CN112773460A

CN112773460A - Deformable distal protection umbrella and distal protection device

Info

Publication number: CN112773460A
Application number: CN202110158193.3A
Authority: CN
Inventors: 郑殿会; 刘颖
Original assignee: Beijing Percutek Therapeutics Co ltd
Current assignee: Beijing Percutek Therapeutics Co ltd
Priority date: 2021-02-04
Filing date: 2021-02-04
Publication date: 2021-05-11
Anticipated expiration: 2041-02-04
Also published as: CN112773460B

Abstract

The invention provides a deformable distal protection umbrella and a distal protection device, which relate to the field of medical devices. The deformable distal protection umbrella includes a proximal developing ring, a distal developing ring, a support frame and a pocket-shaped elastic porous membrane; the support frame It includes a plurality of supporting beams, the proximal ends of the supporting beams are connected to the proximal developing ring, and the distal ends are connected to the distal developing ring, and the plurality of supporting beams are surrounded to form a cylindrical space; , the contraction section can be bent when the pressure of the thrombus exceeds the preset pressure, so as to increase the volume of the cylindrical space; the elastic porous covering film is covered and connected to the supporting beam in such a way that the opening is opened by the supporting beam, and the elastic porous covering film is connected to the supporting beam. The opening of the membrane faces the proximal developing ring; a developing component or a developing coating is arranged on the support frame; the distal protection device includes a guide wire and the aforementioned deformable distal protection umbrella. The invention alleviates the problem that the existing distal protection device for peripheral blood vessels has a small embolization capacity.

Description

Deformable distal protection umbrella and distal protection device

Technical Field

The invention relates to the technical field of medical instruments, in particular to a deformable far-end protective umbrella and a far-end protective device.

Background

Peripheral arterial vascular thrombotic diseases are a group of vascular diseases seriously threatening human health, the incidence rate of which has been remarkably increased in recent years, and the diseases commonly include arteriosclerotic occlusion, arterial thrombosis, aneurysm and the like, wherein: the lower limb arteriosclerosis obliterans is the most common vascular surgical disease, is the main cause of chronic lower limb ischemia, the incidence rate of the lower limb arteriosclerosis obliterans is increased with the age, the incidence rate of the lower limb arteriosclerosis obliterans below 60 years old is about 5.6%, the incidence rate of the lower limb arteriosclerosis obliterans reaches 15.9% between 60 and 70 years old, the incidence rate of the lower limb arteriosclerosis obliterans above 70 years old is about 33.8%, and the incidence rate of the lower limb arteriosclerosis obliterans of men is slightly higher than that of women. The lower limb arteriosclerosis obliterans have uncertain causes, hyperlipidemia, hypertension, diabetes, smoking and the like are main risk factors causing the lower limb arteriosclerosis obliterans, mainly die of cardiovascular and cerebrovascular complications, 5-year death rate of intermittent claudication patients is about 30%, and 5-year death rate of lower limb ischemia patients with resting pain, ulcer and gangrene is 70%.

The pathological basis of peripheral arterial thrombotic disease is the formation of atherosclerotic plaques in the limbs of the artery, leading to stenosis or occlusion of the lumen, and secondary thrombosis. The pathological changes are mainly manifested by atheromatous plaque formation of blood vessels intima, lipid deposition in early stage of the artery intima, fibrous plaque formation, necrosis of deep cells of the fibrous plaque, atheromatous plaque formation, atrophy and necrosis of tunica muscularis media in the artery, deposition of collagen fibers and calcium, no pathological change of the artery adventitia, atheromatous plaque and calcified plaque after atheromatous plaque formation can protrude towards the lumen, resulting in lumen stenosis or occlusion, leading to chronic ischemia of distal limb tissues, hemorrhage or rupture in atheromatous plaque, and the like, which can cause arterial embolism and acute limb ischemia. The clinical manifestations of the patient are intermittent claudication, rest pain, ischemic ulcer and gangrene of limbs, and the main signs are decreased skin temperature of the extremities, weakened or disappeared arterial pulsation of the lower limbs, decreased systolic pressure of the arteries of the lower limbs, changed skin nutrition disorder, including thin skin, hair loss, deformed nails, etc., ulcer of limbs, gangrene, etc.

Interventional intraluminal treatment has the characteristics of less trauma and lower requirements on the physical condition of a patient compared with the traditional surgical operation, and in recent years, with the development of medical materials and imaging technology, intraluminal treatment has been widely applied to the treatment of peripheral arterial vascular embolic diseases.

Percutaneous balloon angioplasty and stent placement are one of the main means of intracavity treatment, and the principle is that the blood vessel stenosis is relieved through the physical expansion of a balloon and the radial supporting force of a stent, an atherosclerotic plaque is pressed to the artery wall, the internal diameter of the blood vessel of the stenosis section is increased, and the blood supply of the far end of a limb is improved. But after years of clinical application, the long-term vascular patency rate of the skin balloon angioplasty and the stent implantation is not ideal, the rate of intervention treatment is higher, the effect of treating a short section of lesion with the diameter of less than 3cm is better, the 5-year patency rate can reach 75%, but the long-term patency rate of stenosis and occlusion lesion with the length of less than 3cm is not ideal, the 6-month patency rate of a narrow lesion with the diameter of less than 7cm is 86.8%, and the 6-month patency rate of the narrow lesion with the diameter of more than 7cm is only 23.1%.

In order to overcome the defects of the saccule and the stent in lower limb arterial lesions, a plurality of novel interventional devices such as a catheter suction embolus technology and a plaque cutting technology appear in recent years, and are widely used clinically due to novel design concepts. However, regardless of the catheter suction technology or the rotational atherectomy technology, calcified plaque in an arterial lumen can be broken during the thrombus removal process, and the broken plaque is easy to block a distal arterial blood vessel, so that the risk of necrosis and amputation of distal tissues caused by blood non-circulation is caused. Therefore, the peripheral blood vessel is required to filter emboli in the blood by using a far-end protection device, and then the emboli is conveyed out of the body through a catheter so as to avoid the far-end embolism in the interventional embolectomy.

However, at present, the existing distal protection device for the peripheral blood vessel at least has the problem of small thrombus containing capacity, and when the thrombus capacity is too much, the thrombus quickly blocks the bottom of the elastic porous covering film of the distal protection device, so that the blood flow is not circulated, and the operation risk and difficulty are increased.

Disclosure of Invention

The invention aims to provide a deformable distal end protection umbrella and a distal end protection device, which are used for solving the technical problem that the plug accommodating capacity of the conventional distal end protection device for peripheral blood vessels is small.

In order to achieve the above purpose, the embodiment of the invention adopts the following technical scheme:

in a first aspect, embodiments of the present invention provide a deformable distal protection umbrella, including a proximal development ring, a distal development ring, a support skeleton, and a pocket-shaped elastic porous coating;

the supporting framework comprises a plurality of supporting beams, the near ends of the supporting beams are connected to the near-end developing ring, the far ends of the supporting beams are connected to the far-end developing ring, and the supporting beams surround to form a cylindrical space;

the distal end of each support beam comprises a reduced diameter section of the beam body, and the reduced diameter section is configured to bend to increase the volume of the cylindrical space when the thrombus pressure exceeds a preset pressure;

the elastic porous coating covers and is connected to the support beam in a manner that the opening is spread by the support beam, and the opening of the elastic porous coating faces the near-end development ring; and the supporting framework is connected with a developing component or coated with a developing coating.

In an alternative embodiment, each of the support beams includes a main beam, a distal beam and a fixed beam, which are connected in sequence;

the near end of the main body beam is connected to the near end developing ring, and the far end of the fixed beam is connected to the far end developing ring;

the far end of the main body beam and the near end of the far end beam are connected through the warp shrinking section, and the far end of the far end beam and the near end of the fixed beam are connected through the warp shrinking section; or the diameter of the distal beam is smaller than that of the main beam and forms the warp shrinking section; or the diameter of the distal beam and the diameter of the fixed beam are both smaller than the diameter of the main body beam and form the warp shrinking section.

Further optionally, the support frame further comprises a proximal support ring, the proximal support ring is connected to the main body beam, and an opening edge of the elastic porous coating film is connected to the proximal support ring.

It is further optional, the main part roof beam includes near-end roof beam and middle part roof beam, the near-end of near-end roof beam connect in near-end development ring, the far end of near-end roof beam with the near-end of middle part roof beam all connect in the near-end support ring, and same root the near-end roof beam of a supporting beam and middle part roof beam be crisscross each other connect in the near-end support ring.

Still further optionally, the distal end of the proximal beam and the proximal end of the middle beam are both provided with a fixing ring, and the proximal end support ring passes through the fixing rings.

In an alternative embodiment, the ring body of the proximal support ring comprises a plurality of first wave segments, a plurality of transition segments, and a plurality of second wave segments, wherein: the first wave segments and the second wave segments are alternately arranged, the first wave segments are connected with the adjacent second wave segments through the transition segments, the bending directions of the first wave segments and the second wave segments are opposite, and the main body beam is connected to the wave crests or the wave troughs of the first wave segments or the second wave segments; and/or a developing component is arranged on the proximal end support ring or a developing coating is coated on the proximal end support ring. Wherein "and/or" means that the two structures are arranged at the same time or alternatively.

In an alternative embodiment, the support frame further comprises a distal support ring connected to the main beam or a proximal end of the distal beam, and the elastic porous covering membrane is connected to the distal support ring in a covering manner.

Further optionally, a fixing ring is arranged on the main body beam or at the proximal end of the distal beam, and the distal support ring penetrates through the fixing ring; and/or the ring body of the distal support ring comprises a plurality of first wave segments, a plurality of transition segments and a plurality of second wave segments, wherein: the first wave segments and the second wave segments are alternately arranged, the first wave segments are connected with the adjacent second wave segments through the transition segments, the bending directions of the first wave segments and the second wave segments are opposite, and the main body beam or the distal beam is connected to the peaks or the troughs of the first wave segments or the second wave segments; and/or a developing component is arranged on the distal end support ring or a developing coating is coated on the distal end support ring. Wherein "and/or" means that the three structures are arranged at the same time or one or any two structures are combined.

In an alternative embodiment, the proximal beam includes an S-shaped connecting section and a proximal straight section, one end of the S-shaped connecting section is connected to the proximal end of the middle beam, the other end of the S-shaped connecting section is connected to the proximal straight section, and the other end of the proximal straight section is connected to the proximal developing ring.

In a second aspect, embodiments of the present invention further provide a distal protection device, which includes a guide wire and a deformable distal protection umbrella provided in one of the alternative embodiments of the first aspect; wherein, the seal wire passes in proper order near-end development ring with the distal end development ring, and be in being located of seal wire the position of the both sides of near-end development ring all is provided with the stopper, near-end development ring can wind the seal wire rotates just near-end development ring can be followed the seal wire is two reciprocal slip between the stopper.

The embodiment of the invention can realize the following beneficial effects:

a first aspect of an embodiment of the present invention provides a deformable distal-end protection umbrella, including a proximal-end developing ring, a distal-end developing ring, a support skeleton, and a pocket-shaped elastic porous coating film; the supporting framework comprises a plurality of supporting beams, the near ends of the supporting beams are connected to the near-end developing ring, the far ends of the supporting beams are connected to the far-end developing ring, and the supporting beams surround to form a cylindrical space; the distal end of each support beam comprises a reduced diameter section of the beam body, and the reduced diameter section is configured to bend to increase the volume of the cylindrical space when the thrombus pressure exceeds a preset pressure; the elastic porous covering film is covered and connected with the supporting beam in a way that the opening is spread by the supporting beam, and the opening of the elastic porous covering film faces to the near-end developing ring; the supporting framework is connected with a developing component or coated with a developing coating.

In the embodiment of the invention, after the deformable distal protection umbrella is released into a blood vessel, in the process of embolic protection, when fewer emboli exist, all emboli fall into the distal bottom of the elastic porous covering film of the deformable distal protection umbrella, when more emboli exist, the emboli completely cover the distal bottom of the elastic porous covering film, so that blood can not flow temporarily, when the blood pressure exceeds the preset pressure, the contracted section is forced to bend, the distal part of the support framework is integrally expanded towards the distal direction, the volume of the cylindrical space is further increased, and the blood can flow out from the side wall pores of the elastic porous covering film. Especially, under the condition that the far-end developing ring is positioned outside a cylindrical space formed by surrounding a plurality of supporting beams, when the blood pressure exceeds the preset pressure, the warp shrinking section is forced to bend, the whole far-end part of the supporting framework is unfolded towards the far-end direction, the thrombus containing space is changed into a structure of a cylindrical structure and a far-end cone from the cylindrical structure, the volume of the thrombus containing space is greatly increased, the elastic porous film is elastically deformed under the action of the warp shrinking section, and the blood flows out from a taper side wall pore at the bottom of the far end of the elastic porous film, so that the thrombus containing amount is greatly increased.

In summary, the embodiment of the invention alleviates the technical problem of small thrombus containing capacity of the existing distal protection device for peripheral blood vessels, can keep blood circulation when a large number of emboli are filtered, does not influence the use of the distal protection device, and further improves the operation safety.

In addition, a second aspect of the embodiments of the present invention further provides a distal protection device, including a guide wire and the deformable distal protection umbrella provided in the first aspect; because the distal protection device provided by the embodiment of the present invention includes the deformable distal protection umbrella provided by the first aspect, the distal protection device provided by the embodiment of the present invention can achieve all the beneficial effects that the deformable distal protection umbrella provided by the first aspect can achieve.

Drawings

In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.

FIG. 1 is a schematic view of the overall structure of a deformable distal umbrella according to an embodiment of the present invention;

FIG. 2 is a schematic view of the deformable distal shroud of the present invention after removal of the flexible porous covering;

FIG. 3 is a schematic view of the overall structure of the proximal beam of FIG. 2;

FIG. 4 is a coupling structure diagram of the middle beam, the distal beam and the fixed beam of FIG. 2;

FIG. 5 is a schematic view of the overall structure of the proximal support ring or the distal support ring of FIG. 2;

FIG. 6 is a schematic view showing the overall structure of the developing member on the proximal support ring or the distal support ring of FIG. 2;

fig. 7 is a schematic overall structure diagram of a distal protection device according to an embodiment of the present invention.

Icon: 100-proximal developer ring; 200-distal developer ring; 300-elastic porous covering film; 400-a support beam; 410-a body beam; 411-a proximal beam; 4111-an S-shaped connecting section; 4112-a proximal straight section; 412-middle beam; 420-a distal beam; 430-a fixed beam; 500-warp shrinking section; 600-a proximal support ring; 601-a first wave segment; 602-a transition section; 603-a second wave segment; 700-a fixed ring; 800-a developing member; 910-a guide wire; 920-a limiting block.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.

Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.

In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or orientations or positional relationships conventionally put in use of products of the present invention, and are only for convenience of description and simplification of description, but do not indicate or imply that the devices or elements referred to must have specific orientations, be constructed in specific orientations, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," "third," and the like are used solely to distinguish one from another and are not to be construed as indicating or implying relative importance.

Further, the term "proximal" refers to the end closer to the human heart during surgery, i.e., the upstream end of blood flow, and "distal" refers to the other end opposite the "proximal".

In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," and "connected" are to be construed broadly, e.g., as meaning fixedly connected, detachably connected, or integrally connected; can be mechanically or electrically connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases to those skilled in the art.

Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.

Example one

The present embodiment provides a deformable distal end protection umbrella, which includes a proximal development ring 100, a distal development ring 200, a support skeleton, and a pocket-shaped elastic porous cover 300, referring to fig. 1 to 6. Wherein: the supporting framework comprises a plurality of supporting beams 400, the near ends of the supporting beams 400 are connected to the near-end developing ring 100, the far ends of the supporting beams 400 are connected to the far-end developing ring 200, and the supporting beams 400 surround to form a cylindrical space; the distal end of each support beam 400 includes a reduced diameter section 500 of reduced beam body diameter, the reduced diameter section 500 being configured to bend to increase the volume of the cylindrical space when subjected to thrombus pressure in excess of a predetermined pressure; the elastic porous coating film 300 is attached to the support beam 400 in such a manner that the opening is spread by the support beam 400, and the opening of the elastic porous coating film 300 faces the proximal development ring 100; the supporting frame is connected with a developing component 800 or coated with a developing coating, the developing component 800 may be but is not limited to a developing spring as shown in fig. 6, the developing spring is formed by winding a metal without projecting a line, the end faces of the two ends of the developing spring are polished flat and cannot touch or scratch blood vessels or the elastic porous coating 300, and the manner of connecting the developing spring to the supporting frame includes but is not limited to bonding, welding, pressing on the supporting frame, and the like.

Referring to fig. 7, the deformable distal protection umbrella can be assembled on the guide wire 910 to form a distal protection device by passing the guide wire 910 through the proximal development ring 100 and the distal development ring 200 of the deformable distal protection umbrella in sequence, and providing a stop block 920 at each of the two sides of the proximal development ring 100 of the guide wire 910, wherein the proximal development ring 100 can rotate around the guide wire 910 and the proximal development ring 100 can slide back and forth between the two stop blocks 920 along the guide wire 910. During operation, the deformable far-end protection umbrella is conveyed to the far end of an affected part by a guide catheter and a guide wire and is released at a distance of 2cm-4cm to filter thrombus, the deformable far-end protection umbrella is withdrawn from the affected part by a recovery catheter after the operation is finished, specifically, a first perforation is arranged on the front end tube wall of the guide catheter, a second perforation is arranged on the rear end tube wall of the guide catheter, a third perforation is arranged on the rear end tube wall of the recovery catheter, and the conveying and recovery operation steps can be carried out by referring to the following steps:

a conveying step: first, the rear end of the guide wire 910 of the distal protection device is inserted into the guide catheter from the front end thereof and passes out of the guide catheter from the second perforation, the guide catheter is held by hand, and the rear end of the guide wire 910 is pulled until the deformable distal protection umbrella is completely pulled into the guide catheter and the distal end of the deformable distal protection umbrella is positioned at the rear side of the first perforation; then a guide wire is penetrated into the guide catheter from the first perforation, and the front end of the guide wire penetrates out of the front end of the guide catheter; then slowly pushing the guide catheter and the guide wire to the human body, ensuring that the guide wire sends the guide catheter to the far end of the affected part, withdrawing the guide wire after reaching the far end of the affected part, holding the guide wire 910, withdrawing the guide catheter, and releasing and opening the deformable far-end protection umbrella, at the moment, the guide wire 910 can be used for placing a bracket or a catheter and the like for treating the affected part, and in the treatment process, the opened deformable far-end protection umbrella filters the dropped embolus to prevent the embolus from entering a downstream blood vessel to cause downstream tissue necrosis;

and (3) a recovery step: after the affected part is treated and relevant treatment accessories are withdrawn, the rear end of the guide wire 910 penetrates into the recovery catheter from the front end of the recovery catheter, the rear end of the guide wire 910 penetrates out of the third perforation, the recovery catheter is slowly pushed forwards to enable the deformable distal protection umbrella containing thrombus to be gradually compressed and coated on the recovery catheter, and then the guide wire 910 and the recovery catheter are withdrawn from the blood vessel together, so that the purpose of recovering the distal protection device is achieved.

In the whole operation process, the near-end developing ring 100, the far-end developing ring 200 and the developing component 800 connected to the supporting framework or the developing coating applied to the supporting framework are used as key developing marks for operation reference so as to determine the releasing and recovering positions of the deformable far-end protective umbrella and the inlet and bottom positions of the elastic porous covering film 300 in the opening state, and improve the operation efficiency and the operation safety.

In this embodiment, after the deformable distal protection umbrella is released into the blood vessel, in the process of thrombus filtering protection, when there are fewer emboli, all emboli fall into the distal bottom of the elastic porous covering membrane 300 of the deformable distal protection umbrella, and when there are more emboli, the emboli completely cover the distal bottom of the elastic porous covering membrane 300, so that blood cannot flow temporarily, and when the blood pressure exceeds a preset pressure, the constricted section 500 is forced to bend, so that the distal end part of the support framework is entirely stretched in the distal direction, thereby increasing the volume of the cylindrical space, and blood can flow out from the side wall pores of the elastic porous covering membrane 300. Especially, when the distal developing ring 200 is located outside the cylindrical space formed by the support beams 400, the constricted section 500 is forced to bend when the blood pressure exceeds the preset pressure, so that the distal portion of the support frame is entirely expanded towards the distal direction, the thrombus containing space is changed from the cylindrical structure to the cylindrical structure + the distal cone structure, the volume of the thrombus containing space is greatly increased, the elastic porous coating 300 is elastically deformed by the constricted section 500, and the blood flows out from the tapered side wall pore at the bottom of the distal end of the elastic porous coating 300, so that the thrombus containing amount is greatly increased.

In conclusion, the technical problem that the thrombus-containing quantity of the existing distal end protection device for the peripheral blood vessel is small is solved, blood circulation can be kept when a large number of emboli are filtered, the use of the distal end protection device is not affected, and the operation safety is improved.

Referring to fig. 2, in an alternative embodiment of the present embodiment, each support beam 400 includes a main beam 410, a distal beam 420, and a fixed beam 430, each connected in series. Wherein: the proximal end of the body beam 410 is connected to the proximal developer ring 100, and the distal end of the fixed beam 430 is connected to the distal developer ring 200; the far end of the main body beam 410 is connected with the near end of the far end beam 420, and the far end of the far end beam 420 is connected with the near end of the fixed beam 430 through a contracted section 500; alternatively, the diameter of the distal beam 420 is smaller than the diameter of the main body beam 410 and constitutes the narrowing section 500; alternatively, the diameter of the distal beam 420 and the diameter of the fixation beam 430 are both smaller than the diameter of the main body beam 410 and constitute the constricted section 500.

With continued reference to FIG. 2, further optionally, the support frame further comprises a proximal support ring 600, the proximal support ring 600 being attached to the body beam 410, the open edge of the resilient porous coating 300 being attached to the proximal support ring 600. By arranging the proximal support ring 600, the opening of the elastic porous covering film 300 can be supported, so that after the deformable distal protection umbrella is inserted into a blood vessel, the opening of the elastic porous covering film 300 can be completely attached to the blood vessel wall, namely, the opening of the elastic porous covering film 300 has good adherence, so that embolic substances in blood are all filtered and intercepted through the elastic porous covering film 300, and the problems of downstream blood vessel blockage and tissue necrosis due to lack of nutrient substance transportation caused by leakage of the embolic substances between the opening of the elastic porous covering film 300 and the blood vessel wall are avoided; in addition, because of having set up near-end support ring 600 and having good adherence in order to guarantee that elasticity porous tectorial membrane 300 opening part has to, can suitably reduce a supporting beam 400's radical, and then improve the whole compliance of this flexible distal end umbrella, do benefit to this flexible distal end umbrella and cross the curvedly and reduce the damage to the vascular wall in the blood vessel, and be convenient for the doctor to adjust the position and the form of this flexible distal end umbrella.

Referring to fig. 3 and 4 in combination with fig. 2, in an alternative embodiment of this embodiment, it is preferable that the main beam 410 includes a proximal beam 411 and a middle beam 412, the proximal end of the proximal beam 411 is connected to the proximal development ring 100, the distal end of the proximal beam 411 and the proximal end of the middle beam 412 are both connected to the proximal support ring 600, and the proximal beam 411 and the middle beam 412 of the same support beam 400 are connected to the proximal support ring 600 in an interlaced manner. Through the structure, the overall flexibility of the deformable distal protection umbrella is improved, the damage to blood vessels is further reduced, and meanwhile, as the proximal beams 411 and the middle beams 412 of the same supporting beam 400 are mutually connected with the proximal supporting ring 600 in a staggered manner, the elastic porous covering film 300 can be well supported under the condition that the number of the supporting beams 400 is small.

With continued reference to fig. 2-4, it is further preferred that a securing ring 700 is provided at both the distal end of the proximal beam 411 and the proximal end of the middle beam 412, and that a proximal support ring 600 is passed through the securing ring 700, which securing ring 700 may be welded to the distal end of the proximal beam 411 and the proximal end of the middle beam 412 or formed by bending the proximal beam 411 and the middle beam 412, respectively. The proximal and

middle beams

411, 412 are not directly connected to the proximal support ring 600, so that during opening and closing, no opposing forces are generated between the proximal beam 411 and the middle beam 412, respectively, and the proximal support ring 600, the proximal beam 411 and the middle beam 412 do not have a large mechanical impact on the proximal support ring 600, that is, the deformation of the proximal support ring 600 is not caused, the adherence of the deformable distal protection umbrella is further improved, the leakage of embolic material at the opening edge of the elastic porous membrane 300 is further prevented, and in addition, because no relative force is generated between the proximal beam 411 and the middle beam 412 and the proximal support ring 600 respectively during the opening and closing processes, the proximal beam 411 and the middle beam 412 do not have large mechanical influence on the proximal support ring 600, therefore, the whole flexibility of the deformable far-end protection umbrella is consistent, the over-bending in the blood vessel is facilitated, and the damage to the blood vessel wall is further reduced. Of course, when the body beam 410 is a unitary beam, it is also possible to attach the proximal support ring 600 by providing such a securing ring 700 on the body beam 410.

Referring to fig. 5, in an alternative embodiment, the ring body of the proximal support ring 600 preferably includes a plurality of first wave segments 601, a plurality of transition segments 602, and a plurality of second wave segments 603, wherein: the first wave segments 601 and the second wave segments 603 are alternately arranged, the first wave segments 601 are connected with the adjacent second wave segments 603 through transition segments 602, the bending directions of the first wave segments 601 and the second wave segments 603 are opposite, and the body beam 410 is connected to the wave crests or the wave troughs of the first wave segments 601 or the second wave segments 603; with such a structure, when the deformable distal protection umbrella is opened or contracted, the support beam 400 can drive the first wave section 601 and the second wave section 603 to open and close along the V-shaped contour thereof, so as to facilitate the operation.

In an alternative embodiment, it is preferable that the proximal support ring 600 is provided with the developing member 800 or coated with a developing coating, it is preferable that the developing member 800 is provided on the transition section 602 of the proximal support ring 600, and the developing member 800 is preferably a developing spring, which covers almost the entire proximal support ring 600, so as to ensure that the deformable distal protection umbrella has a clearer developing effect.

In addition, in some optional embodiments of the present embodiment, the support frame further comprises a distal support ring connected to the proximal end of the main beam 410 or the distal beam 420, and the elastic porous coating 300 is covered and connected to the distal support ring. Thus, the adherence of the deformable distal protection umbrella can be further improved by the distal support ring, increasing the plug-holding capacity of the elastic porous cover film 300.

Further preferably, a fixing ring 700 is provided on the body beam 410 or at a proximal end of the distal beam 420, and the distal support ring passes through the fixing ring 700. And/or, the ring body of the distal support ring comprises a plurality of first wave segments 601, a plurality of transition segments 602, and a plurality of second wave segments 603, wherein: the first wave segments 601 and the second wave segments 603 are alternately arranged, the first wave segments 601 are connected with the adjacent second wave segments 603 through transition segments 602, the bending directions of the first wave segments 601 and the second wave segments 603 are opposite, and the body beam 410 or the distal beam 420 is connected to the peaks or the troughs of the first wave segments 601 or the second wave segments 603; and/or, the distal support ring may be provided with a developer member 800 or a developer coating. Wherein "and/or" means "and/or" preceding structure is provided simultaneously or alternatively to "and/or" following structure. The functional effects that the above structure can achieve are obtained with reference to the proximal support ring 600 described above.

In addition, in an alternative embodiment of this embodiment, it is preferable that, as shown in fig. 2, the proximal beam 411 includes an S-shaped connecting section 4111 and a proximal straight section 4112, a proximal end of the S-shaped connecting section 4111 is connected to a distal end of the proximal straight section 4112, and a proximal end of the proximal straight section 4112 is connected to the proximal developer ring 100. Through the structure arrangement, compared with a distal protection device in the prior art, the elastic filter membrane is covered on a fusiform frame consisting of a plurality of support rods, the proximal invalid axial length is shortened, the proximal axial length of the distal protection device is further reduced, the embodiment can be applied to peripheral blood vessels which are shorter, have shorter, more circuitous or knotted blood vessels in the downstream anchoring area of an embolism part, such as renal artery, and the like, and can be simultaneously applied to longer or shorter anchoring areas.

In this embodiment, the cylindrical space surrounded by the plurality of support beams 400 may be a straight cylindrical structure, a tapered structure with a diameter gradually decreasing from the proximal end to the distal end, or other structures, which is not limited herein.

Example two

This example provides a distal tip protector comprising a guidewire 910 and a deformable distal tip protector umbrella as provided in any of the alternative embodiments of this example, as shown in fig. 7. The guide wire 910 sequentially passes through the proximal developing ring 100 and the distal developing ring 200, the guide wire 910 is provided with the limiting blocks 920 at the positions on the two sides of the proximal developing ring 100, the proximal developing ring 100 can rotate around the guide wire 910, and the proximal developing ring 100 can slide between the two limiting blocks 920 along the guide wire 910 in a reciprocating manner.

In this embodiment, the stop block 920 may be, but is not limited to being, welded to the guide wire 910.

Since the distal protection device provided by this embodiment includes the deformable distal protection umbrella described in the first embodiment, the distal protection device provided by this embodiment can achieve all the advantages that the deformable distal protection umbrella can achieve in the first embodiment, and the specific structure, the operation manner, and the achievable effects can be obtained with reference to the optional or preferred embodiments in the first embodiment.

Finally, it should be noted that:

1. in the present specification, "and/or" means "and/or" the preceding structure is provided simultaneously with or alternatively to or in selective combination with "and/or" the following structure;

2. the embodiments in the present description are all described in a progressive manner, each embodiment focuses on the differences from the other embodiments, and the same and similar parts among the embodiments can be referred to each other; the above embodiments in the present specification are only used for illustrating the technical solutions of the present invention, and not for limiting the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A deformable far-end protective umbrella is characterized by comprising a near-end developing ring (100), a far-end developing ring (200), a supporting framework and a pocket-shaped elastic porous covering film (300);

the supporting framework comprises a plurality of supporting beams (400), the near ends of the supporting beams (400) are connected to the near-end developing ring (100), the far ends of the supporting beams (400) are connected to the far-end developing ring (200), and the supporting beams (400) surround to form a cylindrical space;

the distal end of each support beam (400) comprises a reduced diameter section (500) with the diameter of the beam body being reduced, and the reduced diameter section (500) is configured to be capable of bending under the condition that thrombus pressure exceeds a preset pressure so as to increase the volume of the cylindrical space;

the elastic porous coating (300) is covered and connected to the support beam (400) in a manner that the opening is spread by the support beam (400), and the opening of the elastic porous coating (300) faces the near-end development ring (100);

the supporting framework is connected with a developing component (800) or coated with a developing coating.

2. A deformable distal umbrella according to claim 1, wherein each of the support beams (400) comprises a main body beam (410), a distal beam (420) and a fixed beam (430) each connected in sequence;

the proximal end of the main body beam (410) is connected to the proximal development ring (100), and the distal end of the fixed beam (430) is connected to the distal development ring (200);

the far end of the main body beam (410) and the near end of the far end beam (420) and the far end of the far end beam (420) and the near end of the fixed beam (430) are connected through the warp shrinking section (500); alternatively, the distal beam (420) has a diameter smaller than the diameter of the main body beam (410) and constitutes the warp reducing section (500); alternatively, the diameter of the distal beam (420) and the diameter of the fixation beam (430) are both smaller than the diameter of the main body beam (410) and constitute the warp shrinking section (500).

3. The deformable distal umbrella of claim 2, wherein the support skeleton further comprises a proximal support ring (600), the proximal support ring (600) being connected to the main beam (410), the open edge of the elastic porous membrane (300) being connected to the proximal support ring (600).

4. A deformable distal umbrella of claim 3, wherein the main beam (410) comprises a proximal beam (411) and a middle beam (412), wherein the proximal end of the proximal beam (411) is connected to the proximal developer ring (100), the distal end of the proximal beam (411) and the proximal end of the middle beam (412) are both connected to the proximal support ring (600), and the proximal beam (411) and the middle beam (412) of the same support beam (400) are mutually cross-connected to the proximal support ring (600).

5. A deformable distal umbrella according to claim 4, wherein a fixing ring (700) is provided at both the distal end of the proximal beam (411) and the proximal end of the central beam (412), the proximal support ring (600) passing through the fixing ring (700).

6. A deformable distal umbrella of claim 3,

the ring body of the proximal support ring (600) comprises a plurality of first wave segments (601), a plurality of transition segments (602), and a plurality of second wave segments (603), wherein: the first wave segments (601) and the second wave segments (603) are alternately arranged, the first wave segments (601) are connected with the adjacent second wave segments (603) through the transition segments (602), the bending directions of the first wave segments (601) and the second wave segments (603) are opposite, and the body beam (410) is connected to the peaks or the valleys of the first wave segments (601) or the second wave segments (603);

and/or the proximal end support ring (600) is provided with a developing component (800) or coated with a developing coating.

7. A deformable distal umbrella of any of claims 3-6, wherein the support skeleton further comprises a distal support ring attached to the proximal end of the main beam (410) or the distal beam (420), the elastic porous covering membrane (300) being coveringly attached to the distal support ring.

8. A deformable distal end umbrella of claim 7,

a fixing ring (700) is provided on the body beam (410) or at a proximal end of the distal beam (420), the distal support ring passing through the fixing ring (700);

and/or the ring of the distal support ring comprises a plurality of first wave segments (601), a plurality of transition segments (602) and a plurality of second wave segments (603), wherein: the first wave segments (601) and the second wave segments (603) are alternately arranged, the first wave segments (601) are connected with the adjacent second wave segments (603) through the transition segments (602), the bending directions of the first wave segments (601) and the second wave segments (603) are opposite, and the body beam (410) or the distal beam (420) is connected to the peaks or the valleys of the first wave segments (601) or the second wave segments (603);

and/or a developing component (800) is arranged on the distal end support ring or a developing coating is coated on the distal end support ring.

9. A deformable distal umbrella of claim 4, wherein the proximal beam (411) comprises an S-shaped connecting section (4111) and a proximal straight section (4112), one end of the S-shaped connecting section (4111) is connected with the proximal end of the middle beam (412), the other end of the S-shaped connecting section (4111) is connected with the proximal straight section (4112), and the other end of the proximal straight section (4112) is connected with the proximal developer ring (100).

10. A distal protection device comprising a guidewire (910) and a deformable distal protection umbrella of any of claims 1-9;

wherein, seal wire (910) passes near-end development ring (100) with distal end development ring (200) in proper order, and be in seal wire (910) be located the position of the both sides of near-end development ring (100) all is provided with stopper (920), near-end development ring (100) can wind seal wire (910) rotate just near-end development ring (100) can be followed seal wire (910) are two reciprocal sliding between stopper (920).