Conveying device and conveying system

Abstract

The invention relates to a conveying device. The conveying device comprises a membrane breaking guide wire and a conveyor, the conveyor comprises a sheath core, a conveying sheath tube, a filtering piece and an outer sheath tube which are sleeved from inside to outside; a space for accommodating a lumen stent is formed between the outer peripheral surface of the sheath core and the inner wall surface of the conveying sheath tube; the membrane rupture guide wire is movably arranged in the sheath core; the membrane rupturing guide wire comprises a guide wire body and a membrane rupturing needle, the membrane rupturing needle is movably arranged in the guide wire body, and the membrane rupturing needle can exceed the far end of the guide wire body under the action of external force so as to pierce a covering membrane on a covered stent. The conveying device does not need to go in and out of the human body for many times during in-situ windowing operation, and meanwhile the effect of protecting far-end blood vessels is achieved.

Description

Technical Field

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

[0002] The aortic arch is the arched, curved portion of the upper aorta. Three larger branch arteries emanate from the convex side of the aortic arch, which are divided into the innominate artery, left common carotid artery, and left subclavian artery from right to left. When aortic aneurysm and aortic dissection occur in the aortic arch, the blood vessel wall becomes thinner. If not treated in time, the blood vessel may rupture at any time. Currently, the two main treatments for aortic aneurysm and aortic dissection are open surgery and endovascular repair. Compared with open surgery, endovascular repair is less invasive, has less bleeding, faster recovery, and a lower mortality rate. Endovascular repair surgery usually releases a covered stent in the diseased area of ​​the blood vessel to isolate the aortic aneurysm and aortic dissection. Since the aortic arch connects to the three larger branch arteries, after releasing the covered stent from the aortic arch, it is necessary to make an in situ window on the covered stent at the position corresponding to the branch artery or to reserve a through hole directly on the covered stent.

[0003] Current in situ fenestration techniques typically begin with an in situ fenestration device, followed by an insertion of a guidewire. After the device is removed, a stent delivery device is inserted along the guidewire, ultimately releasing the branch stent. Existing in situ fenestration techniques require multiple insertions and exits of the device, resulting in numerous procedures. Excessive manipulation can easily cause emboli within the diseased vessel to dislodge and travel to the brain, posing a potential risk. Summary of the Invention

[0004] Based on this, it is necessary to provide a delivery device that is easy to operate and protects distal blood vessels.

[0005] The present invention provides a delivery device for delivering a luminal stent, the delivery device comprising: a membrane-breaking guide wire and a delivery device;

[0006] The delivery device comprises a sheath core, a delivery sheath, a filter element and an outer sheath arranged from the inside out; a space for accommodating the endoluminal stent is provided between the outer circumference of the sheath core and the inner wall of the delivery sheath; the outer sheath and the filter element can move relative to each other to release or retract the filter element;

[0007] The membrane-breaking guidewire is movably arranged in the sheath core; the membrane-breaking guidewire includes a guidewire body and a membrane-breaking needle, the membrane-breaking needle is movably arranged in the guidewire body, and the membrane-breaking needle can exceed the distal end of the guidewire body under the action of external force to pierce the membrane on the coated stent.

[0008] In some embodiments, the conveyor further comprises a conveying handle, wherein the conveying handle comprises a fixed handle and a movable handle; the movable handle is disposed at a proximal end of the fixed handle, and the movable handle is axially movable relative to the fixed handle;

[0009] The proximal end of the outer sheath tube and the proximal end of the filter element are connected to the fixed handle, and the proximal end of the delivery sheath tube and the proximal end of the sheath core are connected to the movable handle.

[0010] In some embodiments, the delivery handle further includes a connecting piece, which is sleeved on the distal end of the movable handle; the distal end of the connecting piece is threadedly connected to the proximal end of the fixed handle, and the proximal end of the connecting piece is rotatably connected to the distal end of the movable handle.

[0011] In some embodiments, the filter element includes a filter screen and a frame, the filter screen has a proximal opening and a distal opening, and the distal opening is connected to the lumen of the outer sheath tube through the proximal opening; the frame includes a traction wire, a proximal support ring and a distal support ring, the proximal support ring is connected to the proximal opening of the filter screen, the distal support ring is connected to the distal opening of the filter screen, the distal end of the traction wire is connected to the proximal support ring, and the proximal end of the traction wire is connected to the fixed handle.

[0012] In some embodiments, the guidewire body includes a tubular body portion and a protective sleeve, wherein the protective sleeve is disposed at the distal end of the tubular body portion;

[0013] The protective cover has an open state and a closed state. When the protective cover is in the open state, the protective cover has a distal opening, and the membrane rupture needle can pass through the distal opening to exit the guide wire body.

[0014] In some embodiments, the protective sleeve is made of a soft material and changes from a closed state to an open state when squeezed by the membrane rupturing needle.

[0015] In some embodiments, the protective sleeve includes two protective arms and two connecting arms, and the two protective arms are at least partially exposed at the distal end of the tube body;

[0016] The two protective arms are hingedly connected, and the space between the distal ends of the two protective arms is used to accommodate the distal end of the membrane-breaking needle. The proximal ends of the two protective arms are respectively hinged to the distal ends of the two connecting arms, and the proximal ends of the two connecting arms are hinged to the membrane-breaking needle; when the membrane-breaking needle moves toward the distal end, the distal ends of the two protective arms move away from each other and expose the distal end of the membrane-breaking needle.

[0017] In some embodiments, the delivery device further comprises a guidewire handle detachably connected to the membrane rupturing guidewire, wherein the guidewire handle comprises a handle body and a locking cap;

[0018] The proximal end of the membrane rupture guidewire is arranged in the handle body; the locking cap is sleeved on the distal end of the handle body, and under the action of external force, the distal end of the handle body clamps or releases the membrane rupture guidewire.

[0019] In some embodiments, the guidewire handle further comprises a button movably connected to the proximal end of the handle body;

[0020] The button is at least connected to the membrane rupturing needle of the membrane rupturing guidewire to drive the membrane rupturing needle to move relative to the guidewire body.

[0021] In some embodiments, the guide wire body includes a tubular body portion, an elastic portion, and a connecting portion connected in sequence; the membrane rupture needle passes through the tubular body portion and the elastic portion, and the proximal end of the membrane rupture needle is fixedly connected to the connecting portion;

[0022] The connecting portion is detachably connected to the button, and the button is used to squeeze the elastic portion and cause the membrane rupturing needle to extend from the distal end of the tube body.

[0023] In some embodiments, the button includes a button body and at least two elastic parts; the at least two elastic parts are circumferentially arranged at the distal end of the button body, and the at least two elastic parts enclose a cavity, and the cavity is used to accommodate the connecting part of the guide wire body;

[0024] The outer peripheral surface of the elastic part is provided with a protrusion, and the inner wall of the handle body is provided with a circle of grooves. When the protrusion is facing the groove, the cavity is in an open state and the connecting part can enter the cavity; when the protrusion is separated from the groove, the elastic part is elastically deformed and gathered inward along the radial direction of the button body, the cavity is in a closed state, and the connecting part is locked in the cavity.

[0025] The delivery device of the present invention utilizes a membrane-piercing guidewire to puncture the stent graft. During operation, the membrane-piercing guidewire is first inserted into the position where the fenestration is to be performed. After the delivery device reaches the target position along the membrane-piercing guidewire, a filter element is deployed to protect the distal end of the blood vessel. The membrane-piercing guidewire is then used to puncture the membrane on the stent graft, and finally the delivery device releases the stent to establish communication between the aortic arch and the branch vessels. The delivery device of the present invention eliminates the need for multiple entry and exit from the human body during in situ fenestration operations, while also protecting distal blood vessels.

[0026] The present invention also provides a delivery system, which includes the above-mentioned delivery device and a lumen support, wherein the lumen support is arranged between the sheath core and the delivery sheath. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 This is a front view of the conveying device according to Example 1 of the present invention;

[0028] Figure 2 A partial front view of a conveyor according to embodiment 1 of the present invention;

[0029] Figure 3 This is a partial cross-sectional view of the membrane rupturing guidewire according to Example 1 of the present invention (the protective sheath is in a closed state);

[0030] Figure 4 This is a schematic diagram of the delivery device of Example 1 of the present invention placed in the aorta;

[0031] Figure 5 This is a front view of the handle of Example 1 of the present invention;

[0032] Figure 6 is a cross-sectional view of a handle according to embodiment 1 of the present invention;

[0033] Figure 7 for Figure 6 Enlarged view of point A in the middle;

[0034] Figure 8 It is a front view of a delivery handle according to another embodiment of the present invention;

[0035] Figure 9 This is a schematic diagram of the connection between the filter element and the outer sheath tube of Example 1 of the present invention;

[0036] Figure 10 This is a front view of the frame of Example 1 of the present invention;

[0037] Figure 11 This is a partial cross-sectional view of the membrane rupturing guidewire according to Example 1 of the present invention (the protective cover is in the open state);

[0038] Figure 12 is a partial cross-sectional view of a guidewire body according to another embodiment of the present invention;

[0039] Figure 13 2 is a cross-sectional view of the guidewire handle according to Example 1 of the present invention;

[0040] Figure 14 for Figure 13 Enlarged view of point B in the middle;

[0041] Figure 15 A three-dimensional diagram of a key according to embodiment 1 of the present invention;

[0042] Figure 16 2 is a cross-sectional view of the guidewire handle according to Example 1 of the present invention;

[0043] Figure 17 2 is a cross-sectional view of the guidewire handle according to Example 1 of the present invention;

[0044] Figure 18 This is a partial stereoscopic view of the membrane rupturing guidewire according to Example 2 of the present invention;

[0045] Figure 19 This is a partial three-dimensional diagram of the membrane rupture needle and protective sleeve of Example 2 of the present invention;

[0046] Figure 20 is a three-dimensional diagram of a filter element according to embodiment 3 of the present invention;

[0047] Figure 21 This is a schematic diagram of testing the filter element according to Example 3 of the present invention;

[0048] Figure 22 This is a cross-sectional view of the filter element of Example 3 of the present invention when it is inside the head arm trunk (the first filter screen and the second filter screen are made transparent, and the blocked part is shown in dotted lines);

[0049] Figure 23 This is a left view of the filter element of Example 3 of the present invention (the first filter screen and the second filter screen are made transparent, and the blocked parts are shown in dotted lines);

[0050] Figure 24 Schematic diagram of the length ratio of the first sub-filter element and the second sub-filter element in Example 3 of the present invention (the second filter screen is made transparent, and the blocked part is shown in dotted lines);

[0051] Figure 25 This is a three-dimensional diagram of the filter element according to Example 3 of the present invention (the first filter screen and the second filter screen are made transparent, and the blocked parts are shown in dotted lines);

[0052] Figure 26 A perspective view of a first frame and a second frame according to embodiment 3 of the present invention;

[0053] Figure 27 is a perspective view of a filter element according to another embodiment of the present invention;

[0054] Figure 28 This is a three-dimensional diagram of a first filter screen according to another embodiment of the present invention. DETAILED DESCRIPTION

[0055] In order to make the purpose, technical solutions and advantages of the present invention more clearly understood, the present invention will be further described in detail below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0056] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention pertains. The terms used in this specification of the present invention are for the purpose of describing specific embodiments only and are not intended to limit the present invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0057] In order to more clearly describe the structure of the present invention, "distal end" and "proximal end" are used as directional words, which are commonly used terms in the field of interventional medical devices, where "distal end" refers to the end away from the operator during the operation, and "proximal end" refers to the end close to the operator during the operation.

[0058] Example 1

[0059] like Figure 1 As shown, the delivery device 100 of this embodiment includes: a delivery device 10 and a membrane rupturing guide wire 20.

[0060] like Figure 2 As shown, the conveyor 10 includes a sheath core 11, a conveying sheath 12, a filter 13 and an outer sheath 14 arranged from the inside to the outside; there is a space for accommodating the tubular stent between the outer peripheral surface of the sheath core 11 and the inner wall surface of the conveying sheath 12; the outer sheath 14 and the filter 13 can move relative to each other to release or contract the filter 13.

[0061] The membrane-breaking guide wire 20 is movably arranged in the sheath core 11. Figure 3 As shown, the membrane rupture guidewire 20 includes a guidewire body 21 and a membrane rupture needle 22. The membrane rupture needle 22 is movably arranged in the guidewire body 21, and the membrane rupture needle 22 can exceed the distal end of the guidewire body 21 under the action of external force to pierce the membrane on the coated stent.

[0062] The delivery device 100 of the present invention utilizes a membrane-breaking guidewire 20 to puncture the stent graft. During operation, the membrane-breaking guidewire 20 is first inserted into the position where the window is to be opened. After the delivery device 10 reaches the target position along the membrane-breaking guidewire 20, the filter element 13 is deployed to protect the distal end of the blood vessel. Subsequently, the membrane on the stent graft is punctured using the membrane-breaking guidewire 20, and finally the delivery device 10 releases the stent to achieve connectivity between the aortic arch and the branch vessels. The delivery device 100 of the present invention does not need to enter and exit the human body multiple times when performing an in-situ window opening operation, while also having the effect of protecting the distal blood vessels. For example, Figure 4As shown, after the aortic arch covered stent 300 is released in the aortic arch 1, the delivery device 100 of the present invention enters the brachiocephalic trunk 3 through the right subclavian artery 2. When the distal end of the delivery device 100 reaches the aortic arch covered stent 300, the filter element 13 is released first, and then the aortic arch covered stent 300 is windowed in situ, and finally the branch stent 200 is released to achieve communication between the brachiocephalic trunk 3 and the aortic arch 1.

[0063] The aortic arch stent graft 300 comprises a frame and a membrane. The membrane is preferably made of a highly elastic material, such as a silicone film, PU film, PA film, or PTFE film. Alternatively, the membrane may have a localized elastic coating at locations corresponding to branch vessels. This allows the puncture hole formed by the membrane rupture needle 22 to be propped open by the expansion force of the branch stent 200 itself. Furthermore, after the branch stent 200 is released, the elastic coating adheres closely to the outer circumference of the branch stent 200, providing a good seal.

[0064] like Figure 5 and Figure 6 As shown, the conveyor 10 also includes a conveying handle 15, which includes a fixed handle 151 and a movable handle 152; the movable handle 152 is arranged at the proximal end of the fixed handle 151, and the movable handle 152 can move axially relative to the fixed handle 151; the proximal end of the outer sheath 14 and the proximal end of the filter element 13 are connected to the fixed handle 151, and the proximal end of the conveying sheath 12 and the proximal end of the sheath core 11 are connected to the movable handle 152.

[0065] In this embodiment, if Figure 6As shown, an outer sheath tube drive assembly 153 is provided in the fixed handle 151. The outer sheath tube drive assembly 153 is connected with the proximal end of the outer sheath tube 14, for driving the outer sheath tube 14 to move along the axial direction of the conveying device 100. The outer sheath tube drive assembly 153 includes an outer sheath tube button 1531 and an outer sheath tube sealing valve 1532, and the outer sheath tube button 1531 is axially slidably connected with the shell of the fixed handle 151, for driving the outer sheath tube 14 to move axially under the impetus of external force, and the outer sheath tube sealing valve 1532 is for the delivery sheath tube 12 to pass and to the circumferential sealing of the delivery sheath tube 12. The outer sheath tube drive assembly 153 can also be connected with a three-way valve (not shown). A delivery sheath tube drive assembly 154 is provided in the movable handle 152, and the delivery sheath tube drive assembly 154 is connected with the proximal end of the delivery sheath tube 12, for driving the delivery sheath tube 12 to move along the axial direction of the conveying device 100. The delivery sheath drive assembly 154 includes a delivery sheath button 1541 and a delivery sheath sealing valve 1542. The delivery sheath button 1541 is axially slidably connected to the outer shell of the movable handle 152 and is used to drive the outer sheath 14 to move axially under the push of an external force. The delivery sheath sealing valve 1542 allows the sheath core 11 to pass through and circumferentially seals the sheath core 11. The delivery sheath drive assembly 154 may also be connected to a three-way valve (not shown in the figure).

[0066] Thus, the outer sheath drive assembly 153, under the influence of an external force, can drive the outer sheath 14 to move toward the distal end or the proximal end, thereby achieving the contraction or release of the filter element 13. The delivery sheath drive assembly 154, under the influence of an external force, can drive the delivery sheath 12 to move toward the distal end or the proximal end, thereby achieving the contraction or release of the branch stent 200. The aforementioned external force refers to the thrust exerted by the operator on the outer sheath drive assembly 153 or the delivery sheath drive assembly 154.

[0067] After the filter element 13 is deployed, it is not advisable to move the filter element 13 to avoid scratching the blood vessels. However, before deploying the branch stent 200, it is still necessary to adjust the positions of the sheath core 11 and the delivery sheath 12 so that the branch stent 200 is in the correct position after release to avoid internal leakage. Therefore, the delivery handle 15 is set to a relatively movable fixed handle 151 and a movable handle 152, which can enable the branch stent 200 to move relative to the deployed filter 131 until the branch stent 200 reaches the correct position, and then the delivery sheath 12 is withdrawn to release the branch stent 200. For example, Figure 5As shown, after the delivery device 100 completes puncturing the aortic arch stent graft 300, the sheath core 11 and the delivery sheath tube 12 are further moved distally to further expand the puncture hole in the aortic arch stent graft 300. At the same time, the proximal end of the unreleased branch stent 200 is placed inside the aortic arch stent graft 300 to prevent internal leakage at the connection between the branch stent 200 and the aortic arch stent graft 300 after the branch stent 200 is released. Therefore, it is necessary to adjust the positions of the sheath core 11, the delivery sheath tube 12, and the unreleased branch stent 200 by moving the movable handle 152.

[0068] In this embodiment, if Figure 5 and Figure 6 As shown, the delivery handle 15 further includes a connecting piece 155, and the connecting piece 155 is sleeved on the distal end of the movable handle 152. Figure 7 As shown, the distal end of the connector 155 is threadedly connected to the proximal end of the fixed handle 151, and the proximal end of the connector 155 is rotatably connected to the distal end of the movable handle 152. The proximal end of the fixed handle 151 is provided with an external thread 1511, and the distal end of the connector 155 is provided with an internal thread 1551 that engages with the external thread 1511. The distal outer circumferential surface of the movable handle 152 is provided with a circle of grooves 1521, and the proximal end of the connector 155 is provided with a buckle 1552. The buckle 1552 is movably disposed in the groove 1521, so that when the connector 155 rotates and moves axially, the movable handle 152 can only move axially with the connector 155 and will not rotate circumferentially. When it is necessary to adjust the release position of the branch stent 200, the connector 155 is rotated, and the connector 155 drives the movable handle 152 to move along the axial direction of the delivery device 100. Specifically, the connecting member 155 improves the connection stability between the fixed handle 151 and the movable handle 152. Figure 8 As shown, the delivery handle 15 may not include the connecting piece 155, and the delivery sheath 12a, the sheath core and the unexpanded branch stent can be moved by axially moving the movable handle 152a relative to the fixed handle 151a ( Figure 8 The sheath core and branch stent are not marked).

[0069] Furthermore, a locking structure (not shown) is provided between the delivery sheath drive assembly 154 and the fixed handle 152. When the delivery sheath drive assembly 154 and the fixed handle 152 are in a locked state, the delivery sheath drive assembly 154 can move with the fixed handle 152. When the delivery sheath drive assembly 154 and the fixed handle 152 are in an unlocked state, the delivery sheath drive assembly 154 can move relative to the fixed handle 152. This embodiment is not limited to the specific structure of the locking structure, and can achieve locking of the delivery sheath drive assembly 154 and the fixed handle 152, and unlocking the delivery sheath drive assembly 154 and the fixed handle 152 under the action of an external force (such as a doctor's pressing force).

[0070] In this embodiment, if Figure 9 As shown, the filter element 13 includes a filter screen 131 and a frame 132. The filter screen 131 has a proximal opening 1311 and a distal opening 1312. The distal opening 1312 is connected to the lumen of the outer sheath 14 through the proximal opening 1311. Figure 10 As shown, the frame 132 includes a traction wire 1321, a proximal support ring 1322 and a distal support ring 1323. The proximal support ring 1322 is connected to the proximal opening 1311 of the filter 131, and the distal support ring 1323 is connected to the distal opening 1312 of the filter 131. The traction wire 1321 is connected to the proximal support ring 1322. The proximal end of the traction wire 1321 passes through the wall of the outer sheath 14 and is connected to the fixed handle 151. In this embodiment, the proximal end of the traction wire 1321 is fixedly connected to the outer shell of the fixed handle 151, so that when the outer sheath drive assembly 153 drives the outer sheath 14 to move toward the distal end or proximal end, the filter 131 can maintain its position unchanged under the support of the traction wire 1321, so that the outer sheath 14 can tighten or release the filter 131.

[0071] like Figure 10 As shown, the filter element 13 includes two pulling wires 1321 ; the proximal support ring 1322 has a first opening 1324 , and two ends of the first opening 1324 are respectively connected to the two pulling wires 1321 .

[0072] The frame 132 also includes two connecting wires 1325; the proximal support ring 1322 has a second opening 1326, and the two ends of the second opening 1326 are respectively connected to the proximal ends of the two connecting wires 1325; the distal support ring 1323 has a third opening 1327, and the two ends of the third opening 1327 are respectively connected to the distal ends of the two connecting wires 1325.

[0073] In this embodiment, the two traction wires 1321, the proximal support ring 1322, the two connecting wires 1325, and the distal support ring 1323 are formed by bending a single metal wire multiple times. After the metal wire is bent to form the distal support ring 1323 having the third opening 1327, the two ends of the distal support ring 1323 are bent to form the two connecting wires 1325. The two connecting wires 1325 are bent to form the proximal support ring 1322 having the first opening 1324 and the second opening 1326. The proximal support ring 1322 is bent at the first opening 1324 to form the two traction wires 1321.

[0074] In this embodiment, the two traction wires 1321 are of different lengths, wherein the proximal end of the shorter traction wire 1321 is fixedly connected to the longer traction wire 1321, so as to reduce the space occupied by the traction wire 1321 in the outer sheath 14 or reduce the aperture size required for the traction wire 1321 to pass through the wall of the outer sheath 14. It can be understood that the shorter the length of the shorter traction wire 1321, the more conducive it is to reducing the space occupied by the two traction wires 1321. Therefore, on the basis of meeting the shape and strength requirements of the proximal support ring 1322, the length of one of the traction wires 1321 can be shortened as much as possible.

[0075] The traction wire 1321 drives the filter element 1312 to move axially relative to the outer sheath 14 under the action of an external force. For example, when a doctor applies tension to the traction wire 1321, the frame 132 deforms so that the filter element 1312 is entirely confined within the outer sheath 14. The frame 132 of this embodiment is formed by bending a single metal wire multiple times, which simplifies the process and provides high overall connection strength.

[0076] To facilitate pushing and constricting of the filter element 1312, the pull wire 1321 must be resistant to bending, while the proximal support ring 1322, connecting wire 1325, and distal support ring 1323 must be deformable. Specifically, the diameter of the pull wire 1321 is greater than the diameter of the metal wire segments forming the proximal support ring 1322, connecting wire 1325, and distal support ring 1323. In this embodiment, the frame 132 is entirely made of nickel-titanium wire. The diameter of the pull wire 1321 is 0.3 mm to 0.4 mm, and the diameter of the nickel-titanium wire segments forming the proximal support ring 1322, connecting wire 1325, and distal support ring 1323 is 0.08 mm to 0.1 mm. In other embodiments, the pull wire 1321 is made of stainless steel wire, and the proximal support ring 1322, connecting wire 1325, and distal support ring 1323 are made of nickel-titanium wire. Compared with the tubular structure, the internal space of the outer sheath 14 occupied by the traction wire 1321 is smaller. Therefore, when the caliber of the proximal opening 1311 of the filter 131 is the same, the outer sheath 14 required for the filter element 13 using the traction wire 1321 is smaller, thereby making the conveyor 10 suitable for smaller blood vessels.

[0077] The filter element 13 is deployed and supported in the branch vessel before in-situ windowing and the release of the branch stent 200, and can intercept emboli (air emboli, thrombi, etc.) generated by the membrane rupture guidewire 20 during in-situ windowing and the delivery device 10 during the release of the branch stent 200. After the filter element 13 is deployed, the distal support ring 1323 of the filter element 13 is supported on the vessel wall of the branch vessel, and the proximal support ring 1322 of the filter element 13 is supported in the outer sheath 14. Therefore, the outer sheath 14 is centered in the branch vessel after the filter element 13 is deployed. The delivery sheath 12, sheath core 11, and membrane rupture guidewire 20 that pass through the outer sheath 14 and the filter element 13 are all centered in the branch vessel, improving the accuracy of the puncture position of the membrane rupture guidewire 20 on the aortic arch covered stent 300, and at the same time improving the accuracy of the release position of the branch stent 200.

[0078] In this embodiment, the guide wire body 21 includes a tube body portion 211 and a protective cover 212, and the protective cover 212 is provided at the distal end of the tube body portion 211. Figure 3 and Figure 11 The protective cover 212 has a closed state and an open state. When the protective cover 212 is in the open state, the protective cover 212 has a distal opening 2122 , and the membrane rupturing needle 22 can pass through the guide wire body 21 through the distal opening 2122 .

[0079] The protective sleeve 212 is used to prevent the membrane rupture needle 22 from damaging the blood vessel when passing through the blood vessel. Only when the membrane rupture guidewire 20 reaches the preset position, the membrane rupture needle 22 will pass through the guidewire body 21 and then pierce the membrane on the aortic arch covered stent 300.

[0080] In this embodiment, the protective cover 212 is made of soft material, such as biocompatible silicone, rubber, etc. Figure 3 As shown, the distal end of the protective sleeve 212 is provided with a through hole 2121 axially penetrating the protective sleeve 212. Figure 11 As shown, the through hole expands into the distal opening 2122 when squeezed by the membrane-breaking needle 22 , that is, the protective sleeve 212 changes from a closed state to an open state.

[0081] When the protective sheath 212 is in a closed state, its distal end surface is curved to reduce the resistance of passing through the blood vessel.

[0082] like Figure 12 As shown, in other embodiments, in order to increase the flexibility of the membrane rupturing guidewire 20a, the tube body 211a may include at least one section of spring tube 2111a, and at least one end of the spring tube 2111a is arranged close to the distal end of the tube body 211a.

[0083] like Figure 13 and Figure 14 As shown, the delivery device 100 may also include a guidewire handle 30 detachably connected to the membrane rupture guidewire 20, and the guidewire handle 30 includes a handle body 31 and a locking cap 32; the proximal end of the membrane rupture guidewire 20 is arranged in the handle body 31; the locking cap 32 is sleeved on the distal end of the handle body 31, and under the action of external force, the distal end of the handle body 31 clamps or releases the membrane rupture guidewire 20.

[0084] Specifically, the handle body 31 includes a clamping portion 311 and a first threaded portion 312, and the clamping portion 311 is arranged at the distal end of the first threaded portion 312. The clamping portion 311 has a first inner cavity 313, and the membrane rupture guidewire 20 passes through the first inner cavity 313. The outer peripheral surface of the clamping portion 311 has a first conical surface 314, and the first conical surface 314 gradually tilts toward the central axis from the proximal end to the distal end. The locking cap 32 includes a pressing portion 321 and a second threaded portion 322, and the locking cap 32 also has a second inner cavity 323 that passes through the pressing portion 321 and the second threaded portion 322. The clamping portion 311 and the first threaded portion 312 of the handle body 31 are arranged in the second inner cavity 323. The inner wall surface of the second inner cavity 323 has a second conical surface 324, and the second conical surface 324 gradually tilts toward the central axis from the proximal end to the distal end. The second threaded portion 322 is screwed into the first threaded portion 312. When the locking cap 32 is screwed in toward the proximal end, the second tapered surface 324 gradually presses the first tapered surface 314, so that the clamping portion 311 clamps the membrane rupture guidewire 20, achieving a fixed connection between the guidewire handle and the membrane rupture guidewire 20. To loosen the guidewire handle, the locking cap 32 is loosened toward the distal end.

[0085] The guidewire handle 30 further includes a button 33 movably connected to the proximal end of the handle body 31. The button 33 is connected to at least the membrane rupture needle 22 of the membrane rupture guidewire 20 to drive the membrane rupture needle 22 to move relative to the guidewire body 21. After the guidewire handle is fixed to the membrane rupture guidewire 20, the membrane rupture needle 22 is moved relative to the guidewire body 21 by operating the button 33, so that the membrane rupture needle 22 passes through the distal end of the guidewire body 21 and pierces the membrane.

[0086] Specifically, see Figure 13 The guidewire body 21 includes a tubular portion 211, an elastic portion 212, and a connecting portion 213, which are connected in sequence. The membrane-breaking needle 22 passes through the tubular portion 211 and the elastic portion 212, and the proximal end of the membrane-breaking needle 22 is fixedly connected to the connecting portion 213. The connecting portion 213 is detachably connected to the button 33, which is used to compress the elastic portion 212 and extend the membrane-breaking needle 22 from the distal end of the tubular portion 211. When the pressure applied to the button 33 is removed, the membrane-breaking needle 22 and the connecting portion 213 move proximally under the tension of the elastic portion 212, thereby retracting the membrane-breaking needle 22 into the guidewire body 21.

[0087] like Figure 15As shown, the button 33 includes a button body 331 and at least two deformation parts 332; the at least two deformation parts 332 are circumferentially arranged at the distal end of the button body 331, and the at least two deformation parts 332 enclose a cavity 333, and the cavity 333 is used to accommodate the connecting part 213 of the guide wire body 21; the outer peripheral surface of the deformation part 332 is provided with a protrusion 3321, as shown Figure 13 As shown, the inner wall of the handle body 31 is provided with a circle of grooves 315. Figure 16 and 17 As shown, when the protrusion 3321 faces the groove 315, the cavity 333 is in an open state, and the connecting portion 213 can enter the cavity 333. Figure 18 As shown, when the protrusion 3321 is separated from the groove 315 , the deformation portion 332 is elastically deformed and gathered inward along the radial direction of the key body 331 , the cavity 333 is in a closed state, and the connecting portion 213 is locked in the cavity 333 .

[0088] When the button 33 is in a natural state (ie, not squeezed by external force), Figure 15 As shown, the deformation portion 332 forms a certain angle with the axial direction of the button body 331, that is, the deformation portion 332 pops out radially. The four deformation portions 332 enclose the cavity 333. Figure 16 As shown, when the button 33 is placed in the handle body 31 and the protrusion 3321 of the deformed portion 332 is facing the groove 315 of the handle body 31, the deformed portion 332 is still in a natural state or is squeezed inward to a certain extent, but the cavity 333 formed by the at least two deformed portions 332 can still allow the connecting portion 213 of the guide wire body 21 to pass through. At this time, moving the button 33 allows the connecting portion 213 of the guide wire body 21 to enter the cavity 333. Figure 17 As shown, until the resistance to moving the button 33 increases, indicating that the guidewire body 21 has been installed in place, tighten the locking cap 32 to achieve a fixed connection between the guidewire body 21 and the guidewire handle 30. Then press the button 33. When the button 33 is pushed axially and moves toward the distal end, the deformed portion 332 gradually separates from the groove 315 and is gradually squeezed inward, as shown in FIG. Figure 13 As shown, after the deformation portion 332 is completely separated from the groove 315, the deformation portion 332 moves inward under the pressure of the inner wall of the handle body 31, thereby clamping the connecting portion 213, realizing a fixed connection between the connecting portion 213 and the button 33. At the same time, the button 33 squeezes the deformation portion 332, so that the distal end of the membrane rupture needle 22 extends from the distal end of the guide wire body 21.

[0089] The operation process of the conveying device of this embodiment is as follows:

[0090] 1. After the aortic arch stent graft is released, the membrane-breaking guidewire is inserted along the distal end of one of the three branches on the arch.

[0091] 2. The delivery device is inserted along the membrane rupturing guide wire. After reaching the preset position, the outer sheath is withdrawn to open the filter element.

[0092] 3. Install the guidewire handle onto the membrane rupture guidewire, adjust the position of the membrane rupture guidewire, and press the button to puncture the membrane of the aortic arch covered stent to form a puncture hole in the membrane.

[0093] 4. Rotate the connector to move the sheath core, sheath tube and unreleased branch stent distally until the distal end of the unreleased branch stent enters the aortic arch stent graft, and withdraw the delivery sheath to release the branch stent.

[0094] 5. Push the outer sheath forward to reclaim the filter and remove the conveying device.

[0095] Example 2

[0096] The structure of the delivery device of Example 2 is substantially the same as that of the delivery device of Example 1, and the main difference is that the structure of the membrane rupturing guide wire 20 is different. Figure 18 and Figure 19 As shown, the membrane rupture guidewire 20 includes a guidewire body 21 and a membrane rupture needle 22 disposed within the guidewire body 21. The guidewire body 21 includes a tubular body 211 and a protective sleeve 212 connected to the distal end of the tubular body 211. The protective sleeve 212 includes two protective arms 2121 and two connecting arms 2122. The two protective arms 2121 may be at least partially exposed at the distal end of the tubular body 211.

[0097] The two protective arms 2121 are hingedly connected, and the space between the distal ends of the two protective arms 2121 is used to accommodate the distal end of the membrane-breaking needle 21. The proximal ends of the two protective arms 2121 are respectively hinged to the distal ends of the two connecting arms 2122, and the proximal ends of the two connecting arms 2122 are hinged to the membrane-breaking needle 21; when the membrane-breaking needle 21 moves toward the distal end, the distal ends of the two protective arms 2121 move away from each other and expose the distal end of the membrane-breaking needle 21.

[0098] Specifically, if Figure 19As shown, the two protective arms 2121 are hinged by a first hinge rod 2123, and the two ends of the first hinge rod 2123 are connected to the guide wire body 21. A through hole is provided on the first hinge rod 2123, and the membrane rupture needle 21 passes through the through hole, so that the membrane rupture needle 21 can move axially relative to the protective arm 2121 and the first hinge rod 2123. The proximal end of the protective arm 2121 is hinged to the distal end of the connecting arm 2122 through the second hinge rod 2124. The proximal ends of the two connecting arms 2122 are hinged by a third hinge rod 2125, and the third hinge rod 2125 is fixedly connected to the membrane rupture needle 22. Therefore, when the membrane rupture needle 22 moves toward the distal end, the connecting arm 2122 and the protective arm 2121 are linked to each other so that the protective arms 2121 move away from each other.

[0099] Replay Figure 18 The distal end of the tube body 211 is symmetrically provided with two U-shaped grooves 2112, and the distal ends of the U-shaped grooves pass through the tube body 211. The U-shaped grooves 2112 are used to avoid the protective arms 2121 and the connecting arms 2122, providing sufficient space for the opening of the protective sleeve 212.

[0100] Wherein, the membrane rupture needle 22 includes a support rod 221, a connecting rod 222 and a membrane rupture head 223. Wherein, the connecting rod 222 is connected to the proximal end of the membrane rupture head 223, and the support rod 221 is connected to the proximal end of the connecting rod 222. The rod diameter of the support rod 221 is larger than the rod diameter of the connecting rod 222. The connecting rod 222 with a smaller rod diameter is used to connect with the protective sleeve 212 to avoid the distal end of the membrane rupture guide wire 20 being too large. The support rod 221 with a larger rod diameter provides sufficient support force for the movement of the membrane rupture needle 22. The shape of the membrane rupture head 223 is approximately fusiform, and its distal end is sharp and pointed, which is convenient for puncturing the membrane of the aortic arch covered stent 300.

[0101] In order to increase the flexibility of the membrane rupturing guidewire 20 , the tube body 211 includes at least one section of a spring tube 2111 , and at least one end of the spring tube 2111 is disposed close to the distal end of the tube body 211 .

[0102] Example 3

[0103] The main difference between Example 3 and Example 1 is that Figure 20 As shown, the filter element includes a first sub-filter element 133 and a second sub-filter element 134. The circumferential dimensions of the first sub-filter element 133 and the second sub-filter element 134 are both gradually reduced from the distal end to the proximal end; the proximal end of the first sub-filter element 133 is disposed within the second sub-filter element 134, and the distal end of the first sub-filter element 133 exceeds the distal end of the second sub-filter element 134.

[0104] The first sub-filter element 133 is provided with a first deformation zone 1331, and the second sub-filter element 134 is provided with a second deformation zone 1341. The projections of the first deformation zone 1331 and the second deformation zone 1341 on the cross-section of the filter element 13 do not overlap, wherein the cross-section is perpendicular to the central axis Z of the filter element 13. In this embodiment, the first sub-filter element 133 and the second sub-filter element 134 have the same shape and size, but are oriented in different circumferential directions, thereby ensuring that the projections of the first deformation zone 1331 and the second deformation zone 1341 on the cross-section of the filter element 13 do not overlap.

[0105] The filter element 13 of the present invention provides dual protection for blood vessels by comprising two independent, partially nested first and second sub-filter elements 133, 134. Furthermore, the first and second sub-filter elements 133, 134 have first and second deformation zones 1331, 1341 oriented in different directions. This allows the first and second sub-filter elements 133, 134 to deform to different degrees or in different directions when subjected to radial pressures of the same magnitude. This allows the filter element 13 to better conform to blood vessels of varying shapes.

[0106] The flat plate method can be used to test the changes in the diameters of the first sub-filter element 133 and the second sub-filter element 134 under the same radial direction and the same pressure, thereby testing the degree of deformation of the first sub-filter element 133 and the second sub-filter element 134. Figure 21 With the first and second sub-filter elements 133 and 134 freely deployed, parallel plates 01 and 02 were placed on opposite sides of the first sub-filter element 133. A radial force F of equal magnitude and opposite directions was applied perpendicularly to the plates 01 and 02. The two parallel plates 01 and 02 remained parallel to each other throughout the test, remaining parallel to the central axis. Similarly, parallel plates 03 and 04 were placed on opposite sides of the second sub-filter element 134. A radial force F of equal magnitude and opposite directions was applied perpendicularly to the plates 03 and 04.

[0107] If the diameter of the first sub-filter element 133 clamped against the flat plate in its naturally expanded state is R1, then the change in the diameter of the first sub-filter element 133 under the action of radial force F is the difference between the diameters before and after radial compression, represented by ΔR1, and the rate of change is ΔR1 / R1. To ensure that the flat plate does not deform during the application of the radial force and that the radial force is applied uniformly across the flat plate, the thickness of the flat plate should be at least 5 mm. Similarly, if the diameter of the second sub-filter element 134 clamped against the flat plate in its naturally expanded state is R2, where R2 = R1, then the change in the diameter of the second sub-filter element 134 under the action of radial force F is the difference between the diameters before and after radial compression, represented by ΔR2, and the rate of change is ΔR2 / R2.

[0108] Based on the above test conditions, under the action of radial forces of the same radial direction and magnitude, if ΔR1 / R1 is greater than ΔR2 / R2, or ΔR1 is greater than ΔR2, it means that under the force in this direction, the deformation degree of the first sub-filter element 133 is greater; otherwise, the deformation degree of the second sub-filter element 134 is greater.

[0109] Specifically, the first sub-filter 133 must have a certain supporting force to resist the impact of blood flow. However, due to the presence of a certain degree of deformation in the lesion area or the blood vessel segment near the lesion area, for example, Figure 22 The cross section of the blood vessel 3 is not a regular circle, so the filter element with strong support has poor wall adhesion. Therefore, the first deformation zone 1331 is provided to enable the first sub-filter element 133 to deform to a certain extent under the pressure of the blood vessel wall, so as to better fit the blood vessel wall. Figure 22 When the filter element 13 is deployed in the blood vessel 3, the first sub-filter element 133 is more likely to stretch and deform along the X-axis due to the presence of the first deformation zone 1331. Similarly, the second sub-filter element 134 is more likely to stretch and deform along the Y-axis due to the presence of the second deformation zone 1341. Figure 15 In the embodiment, when the filter element 13 is subjected to a force from the blood vessel wall along the X-axis direction, the deformation degrees of the first sub-filter element 133 and the second sub-filter element 134 are not the same. Even if the first sub-filter element 133 does not completely fit the blood vessel wall, the second sub-filter element 134, which is more easily stretched and deformed along the Y-axis direction, can fit the protruding part of the blood vessel wall and play a role in supplementary blocking. That is, the filter element 13 can adaptively fit the blood vessel wall under the pressure of the blood vessel wall.

[0110] It should be noted that, in the first sub-filter element 133, due to the presence of the first deformation zone 1331, the degree and direction of deformation of the first sub-filter element 133 will change with the relative position between the point of application of pressure applied to the first sub-filter element 133 and the first deformation zone 1331. Similarly, due to the presence of the second deformation zone 1341, the degree and direction of deformation of the second sub-filter element 134 will change with the relative position between the point of application of pressure applied to the second sub-filter element 134 and the second deformation zone 1341. Therefore, at a specific location, the first sub-filter element 133 and the second sub-filter element 134 may experience the same degree of deformation. However, since the first deformation zone 1331 and the second deformation zone 1341 have different circumferential directions of the filter element 13, the deformation shapes of the first sub-filter element 133 and the second sub-filter element 134, that is, the directions of elongation and protrusion are not exactly the same, that is, the projections of the first sub-filter element 133 and the second sub-filter element 134 on the cross-section of the filter element 13 do not completely overlap, and can still adapt to the shape of the blood vessel, thereby improving the overall wall adhesion of the filter element 13.

[0111] like Figure 23 As shown, the perpendicular line segment from the starting point of the first deformation zone 1331 to the central axis of the filter element 13 is the first line segment L1; the perpendicular line segment from the starting point of the second deformation zone 1341 to the central axis of the filter element 13 is the second line segment L2. The angle α formed by the projections of the first and second line segments L1 and L2 on the cross section is 80°-100°. When the angle α is less than 80°, the first and second deformation zones 1331 and 1341 are too close together. When the first and second sub-filter elements 133 and 134 are subjected to radial pressure of the same radial direction and magnitude, the directions in which the first and second sub-filter elements 133 and 134 extend and protrude are also too close. In other words, the projections of the first and second sub-filter elements 133 and 134 on the cross section of the filter element 13 tend to overlap, failing to provide a supplementary sealing effect. Similarly, when the angle α is greater than 100°, when the first sub-filter element 133 and the second sub-filter element 134 are subjected to radial pressure in the same radial direction and magnitude, the first sub-filter element 133 and the second sub-filter element 134 will extend and protrude too close to each other. Preferably, when the angle α is 90°, the overlap of the projections of the first sub-filter element 133 and the second sub-filter element 134 on the cross-section of the filter element 13 is minimized, which is more conducive to improving the fit between the filter element 13 and the blood vessel wall.

[0112] Since the first sub-filter 133 and the second sub-filter 134 are independently arranged components, when the first sub-filter 133 and the second sub-filter 134 are squeezed by the blood vessel wall, the distal openings of the first sub-filter 133 and the second sub-filter 134 can be deformed independently, thereby better fitting the blood vessel wall. It should be noted that if the distance between the first sub-filter 133 and the second sub-filter 134 is too far, the length of the blood vessel required is too long, which is not conducive to the operation. In addition, the deformation shapes of the blood vessel segments that are farther away may be different. It is difficult for the first sub-filter 133 and the second sub-filter 134 to play a role in secondary blocking and intercepting thrombus. Therefore, in this embodiment, if Figure 24 As shown, the length L3 of the portion of the first sub-filter element 133 that extends beyond the distal end of the second sub-filter element 134 accounts for one-quarter to one-half of the overall length L4 of the first sub-filter element 133. The circumferential dimensions of the first sub-filter element 133 and the second sub-filter element 134 both taper from the distal end to the proximal end, meaning that the proximal outer side of the first sub-filter element 133 provides a converging space for the second sub-filter element 134. Even if the first sub-filter element 133 and the second sub-filter element 134 are partially interlocked, this does not affect the smooth converging of the filter element 13 by the outer sheath 14.

[0113] like Figure 25 As shown, the first sub-filter element 133 includes a first filter screen 1333 and a first frame 1332; Figure 26As shown, the first frame 1332 includes a first annular structure 13321 and a first support structure 13322. The first annular structure 13321 is disposed along the edge of the first filter screen 1333, and the first support structure 13322 extends from the first annular structure 13321 to the proximal end of the first sub-filter element 133. In this embodiment, the structure of the second sub-filter element 134 is identical to that of the first sub-filter element 133, namely, the second sub-filter element 134 includes a second filter screen 1343 and a second frame 1342. The second frame 1342 includes a second annular structure 13421 and a second support structure 13422. The second annular structure 13421 is disposed along the distal opening edge of the second filter screen 1343, and the second support structure 13422 extends from the second annular structure 13421 to the proximal end of the second sub-filter element 134. In other embodiments, the structure of the second sub-filter element 134 may differ from that of the first sub-filter element 133. The first frame 1332 and the second frame 1342 are made of materials with good biocompatibility and good elasticity, such as nickel-titanium alloy and stainless steel. The first filter 1333 and the second filter 1343 are made of a material selected from a metal woven mesh, a woven or woven mesh of polymer fibers, a woven or woven mesh of a polymer mixed metal material, or a porous polymer membrane. The pore size of the filter is 0.1-0.5 mm.

[0114] In this embodiment, if Figure 26 As shown, the first annular structure 13321 has a first notch 13323, which forms the first deformation zone 1331; the second annular structure 13421 has a second notch 13423, which forms the second deformation zone 1313. In other embodiments, the first and second deformation zones may also be a wavy line segment, a line segment with a smaller outer diameter, or an elastic segment made of elastic material. The first deformation zone 1331 accounts for no more than 1 / 25 of the length of the first annular structure 13321, and the second deformation zone 1313 accounts for no more than 1 / 25 of the length of the second annular structure 13421. This is because excessive lengths of the first and second deformation zones 1331 and 1313 may make it difficult for the first and second sub-filter elements 133 and 134 to meet anchoring requirements.

[0115] Specifically, taking the first sub-filter element 133 as an example, the first frame 1332 extends from the proximal end to the distal end of the first filter screen 1333, and finally coils around the edge of the distal opening of the first filter screen 1333 to form a first annular structure 13321 with a first gap 13323.

[0116] The first frame 1332 also includes a first proximal support ring 13324 and a traction wire 13325, and the first proximal support ring 13324 is arranged along the proximal opening edge of the first filter screen 1333; the second frame 1342 also includes a second proximal support ring 13424, and the second proximal support ring 13424 is arranged along the proximal opening edge of the second filter screen 1343; the distal end of the traction wire 13325 is connected to the first proximal support ring 13324 and the second proximal support ring 13424 in sequence.

[0117] The distal end of the traction wire 13325 in this embodiment is passed through the outer sheath 14, and the proximal end thereof is passed through a hole in the wall of the outer sheath 14 to the outside of the outer sheath 14, thereby avoiding interference with the delivery sheath that needs to pass through the outer sheath 14. In other embodiments, the traction wire can be entirely passed through the outer sheath; or the outer sheath is a double-lumen tube, one of which is used to pass the traction wire, and the traction wire can be entirely passed through this lumen or partially passed through the lumen.

[0118] The outer diameter of the traction wire 13325 ranges from 0.3 mm to 0.35 mm to provide the strength required to support the first sub-filter 133 and the second sub-filter 134. The diameter of the material used to make the first frame 1332 and the second frame 1342 ranges from 0.08 mm to 0.1 mm, thereby minimizing the space occupied by the first proximal support ring 13324 within the outer sheath 14, allowing the outer sheath 14 of the same inner diameter to accommodate a larger delivery sheath.

[0119] like Figure 26 As shown, the first proximal support ring 13324 and the second proximal support ring 13424 are both open rings, wherein one end of the first proximal support ring 13324 is connected to the first support structure 13322, and the other end of the first proximal support ring 13324 is connected to the traction wire 13325; one end of the second proximal support ring 13424 is connected to the second support structure 13422, and the other end of the second proximal support ring 13424 is connected to the traction wire 13325. When it is necessary to withdraw the first sub-filter 133 and the second sub-filter 134, the traction wire 13325 is pulled, and the first and second proximal support rings 13324 and 13424 can be deformed under the pulling action of the traction wire 13325, thereby facilitating the recovery of the first and second sub-filters 133 and 134 into the outer sheath 14.

[0120] Further, look back Figure 25A connecting post 135 is provided between the first sub-filter element 133 and the second sub-filter element 134. The connecting post 135 is a hollow cylindrical structure. The distal opening of the connecting post 135 is connected to the proximal opening of the first filter screen 1333, and the proximal opening of the connecting post 135 is connected to the proximal opening of the second filter screen 1343. The provision of the connecting post 135 can further stabilize the connection between the first sub-filter element 133 and the second sub-filter element 134. The connecting post 135 is made of a material selected from a metal woven mesh, a woven or woven mesh of polymer fibers, a woven or woven mesh of a polymer mixed metal material, or a porous polymer membrane. The connecting post 135 is connected to the first sub-filter element 133 and the second sub-filter element 134 by welding, bonding, or other methods.

[0121] In some embodiments, one or more openings are provided on the connecting column, and emboli captured by the second sub-filter element can enter the first lumen of the outer sheath tube through the openings, thereby preventing the second sub-filter element from being blocked.

[0122] In other embodiments, Figure 27 and Figure 28As shown, the outer surface of the first filter 133a is provided with a groove 13331a that is recessed toward the inside of the first filter 1333a. The groove 13331a spirally extends from the distal end to the proximal end of the first filter 1333, and the first support structure 13322a is disposed within the groove 13331a. Because the first filter 1333a is relatively thin, the groove 1333a1 appears as a protrusion on the inner side of the first filter 1333a. This protrusion acts as a flow guide within the first filter 1333a, creating a vortex effect when blood flows through the first filter 1333a, attracting blood clots to the bottom of the protective device and preventing them from escaping or being trapped on the wall and blocking blood flow through the micropores of the first filter 1333a. Plasma and healthy blood cells, which are smaller than the micropores of the first filter 1333a, can flow through the micropores to the distal end. Furthermore, the hollow pusher connected to the first sub-filter element can be connected to a suction device or an extracorporeal circulation filtration device to promptly extract the thrombus within the first sub-filter element. Since only the outer circumferential surface of the first sub-filter element 133a is provided with the groove 13331a, the gap between the outer circumferential surface of the first sub-filter element 133a and the inner wall of the second sub-filter element 134a in this embodiment is larger than that in a protective device without the groove 13331a. When the distal opening of the first sub-filter element 133a fails to contact the blood vessel wall, some thrombus may flow into the second sub-filter element 134a through the sufficiently large gap between the outer circumferential surface of the first sub-filter element 133a and the second sub-filter element 134a, thereby being collected by the second sub-filter element 134a. On the contrary, when the distal opening of the first sub-filter element 133 cannot fit the blood vessel wall, if the gap between the outer peripheral surface of the first sub-filter element 133a and the second sub-filter element 134a is too small, the thrombus escaping from the first sub-filter element 133a will easily accumulate at the distal opening of the second sub-filter element 134a and will have difficulty in smoothly entering the second sub-filter element 134a. During the process of withdrawing the protective device, these thrombi may fall back into the blood vessel, increasing the risk of surgery.

[0123] The technical features of the above-mentioned embodiments can be combined arbitrarily. In order to make the description concise, not all possible combinations of the technical features in the above-mentioned embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0124] The above-described embodiments merely illustrate several implementations of the present invention, and while their descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the patent. It should be noted that a person skilled in the art would be able to make numerous variations and improvements without departing from the spirit of the present invention, all of which fall within the scope of protection of the present invention. Therefore, the scope of protection of the patent for this invention shall be determined by the appended claims.

Claims

1. A delivery device for delivering a luminal stent, characterized in that: include: Membrane rupture guidewires and delivery devices; The conveyor comprises a sheath core, a conveying sheath tube, a filter element and an outer sheath tube which are arranged from the inside to the outside; a space for accommodating the luminal stent is provided between the outer peripheral surface of the sheath core and the inner wall surface of the conveying sheath tube; the outer sheath tube and the filter element can move relative to each other to release or gather the filter element; The membrane-breaking guidewire is movably arranged in the sheath core; the membrane-breaking guidewire includes a guidewire body and a membrane-breaking needle, the membrane-breaking needle is movably arranged in the guidewire body, and the membrane-breaking needle can exceed the distal end of the guidewire body under the action of external force to pierce the membrane on the coated stent.

2. The conveying device according to claim 1, characterized in that The conveyor further comprises a conveying handle, wherein the conveying handle comprises a fixed handle and a movable handle; the movable handle is arranged at the proximal end of the fixed handle, and the movable handle can move axially relative to the fixed handle; The proximal end of the outer sheath tube and the proximal end of the filter element are connected to the fixed handle, and the proximal end of the delivery sheath tube and the proximal end of the sheath core are connected to the movable handle.

3. The conveying device according to claim 2, characterized in that: The delivery handle also includes a connecting piece, which is sleeved on the distal end of the movable handle; the distal end of the connecting piece is threadedly connected to the proximal end of the fixed handle, and the proximal end of the connecting piece is rotatably connected to the distal end of the movable handle.

4. The conveying device according to claim 1, characterized in that The filter element includes a filter screen and a frame, the filter screen has a proximal opening and a distal opening, and the distal opening is connected to the lumen of the outer sheath tube through the proximal opening; the frame includes a traction wire, a proximal support ring and a distal support ring, the proximal support ring is connected to the proximal opening of the filter screen, the distal support ring is connected to the distal opening of the filter screen, the distal end of the traction wire is connected to the proximal support ring, and the proximal end of the traction wire is connected to the fixed handle.

5. The conveying device according to claim 1, characterized in that: The guide wire body comprises a tube body and a protective sleeve, wherein the protective sleeve is arranged at the distal end of the tube body; The protective cover has an open state and a closed state. When the protective cover is in the open state, the protective cover has a distal opening, and the membrane rupturing needle can pass through the distal opening to exit the guide wire body.

6. The conveying device according to claim 5, characterized in that The protective sleeve is made of soft material and changes from a closed state to an open state when being squeezed by the membrane rupturing needle.

7. The conveying device according to claim 5, characterized in that The protective sleeve comprises two protective arms and two connecting arms, and the two protective arms may be at least partially exposed at the distal end of the tube body; The two protective arms are hingedly connected, and the space between the distal ends of the two protective arms is used to accommodate the distal end of the membrane rupture needle. The proximal ends of the two protective arms are respectively hinged to the distal ends of the two connecting arms, and the proximal ends of the two connecting arms are hinged to the membrane rupture needle; when the membrane rupture needle moves toward the distal end, the distal ends of the two protective arms move away from each other and expose the distal end of the membrane rupture needle.

8. The conveying device according to claim 1, characterized in that: The delivery device also includes a guide wire handle detachably connected to the membrane rupturing guide wire, and the guide wire handle includes a handle body and a locking cap; The proximal end of the membrane rupture guidewire is arranged in the handle body; the locking cap is sleeved on the distal end of the handle body, and under the action of external force, the distal end of the handle body clamps or releases the membrane rupture guidewire.

9. The conveying device according to claim 8, characterized in that The guidewire handle further comprises a button, wherein the button is movably connected to the proximal end of the handle body; The button is at least connected to the membrane rupturing needle of the membrane rupturing guidewire to drive the membrane rupturing needle to move relative to the guidewire body.

10. The conveying device according to claim 9, characterized in that The guide wire body comprises a tubular body portion, an elastic portion and a connecting portion which are connected in sequence; the membrane-breaking needle passes through the tubular body portion and the elastic portion, and the proximal end of the membrane-breaking needle is fixedly connected to the connecting portion; The connecting portion is detachably connected to the button, and the button is used to squeeze the elastic portion to make the membrane-breaking needle extend from the distal end of the tube body.

11. The conveying device according to claim 10, characterized in that The button comprises a button body and at least two elastic parts; the at least two elastic parts are circumferentially arranged at the distal end of the button body, and the at least two elastic parts enclose a cavity, and the cavity is used to accommodate the connecting part of the guide wire body; The outer peripheral surface of the elastic part is provided with a protrusion, and the inner wall of the handle body is provided with a circle of grooves. When the protrusion is opposite to the groove, the cavity is in an open state, and the connecting part can enter the cavity; when the protrusion is separated from the groove, the elastic part is elastically deformed and gathered inward along the radial direction of the key body, the cavity is in a closed state, and the connecting part is locked in the cavity.

12. A conveying system, characterized in that: It comprises the delivery device as described in any one of claims 1 to 11; the delivery system also comprises a lumen support, and the lumen support is arranged between the sheath core and the delivery sheath.

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