CN211325889U - Thrombus blocking device and embolism protection system - Google Patents
Thrombus blocking device and embolism protection system Download PDFInfo
- Publication number
- CN211325889U CN211325889U CN201922414013.4U CN201922414013U CN211325889U CN 211325889 U CN211325889 U CN 211325889U CN 201922414013 U CN201922414013 U CN 201922414013U CN 211325889 U CN211325889 U CN 211325889U
- Authority
- CN
- China
- Prior art keywords
- thrombus
- support frame
- barrier device
- proximal
- filter element
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Images
Landscapes
- Surgical Instruments (AREA)
Abstract
The utility model relates to a thrombus separation device and embolism protection system, the embolism protection system includes the thrombus separation device, the thrombus separation device includes braced frame and filter element, filter element set up in braced frame is last and cover braced frame encloses the region of closing, just filter element has two at least concave surfaces, the concave surface orientation the face that braced frame injectd. When the thrombus blocking device is placed at the aortic arch, the support frame is bent into an arch shape to adapt to the inner wall of a blood vessel and is tightly attached to the inner wall of the blood vessel, so that the filter element can completely cover the innominate artery, the left common carotid artery and the left subclavian artery, thereby effectively blocking embolic substances and avoiding complications caused by the embolic substances entering the cerebral blood vessel.
Description
Technical Field
The utility model relates to the technical field of medical equipment, concretely relates to thrombus separation device and embolism protection system.
Background
In cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, ascending aorta, etc., involving the heart and aorta, the surgical instruments may generate platelet polymers (such as thrombus, lipid droplets, bacterial clots, tumor cells or other small tissue) during the operation, or the atheroma and remnant on the artery wall may be detached during the operation, and these substances may block the small artery after entering the brain along with the blood flow to cause local cerebral vascular embolism (causing cerebral stroke), which has become a common complication in the heart and aorta operation.
During surgery, plaque, debris or thrombus flowing anteriorly can be diverted, captured or collected by placing a thrombus barrier device at the aortic arch, thereby preventing embolic material from entering the cerebral vessels. The thrombus blocking device in the prior art has the problems of poor adherence, poor blocking effect, incapability of completely covering three blood vessels (namely innominate artery, left common carotid artery and left subclavian artery) at the aortic arch and the like, and in addition, the protection device occupies more aortic space, and surgical instruments easily damage the protection device when entering and exiting the blood vessels, so that the protection effect is reduced.
SUMMERY OF THE UTILITY MODEL
An object of the utility model is to provide a thrombus separation device and embolism protection system, this thrombus separation device set up in aortic arch department, can cover three blood vessels of aortic arch department completely to laminate completely with the inner wall of aortic arch, with the interception embolism material, this thrombus separation device occupies that the radial space in the blood vessel is less simultaneously, can not disturb the operation production of surgical instruments basically.
In order to achieve the purpose, the utility model provides a thrombus barrier device, which comprises a supporting frame and a filter element, wherein the filter element is arranged on the supporting frame and covers the area enclosed by the supporting frame; the filter element has at least two concave surfaces facing a face defined by the support frame.
Optionally, the support frame has opposite first proximal and distal ends, and at least two of the concavities are disposed continuously or spaced between the first proximal and distal ends.
Optionally, at least two of the concave surfaces are disposed in series between the first proximal end and the first distal end, the apexes of two adjacent concave surfaces are connected by a curve having a lowest point, and the distance from the lowest point to the surface defined by the support frame is 0mm to 20 mm.
Optionally, the filter element has a first concave surface and a second concave surface; the distance from the axis of the first concave surface to the first proximal end is the same as the distance from the axis of the second concave surface to the first distal end.
Optionally, the distance from the axis of the first concave surface to the first proximal end is 10mm-30mm, and/or the distance from the axis of the second concave surface to the first distal end is 10mm-30 mm.
Optionally, the apex of at least two of the concave surfaces is the same distance from the face defined by the support frame.
Optionally, the distance from the apex of the concave surface to the face defined by the support frame is from 10mm to 50 mm.
Optionally, the support frame defines a face that is a flat face or an arcuate face, the convex side of the arcuate face facing the concave face of the filter element.
Optionally, at least one opening is formed on the first proximal end and/or the first distal end, and the opening is provided with an anti-bending structure protruding to the outside of the support frame.
Optionally, the bending-resistant structure is V-shaped, circular arc-shaped or polygonal.
Optionally, the width of the opening is 1mm-5mm, and the maximum distance from the bending-resistant structure to the opening is 1mm-5 mm.
Optionally, the support frame defines a face having a length of 40mm to 150mm and a width of 30mm to 100 mm.
Optionally, the support frame comprises a pre-curved first proximal section comprising the first proximal end and a first distal section comprising the first distal end, the first distal section having a larger radial dimension than the first proximal section.
Optionally, the difference between the radial dimension of the first distal proximal segment and the radial dimension of the first proximal segment is between 0.02mm and 0.15 mm.
Optionally, the support frame comprises a pre-curved first proximal section comprising the first proximal end and a first distal section comprising the first distal end, the first distal section having a larger radius of curvature than the first proximal section.
Optionally, the radius of curvature of the support frame decreases sequentially from the first distal end to the first proximal end.
Optionally, a plurality of filtering holes are arranged on the filtering element, and the aperture of each filtering hole is 50um-250 um.
Optionally, the sum of the areas of all the filter holes accounts for 40-70% of the total area of the filter element.
Optionally, at least one surface of the filter element is provided with a coating, the coating being a heparin coating or an anti-coagulant coating.
Optionally, the support frame comprises at least two closed loop structures, the filter element being connected to the at least two closed loop structures.
Optionally, the support frame comprises a pre-bent first proximal section and a first distal section, the support frame comprising a pre-bent first proximal section and a first distal section, the first proximal section comprising the first proximal end, the first distal section comprising the first distal end, and opposing first and second intermediate sections between the first proximal section and the first distal section; the first middle section and/or the second middle section are arc-shaped, and the convex side of the arc faces the inside of the supporting frame.
In order to achieve the above object, the utility model also provides a embolism protection system, include: a handle, an outer sheath, a pusher tube, and a thrombus barrier device as described in any of the preceding; the sheath tube is connected with the handle and is provided with a first inner cavity, the first inner cavity is used for containing the thrombus blocking device and the pushing tube, one end of the pushing tube is connected with the handle, and the other end of the pushing tube is connected with the thrombus blocking device.
Compared with the prior art, the utility model discloses a thrombus separation device and embolism protection system have following advantage:
the utility model discloses a thrombus separation device, including braced frame and filter element, filter element set up in braced frame is last and cover braced frame encloses the region that closes, filter element has two at least concave surfaces, the concave surface orientation the face that braced frame injectd. The thrombus blocking device is arranged at the aortic arch, the supporting frame is bent into an arch shape according to the diameter and the curvature radius of the inner wall of the aortic arch, so that the supporting frame is completely attached to the inner wall of the aortic arch, the filter element can completely cover the innominate artery, the left common carotid artery and the left subclavian artery to block embolism, the embolism can be turned at the aortic arch without entering the innominate artery, the left common carotid artery or the left subclavian artery, and complications caused by the fact that embolic substances enter the brain are avoided. Meanwhile, the filter element of the thrombus barrier device comprises at least two concave surfaces, when the thrombus barrier device is placed at the aortic arch, excessive allowance cannot be generated on the filter element, so that the occupied space is small, the operation of a surgical instrument cannot be interfered basically, and meanwhile, the filter element can be prevented from being damaged by the surgical instrument to reduce the protection effect of the thrombus barrier device.
Drawings
FIG. 1 is a schematic view of a thrombus barrier provided according to an embodiment of the present invention;
FIG. 2 is a projection of the thrombus barrier device shown in FIG. 1 in the XY plane;
FIG. 3 is a partial cross-sectional view of a human aorta, with arrows showing the direction of blood flow;
FIG. 4 is a schematic illustration of the release of a thrombus barrier device provided in accordance with an embodiment of the present invention at the aortic arch;
FIG. 5 is a schematic structural view of a support frame of the thrombus barrier device according to an embodiment of the present invention, wherein the support frame is formed by bending and splicing a wire;
FIG. 6 is a schematic structural view of a support frame of the thrombus barrier device according to an embodiment of the present invention, wherein the support frame is formed by bending and splicing two wires;
FIG. 7a is a schematic view of a first proximal anti-buckling structure of a thrombus barrier device according to one embodiment of the present invention, the anti-buckling structure shown in the figures is V-shaped;
FIG. 7b is a schematic view of a first proximal anti-buckling structure of a thrombus barrier device according to one embodiment of the present invention, the anti-buckling structure shown in the figures being arcuate;
FIG. 8a is a schematic view of a modified configuration of the support frame of the thrombus barrier device shown in FIG. 1;
FIG. 8b is a schematic view of another alternative configuration of the support frame of the thrombus barrier device shown in FIG. 1;
FIG. 9 is a schematic structural view of a support frame of the thrombus barrier device according to an embodiment of the present invention, wherein the support frame is shown as an arc-shaped three-dimensional structure;
FIG. 10a is a schematic view of a support frame of the thrombus barrier device according to one embodiment of the present invention, showing the middle portion of the support frame retracted inwardly;
FIG. 10b is a projection of the support frame of the thrombus barrier device shown in FIG. 10a onto the XZ plane;
fig. 11 is a schematic diagram of an embolic protection system according to an embodiment of the present invention;
fig. 12 is a schematic partial view of an embolic protection system according to an embodiment of the present invention;
fig. 13 is a schematic structural view of a handle of an embolic protection system provided in accordance with an embodiment of the present invention.
[ reference numerals are described below ]:
100-a thrombus barrier device;
110-a support frame;
111-a splice point, 112-a first opening, 113-a first proximal anti-buckling element, 114-a second opening, 115-a first distal anti-buckling element;
120-a filter element;
210-aortic arch, 220-ascending aorta, 230-descending aorta, 240-innominate artery, 250-left common carotid artery, 260-left subclavian artery;
300-embolism;
400-handle, 410-contrast catheter inlet;
500-sheath canal;
600-pushing the pipe;
700-a guide wire;
800-contrast catheter.
Detailed Description
To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of the embodiments of the present invention.
As used in this specification, the singular forms "a", "an" and "the" include plural referents, and the plural forms "a plurality" includes more than two referents unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise, and the terms "mounted," "connected," and "connected" are to be construed broadly, e.g., as meaning either fixedly connected, detachably connected, or integrally connected. Either mechanically or electrically. Either directly or indirectly through intervening media, either internally or in any other relationship. The specific meaning of the above terms in the present invention can be understood according to specific situations by those skilled in the art. The same or similar reference numbers in the drawings identify the same or similar elements.
Herein, the terms "distal" and "proximal" are all relative orientations, relative positions, and directions of elements or actions with respect to one another from the perspective of a clinician using the medical device, and although "distal" and "proximal" are not intended to be limiting, distal generally refers to the end of the medical device that is first introduced into a patient, and proximal generally refers to the end of the medical device that is closer to the clinician during normal operation.
It is an object of the present invention to provide a thrombus barrier device for placement in the ascending aorta or aortic arch or descending aorta prior to or during a transcatheter operation (an operation involving the heart and aorta, such as a cardiac surgery, cardiopulmonary bypass, a catheter-based interventional cardiology operation, an ascending aorta operation, etc.) in which an embolism may occur, so as to filter the ascending blood flow of the innominate artery, the left common carotid artery and the left subclavian artery, thereby preventing the embolism substance generated during the operation from entering the cerebral vessels to cause complications.
As shown in fig. 1 and 2, the thrombus blocking device 100 includes a support frame 110 and a filter element 120, the filter element 120 is disposed on the support frame 110 and covers a region enclosed by the support frame 110, and the filter element 120 has at least two concave surfaces facing a surface defined by the support frame 110.
Fig. 3 shows a partial cross-sectional view of a human aorta, showing primarily the portion of the aortic arch 210 that is arcuately curved in the upper portion of the aorta. Taking the orientation shown in fig. 3 as an example, the left portion of the aortic arch 210 is the ascending aorta 220, the right portion of the aortic arch 210 is the descending aorta 230, and the convex side of the aortic arch 210 has three arteries, namely, the innominate artery 240 (i.e., the brachiocephalic artery), the left common carotid artery 250, and the left subclavian artery 260. The blood flow with the embolic material 300 flows from the ascending aorta 220 to the descending aorta 230 through the aortic arch 210, and enters the innominate artery 240, the left common carotid artery 250 and the left subclavian artery 260 at the aortic arch 210, and the embolic material 300 enters the innominate artery 240, the left carotid artery 250 and the left subclavian artery 260 with the blood flow and flows into the brain to cause complications such as cerebral apoplexy.
Referring to fig. 4, when the thrombus isolation device 100 provided in this embodiment is delivered to the aortic arch 210 and released to the natural deployed state, the support frame 110 can be bent into an arch shape and tightly attached to the upper inner wall of the aortic arch 210, thereby supporting the filter element 120 such that the filter element 120 covers the openings of the innominate artery 240, the left carotid artery 250, and the left subclavian artery 260. Thus, blood flow through the filter element 120 enters the three arteries, and the embolic material 300 is occluded by the filter element 120, diverted at the aortic arch 210, and continues to the descending aorta 230 without entering the brain.
Alternatively, with continued reference to fig. 1 and 2, the support frame 110 is a closed ring structure and has a first proximal end and a first distal end opposite to each other, and at least two of the concave surfaces of the filter element 120 are sequentially disposed between the first proximal end and the first distal end, and may be disposed continuously or at intervals. For convenience of description, a direction from the first proximal end to the first distal end (i.e., an extending direction of a straight line connecting the first proximal end and the first distal end) is hereinafter defined as a "first direction". Taking the orientation shown in fig. 1 and 2 as an example, the first direction may be an X direction. In addition, hereinafter, it is mentioned that "second direction" is a direction perpendicular to the first direction, and "third direction" is a direction perpendicular to both the first direction and the second direction, and specifically, the second direction may be a Y direction, and the "third direction" may be a Z direction.
In an embodiment of the present invention, the filter element 120 is configured as a three-dimensional solid structure having at least two concave surfaces facing the surface defined by the support frame 110, which enables the thrombus barrier device 100 to better conform to the structure of the blood vessel. Specifically, after delivery and release of the thrombus barrier device 100 at the aortic arch 210, the support frame 110 is laterally compressed by the vessel wall, causing the support frame 110 to laterally narrow and longitudinally elongate. The filter element 120 is attached to the support frame 110, and if the filter element 120 is a plane structure or a circular arch structure, after the support frame 110 is laterally narrowed, the lateral allowance of the filter element 120 is too large, which easily interferes with the operation of the subsequent surgical instrument, and the surgical instrument easily causes damage to the thrombus blocking device 100 when entering and exiting the blood vessel, thereby reducing the protection effect. The embodiment of the utility model provides an in, filter element 120 is three-dimensional structure and has two at least concave surfaces, can adapt to the change of blood vessel radius of curvature and diameter better, reduces or even eliminates horizontal surplus to effectively avoid the phenomenon of passing through resistance increase, card pause, even lacerate filter element 120 that arouses because of surgical instruments cuts off filter element 120.
Alternatively, the number of the concave surfaces provided on the filter element 120 may be two, three or more, and in this embodiment, only two concave surfaces are provided on the filter element 120, and the two concave surfaces are continuously arranged in the first direction. Modifications may be made by those skilled in the art, based on the description below, to accommodate the situation when there are more of the concave surfaces.
Referring to fig. 1, each of the concave surfaces has a vertex, and the vertices of two adjacent concave surfaces are connected by a curve, and the curve has a lowest point. The distance H from the apex of each concave surface to the surface defined by the support frame 1101Between 10mm and 50mm, preferably the distance is between 20mm and 30 mm. The distance H from the lowest point to the plane defined by the support frame 1102Between 0 and 20 mm. In this embodiment, the apexes of the two concave surfaces are equidistant from the surface defined by the support frame 110. While in other embodiments the distance from the apex of the two concave surfaces to the surface defined by support element 110 may not be equal. The two concave surfaces of the filter element 120 are defined as a first concave surface near the first proximal end of the support frame 110 and a second concave surface near the first distal end of the support frame 110, respectively. The distance from the axis of the first concave surface to the first proximal end may be the same as or different from the distance from the axis of the second concave surface to the first distal end. In this embodiment, the distance from the axis of the first concave surface to the first proximal endFrom 10mm to 30mm and/or the distance from the axis of the second concave surface to the first distal end is from 10mm to 30 mm. .
Typically, the thromboembolic isolation device 100 is compressed within a delivery device and then delivered by the delivery device to the aortic arch 200 for release to cover three arteries. Therefore, the supporting frame 110 can be made of a flexible material, such as a metal, such as nickel-titanium alloy, stainless steel, cobalt-based alloy, tantalum, or the like, or a polymer material, such as High Density Polyethylene (HDPE), Polyetheretherketone (PEEK), or a composite material formed by mixing a metal, a polymer material, and an inorganic non-metal material, so that the supporting frame 110 can be compressed under the action of an external force, and when the external force is removed, the supporting frame 110 can be unfolded to restore the original shape.
In some embodiments, the support frame 110 may be cut from sheet or tubing. In other embodiments, the support frame 110 may be formed by bending and splicing wires. For example, the support frame 110 is formed by bending a wire, and then connecting two ends of the wire by welding, sleeving or the like to form a closed ring structure, wherein the support frame 110 has a splicing point 111, as shown in fig. 5; or after the support frame 110 is respectively bent by two wires, the four ends of the two wires are sequentially connected to form a closed ring structure, and then the support frame 110 has two splicing points 111, as shown in fig. 6. When the supporting frame 110 is formed by splicing wires, the wires can be monofilaments or multi-strand wires wound with each other, the diameter of the wires can be between 0.3mm and 1mm, and preferably the diameter of the wires can be between 0.5mm and 0.7 mm.
As shown in fig. 2, the area defined by the support frame 110 is in a shape of a drop, and in other embodiments, the area defined by the support frame 110 may also be in a shape of a circle, an oval, an ellipse, or the like. As shown in fig. 5 and 6, in an exemplary embodiment, the plane defined by the support frame 110 is a plane. The drop-shaped support frame 110 will be described as an example.
The length L of the plane defined by the support frame 110 in the first direction according to the size of the aorta1Between 40mm and 150mm and the maximum length of the support frame 110 in the second direction is between 30mm and 100 mm. Preferably, the length L of the face defined by the support frame 110 in the first direction1Between 60mm and 120 mm.
Optionally, as shown in fig. 6, in a specific embodiment, according to a change of the curvature radius of the support frame 110, the drop-shaped support frame 110 may be split into a first circular arc, a first transition section, and a second circular arc, which are connected in a smooth transition manner, where the first circular arc is located on the first proximal section, the second circular arc is located on the first distal section, and then the diameter of the first circular arc is smaller than the diameter of the second circular arc. Width W of the first arc1(i.e. the length of the first arc in the second direction) may be between 20mm and 80mm, the width W of the second arc2(i.e. the width of the second arc in the second direction) may be between 30mm and 120 mm. Width W of the first arc1Between 30mm and 50mm, the width W of the second arc2Between 60mm and 100 mm.
As shown in fig. 6, in the present embodiment, the support frame 110 is formed by connecting two wires that are pre-bent, and the two wires are respectively defined as a first wire and a second wire. Dividing support frame 110 into the first proximal section and the first distal section with a line connecting connection points 111 of the first wire as the first distal section of support frame 110 and the second wire as the first proximal section of support frame 110 as a boundary line, and preferably in a first direction, a length of the first distal section is smaller than a length of the first proximal section, and the first wire is larger than a radial dimension of the second wire. The advantageous effects of this structure are, on the one hand, that the diameter of the blood vessel is gradually reduced from the ascending aorta 220 to the descending aorta 230, and the supporting frame 110 maintains the balance of the supporting force when released at the aortic arch 210; on the other hand, the first proximal end has a lower holding force than the first distal end, which facilitates compression and reduces delivery resistance when the thrombus barrier device 100 is compressed and preloaded in a delivery system for delivery.
Further, as shown in fig. 2, 5 and 6, a plurality of bending-resistant structures are formed on the supporting frame 110. When the thrombus barrier device 100 is compressed in the delivery device, the anti-bending structure can improve the anti-bending performance of the support frame 110, and prevent the support frame 110 from being broken due to compression. On the other hand, when the thrombus barrier device 100 is released, the anti-buckling structure may also enhance the ability of the support frame 110 to expand outward to urge the support frame 110 back to the original state (i.e., the drop shape). Specifically, at least one first opening 112 is formed on a first proximal end of the support frame 110, and a first proximal anti-bending structure 113 protruding toward the outside of the support frame 110 is disposed at the first opening 112.
The specific form of the first proximal bending resistant structure 113 is not limited in this embodiment, as long as it can achieve the predetermined function. The first proximal kink-resisting structure 113 may be a V-shaped structure (as shown in fig. 7 a), an arc-shaped structure (as shown in fig. 7 b), or other polygonal structure (not shown). In some embodiments, at least one second opening 114 is also formed on the first distal end of the support frame 110, and the second opening 114 is provided with a first distal anti-bending structure 115 protruding toward the outside of the support frame 110. Generally, only one first proximal bending-resistant structure 113 may be disposed on the first proximal end of the support frame 110, and only one first distal bending-resistant structure 115 may be disposed on the first distal end, but in this case, both the first proximal bending-resistant structure 113 and the first distal bending-resistant structure 115 are preferably located on the longitudinal symmetry axis of the drop-shaped support frame 110. In this way, when the support frame 110 is released from the compressed state at the aortic arch, the first distal end releases more expansion force when anchored to the ascending aortic vessel and transmits the expansion force to the first proximal end to increase the expansion force of the support frame 110 (particularly at the first transition section) and thereby ensure the coverage area of the thrombus barrier device 100. It is understood that the drop shape is an axisymmetric pattern, and the symmetry axis of the drop-shaped support frame extends in the first direction. The supporting frame with other shapes can also be arranged in the same way.
Further, with continued reference to fig. 7a and 7b, the width W of the first opening 1123Between 1mm and 5mm, the maximum distance L from the first proximal anti-buckling structure 113 to the first opening 1122Between 1mm and 5 mm. Similarly, the width of the second opening 114 is between 1mm and 5mm, and the maximum distance from the first distal anti-buckling structure 115 to the second opening 114 is between 1mm and 5 mm. Preferably, the width W of the first opening 1123Between 2mm and 3mm, the maximum distance L from the first proximal anti-buckling structure 113 to the first opening 1122Between 2mm and 4 mm. The width of the second opening 114 is between 2mm-3mm, and the maximum distance from the first distal anti-buckling structure 115 to the second opening 114 is between 2mm-4 mm.
The support frame 110 may be attached to the filter element 120 by gluing, welding, sewing, heat pressing or laser treatment. The filter element 120 may be a woven mesh or a mesh structure formed by punching holes in a sheet material. Generally, the filter element 120 is made of a biocompatible material, and the specific material may be nickel-titanium alloy, polymer material, inorganic non-metal material, etc. The filter holes of the filter element 120 can be designed to be circular, the pore size of the filter holes can be between 50um and 250um, preferably between 100um and 200um, and the sum of the areas of all the filter holes occupies 40 to 70 percent of the area of the filter element 120, and the design ensures that the filter element 120 can effectively intercept the embolic material 300 without affecting the flow of blood.
Further, at least one surface of the filter element 120 (e.g., the lower surface of the filter element 120, i.e., the surface that is first in contact with the plug in the orientation shown in fig. 8) is provided with a coating of heparin, anti-coagulant, or the like, to prevent clogging of the filter element 120 by build-up of embolic material 300 on the filter element 120. The coating can be formed by spraying, dipping, and the like.
In this embodiment, the supporting frame 110 includes only one closed loop structure, and actually, the supporting frame 110 may further include a plurality of closed loop structures. In some embodiments, as shown in fig. 8a, the support frame 110 comprises two closed loop structures, wherein the two loop structures are disposed on the same plane, and one of the two loop structures is disposed inside the other loop structure, and the two loop structures may or may not be connected to each other, but the filter element 120 is connected to both loop structures. In other embodiments, the support frame 110 comprises two closed loop structures, which may be stacked in a third direction (i.e., as shown in FIG. 8 b), and likewise, the two loop structures may or may not be connected to each other, but the filter element 120 is connected to both loop structures. In some embodiments, the filter element 120 may also have a multi-layer structure, and the filter holes in each layer may have the same or different diameters.
In another exemplary embodiment of the present invention, as shown in fig. 9, the support frame 110 has a three-dimensional structure, and the surface defined by the support frame 110 may be an arc surface, and the convex side of the arc surface faces the concave surface of the filter element 120. The projection of the support frame 110 on the XZ plane is arc-shaped, and the projection of the support frame 110 on the XY plane may be circular, elliptical, oval, or drop-shaped. The support frame 110 of the three-dimensional structure can better accommodate different radii of curvature of the aortic arch.
In this embodiment, the size of the support frame 110 is substantially the same as that of the previous embodiment. I.e., the length L of the support frame 110 in the first direction1May be between 40mm and 150mm, preferably the length L1Between 60mm and 120 mm. And, the maximum length of the support frame 110 in the second direction is 30mm to 100 mm. When the projection of the support frame 110 on the XY plane is in the shape of a drop, the drop-shaped projection can be split into a third arc, a second transition section and a fourth arc which are connected by smooth transition, and the diameter of the third arc is smaller than that of the fourth arc. And the width W of the third arc1May be between 20mm and 80mm, the width W of the fourth arc2May be between 30mm and 120 mm. Preferably, the width W of the third arc1Between 30mm and 50mm, the width W of the fourth arc2Between 60mm and 100 mm.
For the thrombus blocking device 100 provided in this embodiment, other structural components may be arranged with reference to the previous embodiment, and will not be described herein again.
In yet another exemplary embodiment, support frame 110 is configured as shown in FIG. 10a, with support frame 110 including a pre-curved first proximal segment and a first distal segment, and opposing first and second intermediate segments between the first proximal segment and the first distal segment; the first and/or second intermediate sections are arc-shaped with the convex side of the arc being concave towards the interior of the support frame 110. The support frame 110 of this construction is particularly suitable for use in cases where the aorta tapers from the left common carotid artery 260 to the first distal end of the aortic arch 210, and when the thrombus-isolation device 100 is released in the aortic arch 210, the support frame 110 is constrained by the aortic arch 210, and the concave portion of the support frame 110 may increase the outward dilatory force, further improving the opening effect of the support frame 110.
An object of the embodiment of the utility model is also to provide a embolism protection system. Referring to fig. 3, 11 and 12, the embolic protection system includes a handle 400, an outer sheath 500, a pusher tube 600 and the thrombus barrier device 100 as described above. Wherein, the thrombus blocking device 100 is arranged on the pushing tube 600, and the pushing tube 600 is connected with the handle 400. The sheath 500 is connected to the handle 400 and has a first lumen for receiving the pusher tube 600 and the thrombus barrier device 100.
Specifically, the pusher tube 600 has opposing second proximal and distal ends, and the pusher tube 600 also has a second lumen. The outer sheath 500 has a third proximal end and the third distal end the handle 400 has a fourth proximal end and a fourth distal end, the third proximal end of the outer sheath 500 is connected to the fourth distal end of the handle 400, the thrombus blocking device 100 is disposed on the push tube 600, and the second distal end of the push tube 600 extends out of the first distal end of the support frame 110. The thrombus blocking device 100 and the push tube 600 are compressed by a factor of two and then accommodated together in the first lumen of the sheath tube 500, and the second proximal end of the push tube 600 penetrates the handle 400 and is connected with the fourth proximal end of the handle 400. In this embodiment, the first proximal end of the thrombus barrier device 100 may be connected to the pushing tube 600, or the first proximal end and the first distal end may be connected to the pushing tube 600 at the same time, and the thrombus barrier device 100 and the pushing tube 600 may be connected by a wire or a sleeve, but whatever connection method is adopted, the thrombus barrier device 100 may be loaded on the pushing tube 600 and may be transported to a predetermined position in the blood vessel by the pushing tube 600.
In performing transcatheter surgery, an incision is made in the femoral artery to allow surgical instruments to be introduced into the body from the femoral artery. The embolic protection system described in this embodiment is also accessed from an incision in the femoral artery into the vessel and along the femoral artery to the aortic arch to simplify the procedure. The method of use of the embolic protection system is described below.
Referring with emphasis to fig. 4, a guide wire 700 having a diameter of about 0.035 inches is first pre-implanted in the femoral artery, and the guide wire 700 follows the superior wall path of the aortic arch 210. Then, the pushing tube 600 is inserted through the second lumen on the guide wire 700, and drives the thrombus blocking device 100 and the outer sheath tube 500 to go up to the ascending aorta 220 along the guide wire 700, and the second distal end of the pushing tube 600 is bound by the path of the guide wire 700 to form an arch shape. Thereafter, the handle 400 is operated to withdraw the sheath 500, releasing the thrombus blocking device 100 at the aortic arch 210, and the thrombus blocking device 100 is supported by the push tube 600 to form an arch shape.
In this embodiment, when the thrombus barrier device 100 is released at the aortic arch 210, the support frame 110 of the thrombus barrier device 100 is supported by the push tube 600 and bent into an arch-shaped structure matching the aortic arch 210, so that the support frame 110 completely fits the maximum diameter of the aortic arch 210 and clings to the wall of the aortic arch 210 and supports the filter element 120. The filter element 120 thus covers the innominate artery, the left common carotid artery, and the left subclavian artery to form a blocked space to prevent the embolic material 300 from entering the cerebral vessels.
Alternatively, the push tube 600 may be made of stainless steel, nitinol, or polymer tubing. The push tube 600 is provided with an installation section, the thrombus barrier device 100 is arranged on the installation section, and the thrombus barrier device 100 can move along the axial direction and the circumferential direction of the push tube 600 on the installation section, so that the thrombus barrier device 100 can adapt to the aorta with different curvature radiuses.
Optionally, as shown in fig. 4, 11 and 13, the embolic protection system further comprises a contrast catheter 800, and a contrast catheter inlet 410 is provided on the handle 400 for allowing the contrast catheter 800 to pass through and enter the first lumen.
Optionally, at least one of the outer sheath 500, the pusher tube 600 and the thrombus barrier device 100 in the embolic protection system is provided with a visualization element (not shown in the figure), and based on the position of the visualization element, the physician can accurately judge the position of the corresponding component in the blood vessel. The developing element may be made of tantalum, platinum-iridium alloy, or the like.
Although the present invention is disclosed above, it is not limited thereto. Various modifications and alterations of this invention may be made by those skilled in the art without departing from the spirit and scope of this invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims and their equivalents, the present invention is also intended to include such modifications and variations.
Claims (22)
1. A thrombus barrier comprising a support frame and a filter element disposed on the support frame and covering an area enclosed by the support frame; the filter element has at least two concave surfaces facing a face defined by the support frame.
2. The thrombus barrier device of claim 1, wherein the support frame has opposing first proximal and distal ends, and wherein at least two of the concavities are disposed either continuously or in spaced relation between the first proximal and distal ends.
3. The thrombus barrier device of claim 2, wherein at least two of the concave surfaces are disposed in series between the first proximal end and the first distal end, the apexes of adjacent two of the concave surfaces are connected by a curve having a nadir, and the nadir is located between 0mm and 20mm from a surface defined by the support frame.
4. The thrombus barrier device of claim 2, wherein the filter element has a first concave surface and a second concave surface; the distance from the axis of the first concave surface to the first proximal end is the same as the distance from the axis of the second concave surface to the first distal end.
5. The thrombus barrier of claim 4, wherein the distance from the axis of the first concave surface to the first proximal end is 10mm to 30mm, and/or the distance from the axis of the second concave surface to the first distal end is 10mm to 30 mm.
6. The thrombus barrier device of claim 1, wherein the apices of at least two of the concave surfaces are the same distance from the face defined by the support frame.
7. The thrombus barrier device of claim 1, wherein the distance from the apex of the concave surface to the face defined by the support frame is 10mm to 50 mm.
8. The thrombus barrier device of claim 1, wherein the support frame defines a face that is planar or curved, with a convex side of the curved face facing the concave face of the filter element.
9. The thrombus barrier device of claim 2, wherein the first proximal end and/or the first distal end has at least one opening formed therein, the opening being provided with an anti-buckling structure protruding outward of the support frame.
10. The thrombus barrier device of claim 9, wherein the kink-resistant structure is V-shaped, circular arc-shaped, or polygonal.
11. The thrombus barrier device of claim 9, wherein the width of the opening is 1mm to 5mm and the maximum distance of the kink-resistant structure to the opening is 1mm to 5 mm.
12. The thrombus barrier device of claim 1, wherein the support frame defining face has a length of 40mm to 150mm and a width of 30mm to 100 mm.
13. The thrombus barrier device of claim 2, wherein the support frame comprises a pre-curved first proximal segment comprising the first proximal end and a first distal segment comprising the first distal end, the first distal segment having a larger radial dimension than the first proximal segment.
14. The thrombus barrier device of claim 13, wherein the difference between the radial dimension of the first distal proximal segment and the radial dimension of the first proximal segment is 0.02mm to 0.15 mm.
15. The thrombus barrier device of claim 2, wherein the support frame comprises a pre-curved first proximal segment comprising the first proximal end and a first distal segment comprising the first distal end, the first distal segment having a larger radius of curvature than the first proximal segment.
16. The thrombus barrier device of claim 15, wherein the radius of curvature of the support frame decreases sequentially from the first distal end to the first proximal end.
17. The thrombus barrier device according to claim 1, wherein the filter element is provided with a plurality of filter holes having a pore size of 50-250 um.
18. The thrombus barrier device of claim 17, wherein the sum of the areas of all of the filter pores is 40-70% of the total area of the filter element.
19. The thrombus barrier device of claim 1, wherein at least one surface of the filter element is provided with a coating, the coating being a heparin coating or an anti-coagulant coating.
20. The thrombus barrier device of claim 1, wherein the support frame comprises at least two closed loop structures, the filter element being connected to the at least two closed loop structures.
21. The thrombus barrier device of claim 2, wherein the support frame comprises a pre-curved first proximal segment and a first distal segment, the support frame comprising a pre-curved first proximal segment and a first distal segment, the first proximal segment comprising the first proximal end, the first distal segment comprising the first distal end, and opposing first and second intermediate segments between the first proximal segment and the first distal segment; the first middle section and/or the second middle section are arc-shaped, and the convex side of the arc faces the inside of the supporting frame.
22. An embolic protection system, comprising: a handle, an outer sheath, a pusher tube, and the thrombus barrier device of any one of claims 1-21; the sheath tube is connected with the handle and is provided with a first inner cavity, the first inner cavity is used for containing the thrombus blocking device and the pushing tube, one end of the pushing tube is connected with the handle, and the other end of the pushing tube is connected with the thrombus blocking device.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201922414013.4U CN211325889U (en) | 2019-12-25 | 2019-12-25 | Thrombus blocking device and embolism protection system |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201922414013.4U CN211325889U (en) | 2019-12-25 | 2019-12-25 | Thrombus blocking device and embolism protection system |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN211325889U true CN211325889U (en) | 2020-08-25 |
Family
ID=72128313
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201922414013.4U Active CN211325889U (en) | 2019-12-25 | 2019-12-25 | Thrombus blocking device and embolism protection system |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN211325889U (en) |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112263355A (en) * | 2019-12-25 | 2021-01-26 | 上海微创医疗器械（集团）有限公司 | Thrombus blocking device and embolism protection system |
| WO2021104063A1 (en) * | 2019-11-28 | 2021-06-03 | 上海微创医疗器械（集团）有限公司 | Embolic protection device |
| CN112914789A (en) * | 2020-11-05 | 2021-06-08 | 上海微创医疗器械（集团）有限公司 | Anti-embolism protection device and medical instrument |
| CN113229886A (en) * | 2021-04-16 | 2021-08-10 | 核工业总医院 | Brain protection system |
| CN115670738A (en) * | 2022-12-28 | 2023-02-03 | 北京华脉泰科医疗器械股份有限公司 | Thrombolytic catheter filter and thrombolytic filter combination kit |
-
2019
- 2019-12-25 CN CN201922414013.4U patent/CN211325889U/en active Active
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2021104063A1 (en) * | 2019-11-28 | 2021-06-03 | 上海微创医疗器械（集团）有限公司 | Embolic protection device |
| CN112263355A (en) * | 2019-12-25 | 2021-01-26 | 上海微创医疗器械（集团）有限公司 | Thrombus blocking device and embolism protection system |
| CN112914789A (en) * | 2020-11-05 | 2021-06-08 | 上海微创医疗器械（集团）有限公司 | Anti-embolism protection device and medical instrument |
| CN113229886A (en) * | 2021-04-16 | 2021-08-10 | 核工业总医院 | Brain protection system |
| CN115670738A (en) * | 2022-12-28 | 2023-02-03 | 北京华脉泰科医疗器械股份有限公司 | Thrombolytic catheter filter and thrombolytic filter combination kit |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| CN211325889U (en) | Thrombus blocking device and embolism protection system | |
| JP7174087B2 (en) | Device for filtering embolic material in the vascular system | |
| JP6936264B2 (en) | Methods for automatic centering of guide catheters | |
| CN113855167B (en) | Clot removal device for ischemic stroke treatment | |
| EP3346949B1 (en) | Intra-aortic emboli protection filter device | |
| CN106456313B (en) | Intravascular device, delivery system, related methods, and catheter for deflecting thrombus | |
| KR102094046B1 (en) | Angiography catheter | |
| CN108814768B (en) | Implants having expandable regions and methods of making and using the same | |
| CA2910763C (en) | Apparatus and procedure for trapping embolic debris | |
| KR101300437B1 (en) | Vascular stenting for aneurysms | |
| CN113017909A (en) | Thrombus blocking device and embolism protection system | |
| KR20130032911A (en) | Vascular stenting for aneurysms | |
| EP3946146B1 (en) | Transcatheter anti embolic filter for arterial and venous vessels | |
| US10335262B2 (en) | Embolic protection devices having short landing zones | |
| CN210354988U (en) | Bolt steering gear and conveying device thereof | |
| CN211325888U (en) | Plug protection system | |
| WO2022095582A1 (en) | Anti-embolic protection device and anti-embolic protection system | |
| CN211460682U (en) | Embolism collection device and embolism protection system | |
| CN111904654A (en) | Bolt steering gear and conveying device thereof | |
| CN214128919U (en) | Anti-embolism protection device and medical instrument | |
| CN113017906A (en) | Plug protection system | |
| CN113017910A (en) | Embolism collection device and embolism protection system | |
| CN114469437A (en) | Anti-embolism protection device and medical instrument | |
| CN114431997A (en) | Anti-embolism protection device and medical instrument | |
| CN112153950A (en) | Intra-aortic embolic protection filter device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| GR01 | Patent grant | ||
| GR01 | Patent grant | ||
| TR01 | Transfer of patent right | ||
| TR01 | Transfer of patent right |
Effective date of registration: 20210722 Address after: Room 1502, 15 / F, building 1, No. 1601, Zhangdong Road, China (Shanghai) pilot Free Trade Zone, Pudong New Area, Shanghai, 201203 Patentee after: Shanghai Weidun Medical Technology Co.,Ltd. Address before: 201203 No. 1601 Zhangdong Road, Zhangjiang High-tech Park, Pudong New Area, Shanghai Patentee before: SHANGHAI MICROPORT MEDICAL (Group) Co.,Ltd. |