A protection system

Abstract

The present application relates to a protection system, which comprises: at least one protection sheath, which comprises an outer sheath tube and a filter arranged at the distal end of the outer sheath tube; the outer sheath tube has a first lumen, and the filter has a proximal opening and a distal opening, the distal opening is communicated with the first lumen through the proximal opening; a filter bypass device, which has an input port and an output port, the input port is communicated with the first lumen; at least one return tube, the proximal end of the return tube is communicated with the output port, and the distal end of the return tube is used for returning the filtered blood to the human body. The protection system of the present application can protect the branch blood vessels during the expansion of the branch stent, and can return the filtered blood to the human body, thereby reducing the blood loss of the patient during the operation.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to a protection system. BACKGROUND

[0002] In cardiovascular intervention surgery, surgical instruments are often delivered to target lesions through a delivery sheath for surgery, such as balloon dilation for intravascular stenosis, stent expansion; stent reconstruction for aortic dissection and aortic aneurysm, aortic valve replacement for valvular disease, etc. During the treatment, blood clots or calcified fragments may fall off, and without protection, the detached emboli are washed to the distal end of the blood flow, causing distal vascular embolism, which may lead to local pain, tissue necrosis, hemiplegia, dementia, and even death.

[0003] Especially in aortic arch cavity repair surgery, the high degree of atherosclerosis of the patient's aortic arch and excessive intra-arch cavity operation increase the risk of atherosclerotic plaque detachment. In the existing technology, a protection system is usually used at the distal end to intercept and capture the detached emboli for temporary protection of the cerebral vessels. However, in aortic arch cavity repair surgery involving branch vessels (head and arm trunks, left common carotid artery, and left subclavian artery), not only the branch vessels need to be protected, but also branch stents need to be placed in the branch vessels, and there is currently no protection device that can take into account the treatment function. SUMMARY

[0004] Therefore, it is necessary to provide a protection system for interventional surgery that takes into account the treatment function.

[0005] The present application provides a protection system, comprising:

[0006] at least one protection sheath, comprising an outer sheath tube and a filter arranged at the distal end of the outer sheath tube; the outer sheath tube has a first lumen, and the filter has a proximal opening and a distal opening, the distal opening being in communication with the first lumen through the proximal opening;

[0007] a filter and flow diversion device having an input port and an output port, the input port being in communication with the first lumen;

[0008] at least one reflux tube, the proximal end of the reflux tube being in communication with the output port, and the distal end of the reflux tube being used to return the blood filtered by the filter and flow diversion device to the human body.

[0009] In one embodiment, the protection system further comprises an inflow adapter, the inflow adapter comprising at least one inflow adapter port and an inflow port, each of the inflow adapter ports being in communication with one of the outer sheath tubes, and the inflow port being in communication with the input port of the filter and flow diversion device.

[0010] In one embodiment, the protection system further comprises an outflow adapter, the outflow adapter comprising an outflow port and at least one outflow adapter port, the outflow port being in communication with the output port of the filter flow device, each of the outflow adapter ports being in communication with one of the reflux tubes.

[0011] In one embodiment, the reflux tube is connected to the outer sheath tube side by side; the reflux tube has a reflux port, the reflux port being located on the proximal side of the filter element.

[0012] In one embodiment, the protection system further comprises a sliding connector, the reflux tube is connected to the outer sheath tube through the sliding connector, so that the reflux tube can move along the axial direction of the outer sheath tube under the action of external force.

[0013] In one embodiment, the reflux port is inclined relative to the axial direction of the outer sheath tube, the side of the reflux port close to the distal end of the outer sheath tube is closer to the distal end of the outer sheath tube than the side of the reflux port away from the distal end of the outer sheath tube.

[0014] In one embodiment, the filter element comprises a filter screen body, a filter screen skeleton supporting the filter screen body, and a push element;

[0015] The push element is movably arranged in the first lumen or outside the first lumen relative to the axial direction of the outer sheath tube, and the distal end of the push element is connected to the filter screen skeleton.

[0016] In one embodiment, the filter flow device comprises a filter cavity and a filter screen, the filter cavity is in communication with the input port and the output port, and the filter screen is arranged in the filter cavity;

[0017] The density of the filter screen is less than the density of the filter element.

[0018] In one embodiment, the filter flow device further comprises an exhaust port; the filter cavity is connected to the input port, the output port and the exhaust port;

[0019] The input port is arranged on the upper edge of the inflow side of the filter cavity, the output port is arranged on the lower edge of the outflow side of the filter cavity, and the exhaust port is arranged on the upper edge of the outflow side of the filter cavity.

[0020] In one embodiment, the protection system further comprises a pump, the pump is arranged between the filter flow device and the reflux tube.

[0021] The protection sheath of the protection system of the present application is deployed in the branch blood vessel to meet the blood flow in the interventional operation, the delivery device of the branch stent can pass through the first lumen of the protection sheath and pass through the filter of the protection sheath to reach the aortic arch, and the filter intercepts emboli in the branch blood vessel during the expansion of the branch stent. Meanwhile, the protection sheath is circumscribed by the filter bypass device, blood carrying emboli enters the filter bypass device through the first lumen of the protection sheath, and finally the blood filtered by the filter bypass device is returned to the human body, reducing the blood loss of the patient during the operation. BRIEF DESCRIPTION OF DRAWINGS

[0022] Figure 1 It is a top view of the protection system of the embodiment 1 of the present application.

[0023] Figure 2 It is a schematic diagram of the aortic dissection involving the head and arm trunk, left common carotid artery and left subclavian artery.

[0024] Figure 3 It is a schematic diagram after the stent is implanted in the aortic arch.

[0025] Figure 4 It is a working schematic diagram of the protection system of the embodiment 1 of the present application.

[0026] Figure 5 It is a top view of the inflow converter of the embodiment 1 of the present application.

[0027] Figure 6 It is a top view of the protection system in other embodiments of the present application.

[0028] Figure 7 It is a top view of the outflow converter of the embodiment 1 of the present application.

[0029] Figure 8 It is a schematic diagram of the protection sheath and the return tube of the embodiment 1 of the present application.

[0030] Figure 9 It is a cross-sectional view of the protection sheath and the return tube of the embodiment 1 of the present application.

[0031] Figure 10 It is a schematic diagram of the filter bypass device of the embodiment 1 of the present application.

[0032] Figure 11 It is a top view of the protection system of the embodiment 2 of the present application.

[0033] Figure 12 It is a partial perspective view of the protection sheath of the embodiment 3 of the present application.

[0034] Figure 13 It is a test schematic diagram of the protection sheath of the embodiment 3 of the present application.

[0035] Figure 14 A cross-sectional view of the protective sheath of the present application, embodiment 3, when placed in a blood vessel (the first and second filter meshes are transparently treated).

[0036] Figure 15 A left view of the first and second filter members of the present application, embodiment 3 (the first and second filter meshes are transparently treated).

[0037] Figure 16 A length ratio diagram of the first and second filter members of the present application, embodiment 3 (the second filter member is transparently treated).

[0038] Figure 17 A partial perspective view of the protective sheath of the present application, embodiment 3 (the first and second filter meshes are transparently treated).

[0039] Figure 18 A perspective view of the first and second frames of the present application, embodiment 3.

[0040] Figure 19 A partial perspective view of the protective sheath of the present application, embodiment 4 (the first and second filter meshes are transparently treated).

[0041] Figure 20 A perspective view of the first filter mesh of the present application, embodiment 5.

[0042] Figure 21 A perspective view of the first filter member of the present application, embodiment 5.

[0043] Figure 22 A perspective view of the first and second filter members of the present application, embodiment 5. DETAILED DESCRIPTION

[0044] In order to make the objects, technical solutions, and advantages of the present application clearer, the present application 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 application and not intended to limit the present application.

[0045] 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 of the application herein is for the purpose of 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.

[0046] In order to more clearly describe the structure of the present application, "distal" and "proximal" are used as directional words, which are common terms in the field of interventional medical devices, wherein "distal" means the end far from the operator during the operation, and "proximal" means the end close to the operator during the operation.

[0047] Embodiment 1

[0048] As shown in Figure 1 , the protection system 1 of the present embodiment comprises at least one protection sheath 11, a filter bypass device 12 and at least one backflow tube 13. As shown in Figure 8 and Figure 9 , the protection sheath 11 comprises an outer sheath tube 111 and a filter 113 arranged at the distal end of the outer sheath tube; the outer sheath tube 111 has a first lumen 1111, and the filter 113 has a proximal opening and a distal opening, the distal opening being in communication with the first lumen 1111 through the proximal opening.

[0049] Looking back Figure 1 , the filter bypass device 12 has an input port 121 and an output port 122, and the input port 121 is in communication with the first lumen 1111.

[0050] The proximal end of the backflow tube 13 is in communication with the output port 122, and the distal end of the backflow tube 13 is used to return the blood filtered by the filter bypass device to the human body.

[0051] The protection sheath 11 of the protection system 1 of the present application is deployed in the branch blood vessel to meet the blood flow during the interventional operation, and the delivery device of the branch stent can pass through the first lumen 1111 of the protection sheath 11 and pass through the filter 113 of the protection sheath 11 to reach the aortic arch, and the filter 113 intercepts emboli in the branch blood vessel during the expansion of the branch stent. At the same time, the protection sheath 11 is circumscribed by the filter bypass device 12, the blood carrying emboli enters the filter bypass device 12 through the first lumen 1111 of the protection sheath 11, and finally the blood filtered by the filter bypass device 12 is returned to the human body, reducing the amount of blood loss of the patient during the operation.

[0052] As shown in Figure 2As shown, when the aortic dissection 05 involves the brachiocephalic trunk 02, the left common carotid artery 03 and the left subclavian artery 04, the conventional surgical method requires that the main stent 06 is first released in the aortic arch 01, and the main stent 06 can adopt a pre-window stent or a general covered stent. When the main stent 06 adopts a pre-window stent, after the main stent 06 is released, the branch stent 07 is respectively delivered from the brachiocephalic trunk 02, the left common carotid artery 03 and the left subclavian artery 04 through the branch stent 07 delivery device 2, and the branch stent 07 is respectively released in the brachiocephalic trunk 02, the left common carotid artery 03 and the left subclavian artery 04. When the main stent 06 is a general covered stent, the branch stent 07 needs to be delivered after in-situ windowing of the main stent 06. For example Figure 3 As shown, the main stent 06 is placed in the aortic arch 01, and the branch stent 07 is placed in the brachiocephalic trunk 02, the left common carotid artery 03 and the left subclavian artery 04 to repair the aortic arch 01 and ensure blood flow in the branch vessels. Whether the main stent 06 adopts a pre-window stent or a general covered stent, the branch stent 07 needs to be delivered and released through the branch vessels, and emboli generated during the delivery and release of the branch stent 07 can flow to the distal end through the brachiocephalic trunk 02, the left common carotid artery 03 and the left subclavian artery 04, causing possible damage to the patient.

[0053] The protection system 1 of the present application can achieve brain protection for the patient when the branch stent 07 is placed. Specifically, as shown Figure 4 The protection system 1 of the present embodiment includes three protection sheaths 11, and one protection sheath 11 is placed in the brachiocephalic trunk 02, the left common carotid artery 03 and the left subclavian artery 04 respectively before the main stent 06 is placed, and the filter 113 of the protection sheath 11 is opened towards the proximal end, and the branch stent 07 delivery device 2 can pass through the outer sheath tube 111 and the filter 113 of the protection sheath 11 to release the branch stent 07 to the target position. During the delivery and release of the main stent 06 and the branch stent 07, the filter 113 intercepts emboli, and blood carrying emboli enters the filter and bypass device 12 through the first lumen 1111 of the protection sheath 11, and finally the blood filtered by the filter and bypass device 12 is returned to the human body. It should be noted that in Figure 4 The connection between the protection sheaths 11 in the brachiocephalic trunk 02 and the left common carotid artery 03 and the filter and bypass device 12 is not shown.

[0054] In other embodiments, the protection system can include one or two protection sheaths. For example, in aortic dissection 05 involving only left subclavian artery 04, only one protection sheath is needed to complete the protection of left subclavian artery 04 and release of branch stent 07. For example, in aortic dissection 05 involving only brachiocephalic trunk 02, only one protection sheath is used to complete the protection of brachiocephalic trunk 02 and release of branch stent 07, and a conventional filter structure only having a protection function is placed in left common carotid artery 03 and left subclavian artery 04 or at the connection position of left common carotid artery 03, left subclavian artery 04 and aortic arch 01, that is, the protection system of the present embodiment can be used in combination with other protection devices. For example, in aortic dissection 05 involving left common carotid artery 03 and left subclavian artery 04, two protection sheaths are used to complete the protection of left common carotid artery 03 and left subclavian artery 04 and release of branch stent 07.

[0055] As shown in Figure 1 and Figure 5 The protection system 1 of the present embodiment further includes an inflow converter 14, the outer sheath tubes being in communication with the filter flow conversion device 12 through the inflow converter 14; the inflow converter has at least one inflow conversion port 141 and an inflow port 142, each of the inflow conversion ports 141 being in communication with the proximal end of one of the outer sheath tubes 111, and the inflow port 142 being in communication with the input port 121. In the present embodiment, the inflow converter includes three inflow conversion ports 141, which are connected to the three protection sheaths 11 one by one, so as to uniformly input blood from the three protection sheaths 11 into the filter flow conversion device 12.

[0056] The above-mentioned return tube 13 can be connected to the vein of the patient, or can be connected to the artery of the patient. As shown in Figure 6 In other embodiments, when the return tube 13a is used to connect the vein of the patient or one of the branch vessels of aortic arch 01, the protection system 1a can only include one return tube 13a. In the present embodiment, the protection system 1 includes three return tubes 13, which are respectively used to connect to brachiocephalic trunk 02, left common carotid artery 03 and left subclavian artery 04, and return the filtered blood to brachiocephalic trunk 02, left common carotid artery 03 and left subclavian artery 04. Compared with returning the filtered blood to the vein of the patient, returning the filtered blood to brachiocephalic trunk 02, left common carotid artery 03 and left subclavian artery 04 respectively can improve the perfusion of brachiocephalic trunk 02, left common carotid artery 03 and left subclavian artery 04 during the operation, and reduce the risk of ischemia of the patient during the operation.

[0057] When the branch stent conveyor releases the branch stent in the branch blood vessel through the first lumen 1111, although the flow area of ​​the first lumen 1111 becomes smaller, blood can still pass through the filter element 113, thereby ensuring blood supply to the branch blood vessel.

[0058] In order to realize the diversion of the three return pipes 13, as shown in FIG. Figure 1 and Figure 7 As shown, the protection system 1 of this embodiment further includes an outflow converter 15, which has an outflow outlet 151 and three outflow transfer ports 152. The outflow outlet 151 is in communication with the output port 122, and each outflow transfer port 152 is in communication with one of the return pipes 13. In other embodiments, the outflow converter 15 may include one or two outflow transfer ports 152, and the number of the outflow transfer ports 152 may be equal to the number of the return pipes 13.

[0059] During interventional surgery on patients with aortic dissection 05 involving the brachiocephalic trunk 02, left common carotid artery 03, and left subclavian artery 04, if a conventional covered stent is used as the main stent 06, after the main stent 06 is released, in situ fenestration is performed on the main stent 06 at the positions corresponding to the three blood vessels. During this period, normal blood supply from the aortic arch 01 to the brain can only be restored after the fenestration of the corresponding positions of the brachiocephalic trunk 02 and the left common carotid artery 03 is completed. However, the blood supply to the left subclavian artery 04 still needs to wait for the completion of the fenestration of the corresponding position of the left subclavian artery 04 before it can be restored to normal. The whole process is time-consuming, so extracorporeal circulation needs to be established before the main stent 06 is delivered. Since the protection system 1 of this embodiment has three return tubes 13, and the three return tubes 13 are directly connected to the brachiocephalic trunk 02, the left common carotid artery 03 and the left subclavian artery 04, during the operation, only one of the three branch blood vessels of the brachiocephalic trunk 02, the left common carotid artery 03 and the left subclavian artery 04 needs to be restored, and blood will be input into the protection system 1, and then blood will be returned to the other two branch blood vessels at the same time, thereby shortening the extracorporeal circulation time.

[0060] In this embodiment, if Figure 1 and Figure 8 As shown, the return tube 13 is connected side by side with the outer sheath 111; the return tube 13 has a return port 131, which is located on the proximal side of the filter element 113. Therefore, only one puncture hole needs to be made on the branch blood vessel to complete the implantation of the branch stent 07 and the return of blood, reducing harm to the patient. Figure 4 Due to the presence of the filter element 113, the blood pressure at the proximal side of the filter element 113 is lower than the blood pressure at the distal end of the filter element 113. Therefore, the reflux port 131 is located at the proximal side of the filter element 113, which is more conducive to the smooth reinfusion of the filtered blood.

[0061] like Figure 8 As shown, the reflux port 131 is inclined relative to the axial direction of the outer sheath tube 111, and the side of the reflux port 131 close to the outer sheath tube 111 is closer to the distal end of the outer sheath tube 111 than the side of the reflux port 131 away from the outer sheath tube 111. This shape not only facilitates the entry of the reflux tube 13 and the outer sheath tube 111 into the puncture hole, but also expands the flow area of ​​the reflux port 131, allowing the blood in the reflux tube 13 to converge more quickly at the reflux port 131 into the blood of the branch vessels.

[0062] During interventional surgery, the smaller the outer diameter of the delivery sheath, the easier it is to operate. Since the return tube 13 of this embodiment is connected side by side with the outer sheath 111, the outer diameter of the portion of the protective system 1 that enters the blood vessel is increased. To facilitate the entry of the outer sheath 111 into the blood vessel, the length of the return tube 13 entering the blood vessel should be minimized, as long as the return port 131 of the return tube 13 is completely located within the blood vessel. Therefore, for the outer sheath and return tube that are integrally formed or fixedly connected, a distance should be reserved between the return port and the filter element. The size of this distance depends on the length of the blood vessel to be implanted with the branch stent 07 and the location of the puncture hole. Generally, the longer the distance between the puncture hole and the aortic arch 01, the longer the distance between the return port and the filter element. To accommodate different branch vessels, the protective system 1 of this embodiment also includes a sliding connector 132, through which the return tube 13 is connected to the outer sheath, so that the return tube 13 can move along the circumferential direction of the outer sheath 111 under the action of external force. During surgery, after the outer sheath 111 is placed, the reflux tube 13 can be pushed into the blood vessel along the outer sheath 111 so that the reflux port 131 of the reflux tube 13 is completely located in the blood vessel. Figure 8 As shown, the sliding connector 132 is an annular body, which is sleeved outside the outer sheath and the reflux tube 13. The annular body is fixedly connected to the reflux tube 13 and can slide relative to the outer sheath, so that the reflux tube 13 can slide along the outer sheath 111. The distance between the annular body and the nearest end of the reflux port 131 is in the range of 2cm-4cm. When the reflux tube 13 is pushed into the puncture hole, the annular body abuts against the expansion sheath located in the puncture hole to prevent the reflux tube 13 from further entering the blood vessel. Furthermore, a locking structure is provided on the annular body. When the reflux tube 13 is pushed into place, the annular body is locked to prevent the reflux tube 13 from moving during the operation. The locking structure can be a loose tie structure.

[0063] like Figure 9As shown, the shape of the reflux tube 13 is adapted to the shape of the outer wall of the outer sheath tube 111, so that the reflux tube 13 can be closely attached to the outer wall of the outer sheath tube 111.

[0064] Looking back Figure 8 The filter 113 includes a filter screen body 1131 and a filter screen frame 1132 supporting the filter screen body 1131. The protective sheath 11 further includes a pusher 112 movably arranged in the first lumen 1111 or outside the first lumen 1111 in an axial direction of the outer sheath tube 111, and a distal end of the pusher 112 is connected with the filter screen frame 1132. In the embodiment, as shown, Figure 9 The outer sheath tube 111 further has a second lumen 1112, and the pusher 112 is a guide wire arranged in the second lumen 1112, so as to avoid interference with the delivery device 2 passing through the first lumen 1111. The filter 113 further includes a handle 114 connected with a proximal end of the pusher 112, for withdrawing the filter 113. In other embodiments, the pusher can also be arranged in the first lumen as a whole. In some embodiments, the pusher can also be a tubular body arranged in the lumen, and a lumen of the pusher provides a delivery channel for the delivery device 2.

[0065] As shown, Figure 10 The filter diversion device 12 includes a filter cavity 123 and a filter screen 125, the filter cavity 123 is connected with the input port 121 and the output port 122, and the filter screen 125 is arranged in the filter cavity 123; the density of the filter screen 125 is less than the density of the filter screen body 1131.

[0066] Therefore, after the filter 113 is deployed, the pressure difference of blood at the distal end and the proximal end of the filter screen body 1131 is large. The blood entering the outer sheath tube and refluxing to the distal end of the filter screen body 1131 through the filter diversion device 12 has a small pressure loss, and the blood with high pressure can more smoothly reflux to the branch blood vessels on the proximal side of the filter screen body 1131.

[0067] As shown, Figure 10 The filter cavity 123 is connected with the input port 121, the output port 122 and the exhaust port 124; the input port 121 is arranged at an upper edge of an inflow side of the filter cavity 123, the output port 122 is arranged at a lower edge of an outflow side of the filter cavity 123, and the exhaust port 124 is arranged at an upper edge of the outflow side of the filter cavity 123. Specifically, during the operation, the filter diversion device 12 is placed horizontally, the input port 121 is higher than the output port 122, and under the action of gravity, the gas emboli in the blood float to the exhaust port above the output port 122 and are discharged, and the blood with a larger density flows out from the output port 122 at a lower position.

[0068] Embodiment 2

[0069] The main difference between Embodiment 2 and Embodiment 1 is that, as shown in Figure 11 When the delivery device of the branch stent enters the protection sheath 31, the delivery device occupies the flow area of the first lumen of the protection sheath 31. In order to facilitate the blood with stents to pass through the gap between the delivery device and the protection sheath 31, the pump 34 is arranged on the pipeline between the filter bypass device 32 and the return pipe 33 to assist the blood to flow to the return port of the return pipe 33. The pump 34 can be a centrifugal pump, a peristaltic pump, a centrifugal pump, etc., and is preferably a peristaltic pump.

[0070] Embodiment 3

[0071] The main difference between Embodiment 3 and Embodiment 1 is that, as shown in Figure 12 The protection sheath includes a first filter 413 and a second filter 414. The circumferential dimensions of the first filter 413 and the second filter 414 are tapered from the distal end to the proximal end; the proximal end of the first filter 413 is arranged in the second filter 414, and the distal end of the first filter 413 exceeds the distal end of the second filter 414.

[0072] The first filter 413 is provided with a first deformation zone 4131, and the second filter 414 is provided with a second deformation zone 4141; the projections of the first deformation zone 4131 and the second deformation zone 4141 on the cross section of the protection device 1 do not overlap; wherein the cross section is perpendicular to the central axis Z of the protection sheath. In this embodiment, the shapes and sizes of the first filter 413 and the second filter 414 are the same, but the orientations of the first filter 413 and the second filter 414 in the circumferential direction are different, so that the projections of the first deformation zone 4131 and the second deformation zone 4141 on the cross section of the protection sheath do not overlap.

[0073] The protection device 1 of the application can provide double protection for the blood vessel by arranging two first filters 413 and second filters 414 which are independent of each other and partially sleeved. At the same time, the first filter 413 and the second filter 414 have first deformation zones 4131 and second deformation zones 4141 with different orientations, so that the first filter 413 and the second filter 414 have different deformation degrees or different deformation directions when subjected to the same radial pressure, and the protection sheath can better fit blood vessels of various shapes.

[0074] Wherein, the flat plate method can be used to test the radial length change of the first filter 413 and the second filter 414 under the same radial force in the same direction and the same size, so as to test the deformation degree of the first filter 413 and the second filter 414. For example, see Figure 13 Under the premise that the first filter 413 and the second filter 414 remain free to expand, parallel flat plates 10 and 20 are placed on opposite sides of the first filter 413, and the same size and opposite direction radial force F is applied perpendicular to the flat plates 10 and 20; the two parallel flat plates 10 and 20 remain parallel to each other during the entire test, that is, they are always parallel to the central axis during the test. Similarly, parallel flat plates 30 and 40 are placed on opposite sides of the second filter 414 at the same time, and the same size and opposite direction radial force F is applied perpendicular to the flat plates 30 and 40.

[0075] If the radial length of the first filter 413 clamped between the flat plates in the natural expanded state is R1, then the radial length change of the first filter 413 under the action of the radial force F is the difference between the radial length before and after the radial compression, which can be represented by ΔR1, and the radial length change rate is ΔR1 / R1. In order to ensure that the flat plate does not deform during the application of the radial force, so that the radial force can be uniformly applied everywhere on the flat plate, the thickness of the flat plate is at least 5mm. Similarly, if the radial length of the second filter 414 clamped between the flat plates in the natural expanded state is R2, and R2=R1, then the radial length change of the second filter 414 under the action of the radial force F is the difference between the radial length before and after the radial compression, which can be represented by ΔR2, and the radial length change rate is ΔR2 / R2.

[0076] Based on the above test conditions, under the action of the same radial force in the same direction and the same size, if ΔR1 / R1 is greater than ΔR2 / R2, or ΔR1 is greater than ΔR2, it indicates that the deformation degree of the first filter 413 is greater under the action of the force in that direction; otherwise, the deformation degree of the second filter 414 is greater.

[0077] Specifically, the first filter 413 must have a certain support force to resist the impact of blood flow. However, due to the deformation of the lesion area or the blood vessel segment near the lesion area to a certain extent, for example, the blood vessel 100 in Figure 14 The cross section is not a regular circle, so the filter with strong support force has the problem of poor adhesion to the wall. Therefore, the first deformation zone 4131 is provided to enable the first filter 413 to deform to a certain extent under the pressure of the blood vessel wall, thereby better adhering to the blood vessel wall. See Figure 14When the protection device 1 is deployed in the blood vessel 100, the first filter member 413 is more easily elongated and deformed along the X-axis direction due to the presence of the first deformation zone 4131. Similarly, the second filter member 414 is more easily elongated and deformed along the Y-axis direction due to the presence of the second deformation zone 4141. Therefore, for example, when the protection device 1 is subjected to a force from the blood vessel wall along the X-axis direction, the first filter member 413 and the second filter member 414 are not deformed to the same extent, i.e. even if the first filter member 413 does not completely conform to the blood vessel wall, the second filter member 414, which is more easily elongated and deformed along the Y-axis direction, can conform to the protruding part of the blood vessel wall, playing a supplementary blocking role, i.e. the protection device 1 can conform to the blood vessel wall under the pressure of the blood vessel wall. Figure 15

[0078] It should be noted that in the first filter member 413, the deformation degree and deformation direction of the first filter member 413 will change with the relative position between the force point of the pressure applied on the first filter member 413 and the first deformation zone 4131. Similarly, due to the presence of the second deformation zone 4141, the deformation degree and deformation direction of the second filter member 414 will change with the relative position between the force point of the pressure applied on the second filter member 414 and the second deformation zone 4141. Therefore, it is possible that the deformation degree of the first filter member 413 and the second filter member 414 is the same at a specific position. However, since the first deformation zone 4131 and the second deformation zone 4141 are oriented in different circumferential directions of the protection device 1, the deformation shapes of the first filter member 413 and the second filter member 414, i.e. the directions of elongation and protrusion, are not the same, i.e. the projections of the first filter member 413 and the second filter member 414 on the cross section of the protection device 1 do not completely overlap, and the protection device 1 can still adapt to the shape of the blood vessel, thereby improving the overall conformability of the protection device 1.

[0079] As Figure 15 ​As shown, the perpendicular line segment from the starting point of the first deformation zone 4131 to the central axis of the protective device 1 is the first line segment L1; the perpendicular line segment from the starting point of the second deformation zone 4141 to the central axis of the protective device 1 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 4131 and 4141 are too close together. When the first and second filter elements 413 and 414 are subjected to radial pressure of the same direction and magnitude, the first and second filter elements 413 and 414 extend and bulge too close together. In other words, the projections of the first and second filter elements 413 and 414 on the cross section of the protective sheath tend to overlap, failing to provide a supplementary sealing effect. Similarly, when the angle α is greater than 100°, when the first filter element 413 and the second filter element 414 are subjected to radial pressure of the same radial direction and magnitude, the first filter element 413 and the second filter element extend and protrude too close to each other. Preferably, when the angle α is 90°, the overlap between the projections of the first filter element 413 and the second filter element on the cross-section of the protective sheath is minimized, which is more conducive to improving the adhesion between the protective sheath and the blood vessel wall.

[0080] Since the first filter element 413 and the second filter element 414 are independently provided components, only the proximal ends of the two are connected to the pushing element 412. When the first filter element 413 and the second filter element 414 are squeezed by the blood vessel wall, the distal openings of the first filter element 413 and the second filter element 414 can be deformed independently, thereby better fitting the blood vessel wall. It should be noted that if the distance between the first filter element 413 and the second filter element 414 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 filter element 413 and the second filter element 414 to play a role in secondary blocking and intercepting thrombus. Therefore, in this embodiment, if Figure 16 As shown, the length L3 of the portion of the first filter element 413 that extends beyond the distal end of the second filter element 414 accounts for one-quarter to one-half of the overall length L4 of the first filter element 413. The circumferential dimensions of the first filter element 413 and the second filter element 414 both taper from the distal end to the proximal end, i.e., the proximal outer side of the first filter element 413 provides a converging space for the second filter element 414. Even if the first filter element 413 and the second filter element 414 are partially nested, this does not affect the smooth converging of the outer sheath 411 on the protective device 1.

[0081] like Figure 17 As shown, the first filter element 413 includes a first filter screen 4133 and a first frame 4132; Figure 18As shown, the first frame 4132 comprises a first annular structure 41321 arranged along the edge of the first filter screen 4133 and a first support structure 41322 extending from the first annular structure 41321 to the proximal end of the first filter piece 413. In this embodiment, the structure of the second filter piece 414 is the same as that of the first filter piece 413, i.e., the second filter piece 414 comprises a second filter screen 4143 and a second frame 4142; the second frame 4142 comprises a second annular structure 41421 arranged along the distal opening edge of the second filter screen 4143 and a second support structure 41422 extending from the second annular structure 41421 to the proximal end of the second filter piece 414. In other embodiments, the structure of the second filter piece 414 can be different from that of the first filter piece 413. The first frame 4132 and the second frame 4142 are made of materials with good biocompatibility and good elasticity, such as nickel-titanium alloy and stainless steel. The first filter screen 4133 and the second filter screen 4143 are made of metal woven screens, polymer material fiber woven or textile screens, polymer hybrid metal material woven or textile screens, or porous polymer films, and the pore size of the filter screen is 0.1-0.5 mm.

[0082] In this embodiment, as shown in Figure 18 The first annular structure 41321 has a first notch 41323 forming the first deformation zone 4131, and the second annular structure 41421 has a second notch 41423 forming the second deformation zone 4141. In other embodiments, the first deformation zone and the second deformation zone can also be a wave-shaped line segment, a line segment with a smaller outer diameter, or an elastic segment made of elastic material. The proportion of the first deformation zone 4131 to the length of the first annular structure 41321 is not more than 1 / 25, and the proportion of the second deformation zone 4141 to the length of the second annular structure 41421 is not more than 1 / 25, because the length of the first deformation zone 4131 and the second deformation zone 4141 is too long, which makes it difficult to meet the anchoring requirements of the support strength of the first filter piece 413 and the second filter piece 414.

[0083] Specifically, taking the first filter piece 413 as an example, the first frame 4132 extends from the proximal end of the first filter screen 4133 to the distal end, and finally coils around the distal opening edge of the first filter screen 4133 to form a first annular structure 41321 with a first notch 41323.

[0084] The first frame 4132 further comprises a first proximal support ring 41324 arranged along the proximal opening edge of the first filter screen 4133; the second frame 4142 further comprises a second proximal support ring 41424 arranged along the proximal opening edge of the second filter screen 4143; the pushing member is a pulling wire 412, the distal end of which is connected to the first proximal support ring 41324 and the second proximal support ring 41424 in sequence.

[0085] In the embodiment, the pushing member is a pulling wire 412, the distal end of which is arranged in the outer sheath 51, and the proximal end of which is arranged outside the outer sheath 411 through an opening in the wall of the outer sheath 411, so as to avoid interference with a therapeutic instrument such as a stent delivery device that needs to pass through the outer sheath 411. In other embodiments, the pulling wire can be arranged in the outer sheath in whole; or the outer sheath is a double-lumen tube, one lumen of which is used to arrange the pulling wire, and the pulling wire can be arranged in the lumen in whole or partially.

[0086] The outer diameter of the pulling wire 412 ranges from 0.3 mm to 0.35 mm, so as to meet the strength required for supporting the first filter 413 and the second filter 414. The wire diameter of the material used to make the first frame 4132 and the second frame 4142 ranges from 0.08 mm to 0.1 mm, so as to minimize the space occupied by the first proximal support ring 41324 in the outer sheath 411, and enable the outer sheath 411 of the same inner diameter to accommodate a larger size delivery device.

[0087] As shown in Figure 18 The first proximal support ring 41324 and the second proximal support ring 41424 are both open rings, one end of the first proximal support ring 41324 is connected to the first support structure 41322, and the other end of the first proximal support ring 41324 is connected to the pulling wire 412; one end of the second proximal support ring 41424 is connected to the second support structure 41422, and the other end of the second proximal support ring 41424 is connected to the pulling wire 412. When it is necessary to withdraw the first filter 413 and the second filter 414, the pulling wire 412 is pulled, and the first proximal support ring 41324 and the second proximal support ring 41424 can be deformed under the pulling action of the pulling wire 412, so as to facilitate the first filter 413 and the second filter 414 to be withdrawn into the outer sheath 411.

[0088] Further, referring back to Figure 17The first filter 413 and the second filter 414 are connected by a connecting column 415, which is a hollow column structure. The distal end opening of the connecting column 415 is connected to the proximal end opening of the first filter 413, and the proximal end opening of the connecting column 415 is connected to the proximal end opening of the second filter 414. The connecting column 415 can make the connection of the first filter 413 and the second filter 414 more stable. The connecting column 415 is made of a metal woven mesh, a high polymer material fiber woven or textile mesh, a high polymer mixed metal material woven or textile mesh, or a high polymer film with holes. The connecting column 415 is connected to the first filter 413 and the second filter 414 by welding, bonding or other methods.

[0089] In some embodiments, one or more openings are provided on the connecting column. Emboli captured by the second filter can enter the first lumen of the outer sheath through the openings, avoiding the second filter from being blocked.

[0090] Embodiment 4

[0091] The main difference between Embodiment 4 and Embodiment 3 is that, as shown in Figure 19 the pushing member 512 of Embodiment 4 is a hollow structure with a delivery lumen 5121. The first filter 513 and the second filter 514 each have a proximal end opening. The delivery lumen 5121 communicates with the distal end opening of the first filter 513 through the proximal end opening of the first filter 513 to form a delivery channel for a therapeutic device (such as a delivery device of a branch stent) to pass through.

[0092] In this embodiment, the pushing member 512 is provided with a communication hole 5122, which is arranged between the first filter 513 and the second filter 514. The delivery lumen 5121 communicates with the distal end opening of the second filter 514 through the communication hole 5122. Emboli captured by the second filter 514 can enter the delivery lumen 5121 through the communication hole 5122, avoiding the second filter 514 from being blocked.

[0093] Embodiment 5

[0094] Please refer to Figure 20 The difference between this embodiment and Embodiment 4 is that the outer surface of the first filter 6133 is provided with a groove 61331 recessed inwardly of the first filter 6133. The groove 61331 extends spirally from the distal end to the proximal end of the first filter 6133, as shown in Figure 21As shown, the first support structure 61322 is arranged in the groove 61331. Due to the thinness of the first filter screen 6133, the groove 61331 appears as a protrusion on the inner side of the first filter screen 6133, which functions as a flow guide in the first filter screen 6133, forming a vortex effect when blood flows through the first filter screen 6133, attracting thrombus into the bottom of the protection device, preventing escape or retention of thrombus from blocking the micropores of the first filter screen 6133; while plasma and healthy blood cells with a structure smaller than the micropores of the first filter screen 6133 can flow through the micropores to the distal end. Further, the hollow pusher connected to the first filter screen can be connected to a suction device or an extracorporeal circulation filter device to timely extract the thrombus in the first filter screen. In this embodiment, the structure of the second filter screen is the same as that of the second filter screen 514 in Embodiment 4, that is, in this embodiment, as shown in Figure 22 As shown, only the outer circumferential surface of the first filter screen 613 is provided with the groove 61331, so the gap between the outer circumferential surface of the first filter screen 613 and the inner wall of the second filter screen 614 in this embodiment is larger than that of the protection device without the groove 61331. When the distal end opening of the first filter screen 613 cannot fit the blood vessel wall, part of the thrombus flows into the second filter screen 614 from the large enough gap between the outer circumferential surface of the first filter screen 613 and the second filter screen 614, and is collected by the second filter screen 614. Conversely, when the distal end opening of the first filter screen 613 cannot fit the blood vessel wall, if the gap between the outer circumferential surface of the first filter screen 613 and the second filter screen 614 is too small, the thrombus escaping from the first filter screen 613 is easy to accumulate at the distal end opening of the second filter screen 614, and it is difficult to enter the second filter screen 614 smoothly, and these thrombi may fall back into the blood vessel during the process of withdrawing the protection device, increasing the risk of surgery.

[0095] In other embodiments, the groove is not arranged near the distal end opening of the first filter screen, that is, the groove extends from the proximal end to the distal end of the first filter screen, and the distal end of the groove exceeds the distal end opening of the second filter screen but does not reach the distal end opening of the first filter screen; or a plurality of grooves are arranged on the first filter screen. The above-mentioned embodiments are not a limitation on the shape and number of the grooves, and other shapes and numbers of grooves can be arranged on the first filter screen to enable the thrombus to enter the second filter screen from the gap between the first filter screen and the second filter screen.

[0096] The technical features of the above-mentioned embodiments can be combined in any manner. 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 the combinations of the technical features do not exist contradictory, they should be considered as the scope of the present disclosure.

[0097] The above embodiments only express several implementation manners of the present application, which are described in a more specific and detailed manner, but cannot be understood as a limitation on the patent scope of the present application. It should be noted that, for ordinary skilled persons in the art, several modifications and improvements can be made without departing from the concept of the present application, which all belong to the protection scope of the present application. Therefore, the protection scope of the patent of the present application should be subject to the appended claims.

Claims

1. A protection system, characterized in that The protection system comprises: at least one protection sheath, which comprises an outer sheath tube and a filter arranged at the distal end of the outer sheath tube; the outer sheath tube has a first lumen, and the filter has a proximal opening and a distal opening, the distal opening being in communication with the first lumen through the proximal opening; a filter bypass device having an input port and an output port, the input port being in communication with the first lumen; the protection sheath can be deployed in a branch blood vessel against blood flow, and a delivery device of a branch stent can pass through the first lumen and the filter to reach the aortic arch, and during the deployment of the branch stent, the filter intercepts emboli in the branch blood vessel, and blood carrying the emboli enters the filter bypass device through the first lumen; at least one return tube, a proximal end of the return tube being in communication with the output port, and a distal end of the return tube being used for returning the blood filtered by the filter bypass device to the human body; the return tube is connected side by side with the outer sheath tube, and the return tube has a return port, the return port being located on the proximal side of the filter; the shape of the return tube is adapted to the shape of the outer wall of the outer sheath tube, so that the return tube can be closely attached to the outer wall of the outer sheath tube; the protection system further comprises a sliding connector, the return tube is connected with the outer sheath tube through the sliding connector, so that the return tube can move in the axial direction of the outer sheath tube under the action of external force, thereby adapting to different branch blood vessels.

2. The protection system according to claim 1, wherein the protection system further comprises an inflow converter, the inflow converter comprises at least one inflow adapter and an inflow port, each of the inflow adapters is in communication with one of the outer sheath tubes, and the inflow port is in communication with the input port of the filter bypass device.

3. The protection system according to claim 1, wherein the protection system further comprises an outflow converter, the outflow converter comprises an outflow port and at least one outflow adapter, the outflow port is in communication with the output port of the filter bypass device, and each of the outflow adapters is in communication with one of the return tubes.

4. The protection system according to claim 1, wherein the return port is inclined relative to the axial direction of the outer sheath tube, and the side of the return port close to the outer sheath tube is closer to the distal end of the outer sheath tube than the side of the return port away from the outer sheath tube.

5. The protection system according to claim 1, wherein the filter comprises a filter screen body and a filter screen frame supporting the filter screen body; the protection sheath further comprises a pushing member, the pushing member is arranged in the first lumen or outside the first lumen and can move axially relative to the outer sheath tube, and a distal end of the pushing member is connected with the filter screen frame.

6. The protection system according to claim 1, wherein the filter bypass device comprises a filter cavity and a filter screen, the filter cavity is in communication with the input port and the output port, and the filter screen is arranged in the filter cavity; the density of the filter screen is smaller than the density of the filter.

7. The protection system according to claim 6, wherein the filter bypass device further comprises an exhaust port. The filter cavity is connected with the input port, the output port and an exhaust port. The input port is arranged at an upper edge of an inflow side of the filter cavity, the output port is arranged at a lower edge of an outflow side of the filter cavity, and the exhaust port is arranged at an upper edge of the outflow side of the filter cavity.

8. The protection system of claim 1, wherein: The protection system further comprises a pump arranged between the filter rotating flow device and the return pipe.

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