An embolus collection device and an embolization protection system

Abstract

The present invention relates to an embolus collection device, an embolic protection system and an embolus collection method, wherein the embolus collection device comprises a proximal connecting piece; a first supporting element, comprising a plurality of supporting rods arranged around an axis, at least some of the supporting rods being bent to form a concave surface facing the axis, and each of the supporting rods having a first proximal end and a first distal end, the first proximal end being folded and arranged on the proximal connecting piece; a first filtering element being arranged on the first supporting element, and having a second proximal end and a second distal end, the second proximal end being arranged on the first proximal end, and the second distal end forming an opening. The advantages of the present invention are that it effectively prevents embolism from entering into cerebral blood vessels and downstream blood vessels, and does not interfere with the surgical instruments entering and exiting the blood vessels.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an embolus collection device and an embolic protection system. Background Art

[0002] During cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, ascending aortic surgery and other surgeries involving the heart and aorta, surgical instruments may produce platelet aggregates (such as emboli, oil droplets, bacterial clots, tumor cells or other small pieces of tissue) during operation, or atherosclerotic fragments and remnants that fall off the arterial wall during surgery are transported with the bloodstream into the cerebral blood circulation and other important systemic arterial systems to become embolic substances. Embolic substances that enter the cerebral blood circulation can block small arteries, leading to local cerebral vascular embolism (causing stroke), which has become a common complication of cardiac and aortic surgery. Embolic substances that enter the downstream blood circulation can cause embolism of downstream organs, which in turn causes organ function decline and even organ failure.

[0003] During surgery, an embolic protection system is placed in the aorta to divert, capture or collect plaques, debris or emboli flowing forward, thereby preventing the formation of embolic material and avoiding the embolic material from entering the cerebral blood circulation and downstream blood circulation.

[0004] The embolic protection system in the prior art has the problems of complex design and large size, and may also cause different surgical instruments to become tangled during surgery, which is not conducive to surgical operations. Summary of the invention

[0005] The purpose of the present invention is to provide an embolus collection device and an embolic protection system to intercept embolism so that embolic substances cannot enter the cerebral blood vessels and downstream blood vessels, and the embolus collection device will basically not interfere with surgical instruments.

[0006] To achieve the above object, the present invention provides an embolus collection device, comprising:

[0007] Proximal connector;

[0008] A first support element, comprising a plurality of support rods arranged at intervals around an axis, at least some of the support rods being bent to form a concave surface facing the axis, each of the support rods having a first proximal end and a first distal end opposite to each other in a direction parallel to the axis, and the first proximal end of each of the support rods being folded and disposed on the proximal connecting member; and,

[0009] The first filter element has a second proximal end and a second distal end opposite to each other. The first filter element is arranged on the first support element, and the second proximal end is arranged on the first proximal end of the support rod, and the second distal end is arranged on the first support element and forms an opening.

[0010] Optionally, a recessed portion is provided on the embolus collecting device, and the recessed portion is used to form a channel penetrating along the axis between the embolus collecting device and the inner wall of the blood vessel.

[0011] Optionally, the multiple support rods include at least one first support rod. When the number of the first support rods is two or more, the two or more first support rods are arranged adjacent to each other; each of the first support rods has a local recessed structure, the convex side of the local recessed structure faces the axis, and the first filter element is attached to the local recessed structure of the first support rod to form the recessed portion.

[0012] Optionally, the first filter element is attached to surfaces of two adjacent support rods and has a local recessed structure between the two adjacent support rods, wherein a convex side of the local recessed structure faces the axis to form the recessed portion.

[0013] Optionally, the first filter element is attached to surfaces of two adjacent support rods, and when the first filter element is subjected to a force directed toward the axis, the recessed portion is formed between the two adjacent support rods.

[0014] Optionally, the multiple support rods include two adjacent second support rods, and the gap between the two adjacent second support rods is larger than the gap between the remaining two adjacent support rods; when the first filter element is subjected to a force directed toward the axis, the recessed portion is formed between the two adjacent second support rods.

[0015] Optionally, the embolus collecting device further comprises a distal connecting piece, and the first distal end of each of the supporting rods is disposed on the distal connecting piece after being folded.

[0016] Optionally, the first support element has a first position, and the first support element is configured such that, in the expanded state, the first support element abuts against the inner wall of the blood vessel at the first position, and the second distal end of the first filter element is arranged at the first position along the circumference of the first support element, or the second distal end of the first filter element is arranged between the first position and the first distal end along the circumference of the first support element.

[0017] Optionally, in a direction parallel to the axis, a distance from the first position to the first proximal end is not equal to a distance from the first position to the first distal end.

[0018] Optionally, in a direction parallel to the axis, the distance from the first position to the first proximal end is the same as the distance from the first position to the first distal end.

[0019] Optionally, in a plane perpendicular to the axis, a plurality of the support rods are arranged around the axis at unequal intervals.

[0020] Optionally, in a direction parallel to the axis, the length of the first support element is 20 mm - 60 mm; in a direction perpendicular to the axis, the maximum length of the first support element is 20 mm - 40 mm.

[0021] To achieve the above object, the present invention further provides an embolization protection system, comprising a delivery device, an embolus deflection device, and an embolus collection device as described in any one of the preceding items;

[0022] The delivery device has opposite fourth proximal and fourth distal ends;

[0023] The embolus deflection device is connected to the delivery device and includes a second filter element;

[0024] The embolus collection device is connected to the delivery device and is located between the embolus deflection device and the fourth proximal end.

[0025] Optionally, the delivery device includes a first delivery tube and an outer sheath tube. The embolus deflection device and the embolus collection device are respectively connected to the first delivery tube. The outer sheath tube has an axially penetrating first inner cavity for accommodating the embolus deflection device, the embolus collection device, and the first delivery tube.

[0026] Optionally, the embolus deflection device has opposite third distal and third proximal ends, and the first delivery tube is connected to the third distal end and / or the third proximal end.

[0027] Optionally, the delivery device includes an outer sheath tube, a first delivery tube, and a second delivery tube. The outer sheath tube has an axially penetrating first inner cavity, and the first delivery tube has an axially penetrating second inner cavity;

[0028] The embolus collection device is connected to the first delivery tube, and the embolus deflection device is connected to the second delivery tube. The second inner cavity is for accommodating the embolus deflection device and the second delivery tube, and the first inner cavity is for accommodating the embolus collection device and the first delivery tube.

[0029] Optionally, the embolus deflection device has opposite third distal and third proximal ends, and the second delivery tube is connected to the third distal end and / or the third proximal end.

[0030] Optionally, the proximal connecting piece of the embolus collecting device has a first through hole penetrating in a direction parallel to the axis, and the embolus collecting device is sleeved on the first delivery tube through the first through hole and fixedly connected to the first delivery tube.

[0031] Optionally, the embolus collection device also includes a distal connecting piece, and the first distal end of the support rod is arranged on the distal connecting piece after being retracted, and the distal connecting piece has a second through hole passing through a direction parallel to the axis, and the distal connecting piece is sleeved on the first delivery tube through the second through hole and can slide on the first delivery tube along the axial direction of the first delivery tube.

[0032] Optionally, the embolus collection device also includes a distal connecting piece, and the first distal end of the support rod is arranged on the distal connecting piece; the proximal connecting piece has a first through hole extending along a direction parallel to the axial line, and the distal connecting piece has a second through hole extending along a direction parallel to the axial line, and the embolus collection device is sleeved on the first delivery tube through the first through hole and the second through hole, and the first delivery tube is also provided with a limiting protrusion, and the limiting protrusion is located between the proximal connecting piece and the distal connecting piece, so as to limit the embolus collection device from detaching from the first delivery tube.

[0033] Compared with the prior art, the embolus collection device and embolic protection system of the present invention have the following advantages:

[0034] The embolic protection system includes an embolic collection device, which includes a proximal connector, a first support element, and a first filter element; wherein the first support element includes a plurality of support rods arranged at intervals around an axis, each of the support rods is bent to form a concave surface facing the axis, at least some of the support rods have a first proximal end and a first distal end relative to each other in a direction parallel to the axis, and the first proximal end of each support rod is folded and arranged on the proximal connector; the first filter element has a second proximal end and a second distal end relative to each other, the filter element is arranged on the support element, and the second proximal end is arranged on the first proximal end of the support rod, and the second distal end is arranged on the support element to form an opening. In transcatheter surgery, the embolic collection device is used in conjunction with an embolic deflection device to intercept embolic substances in the blood and prevent the embolic substances from entering the cerebral blood vessels and downstream blood vessels.

[0035] A recessed portion may be formed on the embolus collecting device, and the recessed portion is used to form a channel with the inner wall of the blood vessel for the instrument delivery tube to pass through, so that the embolus collecting device will not interfere with the surgical instrument. BRIEF DESCRIPTION OF THE DRAWINGS

[0036] Figure 1aIt is a schematic structural diagram of an embolus collection device provided by the present invention according to the first embodiment;

[0037] Figure 1b is Figure 1a A-A cross-sectional view of the embolus collection device shown in the figure. The proximal connector is not shown in the figure, and only the cross-section of the support rod is shown;

[0038] Figure 2 It is a partial cross-sectional view of the human aorta. The arrow in the figure indicates the blood flow direction;

[0039] Figure 3 It is a schematic diagram of the present invention positioning the embolus collection device shown in FIG. 1 in the ascending aorta;

[0040] Figure 4 It is a schematic diagram of the present invention positioning the embolus collection device shown in FIG. 1 in the ascending aorta. The positional relationship between the surgical instrument and the embolus collection device is shown in the figure;

[0041] Figure 5 It is a schematic diagram of the present invention positioning the embolus collection device shown in FIG. 1 in the descending aorta. In the figure, the embolus collection device is used in cooperation with an embolus deflection device;

[0042] Figure 6 It is a schematic diagram of a deformed structure of the embolus collection device shown in FIG. 1. The filter element is not shown in the figure, and the fitting position is not at the midpoint of the support rod;

[0043] Figure 7 It is a schematic diagram of another deformed structure of the embolus collection device shown in FIG. 1. The filter element is not shown in the figure, and the support rods are arranged circumferentially along the embolus collection device at unequal intervals;

[0044] Figure 8a It is a schematic structural diagram of an embolus collection device provided by the present invention according to the second embodiment. The filter element is not shown in the figure;

[0045] Figure 8b is Figure 8a A cross-sectional view of the embolus collection device shown in the figure;

[0046] Figure 9 It is a schematic structural diagram of an embolus collection device provided by the present invention according to the third embodiment. The filter element is not shown in the figure;

[0047] Figure 10 A schematic structural diagram of an embolization protection system provided according to an embodiment. The embolus deflection device is not shown in the figure;

[0048] Figure 11a is Figure 10Schematic diagram of the first connection relationship between the embolus collection device and the first delivery tube in the shown embolic protection system, with the filter element not shown in the illustration;

[0049] Figure 11b Is Figure 10 Schematic diagram of the second connection relationship between the embolus collection device and the first delivery tube in the shown embolic protection system, with the filter element not shown in the illustration.

[0050] [Description of reference numerals is as follows]:

[0051] 100 - Embolus collection device;

[0052] 110 - Proximal connector;

[0053] 120 - First support element;

[0054] 121 - Support rod, 121a - Third support rod, 121b - Fourth support rod, 121c - Fifth support rod, 121d - First support rod, 121e - Second support rod, 122 - Depression;

[0055] 130 - First filter element;

[0056] 140 - Distal connector;

[0057] 210 - Aortic arch, 220 - Ascending aorta, 230 - Descending aorta, 240 - Innominate artery, 250 - Left common carotid artery, 260 - Left subclavian artery;

[0058] 300 - Embolus;

[0059] 400 - Embolus deflection device;

[0060] 500 - Instrument delivery tube;

[0061] 600 - First delivery tube;

[0062] 610 - Limit protrusion;

[0063] 700 - Outer sheath tube;

[0064] 800 - Guide wire. Detailed implementation manners

[0065] To make the objectives, advantages, and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that the accompanying drawings are in very simplified forms and use non-precise scales, and are only used to conveniently and clearly assist in explaining the objectives of the embodiments of the present invention.

[0066] As used in this specification, the singular forms "a", "an", and "the" include plural referents, and the plural form "plural" includes two or more referents, unless the context clearly dictates otherwise. As used in this specification, the term "or" is generally used in the sense of including "and / or", unless the context clearly dictates otherwise, and the terms "mounted", "connected", "coupled" shall be construed broadly. For example, it may be a fixed connection, a detachable connection, or an integral connection. It may be a mechanical connection or an electrical connection. It may be directly connected or indirectly connected through an intermediate medium, and may be the communication inside two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances. The same or similar reference numerals in the drawings represent the same or similar components.

[0067] As used herein, the terms "proximal" and "distal" refer to the relative positions and relative directions of elements relative to each other from the perspective of a doctor using a medical device. Although "proximal" and "distal" are not restrictive, "distal" generally refers to the end that first enters the patient's body, and "proximal" generally refers to the end of the medical device that is close to the doctor during normal operation.

[0068] One of the objectives of the embodiments of the present invention is to provide an embolus collection device, which is used to be placed at a suitable position in the aorta before or during a transcatheter operation (operations involving the heart and aorta, such as cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology surgery, ascending aorta surgery, etc.) where embolism may occur, so as to filter and intercept emboli in the blood and prevent emboli from entering the cerebral blood vessels and downstream blood vessels and causing complications.

[0069] FIG. 1 shows an embolus collection device 100 provided by the first embodiment of the present invention. The embolus collection device 100 includes a proximal connector 110, a first support element 120, a first filter element 130, and a distal connector 140. Among them, the first support element 120 is used to support the first filter element 130 so that the first filter element 130 can partially fit against the inner wall of the blood vessel to intercept embolic substances.

[0070] Please continue to refer to FIG. 1 , the first support element 120 includes a plurality of support rods 121 arranged at intervals around an axis, at least some of the support rods 121 are bent to form a concave surface facing the axis, each of the support rods 121 has a first proximal end and a first distal end opposite to each other in a direction parallel to the axis, and the first proximal end of each of the support rods 121 is arranged on the proximal connector 110 after being folded, and the first distal end of each of the support rods 121 is arranged on the distal connector 140 after being folded. In other words, from the first proximal end to the first distal end, the distance from the support rod 121 to the axis increases first and then decreases, so that the first support element 120 forms a structure with an expanded middle portion and a gradually contracted two ends.

[0071] The first filter element 130 is an umbrella-shaped filter net and has a second proximal end and a second distal end relative to each other. The first filter element 130 is arranged on the first support element 120, and the second proximal end is arranged on the first proximal end of the support rod 121 (equivalent to the second proximal end of the first filter element 130 being arranged on the proximal connector 110), and the second distal end is arranged on the first support element 120 to form an opening, and the opening is used to allow the embolism to enter the first filter element 130 when capturing the embolism.

[0072] It can be understood that the axis in this embodiment is the axis of the emboli collecting device 100 , the axial direction mentioned below is a direction parallel to the axis, the circumferential direction is a direction surrounding the axis, and the radial direction is a direction perpendicular to the axis.

[0073] When the embolus collecting device 100 is placed in a blood vessel, the second distal end of the first filter element 130 serves as an inflow end of the embolus collecting device 100 , and the second proximal end of the first filter element 130 serves as an outflow end of the embolus collecting device 100 .

[0074] Please refer to Figure 2 , Figure 2 The figure shows a partial cross-sectional view of the human aorta, and mainly shows the aortic arch 210 portion of the upper part of the aorta that is curved in an arch shape. Figure 2 Taking the position shown as an example, the left side of the aortic arch 210 is the ascending aorta 220, the right side of the aortic arch 210 is the descending aorta 230, and three collateral vessels are emitted from the convex side of the aortic arch 210, which are the innominate artery 240 (i.e., the brachiocephalic artery), the left common carotid artery 250, and the left subclavian artery 260 from right to left. The blood flow carrying the embolic material 300 flows from the ascending aorta 220 to the descending aorta 230 through the aortic arch 210, and then continues to flow into the downstream blood vessels. At the same time, the blood flow enters the innominate artery 240, the left common carotid artery 250, and the left subclavian artery 260 at the aortic arch 210, and then flows into the brain blood vessels.

[0075] The embolus collection device 100 can be disposed at different positions of the aorta according to actual conditions. Please refer to Figure 3 and Figure 4 , in some embodiments, the embolus collection device 100 is positioned in the ascending aorta 220, and the blood carrying the embolic material 300 flows from the inflow end to the embolus collection device 100. After the first filter element 130 intercepts the embolic material 300, the blood flows out of the embolus collection device 100 from the outflow end, so that the embolic material 300 is intercepted and captured by the embolus collection device 100 before entering the aortic arch 210. Thus, the embolic material 300 will not enter the brachiocephalic artery 240, the left common carotid artery 250, and the left subclavian artery 260, nor will it enter the descending aorta 230. Or, please refer to Figure 5 , in some other embodiments, the embolus collection device 100 is used in cooperation with an embolus deflection device 400, wherein the embolus deflection device 400 is positioned at the aortic arch 210 to cover the inlets of the brachiocephalic artery 240, the left common carotid artery 250, and the left subclavian artery 260, so that the embolic material 300 turns at the aortic arch 210 and enters the descending aorta 230. At this time, the embolus collection device 100 is positioned at the descending aorta 230, and the blood is filtered to intercept the embolic material 300, so as to achieve the purpose of protecting both the cerebral blood vessels and the downstream blood vessels.

[0076] Furthermore, the embolus collection device 100 also has radiopacity, so as to accurately position the embolus collection device 100 in the ascending aorta 220 or the descending aorta 230. In this embodiment, a radiopaque material can be used to make the first support element 120 or the first filter element 130, or this purpose can be achieved by providing a radiopaque element on the first support element 120 or the first filter element 130.

[0077] As Figure 4 shown, before or during the transcatheter surgery, the embolus collection device 100 is fed into the blood vessel along the femoral artery, and the surgical instrument needs to be fed through the instrument delivery tube 500 via the femoral artery and through the embolus collection device 100 to the surgical position. The embolic material 300 generated during the surgical operation with the surgical instrument flows towards the embolus collection device 100 and is captured. At the same time, during the surgery, it is preferred that the embolus collection device 100 does not interfere with the instrument delivery tube 500. For this purpose, a recessed portion ( Figure 4 shown in) can be provided on the embolus collection device 100, and the recessed portion is configured to form a channel that penetrates along the axis between the embolus collection device 100 and the inner wall of the blood vessel.

[0078] In this embodiment, the first support element 120 is mainly composed of a plurality of the support rods 121. The plurality of support rods 121 are radially distributed, and the plurality of support rods 121 are not connected to each other, that is, there is no circumferential connecting member. Therefore, the first filter element 130 is attached to the surfaces of two adjacent support rods 121, and a local concave structure may be formed between the two support rods 121. The local concave structure faces the axis to form the concave portion. Alternatively, the first filter element 130 is attached to the surfaces of two adjacent support rods 121. When the second filter element 130 is subjected to a force directed towards the axis, the concave portion is formed between the two adjacent support rods 121. In some embodiments, the plurality of support rods 121 may include two adjacent second support rods, and the gap between the two adjacent second support rods is greater than the gap between the other two adjacent support rods 121. When the first filter element 130 is subjected to a force directed towards the axis, the concave portion is formed between the two adjacent second support rods. Specifically, when the embolus collection device 100 is positioned in a blood vessel, if the density of the support rods 121 is relatively large (that is, the gap between two adjacent support rods is relatively small), the instrument delivery tube 500 can also squeeze two adjacent support rods 121 to increase the gap between the two adjacent support rods 121, thereby increasing the concave portion to allow the instrument delivery tube 500 to pass through. That is to say, the first support element 120 will not interfere with the entry and exit of surgical instruments into and out of the blood vessel, resulting in difficulties or even inability for the surgical instrument to pass through.

[0079] The number of the support rods 121 can be 4 - 25, and further preferably, the number of the support rods 121 is 12 - 18. The widths of all the support rods 121 can be equal, or the widths of at least some of the support rods 121 are not equal (as Figure 1b shown). If the widths of at least some of the support rods 121 are not equal, the width ratio between the support rod 121 with the largest width and the support rod 121 with the smallest width can be 1.2 - 2. The first support element 120 is jointly composed of support rods 121 with different widths. When the embolus collection device 100 is placed in a blood vessel, the support rods 121 with different widths can generate different support forces, which is beneficial for the instrument delivery tube 500 to pass through the embolus collection device 100. It can be understood that the "width" refers to the dimension of the support rod 121 in the circumferential direction of the first support element 120.

[0080] Specifically, as Figure 4As shown, according to the anatomical structure of the blood vessel, usually the instrument delivery tube 500 travels along the upper wall of the aorta and enters the aorta. At this time, when the support rod 121 with a smaller width is arranged close to the upper wall of the aorta and the support rod 121 with a larger width is arranged close to the lower wall of the aorta, the support force generated by the support rod 121 with a smaller width is smaller. Therefore, when the support rod 121 is squeezed by the instrument delivery tube 500, the support rod 121 with a smaller width is more likely to deform and increase the recessed part, allowing the instrument delivery tube 500 to pass through. It can be understood that the terms "upper wall" and "lower wall" are both defined according to Figure 4 the relative positions of the inner walls of the aorta blood vessel in the shown orientation. In the figure, the inner wall of the blood vessel located above at the aortic arch 210, the inner wall of the ascending aorta 220 located on the left side, and the inner wall of the descending aorta 230 located on the right side are all defined as the "upper wall", and the inner wall of the blood vessel located below at the aortic arch 210, the inner wall of the ascending aorta 220 located on the right side, and the inner wall of the descending aorta 230 located on the left side are all defined as the "lower wall".

[0081] Please refer to Figure 3 , Figure 4 and Figure 5 . The first support element 120 has a first position. When the embolus collection device 100 is placed in the blood vessel, the radial dimension of the embolus collection device 100 at the first position is the largest and fits against the inner wall of the blood vessel. That is, at the first position, the first support element 120 has a first cross-section, the first cross-section is perpendicular to the axis (i.e., the first cross-section is a radial cross-section), and compared with other radial cross-sections of the first support element 120, the area of the first cross-section is the largest. In this embodiment, in the radial direction, the maximum length of the first support element 120 is 20 mm - 40 mm (i.e., the maximum distance between two points on the first cross-section is 20 mm - 40 mm). For example, when the radial cross-section of the first support element 120 is circular, according to the inner diameter of the blood vessel, at the first position, the diameter of the first support element 120 can be 20 mm - 40 mm, preferably the diameter of the first support element 120 at the first position is 25 mm - 35 mm, and it is specifically selected according to needs. In addition, the length of the first support element 120 can be 20 mm - 60 mm, preferably 35 mm - 50 mm. The "length" mentioned here refers to the dimension of the first support element 120 in the axial direction of the embolus collection device 100.

[0082] In this embodiment, the first support element 120 can have different shapes, such as spherical, ellipsoidal, double-tip shape, etc. The distance from the first position to the first proximal end can be equal to the distance from the first position to the first distal end (i.e., the first position is located in the middle of the first support element 120, as shown in Figure 1a ), or it can be unequal (the first position is not in the middle of the first support element 120, as shown in Figure 6 ). When the first position is not in the middle of the first support element 120, the distance from the first position to the first distal end is less than the distance from the first position to the first proximal end, or the distance from the first position to the first distal end is greater than the distance from the first position to the first proximal end.

[0083] Preferably, the second distal end of the first filter element 130 is circumferentially arranged at the first position along the first support element 120, so that the second distal end of the first filter element 130 can be attached to the inner wall of the blood vessel, enabling the first filter element 130 to capture embolic substances 300 to the greatest extent and avoiding the embolic substances 300 being stuck between the embolus collection device 100 and the inner wall of the blood vessel. Alternatively, the second distal end of the first filter element 130 is circumferentially arranged between the first position and the first distal end of the support rod 121 along the first support element 120.

[0084] Optionally, the plurality of support rods 121 can be evenly arranged around the axis or unevenly arranged around the axis, as shown in Figure 7 . Please refer to Figure 7 for emphasis, Figure 7The three continuously arranged support rods 121 in the first support element 120 of the embolus collection device 100 shown are the third support rod 121a, the fourth support rod 121b, and the fifth support rod 121c respectively. The interval between the third support rod 121a and the fourth support rod 121b is W1, and the interval between the fourth support rod 121b and the fifth support rod 121c is W2. Preferably, W2 is not equal to W1. The advantage of such a setting is also to form the recessed portion to facilitate the passage of the instrument delivery tube 500 through the embolus collection device 100. Especially when the embolus collection device 100 is positioned in the descending aorta 230, the instrument delivery tube 500 travels along the upper wall of the descending aorta 230. Therefore, the two support rods 121 with a larger interval are positioned at the upper wall of the descending aorta 230 (for example, when W2 < W1, the third support rod 121a and the fourth support rod 121b are closer to the upper wall), which can make the instrument delivery tube 500 pass more easily. Moreover, the area of the first filter element 130 disposed between the two support rods 121 with a larger interval can be relatively large, so as to better cover the instrument delivery tube 500 to prevent embolism side leakage.

[0085] Normally, the embolus collection device 100 is compressed in a delivery device and transported to a predetermined position in the blood vessel through the delivery device. Therefore, the first support element 120 can be made of an elastic material. In some embodiments, the first support element 120 is formed by laser cutting a pipe or a sheet, and in other embodiments, the first support element 120 can be woven from wires. The wires can be single wires or wound by multiple wires.

[0086] At least a part of the support rod 121 of the first support element 120 can be connected to the first filter element 130 by means such as gluing, welding, hot pressing, stitching, laser treatment, etc. The first filter element 130 is made of biocompatible materials such as nitinol alloy, polymer materials, inorganic non-metals, etc. These biocompatible materials can be pre-processed into film materials, and then holes are punched in the film materials to form the first filter element 130, or the biocompatible materials are processed into wire materials, and then the wire materials are woven into a mesh structure to form the first filter element 130. According to the type of material, the first filter element 130 can be elastic or non-elastic. The filter holes provided on the first filter element 130 can be circular or other shapes. When the filter holes are circular, the diameter of the filter holes can be 30um - 250um, preferably 100um - 200um, and the sum of the areas of all the filter holes accounts for 40% - 70% of the area of the entire first filter element 130. In addition, the first filter element 130 can be composed of a single-layer filter mesh or can be formed by laminating multiple layers of filter meshes, and the pore diameters of the filter holes on each layer of the filter mesh can be the same or different.

[0087] Furthermore, a coating (not shown in the figure) is provided on at least one surface of the first filter element 130, for example, the surface facing the inflow end. The coating is a heparin coating or an anticoagulant coating to prevent thrombus accumulation on the first filter element 130 and cause blockage to the first filter element 130. The coating can be formed by processes such as spraying or dip coating.

[0088] Figure 8a and Figure 8b is a schematic structural diagram of the embolus collection device 100 provided by the second embodiment of the present invention. The difference between this embodiment and the first embodiment lies in the formation method of the recessed portion. Specifically, the first support element 120 includes at least one first support rod 121d and several second support rods 121e. When there are two or more first support rods 121d, the two or more first support rods 121d are arranged adjacent to each other. Each first support rod 121d has a local recessed structure, and the convex side of the local recessed structure faces the axis. The first filter element 130 is attached to the local recessed structure of the first support tube 121d to form the recessed portion 122. Similarly, when the embolus collection device 100 is placed in a blood vessel, the recessed portion 122 faces the upper wall of the blood vessel, so that an instrument passage is formed between the recessed portion 122 and the upper wall of the blood vessel for the instrument delivery tube 500 to pass through. This design is particularly applicable to the first support element 120 with a large number of support rods 121 (for example, when a first support element 120 includes more than 15 support rods 121).

[0089] In this embodiment, at the first position, the second support rods 12e can be arranged on the same circular arc, and the diameter of this circular arc can be set with reference to the diameter of the first support element 120 in the first embodiment. As long as in the blood vessel, the first support element 120 can support the first filter element 130 and make the first filter element 130 partially fit the inner wall of the blood vessel to intercept the embolism substances 300.

[0090] Figure 9 The structural schematic diagram of the embolus collection device 100 provided by the third embodiment of the present invention is shown. In this embodiment, the embolus collection device 100 does not include a distal connector. Specifically, the support rod 121 is a rod-shaped structure, which can be a bent rod-shaped structure or a straight rod structure. From the first proximal end to the first distal end, the distance from the support rod 121 to the axis gradually increases. In other words, in this embodiment, when the cross-section of the first support element 120 perpendicular to the axis is circular, at the first distal end of the support rod 121, the diameter of the first support element 120 is the largest. Therefore, the first position is located at the first distal end, and the second distal end of the first filter element 130 is also connected to the first distal end of the support rod 121. It can be understood that the first distal end described here can be an end of the support rod 121 or can have a certain length (in this case, the first distal end is a straight rod structure).

[0091] Furthermore, the second objective of the embodiments of the present invention is to provide an embolism protection system, which is used to be implanted into the aorta to collect embolisms before or during a surgery that may generate embolisms, such as transcatheter mitral valve replacement (TMVR), left atrial appendage occlusion and other transcatheter surgeries. Please refer to Figure 5 , the embolism protection system includes a delivery device, an embolus deflection device 400, and the embolus collection device 100 provided in any previous embodiment. The delivery device has opposite fourth proximal and fourth distal ends. The embolus deflection device 400 is connected to the delivery device and includes a second support element and a second filter element provided on the second support element. The embolus deflection device 400 is configured to fit the wall of the aortic arch 210 in the deployed state to cover the collateral vessels at the aortic arch 210. The embolus collection device 100 is connected to the delivery device and is located between the embolus deflection device 400 and the fourth proximal end. The embolus collection device 100 is configured to extend along the wall of the descending aorta 230 in the deployed state, and the opening formed by the second distal end of the first filter element 130 faces the embolus deflection device 400. The delivery device is used to deliver the embolus deflection device 400 and the embolus collection device into the blood vessel.

[0092] In some embodiments, the delivery device includes a first delivery tube 600 and an outer sheath tube 700. The embolus deflection device 400 and the embolus collection device 100 are respectively connected to the first delivery tube 600. The outer sheath tube 700 has a first inner cavity that axially penetrates therethrough, and the first inner cavity is used to accommodate the embolus deflection device 400, the embolus collection device 100, and the first delivery tube 600.

[0093] As Figure 10 - Figure 11b shown, when loading the embolus collection device 100 onto the first delivery tube 600, the axial deformation amount when the embolus collection device 100 is compressed needs to be considered. Figure 11a FIG. shows a first connection relationship between the embolus collection device 100 and the first delivery tube 600. In this figure, the embolus collection device 100 provided in the foregoing first embodiment is taken as an example for illustration. As Figure 11a shown, the proximal connecting member 110 has a first through hole axially penetrating therethrough, and the distal connecting member 140 has a second through hole axially penetrating therethrough. The first delivery tube 600 is inserted through the first through hole of the proximal connecting member 110 and the second through hole of the distal connecting member 140, and the first delivery tube 600 penetrates through the embolus collection device 100. The proximal connecting member 110 is fixedly connected to the first delivery tube 600, and the distal connecting member 140 can slide axially along the first delivery tube 600. Figure 11b FIG. shows a second connection relationship between the embolus collection device 100 and the first delivery tube 600. As Figure 11b shown, the first delivery tube 600 penetrates through the embolus collection device 100, and both the proximal connecting member 110 and the distal connecting member 140 can slide axially along the first delivery tube 600. At the same time, a limiting protrusion 610 is provided on the first connecting tube 600, and the limiting protrusion 610 is located between the proximal connecting member 110 and the distal connecting member 140 to limit the sliding distance of the proximal connecting member 110 or the distal connecting member 140, so as to prevent the entire embolus collection device 100 from detaching from the first delivery tube 600. Regardless of which connection method is adopted, after loading the embolus collection device 100 onto the first delivery tube 600, the first delivery tube 600 is inserted through the first inner cavity of the outer sheath tube 500, and the embolus collection device 100 can be compressed in the first inner cavity of the outer sheath tube 500 by pushing or pulling the first delivery tube 600.

[0094] It should be understood that the first connection relationship is applicable to any of the foregoing embolus collection devices 100 (when the embolus collection device does not have a distal connecting member, the first delivery tube is only inserted through the first through hole), and the second connection relationship is applicable to the embolus collection device 100 that has both a proximal connecting member 110 and a distal connecting member 140.

[0095] The embolus deflection device 400 has opposite third distal and third proximal ends, and the first delivery tube 600 can be connected to at least one of the third distal and third proximal ends, as long as the embolus deflection device 400 can be compressed.

[0096] In some other embodiments, the delivery device includes an outer sheath tube, a first delivery tube, and a second delivery tube. The outer sheath tube has a first inner cavity that axially penetrates, and the first delivery tube has a second inner cavity that axially penetrates; the embolus collection device is connected to the first delivery tube, and the embolus deflection device is connected to the second delivery tube. The second inner cavity is used to accommodate the embolus deflection device and the second delivery tube, and the first inner cavity is used to accommodate the embolus collection device and the first delivery tube (not shown in the figure). That is to say, in these embodiments, the embolus deflection device is delivered into the blood vessel via the second inner cavity, while the embolus collection device is delivered into the blood vessel via the first inner cavity. In addition, the second delivery tube is connected to at least one of the third proximal and third distal ends of the embolus deflection device.

[0097] During the operation, it is also necessary to introduce a contrast catheter (not shown in the figure) into the blood vessel. According to the diameters of the first delivery tube 600 and the outer sheath tube 700, the contrast catheter can enter the blood vessel along the second inner cavity of the first delivery tube or along the first inner cavity of the outer sheath tube 700.

[0098] In addition, as mentioned above, during the operation, it is also necessary to introduce a surgical instrument (such as a ventricular assist pump) into the blood vessel through the instrument delivery tube 500, and the instrument delivery tube 500 generally runs along the upper wall of the aorta. Therefore, the concave portion of the embolus collection device 100 is arranged facing the upper wall of the descending aorta 230.

[0099] Furthermore, in this embodiment, the first delivery tube 600 has opposite fourth proximal and fourth distal ends, and the fourth distal end can be set as a curved structure to play a guiding role, so that the embolus collection device 100 can be smoothly delivered to a predetermined position in the blood vessel.

[0100] As Figure 5 shown, the embolus collection method based on the above embolization protection system includes:

[0101] Step S10, providing the above-mentioned embolization protection system;

[0102] Step S20, delivering the embolization protection system into the blood vessel;

[0103] Step S30: Release the embolus deflecting device 400 at the aortic arch 210 and release the embolus collection device 100 in the descending aorta 230.

[0104] In fact, before introducing the embolization protection system into the blood vessel, a guide wire 800 with a diameter of 0.035 mm should be pre-embedded along the femoral artery, and the delivery device should be guided by the guide wire 800 to guide the embolus deflecting device 400 and the embolus collection device 100 into the blood vessel.

[0105] If the delivery device includes a first delivery tube 600 and an outer sheath tube 700, the first delivery tube 600 has a second inner cavity for sleeving on the guide wire 800 and reaching a predetermined position along the guide wire 800. The embolus deflecting device 400 and the embolus collection device 100 are respectively connected to the first delivery tube 600. The outer sheath tube 700 has an axially through first inner cavity for accommodating the embolus deflecting device 400, the embolus collection device 100 and the first delivery tube 600. At this time, the operation of step S30 is: retract the outer sheath tube 700 to release the embolus deflecting device 400, and continue to retract the outer sheath tube 700 to release the embolus collection device 100.

[0106] If the delivery device includes an outer sheath tube, a first delivery tube and a second delivery tube at the same time, the outer sheath tube has an axially through first inner cavity, the first delivery tube has an axially through second inner cavity, and the second delivery tube has an axially through third inner cavity. The embolus collection device is connected to the first delivery tube, the embolus deflecting device is connected to the second delivery tube. The second inner cavity is for accommodating the embolus deflecting device and the second delivery tube, and the first inner cavity is for accommodating the embolus collection device and the first delivery tube; the third inner cavity is for sleeving on the guide wire and reaching a predetermined position along the guide wire. At this time, the operation of step S30 is: first retract the outer sheath tube and the first delivery tube simultaneously to release the embolus deflecting device, and then retract the outer sheath tube to release the embolus collection device.

[0107] Although the present invention is disclosed as above, it is not limited thereto. Those skilled in the art can make various changes and modifications to the present invention without departing from the spirit and scope of the present invention. Thus, if these modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalent technologies, the present invention also intends to include these modifications and variations.

Claims

1. An embolus collection device, characterized in that, include: Proximal connector; A first support element, comprising a plurality of support rods arranged at intervals around an axis, at least some of the support rods being bent to form a concave surface facing the axis, each of the support rods having a first proximal end and a first distal end opposite to each other in a direction parallel to the axis, and the first proximal end of each of the support rods being folded and disposed on the proximal end connector; as well as, A first filter element having a second proximal end and a second distal end opposite to each other, wherein the first filter element is disposed on the first support element, and the second proximal end is disposed on the first proximal end of the support rod, and the second distal end is disposed on the first support element and forms an opening; A recessed portion can be formed on the embolus collecting device; the embolus collecting device is applied to a blood vessel to collect emboli, the blood vessel has an upper wall and a lower wall which are opposite to each other in the circumferential direction, the recessed portion is arranged toward the upper wall of the blood vessel, the recessed portion is used to form a channel which passes through along the axis between the embolus collecting device and the upper wall of the blood vessel, and the channel is used for a device delivery tube to pass through; At least some of the support rods have unequal widths, wherein the support rods with smaller widths are arranged close to the upper wall of the blood vessel, and the support rods with larger widths are arranged close to the lower wall of the blood vessel. The support rods with smaller widths generate smaller supporting forces, and the support rods with smaller widths are deformed when squeezed by the device delivery tube, thereby increasing the size of the recessed portion and allowing the device delivery tube to pass through. The width refers to the size of the support rod in the circumferential direction of the first support element. The multiple support rods include more than two first support rods, and the more than two first support rods are arranged adjacent to each other; each of the first support rods has a local recessed structure, and the convex side of the local recessed structure faces the axis, and the first filter element is attached to the local recessed structure of the first support rod to form the recessed portion; or, the first filter element is attached to the surfaces of two adjacent support rods and has a local recessed structure between the two adjacent support rods, and the convex side of the local recessed structure faces the axis to form the recessed portion; or, the first filter element is attached to the surfaces of two adjacent support rods, and when the first filter element is subjected to a force directed to the axis, the recessed portion is formed between the two adjacent support rods; or, the multiple support rods include two adjacent second support rods, and the gap between the two adjacent second support rods is larger than the gap between the other two adjacent support rods; when the first filter element is subjected to a force directed to the axis, the recessed portion is formed between the two adjacent second support rods.

2. The embolus collection device according to claim 1, wherein The embolus collecting device further comprises a distal connecting piece, and the first distal end of each supporting rod is arranged on the distal connecting piece after being folded.

3. The embolus collection device according to claim 1, characterized in that, The first support element has a first position, and the first support element is configured such that in the deployed state, the first support element abuts against the inner wall of the blood vessel at the first position, and the second distal end of the first filter element is circumferentially disposed along the first support element at the first position, or the second distal end of the first filter element is circumferentially disposed along the first support element between the first position and the first distal end.

4. The embolus collection device according to claim 3, characterized in that, In the direction parallel to the axis, the distance from the first position to the first proximal end is not equal to the distance from the first position to the first distal end.

5. The embolus collection device according to claim 3, characterized in that, In the direction parallel to the axis, the distance from the first position to the first proximal end is the same as the distance from the first position to the first distal end.

6. The embolus collection device according to any one of claims 1-5, characterized in that, In a plane perpendicular to the axis, a plurality of the support rods are arranged around the axis at unequal intervals.

7. The embolus collection device according to any one of claims 1-5, characterized in that, In the direction parallel to the axis, the length of the first support element is 20 mm - 60 mm; in the direction perpendicular to the axis, the maximum length of the first support element is 20 mm - 40 mm.

8. An embolization protection system, characterized in that, Comprising a delivery device, an embolus deflection device, and an embolus collection device according to any one of claims 1 - 7; The delivery device has opposite fourth proximal and fourth distal ends; The embolus deflection device is connected to the delivery device and includes a second filter element; The embolus collection device is connected to the delivery device and is located between the embolus deflection device and the fourth proximal end.

9. The embolization protection system according to claim 8, characterized in that, The delivery device includes a first delivery tube and an outer sheath tube. The embolus deflection device and the embolus collection device are respectively connected to the first delivery tube. The outer sheath tube has an axially through first inner cavity for accommodating the embolus deflection device, the embolus collection device, and the first delivery tube.

10. The embolization protection system according to claim 9, wherein, The embolus deflection device has opposite third distal and third proximal ends, and the first delivery tube is connected to the third distal end and / or the third proximal end.

11. The embolization protection system according to claim 8, wherein, The delivery device includes an outer sheath tube, a first delivery tube, and a second delivery tube. The outer sheath tube has an axially through first inner cavity, and the first delivery tube has an axially through second inner cavity; The embolus collection device is connected to the first delivery tube, the embolus deflection device is connected to the second delivery tube. The second inner cavity is for accommodating the embolus deflection device and the second delivery tube, and the first inner cavity is for accommodating the embolus collection device and the first delivery tube.

12. The embolization protection system according to claim 11, characterized in that, The embolus deflection device has opposite third distal and third proximal ends, and the second delivery tube is connected to the third distal end and / or the third proximal end.

13. The embolization protection system according to any one of claims 9-12, characterized in that, The proximal connecting member of the embolus collection device has a first through hole penetrating in the direction parallel to the axis. The embolus collection device is sleeved on the first delivery tube through the first through hole and fixedly connected to the first delivery tube.

14. The embolization protection system according to claim 13, wherein The embolus collection device also includes a distal connecting piece, on which the first distal end of the support rod is retracted and arranged, and the distal connecting piece has a second through hole extending in a direction parallel to the axis, and the distal connecting piece is sleeved on the first delivery tube through the second through hole and can slide on the first delivery tube along the axial direction of the first delivery tube.

15. The embolization protection system according to any one of claims 9-12, characterized in that The embolus collecting device also includes a distal connecting piece, and the first distal end of the support rod is arranged on the distal connecting piece; the proximal connecting piece has a first through hole extending along a direction parallel to the axial line, and the distal connecting piece has a second through hole extending along a direction parallel to the axial line, and the embolus collecting device is sleeved on the first delivery tube through the first through hole and the second through hole, and the first delivery tube is also provided with a limiting protrusion, and the limiting protrusion is located between the proximal connecting piece and the distal connecting piece, so as to limit the embolus collecting device from being separated from the first delivery tube.

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