Reverse-penetrating far-end protection device
Technical Field
The invention relates to the technical field of medical instruments, in particular to a reverse-penetrating distal end protection device.
Background
Peripheral arterial vascular thrombotic diseases are a group of vascular diseases seriously threatening human health, the incidence rate of which has been remarkably increased in recent years, and the diseases commonly include arteriosclerotic occlusion, arterial thrombosis, aneurysm and the like, wherein: the lower limb arteriosclerosis obliterans is the most common vascular surgical disease, is the main cause of chronic lower limb ischemia, the incidence rate of the lower limb arteriosclerosis obliterans is increased with the age, the incidence rate of the lower limb arteriosclerosis obliterans below 60 years old is about 5.6%, the incidence rate of the lower limb arteriosclerosis obliterans reaches 15.9% between 60 and 70 years old, the incidence rate of the lower limb arteriosclerosis obliterans above 70 years old is about 33.8%, and the incidence rate of the lower limb arteriosclerosis obliterans of men is slightly higher than that of women. The lower limb arteriosclerosis obliterans have uncertain causes, hyperlipidemia, hypertension, diabetes, smoking and the like are main risk factors causing the lower limb arteriosclerosis obliterans, mainly die of cardiovascular and cerebrovascular complications, 5-year death rate of intermittent claudication patients is about 30%, and 5-year death rate of lower limb ischemia patients with resting pain, ulcer and gangrene is 70%.
The pathological basis of peripheral arterial thrombotic disease is the formation of atherosclerotic plaques in the limbs of the artery, leading to stenosis or occlusion of the lumen, and secondary thrombosis. The pathological changes are mainly manifested by atheromatous plaque formation of blood vessels intima, lipid deposition in early stage of the artery intima, fibrous plaque formation, necrosis of deep cells of the fibrous plaque, atheromatous plaque formation, atrophy and necrosis of tunica muscularis media in the artery, deposition of collagen fibers and calcium, no pathological change of the artery adventitia, atheromatous plaque and calcified plaque after atheromatous plaque formation can protrude towards the lumen, resulting in lumen stenosis or occlusion, leading to chronic ischemia of distal limb tissues, hemorrhage or rupture in atheromatous plaque, and the like, which can cause arterial embolism and acute limb ischemia. The clinical manifestations of the patient are intermittent claudication, rest pain, ischemic ulcer and gangrene of limbs, and the main signs are decreased skin temperature of the extremities, weakened or disappeared arterial pulsation of the lower limbs, decreased systolic pressure of the arteries of the lower limbs, changed skin nutrition disorder, including thin skin, hair loss, deformed nails, etc., ulcer of limbs, gangrene, etc.
Interventional intraluminal treatment has the characteristics of less trauma and lower requirements on the physical condition of a patient compared with the traditional surgical operation, and in recent years, with the development of medical materials and imaging technology, intraluminal treatment has been widely applied to the treatment of peripheral arterial vascular embolic diseases.
Percutaneous balloon angioplasty and stent placement are one of the main means of intracavity treatment, and the principle is that the blood vessel stenosis is relieved through the physical expansion of a balloon and the radial supporting force of a stent, an atherosclerotic plaque is pressed to the artery wall, the internal diameter of the blood vessel of the stenosis section is increased, and the blood supply of the far end of a limb is improved. But after years of clinical application, the long-term vascular patency rate of the skin balloon angioplasty and the stent implantation is not ideal, the rate of intervention treatment is higher, the effect of treating a short section of lesion with the diameter of less than 3cm is better, the 5-year patency rate can reach 75%, but the long-term patency rate of stenosis and occlusion lesion with the length of less than 3cm is not ideal, the 6-month patency rate of a narrow lesion with the diameter of less than 7cm is 86.8%, and the 6-month patency rate of the narrow lesion with the diameter of more than 7cm is only 23.1%.
In order to overcome the defects of the saccule and the stent in lower limb arterial lesions, a plurality of novel interventional devices such as a catheter suction embolus technology and a plaque cutting technology appear in recent years, and are widely used clinically due to novel design concepts. However, regardless of the catheter suction technology or the rotational atherectomy technology, calcified plaque in an arterial lumen can be broken during the thrombus removal process, and the broken plaque is easy to block a distal arterial blood vessel, so that the risk of necrosis and amputation of distal tissues caused by blood non-circulation is caused. Therefore, the peripheral blood vessel is required to filter emboli in the blood by using a far-end protection device, and then the emboli is conveyed out of the body through a catheter so as to avoid the far-end embolism in the interventional embolectomy.
In the operation process, the guide wire of the distal protection device for the peripheral blood vessel firstly passes through a diseased region, and then is used for guiding other treatment catheters to pass through tortuous blood vessels, but the arterial plaque is hard to go forward, namely when the guide wire is inserted in the blood flow direction, the guide wire is difficult to pass through diseased thrombus, so that the operation difficulty is higher, the complexity is higher, the operation risk is increased, and the postoperative recovery of a patient is not facilitated.
Disclosure of Invention
The invention aims to provide a reverse-crossing distal end protection device to solve the technical problems that when a guide wire is inserted into an existing distal end protection device for a peripheral blood vessel in an antegrade manner, namely in the blood flow direction, the guide wire is difficult to penetrate through hard lesion thrombus of an artery, so that the operation difficulty is high, the complexity is high, the operation risk is increased, and postoperative recovery of a patient is not facilitated.
In order to achieve the above purpose, the embodiment of the invention adopts the following technical scheme:
the embodiment of the invention provides a reverse-threading distal end protection device, which comprises a guide wire and a protective umbrella; the protective umbrella comprises a supporting tube, an elastic supporting open ring, a guiding limiting block and a pocket-shaped elastic filter membrane;
the supporting tube is reversely sleeved outside the guide wire;
the tube wall of the supporting tube is provided with a strip-shaped opening which penetrates through the tube wall of the supporting tube and extends along the axial direction of the supporting tube, and the near end of the supporting tube is connected with a developing component or the peripheral surface of the near end of the supporting tube is coated with a developing coating;
the guide limiting block comprises a fixed limiting part and a sliding guide part which are integrated or fixedly connected, the sliding guide part is arranged in the strip-shaped opening in a sliding mode and is fixedly connected with the guide wire, and the fixed limiting part is located outside the supporting tube;
the first end of the elastic support open loop is integrally or fixedly connected with the near end of the supporting tube, and the second end of the elastic support open loop is bent towards the far end direction at the position close to the first end of the elastic support open loop and then integrally or fixedly connected with the fixed limiting part; a developing component is connected to the elastic support open loop or a developing coating is coated on the elastic support open loop;
the elastic filter membrane is axially surrounded and connected with the supporting tube, and an opening of the elastic filter membrane is connected with the elastic supporting open ring.
In an alternative embodiment, a through hole penetrating the sliding guide portion in the axial direction of the support tube is formed in the sliding guide portion, and the guide wire passes through and is fixedly connected to the inside of the through hole.
In an alternative embodiment, the slide guide portion has a circular tube shape, and an outer peripheral wall of the slide guide portion is in contact with a tube wall of the support tube.
In an alternative embodiment, a mounting groove is provided on the fixing and limiting portion, and the second end of the elastic support open loop is inserted into and fixedly connected to the mounting groove.
In an alternative embodiment, a stepped surface is formed between the proximal end surface of the fixed limiting part and the proximal end surface of the slide guide part, and the proximal end surface of the fixed limiting part is located at the distal end of the slide guide part.
In an alternative embodiment, the visualization component comprises a proximal visualization ring connected to the proximal end of the support tube, the guide wire passing through the proximal visualization ring.
In an alternative embodiment, a distal visualization ring is attached to the distal end of the support tube, and the guide wire passes through the distal visualization ring.
In an alternative embodiment, the distal end region of the elastic filter membrane is formed as a continuous membrane region that is not perforated with filter pores.
In an alternative embodiment, the open edge of the elastic filter membrane is fixed after being wound to form a tubular rim portion, and the elastic support ring passes through the tubular rim portion.
In an alternative embodiment, a distal support ring is connected to the distal end of the support tube, and the elastic filter membrane is connected to the surface of the distal support ring or supported outside the distal support ring; and a developing component is arranged on the far-end supporting ring or a developing coating is coated on the far-end supporting ring.
The embodiment of the invention can realize the following beneficial effects:
the embodiment of the invention provides a reverse-threading distal end protection device, which comprises a guide wire and a protective umbrella; the protective umbrella comprises a supporting tube, an elastic supporting open ring, a guiding limiting block and a pocket-shaped elastic filter membrane. Specifically, the support tube is reversely sleeved outside the guide wire; the tube wall of the supporting tube is provided with a strip-shaped opening which penetrates through the tube wall of the supporting tube and extends along the axial direction of the supporting tube, the near end of the supporting tube is connected with a developing component or the peripheral surface of the near end of the supporting tube 2 is coated with a developing coating; the guide limiting block comprises a fixed limiting part and a sliding guiding part which are integrated or fixedly connected, the sliding guiding part is arranged in the strip-shaped opening in a sliding mode and is fixedly connected with the guide wire, and the fixed limiting part is located outside the supporting tube; the first end of the elastic support open loop is integrally or fixedly connected to the near end of the supporting tube, and the second end of the elastic support open loop is bent towards the far end direction at the position close to the first end of the elastic support open loop and then integrally or fixedly connected to the fixed limiting part; the elastic support open loop is connected with a developing component or a developing coating is coated on the elastic support open loop; the elastic filter membrane is axially surrounded and connected with the supporting tube, and the opening of the elastic filter membrane is connected with the elastic supporting open ring.
The embodiment of the invention provides an improved distal protection device for the existing distal protection device for peripheral blood vessels based on the principle that a guide wire runs reversely, namely the guide wire is easy to insert and penetrate through a diseased thrombus along the opposite direction of blood flow.
In addition, in the embodiment of the invention, the elastic filter membrane is supported by the elastic support open ring, so that the opening of the elastic filter membrane can be supported, and after the protective umbrella of the reverse-wearing far-end protection device extends into a blood vessel, the opening of the elastic filter membrane can be completely attached to the blood vessel wall, namely, the opening of the elastic filter membrane has good adherence, so that embolic substances in blood are completely filtered and intercepted through the elastic filter membrane, and the problems of downstream blood vessel blockage and tissue necrosis due to lack of nutrient substance transportation caused by leakage of the embolic substances between the opening of the elastic filter membrane and the blood vessel wall are avoided.
Drawings
In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings used in the description of the embodiments or the prior art will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present invention, and other drawings can be obtained by those skilled in the art without creative efforts.
Fig. 1 is a schematic overall structure diagram of a reverse-penetrating distal protection device according to an embodiment of the present invention;
FIG. 2 is a sectional view showing the overall structure of a protective umbrella in the reverse-through distal protection device according to the embodiment of the present invention;
fig. 3 is a schematic view of an overall structure of a guide limiting block in the reverse-penetrating distal end protection device provided in the embodiment of the present invention;
fig. 4 is a schematic view of the overall structure of the elastic support ring in the reverse-through distal protection device according to the embodiment of the present invention.
Icon: 1-guide wire; 2-supporting a tube; 20-a strip-shaped opening; 21-proximal developer ring; 22-distal developer ring; 3-elastic support open loop; 4-guiding a limiting block; 41-fixing and limiting part; 410-mounting grooves; 42-a sliding guide; 420-perforating; 5-elastic filter membrane; 50-tubular edge portion.
Detailed Description
In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. The components of embodiments of the present invention generally described and illustrated in the figures herein may be arranged and designed in a wide variety of different configurations.
Thus, the following detailed description of the embodiments of the present invention, presented in the figures, is not intended to limit the scope of the invention, as claimed, but is merely representative of selected embodiments of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
It should be noted that: like reference numbers and letters refer to like items in the following figures, and thus, once an item is defined in one figure, it need not be further defined and explained in subsequent figures.
In the description of the present invention, it should be noted that the terms "upper", "lower", "inside", "outside", and the like indicate orientations or positional relationships based on the orientations or positional relationships shown in the drawings or orientations or positional relationships conventionally put in use of products of the present invention, and are only for convenience of description and simplification of description, but do not indicate or imply that the devices or elements referred to must have specific orientations, be constructed in specific orientations, and be operated, and thus, should not be construed as limiting the present invention. Furthermore, the terms "first," "second," and the like are used merely to distinguish one description from another, and are not to be construed as indicating or implying relative importance.
Furthermore, the term "proximal" refers to the end of the body that is closer to the heart of the patient during surgery, i.e., the upstream end of the blood flow, and "distal" refers to the end opposite the "proximal".
In the description of the present invention, it should also be noted that, unless otherwise explicitly specified or limited, the terms "disposed," "mounted," and "connected" are to be construed broadly, e.g., as meaning fixedly connected, detachably connected, or integrally connected; they may be connected directly or indirectly through intervening media, or they may be interconnected between two elements. The specific meanings of the above terms in the present invention can be understood in specific cases by those skilled in the art; well-defined fixed connections include, but are not limited to, bonding, welding, and the like.
Some embodiments of the invention are described in detail below with reference to the accompanying drawings. The embodiments described below and the features of the embodiments can be combined with each other without conflict.
The present embodiment provides a reverse-penetrating distal protection device, which, referring to fig. 1-4, comprises a guide wire 1 and a protective umbrella; the protective umbrella comprises a supporting tube 2, an elastic supporting open ring 3, a guiding limited block 4 and a pocket-shaped elastic filter membrane 5.
Specifically, the support tube 2 is reversely sleeved outside the guide wire 1; a strip-shaped opening 20 which penetrates through the tube wall of the support tube 2 and extends along the axial direction of the support tube 2 is formed in the tube wall of the support tube 2, and a developing part is connected to the near end of the support tube 2 or a developing coating is coated on the outer peripheral surface of the near end of the support tube 2. The guide limiting block 4 comprises a fixed limiting part 41 and a sliding guide part 42 which are integrated or fixedly connected, the sliding guide part 42 is arranged inside the strip-shaped opening 20 in a sliding mode and is fixedly connected to the guide wire 1, and the fixed limiting part 41 is located outside the support tube 2. The first end of the elastic support open loop 3 is integrally or fixedly connected with the near end of the support tube 2, and the second end of the elastic support open loop 3 is bent towards the far end direction at the position close to the first end of the elastic support open loop 3 and then integrally or fixedly connected with the fixed limiting part 41; a developing member is attached to the elastic support open ring 3 or a developing coating is applied to the elastic support open ring 3, for example, but not limited to, a developing spring is attached to the outside of the elastic support open ring 3. The elastic filter membrane 5 is wrapped around and connected to the support tube 2 in the axial direction of the support tube 2, and the opening of the elastic filter membrane 5 is connected to the elastic support open ring 3. In this embodiment, the elastic support ring 3 may be, but is not limited to, a spring-like structure wound from a radiopaque wire.
Referring to fig. 1, during operation, the umbrella of the distal protection device for peripheral blood vessels is delivered to the affected part to be released at a distance of about 2cm-4cm from the distal end of the affected part by using a guide catheter and a guide wire so as to filter thrombus, and after the operation is finished, the umbrella of the reverse puncture distal protection device is withdrawn out of the body by using a recovery catheter to be recovered. Specifically, the first perforation is provided on the front end tube wall of the guide duct, the second perforation is provided on the rear end tube wall of the guide duct, and the third perforation is provided on the rear end tube wall of the recovery duct, and the transporting and recovering operation steps can be performed with reference to the following steps: a conveying step: firstly, inserting the rear end of the guide wire 1 of the reverse-penetrating distal end protection device into the guide catheter from the front end of the guide catheter and penetrating out of the guide catheter from the second perforation, holding the guide catheter by hand, pulling the rear end of the guide wire 1 until the protective umbrella is completely pulled into the guide catheter and the proximal end of the protective umbrella is positioned at the rear side of the first perforation; then a guide wire is penetrated into the guide catheter from the first perforation, and the front end of the guide wire penetrates out of the front end of the guide catheter; then, the guiding catheter and the guiding wire are slowly pushed to the human body along the opposite direction of blood flow in a retrograde motion way, the guiding catheter is ensured to be sent to the far end of the affected part by the guiding wire, the guiding wire 1 is withdrawn after reaching the far end of the affected part, the guiding catheter 1 is held and withdrawn, the elastic supporting open loop 3 at the near end of the protective umbrella is firstly released and opened, the rear end of the protective umbrella is slowly released out of the guiding catheter along with the elastic supporting open loop, the elastic supporting open loop 3 is restored to the circular structure under the action of elastic resilience force in the releasing process to open the protective umbrella, the opened protective umbrella can slide for a certain distance in the axial direction, the protective umbrella and the guiding wire 1 can be ensured to move relatively, the guiding wire 1 can be pushed or withdrawn for a certain distance in the follow-up operation, the protective umbrella can be used for placing a bracket or a catheter and the like to treat the affected part after being, preventing emboli from entering downstream blood vessels to cause necrosis of downstream tissues;
and (3) a recovery step: when the affected part treatment is completed and relevant treatment accessories are withdrawn, the rear end of the guide wire 1 penetrates into the recovery catheter from the front end of the recovery catheter, the guide wire 1 penetrates out of the third perforation and is slowly pushed forward to the recovery catheter, when the front end of the recovery catheter abuts against the distal end of the protective umbrella, the guide wire 1 is pulled backwards, the sliding guide part 42 of the guide limiting block 4 connected to the guide wire 1 slides towards the distal end of the protective umbrella along the strip-shaped opening 20, so that the opening of the elastic filter membrane 5 is gradually contracted, when the fixed limiting part 41 of the guide limiting block 4 is contacted with the distal end face of the strip-shaped opening 20, the opening of the elastic filter membrane 5 of the protective umbrella is completely sealed, at the moment, thrombus intercepted by the protective umbrella cannot leak, the guide wire 1 is continuously pulled backwards, the fixed limiting part 41 of the guide limiting block 4 drives the elastic support open ring 3 to slide towards the interior of the recovery catheter, and the protective umbrella containing the thrombus is gradually compressed, then the guide wire 1 and the recovery catheter are withdrawn from the blood vessel together, so as to achieve the purpose of recovering the far-end protection device for the peripheral blood vessel.
In the whole operation process, the developing part connected with the near end of the supporting tube 2 and the developing part connected with the elastic supporting ring 3 or the developing coating coated on the elastic supporting open ring 3 are used as key developing marks for operation reference so as to determine the releasing and recovering position of the protective umbrella and the inlet position of the elastic filter membrane 5 in an opening state, thereby improving the operation efficiency and the operation safety.
The embodiment of the invention is an improved distal protection device for the existing distal protection device for peripheral blood vessels based on the principle that the guide wire 1 runs in the reverse direction, namely the guide wire is easier to insert and penetrate lesion thrombus along the opposite direction of blood flow, the guide wire 1 of the protective umbrella can run in the reverse direction to penetrate through a lesion part to implement treatment, after the treatment is finished, the intercepted thrombus is taken out from the blood vessel, and the thrombus does not leak in the taking-out process.
In addition, in this embodiment, support the elastic filter membrane 5 through setting up elastic support open loop 3, thereby, can support the opening part of elastic filter membrane 5, so that this protection umbrella of wearing distal end protection device against stretches into in the blood vessel after, the opening part of its elastic filter membrane 5 can be attached on the vascular wall completely, namely, make 5 opening parts of elastic filter membrane have good adherence, filter the interception through elastic filter membrane 5 with the embolic material in guaranteeing blood is whole, avoid appearing the embolic material and leak between the opening part of elastic filter membrane 5 and the vascular wall and cause the problem of low reaches vascular jam, the tissue is because of lacking the transport necrosis of nutrient substance.
Referring to fig. 3, in an alternative embodiment of the present embodiment, a through hole 420 penetrating the slide guide portion 42 in the axial direction of the support tube 2 is formed in the slide guide portion 42, and the guide wire 1 is inserted and fixedly connected into the through hole 420. To improve the sliding stability, it is preferable that the slide guide 42 has a circular tube shape, and the outer peripheral wall of the slide guide 42 is in contact with the wall of the support tube 2.
With continued reference to fig. 3, in an alternative embodiment of the present embodiment, a mounting groove 410 is provided on the fixing and limiting portion 41, and the second end of the elastic support ring 3 is inserted into and fixedly connected to the mounting groove 410.
With continued reference to fig. 3, in an alternative embodiment of this embodiment, it is preferable that a step surface is formed between the proximal end surface of the fixed position-limiting portion 41 and the proximal end surface of the sliding guide portion 42, and the proximal end surface of the fixed position-limiting portion 41 is located at the distal end of the sliding guide portion 42.
Referring to fig. 1 and 2, in an alternative structure of the present embodiment, it is preferable that the visualization member includes a proximal visualization ring 21 connected to the proximal end of the support tube 2, and the guide wire 1 passes through the proximal visualization ring 21. Optionally, a distal developing ring 22 is further connected to the distal end of the support tube 2, and the guide wire 1 passes through the distal developing ring 22. The proximal development ring 21 and the distal development ring 22 may be, but are not limited to, welded or bonded or screwed to the corresponding ends of the support tube 2, and the proximal development ring 21 and the distal development ring 22 are preferably, but not limited to, made of a metal tube member without projecting a line, and the outer circumferential surface of the development rings is preferably a smooth surface which is polished so as not to touch or scratch the blood vessel or the elastic filter membrane 5.
In an alternative embodiment of this embodiment, the overall outer contour of the elastic filter membrane 5 in the open state is formed conical.
In addition, in order to accommodate finer emboli and prevent leakage of thrombus, in an alternative configuration of the present embodiment, it is preferable that the distal end region of the elastic filtering membrane 5 is formed as a continuous coating region in which no filtering holes are opened.
Referring to fig. 1 and 2, in an alternative embodiment of the present embodiment, it is preferable that the opening edge of the elastic filter membrane 5 is wound and fixed to form a tubular rim 50, and the elastic support ring 3 passes through the tubular rim 50.
In order to further improve the visualization of the reverse-penetrating distal protection device, in some optional embodiments of this embodiment, it is preferable that a distal support ring (not shown) is further connected to the distal end of the support tube 2, and the elastic filter membrane 5 is connected to the surface of the distal support ring or is supported outside the distal support ring; the developing part is arranged on the far-end support ring or the developing coating is coated on the far-end support ring, so that the information of the whole length and the specific position and shape of the protective umbrella can be effectively known, the convenience and the safety of the operation are further improved, and under the condition, the whole outer contour of the elastic filter membrane 5 in the opening state can be formed into a frustum shape without limitation.
Finally, it should be noted that: the embodiments in the present description are all described in a progressive manner, each embodiment focuses on the differences from the other embodiments, and the same and similar parts among the embodiments can be referred to each other; the above embodiments in the present specification are only used for illustrating the technical solutions of the present invention, and not for limiting the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.