Deformable distal umbrella and distal protection device

Abstract

The present invention provides a deformable distal protective umbrella and a distal protective device, which relate to the field of medical devices. The deformable distal protective umbrella comprises a proximal developing ring, a distal developing ring, a supporting frame and a pocket-shaped elastic porous coating; the supporting frame comprises a plurality of supporting beams, the proximal ends of the supporting beams are all connected to the proximal developing ring, and the distal ends are all connected to the distal developing ring, and the plurality of supporting beams surround and form a cylindrical space; the distal ends of the supporting beams each comprise a reduced diameter section with a reduced beam body diameter, and the reduced diameter section can be bent when the thrombus pressure received exceeds a preset pressure to increase the volume of the cylindrical space; the elastic porous coating is covered and connected to the supporting beam in a manner that the opening is opened by the supporting beam, and the opening of the elastic porous coating faces the proximal developing ring; a developing component or a developing coating is provided on the supporting frame; the distal protective device comprises a guide wire and the aforementioned deformable distal protective umbrella. The present invention alleviates the problem of small thrombus capacity of the existing distal protective device for peripheral blood vessels.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to a deformable distal protection umbrella and a distal protection device. Background Art

[0002] Peripheral arterial vascular embolism diseases are a group of vascular diseases that seriously threaten human health, and their incidence has increased significantly in recent years. Common ones include arteriosclerotic occlusion, arterial thrombosis, aneurysm, etc. Among them, arteriosclerosis obliterans of the lower extremities is the most common vascular surgical disease and the main cause of chronic lower limb ischemia. Its incidence shows an upward trend with age. The incidence of arteriosclerosis obliterans of the lower extremities is about 5.6% for those under 60 years old, 15.9% for those aged 60 - 70 years old, and about 33.8% for those over 70 years old. And the incidence of arteriosclerosis obliterans of the lower extremities in men is slightly higher than that in women. The cause of arteriosclerosis obliterans of the lower extremities is not yet clear. Hyperlipidemia, hypertension, diabetes, and smoking are the main risk factors for arteriosclerosis obliterans of the lower extremities. The main cause of death is cardiovascular and cerebrovascular complications. The 5-year mortality rate of patients with intermittent claudication is about 30%, and the 5-year mortality rate of patients with lower limb ischemia with rest pain, ulcer, and gangrene is 70%.

[0003] The pathological basis of peripheral arterial vascular embolism diseases is the formation of atherosclerotic plaques in limb arterial blood vessels, which causes lumen stenosis or occlusion, and secondary thrombosis. The pathological changes are mainly manifested as the formation of atherosclerotic plaques in the vascular intima, early lipid deposition in the arterial intima to form fibrous plaques, necrosis of the deep cells of the fibrous plaques to form atherosclerotic plaques, atrophy and necrosis of the muscular layer in the arterial media, and deposition of collagen fibers and calcium. There may be no pathological changes in the arterial adventitia. After the formation of atherosclerotic plaques, the atherosclerotic plaques and calcified plaques can protrude into the lumen, causing lumen stenosis or occlusion, leading to chronic ischemia of distal limb tissues. Hemorrhage or rupture in the atherosclerotic plaques can cause arterial embolism, resulting in acute limb ischemia. The clinical manifestations of patients are symptoms such as intermittent claudication, rest pain, ischemic ulcer, and limb gangrene. The main physical signs include decreased skin temperature at the extremities, weakened or disappeared pulsation of the lower limb arteries, decreased systolic blood pressure of the lower limb arteries, skin trophic disorders, including thin skin, hair loss, nail deformation, etc., limb ulcers, gangrene, etc.

[0004] Interventional endovascular treatment has the characteristics of less trauma and lower requirements for the patient's own physical condition compared with traditional surgical operations. In recent years, with the development of medical materials and imaging technologies, endovascular treatment has been widely applied to the treatment of peripheral arterial vascular embolism diseases.

[0005] Percutaneous balloon angioplasty and stent implantation are one of the main means of endovascular treatment. Its principle is to relieve vascular stenosis through the physical expansion of the balloon and the radial supporting force of the stent, press atherosclerotic plaques against the arterial wall, increase the inner diameter of the stenotic segment of the blood vessel, and improve the blood supply to the distal limb. However, after years of clinical application, it was found that the long-term patency rate of percutaneous balloon angioplasty and stent implantation is not ideal, and the ratio of patients who need re-intervention is relatively high. It has a good effect in treating short-segment lesions less than 3 cm, and the 5-year patency rate can reach 75%. However, the long-term patency rate is not ideal in long-segment stenosis and occlusion lesions. The 6-month patency rate of stenosis lesions less than 7 cm is 86.8%, while the 6-month patency rate of stenosis lesions greater than 7 cm is only 23.1%.

[0006] To solve the above deficiencies of balloons and stents in lower extremity arterial diseases, many new interventional devices have emerged in recent years, such as catheter aspiration thrombectomy technology and plaque cutting technology. Due to their novel design concepts, they are widely used in clinical practice. Their working principle is to aspirate and mechanically cut atherosclerotic plaques in the arterial lumen through the high-speed water flow scouring at the distal end of the catheter and the rotary cutting blade, so that the atherosclerotic plaques in the arterial lumen are transported to the outside of the body through the catheter, which can effectively expand the lumen, reconstruct the blood flow channel and improve the distal blood supply. It is a good device for solving peripheral vascular sclerosis and occlusion lesions. However, whether using catheter aspiration technology or plaque rotary cutting technology, during the thrombus removal process, the calcified plaques in the arterial lumen will be broken, and the broken plaques are extremely likely to block the distal arterial blood vessels, causing the risk of necrosis or even amputation of the distal tissues due to poor blood circulation. Therefore, it is necessary to use a distal protection device for peripheral blood vessels to filter out the thrombi in the blood and then transport them to the outside of the body through the catheter to avoid distal embolism during the interventional thrombus removal operation.

[0007] However, currently, the existing distal protection devices for peripheral blood vessels at least have the problem of small thrombus capacity. When the thrombus volume is too large, the thrombus quickly blocks the bottom of the elastic porous membrane of the distal protection device, resulting in poor blood flow and increasing the surgical risk and difficulty. Summary of the Invention

[0008] The purpose of the present invention is to provide a deformable distal umbrella and a distal protection device to alleviate the technical problem of small thrombus capacity of the existing distal protection devices for peripheral blood vessels.

[0009] To achieve the above purpose, the embodiments of the present invention adopt the following technical solutions:

[0010] In the first aspect, the embodiments of the present invention provide a deformable distal umbrella, including a proximal imaging ring, a distal imaging ring, a support skeleton, and a pocket-shaped elastic porous membrane;

[0011] The support frame includes a plurality of support beams, the proximal ends of the plurality of support beams are connected to the proximal developing ring, the distal ends of the plurality of support beams are connected to the distal developing ring, and the plurality of support beams surround to form a cylindrical space;

[0012] The distal end of each of the support beams comprises a reduced diameter section with a reduced diameter of the beam body, and the reduced diameter section is configured to be able to bend when the thrombus pressure exceeds a preset pressure, so as to increase the volume of the cylindrical space;

[0013] The elastic porous coating is connected to the support beam in a manner that its opening is propped open by the support beam and the opening of the elastic porous coating faces the proximal developing ring; a developing component is connected to the support frame or a developing coating is applied thereon.

[0014] In an optional embodiment, each of the support beams comprises a main beam, a distal beam and a fixed beam which are connected in sequence;

[0015] The proximal end of the main beam is connected to the proximal developing ring, and the distal end of the fixed beam is connected to the distal developing ring;

[0016] The distal end of the main beam and the proximal end of the distal beam, as well as the distal end of the distal beam and the proximal end of the fixed beam are connected via the reduced diameter section; or, the diameter of the distal beam is smaller than the diameter of the main beam and constitutes the reduced diameter section; or, the diameter of the distal beam and the diameter of the fixed beam are both smaller than the diameter of the main beam and constitute the reduced diameter section.

[0017] Further optionally, the support frame also includes a proximal support ring, the proximal support ring is connected to the main beam, and the opening edge of the elastic porous membrane is connected to the proximal support ring.

[0018] Further optionally, the main beam includes a proximal beam and a middle beam, the proximal end of the proximal beam is connected to the proximal developing ring, the distal end of the proximal beam and the proximal end of the middle beam are both connected to the proximal support ring, and the proximal beam and the middle beam of the same support beam are staggeredly connected to the proximal support ring.

[0019] Still further optionally, a fixing ring is provided at the distal end of the proximal beam and the proximal end of the middle beam, and the proximal support ring passes through the fixing ring.

[0020] In an alternative embodiment, the ring body of the proximal support ring includes 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 arranged alternately, the first wave segments and the adjacent second wave segments are connected by the transition segments, and the bending directions of the first wave segments and the second wave segments are opposite, and the main body beam is connected to the peak or valley of the first wave segment or the second wave segment; and / or, a developing component is provided on the proximal support ring or a developing coating is applied thereto. Herein, "and / or" means that the above two structures are provided simultaneously or alternatively.

[0021] In an alternative embodiment, the support framework further includes a distal support ring, the distal support ring is connected to the proximal end of the main body beam or the distal beam, and the elastic porous film is hermetically connected to the distal support ring.

[0022] Further alternatively, a fixing ring is provided on the main body beam or the proximal end of the distal beam, and the distal support ring passes through the fixing ring; and / or, the ring body of the distal support ring includes 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 arranged alternately, the first wave segments and the adjacent second wave segments are connected by the transition segments, and 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 peak or valley of the first wave segment or the second wave segment; and / or, a developing component is provided on the distal support ring or a developing coating is applied thereto. Herein, "and / or" means that the above three structures are provided simultaneously, alternatively, or in any combination of any two structures.

[0023] In an alternative embodiment, the proximal beam includes an S-shaped connecting segment and a proximal straight segment, one end of the S-shaped connecting segment is connected to the proximal end of the middle beam, the other end of the S-shaped connecting segment is connected to the proximal straight segment, and the other end of the proximal straight segment is connected to the proximal developing ring.

[0024] In a second aspect, an embodiment of the present invention further provides a distal protection device, the distal protection device includes a guide wire and a deformable distal umbrella provided by any one of the alternative embodiments in the first aspect above; wherein, the guide wire sequentially passes through the proximal developing ring and the distal developing ring, and limiting blocks are provided at both sides of the guide wire located at the proximal developing ring, and the proximal developing ring can rotate around the guide wire and the proximal developing ring can reciprocally slide along the guide wire between the two limiting blocks.

[0025] The embodiments of the present invention can achieve the following beneficial effects:

[0026] In a first aspect of the embodiments of the present invention, a deformable distal protection umbrella is provided, which includes a proximal imaging ring, a distal imaging ring, a support framework, and a pocket-shaped elastic porous film; the support framework includes a plurality of support beams, the proximal ends of the plurality of support beams are all connected to the proximal imaging ring, the distal ends of the plurality of support beams are all connected to the distal imaging ring, and the plurality of support beams enclose a cylindrical space; the distal end of each support beam includes a reduced-diameter section where the beam diameter is reduced, and the reduced-diameter section is configured to be able to bend when the thrombus pressure received exceeds a preset pressure, so as to increase the volume of the cylindrical space; the elastic porous film is covered and connected to the support beams in a manner that the opening is propped open by the support beams, and the opening of the elastic porous film faces the proximal imaging ring; a imaging component is connected to the support framework or a imaging coating is provided on it.

[0027] In the embodiments of the present invention, after the deformable distal protection umbrella is released into the blood vessel, during the embolism protection process, when there are fewer emboli, all the emboli fall to the distal bottom of the elastic porous film of the deformable distal protection umbrella. When there are more emboli, the emboli completely cover the distal bottom of the elastic porous film, resulting in the temporary inability of blood to flow. When the blood pressure exceeds the preset pressure, it will force the reduced-diameter section to bend, causing the distal part of the support framework to expand towards the distal direction as a whole, thereby increasing the volume of the cylindrical space, and the blood will flow out from the micropores on the side wall of the elastic porous film. Especially when the distal imaging ring is located outside the cylindrical space formed by the plurality of support beams, when the blood pressure exceeds the preset pressure, it will force the reduced-diameter section to bend, causing the distal part of the support framework to expand towards the distal direction as a whole, and the thrombus-containing space will change from a cylindrical structure to a structure of a cylindrical structure + a distal cone, thereby greatly increasing the volume of the thrombus-containing space. The elastic porous film undergoes elastic deformation under the action of the reduced-diameter section, and the blood flows out from the micropores on the conical side wall at the distal bottom of the elastic porous film, thereby greatly increasing the thrombus-containing capacity.

[0028] In summary, the embodiments of the present invention alleviate the technical problem of the small thrombus-containing capacity of the existing distal protection devices for peripheral blood vessels. When a large number of emboli are filtered, the blood can still flow, which does not affect the use of the distal protection device, and thus improves the surgical safety.

[0029] In addition, a second aspect of the embodiments of the present invention further provides a distal protection device, which includes a guide wire and the deformable distal protection umbrella provided in the first aspect above; since the distal protection device provided in the embodiments of the present invention includes the deformable distal protection umbrella provided in the first aspect, therefore, the distal protection device provided in the embodiments of the present invention can achieve all the beneficial effects that the deformable distal protection umbrella provided in the first aspect can achieve. Description of the Drawings

[0030] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the following will briefly introduce the drawings required for the description of the specific embodiments or the prior art. Obviously, the drawings in the following description are some embodiments of the present invention. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0031] Figure 1 Schematic diagram of the overall structure of the deformable distal umbrella provided by an embodiment of the present invention;

[0032] Figure 2 Schematic diagram of the overall structure of the deformable distal umbrella provided by an embodiment of the present invention after removing the elastic porous film;

[0033] Figure 3 For Figure 2 Schematic diagram of the overall structure of the proximal beam in

[0034] Figure 4 For Figure 2 Connection structure diagram of the middle beam, distal beam and fixed beam in

[0035] Figure 5 For Figure 2 Schematic diagram of the overall structure of the proximal support ring or distal support ring in

[0036] Figure 6 For Figure 2 Schematic diagram of the overall structure of the imaging component on the proximal support ring or distal support ring in

[0037] Figure 7 Schematic diagram of the overall structure of the distal protection device provided by an embodiment of the present invention.

[0038] Icon: 100 - proximal imaging ring; 200 - distal imaging ring; 300 - elastic porous film; 400 - support beam; 410 - main beam; 411 - proximal beam; 4111 - S-shaped connection section; 4112 - proximal straight section; 412 - middle beam; 420 - distal beam; 430 - fixed beam; 500 - reduced diameter section; 600 - proximal support ring; 601 - first wave section; 602 - transition section; 603 - second wave section; 700 - fixed ring; 800 - imaging component; 910 - guide wire; 920 - limit block. Specific embodiments

[0039] To make the objectives, 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 accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are some, but not all, of the embodiments of the present invention. Components of the embodiments of the present invention typically described and illustrated in the drawings herein can be arranged and designed in a variety of different configurations.

[0040] Therefore, the following detailed description of the embodiments of the present invention provided in the drawings is not intended to limit the scope of the claimed invention, but merely represents selected embodiments of the present invention. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts fall within the scope of protection of the present invention.

[0041] It should be noted that like reference numerals and letters denote like items in the following drawings. Therefore, once an item is defined in one drawing, it does not require further definition and explanation in subsequent drawings.

[0042] In the description of the present invention, it should be noted that the orientation or positional relationship indicated by the terms "upper", "lower", "inner", "outer", etc. is based on the orientation or positional relationship shown in the drawings, or the orientation or positional relationship in which the inventive product is customarily placed during use. It is only for the convenience of describing the present invention and simplifying the description, and does not indicate or imply that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus should not be construed as a limitation of the present invention. In addition, the terms "first", "second", "third", etc. are only used for descriptive distinction and should not be construed as indicating or implying relative importance.

[0043] In addition, the term "proximal end" refers to the end closer to the human heart during surgery, that is, the upstream end of blood flow, and the "distal end" refers to the other end opposite to the "proximal end".

[0044] In the description of the present invention, it should also be noted that unless otherwise clearly specified and defined, the terms "set", "installed", "connected" should be understood in a broad sense. For example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be directly connected or indirectly connected through an intermediate medium, and it can be the communication inside two elements. For those of ordinary skill in the art, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0045] The following will describe in detail some embodiments of the present invention with reference to the accompanying drawings. Without conflict, the following embodiments and the features in the embodiments can be combined with each other.

[0046] Embodiment 1

[0047] This embodiment provides a deformable remote protection umbrella, referring to Figures 1 to 6 The deformable distal protective umbrella includes a proximal developing ring 100, a distal developing ring 200, a supporting frame and a pocket-shaped elastic porous coating 300. Among them: the supporting frame includes a plurality of supporting beams 400, the proximal ends of the plurality of supporting beams 400 are all connected to the proximal developing ring 100, the distal ends of the plurality of supporting beams 400 are all connected to the distal developing ring 200, and the plurality of supporting beams 400 surround and form a cylindrical space; the distal end of each supporting beam 400 includes a reduced diameter section 500 with a reduced beam diameter, and the reduced diameter section 500 is configured to be able to bend when the 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 supporting beam 400 in a manner that the opening is opened by the supporting beam 400, and the opening of the elastic porous coating 300 faces the proximal developing ring 100; a developing component 800 is connected to the supporting frame or coated with a developing coating, and the developing component 800 can be, but is not limited to, such as Figure 6 The developing spring shown is formed by winding a metal that does not project lines. The end faces of both ends of the developing spring are polished so that it cannot touch or scratch the blood vessels or the elastic porous coating 300. The ways in which the developing spring is connected to the supporting frame include but are not limited to bonding, welding, and pressing on the supporting frame.

[0048] refer to Figure 7 , the deformable distal protective umbrella can be assembled on the guide wire 910 to form a distal protective device by passing the guide wire 910 through the proximal developing ring 100 and the distal developing ring 200 of the deformable distal protective umbrella in sequence, and setting limit blocks 920 at the positions of the guide wire 910 located on both sides of the proximal developing ring 100, wherein the proximal developing ring 100 can rotate around the guide wire 910 and the proximal developing ring 100 can slide back and forth between the two limit blocks 920 along the guide wire 910. During the operation, the deformable distal protective umbrella is delivered to a distance of about 2cm-4cm from the distal end of the affected part by using the guide catheter and the guide wire and released to filter the thrombus. After the operation, the deformable distal protective umbrella is withdrawn from the body by using the recovery catheter for recovery. Specifically, a first perforation is provided on the front end wall of the guide catheter, a second perforation is provided on the rear end wall of the guide catheter, and a third perforation is provided on the rear end wall of the recovery catheter. The delivery and recovery operation steps can be performed with reference to the following steps:

[0049] Delivery steps: first, insert the rear end of the guide wire 910 of the distal protection device into the guide catheter from the front end of the guide catheter and pass it out of the guide catheter from the second perforation, hold the guide catheter, pull the rear end of the guide wire 910 until the deformable distal protection umbrella is completely pulled into the guide catheter and the distal end of the deformable distal protection umbrella is located at the rear side of the first perforation; then insert the guide wire from the first perforation into the inside of the guide catheter, and the front end of the guide wire passes out from the front end of the guide catheter; then slowly push the guide catheter and the guide wire into the human body to ensure that the guide wire sends the guide catheter to the distal end of the affected part, and withdraw the guide wire after reaching the distal end of the affected part, hold the guide wire 910, withdraw the guide catheter, and the deformable distal protection umbrella can be released and opened. At this time, the guide wire 910 can be used to place a stent or catheter to treat the affected part. During the treatment process, the opened deformable distal protection umbrella filters the detached emboli to prevent the emboli from entering the downstream blood vessels and causing downstream tissue necrosis;

[0050] Retrieval step: After the treatment of the affected area is completed and the related treatment accessories are withdrawn, the rear end of the guide wire 910 is inserted into the retrieval catheter from the front end of the retrieval catheter, and the rear end of the guide wire 910 is passed out from the third perforation. The retrieval catheter is slowly pushed forward so that the deformable distal protective umbrella containing the thrombus is gradually compressed and covered by the retrieval catheter, and then the guide wire 910 and the retrieval catheter are withdrawn from the blood vessel together, thereby achieving the purpose of recovering the distal protection device.

[0051] During the entire operation, the proximal developing ring 100, the distal developing ring 200 and the developing component 800 connected to the supporting frame or the developing coating applied to the supporting frame are used as key developing marks for surgical reference to determine the release and recovery positions of the deformable distal protective umbrella and the entrance and bottom positions of the elastic porous coating 300 in the open state, thereby improving surgical efficiency and safety.

[0052] In this embodiment, after the deformable distal umbrella is released into the blood vessel, during the thrombus filtration and protection process, when there are fewer thrombi, all the thrombi fall into the distal bottom of the elastic porous film 300 of the deformable distal umbrella. When there are more thrombi, the distal bottom of the elastic porous film 300 is completely covered, resulting in temporary blood stasis. When the blood pressure exceeds the preset pressure, it will force the diameter-reducing section 500 to bend, causing the distal part of the support framework to expand towards the distal direction as a whole, thereby increasing the volume of the cylindrical space. Blood will flow out from the small holes on the side wall of the elastic porous film 300. Especially when the distal imaging ring 200 is located outside the cylindrical space formed by the surrounding of multiple support beams 400, when the blood pressure exceeds the preset pressure, it will force the diameter-reducing section 500 to bend, causing the distal part of the support framework to expand towards the distal direction as a whole. The thrombus-containing space will change from a cylindrical structure to a structure of "cylindrical structure + distal cone", thereby greatly increasing the volume of the thrombus-containing space. The elastic porous film 300 undergoes elastic deformation under the action of the diameter-reducing section 500, and blood flows out from the small holes on the tapered side wall at the distal bottom of the elastic porous film 300, thus greatly increasing the thrombus-containing capacity.

[0053] In summary, this embodiment alleviates the technical problem of the small thrombus-containing capacity of the existing distal protection device for peripheral blood vessels. When a large number of thrombi are filtered, blood circulation can still be maintained without affecting the use of the distal protection device, thereby improving the surgical safety.

[0054] Refer to Figure 2 In an alternative embodiment of this embodiment, each support beam 400 respectively includes a main beam 410, a distal beam 420, and a fixing beam 430 that are sequentially connected to each other. Among them: the proximal end of the main beam 410 is connected to the proximal imaging ring 100, and the distal end of the fixing beam 430 is connected to the distal imaging ring 200; between the distal end of the main beam 410 and the proximal end of the distal beam 420, and between the distal end of the distal beam 420 and the proximal end of the fixing beam 430, they are both connected by a diameter-reducing section 500; alternatively, the diameter of the distal beam 420 is smaller than that of the main beam 410 and constitutes the diameter-reducing section 500; or the diameters of both the distal beam 420 and the fixing beam 430 are smaller than that of the main beam 410 and constitute the diameter-reducing section 500.

[0055] Continue to refer to Figure 2Further optionally, the support frame also includes a proximal support ring 600 , the proximal support ring 600 is connected to the main beam 410 , and the opening edge of the elastic porous membrane 300 is connected to the proximal support ring 600 . By providing the proximal support ring 600, the opening of the elastic porous membrane 300 can be supported, so that after the deformable distal protective umbrella is inserted into the blood vessel, the opening of the elastic porous membrane 300 can be completely attached to the blood vessel wall, that is, the opening of the elastic porous membrane 300 has good wall adhesion, so as to ensure that all embolic substances in the blood are filtered and intercepted by the elastic porous membrane 300, and avoid the problem that the embolic substances leak from the opening of the elastic porous membrane 300 and the blood vessel wall to cause downstream blood vessel blockage and tissue necrosis due to lack of nutrient delivery; in addition, since the proximal support ring 600 is provided to ensure that the opening of the elastic porous membrane 300 has good wall adhesion, the number of support beams 400 can be appropriately reduced, thereby improving the overall flexibility of the deformable distal protective umbrella, facilitating the deformable distal protective umbrella to bend in the blood vessel and reduce damage to the blood vessel wall, and facilitating the doctor to adjust the position and shape of the deformable distal protective umbrella.

[0056] Reference Figure 3 and Figure 4 , combined with Figure 2 In the optional implementation of this embodiment, it is more preferred 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 developing 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 staggered and connected to the proximal support ring 600. Such a structure is conducive to improving the overall flexibility of the deformable distal protective umbrella and further reducing damage to blood vessels. At the same time, since the proximal beam 411 and the middle beam 412 of the same support beam 400 are mutually staggered and connected to the proximal support ring 600, a good supporting effect can be achieved for the elastic porous coating 300 when the number of support beams 400 is small.

[0057] Continue to refer to Figures 2 to 4, Further preferably, fixing rings 700 are provided at both the distal end of the proximal beam 411 and the proximal end of the middle beam 412. The proximal support ring 600 passes through the fixing rings 700. The fixing rings 700 can 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 beam 411 and the middle beam 412 are not directly connected to the proximal support ring 600. During the opening and closing process, no relative force is generated between the proximal beam 411 and the middle beam 412 and the proximal support ring 600 respectively, and the proximal beam 411 and the middle beam 412 will not cause a large mechanical impact on the proximal support ring 600, that is, it will not cause the proximal support ring 600 to deform. This further improves the wall attachment of the deformable distal umbrella, and further avoids the leakage of embolization substances at the opening edge of the elastic porous film 300. In addition, during the opening and closing process, no relative force is generated between the proximal beam 411 and the middle beam 412 and the proximal support ring 600 respectively, and the proximal beam 411 and the middle beam 412 will not cause a large mechanical impact on the proximal support ring 600, so that the overall flexibility of the deformable distal umbrella is consistent, which is beneficial for it to bend in the blood vessel and further reduces the damage to the blood vessel wall. Of course, when the main beam 410 is an integral beam, such fixing rings 700 can also be provided on the main beam 410 to connect the proximal support ring 600.

[0058] Refer to Figure 5 , In an alternative embodiment, more preferably, the ring body of the proximal support ring 600 includes a plurality of first wave segments 601, a plurality of transition segments 602, and a plurality of second wave segments 603, where: the first wave segments 601 and the second wave segments 603 are arranged alternately, the first wave segment 601 is connected to the adjacent second wave segment 603 through the transition segment 602, and the bending directions of the first wave segment 601 and the second wave segment 603 are opposite, and the main beam 410 is connected to the peak or valley of the first wave segment 601 or the second wave segment 603; with such a structure, when opening or contracting the deformable distal umbrella, the support beam 400 can drive the first wave segment 601 and the second wave segment 603 to open and close along its "V"-shaped contour, which is convenient for operation.

[0059] In an alternative embodiment, more preferably, a developing component 800 is provided on the proximal support ring 600 or a developing coating is applied. Preferably, the developing component 800 is provided on the transition segment 602 of the proximal support ring 600. The developing component 800 preferably uses a developing spring, which almost covers the entire proximal support ring 600, and can ensure a relatively clear developing effect of the deformable distal umbrella.

[0060] In addition, in some alternative embodiments of the present embodiment, the support framework further includes a distal support ring, which is connected to the proximal end of the main body beam 410 or the distal beam 420, and the elastic porous film 300 is covered and connected to the distal support ring. Thus, the wall adhesion of the deformable distal umbrella can be further improved through the distal support ring, and the thrombus capacity of the elastic porous film 300 can be increased.

[0061] Further preferably, a fixing ring 700 is provided on the main body beam 410 or the 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 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 arranged alternately, the first wave segment 601 is connected to the adjacent second wave segment 603 through the transition segment 602, and the bending directions of the first wave segment 601 and the second wave segment 603 are opposite, and the main body beam 410 or the distal beam 420 is connected to the peak or valley of the first wave segment 601 or the second wave segment 603; and / or, a developing component 800 is provided on the distal support ring or a developing coating is applied. Among them, "and / or" means that the structure before "and / or" and the structure after "and / or" are provided simultaneously or alternatively. The functional effects that the above structures can achieve can be obtained by referring to the aforementioned proximal support ring 600.

[0062] In addition, in the alternative embodiments of the present embodiment, more preferably, as Figure 2 shown, the proximal beam 411 includes an S-shaped connecting section 4111 and a proximal straight section 4112. The proximal end of the S-shaped connecting section 4111 is connected to the distal end of the proximal straight section 4112, and the proximal end of the proximal straight section 4112 is connected to the proximal developing ring 100. Through such a structural setting, compared with the distal protection device in the prior art where an elastic filter membrane covers a spindle-shaped frame composed of multiple support rods, the proximal ineffective axial length is shortened, and the length of the distal protection device in the proximal axis is further reduced, which is beneficial to making the present embodiment applicable to peripheral blood vessels such as the renal artery with shorter lengths, shorter, more tortuous, or knotted blood vessels in the downstream anchoring area of the embolization site, so that the deformable distal umbrella can be applied to both longer or shorter anchoring regions.

[0063] In this embodiment, the cylindrical space surrounded by the multiple support beams 400 can be a straight cylindrical structure, a conical structure with a diameter gradually decreasing from the proximal end to the distal end, or other structures, which are not limited herein.

[0064] Embodiment 2

[0065] This embodiment provides a distal protection device, as Figure 7As shown, the distal protection device includes a guide wire 910 and a deformable distal umbrella provided by any optional implementation manner in Embodiment 1. Among them, the guide wire 910 sequentially passes through the proximal imaging ring 100 and the distal imaging ring 200, and limiting blocks 920 are provided at both sides of the guide wire 910 where it is located at the proximal imaging ring 100. The proximal imaging ring 100 can rotate around the guide wire 910 and the proximal imaging ring 100 can reciprocally slide along the guide wire 910 between the two limiting blocks 920.

[0066] In this embodiment, the limiting block 920 can be, but is not limited to, welded to the guide wire 910.

[0067] Since the distal protection device provided in this embodiment includes the deformable distal umbrella described in Embodiment 1, therefore, the distal protection device provided in this embodiment can achieve all the beneficial effects that the deformable distal umbrella in Embodiment 1 can achieve. Its specific structure, operation mode, and the effects that can be achieved can be obtained by referring to the optional or preferred implementation manners in Embodiment 1.

[0068] Finally, it should be noted that:

[0069] 1. In this specification, "and / or" means that the structure before "and / or" and the structure after "and / or" are set simultaneously, alternatively, or selectively combined;

[0070] 2. Each embodiment in this specification is described in a progressive manner. The key point of each embodiment is to illustrate the differences from other embodiments. The same and similar parts among the embodiments can be referred to each other; the above embodiments in this specification are only used to illustrate the technical solutions of the present invention, rather than to limit it; although the present invention has been described in detail with reference to the foregoing embodiments, those of ordinary skill in the art should understand that they can still modify the technical solutions recorded in the foregoing embodiments, or perform equivalent replacements on some or all of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A deformable distal umbrella protector, characterized in that, it includes a proximal imaging ring (100), a distal imaging ring (200), a support framework, and a pocket-shaped elastic porous film (300); the support framework includes a plurality of support beams (400), the proximal ends of the plurality of support beams (400) are all connected to the proximal imaging ring (100), the distal ends of the plurality of support beams (400) are all connected to the distal imaging ring (200), and the plurality of support beams (400) enclose a cylindrical space; the distal end of each support beam (400) includes a reduced-diameter section (500) with a reduced beam diameter, and the reduced-diameter section (500) is configured to be able to bend when the thrombus pressure received exceeds a preset pressure, so as to increase the volume of the cylindrical space; the elastic porous film (300) is covered and connected to the support beam (400) in a manner that the opening is propped open by the support beam (400), and the opening of the elastic porous film (300) faces the proximal imaging ring (100); a imaging component (800) is connected to the support framework or a imaging coating is provided; each support beam (400) respectively includes a main body beam (410), a distal beam (420), and a fixed beam (430) that are sequentially connected; the proximal end of the main body beam (410) is connected to the proximal imaging ring (100), the distal end of the fixed beam (430) is connected to the distal imaging ring (200); between the distal end of the main body beam (410) and the proximal end of the distal beam (420), and between the distal end of the distal beam (420) and the proximal end of the fixed beam (430), they are all connected through the reduced-diameter section (500); or, the diameter of the distal beam (420) is smaller than the diameter of the main body beam (410) and constitutes the reduced-diameter section (500); or, the diameters of the distal beam (420) and the fixed beam (430) are both smaller than the diameter of the main body beam (410) and constitute the reduced-diameter section (500).

2. The deformable distal umbrella protector according to claim 1, characterized in that, the support framework further includes a proximal support ring (600), the proximal support ring (600) is connected to the main body beam (410), and the opening edge of the elastic porous film (300) is connected to the proximal support ring (600).

3. The deformable distal umbrella protector according to claim 2, characterized in that, the main body 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 imaging 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 cross-connected to the proximal support ring (600).

4. The deformable distal umbrella protector according to claim 3, characterized in that, A fixing ring (700) is provided at both the distal end of the proximal beam (411) and the proximal end of the middle beam (412), and the proximal support ring (600) passes through the fixing ring (700).

5. The deformable distal umbrella protector according to claim 2, wherein, the ring body of the proximal support ring (600) 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 arranged alternately, the first wave segment (601) is connected to the adjacent second wave segment (603) through the transition segment (602), and the bending directions of the first wave segment (601) and the second wave segment (603) are opposite, and the main beam (410) is connected to the peak or valley of the first wave segment (601) or the second wave segment (603); and / or, a developing component (800) is provided on the proximal support ring (600) or a developing coating is applied.

6. The deformable distal umbrella protector according to any one of claims 2-5, wherein, the support skeleton further includes a distal support ring; the distal support ring is connected to the main beam (410), or the distal support ring is connected to the proximal end of the distal beam (420); the elastic porous film (300) is covered and connected to the distal support ring.

7. The deformable distal umbrella protector according to claim 6, wherein, a fixing ring (700) is provided on the main beam (410) or at the 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 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 arranged alternately, the first wave segment (601) is connected to the adjacent second wave segment (603) through the transition segment (602), and the bending directions of the first wave segment (601) and the second wave segment (603) are opposite, and the main beam (410) or the distal beam (420) is connected to the peak or valley of the first wave segment (601) or the second wave segment (603); and / or, a developing component (800) is provided on the distal support ring or a developing coating is applied.

8. The deformable distal umbrella protector according to claim 3, wherein, the proximal beam (411) includes an S-shaped connecting segment (4111) and a proximal straight segment (4112), one end of the S-shaped connecting segment (4111) is connected to the proximal end of the middle beam (412), the other end of the S-shaped connecting segment (4111) is connected to the proximal straight segment (4112), and the other end of the proximal straight segment (4112) is connected to the proximal developing ring (100).

9. A distal protection device, wherein, Comprising a guide wire (910) and a deformable distal protection umbrella according to any one of claims 1-8; Wherein, the guide wire (910) sequentially passes through the proximal development ring (100) and the distal development ring (200), and limiting blocks (920) are provided at both parts of the guide wire (910) located on both sides of the proximal development ring (100), the proximal development ring (100) can rotate around the guide wire (910) and the proximal development ring (100) can reciprocally slide along the guide wire (910) between the two limiting blocks (920).

Images