has opposite locking and unlocking states. In the locking state, the locking wire 126 passes through the implantable medical device 100 to limit disengagement of the implantable medical device 100 from the adjustment wire. In the unlocking state, the locking wire 126 is disengaged from the implantable medical device 100, allowing each locking hole to disengage and release the implantable medical device 100.

[0326] The main difference between the present embodiment and the above embodiment is that after the adjustment wire and the implantable medical device are mutually threaded, the locking wire cooperates with the implantable medical device. For example, in one embodiment, the implantable medical device 100 is provided with a ring body 105. In the locking state, the ring body 105 passes through the corresponding end of the adjustment wire with the locking hole, and cooperates with the locking wire 126.

[0327] For details, please refer to Figures 20-24 In one embodiment, the delivery system further comprises a bending adjustment member 300, which acts on the balloon catheter 120 at the distal end portion to change the spatial orientation of the balloon catheter 120.

[0328] In the radial relationship between the bending member 300 and the catheter body 124, in some embodiments, the bending member 300 is inside, outside or in the sandwich of the catheter body 124, and the interaction between the two distal ends of the bending member 300 and the catheter body 124 causes the balloon catheter 120 to bend at the distal end.

[0329] The bending member 300 itself can be a combination of one or more tubes, wires or rods, and the proximal end of the bending member 300 is connected to and controlled by the control handle 200. The bending member 300 can generate a force at the distal end that causes the catheter body 124 to bend.

[0330] The bending member 300 can act directly or indirectly on the balloon catheter 120, and in some embodiments below, the bending member 300 is connected to the catheter body 124 in various specific ways. For example, the distal end of the bending member 300 and the catheter body 124 are fixedly connected or movably connected.

[0331] Referring to Figure 21 and Figure 22 In one embodiment, the bending member 300 is a bending wire or a bending tube, and the distal end of the bending member 300 and the catheter body are fixed, and the proximal end is movably connected to cause the balloon catheter 120 to bend at the distal end.

[0332] The distal end of the bending member 300 and the catheter body 124 are fixed to each other, and when the proximal end of one of them is subjected to a force relative to the other, it will cause the distal end of the two to bend, thereby causing the distal end of the delivery system to bend as a whole, changing the direction of the balloon catheter 120 to adapt to the intervention path or the lesion position. For example, the bending tube can be arranged inside the catheter body or outside the catheter body.

[0333] Referring to Figure 23 and Figure 24 In one embodiment, the bending member 300 includes an inner bending tube 301 and an outer bending tube 302 nested with each other, and the distal end of the inner bending tube 301 and the outer bending tube 302 are fixed, and the proximal end is movably connected to cause the bending member 300 to bend at the distal end and act on the catheter body 124.

[0334] The bending member 300 adopts a double-tube structure, and the relative movement of the two proximal ends can cause the distal end to bend, thereby driving the catheter body 124 to bend. The bending member 300 is inside or outside the catheter body 124. In the figure, the bending member 300 is outside the catheter body 124, and one of the two bending tubes can be replaced by a bending wire.

[0335] In this embodiment, at least one of the inner bending tube 301 and the outer bending tube 302 is movably connected relative to the control handle 200.

[0336] The control handle 200 mentioned above for implementing various remote operations can utilize the prior art to drive corresponding components. The improved structure of the control handle 200 will be provided below, and the working principle will be described in detail.

[0337] Referring to Figure 16 and Figures 27-42 , the delivery system of the present application includes a control handle 200 for operating an implantable medical device, the control handle 200 including a support body 210 and a first drive assembly 220 mounted on the support body 210, the first drive assembly including:

[0338] a first mounting seat 221 slidingly arranged on the support body 210;

[0339] a first drive member 222 movably mounted on the support body 210 and in driving cooperation with the first mounting seat 221.

[0340] The first mounting seat 221 includes a body with an inner cavity, and the body is provided with:

[0341] a distal interface 261 for connecting a balloon catheter 120;

[0342] a drive interface 262 for injecting fluid into the balloon catheter 120;

[0343] a limiting interface 263 for guiding a locking wire 126;

[0344] a proximal interface 264 for guiding a guide wire.

[0345] The balloon catheter 120 extends through the support body via a tube and is fixedly connected to the distal interface 261. Movement of the first drive member 222 relative to the support body drives the first mounting seat 221 to slide, thereby driving the tube connected to the balloon catheter 120 to slide, adjusting the position of the balloon catheter 120 after reaching the vicinity of the lesion, and achieving the optimal position for releasing the implantable medical device.

[0346] The first mounting seat 221 is arranged at the proximal end of the control handle 200, and is a tube having at least four tube openings corresponding to the four interfaces.

[0347] Referring to Figures 31-33 In an embodiment, the control handle 200 further includes a second drive assembly 230 mounted on the support body 210, the second drive assembly being arranged on the proximal side of the first drive assembly, and the second drive assembly including:

[0348] a second mounting seat 231 slidingly arranged on the support body 210;

[0349] a second drive member 232 movably mounted on the support body 210 and in driving cooperation with the second mounting seat 231.

[0350] The second mounting base 231 is used to connect the sheath 123, and the second driving member 232 moves relative to the support body 210 to drive the second mounting base 231 to slide the sheath 123, thereby completing the operation of wrapping / unwrapping the balloon catheter 120.

[0351] Referring to Figures 34-36 In an embodiment, the control handle further comprises a third driving assembly 250 mounted on the support body 210, the third driving assembly being located between the first and second driving assemblies, and the third driving assembly comprising:

[0352] The fixed mounting base 253;

[0353] The third mounting base 251 is slidingly arranged on the support body 210;

[0354] The third driving member 252 is movably mounted on the support body 210 and in transmission cooperation with the third mounting base 251.

[0355] The outer bending tube 302 is connected to the fixed mounting base 253, and the inner bending tube 301 is connected to the third mounting base 251. When the third driving member 252 drives the third mounting base 251 to move relative to the fixed mounting base 253, the bending member as a whole will bend at the distal end, thereby acting on the balloon catheter to produce a bending effect. As for the transmission relationship between each driving member and the corresponding mounting base, and the cooperation relationship with the support body, in an embodiment, the support body 210 has a spatial axial direction, and the support body is provided with a guide groove 211 extending along the axial direction thereof, and each mounting base is slidingly arranged in the corresponding guide groove 211; each driving member is rotatably sleeved on the outer periphery of the support body and in threaded cooperation with the corresponding mounting base.

[0356] In an embodiment, the support body 210 has a spatial axial direction, the first mounting base is a four-way structure having four branch pipes, and the distal end interface, the driving interface, the limiting interface and the proximal end interface are respectively the pipe openings of the corresponding branch pipes; along the axial direction of the support body, the distal end interface and the proximal end interface are aligned with each other.

[0357] In order to reduce the space occupation, the axes of the four branch pipes are substantially coplanar. The branch pipes corresponding to the driving interface and the limiting interface are located on the two sides of the pipe at the distal end interface, thereby facilitating the connection of the pipe.

[0358] In an embodiment, the end portions of the branch pipes corresponding to the driving interface, the limiting interface and the proximal end interface are provided with external threads, thereby facilitating the connection with the external pipe.

[0359] In an embodiment, the proximal end of the catheter body 124 is sealingly connected to the distal end interface, and the proximal end of the central pipe 133 extends out of the catheter body and extends in the inner cavity of the first mounting base and is sealingly connected to the proximal end interface.

[0360] The drive interface communicates with the radial gaps of both the catheter body and the central tube, and fluid flows from the gaps to the balloon body at the distal end.

[0361] In an embodiment, the proximal end of the locking wire 126 extends into the inner cavity of the first mounting seat, and then directly passes through the first mounting seat via the limiting interface or passes through the first mounting seat via the side wall of the limiting interface branch.

[0362] Referring to Figure 42 The first mounting seat is detachably connected with an operating member 265 at the limiting interface 263, and the operating member 265 is fixedly connected with the locking wire 126. After the operating member 265 is separated from the first mounting seat, it serves as an operating handle for the operator to hold, facilitating the driving of the locking wire 126. When the locking wire 126 does not need to be driven, the operating member 265 is mounted and fixed on the first mounting seat. The operating member 265 and the first mounting seat are connected in a threaded manner.

[0363] In an embodiment, the branch pipe where the limiting interface is located extends obliquely towards the proximal end of the support body and forms an angle α with the axis of the support body, and 0° < α < 60°, for example, 10° < α < 45°, and for example, 15° < α < 30°. Referring to Figure 49 In an embodiment, the control handle 200 comprises an exhaust assembly 240, which comprises:

[0364] A connecting head 241 and a liquid injection pipe 242, one end of which is connected to the connecting head and the other end of which communicates with the fixed mounting seat 253.

[0365] For example, physiological saline is used for exhaust, which enters the fixed mounting seat 253 via the exhaust assembly 240, and then enters the gap between adjacent pipe members through the communication holes formed on the pipe wall of each pipe member to exhaust air.

[0366] In order to facilitate operation and reduce interference with the operator, the liquid injection pipe 242 extends inside the control handle from the fixed mounting seat 253 to the distal end of the control handle, and then passes out of the control handle and cooperates with the connecting head 241.

[0367] The proximal end of the bending member 300 is operated by the control handle 200, and acts on the catheter body 124 to complete the bending of the balloon catheter 120, and then the operation of the bending member is stopped, so that the proximal end of the bending member 300 is fixed and the distal end remains pointing in the same direction.

[0368] The control handle 200 operates the balloon catheter 120 to move along the support body 300, drives the distal end of the balloon catheter 120 to move along the axis thereof, adjusts the position of the balloon catheter relative to the lesion site, and reaches the optimal position for releasing the implantable medical device.

[0369] The control handle 200 operates the balloon catheter 120 to move along the support body 300, drives the distal end of the balloon catheter 120 to move along the axis thereof, adjusts the position of the balloon catheter relative to the lesion site, and reaches the optimal position for releasing the implantable medical device.

[0370] The implantable medical device is expanded by a balloon body after expansion, but when there is a change in the radial dimension of the implantable medical device locally, it is difficult to achieve by using a conventional balloon body, and even if a balloon body of a special shape is used, the implantable medical device will change due to other areas, resulting in that the desired effect cannot be achieved in the expanded state.

[0371] To solve the above problems, referring to Figures 43-48 An embodiment of the present application provides an implantable medical device 100, comprising a stent 103 and a leaflet 108 connected to the stent 103, the stent 103 is a radially deformable structure and has opposite compressed and expanded states, and the implantable medical device 100 further comprises a bundle-shaped ring 109 connected to the stent 103 along the circumference of the stent, and the bundle-shaped ring 109 limits the radial deformation amplitude of the stent 103 during the process of the stent 103 entering the expanded state.

[0372] The inside of the stent 103 is an axial through blood flow passage, and the leaflet 108 is 2, 3 or 4 petals, each leaflet 108 cooperates with each other to open or close the blood flow passage.

[0373] The bundle-shaped ring 109 is installed and positioned in a circle around the circumference of the stent 103, so that the stent 103 presents a relatively reduced diameter waist structure in the expanded state. In the radial direction of the stent, the bundle-shaped ring 109 is arranged on the outer periphery or the inner wall of the stent or is arranged on both sides of the stent. In the axial direction of the stent 103, the position of the bundle-shaped ring 109 is in the middle of the stent or adjacent to the inflow side of the stent or adjacent to the position of the inflow side of the leaflet. There are many ways to arrange, for example, the bundle-shaped ring 109 is sewn on the edge of the stent's hollow structure.

[0374] According to the relative position of the bundle-shaped ring 109 in the axial direction of the stent 103, the position of the neck-in will also change accordingly. Among them, along the axial direction of the stent, the stent 103 includes a bundle-shaped segment corresponding to the position of the bundle-shaped ring 109, and free segments on both sides of the bundle-shaped segment, and in the expanded state, the bundle-shaped segment has a smaller outer diameter than each free segment. The bundle-shaped ring 109 changes the expansion deformation amount of the bundle-shaped segment relative to the free segment, and in a unit of time, the deformation amount of the bundle-shaped segment is smaller than that of the free segment. Correspondingly, the connecting segment between the bundle-shaped segment and the free segment is also slowly deformed by the bundle-shaped ring 109, and finally bends and transitions with the bundle-shaped segment and the free segment.

[0375] In this embodiment, the bundle-shaped ring 109 is a ring structure. The ring structure can be a long strip-shaped body with both ends fixed to each other, or a complete ring or other ways to obtain.

[0376] In some embodiments, the width of the bundle-shaped ring 109 along the stent axial direction ranges from 2mm to 30mm (the width of the bundle-shaped ring in the flat state is used as the reference). For example, the width ranges from 5mm to 20mm, or from 5mm to 15mm. For example, the width is 8mm. The bundle-shaped ring 109 is made of a flexible material that can be compressed along with the stent 103.

[0377] The bundle-shaped ring 109 has a low tensile rate, for example, PTFE or other materials. During the expansion of the stent 103, the bundle-shaped ring 109 expands synchronously with the stent 103. When the bundle-shaped ring 109 approaches the elastic limit, the expansion of the bundle-shaped ring 109 is slowed down or stopped.

[0378] The bundle-shaped ring 109 can also be made of a metal wire. The two ends of the metal wire are fixed to form a ring, or the metal wire is an integral ring. The cross-sectional shape of the metal wire can be circular, oval, or the like.

[0379] In an embodiment, the stent 103 is a mesh tube with a hollow structure and has a spatial axial direction. According to the direction of blood flow, one end of the stent axial direction is the inflow side 113, and the other end is the outflow side 114. The implantable medical device 100 further comprises a first covering film 111 connected to the inner side of the stent. The first covering film 111 is connected to the inflow side of the valve leaflet 108.

[0380] The first covering film 111 is arranged on the inner circumferential side of the stent 103 and is connected to the connection part of the valve leaflet 108 and the stent 103. The first covering film 111 is used to close the hollow structure part. In an embodiment, the implantable medical device further comprises a second covering film 112 connected to the outer side of the stent. The second covering film 112 is connected to the inflow side of the bundle-shaped ring 109.

[0381] The second covering film 112 covers the outer circumferential side of the stent 103 and cooperates with the first covering film 111 to prevent leakage. The second covering film 112 can be fixed to the stent 103 in the same way as the first covering film 111.

[0382] The first covering film 111 and the second covering film 112 both extend to the inflow side of the stent 103 and are connected to each other to wrap the inflow side edge of the stent 103.

[0383] In order to facilitate assembly, in an embodiment, the first covering film 111 and the second covering film 112 are integrated.

[0384] That is, the two covering films are actually one complete film. The end edge of the stent 103 on the inflow side is bent and folded to form the first covering film 111 and the second covering film 112, which are respectively fixedly connected to the stent 103.

[0385] Preferably, the covering film is also fixedly connected to the stent 103 at the folding part.

[0386] In combination with the foregoing, the covering film is provided with a hole for the ring body 105 on the stent 103 to extend out of.

[0387] Further preferably, one of the first covering film 111 and the second covering film 112 extends to the inflow side of the stent 103, and after being folded back, wraps around the inflow side edge of the stent 103, and further extends to abut the outflow side of the other.

[0388] In the compressed state, the covering films are stacked on each other on the inflow side, increasing the radial thickness and interfering with the movement path of the sheath 123, affecting the operation of the sheath 123.

[0389] To solve the above problems, the first covering film 111 and / or the second covering film 112 has a cut at the edge portion adjacent to the inflow side of the stent, and the position of the cut matches the shape of the inflow side edge of the stent 103.

[0390] There is a gap between the two adjacent cuts, which gradually decreases during the compression of the stent 103, reducing the mutual stacking of the covering films on the inflow side and facilitating the sheathing of the sheath 123.

[0391] In one embodiment, the inflow side of the stent 103 includes a plurality of unit cells 102 arranged circumferentially, and the cut matches the position of the corresponding structural gap between the adjacent unit cells 102.

[0392] In one embodiment, the first covering film 111 and / or the second covering film 112 is sawtooth-shaped at the edge portion adjacent to the inflow side of the stent, and the cut is between the adjacent teeth, and the positions on both sides of the cut are sutured to the corresponding positions of the stent.

[0393] An embodiment of the present application provides an implantable system, which includes an implantable medical device and a delivery system cooperating with the implantable medical device.

[0394] The implantable medical device and the delivery system can adopt or combine any of the above embodiments, and the implantable medical device is radially contracted and attached to the outer peripheral wall of the balloon catheter in the compressed state, and the balloon catheter has two adjustment wires with lock holes releasably fixed on the balloon catheter in the axial direction of the implantable medical device, and the adjustment wires with lock holes are arranged through the two ends of the implantable medical device in the axial direction. The delivery system further includes a lock wire arranged on the balloon catheter in the axial direction, and the lock wire is arranged through the lock holes to prevent the adjustment wires from being separated from the implantable medical device.

[0395] The lock holes of the two adjustment wires allow a certain distance from the ends of the implantable medical device, which can be artificially adjusted, so that the relative position of the implantable medical device on the balloon catheter in the axial direction is controllable, and the distance can be zero, thereby limiting the movement of the implantable medical device on the balloon catheter.

[0396] An embodiment of the present application also provides a releasing method of an implantable medical device. The implantable medical device 100 is previously fixed on a delivery system. The releasing method comprises:

[0397] Driving the sheath 123 to move towards the proximal side of the delivery system to expose the implantable medical device 100;

[0398] Pulling the locking wire 126 out of the locking hole of the adjusting wire;

[0399] Driving the balloon body 122 to expand and deform the implantable medical device 100 to an expanded state, and also pulling the adjusting wire out of the implantable medical device 100;

[0400] Constricting the balloon body 122, and moving the balloon catheter 120 towards the proximal side of the delivery system to separate from the implantable medical device 100.

[0401] The delivery system can adopt or combine any of the above embodiments.

[0402] After the implantable medical device 100 is delivered to the lesion site, the proximal end of the delivery system can control the sheath 123 to slide along the balloon catheter axially towards the proximal end through the control handle at the distal end, gradually exposing the implantable medical device 100 until the sheath 123 completely exits the radial expansion path of the implantable medical device 100.

[0403] The locking wire 126 is pulled out along the balloon catheter axis, and the first locking hole 135 and the second locking hole 136 will automatically and completely separate from the corresponding ring body 105. The locking area 8b shows the separation between the locking hole and the ring body 105. Next, in the Figure 8 , the locking wire 126 is completely pulled out and the balloon body 122 is deflated into a constricted state. Finally, in the Figure 9 , the balloon catheter 120 is pulled out.

[0404] If the locking wire 126 has sufficient compliance and does not hinder the expansion of the implantable medical device 100, the locking wire 126 can also be withdrawn after the implantable medical device 100 is expanded, so that the axial relative position with the balloon catheter can be maintained during the expansion process.

[0405] After the expansion is completed, the releasing fluid is released, the balloon body 122 is constricted and separated from the implantable medical device 100, and finally the delivery system is pulled out of the body.

[0406] The steps in the above releasing method are not strictly limited in order, for example, the following method can also be used:

[0407] Driving the sheath 123 to move towards the proximal side of the delivery system to expose the implantable medical device 100;

[0408] The balloon body 122 is driven to expand and the implantable medical device 100 is deformed to the expanded state, and the adjustment wire is pulled out of the implantable medical device 100;

[0409] The balloon body 122 is driven to contract, and the locking wire 126 is pulled out of the locking hole of the adjustment wire;

[0410] The balloon catheter 120 is separated from the implantable medical device 100 by moving towards the proximal side of the delivery system.

[0411] The difference from the foregoing release method is that the locking wire 126 is adaptively deformed and bent during the expansion of the stent (the length change of the stent peripheral part can be compensated by the movement of the distal end or the proximal end during the deformation process), but is always not out of the locking hole to limit the movement of the stent in the axial direction, and after the expansion is completed and the balloon body 122 is contracted, the locking wire 126 is driven to be out of the locking hole, and then the separation of the balloon catheter and the implantable medical device is controlled through the delivery system, and is pulled out of the body.

[0412] An embodiment of the present application also provides a loading method of an implantable medical device for fixing the implantable medical device to a delivery system, wherein the delivery system can adopt or combine any of the foregoing embodiments.

[0413] The loading method comprises:

[0414] Placing the implantable medical device 100 in the expanded state outside the balloon body 122 in the contracted state;

[0415] Radially compressing the implantable medical device 100 to the compressed state;

[0416] Passing the end of the adjustment wire with the locking hole through the implantable medical device 100;

[0417] Passing the locking wire through the locking hole;

[0418] Sliding the sheath 123 towards the distal side of the delivery system until the implantable medical device 100 is wrapped.

[0419] The implantable medical device 100 in the expanded state can be uniformly compressed in the circumferential direction by existing equipment such as a compression holder, until it is switched to the compressed state.

[0420] Reference Figure 3A The first locking hole 135 of the first adjustment wire 121 passes through the ring body 105 of the distal end 106 of the implantable medical device 100, and the second locking hole 136 of the second adjustment wire 131 passes through the ring body 105 at the proximal end 107 of the implantable medical device 100.

[0421] This can be done manually during assembly or with the aid of a tool. Once this is done, the locking wire 126 passes through the lumen 137 defined between the sheath 123 and the catheter body 124 and protrudes from the distal end 138 of the sheath 123.

[0422] Next, as shown in Figure 3B the locking wire 126 is passed forward through the first and second locking holes 135, 136 and into the receptacle 138 in the guide head 127. Figure 3B The locking region LK in the cross-sectional view shows the engagement at the locking point, where the locking wire 126 is passed through the respective ring body 105 after passing through the respective locking hole. The hole in the guide head 127 should have a certain depth so that the locking wire 126 can be safely locked in the guide head 127.

[0423] An embodiment of the present application also provides a method for fixing an implantable medical device on a balloon catheter, comprising the steps of:

[0424] Provided is an implantable medical device, the implantable medical device having a tubular device body, the tubular device body having a first end and a second end, the first end being provided with a first ring body, and the second end being provided with a second ring body;

[0425] Provided is a balloon catheter, the balloon catheter comprising:

[0426] a catheter body, the catheter body having a guide head;

[0427] a balloon body, the balloon body being adjacent to the guide head and located at the proximal end of the guide head, the balloon body having opposite distal and proximal ends;

[0428] a first adjustment wire having a first locking hole, the first adjustment wire being located adjacent to the distal end of the balloon catheter and fixed to the balloon catheter; and

[0429] a second adjustment wire having a second locking hole, the second adjustment wire being located adjacent to the proximal end of the balloon catheter and fixed to the balloon catheter;

[0430] Provided is a sheath for sliding movement on the catheter body and the balloon, the sheath having a distal end;

[0431] placing the implantable medical device in an expanded state on the balloon body in a contracted state;

[0432] radially deforming the implantable medical device on the balloon body in the contracted state to a compressed state;

[0433] passing the first locking hole on the first adjustment wire through the first ring body and the second locking hole on the second adjustment wire through the second ring body;

[0434] passing the locking wire through the first and second locking holes and into the guide head;

[0435] sliding the sheath over the compressed implantable medical device until advanced over the leading head to completely cover the implantable medical device.

[0436] The technical features of the above-mentioned embodiments can be combined in any manner. In order to make the description simple, all possible combinations of the technical features in the above-mentioned embodiments are not described, however, as long as the combinations of the technical features do not exist contradictory, it should be considered that the combinations are within the scope of the present disclosure. When the technical features in different embodiments are embodied in the same figure, it can be considered that the figure also discloses the combination of the embodiments involved.

[0437] The above-mentioned embodiments only express several implementation manners of the present application, and the description is relatively specific and detailed, but it should not be understood as a limitation on the patent application scope. It should be pointed out that, for ordinary skilled in the art, without departing from the concept of the present application, a number of modifications and improvements can be made, which are within the protection scope of the present application.

Claims

1. A delivery system for an implantable medical device, comprising a balloon catheter, characterized in that, The balloon catheter comprises: a guide head; a balloon body adjacent to the guide head and located on the proximal side of the guide head, the outer periphery of the balloon body being a loading area of the implantable medical device, and the balloon body being driven to expand and the implantable medical device being deformed to an inflated state when the implantable medical device is released; a catheter body connected to the balloon body and extending to the proximal side of the delivery system; The delivery system further comprises: a sheath slidingly fitted on the outer periphery of the balloon catheter for wrapping the implantable medical device; an adjusting wire for releasably fixing the implantable medical device on the balloon catheter, one end of the adjusting wire being capable of penetrating the implantable medical device and having a locking hole, and the other end being a movable end capable of controllable extension and retraction relative to the balloon catheter, controlling the length of the exposed part of the adjusting wire outside the balloon catheter, and limiting the sliding range of the implantable medical device, the adjusting wire comprising: a first adjusting wire having a first locking hole, the first adjusting wire being connected to the balloon catheter and adjacent to the distal end of the balloon catheter; a second adjusting wire having a second locking hole, the second adjusting wire being connected to the balloon catheter and adjacent to the proximal end of the balloon catheter; the first adjusting wire and the second adjusting wire are connected by a connecting wire; a locking wire having opposite locking and unlocking states, in the locking state, the locking wire penetrates into each locking hole to limit the implantable medical device, and in the unlocking state, the locking wire is separated from each locking hole to release the implantable medical device; the implantable medical device is provided with a ring body, in the locking state, the end of the adjusting wire with the locking hole penetrates through the corresponding ring body and cooperates with the locking wire, and the ring body is formed in at least one of the following ways: way a, using an independent component and fixing it to the implantable medical device; way b, by punching a hole in the implantable medical device; way c, directly using the structural gap of the implantable medical device itself; The delivery system further comprises a control handle, and the balloon catheter, the sheath, the locking wire and the connecting wire all extend to the control handle.

2. The delivery system of an implantable medical device according to claim 1, characterized in that, The balloon catheter, the sheath and the locking wire can move relative to each other.

3. The delivery system of an implantable medical device according to claim 2, wherein, The guide head is provided with a receptacle, and the end of the locking wire in the locking state extends into the receptacle.

4. The delivery system of an implantable medical device according to claim 3, wherein, The balloon catheter further comprises: a central tube provided in the catheter body, one end of the central tube extending to the proximal side of the delivery system, and the other end penetrating through the balloon body and being connected to the guide head.

5. The delivery system of an implantable medical device according to claim 3, wherein, The locking wire extends to the proximal side of the delivery system from the lumen defined between the sheath and the catheter body.

6. The delivery system of an implantable medical device according to claim 3, wherein, The locking wire extends to the proximal side of the delivery system from the lumen defined inside the catheter body.

7. The delivery system of an implantable medical device according to claim 6, wherein, The pipe wall of the catheter body is provided with a through hole, and the distal end of the locking wire extends to the outside of the catheter body through the through hole to cooperate with the adjusting wire.

8. The delivery system of an implantable medical device according to claim 7, wherein, The pipe wall of the catheter body has a radially concave area, and the through hole is provided at the proximal side of the radially concave area.

9. The delivery system of an implantable medical device according to claim 1, wherein, There is only one joint between the adjusting wire and the locking wire.

10. The delivery system of an implantable medical device according to claim 1, wherein, The adjustment wire and the locking wire have at least two binding sites, at least one of which limits the movement of the implantable medical device in the distal direction, and at least one of which limits the movement of the implantable medical device in the proximal direction.

11. The delivery system of an implantable medical device according to claim 4, wherein, The same adjustment wire can provide one or more locking holes.

12. The delivery system of an implantable medical device according to claim 11, wherein, The locking holes are arranged in pairs, and in the same pair of locking holes, one is close to the distal end of the balloon catheter, and the other is close to the proximal end of the balloon catheter.

13. The delivery system of an implantable medical device according to claim 12, wherein, The first adjustment wire and the second adjustment wire are both movably connected to the balloon catheter.

14. The delivery system of an implantable medical device according to claim 13, wherein, At least one of the first adjustment wire and the second adjustment wire is an integral structure with the connecting wire.

15. The delivery system of an implantable medical device according to claim 14, wherein, The connecting wire extends to the proximal side of the delivery system.

16. The delivery system of an implantable medical device according to claim 15, wherein, The connecting wire extends to the proximal side of the delivery system within the central tube and can be pulled relative to the balloon catheter.

17. The delivery system of an implantable medical device according to claim 4, wherein, One of the first adjustment wire and the second adjustment wire is a fixed adjustment wire fixedly connected to the balloon catheter, and the other is a movable adjustment wire that can be pulled relative to the balloon catheter, and an intermediate sheath is movably arranged in the lumen defined between the sheath and the catheter body. The movable adjustment wire is connected to the intermediate sheath.

18. The delivery system of an implantable medical device according to claim 17, wherein, The central tube has a plurality of lumens, and the movable adjustment wire extends along one of the lumens.

19. The delivery system of an implantable medical device according to claim 18, wherein, Among the plurality of lumens, one is a central lumen, and at least one is a second lumen arranged eccentrically, and the movable adjustment wire extends through the second lumen.

20. The delivery system of an implantable medical device according to claim 19, wherein, The lumen wall of the second lumen is provided with two openings, and the first adjustment wire and the second adjustment wire extend out of the central tube through the corresponding openings.

21. The delivery system of an implantable medical device according to claim 4, wherein, The central tube has a plurality of lumens, and among the plurality of lumens, one is a central lumen, and at least one is a second lumen arranged eccentrically. The lumen wall of the second lumen is provided with two openings, and the two openings are arranged in a spaced manner and are respectively a first opening at the distal end and a second opening at the proximal end. The two openings allow the second lumen to communicate with the outside of the central tube, allowing the two adjustment wires to extend out and be exposed, wherein the first adjustment wire extends through the first opening, and the second adjustment wire extends through the second opening.

22. The delivery system of an implantable medical device according to claim 21, wherein, The connecting wire extends through the second lumen between the two openings, so that the first end of the connecting wire is connected to the first adjustment wire, and the opposite second end of the connecting wire is connected to the second adjustment wire.

23. The delivery system of an implantable medical device according to claim 1, wherein, The ring body has at least two, respectively at the two opposite ends of the implantable medical device, or at least one of the two ring bodies is adjacent to the opposite end of the implantable medical device.

24. The delivery system of an implantable medical device according to claim 1, wherein, The implantable medical device has a tubular device body, and one end of the adjustment wire with the locking hole is guided from the inside of the device body to the outside of the device body in the radial direction.

25. The delivery system of an implantable medical device according to claim 1, wherein, The locking wire is a metal rod.

26. The delivery system of an implantable medical device according to claim 1, wherein, The delivery system further comprises a bending adjustment member, which is arranged inside, outside, or in the sandwich layer of the catheter body wall. The bending adjustment member interacts with the distal end of the catheter body to bend the balloon catheter at the distal end.

27. The delivery system of an implantable medical device according to claim 26, wherein, The proximal end of the bending adjustment member is connected to and controlled by the control handle.

28. The delivery system of an implantable medical device according to claim 26, wherein, The bending adjustment member is a bending wire or a bending tube, and the bending adjustment member is fixed at the distal end of the catheter body and slidably connected at the proximal end to bend the balloon catheter at the distal end.

29. The delivery system of an implantable medical device according to claim 4, wherein, A control handle for operating an implantable medical device includes a support body and a first drive assembly mounted on the support body, the first drive assembly including: a first mounting seat slidingly disposed on the support body; a first drive member movably mounted on the support body and in transmission cooperation with the first mounting seat; wherein the first mounting seat includes a body with an inner cavity, and a distal interface, a drive interface, a limiting interface and a proximal interface are formed in the body and in communication with the inner cavity; the distal interface is used for connecting a balloon catheter the drive interface is used for injecting fluid into the balloon catheter, the limiting interface is used for guiding a locking wire, the proximal interface is used for guiding a guide wire.

30. The delivery system of an implantable medical device according to claim 29, wherein, The control handle further includes a second drive assembly mounted on the support body, the second drive assembly being located on the proximal side of the first drive assembly, the second drive assembly including: a second mounting seat slidingly disposed on the support body; a second drive member movably mounted on the support body and in transmission cooperation with the second mounting seat.

31. The delivery system of an implantable medical device according to claim 30, wherein, The control handle further includes a third drive assembly mounted on the support body, the third drive assembly being located between the first drive assembly and the second drive assembly, the third drive assembly including: a fixed mounting seat; a third mounting seat slidingly disposed on the support body; a third drive member movably mounted on the support body and in transmission cooperation with the third mounting seat.

32. The delivery system of an implantable medical device according to claim 31, wherein, The support body has a spatial axial direction, the support body is provided with guide grooves extending along the axial direction thereof, and each mounting seat is slidingly disposed in a corresponding guide groove; each drive member is rotatably sleeved on the outer periphery of the support body and is in threaded cooperation with the corresponding mounting seat.

33. The delivery system of an implantable medical device according to claim 32, wherein, The support body has a spatial axial direction, the first mounting seat is a four-way structure having four branch pipes, and the distal interface, the drive interface, the limiting interface and the proximal interface are respectively a pipe opening corresponding to one branch pipe; Along the axial direction of the support body, the distal interface and the proximal interface are aligned with each other.

34. The delivery system of an implantable medical device according to claim 33, wherein, The axes of the four branch pipes are coplanar.

35. The delivery system of an implantable medical device according to claim 34, wherein, The proximal end of the catheter body is sealingly connected to the distal interface and the proximal interface, and the proximal end of the central pipe extends out of the catheter body, extends in the inner cavity of the first mounting seat and is sealingly connected to the proximal interface. The drive interface is in communication with the radial gap between the catheter body and the central pipe.

36. The delivery system of an implantable medical device according to claim 35, wherein, The proximal end of the locking wire extends into the inner cavity of the first mounting seat, and then directly passes out of the first mounting seat through the limiting interface or passes out of the first mounting seat through the side wall of the branch pipe where the limiting interface is located.

37. The delivery system of an implantable medical device according to claim 36, wherein, The branch pipe where the limiting interface is located extends obliquely to the proximal end of the support body and forms an angle α with the axial direction of the support body, and 0° < α < 60°.

38. A delivery system for an implantable medical device, comprising a balloon catheter, characterized in that, The balloon catheter includes: a guide head; a balloon body adjacent to the guide head and located on the proximal side of the guide head, the outer periphery of the balloon body being a loading area of the implantable medical device; a catheter body in communication with the balloon body and extending to the proximal side of the delivery system; The delivery system further includes: a sheath slidingly fitted on the outer periphery of the balloon catheter for wrapping the implantable medical device; An adjusting wire for releasably fixing the implantable medical device on the balloon catheter, one end of the adjusting wire is provided with a locking hole and passes through the implantable medical device, the other end is a free end, the adjusting wire can be controlled to stretch and contract relative to the balloon catheter, the length of the exposed part of the adjusting wire outside the balloon catheter is controlled, the sliding range of the implantable medical device is limited, and the adjusting wire comprises: A first adjusting wire provided with a first locking hole, the first adjusting wire is connected to the balloon catheter and is adjacent to the distal end of the balloon catheter; A second adjusting wire provided with a second locking hole, the second adjusting wire is connected to the balloon catheter and is adjacent to the proximal end of the balloon catheter; The first adjusting wire and the second adjusting wire are connected by a connecting wire; A locking wire having opposite locking and unlocking states, in the locking state, the locking wire passes through the implantable medical device to limit the implantable medical device from being separated from the adjusting wire, in the unlocking state, the locking wire is separated from the implantable medical device, and each locking hole is separated from and releases the implantable medical device; the implantable medical device is provided with a ring body, in the locking state, the ring body passes through the end of the corresponding adjusting wire provided with the locking hole and cooperates with the locking wire; the ring body is formed in at least one of the following ways: Way a, using an independent part and being fixed to the implantable medical device; Way b, being formed by punching on the implantable medical device; Way c, directly using the structural gap of the implantable medical device itself; The delivery system further comprises a control handle, and the balloon catheter, the sheath, the locking wire and the connecting wire all extend to the control handle.

39. An implantable system, characterized by The delivery system comprises an implantable medical device and a delivery system matched with the implantable medical device; the delivery system is the delivery system of the implantable medical device as claimed in any one of claims 1-38.

40. A method of releasing an implantable medical device, comprising: The implantable medical device is pre-fixed on the delivery system as claimed in any one of claims 1-38, and the releasing method comprises the following steps: Driving the sheath to move to the proximal end side of the delivery system to expose the implantable medical device; Pulling the locking wire out of the locking hole of the adjusting wire; Driving the balloon body to expand and deforming the implantable medical device to an expanded state, and also pulling the adjusting wire out of the implantable medical device; Making the balloon body contract and moving the balloon catheter to the proximal end side of the delivery system to separate the implantable medical device.

41. A method of loading an implantable medical device, characterized by, The loading method for fixing the implantable medical device to the delivery system as claimed in any one of claims 1-38 comprises the following steps: Placing the implantable medical device in an expanded state around the balloon body in a contracted state; Radially compressing the implantable medical device to a compressed state; Passing the end of the adjusting wire provided with the locking hole through the implantable medical device; Passing the locking wire through the locking hole; Sliding the sheath to the distal end side of the delivery system until the implantable medical device is wrapped.

42. A method of securing an implantable medical device to a balloon catheter, the method comprising: The method comprises the following steps: Providing an implantable medical device, the implantable medical device has a tubular device body, the tubular device body has a first end and a second end, the first end is provided with a first ring body, the second end is provided with a second ring body, and each ring body is formed in at least one of the following ways: Way a, using an independent part and being fixed to the implantable medical device; Mode b, by punching holes on the implanted medical device; Mode c, directly using the structural gap of the implanted medical device itself; A balloon catheter is provided, the balloon catheter comprising: a catheter body having a guide head; a balloon body adjacent to and proximal to the guide head, the balloon body having opposite distal and proximal ends; a first adjustment line having a first locking hole, the first adjustment line being adjacent to a distal position of the balloon catheter and fixed to the balloon catheter; and a second adjustment line having a second locking hole, the second adjustment line being adjacent to a proximal position of the balloon catheter and fixed to the balloon catheter; wherein the first adjustment line and the second adjustment line are connected by a connecting line; a sheath is provided for sliding movement on the catheter body and the balloon, the sheath having a distal end; an implanted medical device in an expanded state is placed on the balloon body in a contracted state; the implanted medical device is radially deformed on the balloon body in a contracted state to a compressed state; the first locking hole on the first adjustment line is threaded through the first ring body, and the second locking hole on the second adjustment line is threaded through the second ring body, the other end of the two adjustment lines opposite to the locking hole being a movable end, which can be controlled to stretch and retract relative to the balloon catheter, control the length of the exposed part of the balloon catheter, and limit the sliding range of the implanted medical device; the locking line is threaded through the first locking hole and the second locking hole and into the guide head; and the sheath is slid over the implanted medical device in a compressed state until it is advanced to the guide head to completely cover the implanted medical device; wherein the step of advancing the locking line includes the step of advancing the locking line through a lumen defined between the sheath and the catheter body to extend out of the distal end of the sheath; the balloon catheter, the sheath, the locking line, and the connecting line all extend proximally to a control handle.

43. The method of securing an implantable medical device to a balloon catheter of claim 42, wherein, wherein the step of threading the first and second locking holes includes the step of locking the first and second locking holes in the first and second ring bodies, respectively.

44. The method of securing an implantable medical device to a balloon catheter of claim 42, wherein, wherein each of the first and second ring bodies is provided as a separate ring body and is connected to the first and second ends of the implanted medical device, respectively.

45. The method of securing an implantable medical device to a balloon catheter of claim 42, wherein, wherein each of the first and second ring bodies is provided as a circular tip at the first and second ends of the implanted medical device, respectively.

46. The method of securing an implantable medical device to a balloon catheter of claim 42, wherein, wherein each of the first and second ring bodies is provided as an opening in the vertex of the first and second ends of the implanted medical device, respectively.

47. The method of securing an implantable medical device to a balloon catheter of claim 42, wherein, further providing a connecting line connecting the first and second adjustment lines.

48. The method of securing an implantable medical device to a balloon catheter of claim 42, wherein, further comprising providing a central lumen extending through the balloon body, wherein the connecting line extends through the central lumen.

49. The method of securing an implantable medical device to a balloon catheter of claim 48, wherein, further comprising providing an intermediate sheath extending through a lumen defined between the sheath and the catheter body, the second adjustment line being connected to a distal end of the intermediate sheath.

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