CN218870349U - Thrombus blocking device and thrombus blocking device - Google Patents

Abstract

The utility model relates to a thrombus separation device and thrombus separation ware. The thrombus blocking device comprises a frame and a filter screen. The frame comprises a main body part, a first supporting part and a second supporting part. The frame is made of memory materials, when the frame is in an expanded state, the first supporting part bends towards one side of the main body part, and the second supporting part bends towards the other side of the main body part or is positioned on the same plane with the main body part; the filter screen is respectively connected with the second supporting part and the main body part. The filter screens attached to the first supporting part and the main body part can completely filter blood flowing to three branches of the aortic arch, so that full protection of cerebral vessels is realized; meanwhile, the far end of the first supporting part and the far end of the second supporting part are respectively mutually abutted with two opposite side walls of the aortic arch starting part, so that the thrombus blocking device is stably supported at the aortic arch starting part, the axial stability and the circumferential stability of the thrombus blocking device are improved, and the circumferential stability enables the thrombus blocking device to have a self-recovery function after deviation.

Description

Thrombus blocking device and thrombus blocking device

Technical Field

The utility model relates to the technical field of medical equipment, especially relate to a thrombus separation device and thrombus separation ware.

Background

Some procedures involving the heart and aorta, such as cardiac surgery, cardiopulmonary bypass, catheter-based interventional cardiology, and aortic surgery, involve the removal of atheroma or partial tissue fragments that, along with the blood flow, can enter the cerebral blood circulation as embolized vascular material. Referring to fig. 1, fig. 1 is a schematic diagram illustrating that embolic material enters three branches of an aortic arch 10 through the aortic arch, and the embolic material entering cerebral blood circulation blocks arteries, thereby causing local cerebral vascular embolism, which is now an important complication of cardiac and aortic surgery.

Generally, in order to prevent nerve function damage caused by emboli, it is often necessary to place an embolic protection device at the aortic arch, ascending aorta or descending aorta during surgery to filter emboli such as plaque, debris or thrombus in the blood flow to the brain to prevent emboli from entering the aorta.

Wherein, traditional plug protection device mainly includes following three kinds of design: the first scheme releases the anti-embolism protection device into a branch blood vessel from the radial artery access, and the scheme can not cover three branches of an aortic arch, namely a brachiocephalic artery 11, a left common carotid artery 12 and a left subclavian artery 13; the second approach is from the femoral artery, but the device is prone to deflection during matching application with TAVR (transcatheter arterial replacement), and cannot completely cover the branch vessels on the aortic arch 10; the third solution is designed with a catching device, but since the catching device is usually arranged in the descending aorta region, it causes obstacles to the passage of subsequent instruments such as TAVR, and is liable to cause embolus side leakage.

SUMMERY OF THE UTILITY MODEL

The application provides a thrombus separation device and thrombus separation ware to solve one or more technical problem among the prior art.

The technical scheme is as follows: a thrombus barrier, comprising:

the frame comprises a main body part, a first supporting part and a second supporting part, wherein the near end of the first supporting part and the near end of the second supporting part are connected with the far end of the main body part; when the frame is in an expanded state, the first supporting part bends towards one side of the main body part, and the second supporting part bends towards the other side of the main body part or is positioned on the same plane with the main body part; and

the filter screen is respectively connected with the second supporting part and the main body part;

at least one of the main body part, the first support part and the second support part is provided with an elastic expansion part.

In one embodiment, the main body portion comprises two main support bars, proximal ends of the two main support bars being connected to each other, the two main support bars being provided with a first spacing;

the first supporting part comprises two first supporting rods, the far ends of the two first supporting rods are connected with each other, the two first supporting rods are provided with a second interval, and the near ends of the two first supporting rods are correspondingly connected with the far ends of the two main supporting rods respectively;

the second supporting part comprises two second supporting rods, two far-end interconnection of second supporting rods, two the second supporting rod is equipped with the third interval, two the near-end of second supporting rod respectively with two the far-end of main tributary vaulting pole corresponds and is connected.

In one embodiment, the diameter of the main support rod is set to 0.2mm-1mm; the diameter of the first supporting rod is set to be 0.2mm-1mm; the diameter of the second supporting rod is set to be 0.2mm-1mm.

In one embodiment, when the main body part is provided with the elastic expansion part, an included angle formed by a plane where the elastic expansion part is located on the main body part and a plane where the main body part is located is defined as a, and a is 0-20 degrees; when the first supporting part is provided with the elastic expansion part, an included angle formed by a plane where the elastic expansion part is located on the first supporting part and a plane where the first supporting part is located is defined as b, and the b is 0-20 degrees; when the second supporting part is provided with the elastic expansion part, an included angle formed by a plane where the elastic expansion part is located and a plane where the second supporting part is located on the second supporting part is defined as c, and the c is 0-20 degrees.

In one embodiment, a is 0 ° to 5 °, b is 0 ° to 5 °, and c is 0 ° to 5 °.

In one embodiment, at least one elastic expansion part is arranged on the proximal end of the main body part; the far end of the first supporting part is provided with at least one elastic expansion part; the far end of the second supporting part is provided with at least one elastic expansion part.

In one embodiment, the elastic expansion part is one or more of a combination of a U shape, an omega shape, a circular ring shape, an arc shape, a V shape, a Z shape and a W shape.

In one embodiment, when the elastic expansion part is in a ring shape, the diameter of the ring shape is 0.6mm-2mm.

In one embodiment, when the elastic expansion part is U-shaped, the opening width of the U-shape is 1mm to 8mm, and the depth of the U-shape is 1mm to 5mm.

In one embodiment, the proximal end of the main body portion is provided with an annular elastic expansion portion protruding towards the center of the surrounding area, the distal end of the first support portion is provided with an annular elastic expansion portion protruding towards the center of the surrounding area, and the distal end of the second support portion is provided with a U-shaped elastic expansion portion protruding towards the center of the surrounding area.

In one embodiment, the main body portion comprises two main support bars, the proximal ends of the two main support bars being connected to each other, the two main support bars being provided with a first spacing; one of the main supporting rods is provided with at least one annular elastic expansion part which is arranged towards the center of the surrounding area in a protruding way, and/or at least one U-shaped elastic expansion part which is arranged towards the center of the surrounding area in a protruding way; and at least one annular elastic expansion part which is convexly arranged towards the center of the surrounding area of the main support rod and/or at least one U-shaped elastic expansion part which is convexly arranged towards the center of the surrounding area of the main support rod is arranged on the other main support rod.

In one embodiment, when the elastic expansion part is in a circular ring shape, the diameter of the circular ring shape is 1mm-1.5mm; when the elastic expansion part is U-shaped, the width of the opening of the U-shape is 3mm-6mm, and the depth of the U-shape is 2mm-4mm.

The utility model provides a thrombus separation device, thrombus separation device include thrombus separation ware, thrombus separation device still includes push rod, leading-in sheath pipe, the push rod with the frame links to each other, the push rod is worn to locate leading-in sheath intraduct, the frame before the release with the push rod is located together leading-in sheath pipe's inside, the frame is located after the release leading-in sheath pipe's outside.

The thrombus blocking device and the thrombus blocking device are placed on the aortic arch before a transcatheter operation which can generate embolism, the enclosed area of the second supporting part and the main body part completely surrounds the three branches of the aortic arch, and the filter screens attached to the second supporting part and the main body part can filter blood flowing to the three branches of the aortic arch, so that the complete protection of cerebral vessels is realized; meanwhile, the fish mouth-shaped ring surrounded by the first supporting part and the second supporting part is abutted against the side wall of the aortic arch starting part, so that the thrombus blocking device is stably supported at the aortic arch starting part, the axial stability and the circumferential stability of the thrombus blocking device are improved, and the circumferential stability enables the thrombus blocking device to have a self-recovery function after deviation.

Drawings

The accompanying drawings, which are incorporated in and constitute a part of this application, illustrate embodiments of the application and, together with the description, serve to explain the application and are not intended to limit the application.

In order to more clearly illustrate the technical solutions in the embodiments of the present application, the drawings required to be used in the description of the embodiments are briefly introduced below, and it is obvious that the drawings in the description below are only some embodiments of the present application, and it is obvious for those skilled in the art to obtain other drawings without creative efforts.

FIG. 1 is a schematic view of embolic material entering three branches of the aortic arch through the arch, respectively;

fig. 2 is a schematic view of the internal structure of the thrombus barrier located in the aortic arch according to an embodiment of the present invention;

fig. 3 is a schematic structural view of a thrombus barrier in an expanded state according to an embodiment of the present invention;

fig. 4 is a schematic structural diagram of a frame according to an embodiment of the present invention;

fig. 5 is a schematic structural diagram of a frame according to another embodiment of the present invention;

fig. 6 is a schematic structural diagram of a frame according to another embodiment of the present invention;

fig. 7 is a schematic structural diagram of a frame according to another embodiment of the present invention;

fig. 8 is a schematic structural view of a frame according to another embodiment of the present invention;

fig. 9 is a schematic connection diagram of two components connected by a peripheral sleeve according to an embodiment of the present invention;

fig. 10 is a schematic view of a connection of two components nested together according to an embodiment of the present invention;

fig. 11 is a schematic view of the connection of two components of an embodiment of the present invention;

fig. 12 is a schematic structural view of a frame according to another embodiment of the present invention;

fig. 13 is a schematic structural view of a frame according to yet another embodiment of the present invention;

fig. 14 is a schematic structural view of the elastic expansion portion of an embodiment of the present invention, which is U-shaped and is protruded away from the center of the surrounding area;

fig. 15 is a schematic structural view of an embodiment of the present invention, in which the elastic expansion portion is in an omega shape and is protruded away from the center of the surrounding area;

fig. 16 is a schematic view of a structure of an embodiment of the present invention in which the elastic expansion portion is circular and protruded toward the center of the surrounding area;

fig. 17 is a schematic view of an embodiment of the present invention, in which the elastic expansion portion is circular and protruded toward the center of the surrounding area.

10. The aortic arch; 11. the brachiocephalic trunk; 12. the left common carotid artery; 13. the left subclavian artery; 20. a thrombus blocker; 21. a frame; 211. a main body part; 2111. a main support bar; 212. a first support section; 2121. a first support bar; 213. a second support portion; 2131. a second support bar; 214. a first member; 2141. a groove; 215. a second component; 216. a sleeve; 217. an elastic expansion portion; 22. and (5) a filter screen.

Detailed Description

In order to make the aforementioned objects, features and advantages of the present application more comprehensible, embodiments accompanying the present application are described in detail below with reference to the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present application. This application is capable of embodiments in many different forms than those described herein and that modifications may be made by one skilled in the art without departing from the spirit and scope of the application and it is therefore not intended to be limited to the specific embodiments disclosed below.

Herein, the terms "distal" and "proximal" refer to the relative orientation, relative position, and direction of elements or actions relative to each other from the perspective of a clinician using the medical device, and although "distal" and "proximal" are not intended to be limiting, the term "proximal" generally refers to an end that is relatively close to the clinician, i.e., the end that is advanced into the body of a patient, and the opposite end is distal.

The application provides a thrombus separation device and thrombus separator 20 scheme, can place aorta arch 10, ascending aorta or descending aorta before the transcatheter operation that probably produces the embolism, this paper will specifically introduce taking placing in aorta arch 10 as an example, can cover aorta arch 10 three branch blood vessels, and stability and adherence are good after releasing, play and filter through head and arm trunk artery 11, left common carotid artery 12, left subclavian artery 13 flow to cerebrovascular blood, prevent that the thrombus that produces from getting into the brain in the operation process, the embolus side leakage problem that leads to the protection device to shift and cause when having solved instruments such as TAVR to pass through.

Referring to fig. 2 to 3, fig. 2 shows an internal structure diagram of the thrombus barrier 20 located in the aortic arch 10 according to an embodiment of the present invention, and fig. 3 shows a structure diagram of the thrombus barrier 20 in an expanded state according to an embodiment of the present invention. An embodiment of the present application provides a thrombus blocking device, which includes a thrombus blocking device 20. The thrombus blocking device also comprises a pushing rod and an introducing sheath tube. The push rod is connected with the thrombus blocking device, the push rod penetrates through the inner part of the guide-in sheath tube, the thrombus blocking device 20 is located in the guide-in sheath tube together with the push rod before release, and the thrombus blocking device 20 is located outside the guide-in sheath tube after release.

In the thrombus barrier device, the assembled push rod and the thrombus barrier 20 are compressed into the introduction sheath so as to be conveniently conveyed to the aortic arch 10, and after the thrombus barrier 20 is conveyed to the aortic arch 10, the push rod drives the thrombus barrier 20 to move out of the interior of the introduction sheath, so that the thrombus barrier 20 moves out of the interior of the introduction sheath and is released, and then the thrombus barrier 20 can completely cover three branches of the aortic arch 10.

Referring to fig. 2 to 4, fig. 4 is a schematic structural diagram of a frame 21 according to an embodiment of the present invention. In one embodiment, the thrombus barrier 20 includes a frame 21 and a filter screen 22. The frame 21 includes a main body 211, a first support 212, and a second support 213. The proximal ends of the first and second support portions 212 and 213 are connected to the distal end of the body portion 211. Specifically, the frame 21 is made of a memory material. In the expanded state of the frame 21, the first supporting portion 212 is bent toward one side of the main body portion 211 (the lower side of the main body portion 211 as shown in fig. 4), and the second supporting portion 213 is bent toward the other side of the main body portion 211 (the upper side of the main body portion 211 as shown in fig. 4) or is on the same plane as the main body portion 211. The filter 22 is connected to the second support part 213 and the main body part 211, respectively.

The thrombus barrier 20 is placed on the aortic arch 10 before and during the transcatheter operation which may cause embolism, the region enclosed by the second support part 213 and the main body part 211 completely surrounds the three branches of the aortic arch 10 (the brachiocephalic trunk 11, the left common carotid artery 12 and the left subclavian artery 13, respectively), and the filter net 22 attached to the second support part 213 and the main body part 211 can completely filter the blood flowing to the three branches of the aortic arch 10, thereby realizing the complete protection of the cerebral vessels; meanwhile, the first support part 212 and the second support part 213 surround a synthetic fish-mouth-shaped ring and are abutted against the side wall of the initial part of the aortic arch 10, so that the first support part and the second support part are stably supported at the initial part of the aortic arch 10, the axial stability and the circumferential stability of the thrombus barrier 20 are improved, and the circumferential stability enables the thrombus barrier 20 to have a self-recovery function after deviation.

The memory material includes, but is not limited to, memory alloy or memory metal, which has less damage to human tissue, and the memory alloy or memory metal is durable, long in service life and low in cost. In addition, the memory alloy or memory metal can be compressed into a strip shape, thereby facilitating transportation. Optionally, the memory alloy includes, but is not limited to, a titanium-nickel alloy, an aluminum alloy, a titanium alloy, a nickel alloy, and the like, which can be selected and configured according to actual requirements.

Referring to FIG. 4, in one embodiment, the main body portion 211 includes two main support bars 2111. The proximal ends of the two main support bars 2111 are connected to each other, and the two main support bars 2111 are provided with a first space S1.

In one embodiment, the first support part 212 includes two first support rods 2121. The distal ends of the two first support rods 2121 are connected to each other, the two first support rods 2121 are provided with a second spacing S2, and the proximal ends of the two first support rods 2121 are correspondingly connected to the distal ends of the two main support rods 2111, respectively.

In one embodiment, the second support 213 includes two second support rods 2131. The distal ends of the two second support rods 2131 are connected to each other, the two second support rods 2131 have a third space S3, and the proximal ends of the two second support rods 2131 are correspondingly connected to the distal ends of the two main support rods 2111, respectively.

It should be noted that, in the above embodiment, the structural form in which the main body portion 211 includes two main support rods 2111, the structural form in which the first support portion 212 includes two first support rods 2121, and the structural form in which the second support portion 213 includes two second support rods 2131 may be flexibly combined according to actual requirements.

In a particular embodiment, the main body portion 211 includes two main support bars 2111. The proximal ends of the two main support bars 2111 are connected to each other, and the two main support bars 2111 are provided with a first space S1. The first support part 212 includes two first support rods 2121. The distal ends of the two first support rods 2121 are connected to each other, the two first support rods 2121 are provided with a second space S2, and the proximal ends of the two first support rods 2121 are connected to the distal ends of the two main support rods 2111, respectively. The second support portion 213 includes two second support rods 2131. The distal ends of the two second support rods 2131 are connected with each other, the two second support rods 2131 are provided with a third space S3, and the proximal ends of the two second support rods 2131 are correspondingly connected with the distal ends of the two main support rods 2111, respectively. Thus, before the thrombus barrier 20 is released, the main body part 211, the first supporting part 212 and the second supporting part 213 can be compressed and folded respectively, so that the volume and size of the product can be reduced, and the product can be conveniently compressed into the sheath together with the pushing rod so as to be conveniently conveyed. In addition, after the thrombus barrier 20 is completely released inside the aortic arch 10, the first supporting portion 212 and the second supporting portion 213 can be combined to form an opening and completely attached to two opposite portions of the inner wall of the aortic arch 10, so that the occupied space of the blood vessel is greatly reduced due to good adherence, stable support can be formed, and the resistance for passing subsequent instruments can be reduced.

In one embodiment, the main support bar 2111, the first support bar 2121, and the second support bar 2131 are each provided as memory wires.

In one embodiment, the diameter of the main support rod is set to 0.2mm to 1mm; the diameter of the first supporting rod is set to be 0.2mm-1mm; the diameter of the second supporting rod is set to be 0.2mm-1mm. Thus, when the diameters of the rod bodies combined to form the frame are set within the range, the produced thrombus blocking device has excellent mechanical properties and the required outer diameter of the conveying system can be controlled below 14F. In addition, when the diameter of each support rod is too large, the outer diameter of the conveying system is too large, and burden is brought to a patient; when the diameter of each support rod is too small, the mechanical property of the frame is weak, and the frame cannot be stably anchored at the target blood vessel position.

It should be noted that the diameters of the main support rod, the first support rod, and the second support rod may be flexibly adjusted and set according to requirements, and the diameters of the main support rod, the first support rod, and the second support rod may be completely the same or different, which is not limited herein.

It should be noted that the length of the main body portion 211, the length of the first supporting portion 212, and the length of the second supporting portion 213 can be flexibly adjusted and set according to actual requirements, so that the requirement that the filter net 22 attached to the main body portion 211 and the second supporting portion 213 can cover three branches of the aortic arch 10 can be met. Wherein, the length of the body portion 211 refers to the length of the path (as indicated by double arrow M1 in fig. 4) that the proximal end of the body portion 211 extends to the distal end of the body portion 211. The length of the first support 212 refers to the length of a path (indicated by a double-headed arrow M2 in fig. 4) extending from the proximal end of the first support 212 to the distal end of the first support 212. The length of the second support part 213 refers to the length of a path (as indicated by a double-headed arrow M3 in fig. 4) in which the proximal end of the second support part 213 extends to the distal end of the second support part 213.

It should be noted that the width of the main body 211, that is, the distance between the two main supporting rods 2111 (as shown in S1 in fig. 4), can be flexibly adjusted and set according to actual requirements, as long as the filter screen 22 attached to the main body 211 and the second supporting portion 213 can cover three branches of the aortic arch 10. Alternatively, the spacing S1 between the two main support bars 2111 may gradually increase in the proximal-to-distal direction, for example, and then remain substantially constant.

In addition, the width of the first supporting portion 212, that is, the distance between the two first supporting rods 2121 (as shown in S2 in fig. 4), can be flexibly adjusted and set according to actual requirements, as long as the first supporting portion 212 can be firmly attached to the inner wall of the aortic arch 10. Alternatively, the distance S2 between the two first supporting rods 2121 in the proximal-to-distal direction may be, for example, constant first and then gradually decreasing, or may be gradually decreasing first and then constant and then gradually decreasing, or may be gradually decreasing as a whole.

In addition, the width of the second supporting portion 213, that is, the distance between the two second supporting rods 2131 (S3 shown in fig. 4) can be flexibly adjusted and set according to actual requirements, as long as the second supporting portion 213 can be firmly attached to the inner wall of the aortic arch 10. Optionally, the distance S3 between the two second support rods 2131 in the proximal to distal direction is, for example, constant first and then gradually decreased, or gradually decreased first and then constant and then gradually decreased, or gradually decreased as a whole.

Thus, when the first supporting portion 212 and the second supporting portion 213 are both attached to two opposite portions of the inner wall of the aortic arch 10, i.e., the whole thrombus barrier 20 is attached to the wall of the aortic arch 10, the good adherence reduces the occupation of the blood vessel space, and simultaneously reduces the resistance of the subsequent instruments passing through, thereby improving the axial stability of the thrombus barrier 20 and being more suitable for aortic blood vessel dissection.

Wherein the outer edges of the filter net 22 are connected to the outer edge of the main body portion 211 and the outer edge of the second supporting portion 213, respectively, to achieve the attachment to the frame 21. Specifically, the distal ends of the two main support bars 2111 are correspondingly connected to the proximal ends of the two secondary support bars 2131, respectively, to form an annular support structure, and the outer edge of the filter screen 22 is connected to the annular support structure.

In one embodiment, the two main support bars 2111 may be either integrally formed or attached to each other at their proximal ends to form a unitary body, including, but not limited to, at least one of welding, gluing, externally sleeving, nesting, and wrapping.

Likewise, the two first struts 2121 can be a unitary structure, and can include, but are not limited to, at least one of welding, bonding, sleeving, nesting, and wrapping to connect the proximal ends of the two first struts 2121 to one another to form a unitary body.

Similarly, the two second support rods 2131 may be an integral structure, or may include, but not limited to, at least one of welding, gluing, sleeving, nesting, and winding to connect the proximal ends of the two second support rods 2131 to each other to form a whole.

Referring to fig. 4 to 6, in an embodiment, one of the first supporting portion 212 and the second supporting portion 213 is integrally formed with the main body portion 211; the other is integrally formed with the main body portion 211 or is connected with the main body portion by at least one of welding, bonding, externally arranging a sleeve, nesting and winding.

Referring to fig. 4, fig. 4 shows that the first supporting portion 212 and the main body portion 211 are integrally formed, and the second supporting portion 213 and the main body portion 211 are connected by at least one of welding, adhesion, external sleeve 216, nesting and winding. Specifically, the two first support rods 2121 are integrally formed with the two main support rods 2111, and the proximal ends of the second support rods 2131 are connected to the proximal ends of the main support rods 2111 by at least one of welding, gluing, external sleeving 216, nesting, and wrapping.

Referring to fig. 5, fig. 5 shows that the second supporting portion 213 and the main body portion 211 are integrally formed, and the first supporting portion 212 and the main body portion 211 are connected by at least one of welding, bonding, sleeving, nesting and winding. Specifically, the two second support rods 2131 are integrally formed with the two main support rods 2111, and further, the proximal ends of the first support rods 2121 are connected to the proximal ends of the main support rods 2111 by at least one of welding, gluing, external sleeving, nesting, and wrapping.

Referring to fig. 6, fig. 6 illustrates that the first supporting portion 212, the second supporting portion 213 and the main body portion 211 are integrally formed. Specifically, the two first support rods 2121 and the two second support rods 2131 are integrally formed with the two main support rods 2111.

It should be noted that, in this embodiment, two components, including but not limited to any two of the first supporting portion 212, the second supporting portion 213 and the main body portion 211, nor limited to two main supporting rods, two first supporting rods and two second supporting rods, may be respectively connected by welding, bonding, connecting with a peripheral sleeve, nesting, winding, etc.

In addition, in order to make the specific connection manner of the two components in the present embodiment, which are respectively defined as the adhesive connection, the peripheral sleeve connection, the nesting connection and the winding connection between the first component 214 and the second component 215, more clear, the following description will be made with reference to fig. 9 to 11:

referring to fig. 9, fig. 9 illustrates a connection diagram of two components of the present invention, which are connected to an external sleeve 216, and it can be seen from fig. 9 that both the first component 214 and the second component 215 are inserted into the sleeve 216, and the first component 214 and the second component 215 inside the sleeve 216 are connected to each other through the sleeve 216.

Referring to fig. 10, fig. 10 is a schematic diagram illustrating a connection of two components of the present invention in a nested manner, and as can be seen from fig. 10, a groove 2141 adapted to the second component 215 is formed on the first component 214, and the second component 215 is disposed inside the groove 2141, so that the first component 214 and the second component 215 are connected in a nested manner. Further, in order to ensure the stability of the connection mode, welding and/or bonding and the like can be added on the basis of nesting connection. In addition, the groove 2141 is configured as a card slot, for example, and the second component 215 is fixed in the groove 2141 by card connection. In addition, the size of the second member 215 can be designed to be larger than that of the groove 2141, so that the second member 215 can be clamped in the groove 2141.

Referring to fig. 11, fig. 11 is a schematic diagram illustrating the connection of two components wound together according to an embodiment of the present invention. As can be seen in fig. 11, the first part 214 is for example helically coiled on the second part 215, but the second part 215 can also be helically coiled on the first part 214. And is connected by welding or bonding at the contact position of the first member 214 and the second member 215 on the basis of the mutual winding of the first member 214 and the second member 215, further securing the connection strength of the two.

Referring to fig. 4, 12 or 13, in an embodiment, at least one of the main body portion 211, the first supporting portion 212 and the second supporting portion 213 is provided with an elastic expansion portion 217. Thus, the elastic expansion part 217 is added on the frame 21, and the elastic expansion part 217 can be extended when being stressed, so that the expansion performance of the frame 21 can be improved, the capability of the frame 21 to be attached to the tube wall of the aortic arch 10 can be improved, and the matching performance of the thrombus blocking device 20 to different anatomical structures of the aortic arch 10 can be further improved. The crimping performance of the frame 21 is also improved, so that the operation of the thrombus barrier 20 is more convenient.

When the main body portion 211, the first supporting portion 212 and the second supporting portion 213 are respectively provided with one or more elastic expansion portions 217, the frame 21 has a better unfolding performance, and has a stronger capability of attaching to the wall of the aortic arch 10, so as to have a better matching performance for different anatomical structures of the aortic arch 10.

When the main body portion 211 is provided with the elastic expansion portion 217, the elastic expansion portion 217 may be flexibly provided at any position on the main body portion 211 according to actual requirements, for example, at a position between the proximal end of the main body portion 211 or the proximal end of the main body portion 211 and the distal end of the main body portion 211, or at another position. Similarly, the elastic expansion portions 217 of the first and second supporting portions 212 and 213 can be flexibly adjusted according to actual requirements, and are not limited herein.

It should be noted that, alternatively, one or more elastic expansion portions 217 are provided only on one of the main body portion 211, the first support portion 212, and the second support portion 213, and the other two are not provided with the elastic expansion portions 217. Alternatively, one or more elastic expansion portions 217 are provided only on two of the body portion 211, the first support portion 212, and the second support portion 213, and the other one is not provided with the elastic expansion portion 217.

Referring to fig. 4, 12 or 13, in one embodiment, the proximal end of the main body portion 211 is provided with at least one elastic expansion portion 217. The distal end of the first support portion 212 is provided with at least one elastic expansion portion 217. At least one elastic expansion part 217 is provided on the distal end of the second support part 213. By means of the arrangement, researches show that the unfolding performance of the frame 21 can be better improved, the capability of the frame 21 attached to the tube wall of the aortic arch 10 can be better improved, and the matching performance of the thrombus barrier 20 to different anatomical structures of the aortic arch 10 can be further improved.

The number of the elastic expansion portions 217 disposed on the body portion 211, the number of the elastic expansion portions 217 disposed on the first support portion 212, and the number of the elastic expansion portions 217 disposed on the second support portion 213 may be the same or different from each other.

Referring to fig. 6 to 8, fig. 7 and 8 respectively show structural schematic diagrams of two different embodiments of frames, and the frames shown in fig. 6, 7 and 8 are different in the arrangement positions and the arrangement numbers of the elastic expansion portions.

Referring to fig. 7, the number of the elastic expansion parts provided in the frame shown in fig. 7 is 5, one elastic expansion part 217 is provided on the proximal end of the main body portion 211, and one elastic expansion part 217 is provided on each of the two main support bars 2111. The distal end of the first support portion 212 is provided with a resilient expansion portion 217. The distal end of the second support part 213 is provided with an elastic expansion part 217. Researches show that the thrombus barrier has excellent unfolding performance and vessel wall attaching performance, and can realize better thrombus barrier effect.

Referring to fig. 8, the number of the elastic expansion portions provided in the frame shown in fig. 8 is 6, an elastic expansion portion 217 is provided on the proximal end of the main body portion 211, one elastic expansion portion 217 is provided on one main support bar 2111, and two elastic expansion portions 217 are provided on the other main support bar 2111. The distal end of the first support portion 212 is provided with an elastic expansion portion 217. The distal end of the second support part 213 is provided with an elastic expansion part 217. Researches show that the thrombus barrier has excellent unfolding performance and vessel wall attaching performance, and can realize better thrombus barrier effect. The body portion 211 has different expansion forces on opposite sides thereof to accommodate particular types of complex vascular anatomy.

Referring to fig. 6, the number of the elastic expansion portions provided in the frame shown in fig. 6 is 3, and an elastic expansion portion 217 is provided on the proximal end of the main body portion 211. The distal end of the first support portion 212 is provided with a resilient expansion portion 217. The distal end of the second support part 213 is provided with an elastic expansion part 217. It has been found that compared to the frames shown in fig. 7 and 8, a delivery system with a relatively small outer diameter can be used for delivery, and the difficulty of the overall thrombus barrier device process is reduced.

Referring to fig. 14 to 17, fig. 14 is a schematic structural view illustrating that the elastic expansion portion 217 of the embodiment of the present invention is U-shaped and is protruded away from the center of the surrounding area; fig. 15 is a schematic structural view illustrating that the elastic expansion portion 217 of the embodiment of the present invention is in an omega shape and is protruded toward a direction away from the center of the surrounding area; fig. 16 is a schematic view showing a structure that the elastic expansion portion 217 of an embodiment of the present invention is circular ring-shaped and is protruded toward the center of the surrounding area; fig. 17 is a schematic structural view illustrating that the elastic expansion portion 217 of the present invention is circular and is protruded toward the center of the surrounding area. In one embodiment, the resilient extension 217 has a serpentine shape in the expanded state, and thus when subjected to a force, is capable of stretching to enhance the deployment performance of the frame 21. Optionally, the zigzag shape specifically includes, but is not limited to, one or more combinations of U shape (as shown in fig. 14), Ω shape (as shown in fig. 15), circular shape (as shown in fig. 16 and 17), arc shape, V shape, Z shape, and W shape, which may be regular shape, or designed into irregular shape, and may be flexibly adjusted and arranged according to actual needs, and is not limited herein.

The elastic expansion parts 217 with different shapes have different performances, and the following analysis is specifically performed on the typical shapes of the elastic expansion parts 217 in the U shape, the omega shape and the circular ring shape in the embodiment:

for example, the elastic expansion part 217 is U-shaped, and the elastic expansion part 217 protrudes away from the peripheral region of the frame 21, and it is found through research that the elastic expansion part 217 with this shape has relatively good adaptability, can achieve good vessel wall adhesion together with the frame 21, and has minimal resistance to subsequent instruments;

when the resilient expansion portion is U-shaped, the width of the opening of the U-shape includes, but is not limited to, 1mm to 8mm, and the depth of the U-shape includes, but is not limited to, 1mm to 5mm. Thus, when the size of the U-shaped flexible expansion portion is set within this range, on the one hand, the size of the flexible expansion portion is sufficiently small, i.e., the required outer diameter of the delivery system is sufficiently small, and the smaller the access opening is required, the more beneficial the patient; on the other hand, the size of the elastic expansion part is not too small, so that the processing difficulty is not too high, and the processing cost is lower.

For example, the elastic expansion portion 217 is, for example, a circular ring shape, and meanwhile, the elastic expansion portion 217 is protruded toward the surrounding area of the frame 21, and it is found through research that the elastic force of the elastic expansion portion 217 of this shape is relatively good, but the elastic expansion portion 217 is easily warped after the frame 21 is bent to fit the blood vessel wall, so that interference with subsequent instruments occurs; in addition, when the elastic expansion portion 217 is protruded toward the peripheral region of the frame 21, it is found through research that it is challenging for a lesion with a narrow space due to the need of occupying an additional axial space;

further, when the elastic expansion portion has a circular ring shape, the diameter dimension of the circular ring shape includes, but is not limited to, 0.6mm to 2mm. Thus, when the size of the annular elastic expansion part is set in the range, on one hand, the size of the elastic expansion part is small enough, namely the required external diameter size of the delivery system is small enough, and the smaller the required access opening is, the more beneficial the patient is; on the other hand, the size of the elastic expansion part is not too small, so that the processing difficulty is not too high, and the processing cost is lower.

For example, the elastic expansion portion 217 is, for example, omega-shaped, and the elastic expansion portion 217 is protruded toward the peripheral region of the frame 21, and it is found through research that an additional axial space is required, which is a challenge for a lesion with a narrow space; when the elastic expansion part 217 is protruded towards the surrounding area of the frame 21, the elastic force is relatively good, but the elastic expansion part 217 is easy to warp after the elastic expansion part is bent along with the frame 21 and attached to the vessel wall, so that interference with subsequent instruments is caused.

In one embodiment, one or more elastic expansion parts 217 may be disposed at each position of the main body part 211, the first supporting part 212, and the second supporting part 213, and the shapes of the disposed elastic expansion parts 217 may be kept consistent or may be different from each other, and how to set the elastic expansion parts may be flexibly adjusted and set according to actual requirements.

It should be noted that the thrombus barrier 20 needs the frame 21 to have good elastic expansion force to ensure that the frame 21 is adapted and attached to the wall of the aortic arch 10 and to reduce lateral leakage, and needs the frame 21 to reduce the occupation of the space near the side of the aortic arch 10 with large curvature as much as possible, so as to provide a larger space for subsequent instruments and facilitate the passage of the subsequent instruments. Because the near end of the main body part 211 and the far end of the first supporting part 212 of the frame 21 are not easy to interfere with subsequent instruments, the elastic expansion part 217 which is circular and is convexly arranged towards the center of the surrounding area of the frame 21 can be selected, so that the elastic force is relatively good; in addition, the distal end of the second supporting portion 213 is located at the side of the aortic arch 10 where the aortic arch is strongly curved (the following instruments pass through the main path), and thus easily interferes with the following instruments, and the passability is a main consideration, so that the U-shaped elastic expansion portion 217 is selected. Thus, the combination of the elastic expansion portions 217 of the frame 21 shown in fig. 4 is designed as one of the better design solutions, as shown in fig. 4, in one embodiment, the proximal end of the main body portion 211 is provided with an elastic expansion portion 217 protruding towards the center of the surrounding area and presenting a circular ring shape, the distal end of the first supporting portion 212 is provided with an elastic expansion portion 217 protruding towards the center of the surrounding area and presenting a circular ring shape, and the distal end of the second supporting portion 213 is provided with an elastic expansion portion 217 protruding towards the center away from the surrounding area and presenting a U shape. Thus, the combination has sufficient expansion elasticity, and the second support part 213 can be well attached to the blood vessel wall, thereby reducing the subsequent instrument passing resistance.

In one embodiment, when the main body part is provided with the elastic expansion part, an included angle formed by a plane where the elastic expansion part is located on the main body part and a plane where the main body part is located is defined as a, and a is 0-20 degrees; when the first supporting part is provided with the elastic expansion part, an included angle formed by a plane where the elastic expansion part on the first supporting part is located and a plane where the first supporting part is located is defined as b, and the b is 0-20 degrees; when the second supporting part is provided with the elastic expansion part, an included angle formed by a plane where the elastic expansion part on the second supporting part is located and a plane where the second supporting part is located is defined as c, and the c is 0-20 degrees. Therefore, the included angle of the a, the b and the c is small, so that better expansion and elongation can be ensured when the force is applied.

Wherein optionally a is 0 ° to 5 °, b is 0 ° to 5 °, and c is 0 ° to 5 °.

Referring to fig. 4, in one embodiment, the proximal end of the main body portion 211 is provided with at least one elastic expansion portion 217, and the elastic expansion portion 217 is protruded toward the center of the surrounding area and has a circular ring shape, and the diameter of the circular ring shape is 1mm to 1.5mm. In addition, the distal end of the first supporting portion 212 is provided with at least one elastic expansion portion 217, the elastic expansion portion 217 is convexly arranged towards the center of the surrounding area and is in a ring shape, and the diameter of the ring shape is 1mm-1.5mm. In addition, the far end of the second supporting part 213 is provided with at least one elastic expansion part 217 which is convexly arranged towards the center deviating from the surrounding area and is U-shaped, the width of the opening of the U-shape is 3mm-6mm, and the depth of the U-shape is 2mm-4mm.

By means of the arrangement, researches show that the unfolding performance of the frame 21 can be better improved, the capability of the frame 21 to be attached to the tube wall of the aortic arch 10 can be better improved, and the matching performance of the thrombus blocking device 20 on different anatomical structures of the aortic arch 10 can be further improved.

Referring to fig. 7, fig. 7 is different from fig. 4 in that at least one annular elastic expansion portion protruding toward the center of the surrounding area of one of the main support rods is disposed on one of the main support rods; the other main supporting rod is provided with at least one annular elastic expansion part which is convexly arranged towards the center of the surrounding area of the main supporting rod. Wherein the diameter of the circular ring is 1mm-1.5mm. In this way, the unfolding performance of the frame 21 can be further improved.

Referring to fig. 8, fig. 8 is different from fig. 4 in that at least one annular elastic expansion portion protruding toward the center of the surrounding area of one of the main support rods is disposed on one of the main support rods; the other main support rod is provided with at least one U-shaped elastic expansion part protruding towards the center of the surrounding area, and particularly, the other main support rod is provided with two U-shaped elastic expansion parts protruding towards the center of the surrounding area, so that the unfolding performance is better than that of one main support rod. When the elastic expansion part is in a circular ring shape, the diameter of the circular ring shape is 1mm-1.5mm; when the elastic expansion part is U-shaped, the width of the opening of the U-shape is 3mm-6mm, and the depth of the U-shape is 2mm-4mm.

The "elastically-expanding portion 217" may be a part of the main body portion 211, the first support portion 212, or the second support portion 213, that is, the "elastically-expanding portion 217" may be integrally formed with the other part of the main body portion 211, the first support portion 212, or the second support portion 213; or an independent member that is separable from the "main body portion 211, the first support portion 212, or the other portion of the second support portion 213", that is, the "elastic expansion portion 217" may be manufactured separately and then combined with the "main body portion 211, the first support portion 212, or the other portion of the second support portion 213" into a whole.

The technical features of the above embodiments can be arbitrarily combined, and for the sake of brevity, all possible combinations of the technical features in the above embodiments are not described, but should be considered as the scope of the present specification as long as there is no contradiction between the combinations of the technical features.

The above examples only express several embodiments of the present application, and the description thereof is more specific and detailed, but not to be construed as limiting the claims. It should be noted that, for a person skilled in the art, several variations and modifications can be made without departing from the concept of the present application, which falls within the scope of protection of the present application. Therefore, the protection scope of the present patent shall be subject to the appended claims.

In the description of the present application, it is to be understood that the terms "center," "longitudinal," "lateral," "length," "width," "thickness," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," "clockwise," "counterclockwise," "axial," "radial," "circumferential," and the like are used in the orientations and positional relationships indicated in the drawings for convenience in describing the present application and for simplicity in description, and are not intended to indicate or imply that the referenced devices or elements must have a particular orientation, be constructed and operated in a particular orientation, and are therefore not to be considered limiting of the present application.

Furthermore, the terms "first", "second" and "first" are used for descriptive purposes only and are not to be construed as indicating or implying relative importance or to implicitly indicate the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include at least one such feature. In the description of the present application, "plurality" means at least two, e.g., two, three, etc., unless specifically limited otherwise.

In this application, unless expressly stated or limited otherwise, the terms "mounted," "connected," "secured," and the like are to be construed broadly and can include, for example, fixed connections, removable connections, or integral parts; can be mechanically or electrically connected; they may be directly connected or indirectly connected through intervening media, or they may be connected internally or in any other suitable relationship, unless expressly stated otherwise. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as the case may be.

In this application, unless expressly stated or limited otherwise, a first feature is "on" or "under" a second feature such that the first and second features are in direct contact, or the first and second features are in indirect contact via an intermediary. Also, a first feature "on," "over," and "above" a second feature may be directly or diagonally above the second feature, or may simply indicate that the first feature is at a higher level than the second feature. A first feature "under," "beneath," and "under" a second feature may be directly under or obliquely under the second feature, or may simply mean that the first feature is at a lesser elevation than the second feature.

It will be understood that when an element is referred to as being "secured to" or "disposed on" another element, it can be directly on the other element or intervening elements may also be present. When an element is referred to as being "connected" to another element, it can be directly connected to the other element or intervening elements may also be present. As used herein, the terms "vertical," "horizontal," "upper," "lower," "left," "right," and the like are for purposes of illustration only and do not denote a single embodiment.

Claims (13)

1. A thrombus barrier, comprising:

the frame comprises a main body part, a first supporting part and a second supporting part, wherein the near end of the first supporting part and the near end of the second supporting part are connected with the far end of the main body part; when the frame is in an expanded state, the first supporting part bends towards one side of the main body part, and the second supporting part bends towards the other side of the main body part or is positioned on the same plane with the main body part; and

the filter screen is respectively connected with the second supporting part and the main body part;

at least one of the main body portion, the first support portion and the second support portion is provided with an elastic expansion portion.

2. The thrombus barrier of claim 1, wherein the main body portion comprises two main support rods, proximal ends of the two main support rods being connected to each other, the two main support rods being provided with a first spacing;

the first supporting part comprises two first supporting rods, the far ends of the two first supporting rods are connected with each other, the two first supporting rods are provided with a second interval, and the near ends of the two first supporting rods are correspondingly connected with the far ends of the two main supporting rods respectively;

the second supporting part comprises two second supporting rods, the two far ends of the second supporting rods are connected with each other, the two second supporting rods are provided with third intervals, and the near ends of the two second supporting rods are respectively connected with the far ends of the two main supporting rods correspondingly.

3. The thrombus barrier of claim 2, wherein the diameter of the main support rod is set to 0.2mm-1mm; the diameter of the first supporting rod is set to be 0.2mm-1mm; the diameter of the second supporting rod is set to be 0.2mm-1mm.

4. The thrombus barrier according to claim 1, wherein when the main body part is provided with the elastic expansion part, the plane of the elastic expansion part on the main body part forms an included angle with the plane of the main body part, which is defined as a, and a is 0-20 °; when the first supporting part is provided with the elastic expansion part, an included angle formed by a plane where the elastic expansion part is located on the first supporting part and a plane where the first supporting part is located is defined as b, and the b is 0-20 degrees; when the second supporting part is provided with the elastic expansion part, an included angle formed by a plane where the elastic expansion part is located on the second supporting part and a plane where the second supporting part is located is defined as c, and the c is 0-20 degrees.

5. The thrombus barrier of claim 4, wherein a is 0 ° to 5 °, b is 0 ° to 5 °, and c is 0 ° to 5 °.

6. The thrombus barrier of claim 1, wherein the proximal end of the body portion is provided with at least one of the resilient distended portions; the far end of the first supporting part is provided with at least one elastic expansion part; the far end of the second supporting part is provided with at least one elastic expansion part.

7. The thrombus barrier of claim 1, wherein the resilient expanse is one or a combination of U-shaped, Ω -shaped, circular, arc-shaped, V-shaped, Z-shaped, W-shaped.

8. The thrombus barrier of claim 7, wherein when the elastic expansion portion is annular, the diameter of the annular shape is 0.6mm-2mm in size.

9. The thrombus barrier of claim 7, wherein when the elastic expansion portion is U-shaped, the opening width of the U-shape is 1mm to 8mm and the depth of the U-shape is 1mm to 5mm.

10. The thrombus barrier according to claim 7, wherein the proximal end of the main body is provided with a circular ring-shaped elastic expansion portion protruding toward the center of the surrounding area, the distal end of the first support portion is provided with a circular ring-shaped elastic expansion portion protruding toward the center of the surrounding area, and the distal end of the second support portion is provided with a U-shaped elastic expansion portion protruding toward the center of the surrounding area.

11. The thrombus barrier of claim 10, wherein the main body portion comprises two main support rods, proximal ends of the two main support rods being connected to each other, the two main support rods being provided with a first spacing; one of the main supporting rods is provided with at least one annular elastic expansion part which is arranged towards the center of the surrounding area in a protruding way, and/or at least one U-shaped elastic expansion part which is arranged towards the center of the surrounding area in a protruding way; and at least one annular elastic expansion part which is convexly arranged towards the center of the surrounding area of the main support rod and/or at least one U-shaped elastic expansion part which is convexly arranged towards the center of the surrounding area of the main support rod is arranged on the other main support rod.

12. The thrombus barrier of claim 10 or 11, wherein when the elastic expansion portion is annular, the diameter dimension of the annular shape is 1mm to 1.5mm; when the elastic expansion part is U-shaped, the width of the opening of the U-shape is 3mm-6mm, and the depth of the U-shape is 2mm-4mm.

13. A thrombus blocking device, characterized in that, the thrombus blocking device includes the thrombus blocking device of any one of claims 1 to 12, the thrombus blocking device further includes a push rod and an introducing sheath, the push rod is connected with the frame, the push rod is arranged inside the introducing sheath in a penetrating manner, the frame is located inside the introducing sheath together with the push rod before release, and the frame is located outside the introducing sheath after release.

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