Distal protection device for umbrella and peripheral blood vessels

Abstract

The present invention provides an umbrella-shaped protector and a distal protection device for peripheral blood vessels, which relates to the field of medical devices. The umbrella-shaped protector includes a proximal imaging ring, a proximal support ring, support beams, and a pocket-shaped elastic filter membrane; the proximal ends of multiple support beams are all connected to the proximal imaging ring, and multiple support beams are connected to the proximal support ring at intervals of two; the opening edge of the elastic filter membrane is connected to the proximal support ring, and the opening of the elastic filter membrane faces the proximal imaging ring; a imaging component is provided on the proximal support ring, or a imaging coating is applied on the proximal support ring; the distal protection device for peripheral blood vessels includes the aforementioned umbrella-shaped protector. The present invention at least alleviates the technical problems existing in the existing distal protection device for peripheral blood vessels, such as poor wall attachment of the umbrella body structure at the entrance of the elastic filter membrane and poor overall flexibility of the umbrella body structure of the distal protection device, and improves the surgical safety.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to an umbrella-shaped protector and a distal protection device for peripheral blood vessels. 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 arteriosclerosis obliterans, arterial thrombosis, aneurysm, etc. Among them: Lower extremity arteriosclerosis obliterans is the most common vascular surgical disease and the main cause of chronic lower extremity ischemia. Its incidence shows an upward trend with age. The incidence of lower extremity arteriosclerosis obliterans 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 lower extremity arteriosclerosis obliterans in men is slightly higher than that in women. The cause of lower extremity arteriosclerosis obliterans is not yet clear. Hyperlipidemia, hypertension, diabetes, and smoking are the main risk factors for lower extremity arteriosclerosis obliterans. 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 extremity ischemia with rest pain, ulcers, 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-layer cells of the fibrous plaques to form atherosclerotic plaques, atrophy and necrosis of the arterial media muscular layer, and deposition of collagen fibers and calcium. There may be no pathological changes in the arterial adventitia. After the formation of atherosclerotic plaques, 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 atherosclerotic plaques can cause arterial embolism and acute limb ischemia. The clinical manifestations of patients are symptoms such as intermittent claudication, rest pain, ischemic ulcers, and limb gangrene. The main physical signs include decreased skin temperature at the extremities, weakened or disappeared pulsation of the lower extremity arteries, decreased systolic blood pressure of the lower extremity arteries, and skin trophic disorders, including thin skin, hair loss, nail deformation, 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 used in 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 many 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 the need for re-intervention is relatively high. It has a good effect in treating short-segment lesions < 3 cm, and the 5-year patency rate can reach 75%. However, the long-term patency rate of long-segment stenosis and occlusion lesions is not ideal. The 6-month patency rate of stenosis lesions < 7 cm is 86.8%, while the 6-month patency rate of stenosis lesions > 7 cm is only 23.1%.

[0006] To solve the above deficiencies of balloons and stents in lower extremity arterial lesions, 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, and 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, resulting in 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 emboli 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, at present, the existing distal protection devices for peripheral blood vessels at least have problems such as poor wall adhesion of the umbrella structure at the elastic membrane inlet and poor overall flexibility of the umbrella structure of the distal protection device. Among them, the poor wall adhesion at the elastic membrane inlet is specifically manifested as follows: the umbrella structure of the existing distal protection devices for peripheral blood vessels is generally a structure in which an elastic membrane covers a spindle-shaped frame composed of multiple support rods. The inlet end of the elastic membrane is supported at multiple points by the parts in contact with the multiple support rods. The part of the elastic membrane located between two adjacent support rods is not supported. That is, this part of the structure of the elastic membrane does not fit the blood vessel wall. During filtration, this part of the structure of the elastic membrane will bend, and then part of the unfiltered blood will flow through the gap between the elastic membrane and the blood vessel wall to the distal blood vessel, blocking the distal blood vessel and causing necrosis of the distal tissue; the poor overall flexibility of the umbrella structure of the distal protection device is caused by the fact that more support rods must be set to minimize the leakage amount. The poor flexibility of the umbrella structure of the distal protection device for peripheral blood vessels will cause more damage to the blood vessels during the operation. Summary of the Invention

[0008] The object of the present invention is to provide an umbrella-shaped protector and a distal protection device for peripheral blood vessels, so as to at least alleviate the technical problems existing in the existing distal protection device for peripheral blood vessels, such as poor wall attachment of the umbrella structure at the elastic filter membrane inlet and poor overall flexibility of the umbrella structure of the distal protection device.

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

[0010] In a first aspect, an embodiment of the present invention provides an umbrella-shaped protector, which is applied to a distal protection device for peripheral blood vessels, and includes a proximal imaging ring, a proximal support ring, support beams, and a pocket-shaped elastic filter membrane;

[0011] The proximal ends of multiple support beams are all connected to the proximal imaging ring, and multiple support beams are connected to the proximal support ring at intervals in pairs;

[0012] The opening edge of the elastic filter membrane is connected to the proximal support ring, and the opening of the elastic filter membrane faces the proximal imaging ring;

[0013] An imaging component is provided on the proximal support ring, or an imaging coating is provided on the proximal support ring.

[0014] In an optional embodiment, multiple support beams are all curved, and the distal ends of multiple support beams are connected to the proximal support ring at intervals in pairs.

[0015] Further optionally, each support beam respectively includes a proximally curved beam and a straight beam integrally connected thereto. The proximal end of the proximally curved beam is connected to the proximal imaging ring, the proximal end of the straight beam is connected to the distal end of the proximally curved beam, the proximal support ring is connected to the proximally curved beam and / or the straight beam, and the elastic filter membrane is covered and connected to the inner surface or the outer surface of multiple straight beams.

[0016] In an optional embodiment, fixing rings are provided on each support beam, and the proximal support ring is connected to multiple support beams in a manner of passing through the fixing rings.

[0017] In any of the above optional embodiments, further optionally, the ring body of the proximal support ring includes multiple first wave segments, multiple transition segments, and multiple second wave segments, where: 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 support beams are connected to the wave crests or wave troughs of the first wave segments or the second wave segments.

[0018] In any of the above optional embodiments, further optionally, the umbrella-shaped protector further includes a distal developing ring, the distal ends of multiple support beams are all connected to the distal developing ring, and the elastic filter membrane is covered and connected to the inner surface or the outer surface of multiple support beams.

[0019] Further optionally, each of the support beams respectively includes a proximal bent beam, a straight beam, and a distal bent beam that are integrally and sequentially connected;

[0020] The proximal end of the proximal bent beam is connected to the proximal developing ring;

[0021] The distal end of the proximal bent beam and / or the proximal end of the straight beam are connected to the proximal support ring;

[0022] The distal developing ring is disposed inside the space formed by surrounding the straight beams of the multiple support beams, and the distal ends of the distal bent beams are connected to the distal developing ring;

[0023] The elastic filter membrane is covered and connected to the inner surface or the outer surface of the straight beams of multiple support beams and the proximal support beams.

[0024] Further optionally, a distal support ring is further connected to the distal ends of the multiple support beams.

[0025] Further optionally, fixing rings are disposed on each of the support beams, and the distal support ring is connected to the multiple support beams in a manner of passing through the fixing rings; and / or, the ring body of the distal support ring includes multiple first wave segments, multiple transition segments, and multiple second wave segments, where: the first wave segments and the second wave segments are alternately arranged, 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 support beams are connected to the wave crests or wave troughs of the first wave segments or the second wave segments; and / or, a developing component is connected to the distal support ring or a developing coating is applied to the distal support ring. Herein, "and / or" means that the above three structures are set simultaneously, alternatively, or in any combination of any two structures.

[0026] In a second aspect, an embodiment of the present invention further provides a distal protection device for peripheral blood vessels, including a guide wire and an umbrella-shaped protector provided by any one of the optional embodiments in the first aspect;

[0027] Wherein, the guide wire passes through the proximal developing ring, and limiting blocks are disposed on both sides of the proximal developing ring of the guide wire, 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.

[0028] The embodiments of the present invention can achieve the following beneficial effects:

[0029] In a first aspect of an embodiment of the present invention, a protective umbrella is provided, which is applied to a distal protection device for peripheral blood vessels and includes a proximal imaging ring, a proximal support ring, support beams, and a pocket-shaped elastic filter membrane; the proximal ends of multiple support beams are all connected to the proximal imaging ring, and multiple support beams are connected to the proximal support ring at intervals of two; the opening edge of the elastic filter membrane is connected to the proximal support ring, and the opening of the elastic filter membrane faces the proximal imaging ring; a developing component is provided on the proximal support ring, or a developing coating is applied on the proximal support ring.

[0030] In the embodiment of the present invention, by providing a proximal support ring, the opening of the elastic filter membrane can be supported, so that after the protective umbrella extends into the blood vessel, the opening of its elastic filter membrane can completely adhere to the blood vessel wall, that is, the opening of the elastic filter membrane has good wall adhesion, so as to ensure that all embolism substances in the blood are filtered and intercepted by the elastic filter membrane, and avoid the problem that embolism substances leak between the opening of the elastic filter membrane and the blood vessel wall, causing downstream blood vessel blockage and tissue necrosis due to lack of nutrient delivery; in addition, because a proximal support ring is provided to ensure good wall adhesion at the opening of the elastic filter membrane, the number of support beams can be appropriately reduced, thereby improving the overall flexibility of the protective umbrella, facilitating the bending of the protective umbrella in the blood vessel and reducing damage to the blood vessel wall, and facilitating the doctor to adjust the position and shape of the protective umbrella.

[0031] In summary, the embodiment of the present invention at least alleviates the technical problems of poor wall adhesion at the inlet of the elastic filter membrane in the existing umbrella structure of the existing distal protection device for peripheral blood vessels and poor overall flexibility of the umbrella structure of the distal protection device in the prior art, and improves the surgical safety.

[0032] In addition, a second aspect of an embodiment of the present invention further provides a distal protection device for peripheral blood vessels, including a guide wire and the protective umbrella provided in the first aspect; since the distal protection device for peripheral blood vessels provided in the embodiment of the present invention includes the protective umbrella provided in the first aspect, therefore, the distal protection device for peripheral blood vessels provided in the embodiment of the present invention can achieve all the beneficial effects that the protective umbrella provided in the first aspect can achieve. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order 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 following drawings are some embodiments of the present invention. For those of ordinary skill in the art, other drawings can be obtained based on these drawings without creative efforts.

[0034] Figure 1Schematic diagram of the overall structure of an alternative embodiment of the umbrella provided by the embodiment of the present invention;

[0035] Figure 2 For Figure 1 Schematic diagram of an alternative structure of the umbrella after removing the elastic filter membrane;

[0036] Figure 3 For Figure 1 Another alternative schematic diagram of the structure of the umbrella after removing the elastic filter membrane;

[0037] Figure 4 Schematic diagram of the overall structure of another alternative embodiment of the umbrella provided by the embodiment of the present invention;

[0038] Figure 5 For Figure 4 Schematic diagram of the overall structure of the umbrella after removing the elastic filter membrane;

[0039] Figure 6 For Figure 4 Schematic diagram of the overall structure of the support beam;

[0040] Figure 7 Schematic diagram of the overall structure of the proximal support ring or the distal support ring;

[0041] Figure 8 Schematic diagram of the overall structure of the imaging component on the proximal support ring or the distal support ring;

[0042] Figure 9 For Figure 4 Schematic diagram of the overall structure of the distal protection device for peripheral blood vessels formed by assembling the umbrella on the guide wire.

[0043] Icon: 11 - proximal imaging ring; 12 - distal imaging ring; 21 - proximal support ring; 22 - distal support ring; 201 - first wave segment; 202 - transition segment; 203 - second wave segment; 3 - support beam; 31 - proximal bending beam; 311 - S-shaped connection segment; 312 - proximal straight segment; 32 - straight beam; 33 - distal bending beam; 331 - first distal straight segment; 332 - second distal straight segment; 4 - elastic filter membrane; 5 - imaging component; 6 - fixing ring; 71 - guide wire; 72 - limiting block. Detailed implementation manners

[0044] 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. Usually, the components of the embodiments of the present invention described and illustrated herein can be arranged and designed in various different configurations.

[0045] Accordingly, the following detailed description of the embodiments of the present invention provided in the accompanying 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 in the present invention without creative efforts shall fall within the scope of protection of the present invention.

[0046] 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 need to be further defined and explained in subsequent drawings.

[0047] 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, rather than indicating or implying 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.

[0048] In addition, the term "proximal end" refers to being 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".

[0049] 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.

[0050] The following will describe in detail some embodiments of the present invention in conjunction with the accompanying drawings. Without conflict, the following embodiments and the features in the embodiments can be combined with each other.

[0051] Embodiment 1

[0052] This embodiment provides an umbrella, which is applied to a distal protection device for peripheral blood vessels. Refer to Figure 1 and Figure 4, the umbrella-shaped protector includes a proximal developing ring 11, a proximal support ring 21, support beams 3, and a pocket-shaped elastic filter membrane 4. Among them, the proximal ends of multiple support beams 3 are all connected to the proximal developing ring 11, and multiple support beams 3 are connected to the proximal support ring 21 at intervals; the opening edge of the elastic filter membrane 4 is connected to the proximal support ring 21, and the opening of the elastic filter membrane 4 faces the proximal developing ring 11; a developing component 5 is provided on the proximal support ring 21, and the developing component 5 can be but is not limited to a developing spring as shown in Figure 8 . The developing spring is formed by winding a metal that does not emit X-rays. The end faces of both ends of the developing spring are ground flat so as not to touch or scratch the blood vessel or the elastic filter membrane 4. The way of arranging the developing spring on the proximal support ring 21 includes but is not limited to bonding, welding, pressing on the proximal support ring 21, etc. Or, a developing coating is provided on the proximal support ring 21.

[0053] Reference Figure 9 , the umbrella-shaped protector can be assembled with the guide wire 71 to form a distal protection device for peripheral blood vessels by passing the guide wire 71 through the proximal developing ring 11 of the umbrella-shaped protector and arranging limit blocks 72 at both sides of the guide wire 71 where it is located at the proximal developing ring 11. Among them, the proximal developing ring 11 can rotate around the guide wire 71 and the proximal developing ring 11 can reciprocally slide along the guide wire 71 between the two limit blocks 72. During the operation, the distal protection device for peripheral blood vessels is transported to a position about 2 cm - 4 cm distal to the affected area by using a guiding catheter and a guiding wire and released to filter thrombus. After the operation, the umbrella-shaped protector is withdrawn from the body and recycled by using a retrieval catheter. Specifically, a first perforation is provided on the front-end tube wall of the guiding catheter, a second perforation is provided on the rear-end tube wall of the guiding catheter, and a third perforation is provided on the rear-end tube wall of the retrieval catheter. The transportation and retrieval operation steps can be carried out with reference to the following steps:

[0054] Transportation step: First, insert the rear end of the guide wire 71 of the distal protection device for peripheral blood vessels into the guiding catheter from the front end of the guiding catheter and pass through the second perforation to exit the guiding catheter. Hold the guiding catheter by hand and pull the rear end of the guide wire 71 until the entire umbrella-shaped protector is pulled into the guiding catheter and the distal end of the umbrella-shaped protector is located behind the first perforation; then insert a guiding wire into the interior of the guiding catheter from the first perforation, and the front end of the guiding wire passes through the front end of the guiding catheter; then slowly push the guiding catheter and the guiding wire into the human body, ensure that the guiding wire sends the guiding catheter to the distal end of the affected area. After reaching the distal end of the affected area, withdraw the guiding wire, hold the guide wire 71, and withdraw the guiding catheter backward. The umbrella-shaped protector can be released and opened. At this time, a stent or a catheter can be placed by using the guide wire 71 to treat the affected area. During the treatment process, the opened umbrella-shaped protector filters the shed emboli to prevent the emboli from entering the downstream blood vessels and causing necrosis of the downstream tissues;

[0055] Recovery step: When the treatment of the affected area is completed and the relevant treatment accessories are removed, the rear end of the guide wire 71 is inserted into the recovery catheter from the front end of the recovery catheter. The rear end of the guide wire 71 passes through the third perforation, and the recovery catheter is slowly advanced forward so that the umbrella protector containing the thrombus is gradually compressed and wrapped in the recovery catheter. Then, the guide wire 71 and the recovery catheter are withdrawn from the blood vessel together, thus achieving the purpose of recovering the distal protection device for peripheral blood vessels.

[0056] During the whole operation process, the proximal imaging ring 11 and the imaging component 5 provided on the proximal support ring 21 or the imaging coating applied on the proximal support ring 21 serve as the key imaging markers for surgical reference to determine the release and recovery positions of the umbrella protector and the inlet position of the elastic filter membrane 4 in the open state, thereby improving the surgical efficiency and safety.

[0057] In this embodiment, by providing the proximal support ring 21, the opening of the elastic filter membrane 4 can be supported so that after the umbrella protector extends into the blood vessel, the opening of the elastic filter membrane 4 can completely adhere to the blood vessel wall, that is, the opening of the elastic filter membrane 4 has good wall adhesion, so as to ensure that all embolism substances in the blood are filtered and intercepted by the elastic filter membrane 4, and avoid the problem that embolism substances leak between the opening of the elastic filter membrane 4 and the blood vessel wall, causing blockage of the downstream blood vessel and necrosis of tissues due to lack of nutrient delivery; in addition, because the proximal support ring 21 is provided to ensure good wall adhesion at the opening of the elastic filter membrane 4, the number of support beams 3 can be appropriately reduced, thereby improving the overall flexibility of the umbrella protector, facilitating the umbrella protector to bend in the blood vessel and reducing damage to the blood vessel wall, and also facilitating the doctor to adjust the position and shape of the umbrella protector.

[0058] In summary, this embodiment alleviates the technical problems in the prior art that the wall adhesion at the inlet of the elastic filter membrane of the existing distal protection device for peripheral blood vessels is poor and the overall flexibility of the umbrella body structure of the distal protection device is poor, and improves the surgical safety.

[0059] Refer to Figure 1 and Figure 2 , in an optional structure of an optional implementation manner of this embodiment, multiple support beams 3 are all curved, and the distal ends of multiple support beams 3 are connected to the proximal support ring 21 at intervals in pairs; refer to Figure 1 and Figure 3, in another alternative structure, each support beam 3 respectively includes a proximal curved beam 31 and a straight beam 32 integrally connected thereto. The proximal end of the proximal curved beam 31 is connected to the proximal development ring 11, the proximal end of the straight beam 32 is connected to the distal end of the proximal curved beam 31, the proximal support ring 21 is connected to the proximal curved beam 31 and / or the straight beam 32, and the elastic filter membrane 4 is covered and connected to the inner surface or the outer surface of the plurality of straight beams 32. Among them, "the proximal support ring 21 is connected to the proximal curved beam 31 and / or the straight beam 32" means that: the proximal support ring 21 is connected to the proximal curved beam 31, or the proximal support ring 21 is connected to the straight beam 32, or the proximal support ring 21 is connected to the part where the proximal curved beam 31 and the straight beam 32 are connected to each other, that is, the proximal support ring 21 is simultaneously connected to the proximal curved beam 31 and the straight beam 32.

[0060] Continue to refer to Figures 1 - 3 , in any of the above alternative structures of this embodiment, further optionally, a fixing ring 6 is provided on each support beam 3, and the proximal support ring 21 is connected to the plurality of support beams 3 in a manner of passing through the fixing ring 6. The fixing ring 6 can be welded to the support beam 3 or formed by bending the support beam 3. In this structure, by providing the fixing ring 6, when the umbrella is opened or contracted, the support beam 3 and the proximal support ring 21 are not directly connected, so that during the opening and closing process, no relative force is generated between the support beam 3 and the proximal support ring 21, and the support beam 3 will not cause a large mechanical impact on the proximal support ring 21, that is, it will not cause the proximal support ring 21 to deform, further improving the wall attachment of the umbrella, further avoiding the leakage of embolization substances at the opening edge of the elastic filter membrane 4. In addition, since no relative force is generated between the support beam 3 and the proximal support ring 21 during the opening and closing process, the support beam 3 will not cause a large mechanical impact on the proximal support ring 21, so that the overall flexibility of the umbrella is consistent, which is beneficial for it to bend in the blood vessel and further reduce the damage to the blood vessel wall.

[0061] Refer to Figure 7 , in combination with Figures 1 - 3 , preferably, the ring body of the proximal support ring 21 includes a plurality of first wave segments 201, a plurality of transition segments 202 and a plurality of second wave segments 203, where: the first wave segments 201 and the second wave segments 203 are arranged alternately, the first wave segment 201 is connected to the adjacent second wave segment 203 through the transition segment 202, and the bending directions of the first wave segment 201 and the second wave segment 203 are opposite, and the support beam 3 is connected to the peak or valley of the first wave segment 201 or the second wave segment 203. With such a structure, when the umbrella is opened or contracted, the support beam 3 can drive the first wave segment 201 and the second wave segment 203 to open and close along its "V"-shaped contour, which is convenient for operation.

[0062] Refer to Figure 4 and Figure 5, in an alternative embodiment of the present embodiment, preferably, the umbrella also includes a distal imaging ring 12. The distal ends of multiple support beams 3 are all connected to the distal imaging ring 12, and the elastic filter membrane 4 is covered and connected to the inner surface or the outer surface of the multiple support beams 3. By providing the distal imaging ring 12, it is beneficial for the operating doctor to timely understand the overall length of the umbrella, so as to accurately determine its position and shape when extending into the blood vessel. Specifically, when applied, the guide wire 71 in the umbrella assembly is sequentially passed through the proximal imaging ring 11 and the distal imaging ring 12.

[0063] Referring to Figure 5 and Figure 6 , further preferably, each support beam 3 respectively includes a proximal curved beam 31, a straight beam 32, and a distal curved beam 33 that are integrally and sequentially connected. Among them: the proximal end of the proximal curved beam 31 is connected to the proximal imaging ring 11; the distal end of the proximal curved beam 31 and / or the proximal end of the straight beam 32 are connected to the proximal support ring 21; the distal imaging ring 12 is disposed inside the space formed by surrounding the straight beams 32 of the multiple support beams 3, and the distal end of the distal curved beam 33 is connected to the distal imaging ring 12; the elastic filter membrane 4 is covered and connected to the inner surface or the outer surface of the straight beams 32 of the multiple support beams 3 and the proximal support beams 3. "The distal end of the proximal curved beam 31 and / or the proximal end of the straight beam 32 are connected to the proximal support ring 21" means that the proximal support ring 21 can be connected to the distal end of the proximal curved beam 31, or connected to the proximal end of the straight beam 32, or connected to the part where the distal end of the proximal curved beam 31 and the proximal end of the straight beam 32 are connected to each other. In this embodiment, since the distal imaging ring 12 is disposed inside the space formed by surrounding the straight beams 32 of the multiple support beams 3, thus, at the distal end of the umbrella, the support beams 3 form a skeleton that is recessed into the space formed by surrounding the straight beams 32 of the multiple support beams 3. Compared with the umbrella structure of the peripheral blood vessel distal protection device in the prior art where the elastic filter membrane covers the spindle-shaped frame composed of multiple support rods, the distal thrombus capacity is increased, so that the overall length of the umbrella structure of the distal protection device is shortened, enabling the umbrella provided in this embodiment to be applied in scenarios with a shorter anchoring area, improving the applicability of the umbrella. At the same time, compared with the umbrella structure of the peripheral blood vessel distal protection device in the prior art where the elastic filter membrane covers the spindle-shaped frame composed of multiple support rods, the length after contraction is longer and more release catheter needs to be withdrawn during release. The umbrella provided in this embodiment contracts towards the inside of the space formed by surrounding the straight beams 32 of the multiple support beams 3 at the distal end, which is more conducive to the release and recovery of the distal protection device, further improving the safety of the operation.

[0064] To strengthen the above functions, referring to Figure 6, Further preferably, the distal curved beam 33 includes a first distal straight section 331 and a second distal straight section 332. The proximal end of the first distal straight section 331 is connected to the distal end of the straight beam 32, the distal end of the first distal straight section 331 is connected to the proximal end of the second distal straight beam 32, the distal end of the second distal straight section 332 is connected to the distal developing ring 12, and the second distal straight section 332 is parallel to the straight beam 32. The included angle between the first distal straight section 331 and the straight beam 32 is an acute angle.

[0065] In this embodiment, the space formed by enclosing the straight beams 32 of the plurality of support beams 3 may 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.

[0066] Refer to Figure 6 , In an alternative embodiment of this embodiment, the proximal curved beam 31 includes an S-shaped connecting section 311 and a proximal straight section 312. One end of the S-shaped connecting section 311 is connected to the proximal end of the straight beam 32, the other end of the S-shaped connecting section 311 is connected to the proximal straight section 312, and the other end of the proximal straight section 312 is connected to the proximal developing ring 11. Through such a structural arrangement, compared with the umbrella structure of the prior-art distal protection device for peripheral blood vessels in which an elastic filter membrane covers a spindle-shaped frame composed of a plurality of support rods, the proximal ineffective axial length is shortened, and the length of the proximal end of the protection umbrella in the axial direction is further reduced, which is beneficial to enabling this embodiment to be applied to peripheral blood vessels such as renal arteries that are shorter, have shorter, more tortuous, or knotted blood vessels in the anchoring area downstream of the embolization site, so that the protection umbrella can be applied to both longer or shorter anchoring areas.

[0067] Continue to refer to Figure 5 , Even more preferably, a distal support ring 22 is further connected to the distal ends of the plurality of support beams 3. Thus, the wall attachment property of the protection umbrella can be further improved through the distal support ring 22, and the thrombus filtration volume of the elastic filter membrane 4 can be increased.

[0068] Even further preferably, a fixing ring 6 is provided on each support beam 3, and the distal support ring 22 is connected to the plurality of support beams 3 in a manner of passing through the fixing ring 6; and / or, refer to Figure 7, the ring body of the distal support ring 22 includes a plurality of first wave segments 201, a plurality of transition segments 202, and a plurality of second wave segments 203, where: the first wave segments 201 and the second wave segments 203 are arranged alternately, the first wave segment 201 is connected to the adjacent second wave segment 203 through the transition segment 202, and the bending directions of the first wave segment 201 and the second wave segment 203 are opposite, and the support beam 3 is connected to the peak or trough of the first wave segment 201 or the second wave segment 203; and / or, a developing component 5 is connected to the distal support ring 22 or a developing coating is provided on the distal support ring 22. Wherein, "and / or" means that the structure before "and / or" and the structure after "and / or" are set simultaneously or alternatively. The functional effects that the above structure can achieve can be obtained by referring to the aforementioned proximal support ring 21. More preferably, the developing component 5 is arranged on the transition segment 202 of the proximal support ring 21 and the distal support ring 22. The developing component 5 preferably adopts a developing spring, which almost covers the entire support ring, and can ensure that the umbrella has a relatively clear developing effect.

[0069] Embodiment 2

[0070] This embodiment provides a distal protection device for peripheral blood vessels, as Figure 9 shown. The distal protection device for peripheral blood vessels includes a guide wire 71 and an umbrella provided by any optional implementation manner in Embodiment 1. Wherein, the guide wire 71 passes through the proximal developing ring 11, and limiting blocks 72 are arranged at both sides of the guide wire 71 where the proximal developing ring 11 is located. The proximal developing ring 11 can rotate around the guide wire 71 and the proximal developing ring 11 can reciprocally slide along the guide wire 71 between the two limiting blocks 72.

[0071] In this embodiment, the limiting block 72 can be, but is not limited to, welded to the guide wire 71.

[0072] Since the distal protection device for peripheral blood vessels provided in this embodiment includes the umbrella described in Embodiment 1, therefore, the distal protection device for peripheral blood vessels provided in this embodiment can achieve all the beneficial effects that the 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.

[0073] Finally, it should be noted that:

[0074] 1. In this specification, "and / or" means that the structure before "and / or" and the structure after "and / or" are set simultaneously or alternatively or in a selectively combined manner;

[0075] 2. Each embodiment in this specification is described in a progressive manner. Each embodiment focuses on the differences from other embodiments. For the same or similar parts among the embodiments, reference can be made 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 described 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. An umbrella-shaped protector, applied to a distal protection device for peripheral blood vessels, characterized in that, It includes a proximal developing ring (11), a proximal support ring (21), support beams (3) and a pocket-shaped elastic filter membrane (4); The proximal ends of multiple said support beams (3) are all connected to the proximal developing ring (11), and multiple said support beams (3) are connected to the proximal support ring (21) at intervals of two by two; The opening edge of the elastic filter membrane (4) is connected to the proximal support ring (21), and the opening of the elastic filter membrane (4) faces the proximal developing ring (11); A developing component (5) is provided on the proximal support ring (21); Fixing rings (6) are provided on each of the support beams (3), and the proximal support ring (21) is connected to multiple said support beams (3) in a way of passing through the fixing rings (6); Wherein, each of the support beams (3) respectively includes a proximally bent beam (31) and a straight beam (32) integrally connected thereto. The proximal end of the proximally bent beam (31) is connected to the proximal developing ring (11), the proximal end of the straight beam (32) is connected to the distal end of the proximally bent beam (31), the fixing ring (6) is connected to the proximally bent beam (31) and / or the straight beam (32), and the elastic filter membrane (4) is coveringly connected to the inner surface or the outer surface of multiple said straight beams (32).

2. An umbrella-shaped protector, applied to a distal protection device for peripheral blood vessels, characterized in that, It includes a proximal developing ring (11), a proximal support ring (21), support beams (3) and a pocket-shaped elastic filter membrane (4); The proximal ends of multiple said support beams (3) are all connected to the proximal developing ring (11), and multiple said support beams (3) are connected to the proximal support ring (21) at intervals of two by two; The opening edge of the elastic filter membrane (4) is connected to the proximal support ring (21), and the opening of the elastic filter membrane (4) faces the proximal developing ring (11); A developing coating is provided on the proximal support ring (21); Fixing rings (6) are provided on each of the support beams (3), and the proximal support ring (21) is connected to multiple said support beams (3) in a way of passing through the fixing rings (6); Wherein, each of the support beams (3) respectively includes a proximally bent beam (31) and a straight beam (32) integrally connected thereto. The proximal end of the proximally bent beam (31) is connected to the proximal developing ring (11), the proximal end of the straight beam (32) is connected to the distal end of the proximally bent beam (31), the fixing ring (6) is connected to the proximally bent beam (31) and / or the straight beam (32), and the elastic filter membrane (4) is coveringly connected to the inner surface or the outer surface of multiple said straight beams (32).

3. The umbrella-shaped protector according to claim 1 or 2, characterized in that, The ring body of the proximal support ring (21) includes a plurality of first wave segments (201), a plurality of transition segments (202) and a plurality of second wave segments (203), wherein: the first wave segments (201) and the second wave segments (203) are arranged alternately, the first wave segments (201) and the adjacent second wave segments (203) are connected by the transition segments (202), and the bending directions of the first wave segments (201) and the second wave segments (203) are opposite, and the support beam (3) is connected to the peak or valley of the first wave segment (201) or the second wave segment (203).

4. The umbrella-shaped protector according to claim 1 or 2, characterized in that, The umbrella-shaped protection device further includes a distal developing ring (12), the distal ends of the plurality of support beams (3) are all connected to the distal developing ring (12), and the elastic filter membrane (4) is covered and connected to the inner surface or the outer surface of the plurality of support beams (3).

5. The umbrella-shaped protector according to claim 4, characterized in that, Each of the support beams (3) respectively includes a proximal bent beam (31), a straight beam (32) and a distal bent beam (33) which are integrated and sequentially connected; The proximal end of the proximal bent beam (31) is connected to the proximal developing ring (11); The distal end of the proximal bent beam (31) and / or the proximal end of the straight beam (32) are connected to the proximal support ring (21); The distal developing ring (12) is arranged inside the space surrounded by the straight beams (32) of the plurality of support beams (3), and the distal ends of the distal bent beams (33) are connected to the distal developing ring (12); The elastic filter membrane (4) is covered and connected to the inner surface or the outer surface of the straight beams (32) and the distal bent beams (33) of the plurality of support beams (3).

6. The umbrella-shaped protector according to claim 4, characterized in that, A distal support ring (22) is further connected to the distal ends of the plurality of support beams (3).

7. The umbrella-shaped protector according to claim 6, characterized in that, A fixing ring is arranged on each of the support beams (3), and the distal support ring (22) is connected to the plurality of support beams (3) in a way of passing through the fixing ring; and / or, the ring body of the distal support ring (22) includes a plurality of first wave segments (201), a plurality of transition segments (202) and a plurality of second wave segments (203), wherein: the first wave segments (201) and the second wave segments (203) are arranged alternately, the first wave segments (201) and the adjacent second wave segments (203) are connected by the transition segments (202), and the bending directions of the first wave segments (201) and the second wave segments (203) are opposite, and the support beam (3) is connected to the peak or valley of the first wave segment (201) or the second wave segment (203); and / or, a developing component (5) is connected to the distal support ring (22) or a developing coating is applied to the distal support ring (22).

8. A distal protection device for peripheral blood vessels, characterized in that, Including a guide wire (71) and the umbrella-shaped protection device according to any one of claims 1-7; Wherein, the guide wire (71) passes through the proximal developing ring (11), and limiting blocks (72) are provided at both parts of the guide wire (71) on both sides of the proximal developing ring (11). The proximal developing ring (11) can rotate around the guide wire (71) and can reciprocally slide along the guide wire (71) between the two limiting blocks (72).

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